Abstract:
A two-piece sealing plug for facilitating controlled regulation of a specimen flow to mitigate occurrence of hemolysis. The sealing plug has a pierceable section adapted to receive a needle with a lumen extending therein. In addition, the sealing plug has a flow diverting section conformed to slide the needle therethrough, wherein its first end is attachable to the pierceable section and its second end forms a plurality of alternate configurations to facilitate the controlled regulation of the specimen flow extruding from the lumen.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This invention disclosure is related to and claims the benefit of filing dates of the following U.S. Provisional Patent Applications: (1) Ser. No. 60/042,978, entitled METHOD AND APPARATUS FOR REGULATING SPECIMEN FLOW TO A COLLECTION CONTAINER, filed Apr. 8, 1997; (2) Ser. No. 60/055,517, entitled IMPROVED METHOD AND APPARATUS FOR COLLECTING BLOOD, filed Aug. 13, 1997; (3) Ser. No. 60/062,292, entitled IMPROVED METHOD AND APPARATUS FOR COLLECTING BLOOD, filed Oct. 17, 1997; (4) U.S. Non Provisional patent application Ser. No. 09/057,335, entitled METHOD AND APPARATUS FOR COLLECTING BLOOD, filed Apr. 8, 1998; and (5) U.S. Non Provisional patent application Ser. No. 09/610,027, entitled METHOD AND APPARATUS FOR COLLECTING BLOOD, filed Jul. 3, 2000. 
     
    
     
       STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT  
         [0002]    (Not Applicable)  
         BACKGROUND OF THE INVENTION  
         [0003]    The present invention relates generally to a method and apparatus for the collection of blood specimens, and more particularly to a blood collection apparatus which diverts, channels, regulates, diffuses or controls fluid or specimen flow to a collection container to reduce the occurrence of hemolysis, reduces the probability of collapsing the blood vessel during the specimen drawing procedure, minimizes container breakage during manufacture, use and testing, improves vacuum retention in a sealed container, allows a specimen to be placed on a slide directly from a closed collection container without using a needle, or by a blunt tipped needle, and an improved blood collection needle with a manually activated needle guard.  
           [0004]    The collection and analysis of blood is one of the most commonly used procedures in the diagnosis of many illnesses and diseases. Blood, the essential element to human, as well as animal and marine existence, consists primarily of red blood cells, which usually range from 6-8μ (microns) in size; white blood cells, normally being from 10-14μ in size, but sometimes reaching 19-20μ in size; with additional proteins and antibodies.  
           [0005]    The dynamics involved in collecting blood involve a number of variables and the present invention addresses these both individually and in combination, allowing a more accurate, viable sample to be safely obtained.  
           [0006]    Blood is made up of particulate cell forms suspended in a fluid medium called plasma. The blood is contained within a closed system of pumps, passageways, chambers and valves which make up the circulatory system. Blood consists mostly of red cells and plasma, 45% and 55% respectively by volume, with the gaseous carrying red cells being suspended in the fluid plasma. The blood is pumped throughout the circulatory system by the heart, and kept in a fluid suspension medium in the blood vessels. Blood cells are actually tiny, delicate living cells which must be maintained in a chemically balanced fluid environment in order to survive and properly function.  
           [0007]    Potassium, one of a number of inorganic substances needed to maintain a healthy metabolism, is the major cation of the intracellular fluid in red cells. The average cellular concentration of potassium in red cells is 105 mmol/l, or approximately 23 times greater than that of the average serum potassium level. Additionally, the permeability of cell membranes for potassium is extremely low, so rapid shifts of potassium in or out of cell membranes by diffusion are unlikely. Hemolyzed blood results in elevated serum potassium levels because the intracellular potassium is released from the ruptured red cells into the serum. Thus, hemolysis invalidates measured serum potassium levels.  
           [0008]    [0008]FIG. 1 illustrates a cross-sectional and full view of a prior art blood collection device  10  that is used to withdraw a blood, bodily fluid or gas specimen from a patient. The prior art blood collection device has three primary components. These include: (1) a hollow container or vacuum tube  140 , sealed by a puncturable diaphragm or stopper  141 , for obtaining a fluid or gaseous sample; (2) a separate holder  130  which accepts and temporarily holds the evacuated container; and (3) a hollow bore hypodermic needle  121  having a lumen  124  therethrough and a sharpened distal tip distal  120  and sharpened proximal tip  123 .  
           [0009]    Needle  121  is attached to holder  130  with the proximal sharpened tip  123  residing in the interior of holder  130  and sharpened tip  120  extending away from holder  130 . Proximal end of needle  121  typically includes a piercable resilient cover  125 . Container  140 , having an open end and closed end, and internal chamber  143  with removable sealing plug  141  placed in the open end of tube  140 . Blood is drawn from a patient by first inserting the sharpened distal tip  120  of needle  121  into the blood vessel of the patient. Cover  125  inhibits the flow of blood from the proximal end of needle  121 . Vacuum tube  140  is then positioned within hollow body  135  of holder  130  and slid forward in holder  130  (indicated by arrow M) allowing proximal end  123  of needle  121  to puncture sealing plug  141  of vacuum tube  140 . The specimen fills the collection container  140  and then is removed from the needle holder  130 .  
           [0010]    The pressure difference between the patient&#39;s blood flowing in the blood vessel and the negative pressure in the vacuum chamber causes blood to be rapidly drawn into internal chamber  143  of vacuum tube  140 .  
           [0011]    [0011]FIG. 28 is a cross sectional view of a prior art needle  121  having a jagged inner wall  111 .  
           [0012]    [0012]FIG. 42 is a prior art collection container  140  having a chamber  143  sealed by a sealing plug or puncturable diaphragm  141 .  
           [0013]    The present invention addresses each aspect associated with the collection of venous or arterial blood and improves on each individual component: the needle; the needle holder; the collection container; the sealing plug or diaphragm; the sealing plug shield; and a collection adapter.  
           [0014]    The present invention comprises a number of embodiments related to blood collection including a simple, one-piece flow diverting sealing plug, shown in FIGS.  3 - 10 , whereby the specimen is “cushioned” in a fluid medium as it is collected through a hollow bore needle and fills collection container, rather than subjecting the blood to high impact and shear forces inherent in standard blood collecting equipment and procedures.  
           [0015]    Another one piece sealing plug, described in FIGS.  11 - 15  and  30 , impedes the specimen flow prior to entering collection container; a two piece sealing plug and flow controlling portion, are disclosed in FIGS.  16 - 19 , where the specimen first enters an intermediate or inner chamber(s) prior to entering a collection container; an adjustable flow rate sealing plug having a diverter shown in FIGS.  24 - 27 , allowing the user to easily start, stop or vary the specimen flow rate during the collection procedure.  
           [0016]    A one piece sealing plug, described in FIGS.  20 - 23 , discloses a reed valve means to control specimen flow through the sealing plug. Another one-piece sealing plug, described in FIG. 32, discloses a permeable or pre-pierced membrane to regulate or divert specimen flow through the sealing plug. Another one piece, multi-chambered sealing plug, shown in FIG. 33, comprises a chamber and recess or chamber to divert the specimen flow through the sealing plug.  
           [0017]    The needle is addressed in FIG. 29, having a friction reducing coated inner wall, or the needle itself can be manufactured to smooth the jagged, rough inner surface produced by the current manufacturing processes when drawing metal tubing to size. These improvements are designed to reduce the high shear forces placed on the blood as it is sucked through the needle lumen. An increasing diameter needle, shown in FIG. 31, can be used with either the conventional sealing plug or any of the other sealing plugs described herein.  
           [0018]    [0018]FIG. 30 describes a penetration-related adjustable flow blood collection system where the specimen flow is controlled by rotational movement of a container relative to needle holder.  
           [0019]    A two component flow diverting sealing plug and shield, which isolates blood or bodily fluids from the phlebotomist or healthcare worker during blood collection procedures, is shown in FIGS. 34, 35,  40  and  41 , with sealing plug with a chamber and covering shield having the chamber manufactured in a pre-determined position whereby needle tip penetrates only into the chamber, and not directly into the internal chamber of the collection container.  
           [0020]    Another two component sealing plug and diverter, shown in FIGS. 47 and 48, has a means to divert the specimen radially towards the perimeter of a collection container as it exits needle lumen within the chamber, sealing plug and diverter allow specimen to enter the internal chamber of a collection container at the lower extremity, regardless of how the collection container is positioned in needle holder, where specimen can fill into itself, thus cushioning entry into collection container. Separate components of these sealing plugs are shown in FIGS.  49 - 52 , although a multitude of configurations may also achieve the same, or similar, result.  
           [0021]    The two component sealing plug and diverter, shown in FIGS. 47 and 48 could also be manufactured as a single component to achieve a similar desired result.  
           [0022]    Another two piece sealing plug and diverter, shown in FIGS. 38 and 39, discloses a lower cost, reduced mass sealing plug and a diverting means to fill the container with specimen beginning at the sealing cap and filling to the opposite end of the container. The blood collection needle punctures the sealing plug concentrically and the specimen flows through the concentrically positioned diverter. A longer needle typically used to draw collected specimen from the collection container may by-pass the diverter be being inserted away from the center of the sealing plug. The sealing plug does not have to be removed to withdraw a specimen from the collection container.  
           [0023]    A sealing plug with a reducing chamber is shown in FIG. 36 which regulates and diverts the specimen flow from a needle to a container. The reducing section also slows the specimen flow to reduce vein collapse probability during the collection process. A sealing plug, shown in FIG. 37, has a filtering means within, in or adjacent to a sealing plug or container; an adjustable depth penetration sealing plug with shield, shown in FIGS. 40 and 41, allow the user to easily start, stop or vary the specimen flow rate with a control means limiting the longitudinal movement of collection container towards needle, yet an unrestricted withdrawal of container from needle holder. The shield is included, but not necessary to practice this embodiment of the invention.  
           [0024]    Container, shown in FIGS. 43 and 44, has a coating or film about the outside glass or plastic surface of container, reducing the probability of container breakage in the event the container is dropped or crushed during manufacturing, storage or use; container, shown in FIG. 45, has a coating, film or label about the intersection of the sealing plug and container, reducing the probability of vacuum leakage from within chamber.  
           [0025]    Another two component sealing plug and sensor, shown in FIG. 46, has a sensor or probe which allows analysis of specimen without removal from collection container.  
           [0026]    An automatically shielding sealing plug and shield are described in FIGS. 53 and 54 where sealing plug is slidable relative to a shield. The container has a greater gripping force on the shield whereby axial movement of the sealing plug occurs first and projection of the shield engages the sealing plug during removal with the sliding shield closing the port at an intersection.  
           [0027]    A flow indicator or viewing section is shown in FIG. 55 allowing user to observe specimen flow in the chamber of the sealing plug. A collection container having round ends for inserting either end into a centrifuge is shown in FIG. 56. A coupling device is shown in FIG. 57 which allows a smaller pediatric needle holder, shown in FIG. 59, to be used with a standard, or larger collection container. The use of a smaller diameter device allows a shallow angle to be used for easier access of a blood vessel during blood collection procedures.  
           [0028]    A coupling device having a flow regulating or diverting plug is shown in FIG. 58, coupling device or extension allows a smaller pediatric needle holder to be used with a larger collection container. A new collection container having two pierceable ends which can be used with both small and large needle holders is shown in FIG. 59. Larger end of collection container having a rounded contour for insertion into a centrifuge. Both sealing plugs comprise chambers, for diverting specimen flow prior to entry into collection container.  
           [0029]    A one piece sealing plug with venting means is shown in FIGS.  61 - 63  to equalize the internal pressure within a collection container with the ambient atmospheric pressure prior to full removal of the sealing plug from a collection container.  
           [0030]    A sealing plug with a chamber having external access is shown in FIGS. 64 and 65. A removable cover or seal allows the specimen deposited in the chamber to be placed on a slide without using a needle to access the specimen in the container.  
           [0031]    A sealing plug with a chamber having external access and a movable shield with an aperture is shown in FIGS.  66 - 69 . The movable shield allows the specimen deposited in the chamber to be placed on a slide without using a needle to access the specimen in the container.  
