Patent Publication Number: US-2019167172-A1

Title: Method and apparatus for blood collection

Description:
RELATED APPLICATIONS 
     This application is a continuation of and claims the benefit of priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 15/240,915, filed on Aug. 18, 2016, which is a continuation of and claims the benefit of priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 13/800,857, filed on Mar. 13, 2013, each of which is hereby incorporated by reference herein in its entirety. 
    
    
     TECHNICAL FIELD 
     This technology relates to blood collection in general and more particularly to blood collection methods and apparatus. 
     BACKGROUND 
     Each day, worldwide, hundreds of thousands of patients visit blood collection centers for the purpose of getting their blood sampled for eventual or immediate diagnostic testing. During a patient visit, the phlebotomist punctures the patient&#39;s superficial vein (usually an arm vein) with a hollow needle and blood is aspirated into evacuated plastic or glass tubes. These plastic or glass tubes usually contain anticoagulants or procoagulants, compounds that are placed as liquid into the blood collection tube or sprayed onto the inside surface of the tube. For these anticoagulants (or procoagulants) to work properly, the fresh incoming blood must be adequately mixed with the anti- or pro-coagulant. In the absence of mixing or because of insufficient mixing, the incompletely reacted blood can form clots that can result in the malfunction of the blood analyzer (including plugging) or an incorrect analysis of the blood specimen leading to diagnostic errors and delays in diagnosis. One example of insufficient mixing causing misdiagnosis is falsely elevated troponin (an indicator of myocardial infarction) in plastic blood tubes containing the anticoagulant lithium heparin. Moreover, despite continuingly reminding blood drawing staff to mix their blood tubes after drawing, the inversion step constitutes only one of a great many steps in the typical phlebotomy process, and there are considerable external and internal pressures that hurry the phlebotomist. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying figures, in which like reference numerals refer to identical or functionally-similar elements throughout the separate views and which are incorporated in and form a part of the specification, further illustrate the present technology and, together with the detailed description of the technology, serve to explain the principles of the present technology. 
         FIGS. 1, 2A, 2B and 3  illustrate blood collection apparatus according to the present technology. 
     
    
    
