Abstract:
A capillary chamber for performing chemical and physical analysis using a plurality of whole blood samples is presented. Following a loading of the whole blood samples into a plastic tube, the whole blood samples are distributed into a collection chamber and the capillary chamber has means of adding respective vaccines or similar biological products into each capillary tubes. The whole blood is then analyzed using standard microscopic techniques with sufficient resolution and contrast to record the chemical and physical properties of the blood immediately after withdrawal.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention is related to a blood analysis method and apparatus utilizing a standard microscopic optical system to analyze whole blood subsequent to the administration of a biological product. The invention is concerned with the analysis of blood for proper physical or chemical response to vaccines and other biological products as described below. 
         [0002]    The device can be used to analyze the chemical or physical reaction of blood by measuring the electrolytes, antibody levels and cell count in a capillary chamber having a plurality of capillary tubes. Several physical or chemical exams can be conducted using the sample from an initial puncture of the patient or from collected blood samples. The aim is to produce a plurality of aliquots of blood for the on-site hematological examination of the blood. 
         [0003]    The administration of any biological product, including vaccines, can create side effects. Some reactions to biological products might be subtle and the patient would eventually recover. For example, a patient might experience redness, warmth, or swelling in the location where the shot was administered (see Table 1 below). It is also known that patients can faint after the administration of a vaccine. Some patients experience severe pain in the shoulder and might have difficulty moving the arm. Most of these side effects are mild and would eventually subside after a few days. 
         [0000]    
       
         
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 VACCINE 
                 SIDE EFFECTS 
               
               
                   
               
             
             
               
                 Adenovirus 
                 headaches, fever and abdominal pain 
               
               
                 Anthrax 
                 headaches, fatigue, lump and tenderness 
               
               
                 DTaP (Diphtheria, Tetanus 
                 fussiness, tiredness, vomiting, seizure, 
               
               
                 and Cellular Pertussis) 
                 fever, coma and brain damage 
               
               
                 Hepatitis A 
                 soreness, fatigue, loss of appetite and 
               
               
                   
                 headache 
               
               
                 Hepatitis B 
                 soreness where the shot was given 
               
               
                   
                 and temperature of 99.9° F. or higher 
               
               
                 Hib ( Haemophilus influenzae   
                 redness, warmth, or swelling where the 
               
               
                 type b) 
                 shot was given and fever 
               
               
                 HPV-Cervarix 
                 headache, pain, jerking spells and fainting 
               
               
                 HPV--Gardasil-9 
                 fever, headache, redness and swelling 
               
               
                 Inactivated Influenza 
                 risk of Guillain-Barré Syndrome (GBS), 
               
               
                   
                 seizure and fainting 
               
               
                   
               
             
          
         
       
     