           [0032]    The present invention also comprises a simple, two-piece flow diffusing sealing plug, shown in FIGS. 70, 71, and  71 A, whereby the specimen is “diffused” in a porous medium as it exits the hollow bore needle prior to filling a collection container.  
           [0033]    [0033]FIG. 71B shows a simple flow regulating means within a needle lumen, allowing a specimen to be collected with a conventional, evacuated blood collection container yet reducing both hemolysis and vein collapse probability.  
           [0034]    Another simple, two-piece flow diverting sealing plug, is shown in FIGS. 72 and 73, whereby the specimen is diverted through an aperture during the collection process. An expandable material creating the aperture is activated by a contact with a liquid and swells to close the aperture within minutes of becoming wetted.  
           [0035]    A two-piece sealing plug which adds a single diverting component to an existing prior art sealing plug or the like is shown in FIG. 74. The diverting component may also include a supporting means to keep the sealing plug wall from collapsing or moving when positioned in the tube, thus improving vacuum retention inside the tube by maintaining a proper seal between a sealing plug and tube. A compressive, radial force is exerted on the elastomeric sealing plug wall by the inner support or diverting component. The distal diverter wall section between the chamber created within the sealing plug and collection container is positioned far enough away from the blood collection needle so the needle does not puncture the wall section when a specimen is collected. The distal diverter wall section may be puncturable by a longer needle which safely draws out the collected specimen from the container during testing and analysis without removing the sealing plug. The diverting wall section may also include a dissolvable or separable material. The separable wall section would be sufficiently held in place during the collection process, and removed by the centrifugal forces created when the collection container is centrifuged.  
           [0036]    Another two-piece sealing plug with a supporting means to keep the sealing plug wall from collapsing or moving when positioned in the tube is shown in FIG. 75. This invention improves vacuum retention inside the tube by maintaining a proper seal between a sealing plug and container wall.  
           [0037]    A two-piece sealing plug is shown in FIGS. 76 and 77 included a diverting component which is activated when a pressure difference is created between the intermediate chamber of the sealing plug and the internal chamber of the collection tube. A valve opens when a specimen is drawn into the chambers, and closes when the pressure in the chambers is substantially equal.  
           [0038]    A sealing plug with a diverting component with a channel or slot is shown in FIGS. 78 and 79. The specimen is collected through the diverter which is concentrically positioned to accept a puncturing blood collection needle. A channel is eccentrically positioned to allow a long needle to be inserted into the collected specimen without contacting any specimen which may remain in the intermediate chamber of the sealing plug and diverter after the specimen is collected.  
           [0039]    A blood collection needle is shown in FIG. 80 with a needle guard and a positive stop to keep the needle guard adjacent to the needle hub during the blood collection procedure. A compressive force exerted on a finger pad or button selectively releases the needle guard from a retained position to a protecting position where the sharp needle tip is safely covered when the user so desires.  
           [0040]    There are no known blood collecting devices which take the delicate physical nature of living blood cells into consideration during the collection process as thoroughly and comprehensively as the present invention does.  
           [0041]    Standard blood collection vacuum tubes are popular for everyday blood drawing procedures, with a variety of additives such as anti-clotting agents, clotting agents, wax, reagents or the like included in the evacuated chamber to facilitate the examination of the blood specimen. Basically, all standard, single chambered vacuum tubes are designed to draw fluids or gaseous substances into the evacuated chamber at a rapid, uncontrolled rate. Single chambered vacuum tubes comprise a single negative pressure in a chamber  143 , which causes a rapid suction of fluids or gaseous substances to be drawn through a small, hollow bore needle lumen  124  and into evacuated chamber  143  when sealing plug  141  is punctured by the needle. The manner in which a specimen is drawn into chamber  143  causes high forces to act on the delicate blood cells.  
           [0042]    Since the introduction of evacuated blood collection containers, widely known as the VACUTAINER® brand blood collection system, described in FIG. 1, improvements have been limited to sharper needles, new additives for inside the collection container, tubes made of plastic resin to reduce container breakage, and vacuum retention to improve shelf life of the collection tube.  
           [0043]    There are major limitations inherent to the use of standard, single chambered blood collection vacuum tubes. First, the unrestricted, high velocity flow rate of the specimen through the hollow bore needle into the evacuated chamber launches the specimen into an empty chamber on a collision course with the far wall of container, causing physical damage to the blood cells, or even cell membrane rupture, which is also known as hemolysis. Secondly, the unrestricted suction pressure of vacuum tube often results in the collapse of the patient&#39;s blood vessel, which then requires the use of a syringe to obtain the specimen.  
           [0044]    The pressure difference between the existing blood pressure of the patient and the sub-atmospheric pressure in the evacuated collection container determines the velocity and flow rate of the specimen entering the container. The sub-atmospheric pressure in evacuated chamber is greatest when the sealing plug is initially punctured by the needle. The specimen is uncontrollably projected at a high velocity through the empty chamber, impacting the far wall of container.  
           [0045]    Furthermore, standard blood collection equipment and procedures place the delicate blood specimen in a very precarious environment, creating high shear forces as the specimen is sucked through and exits the small, hollow bore needle. The shear forces may hemolyze the blood cells. The velocity and momentum of the specimen entering the vacuum container causes it to be launched across an empty chamber and into the hard, unforgiving far wall of the collection container. The flow velocity of the specimen entering the container is great enough to injure and rupture many red cells as they impact the container wall, causing hemolysis. Many of the blood cells which initially survive the impact with the far wall of the container intact may be injured due to the serious blunt force trauma imposed on the cells.  
           [0046]    Of course, the main objective of collecting the specimen is to determine the health of the patient. This is best accomplished by keeping the blood specimen intact, and in the most viable condition possible, in other words, alive and living.  
           [0047]    During analysis, some specimens are found to be so damaged and grossly hemolyzed during the collection process, that the laboratory issues a disclaimer and orders another blood sample taken from the patient for analysis. The re-drawing of a specimen creates an additional, unnecessary cost for the medical institution and requires the patient to be punctured with a needle a second or third time.  
           [0048]    In the history of blood collection, few attempts have been made to prevent hemolysis from occurring during the collection process. The majority of hemolysis related prior art simply makes adjustments to the test results, essentially compensating for the damage inflicted on the specimen during the collection process. This “after the fact” procedure further complicates analysis and is at best a speculative attempt to determine the health of the specimen, and patient.  
           [0049]    The most notable attempt to prevent hemolysis during the collection process is taught by Villa-Real in U.S. Pat. No. 4,492,634 where a sealing plug with a baffle extension simply deflects the high velocity stream of blood into the side wall of the collection tube. This deflection causes the fragile blood cells to impact the hard side wall of the tube. The apparatus of Villa-Real also generates additional turbulence within the collection tube.  
           [0050]    An earlier valvular device is also taught by Villa-Real in U.S. Pat. No. 3,848,579, which attempts to control the flow of blood passing through the hollow bore hypodermic needle. This apparatus draws blood through a small hollow bore needle into a larger diameter chamber housing a reed valve, again reducing to a hollow bore needle and exiting into a collection tube. One problem also created with the apparatus of Villa-Real is that the opening and closing of the valve causes additional turbulence and forces to act upon the delicate living blood cells during the collection process. After passing through the valve, the specimen flow path is again reduced. Additional components are also needed to fabricate this invention, increasing the cost.  
           [0051]    The rate at which blood is drawn from a blood vessel is determined by the volume of blood in the vessel, the pressure difference between the internal pressure of blood vessel and the sub-atmospheric pressure in the collection vacuum tube, and the internal diameter size of the needle lumen. For instance, a common 21G blood collection needle has an inside diameter of approximately 0.028″, which allows an evacuated tube to be filled in only a few seconds.  
           [0052]    Another problem which regularly presents itself during the collection process is blood vessel collapse. The volumetric capacity of the blood vessel in certain patients is inadequate to self-replenish when blood is rapidly collected into a standard collection container. This problem is typical with young, older or anxious patients.  
           [0053]    The inadequate replenishment of blood causes the blood vessel to collapse, interfering with the blood collection procedure and forcing the phlebotomist to use a standard, sterile syringe and hypodermic needle to collect the blood sample. The syringe permits a manually operated suction to be applied to the blood vessel, thus enabling the healthcare worker to collect the blood sample at a rate that usually is slow enough to keep the vessel from collapsing.  
           [0054]    Routinely, when a syringe is used to collect a blood specimen in a patient whose vessels are prone to collapse, the patient&#39;s blood vessels must be punctured a number of times to collect enough blood specimen for analysis. Multiple punctures are painful to the patient and can take an extra 5 to 15 minutes to complete. The healthcare worker may also become anxious because of the inability to collect the needed specimen in an allotted time without undue discomfort to the patient. The collected blood specimen must be then transferred into an evacuated tube for storage and testing.  
           [0055]    Conversely, another problem occurs when the vacuum within the collection container diminishes or leaks over time, reducing the shelf-life of evacuated tubes. This results from an improper seal at the sealing plug/container surface interface. The seal is discontinuous because of the uneven surface inherent to molded or compression molded elastomeric materials. Small voids in the sealing plug or stopper surface allow the seal to be breached by the ambient atmosphere and the vacuum within the container is lost over time. Areas where the seal is discontinuous is known in the industry as “gray band” regions. Elastomeric materials are known to be susceptible to temperature fluctuations and typically contract over the course of time.  
           [0056]    Vacuum leakage was so prevalent when evacuated collection containers were first introduced that the evacuated collection tubes were packaged in sealed shipping containers which also had been evacuated. The user would open the shipping container releasing the vacuum inside the container and then use the collection tubes.  
           [0057]    Collection containers with reduced vacuum do not provide a sufficient amount of specimen needed for analysis and are normally disposed of as medical waste. Another tube must then be used to collect an adequate amount of specimen for analysis. Despite the attempts to minimize vacuum leakage in containers through computer generated sealing plugs and the use of different materials, vacuum loss still remains a problem.  
           [0058]    The present invention provides an improved sealing means at the sealing plug/container surface interface. The improved sealing means invention can be used with prior art sealing plugs or with the flow diverting, regulating or diffusing sealing plugs disclosed in this application.  
           [0059]    A blood specimen is normally prepared for analysis either of two ways, depending on the nature of the test to be performed. If the serum is to be analyzed, the elements of red cells and plasma remain combined as whole blood serum. The specimen is allowed to clot and retract overnight before being decanted and analyzed.  
           [0060]    If the plasma or red cells are to be analyzed individually, they are spun in a centrifuge to separate the red cells from the plasma. Additives are normally included in the collection container to delay clotting.  
           [0061]    The present invention also includes a flow diverting sealing plug with a liquid activated material surrounding an aperture which is in the fluid path. The blood is collected and within minutes, the liquid activated material swells closing the aperture. The closed aperture prevents any specimen remaining in the sealing plug from combining with the specimen in the collection container after the collection process is completed.  
           [0062]    Another test, the complete blood count (CBC) test is performed on whole blood immediately after the specimen is collected.  
           [0063]    Blood which is collected with a syringe must be transferred to an evacuated tube prior to analysis or centrifuging. Transferring the collected specimen from a hypodermic syringe to an evacuated tube is considered the most dangerous blood transferring procedure in medicine today because the healthcare worker must move the exposed needle containing blood directly towards the hand holding the evacuated tube. One small miscalculation and the healthcare worker receives a direct inoculation of the specimen blood contained in the needle lumen.  
           [0064]    If a needlestick occurs during the transfer of blood contained in the syringe and needle to a vacuum tube, and the blood specimen contains a bloodborne pathogen such as of Human Immunodeficiency virus (HIV), Hepatitis C (HCV) or any of the other twenty-odd bloodborne pathogens which are transmitted by blood, the healthcare worker may become infected by that pathogen. Bacterial pathogens such as  Yersinia enterocolitica  and  Pseudomonas fluorenscens  have recently been identified in collected blood, further threatening the well being of healthcare workers if a needlestick occurs and the bacteria is present in the blood.  