     DETAILED DESCRIPTION 
     The following description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. Although examples of systems and methods are illustrated in the various views, those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized 
     Referring now to  FIGS. 1, 2A, 2B and 3 , there is illustrated various embodiments of method and apparatus for collecting blood. An empty blood drawing container  100 , in this example a cylindrical tube, includes anti-coagulant substance  110 , and a mix detection unit  120  mounted in a housing  121  and capable of detecting, directly or indirectly, the level of mixing of blood  115  drawn from a patient into the container  100  and anti-coagulant  110 . A stopper or other closure element  102  provides for closing the container  100  once the blood is collected into the container, and before the blood is mixed with the anti-coagulant  110 . In one embodiment, blood  115  is drawn from a patient using a needle inserted into a vein or artery. 
     According to one example embodiment, the mix detection unit  120  comprises an inversion counting device  200  including a pair of contacts  210 A,  210 B,  212 A and  212 B, on each end of an enclosure  220 . Enclosure  220  may, for example, be tubular in shape. A metallic element  225 , such as a metallic ball or slug, is positioned and sized to travel between the opposite ends or sides of enclosure  220 , alternately closing a circuit  230  or  232  between the contacts, as the container  100  is inverted. Alternatively, element  225  may be a conductive liquid, such as mercury, or a conductive granular material that can flow between ends or sides of the enclosure  220 . The closing of circuit  230  or  232  is detected by electronic circuit closure detector  235  that produces an electronic signal, count or record  237  for each detection of the closing of circuit closure detector  235 . Electronic counting circuits  245  counts each electronic signal, or otherwise keeps track of the number of counts detected by detector  235 . Counting circuits  245  are connected to, in one embodiment, a display  270  that, under control of count circuits  245 , displays a count, which is representative of the number of inversions of the container  100 . A power supply  250 , such as but not limited to a battery of any suitable type, supplies power P to counting circuits  245 . According to one example embodiment, a switch  255  activates counting circuits  245 . Switch  255  may be activated by the medical personnel withdrawing blood from a patient into collection container  100  in order to activate counting circuits  245 . Switch  255  may be a mechanical switch, an electrostatic switch, or any other type of switch, but preferably a switch readily activated medical personnel handling the collection container with latex gloves or other sterile hand wear. According to one example embodiment, circuits  245  include a timer  260  that, upon activation of circuits  245 , allows circuits  245  to count only those circuit closures occurring within a set period of time from activation, such as one minute, or to determine the time elapsed between each full inversion, so that the rate of inversion may be measured or recorded. The count of circuit closures, in one embodiment, is stored in a memory circuit  262 , and can be read out by use of the display  270  or read out by wireless signals, such as by use of an RFID reader  280  and an RFID circuit  275 , capable of wirelessly communicating with reader  280 , connected directly or indirectly to the memory circuit  262 . According to one example embodiment, circuits  245  are implemented using a programmable processing device such as a microprocessor with internal or external memory, and software is used to program the processing device to carry out the functions described herein with respect to circuits  245 . 
     According to another example embodiment, the circuits  245  may be powered at all times and not require a switch, but only count and record the number of contact closures it detects if at least a predetermined number occur with a set period of time. For example, circuits  245  may be configured to only record the number of contact closures if at least at desired number of consecutive opposite end closures are recorded within a specified or desired period of time, such as at least four (4) consecutive closures within six (6) seconds. This would, for example, preclude counting most all instances of inadvertent inversions or jostling or shaking of the blood container  100 , while providing a count of intended inversions or movements of the blood container by a blood handling professional for the purposes of mixing drawn blood with the anti-coagulant  110 . 
     According to yet another example embodiment, memory circuit  262  may be used to store a desired or expected count  282  of container inversions, represented in this example embodiment by circuit closures, and counting circuits  245  can further be configured to compare the count of circuit closures to the count  282 , and indicate, for example with a message or symbol displayed on display  270 , that the count has been reached. Alternatively, circuits  245  may produce a sound to indicate the count has been reached, through an optional speaker element  290 . A desired inversion count  282  may be obtained, for example, from the manufacturer of each particular type of blood drawing container. The manufacturer typically enumerates the number of inversions that must be performed for each type of blood drawing tube they distribute. 
     In still another embodiment, either or both the type  295  of blood collection container, and a unique serial number or identification (ID)  296  for the container, are also stored in the memory circuit  262 , for later recall and display on display  270  or electronic output to a reading device or computing apparatus. 
     According to other example embodiments, the counting apparatus or mechanism may take many other forms, and the blood collection technology described herein is not limited to any particular counting mechanism. For example, the movement of the movable element may be optically detected with an optical sensor in each end of the tube, wherein a light (visible or not visible) beam shone from an optical emitter is received on a corresponding optical light detector and the beam is broken by the presence of the moving element. In the alternative, many other mechanical, optical or other mechanisms may be provided to count inversions or mixing action. In another form, the counting apparatus may be formed from micro-mechanical components. Or, an integrated circuit accelerometer may be provided, wherein counting circuits  245  is configured to receive accelerometer signals and determine the changing orientation of the collection container, and derive a count of inversions or mixing motions therefrom. 