         [0004]    A vaccine, like any medicine, can cause a serious reaction. For example, in the case of the DTaP (Diphtheria, Tetanus and Cellular Pertussis) vaccine shown above, serious allergic reaction can occur in less than 1 out of a million cases. These severe reactions include long-term seizures, coma, lowered consciousness or permanent brain damage. Additional reactions to DTaP have been reported. Moderate reported problems include seizure, jerking or staring (about 1 child out of 14,000), non-stop crying for 3 hours or more (up to about 1 child out of 1,000) high fever, 105 degrees Fahrenheit or higher (about 1 child out of 16,000). 
         [0005]    An increased number of scientists have questioned the use of preservatives in vaccines. These are compounds that minimize the growth of microorganisms in a vaccine. In the case of multi-dose vials that are repeatedly used in a clinical setting, a preservative would prevent microbial growth. In most cases, manufacturers add the preservatives in the production stage of the vaccine. 
         [0006]    Thimerosal is a mercer-containing preservative that has been widely used in vaccines. Some scientists believe that this preservative can cause autism and other neurodevelopmental disorders. The scientific community agrees that the risk of a vaccine causing serious harm, or death is extremely small and in most cases, severe allergic reactions are believed to occur about once in 1.1 million doses. However, hundreds of millions of people have been vaccinated and it is likely that parental and patient concern would increase with the knowledge that there is a risk of any complication. 
         [0007]    In the event of patient or parental concern regarding the side effects or administration of biological products, the invention as described herein can be employed. The improved blood analysis method and apparatus of the present invention would reduce the number of personnel and the amount of equipment needed to perform physical and chemical analysis of blood. The core blood tests would be analyzed and stored in a single location. For example, the complete metabolic profile of a blood sample measuring electrolytes, protein level and liver enzymes could be produced using one or more of the plurality of capillary tubes. A separate capillary tube can be used to measure a complete blood count of a patient including the automatic differential of the white blood cells, neutrophils, lymphocytes, monocytes basophils and eosinophils. 
         [0008]    Mandatory rules under the Occupational Safety and Health Agency (OSHA) guidelines must be strictly applied to all collection of blood or other testing samples. The venipuncture site should be cleansed before and after puncture and completed using standard venipuncture techniques. It can be cleaned with required antiseptic such as betadine or 70% isopropyl alcohol. 
         [0009]    The administration or handling of this system is to be performed by a trained medical practitioner or scientist. This analysis system would require proficient administration and particular attention to hygiene concerns before and after use of the product. The scientist or medical practitioner must pay keen attention to the appropriate method for the collection and storage of blood for analysis using the described capillary chamber. 
         [0010]    This system is also suitable for mass production. It features a simple design and construction that provides for easy handling and appropriate disposal after blood collection and analysis. 
       BRIEF SUMMARY OF THE INVENTION 
       [0011]    It is therefore an objective of the present invention to provide a blood analysis method and apparatus utilizing a standard microscopic system to analyze whole blood subsequent to the administration of a biological product wherein each patient receives an injection and whole blood is collected and analyzed for quantitative, semi-quantitative or qualitative results. 
         [0012]    An objective of the present invention is to provide a whole blood analysis of a plurality of vaccines and additional biological products in a single analysis chamber. 
         [0013]    Another objective of the present invention is to perform core hematological, biochemical and immunological testing in a single analysis chamber. 
         [0014]    Another objective of the present invention is to produce core hematological, biochemical and immunological testing results of whole blood in the same facility or clinical location. 
         [0015]    Still another objective of the present invention is to provide an analysis chamber that is simple and economically feasible to manufacture. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0016]      FIG. 1  is a perspective view of the blood analysis apparatus and the biological product being administered. 
           [0017]      FIG. 2  illustrates an exemplary representation of a patient being injected and the whole blood sample being analyzed. 
           [0018]      FIG. 3  is a perspective view of the blood analysis apparatus. 
           [0019]      FIG. 4  is a cross-sectional view of the blood analysis apparatus. 
           [0020]      FIG. 5  illustrates a plurality of the blood analysis apparatus in accordance with the present invention. 
           [0021]      FIG. 6  is an exploded top view of the capillary chamber and the plurality of capillary tubes. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    The detailed description is for illustrative purposes and does not limit the scope of the present invention. The embodiments described below provide sufficient information to enable a person having ordinary skill in the art to practice the invention. It should be understood that other embodiments could be practiced with multiple variations without departing from the scope of the invention. 
         [0023]    The blood analysis method and apparatus  10  as described herein can be performed by medical technologists, medical laboratory scientists, nurses, physicians who are specialized in hematology or physicians who are trained to operate the equipment as described herein. The hematological assessments can be conducted to study blood conditions including anemia, hemophilia and bleeding disorders. Arterial, capillary or venous blood, bone marrow and cord blood can be used for a plurality of physical and chemical assessments. Hematological assessments utilizing tissue or blood samples relating to reticuloendothelial systems (bone marrow, spleen or liver), blood transfusions (blood plasma), red blood cell sampling for testing (hemoglobin, glycolysis, chemical metabolism or erythropoiesis) and additional tissue or blood sampling can be used. 