           [0065]    If the healthcare worker forcibly transfers the specimen from the syringe into the vacuum tube, over pressurizing the vacuum tube may cause the sealing plug to dislodge from the vacuum tube and spray the collected blood into the workplace.  
           [0066]    Two posters highlighting the problem of transferring the blood collected in a syringe into a vacuum tube were presented at the August 1995 Centers for Disease Control conference on preventing needlesticks. One alternative solution to the problem is taught in U.S. Pat. No. 5,439,450, where the blood is collected in a user-activated 10 cc sliding sleeve syringe. This rather large size syringe has a sliding sleeve with a diameter sufficient to insert the evacuated tube into the extended sliding sleeve thereby isolating the needle from the healthcare workers&#39; hands during the transfer from the syringe.  
           [0067]    The standard blood collection system may work adequately in instances where patients&#39; blood vessels have the capacity to quickly replace the blood volume being removed and collected. However, approximately five percent of blood collections must be accomplished with a manually activated syringe. This translates into approximately 150 million blood collection specimen procedures with a syringe per year.  
           [0068]    Essentially, blood cells are living, microscopic “liquid balloons” containing liquid in a permeable membrane, which may be injured, or even rupture, when exposed to excessive force. The membrane may also break as a result of being torn or otherwise traumatized. Hemolysis of red blood cells is one problem that may result from the over traumatization of the blood sample.  
           [0069]    In addition to hemolysis of red blood cells, vacuum drawing may result in other abnormalities which tend to confound interpretation of data relying on visual examination of cells. The appearance of cell abnormalities or cell fragments, which may be regarded as an indication of illness, may actually comprise artifact caused in the vacuum drawing process. For instance, red blood cell abnormalities such as clumping or stacking, which may otherwise be indicative of disease, may in actuality be caused by the blood drawing process, and not the disease. A more optimal sample of blood can be obtained if the blood collection procedure can be accomplished without creating unnecessary trauma to the blood cells in the sample, the circulatory system or the patient.  
           [0070]    [0070]FIG. 2 shows a blood specimen being introduced into the internal cavity  143  of the blood collection container  140  of FIG. 1. As illustrated, once the distal end  123  of the needle  121  pierces the collection container sealing plug  141 , the blood specimen rushes into the evacuated cavity  143 . Initially, the blood specimen impinges the collection container wall at a high velocity. The high velocity impact of the blood specimen against the internal walls of cavity  143  traumatizes the blood specimen causing hemolysis and other undesirable physical changes to occur within the specimen.  
           [0071]    Even as the evacuated cavity  143  fills, the specimen continues to enter the tube  140  at a high velocity causing an inner fluid and gaseous turbulence within the cavity  143 .  
           [0072]    It is also important to note that a small amount, or smear, of blood is normally placed on a slide during the collection process. The slide specimen is used to determine the percentage of white cells per 100 blood cells, or the complete blood count (CBC) by means of a visual test. The CBC test can be conducted manually, or in an automated fashion, where a laser is directed on the specimen and the cell count is determined by the way the laser bounces off the different cells.  
           [0073]    The smear is obtained by removing the blood collecting apparatus from the venipuncture site with an needle exposed by pressing the filled collection container against the needle holder, forcing a small amount of blood through the needle and onto a slide. Sometimes the needle used to directly access the blood vessel is disposed of and a new needle is placed on the needle holder whereby a filled collection container is pressed in the needle holder to obtain a smear for a slide.  
           [0074]    If the needle is withdrawn from the venipuncture site covered, a new needle must be used to obtain a smear for a slide. The use of another needle to obtain a smear for a slide adds cost and exposes the healthcare worker to another sharp needle containing blood.  
           [0075]    What is needed is an apparatus and method for collecting a specimen sample, such as blood or other bodily fluids or gases into a collection container that solves the aforementioned problems.  
         BRIEF SUMMARY OF THE INVENTION  
         [0076]    The foregoing objects have been achieved by the specimen collecting apparatus of the present invention capable of regulating, restricting, controlling, diverting or varying the flow of a specimen within or into a collection container, evacuated container or syringe.  
           [0077]    The present invention provides an improved apparatus and method for delivering a specimen sample into a collection container.  
           [0078]    In one embodiment, a specimen collection apparatus is provided having a flow diverting or regulating means which diverts or regulates the flow of a specimen into or within a specimen collection container.  
           [0079]    In one embodiment, a specimen collection apparatus is provided with a needle or other fluid communication means, having an occluded or restricted lumen that regulates the flow rate of a specimen into a specimen collection container.  
           [0080]    In another embodiment, a hypodermic needle, or other fluid/gas communication means, is provided having a lumen bore that is coated with a friction reducing material, such as silicone.  
           [0081]    In yet another embodiment, a hypodermic needle, or other fluid/gas communication means, is provided having a lumen bore that is coated with a anti-clotting material, such as heparin.  
           [0082]    In yet another embodiment, the vacuum tube sealing plug is provided having a flow diverting or regulating means that diverts or regulates the flow into and/or within a collection container. The sealing plug contains a least one opening, channel, cavity, area or passageway which diverts or regulates the specimen flow through the sealing plug from a needle into the collection container. The flow diverting or regulating opening, channel, cavity, area or passageway is in direct communication with the internal cavity of collection container. The flow diverting or regulating opening, channel, cavity, area or passageway can also be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0083]    In yet another embodiment, the sealing plug is provided having a flow diverting or regulating means that diverts or regulates the flow through, into or within the sealing plug itself. The sealing plug is provided with at least one chamber, which can be an internal, open, intermediate or inner chamber, that diverts or regulates the specimen flow into and/or within the collection container. Blood, or other bodily fluids or gases, is introduced into the chamber of the sealing plug before being directed into the internal cavity of the collection container. The chamber can be coated with a friction reducing material, anti-clotting material or the like normally used in the analysis of blood.  
           [0084]    The sealing plug of the present invention suspends the blood in a fluid medium as it is collected, thus reducing the probability of damaging the blood elements during the collection process.  
           [0085]    In another embodiment, the sealing plug comprises a plurality of sections which create a specimen flow diverting or regulating means. The plurality of sections can be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0086]    In still another embodiment, the sealing plug comprises a plurality of sections which create a specimen flow diverting or regulating means whereby an intermediate chamber is created by joining the sealing plug sections together. The plurality of sections can also be coated with a friction reducing material, anti-clotting material or the like normally used in the analysis of blood.  
           [0087]    In another embodiment, the sealing plug comprises a plurality of components which create a specimen flow diverting or regulating means whereby an intermediate chamber is created by joining the sealing plug and a separate component together. The plurality of sections can also be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0088]    In yet another embodiment, the vacuum tube sealing/plug is provided having an adjustable flow diverting or regulating means that diverts or regulates the flow into and/or within a collection container. The flow diverting or regulating section sealing plug is contained within the container opening.  
           [0089]    In still yet another embodiment, the vacuum tube sealing plug is provided having an adjustable flow diverting or regulating means that diverts or regulates the flow into and/or within the sealing plug. The sealing plug contains a secondary plug or section which is denser than the sealing plug and is engaged by the needle during the blood drawing procedure. The advancing needle moves the secondary plug or section allowing a port on the sealing plug to open and the specimen to enter the collection container at a controlled rate. The secondary plug or section can be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0090]    In another embodiment, a vacuum tube sealing plug, or sealing closure is provided having an adjustable flow diverting or regulating means that frictionally or threadedly engages the inner section of the collection needle holder allowing the healthcare worker to adjust the specimen flow into and/or within the collection container. The engaging components may also be coated with a friction reducing material.  
           [0091]    In one embodiment, the sealing plug includes a flow diverting or regulating means to limit the specimen flow from the chamber of the sealing plug into the inner cavity of the collection container.  
           [0092]    In another embodiment, the sealing plug includes a connected flow diverting or regulating means to limit the specimen flow from the sealing plug into the collection container.  
           [0093]    In one embodiment, a specimen collection apparatus is provided having a flow diverting or regulating means that diverts or regulates the flow rate of a specimen into or within a specimen collection container.  
           [0094]    In one embodiment, a specimen collection apparatus is provided with a removable shield over the sealing plug, which protects the healthcare worker from being exposed to the patient&#39;s blood during the collection and testing procedure and also allows easy removal of the sealing plug from the collection container.  
           [0095]    In another embodiment, the vacuum tube sealing plug is provided having a flow diverting or regulating means that diverts or regulates the flow into and/or within a collection container. The sealing cap contains a least one opening, channel, cavity or area which regulates the specimen flow through the sealing plug from a hollow bore needle into the collection container. The flow regulating opening, channel, cavity, area or passageway can also be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0096]    In yet another embodiment, the vacuum tube sealing plug is provided having a two piece flow regulating means that regulates the flow into and/or within a collection container. The flow regulating section is simply pushed into the sealing plug prior to insertion into the opening of the container.  
           [0097]    In still yet another embodiment, the vacuum tube sealing plug is provided having an filtering means that filters the specimen as it flows into and/or within the sealing plug.  
           [0098]    In another embodiment, a vacuum tube, sealing plug, or sealing closure is provided having an adjustable flow diverting or regulating means that frictionally or threadedly engages the inner section of the collection needle holder allowing the healthcare worker to adjust the specimen flow into and/or within the collection container. The engaging components can be coated with a friction reducing material, anti-clotting material or the like used in the analysis of blood.  
           [0099]    In one embodiment, the sealing plug includes a flow diverting or regulating means to limit the specimen flow from the chamber of the sealing plug into the inner cavity of the collection container by means of a filter or reduced passageway.  
           [0100]    In another embodiment, the sealing plug includes a connected flow diverting or regulating means to limit the specimen flow from the sealing plug into the collection container.  
           [0101]    In another embodiment, the position of the needle tip in the piercable sealing plug is provided so as to limit the longitudinal movement of the needle tip only within the sealing plug chamber, and not into the internal chamber of the collection container.  
           [0102]    In yet another embodiment, a collection container is provided having an enveloping coating or film to increase shatter resistance of the collection container.  
           [0103]    In one embodiment, a collection container is provided having a breakable polymeric, elastomeric or the like coating or film applied to the interface of the container and sealing plug to reduce the probability of vacuum leakage from within the evacuated container. This embodiment also serves as a vacuum leak or tampering indicator. Breakage of this seal or coating will alert the healthcare worker of a possible vacuum leak or tampering.  
           [0104]    In another embodiment, a collection container is provided having a sealing plug with a sensor which is accessible from the outside of the collection container whereby the specimen can be analyzed without removal of the sealing plug.  
           [0105]    In another embodiment, a collection container is provided having an automatically shielding sealing plug when a sealing plug is removed from a collection container. Sliding shield covers the inner surface of a sealing plug which has been in contact with a collected specimen. The sliding shield closes sealing plug chamber and traps any remaining specimen contained within chamber from coming in contact with healthcare personnel.  
           [0106]    In another embodiment, a collection container is provided having a flow indicating or viewing area to observe specimen flow during the collection process.  
           [0107]    In still another embodiment, a collection container is provided having either end being semi-circular for inserting either end container into a centrifuge.  
           [0108]    In another embodiment, a coupler or extension is disclosed allowing a larger diameter collection container to be used with a smaller diameter needle holder whereby a shallower angle is available for accessing a insertion site.  
           [0109]    In yet embodiment, a flow regulating coupler or extension is disclosed allowing a larger diameter collection container to be used with a smaller diameter needle holder whereby a shallower angle is available for accessing a insertion site.  
           [0110]    In one embodiment, a single collection container can be used with needle holders having different diameters.  
           [0111]    In another embodiment, a sealing plug with venting means is provided to equalize the internal pressure within the collection container with the ambient atmospheric pressure prior to full removal of the sealing plug from the collection container.  
           [0112]    In one embodiment, a specimen is deposited in a chamber of a sealing plug having external access, allowing a specimen to be placed on a slide without using a needle to access the specimen.  
           [0113]    In another embodiment, a needle with a sharp tip is used to gain access to a filled collection container, with the other exposed needle end having a blunted tip to reduce needlestick probability and allow a specimen to be safely placed on a slide.  