     According to still another example embodiment, unit  120  includes a blood sensing unit  124  ( FIG. 2B ), for example employing optical sensing elements, and circuits  245  include an input that is activated by a signal  127  generated by unit  124  when blood flows into the container. Upon detection of blood in the container  100 , circuits  245  are activated to count the number of inversions that occur in a set amount of time after detection of the blood. For example, the sensing unit  124  may detect a change in the ambient level of light in the blood collection container due to the receipt of blood into the container. However, any other suitable approach to detecting the presence of blood may also be used. By use of this mechanism, the unit  120  is capable of determining how soon after blood is received in the container  100  that the mixing occurs. 
     According to still another example embodiment, apparatus  120  may use one or more chemical reactions to detect the level of mixing, such as shown in  FIG. 3 . As illustrated in  FIG. 3 , an apparatus  300  may include solution  310  contained inside a breakable capsule  320  inside a flexible walled tube  330 . Capsule  320  may be broken by medical personnel by applying pressure on the outside surface of the wall of tube  330  and in turn capsule  320  to break the capsule, which may be formed of thin glass or plastic or other material. Chemical elements or compounds  350  on each end of a tube  330  react with solution  310  released from capsule  320 , and in one example embodiment, turn color based on the level of mixing of solution  310  with elements or compounds  350 . If elements or compounds  350  on both end of the tube attain the desired color the proper mixing level would be evidenced. 
     According to still other embodiments of the present technology, the mix detection unit  120  may be operatively coupled or attached to the blood collection container in a variety of different ways. In one example embodiment, unit  120 , and more particularly the housing  121  of unit  120 , may be mounted outside the collection container, either in a removable fashion or in a permanent fashion, using a fastening mechanism  122 . Mechanism  122  may be, for example in one example embodiment, an adhesive that fixes, through adhesive action, the housing  121  to container  100 . In another embodiment, mechanism  122  may be a sleeve  123  that wraps around the outside perimeter of container  100 , to hold housing  121  in place adjacent container  100 . Or, a Sleeve  123  may be elastic or inelastic, and provide for elastically encircling the container  100  or providing an interference fit with the container  100 . Alternatively, container  100  may include a mechanical or topographical feature on its outside surface to allow mechanism  122  to snap on or clip onto housing  121 . In operation, accordingly, housing  121  would be disposed of with container  100  should container  100  be disposed of, or it could be sterilized with container  100  if container  100  were to be reused. Alternatively, housing  121  could be removed from attachment to container  100  and disposed of or sterilized and reset by electronic means for reuse with a new or recycled container  100 . 
     Thus, as described above, there is provided a number of methods for collecting blood, including a method that provides for filling a blood collection container with blood, inverting the blood collection container by hand to mix the blood with an anti-coagulant, and viewing or listening to an indication generated by a mix detection device attached to the blood collection container, wherein the indication provides information about the appropriate amount of mixing for the blood 
     According to one example embodiment ( FIG. 2B ), the count of inversions (or other indication of mixing) is read or transmitted, for example using the above-mentioned RFID mechanism, or any other wireless mechanism such as near-field, Blue Tooth® or other wireless transmissions, to a central device or computing system, or network  500 , optionally along with the serial number of the blood container or type of blood container, as either or both may be optionally stored and read. The blood mixing practices of phlebotomists can thus be continually or intermittently assessed. This count could also be available in the central laboratory where the blood specimens are processed and distributed. Specimens that were not mixed might be pulled of the line and not analyzed. Research could correlate the mixing to deficiencies in laboratory testing. Such research would be useful in developing newer blood containers and tubes. The end product of such a counter would result in improved patient safety, higher efficiency in phlebotomy and total decreased costs to the health care system. Furthermore, having records of mixing compliance would be useful in training new phlebotomists. 
     Thus, as described above, the present technology provides a number of benefits. The most direct benefit is an opportunity to improve compliance with blood mixing requirements, as phlebotomists&#39; efforts to reliably mix the blood specimen will be made more measurable. Furthermore, with improved compliance for mixing, time will be saved that is now spent by laboratory personnel attempting to visualize clots within anti-coagulated specimens and preventing their introduction into today&#39;s blood analyzers. Furthermore, by improving the mixing, fewer suboptimal specimens will be analyzed by the laboratory, and many negative ramifications may be avoided, such as compromised laboratory instruments, delayed or incorrect diagnoses, increased costs of follow-up patient investigation and associated patient risks. 
     The embodiments and examples set forth herein are presented to best explain the present technology and its practical application and to thereby enable those skilled in the art to make and utilize the technology. Those skilled in the art, however, will recognize that the foregoing description and examples have been presented for the purpose of illustration and example only. Other variations and modifications of the present technology will be apparent to those of skill in the art, and it is the intent of the appended claims that such variations and modifications be covered. 
     The description as set forth is not intended to be exhaustive or to limit the scope of the technology. Many modifications and variations are possible in light of the above teaching without departing from the scope of the following claims. It is contemplated that the use of the present technology can involve components having different characteristics. It is intended that the scope of the present technology be defined by the claims appended hereto, giving full cognizance to equivalents in all respects.