         [0024]    Referring now to the drawings,  FIG. 1  shows a blood analysis method and apparatus  10  comprising a capillary chamber  2 , a collection chamber  4 , a chamber retainer  6  and a chamber station  8 .  FIG. 2  shows an exemplary microscopic system  20  that can be used. Standard microscopic systems  20  can include scanning electron microscopes, transmission electron microscopes or compound light microscopes. The microscopic system  20  used for a blood analysis as described herein will depend on the clarity desired for a specific test or blood specimen. 
         [0025]      FIGS. 3-6  show the capillary chamber  2  together with the additional parts as described herein functioning as an overall whole blood analysis system. The microscopic system  20  as required herein has the resolving and contrast power to view, clearly examine and analyze whole blood. It i s further enabled to detect the progressive interaction of the blood and biological product  36  to reproduce images and produce results of each capillary tube  18  on enlarged screens  62 . 
         [0026]    Biological products  36  are medical products that can be used to treat a specific medical condition. These can include vaccines, blood or blood products for transfusion, allergenic extracts such as allergy shots, gene therapies, cellular therapies or tests to screen potential blood donors for infectious diseases such as chicken pox, herpes, human immune deficiency virus (HIV) or zika virus. 
         [0027]    The capillary chamber  2  has a top wall  12 , an inner cavity  13  and an outer wall  14 . The top wall  12  is preferably prepared by the manufacturer during the production of the blood analysis apparatus  10 . The inner cavity  13  houses a plurality of capillary tubes  18  and is coated with an anticoagulant agent  22 . The anticoagulant agent  22  prevents coagulation of the whole blood prior to analysis using the microscopic system  20 . Heparin and various types of heparin salts are popular types of anticoagulant agents  22  that can be used to prevent blood or plasma clotting in the capillary tubes  18 . 
         [0028]    The top wall  12  of the capillary chamber  2  is a thin flat piece of glass that is less than one millimeter thick and allows for physical and chemical analysis of the whole blood. The top wall  12  is made from optical quality materials such as soda lime glass, borosilicate glass, specialty plastics or fused quarts. It is permanently affixed to the top perimeter of the capillary chamber  2  to prevent the entrance of air and contaminants. The capillary tubes  18  extend in a downward position from the top wall  12  toward the on-off valve  26  and valve opening  27 . The downward extending plurality of capillary tubes  18  form a capillary spout  58  that is arranged to reduce the risk of formation of air bubbles in the capillary tubes  18 . 
         [0029]    The plurality of capillary tubes  18  is used for physical or chemical analysis of more than one biological product  36  in each capillary tube  18 . The capillary valves  28  radiate outward from the exterior wall of the capillary chamber  2  and are sized to receive the tips  40  of a standard syringe  34 . The capillary valves  28  are located at different circumferential locations on the exterior of the capillary chamber  2 . The capillary valves  28  have capillary caps  42  to prevent air from entering the capillary chamber  2  after a biological product  36  has been administered. 
         [0030]    The outer wall  14  has horizontal grooves  44  on the surface and allows the user to properly engage the outer wall  14  while administering the biological product  36 . The on-off valve  26  has an actuating member  46  facilitating the flow of whole blood into and out of the capillary chamber  2 . The syringe  34  is used to administer the biological product  36  and to draw the whole blood upwards into the capillary tube  18 . The syringe  34  is further compressed to discharge the biological product  36  and in union with the osmotic force of the on-off valve  26  allow the whole blood to flow into the capillary tubes  18 . 
         [0031]    The collection chamber  4  has a plastic tube  48 , an injection needle  52  and an anticoagulant agent  22  embedded on the inner wall of the collection chamber  4  in order to prevent coagulation of the whole blood prior to analysis. The injection needle  52  is cohesively joined to the plastic and is of conventional size and construction in order to facilitate the rapid flow of whole blood into the collection chamber  4 . The injection needle  52  is connected to the plastic tube  48  by assembly or by the administrator  64 . After injection, the volume of whole blood is increased automatically by the prevailing pressure gradient that allows the blood to flow through the injection needle  52  and into the capillary tube  18 . 
         [0032]    The chamber retainer  6  holds the capillary chamber  2  in place and retracts easily into the capillary chamber  2 . The chamber retainer  6  increases the effectiveness of the microscopic resolution of the microscopic system  20  by moving the top wall  12  of the capillary chamber  2  in order to obtain a focal point of view and allow examination of a specific capillary tube  18  or to obtain a desired scanning location. The chamber station  8  is adapted to hold the chamber retainer  6 . 
         [0033]    The geometry and size of the apparatus  10  including the length and diameter of the injection needle  52  will vary by the type of application that is desired. The blood analysis method and apparatus  10  can be combined with routine biochemical and hematological analyses methods for qualitative analysis. Common routine biochemical analyses methods include serum chemistries, liver function tests, complete blood count analysis, blood gas analysis, toxicology screenings and biochemical strips. The apparatus  10  cannot be removed for sterilization or reused and must be properly discarded after use.