           [0114]    In another embodiment, a container with an improved sealing plug/container surface interface is used to increase the shelf life of the evacuated container.  
           [0115]    In yet another embodiment, a sealing plug includes a porous material to diffuse or filter a liquid being drawn into a container.  
           [0116]    In another embodiment, a needle lumen includes a regulating means within the lumen so the specimen flow may be regulated during the collection process using a conventional, evacuated blood collection tube.  
           [0117]    In still another embodiment, a sealing plug with a liquid activated section allows a specimen to be collected, and prevents any specimen remaining within a sealing plug to remain there during the centrifuge process.  
           [0118]    In another embodiment, a diverting component with at least one aperture is inserted in the hollow end of a prior art sealing plug, allowing existing sealing plug tooling and existing containers to be utilized. This embodiment reduces the overall cost of implementing the flow diverting or regulating invention. The size of the aperture can be made smaller than the inner diameter area of the needle used to puncture the sealing plug, reducing the specimen flow and the probability of vein collapse. A procedure incorporating a reduced aperture size in the diverter will take longer to complete since the flow is reduced or restricted.  
           [0119]    The aperture size can also be equal to or greater than the inner diameter area of the needle used to puncture the sealing plug, allowing full flow through the needle during the collection process. A procedure incorporating an equal or increased aperture size in the diverter will take the same amount of time as a standard blood draw.  
           [0120]    In one embodiment, a sealing plug with a pressure sensitive valve is activated when a pressure difference exists on either side of the valve.  
           [0121]    In another embodiment, a sealing plug is shown with and diverter having an aperture and an adjacent channel.  
           [0122]    In another embodiment a blood collection needle with a needle guard is shown where the needle guard can be selectively activated by the user.  
           [0123]    Wherefore, it is an object of the invention to provide a hypodermic blood collecting apparatus and method which allows a diverted, regulated, controlled, diffused, or variable specimen flow into a collection container.  
           [0124]    It is another object of the invention to provide a hypodermic blood collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into through, or within a diaphragm or plug and into a collection container.  
           [0125]    It is also an object of the invention to provide a hypodermic blood collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container without adding any additional parts to the apparatus.  
           [0126]    It is another object of the invention to provide a hypodermic specimen collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container and looks and functions in a similar manner to a standard, blood collecting hypodermic needle system.  
           [0127]    It is yet another object of the invention to provide a hypodermic blood collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container which lends itself to automated manufacturing.  
           [0128]    It is a further object of the invention to provide a hypodermic specimen collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container where the hypodermic specimen collecting apparatus can be positioned away from the vascular access site by means of a tube or the like.  
           [0129]    It is still another object of the invention to provide a hypodermic specimen collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container where the sealing cap of the collection container comprises a flow regulating means.  
           [0130]    It is an additional object of this invention to provide a hypodermic specimen collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container where a variable compressive or circumferential force is used to limit or regulate the interaction between the sealing plug and the openable port of the sealing plug.  
           [0131]    It is another object of the invention to provide a hypodermic specimen collecting apparatus and method which allows a regulated, controlled, governed, gated, diverted, diffused or variable specimen flow into a collection container where a variable compressive force is used to limit or regulate the interaction between the needle holder and the collection container.  
           [0132]    It is also an object of the invention to provide a low-cost hypodermic specimen collecting apparatus and method which allows the specimen to primarily remain in a fluid medium, cushioning its flow into and within a collection container.  
           [0133]    It is another object of the invention to provide a hypodermic specimen collecting apparatus and method which allows a specimen flow into a collection container where at least one diaphragm or barrier regulates, restricts, diverts or controls the specimen flow within a collection container.  
           [0134]    It is a yet an additional object of the invention to utilize the flow regulation means to other collection or transferring procedures, such as transferring blood from a syringe to a collection container.  
           [0135]    It is still another object of this invention to provide a specimen collecting apparatus that reduces the probability of collapsing a blood, or other bodily, vessel of a patient during a specimen drawing procedure.  
           [0136]    It is a further object of the invention to reduce specimen trauma during the specimen collection procedure.  
           [0137]    It is another object of the invention to provide a specimen collecting apparatus and method which minimizes the hemolysis of a specimen collected during a blood collection procedure.  
           [0138]    It is still another object of the invention to provide a flow reducing, then increasing means on a sealing plug which regulates the specimen flow into a collection container.  
           [0139]    It is a still further object of the invention to provide a filtering means within, in, or adjacent to, a sealing plug which regulates, controls, governs, gates, diverts or adjusts the specimen flow into a collection container.  
           [0140]    It is another object of the invention to provide a sensing means within a sealing plug or container which determines the status of the blood, blood elements, or blood gasses while the blood is contained within the collection container, sealing plug chamber or passageway.  
           [0141]    It is yet another object of the invention to provide a protective coating or film on a collection container to reduce breakage and leak probability during manufacturing, storage and use.  
           [0142]    It is still another object of the invention to provide a coating or film on a collection container seal to prevent vacuum leakage of the collection container prior to use.  
           [0143]    It is another object of the invention to preserve the shelf life of the collected specimen in the best possible condition for as long as possible.  
           [0144]    It is another object of the invention to keep the collected specimen cells alive and living until they are analyzed.  
           [0145]    It is an object of the invention to provide a collection container which has a sealing plug, which when removed, automatically shields the surfaces of a sealing plug which have been in contact with a specimen in a collection container.  
           [0146]    It is another object of the invention to provide a collection container which has a flow indicating means viewable by the user.  
           [0147]    It is another object of the invention to provide a coupler which allows a large diameter collection container to be used with a smaller diameter needle holder.  
           [0148]    It is yet another object of the invention to provide a flow regulating coupler which allows a large diameter collection container to be used with a smaller diameter needle holder.  
           [0149]    It is still another object of the invention to provide a single collection container which can be used with needle holders having different diameters.  
           [0150]    It is another object of the invention to provide a needle access angle which is as close as possible to being parallel with the plane of the insertion site.  
           [0151]    It is a further object of the invention to provide a venting means to equalize the internal pressure within a collection container with the ambient atmospheric pressure prior to full removal of a sealing plug from a collection container.  
           [0152]    It is another object of the invention to provide access to a small amount of specimen from a collection container without using a needle to obtain the specimen.  
           [0153]    It is still another object of the invention to provide a hollow bore needle with one sharp tip to gain access to a filled container, with the other exposed needle end having a blunted tip to reduce needlestick probability and allow a specimen to be safely placed on a slide.  
           [0154]    It is another object of the invention to provide a means to diffuse the liquid entering a container.  
           [0155]    It is another object of the invention to provide a means within a needle lumen to diffuse or regulate the liquid entering a container.  
           [0156]    It is another object of the invention to provide a blood collection needle that includes a regulating means, allowing a specimen to be safely collected with a conventional, evacuated blood collection tube without hemolyzing the red cells, or collapsing the patient&#39;s blood vessel during the collection procedure.  
           [0157]    It is still a further object of the invention to provide an improved sealing means at the sealing at the sealing plug/container surface interface.  
           [0158]    It is still another object of the invention to provide an improved sealing means at the sealing plug/container surface interface which may include a specimen diverting, diffusing or regulating means.  
           [0159]    It is another object of the invention to provide a sealing plug with a pressure sensitive valve means which is activated when a pressure difference exists on either side of the valve.  
           [0160]    It is another object of the invention to provide a sealing plug with a diverting means and an adjacent channel which allows a specimen to be collected in a normal manner where the blood collection needle punctures a sealing plug in a normal concentric manner, and a longer needle for obtaining the collected specimen for analysis punctures the sealing plug in an eccentric manner without contacting any specimen residing in the chamber created by the sealing plug and diverter.  
           [0161]    It is a further object of the invention to provide a blood collection needle where a needle guard can be selectively activated only by a manual releasing means.  
           [0162]    For simplicity sake, the numbered components shown herein could be interchanged throughout the drawings, providing a variety of combinations of the described invention.  
           [0163]    Other objects and benefits of this invention will become apparent from the description which follows hereinafter when read in conjunction with the drawing figures which accompany it. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0164]    The present invention is illustrated by way of example and is not limited by the figures of the accompanying drawings, in which like references indicate similar elements and in which:  
         [0165]    [0165]FIG. 1 illustrates a prior art blood collection apparatus.  
         [0166]    [0166]FIG. 2 shows a blood specimen being introduced into the prior art blood collection apparatus of FIG. 1.  
         [0167]    [0167]FIG. 3 illustrates a full view of a sealing plug for a blood collection container having a chamber open to the side of the sealing plug.  
         [0168]    [0168]FIG. 4 illustrates a side view of a specimen collection needle and cut away view of a needle holder with a full view of a specimen collection tube of the present invention having a sealing plug with an intermediate chamber.  
         [0169]    [0169]FIG. 5 illustrates the blood collection apparatus of FIG. 4 with a cross sectional side view of a sealing plug.  
         [0170]    [0170]FIG. 6 shows the apparatus of FIG. 5 with a specimen being introduced into the collection tube.  
         [0171]    [0171]FIG. 7 illustrates a cross sectional side view of a sealing plug with one chamber.  
         [0172]    [0172]FIG. 8 illustrates a cross sectional view of the sealing plug of FIG. 7 inserted in the open end of a container wherein the chamber has at least one aperture or port.  
         [0173]    [0173]FIG. 9 illustrates a full bottom view of the sealing plug of FIG. 7.  
         [0174]    [0174]FIG. 10 shows a full bottom view of one embodiment of the present invention comprising a plurality of channels.  
         [0175]    [0175]FIG. 11 illustrates another embodiment of the present invention whereby the sealing plug regulates the specimen flow by partially impeding or blocking the specimen exiting the hollow bore of the needle lumen.  
         [0176]    [0176]FIG. 12 shows a full bottom view of the sealing plug of FIG. 11.  
         [0177]    [0177]FIG. 13 illustrates a cut away view of a sealing plug in another embodiment of the invention.  
         [0178]    [0178]FIG. 14 illustrates a cut away view of the sealing plug of the present invention having a plurality of reducing channels or apertures.  
         [0179]    [0179]FIG. 15 illustrates a cut away view of the present invention wherein the sealing plug of the specimen collection container comprises a plurality of increasing or expanding channels.  
         [0180]    [0180]FIG. 16 illustrates one embodiment of the present invention wherein the sealing plug of the specimen collection container comprises two components.  
         [0181]    [0181]FIG. 17 is a cross sectional view of the sealing plug shown in FIG. 16.  
         [0182]    [0182]FIG. 18 is a cross sectional view of one embodiment of the present invention shown as molded.  
         [0183]    [0183]FIG. 19 shows a sealing plug with a hinge ready to be inserted into the open end of a collection container.  
         [0184]    [0184]FIG. 20 illustrates a sealing plug of the present invention having a reed valve.  
         [0185]    [0185]FIG. 21 illustrates a sealing plug of the present invention having a recessed reed valve.  
         [0186]    [0186]FIG. 22 illustrates the sealing plug shown in FIG. 20.  
         [0187]    [0187]FIG. 23 illustrates the sealing plug shown in FIG. 21.  
         [0188]    [0188]FIG. 24 illustrates another embodiment of the present invention whereby the sealing plug comprises a movable component with a closed port or aperture, and the needle holder comprises a compressive longitudinal resisting member.  
         [0189]    [0189]FIG. 25 shows the sharpened tip of the needle engaging a movable component of the sealing plug and opening the aperture. The vacuum tube closure and needle holder provide a threaded or frictional means to adjust the specimen flow into the collection container.  
         [0190]    [0190]FIG. 26 shows a cross sectional view of the sealing plug of the present invention with a movable component and closed aperture.  
         [0191]    [0191]FIG. 27 shows a cross sectional view of the sealing plug of the present invention with an integrally molded movable component and closed aperture.  
         [0192]    [0192]FIG. 28 illustrates a cross sectional view of a prior art hypodermic needle wall.  
         [0193]    [0193]FIG. 29 illustrates a cross sectional view of a hypodermic needle wall wherein the inner wall is coated with a friction reducing material, filler or anti-clotting material.  
         [0194]    [0194]FIG. 30 shows a vacuum tube and needle holder provided with a threaded or frictional means to adjust the specimen flow into a collection container.  
         [0195]    [0195]FIG. 31 illustrates a cross sectional view of a needle with an expanded needle bore.  
         [0196]    [0196]FIG. 32 illustrates a cross sectional view of a collection container with sealing plug and an adjacent chamber.  
         [0197]    [0197]FIG. 33 shows a cross sectional view of a collection tube with a multi-chamber sealing plug.  
         [0198]    [0198]FIG. 34 illustrates a specimen collection needle and needle holder with a specimen collection tube of the present invention having a sealing plug with an intermediate chamber, passageway and a shield engaging the sealing plug.  
         [0199]    [0199]FIG. 35 illustrates a cross sectional side view of the assembly of FIG. 34 with the needle tip residing within the intermediate chamber.  
         [0200]    [0200]FIG. 36 shows the apparatus of FIG. 35 with an outer sealing means and a reducing internal chamber.  
         [0201]    [0201]FIG. 37 illustrates a partial cut away side view of a collection container having a sealing plug with one intermediate chamber and a filter means.  
         [0202]    [0202]FIG. 38 illustrates a two piece sealing plug of the present invention wherein the intermediate chamber is created by adjoining two components together.  
         [0203]    [0203]FIG. 39 illustrates a full bottom view of the sealing plug of FIG. 38.  
         [0204]    [0204]FIG. 40 shows a partial cross sectional view of one embodiment of the present invention comprising an adjustable flow regulation means.  
         [0205]    [0205]FIG. 41 illustrates an alternative side view of the apparatus shown in FIG. 40.  
         [0206]    [0206]FIG. 42 shows a partial cut away side view of a prior art collection container.  
         [0207]    [0207]FIG. 43 illustrates a cross sectional view of one embodiment of the present invention of a collection container with a protective coating or film on the outer surface of the container.  
         [0208]    [0208]FIG. 44 illustrates a cross sectional view of one embodiment of the present invention of a collection container with a coating or film on the outer surface of the collection container extending over the outer surface of the interface of the sealing plug and container.  
         [0209]    [0209]FIG. 45 illustrates a cross sectional view of one embodiment of the present invention of a collection container with a coating, film or label on the outer surface of the interface of the sealing plug and container.  
         [0210]    [0210]FIG. 46 illustrates a partial cut away view of the present invention wherein the sealing plug of a collection container includes a sensor which is accessible to both the inside and the outside of the container.  
         [0211]    [0211]FIG. 47 illustrates another embodiment of the present invention with a sealing plug and a diverting component.  
         [0212]    [0212]FIG. 48 illustrates another embodiment of the present invention with a sealing plug and a diverting component with an internal well.  
         [0213]    [0213]FIG. 49 illustrates a side view of a diverting component that may be joined to a sealing plug of the present invention.  
         [0214]    [0214]FIG. 50 illustrates a bottom view of a diverting component which shown in FIG. 49.  
         [0215]    [0215]FIG. 51 illustrates a cross sectional side view of a sealing plug in one embodiment of the present invention.  
         [0216]    [0216]FIG. 52 illustrates a full bottom view of the sealing plug shown in FIG. 51.  
         [0217]    [0217]FIG. 53 illustrates another embodiment of the present invention of a self-shielding sealing plug residing in an openable end of a container.  
         [0218]    [0218]FIG. 54 illustrates a cross sectional view of the sealing plug of FIG. 53 with a self-shielding sealing plug removed from an openable end of a container with a slidable shield activated on a sealing plug.  
         [0219]    [0219]FIG. 55 illustrates another embodiment of a sealing plug and shield with a flow indicating or viewing section.  
         [0220]    [0220]FIG. 56 illustrates a cross sectional view of a collection container of the present invention with rounded ends.  
         [0221]    [0221]FIG. 57 illustrates a cross sectional view of the present invention wherein a coupler or extension allows a large diameter collection container to be used with a needle holder having a diameter smaller than the larger diameter container.  
         [0222]    [0222]FIG. 58 illustrates a cross sectional view of the present invention wherein a flow regulating coupler or extension allows a large diameter container to be used with a needle holder having a diameter smaller than the larger diameter container.  
         [0223]    [0223]FIG. 59 illustrates cross sectional view of the present invention wherein a single collection container can be used with needle holders having different size diameters.  
         [0224]    [0224]FIG. 60 illustrates a side view of a sealing plug of the present invention with a venting means.  
         [0225]    [0225]FIG. 61 illustrates a full bottom view of the sealing plug of FIG. 60.  
         [0226]    [0226]FIG. 62 illustrates a cross sectional view of a sealing plug shown in FIG. 60 closing a open end of a collection container.  
         [0227]    [0227]FIG. 63 illustrates a cross sectional view of a sealing plug shown in FIG. 62 exposing the internal chamber of a collection container to the outside of a container prior to full removal of a sealing plug from a collection container.  
         [0228]    [0228]FIG. 64 illustrates a cross sectional view of a sealing plug of the present invention with a sealed chamber having external access.  
         [0229]    [0229]FIG. 65 illustrates a cross sectional view of the sealing plug of FIG. 64 with a chamber being open.  
         [0230]    [0230]FIG. 66 illustrates a full side view a sealing plug of the present invention with a movable shield having an aperture.  
         [0231]    [0231]FIG. 67 illustrates a full side view of the sealing plug of FIG. 66 with the aperture of a movable shield positioned adjacent to a chamber of the sealing plug.  
         [0232]    [0232]FIG. 68 illustrates a cross sectional view of a sealing plug and a movable shield shown in FIG. 66.  
         [0233]    [0233]FIG. 69 illustrates a cross sectional view of a sealing plug and movable shield of FIG. 67 with the aperture of a movable shield positioned adjacent to a chamber of a sealing plug.  
         [0234]    [0234]FIG. 70 illustrates a cross sectional side view of a container with a sealing plug including a means to diffuse fluid entering the container.  
         [0235]    [0235]FIG. 71 illustrates the blood collection apparatus of FIG. 70 with a specimen being diffused as it is introduced into the container.  
         [0236]    [0236]FIG. 71A illustrates the blood collection apparatus of FIG. 71 showing a cross sectional side view of a needle lumen as a specimen is being introduced and diffused from the needle into the container .  
         [0237]    [0237]FIG. 71B illustrates a blood collection apparatus having a regulating means within a needle lumen to regulate or diffuse the fluid flowing through the needle and into a container.  
         [0238]    [0238]FIG. 72 illustrates a partial, cross sectional side view of a container with a sealing plug including an aperture with a liquid activated section.  
         [0239]    [0239]FIG. 73 illustrates a cross sectional side view of the container of FIG. 72 containing a liquid with the aperture closed at the liquid activated section.  
         [0240]    [0240]FIG. 74 illustrates a cross sectional view of the present invention with a diverting means combined with a prior art sealing plug. The diverting component may also include a means to improve the seal at the sealing plug/container surface interface.  
         [0241]    [0241]FIG. 75 illustrates a cross sectional view of the present invention with a means to improve the seal at the sealing plug/container surface interface.  
         [0242]    [0242]FIG. 76 illustrates a cross sectional view of the present invention having a sealing plug with a pressure sensitive valve which is activated when a pressure difference exists on either side of the valve.  
         [0243]    [0243]FIG. 77 is a full side view of the valve component of FIG. 76.  
         [0244]    [0244]FIG. 78 illustrates a cross sectional side view of a sealing plug with a diverter having an open channel or slot for accessing the specimen in a container with a long needle without having to remove the sealing plug.  
         [0245]    [0245]FIG. 79 illustrates a cross sectional top view of the diverter of FIG. 78 having an open channel or slot and a diverter chamber separated by a wall section.  
         [0246]    [0246]FIG. 80 illustrates a blood collection needle with a needle guard which can only be activated manually. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0247]    An apparatus and method for collecting a blood specimen or other bodily fluid or gaseous substance is described. In the following description, numerous specific details are set forth, such as material types, dimensions, processes, etc., in order to provide a thorough understanding of the present invention. However, it will be obvious to one of ordinary skill in the art that the invention may be practiced without these specific details. In other instances, well-known structures and processing steps have not been shown in particular detail in order to avoid unnecessarily obscuring the present invention. Additionally, it should be noted that this discussion will focus primarily on the collection of blood from a human patient. It should be understood, however, that such focus is for illustrative purposes only. The present invention is not limited to blood collection nor is it limited to the collection of a specimen sample from a human patient.  
         [0248]    The collection container used to collect a specimen, referred to as  40  throughout this application, is made of glass, plastic resin, or a composite material and is normally evacuated and closed by a puncturable sealing plug. The internal chamber, referred to as  43  throughout this application, is the void or chamber within the container  40 .  
         [0249]    Referring to FIG. 3, a full side view of a sealing plug  41  having a chamber  61  openly connected to the side of the sealing plug. Sealing plug  41  is insertable into the open end of a container.  
         [0250]    [0250]FIG. 4 is a full view of a blood collection needle  21  and sealing plug  41  are shown, and a cross sectional view of a needle holder  30 , proximal needle cover  25  and container  40  are shown. Collection tube  40  has an open end and closed end, with inner cavity  43  created by placing sealing plug  41  in the open end for maintaining a sub-atmospheric pressure within the tube.  
         [0251]    Piercable sealing plug  41  comprises a diverting means  73  and at least one chamber  61  for diverting a specimen flow as it enters the sealing plug. Chamber  61  is connected to internal chamber  43  of container  40  by at least one passageway  60 . Container  40  is positioned in a cavity  35  of needle holder  30 . Needle  21  has a sharpened, distal end  20  and proximal end  23 . Distal end  20  is insertable into a blood vessel to obtain a specimen sample of blood for examination. Proximal end  23  resides within needle holder  30  and pierces sealing plug  41  during the collection procedure allowing specimen to flow from a blood vessel and into container  40 . Needle  21  includes a lumen  24  communicating openly with each end creating a passageway from proximal end  23  to distal end  20 . A needle cover  25  is typically provided to seal the proximal end of the needle  21 .  
         [0252]    Sealing plug  41  automatically diverts the specimen from its original fluid path when the sealing plug  41  is initially punctured by the needle  21 , eliminating the probability of the specimen gaining momentum as it enters container  40 . the size of passageway  60  may be lesser, equal to, or greater than the area of the needle lumen. A passageway  60  equal to or greater than the area of the needle lumen allows the specimen to flow freely. A passageway  60  smaller than the area of the needle lumen reduces and regulates the specimen with no change in the collection process.  
         [0253]    [0253]FIG. 5 shows a cross sectional view of container  40 , sealing plug  41  and needle holder  30  of FIG. 4 with container  40  positioned within cavity  35  of needle holder  30 . Sealing plug  41  includes at least one chamber  61  for diverting a specimen flow. In one embodiment, chamber  61  includes a diverting means  73  in the front of a convex wall section which regulates specimen flow from a patient to a collection container  40 . Convex wall section allows any specimen remaining in chamber  61  to flow into container  40  prior to, or during the centrifuge process.  
         [0254]    At least one passageway or aperture  60  is provided between chamber  61  to provide fluid communication between chamber  61  and tube cavity  43 . Diverter  73  can include a dissolvable material, which diverts the specimen during the collection process and dissolves after the specimen is collected. A dissolvable material may also be used which facilitates analysis of the collected specimen.  
         [0255]    A smaller or reduced passageway  60  is capable of regulating the volume of specimen being collected to prevent vein collapse associated with standard blood collection procedures. Different passageway  60  sizes would allow a variety of flow collection rates to be achieved without changing any currently used techniques.  
         [0256]    [0256]FIG. 6 is a cross sectional view of FIGS. 4 and 5 showing a specimen being introduced first into chamber  61  of sealing plug  41  and then into container  40 . Specimen flow is diverted from needle  21  prior to entering internal cavity  43  of collection container  40  by diverter  73 , chamber  61  and passageway  60 . Sealing plug  41  maintains specimen within container  41  after collection, keeping the specimen free of contamination.  
         [0257]    [0257]FIG. 7 is a cross sectional view of a sealing plug shown in axis  7 - 7  in FIG. 9 used to close a collection container, comprising chamber  261  and diverter  273  for regulating, governing, diverting, reducing, increasing, re-directing or interrupting the specimen flow through, into or within sealing plug  241  during blood collection procedures, chamber  261  is positioned adjacent to recess  260 .  
         [0258]    [0258]FIG. 8 is a cross sectional view of a container  40  of the present invention having one open end, a closed end and an internal chamber  43 . The open end being sealingly closed by removable sealing plug  241  with a diverter  273 , at least one chamber  261  and at least one recess or void  260  creating an inner channel, port or passageway when sealing plug  241  is positioned within open end of container or evacuated tube  40 . The sealing plug  241  and chamber  261  could also have a smaller cross sectional thickness to reduce the overall mass of the plug. By reducing the size and mass of the sealing plug, manufacturing costs are lowered.  
         [0259]    The inner wall of container or collection tube  40  or chamber  261  may also include a coating, additive, gel, inert polymer, or other substances which are used in the normal course of collecting and analyzing blood and blood products.  
         [0260]    [0260]FIG. 9 is a full bottom view of the sealing plug of FIG. 7 comprising a sealing plug  241 , used to close a container, having a diverter  273  for regulating, governing, diverting, reducing, increasing, re-directing or interrupting specimen flow through, into or within sealing plug  241  and through at least one recess  260  during blood collection procedures, recess  260  creates an inner channel or passageway when sealing plug  241  is positioned in or within the open end of container or evacuated tube  40 . Sealing plug  241  may include a passageway from chamber directly through the bottom of diverter  273 , eliminating the need to be positioned in or within the open end of container or evacuated tube to create a passageway.  
         [0261]    [0261]FIG. 10 is a full bottom view of another embodiment of a sealing plug  241 , used to close a container, having a diverter  273 , and a plurality of recesses, ports or channels  360  for regulating, diverting, re-directing, reducing, increasing or interrupting the specimen flow through, into or within sealing plug  241  during blood collection procedures. Recess  360  creates an inner channel or passageway when sealing plug  241  is inserted in or within the open end of container or evacuated tube.  
         [0262]    [0262]FIG. 11 is a cross sectional side view of a collection container  40  with an internal chamber  43 , with a cut away view of a sealing plug  441 , used to close container  40 , having a plurality of uniformly sized distal apertures or channels  467  for regulating, controlling or slowing the specimen flow through, into or within sealing plug  441  before the specimen enters container  40 . Although apertures  467  are shown having a uniform shape here, they may be tapered, irregular, contoured or the like.  
         [0263]    [0263]FIG. 12 is a full bottom view of the sealing plug of FIG. 11 comprising sealing plug  441 , which may include an elastomeric material sufficient to frictionally engage and seal an internal chamber of a container, and at least one section  467  to regulate, control or slow specimen flow through, into or within sealing plug  441 . Regulating means  467  may comprise a honeycombed, specific or random pattern.  
         [0264]    [0264]FIG. 13 is a partial cut away side view of a sealing plug of the present invention showing a flow regulating means comprising sealing plug  114 , having a plurality of internal chambers  166  for accepting the end of a tube or needle which pierces sealing plug  114  and enters chambers  166 , a reduced distal aperture  167  for regulating or slowing the specimen flow through, into or within sealing plug  114  before the specimen enters a connected collection container. Although internal chambers  166  are shown at one depth here, they may be positioned or staggered at different levels or depths to facilitate core extraction during manufacturing.  
         [0265]    [0265]FIG. 14 is a partial cut away side view of a sealing plug of the present invention used to close a collection container, showing a flow controlling means comprising sealing plug  214 , having a plurality of chambers  266  for accepting the end of a tube or needle which pierces sealing plug  214  and enters chambers  266 . Reduced distal apertures  267  for regulating or slowing the specimen flow through, into or within sealing plug  214  before the specimen enters a connected collection container. Although internal chambers  266  are shown at one depth here, they may be positioned or staggered at different levels or depths to facilitate core extraction during manufacturing.  
         [0266]    [0266]FIG. 15 is a partial cut away view of sealing plug of the present invention used to close a container showing a flow regulating means comprising a sealing plug  314 , having a plurality of chambers  366  for accepting the end of a tube or needle which pierces sealing plug  314  and enters chambers  366 , increasing or expanding distal apertures  367  for regulating, slowing or increasing specimen flow through, into or within sealing plug  314  before the specimen enters a collection container. Although internal chambers  366  are shown at one depth here, they may be positioned or staggered at different levels or depths to facilitate core extraction during manufacturing. The specimen flow increases as the needle is advanced further into or through increasing chambers  366 .  
         [0267]    [0267]FIG. 16 is a full side view of a two-piece sealing plug of the present invention used to close a container having a piercable section  32  and a flow regulating or diverting section  42 . Flow diverting section  42  having at least one aperture  767  for regulating, diverting or slowing the specimen flow through, into or within sealing plug  32  as specimen exits needle. Section  42  being slightly smaller in diameter or size than section  32  for easy removal of both sections  32  and  42  from a collection container.  
         [0268]    [0268]FIG. 17 is a cross sectional side view of the two-piece sealing plug shown in FIG. 16 having a piercable section  32  and a flow regulating section  42 . Flow regulating section  42  having a plurality of internal chambers  66  for accepting the end of a tube or needle which pierces sealing plug  32  and enters chambers  66 . Chambers  66  are connected to a plurality of distal apertures  767  for regulating or controlling specimen flow through, into or within sealing plug  42  Although internal chambers  66  are shown at one depth here, they may be positioned or staggered at different levels or depths to facilitate core extraction during manufacturing.  
         [0269]    [0269]FIG. 18 is a cross sectional side view of a two section sealing plug of the present invention having a joinable sealing plug  532  used to close a container. Sealing plug  532  is shown in an open faced configuration having two connected sections with piercable section  532 , connected to a flow regulating section  542  having a recess  68  for creating an internal chamber when sealing plug sections  532  and  542  are joined together, and connecting means  70 . Flow controlling section  542  having at least one recessed chamber  68  for accepting the end of a tube or needle which pierces sealing plug  532  and enters the chamber  68 . Chamber  68  is connected to a plurality of distal apertures  567  for regulating or diverting the specimen flow through, into or within sealing plug  542  as specimen exits needle.  
         [0270]    Although internal chamber  68  is shown at one depth here, it may be manufactured having different levels or depths. This open faced embodiment of the flow controlling sealing plug  542  allows a wide variety of flow controlling features to be easily incorporated into the invention during manufacture, including, but not limited to, reducing, increasing, tapered or contoured shapes of distal aperture  567 .  
         [0271]    [0271]FIG. 19 is a cross sectional side view of a two part sealing plug  632  shown in FIG. 18, now shown in a joined configuration having two connected sections  632  and  642 , with one piercable section  632  having recess  668  for creating a chamber when sealing plug sections  632  and  642  are joined together, a connected piercable, flow controlling section  642 , and connecting means  670 . Piercable sealing plug  632  having at least one internal recessed chamber  668  for accepting the end of a tube or needle which pierces sealing plug  632  and enters chamber  668 . Flow controlling section  642  having a plurality of distal apertures  667  for controlling or diverting the specimen flow through, into or within sealing plug  642  as specimen exits needle.  
         [0272]    Although internal recessed chamber  668  is shown at one depth here, it may be manufactured having different levels or depths. Sealing plug sections  632  and  642  join together, shown here having a male pin or post  9079  into a female aperture or section. Joining section may also comprise an undercut, or other means for fixedly attaching or joining sealing plug sections  632  and  642  together.  
         [0273]    [0273]FIG. 20 is a partial cut away view of a sealing plug of the present invention comprising one-piece, puncturable sealing plug  37  used to close a collection container showing a flow controlling means with intermediate chamber  168  and flow controlling reed valve  76 .  
         [0274]    [0274]FIG. 21 is a partial cut away view of a sealing plug of the present invention comprising a one-piece, puncturable sealing plug  137  used to close a container showing a recessed flow controlling means including a chamber  268 , piercable wall section  77  and flow controlling reed valve  176 . As the needle is advanced into chamber  268 , reed valve  176  allows the specimen to flow into a container. The needle can be advanced further to pierce wall section  77 , allowing a direct specimen flow into a container during the collection procedure.  
         [0275]    [0275]FIG. 22 is a full bottom view of the sealing plug shown in FIG. 20 comprising sealing cap  37  with a reed valve  76 .  
         [0276]    [0276]FIG. 23 is a full bottom view of the sealing plug shown in FIG. 21 comprising sealing cap  137  with a recessed chamber wall  77  and reed valve  176 .  
         [0277]    [0277]FIG. 24 is a cross sectional view of a blood collecting apparatus of the present invention prior to insertion showing a full view of needle  21 , a needle holder  230  and container  40  having an internal cavity  43  with an adjustable flow, puncturable sealing plug  83 , internal chamber  368 , openable valve or port  75  and movable, substantially impenetrable secondary plug or diverter  80 . Port  75  is shown here closed and adjacent to port or passageway  160 . Needle holder  230  having a plurality of projections  34  for compressively resisting axial movement of container  40 . A compressive force must be placed on container  40  in holder  230  to collect specimen.  
         [0278]    [0278]FIG. 25 is a cross sectional view of the blood collecting apparatus of the present invention during the collection process comprising needle  21 , needle holder  330  and container  40  having an internal cavity  43  with an adjustable flow, puncturable sealing plug  183 , internal chamber  468 , openable valve or port  175  and movable, substantially impenetrable secondary plug  80 . As needle  21  enters chamber  468 , needle tip  23  engages diverter  80  which opens port  175  allowing specimen to flow into inner cavity  43  of collection tube  40 . Port  175  opening can be reduced by partially disengaging needle tip  23  from movable plug  80 . Port  175  opening can be closed completely by fully disengaging needle tip  23  from secondary plug  80 .  
         [0279]    Penetration-related adjustable flow is rotationally controlled by frictional or threaded means  84  of sealing plug  183  and frictional or threaded means  82  of needle holder  330 .  
         [0280]    [0280]FIG. 26 is a cross sectional side view of an adjustable flow sealing plug of the present invention used to close a container, used in the same manner as the sealing plugs shown in FIGS. 25 and 26, comprising a puncturable sealing plug  283  having an intermediate chamber  568 , openable port  275 , and movable plug  88  with a uniformly consistent wall section.  
         [0281]    [0281]FIG. 27 is a cross sectional side view of an adjustable flow, puncturable sealing plug of the present invention comprising a sealing plug  85  having an intermediate chamber  668 , openable port  675 , and integrally molded, substantially impenetrable section or stop  81 , which is movable when a needle engages stop  81 .  
         [0282]    [0282]FIG. 28 is a cross sectional front view of a prior art hollow bore needle  121  having an outer smooth wall and rough inner wall  111 .  
         [0283]    [0283]FIG. 29 is a cross sectional front view of hollow bore needle of the present invention having an outer smooth wall, with an inner wall  211  being coated with friction reducing lubricant  212  to reduce the rough surface of the inner wall  211 . Inner wall  211  may also be manufactured in a smooth fashion by mechanical or chemical means. Lubricant or filler  212  is deposited into recesses of inner wall  211 , creating a smoother, inner wall surface. Inner wall coating  212  can also comprise a material which inhibits blood clotting.  
         [0284]    [0284]FIG. 30 is a cross sectional view of a blood collecting apparatus of the present invention during the collection process comprising a needle  21 , needle holder  430  and container  240  having an internal chamber  43  with an inserted sealing plug  441  having a plurality of uniformly sized distal apertures  467  for controlling or diverting the specimen flow through, into or within sealing plug  441  as the specimen exits the needle  21 .  
         [0285]    Penetration-related adjustable flow is controlled by rotational movement of container  240  relative to needle holder  430  by projection or thread  86  of container  240  and corresponding projection or thread  182  of needle holder  430 . Penetration-related adjustable flow may be controlled by frictional engagement of container  240  and needle holder  430 .  
         [0286]    [0286]FIG. 31 is a cross sectional view of a blood collecting apparatus of the present invention prior to use comprising a needle  21  connected to enlarged bore needle  321 , needle holder  30  and collection container  140  having inner cavity  143  and sealing plug  141 .  
         [0287]    [0287]FIG. 32 is a cross sectional view of a container of the present invention showing a container  40  having inner cavity  43 , a puncturable sealing plug  55  with separate membrane  29  with at least one aperture or port  867  whereby a membrane  29  creates intermediate chamber  868  adjacent to sealing plug  55 . Membrane  29  can be permeable, or impermeable with at least on pre-pierced section  867 .  
         [0288]    [0288]FIG. 33 is a cross sectional view of a collection container of the present invention showing container  40  having inner cavity  43 , with open end of container  40  being sealed by a multi-chambered sealing plug  65  with inner chamber  968  and secondary chamber  69  created by diverter  973 . Chamber  69  is connected to first chamber  968  by port, aperture or passageway  72 . Specimen flows first into chamber  968  then into chamber  69  through port or passageway  960  to inner cavity  43 . Secondary chamber  69  is originally a recess or channel of sealing plug  65  and creates chamber  69  when sealing plug  65  is positioned in or within the open end of container or vacuum tube  40 .  
         [0289]    Sealing plug  65  has an external configuration similar to a standard syringe piston.  
         [0290]    [0290]FIG. 34 illustrates a blood collection apparatus of the present invention prior to use with a full view needle  21  and sealing plug  51 , with a cross sectional view of needle holder  30 , tube  40  and a partial cut away view of shield  50 , comprising a puncturable sealing plug  51  with inner chamber  361  and passageway  360  connected to internal chamber  43  of container  40 . Sealing plug  51  comprises at least one intermediate chamber  361  for regulating or diverting specimen flow from a needle  21  to a container  40 . Shield  50  is connected to sealing plug  51  at interface  46  for removal from container  40 , reducing exposure of blood and bodily fluids to healthcare workers during collection and testing procedures. Shield  50  having a radially extending face covering top of shield  50  with aperture or opening  44  for accessing sealing plug  51  with needle  21 . Sealing plug  51  is contained within shield  50  which extends annularly around sealing plug  51 .  
         [0291]    Shield  50  facilitates easy removal of sealing plug  51  from container  40 . Container  40  is positioned in cavity  35  of needle holder  30 . Distal end  20  of hollow bore needle  21  is insertable into a blood vessel to obtain a specimen sample of blood for examination.  
         [0292]    [0292]FIG. 35 shows a cross sectional side view of collection container of FIG. 34 during use with container  40  having sealing plug  51  with at least one intermediate chamber  361  for diverting or maintaining specimen flow in a fluid suspension as specimen is collected from a patient to container  40 . At least one port or aperture  360  provides a passageway between chamber  361  of sealing plug  51  and internal cavity  43  of container  40 . Sealing plug  51  having a shield  50  to facilitate easy removal of sealing plug  51  from container  40 . Sealing plug  51  having at least one recess  46  which may be annular or intermittent for fittingly engaging sealing plug  51  and protrusion or lip  45 . Shield  50  having a recess  55  for fittingly engaging protrusion  45  of sealing plug  51 . Shield  50  having at least one projection  56  which may be annular or intermittent for attaching sealing plug  51 .  
         [0293]    Chamber  361  is manufactured in a pre-determined position whereby relationship of needle tip  23  penetrates only into chamber  361 , and not directly into internal chamber  43  of container  40 . Needle tip  23  could also be manufactured longer to penetrate intermediate chamber  361  first to allow specimen flow from needle  21 , and with further axial advancement needle tip  23  could reside within diverting means  373 , stopping specimen flow during the collection process, and finally needle tip  23  could also be manufactured to penetrate intermediate chamber  361  first to allow specimen flow from needle  21  and with further axial advancement needle tip  23  could reside within diverting means  373 , stopping specimen flow during the collection process, and with even further axial advancement, needle tip  23  could penetrate through diverting means  373  and directly into internal chamber  43  of container  40 , totally bypassing intermediate chamber  361  and diverting means  373  and allowing direct specimen flow from needle  21  into container  40 .  
         [0294]    [0294]FIG. 36 is a cross sectional side view of a collection container of the present invention showing container  40  having sealing plug  541 , intermediate chamber  561  with reducing section  62  to control, regulate or divert specimen flow into container  40  with passageway  560  connecting intermediate chamber  561  to internal chamber  43 . Sealing plug  541  having an extending outer section  22  for maintaining a sub-atmospheric pressure within container  40 .  
         [0295]    [0295]FIG. 37 is a partial cut away view of a collection container of the present invention having one open end and an internal chamber  43 , with a sealing plug  641  used to close container  40 . Sealing plug  641  having chamber  661  for regulating, governing, diverting, re-directing, reducing, increasing or interrupting the specimen flow through, into or within sealing plug  641  during blood collection procedures. Passageway  660  connects intermediate chamber  661  to internal chamber  43 . Chamber  661  having filtering means  63  to filter or control specimen flow during blood collection procedures. Filtering means  63  may also comprise a dissolvable material. Sealing plug  641  having an extending outer section  22  for maintaining a sub-atmospheric pressure within container  40 .  
         [0296]    [0296]FIG. 38 is a cross sectional view of a collection container of the present invention comprising a container  40 , having one open end and internal chamber  43 , open end being sealingly closed by removable, puncturable sealing plug  71  with at least one diverting component  74  creating chamber  761  and at least one recess  760  for creating an inner channel, port or passageway to internal chamber  43  when sealing plug  71  is positioned within open end of container or evacuated tube  40 . Diverter  74  having an angled lead-in section  86  for easy assembly of component  74  to sealing plug  71 . Sealing plug  71  having a chamfered or tapering bottom perimeter  65  for easy insertion into open end of container  40 .  
         [0297]    Internal cavity  43 , inner wall of the tube  40  or diverter  74  may also include a coating, additive, gel, inert polymer, or other substances which are used in the normal course of analyzing blood and blood products.  
         [0298]    Smaller sized sealing plug  71  requires less puncturable material to close a collection container by adding another low-cost, diverting component  74  to create chamber  761  and passageway  760 . Indicator  64  is shown on sealing plug  71  to determine the location of passageway  760  leading from sealing plug  71  into internal chamber  43  of container  40 . Indicator  64  is shown directly adjacent to passageway  760  of sealing plug  71 . Indicator  64  can also be placed at any position, or directly opposite, or 180° away from, the location of passageway  760 .  
         [0299]    Diverting component  74  may include a hinged section whereby diverting section is maintained in a diverting position during the normal collection procedure and is opened by the centrifugal force generated during the centrifuge process. This allows any specimen remaining within an intermediate chamber to be combined with the specimen in the internal chamber  43  of container  40 .  
         [0300]    Diverting component  74  may also re-direct specimen flow first toward the sidewall of container  40  and then directly into internal cavity  43 , forming a “Z” like configuration.  
         [0301]    [0301]FIG. 39 is a full bottom view of the sealing plug shown in FIG. 38 comprising a sealing plug  71 , with a chamfered section  65 , an indicator  64 , and a separate diverter  74 . Diverter  74  may include a dissolvable material when activated by a wet solution like blood.  
         [0302]    [0302]FIG. 40 is a full, cross sectional and partial cut away view of a blood collecting apparatus of the present invention showing sealing plug  51  being partially pierced by needle  21 . The blood collection apparatus comprises a blood collection needle  21 , a needle holder  530 , and a container  40  with a sealing plug  51  and shield  150 . Sealing plug  51  is used to close container  40 , and has at least one intermediate chamber  361  and diverter  373  for regulating, diverting, re-directing, reducing, increasing or interrupting the specimen flow through, into or within sealing plug  51  during blood collection procedures. Recess  360  creates an inner channel or passageway when sealing plug  51  is positioned in or within the open end of container  40 .  
         [0303]    Shield  150  having an aperture  9044  for unrestricted access of needle  21  into sealing plug  51 , and a projection  52  for frictionally or rotationally engaging needle holder  530  and internal open-faced projection  54 . Projection  52  engages projection  54  during rotational movement of container  40  towards needle  21 , maintaining a positive control during sealing plug  51  puncture by needle  21 . Direct axial removal of container  40  is unrestricted due to the open-faced configuration of projection  54  of needle holder  530 , allowing container  40  to be removed by a straight pulling movement like a standard collection container is now removed from a needle holder.  
         [0304]    Penetration-related adjustable specimen flow is regulated by frictional or threaded engagement of projection  52  of container  40  or shield  150  and frictional or threaded engagement of projection  54  of needle holder  30 .  
         [0305]    [0305]FIG. 41 is a full and cut away view of a blood collecting apparatus illustrated in FIG. 40 showing the needle  21  fully piercing sealing plug  51 , with container turned 90° in a rotational manner. The blood collection apparatus comprises blood collection needle  21 , needle holder  530 , and container  40  with sealing plug  51  and shield  150 . Sealing plug  51  is used to close container  40 , having at least one internal chamber  361  and diverter  373  for regulating, diverting, re-directing, reducing, increasing or interrupting the specimen flow through, into or within sealing plug  51  during blood collection procedures. Recess  360  creates an inner channel or passageway when sealing plug  51  is positioned in or within the open end of container  40 .  
         [0306]    Shield  50  having a projection  52  for frictionally or rotationally engaging needle holder  530  and internal projection  54 . Projection  52  engages projection  54  during rotational or frictional movement of container  40  towards needle  21 , maintaining a positive control during sealing plug  51  puncture by needle  21 . Direct axial removal of container  40  is unrestricted due to the open faced configuration of projection  54  of needle holder  530  whereby container  40  can be removed from needle holder  530  by a straight pulling motion.  
         [0307]    [0307]FIG. 42 is a partial cut away view of a prior art blood collection container  140  having a sealing plug  141  to maintain a sub-atmospheric pressure within internal chamber  143 . Container  140  is normally comprised of either glass or shatter resistant plastic. The major limitation of using plastic as the container body  140  is the tendency of the collected blood to react unfavorably with the elements contained in the plastic resin. The inside of the plastic tube must be completely coated with an additional barrier or film to achieve the same compatibility as the glass substrate. This adds additional cost to the collection container.  
         [0308]    [0308]FIG. 43 is a cross sectional view of a collection container of the present invention comprising a container  840  having piercable sealing plug  33  to maintain a sub-atmospheric pressure within internal chamber  843  and coating or film  49  on the outer surface of container  840  to reduce shattering probability in the event container  840  is broken during manufacturing, storage or use. Coating or film  49  comprises a protective material, which bonds to the outside surface of container  840 . Coating or film  49  keeps collection container  840  intact during manufacture, storage and use.  
         [0309]    Coating or film  49  can include, but is not limited to, a polymeric or elastomeric material which can also be applied or sized by chemical, electrical or heat processes. Coating or film  49  maintains tube substrate in an integral fashion and houses specimen safely within container  840  when container is dropped or crushed, keeping the healthcare worker from being exposed to the blood or bodily fluid specimen and keeping the workplace safe. Film or coating  49  is applicable to any and all collection containers disclosed within this application.  
         [0310]    [0310]FIG. 44 is a cross sectional view of a collection container of the present invention comprising a container  840  having piercable sealing plug  33  to maintain a sub-atmospheric pressure within internal chamber  843  and a coating or film  149  on the outer surface of container  840  extending over the juncture or interface where sealing plug  33  and container  840  join together. Coating or film  149  improves vacuum retention within internal chamber  843  and alerts healthcare worker if the seal has been tampered with if a tearing, stretching, or other deforming indication is present on coating or film  149  where vacuum could have been compromised.  
         [0311]    [0311]FIG. 45 is a cross sectional view of the present invention comprising a container  840  having a sealing plug  33  to maintain a sub-atmospheric pressure within internal chamber  843  and a coating, film or label  249  over the juncture or interface where sealing plug  33  and container  840  join together. Coating, film or label  249  improves vacuum retention within internal chamber  843  and alerts healthcare worker if the seal has been tampered with if a tearing, stretching, or other deforming indication is present on coating, film or label  249  where vacuum could have been compromised.  
         [0312]    [0312]FIG. 46 is a partial cut away view of a collection container of the present invention comprising a container  40  having a sealing plug  31  to maintain a sub-atmospheric pressure within internal chamber  43  and a sensor or probe  90  which is accessible from the outside of container  40 . Specimen can be analyzed without removal of sealing plug  31  from container  40 .  
         [0313]    [0313]FIG. 47 is a partial cross sectional view of a collection container of the present invention comprising a container  40  having a sealing plug  91  to maintain a sub-atmospheric pressure within internal chamber  43  and a diverter  78 , which can be comprised of a dissolvable or undissolvable material, creating an intermediate chamber  861  when attached to sealing plug  91 , which re-directs specimen flow entering chamber  861  towards the outer perimeter o container  40 . Diverter  78  is attached to sealing plug  91  by means of a plurality of projections  85  which engage sealing plug  91  at recess  47 . Annular passageway  860  allows specimen flow to gravitate toward perimeter of collection container  40 , or to the lower extremity of collection container  40  regardless of how container is positioned in a needle holder. A 360° specimen diversion, or any fraction thereof, is accomplished by diverter  78 .  
         [0314]    Diverter  78  is shown frictionally engaging recess  47  of sealing plug  91  whereby gripping force is sufficient to maintain attachment during the normal specimen collection procedure. All collected specimens are placed in a centrifuge and spun to separate the plasma from the red cells prior to testing. The gripping force of diverter  78  to sealing plug  91  is capable of releasing during the centrifuge process. This allows any specimen which remained within intermediate chamber  861  after the collection procedure to be combined with the specimen in the internal chamber  43 .  
         [0315]    Diverter  78  can also comprise a hinged section whereby diverting section is maintained in a diverting position during the normal collection procedure and is opened by the centrifugal force generated during the centrifuge process. This allows any specimen remaining within intermediate chamber  861  to be combined with the specimen in the internal chamber  43 .  
         [0316]    [0316]FIG. 48 is a partial cross sectional view of a collection container of the present invention comprising a container  40  having a sealing plug  91  to maintain a sub-atmospheric pressure within internal chamber  43  and a diverter  178  with a well which creates intermediate chamber  961  and re-directs a specimen flow entering chamber  961  towards the outer perimeter of container  40 . Diverter  178  is attached to sealing plug  91  by means of a plurality of projections  85  which engage sealing plug  91  at recess  47 . Diverter  178  having an aperture or channel  9079  for draining specimen within intermediate chamber  961  after collection.  
         [0317]    Diverter  178  can be made of a dissolvable or undissolvable material. Aperture  9079  can include a dissolvable material which blocks aperture  9079  during the collection process and dissolves when exposed to liquid, opening aperture  9079  to allow any specimen contained in chamber  961  to empty into container  40 . Annular passageway  960  allows specimen flow to gravitate toward perimeter of container  40  or to lower extremity of collection container  40 .  
         [0318]    [0318]FIG. 49 is a full side view of a diverter of the present invention which engages a sealing plug and creates intermediate chamber which re-directs specimen flow to the outer perimeter of a collection container. Diverter  278  having a plurality of projections  85  and barbs  79  which engage a sealing plug.  
         [0319]    [0319]FIG. 50 is a full top view of the diverter shown in FIG. 49 having a plurality of projections  85  and barbs  79  extending from diverter  278 .  
         [0320]    [0320]FIG. 51 is a cross sectional side view of a sealing plug of the present invention comprising a piercable sealing plug  91  having at least one recess  47  for engaging a separate component. Recess may be annular, intermittent or the like to facilitate attachment of another component to sealing plug  91 .  
         [0321]    [0321]FIG. 52 is a full bottom view of the sealing plug shown in FIG. 51 in axis  52 - 52  having at least one recess  47  for engaging a separate component. Recess may be annular, intermittent or the like to facilitate attachment of another component to sealing plug  91 .  
         [0322]    [0322]FIG. 53 is a partial cross sectional view of a collection container of the present invention comprising self-shielding sealing plug  18  having an axially slidable shield  17  about one portion of shielding plug  18  inserted in an openable end of container  40 . Puncturable sealing plug  18  having chamber  19  formed by diverter  13  for diverting specimen flow as it exits a needle, shown in other drawings. Passageway  15  openly connecting chamber  19  with internal chamber  43  of container  40 .  
         [0323]    Sealing plug  18  having an annular recess  27  for housing annular projection  16  for maintaining shield  17  in slidable engagement with sealing plug  18 . Projection  16  is shown with chamfered top which allows easy, self-centering assembly of sealing plug  18  into shield  17  prior to insertion in openable end of container  40 . Sealing plug and shield  17  comprise an air-tight seal to maintain a sub-atmospheric pressure within collection container  40 .  
         [0324]    [0324]FIG. 54 is a partial cross sectional view of the collection container shown in FIG. 53 with self-shielding sealing plug  18  and axially slidable shield  17  removed from openable end of container  40  with shield  17  automatically shielding portion of sealing plug  18  which was in contact with specimen in container  40 . Shield  17  closing port  15  at intersection  59  of shield  17  and sealing plug  18  safely containing any specimen remaining within chamber  19  of sealing plug  18  from coming in contact with healthcare personnel. Specimen remaining in chamber  19  is unlikely after centrifuging container  40  with closed end of container  40  placed to the outer end of centrifuge. Puncturable sealing plug  18  having chamber  19  formed by diverter  13  for diverting specimen flow as it exits needle  21 , shown in other drawings, and passageway or port  15  in communication with chamber  19  and internal chamber  43  of collection container  40 . Projection  16  of shield  17  limits axial movement of sealing plug  18  as collection container  40  is opened. It is not necessary for shield  17  to close port  15  when shield  17  is moved to a protective position, as long as outer wall of diverter  13  is shielded by shield  17 . Sealing plug and shield  17  comprise an air-tight seal to maintain a sub-atmospheric pressure within collection container  40 .  
         [0325]    When sealing plug  18  is removed from container  40 , a greater gripping force between container  40  inner wall and sliding shield  17  outer wall allow sealing plug  18  to slide first in an axial manner in shield  17 . Sealing plug  18  then is limited in axial movement within shield  17  by projection  16  whereby continued axial force removes both sealing plug  18  and shield  17  from openable end of container  40 .  
         [0326]    [0326]FIG. 55 is a cross sectional view of a collection container of the present invention comprising a translucent, flexible shield  250  and sealing plug  451  having a flow indicator or viewing area  99  to determine specimen flow into chamber  461 . Specimen flow is diverted during the collection process by chamber  461  and diverter  473 , and through passageway  460  into cavity  43  of container  40 .  
         [0327]    Since the container  40  and shield  250  are made of clear or translucent materials, specimen flow is easily observed. Shield  250  is not a necessary component whereby specimen flow is viewable through clear container  40  wall when sealing plug  451  is used individually. Flow Chamber  461  is easily manufactured by standard injection molding methods. It is preferable to have shield  250  as clear as possible for easiest viewing of specimen flow.  
         [0328]    [0328]FIG. 56 is a cross sectional view of a collection container of the present invention comprising container  40  with an internal cavity  43 , which may be evacuated, closed by sealing plug  37  with a semi-circular outer perimeter allowing either end of container  40  to be placed in a centrifuge. Tubular shield  350  having at least one projection  28  for engaging at least one recess  44  of sealing plug  37 . Shield  350  has no top face and extends around the inserted sealing plug  37  with chamber  161  and diverter  173  to contain specimen within sealing plug  37  and shield  350  when both are removed from container  40 . Recessed well  34  creates a smaller puncturable section of sealing plug  37  for easy insertion of needle through sealing plug  37 . Sealing plug  37  having a diverter  173 , chamber  161  and passageway  160  are connected with internal chamber  43  of container  40 . Container  40  can include a closed end configuration having a square, geometric, oval or other non-circular shape.  
         [0329]    [0329]FIG. 57 is a cross sectional view of a blood collection adapter of the present invention comprising an extension or coupler  87  where a standard, or larger container  40 , shown throughout this application, is usable with smaller, pediatric needle holder  95 , shown in FIG. 59. Smaller diameter needle holder  95  allows a shallower angle to be used to access a blood vessel during blood collection procedures.  
         [0330]    A hollow bore needle, attached to smaller diameter needle holder  95 , is inserted into a blood vessel and sealing plug  88  end of coupler  87  is inserted into needle holder  95 . Cover  25  contains specimen within chambers  46  and  93 , and needle  421  until a larger diameter collection container is slid into coupler  87  and sealing plug of larger diameter container is pierced. A larger diameter collection container can be used to collect a specimen using a smaller diameter needle holder  95 , shown in FIG. 59. The smaller diameter needle holder allows a shallower angle to be used to access a blood vessel because the center point of needle holder  95  is closer to body surface of the patient. Coupler  87  is attached to piercable cap  88  at interface  89 . Smaller diameter sealing plug  48  having an external well  92  to prevent residual specimen from coming in contact with healthcare personnel during specimen collection and analysis.  
         [0331]    [0331]FIG. 58 is a cross sectional view of a blood collection adapter of the present invention comprising an extension or coupler  187  with a flow regulating plug  48  where a standard, or larger collection container, shown throughout this application, is usable with smaller diameter, pediatric needle holder  95 . Plug  48  having chamber  94 , diverter  26  and passageway  36  created by inserting plug  48  into coupler  187 .  
         [0332]    A hollow bore needle, attached to smaller diameter needle holder  95 , is inserted into a blood vessel and sealing plug  48  end of coupler  187  is inserted into needle holder  95 . Cover  25  contains specimen within chambers  46  and  94  and needle  421  until a larger diameter collection container is slid into coupler  187  and sealing plug of a larger diameter container is pierced. A larger diameter container  40  can be used to collect a specimen. using a smaller diameter needle holder  95 . Smaller diameter needle holder  95  allows a shallower angle to be used to access a blood vessel because the center point of needle is closer to body surface of the patient. Smaller diameter sealing plug  88  having an external well  92  to prevent residual specimen from coming in contact with healthcare personnel during specimen collection and analysis.  
         [0333]    [0333]FIG. 59 is a cross sectional view of a blood collecting apparatus of the present invention comprising container  39  capable of being used with either the standard needle holder, shown as a needle holder, or smaller diameter, pediatric needle holder  95 . Smaller diameter needle holder  95  allows a shallower angle to be used to access a blood vessel because the center point of needle is closer to body surface of the patient. Smaller diameter sealing plug  98  having chamber  97 , diverter  126 , and passageway  96  for diverting specimen exiting from needle  21  into container  39 . Larger diameter, opposite end of container  39  can be safely placed in a centrifuge to separate red cells from the plasma. Smaller diameter sealing plug  98  having an external well  92  to prevent residual specimen from coming in contact with healthcare personnel during specimen collection and analysis.  
         [0334]    Larger diameter sealing plug  137  having chamber  161 , diverter  173 , and passageway  160  for diverting specimen exiting from a needle into container  39  Larger diameter sealing plug  137  having an external well  134  to prevent residual specimen from coming in contact with healthcare personnel during specimen collection and analysis. Container  39  can include just one open end whereby the opposite end would be closed.  
         [0335]    [0335]FIG. 60 is a full side view of sealing plug of the present invention having a channel  360  for equalizing the internal pressure within the container with the ambient atmospheric pressure prior to full removal of sealing plug  341  from a container. Chamfer  365  aids assembly of sealing plug  341  into the open end of a collection container.  
         [0336]    [0336]FIG. 61 is a full bottom view of the sealing plug shown in FIG. 60 having a channel  360  for equalizing the internal pressure within the collection container with the ambient atmospheric pressure prior to full removal of sealing plug  341  from a container. Chamfer  365  aids assembly of sealing plug  341  into the open end of a container.  
         [0337]    [0337]FIG. 62 is a cross sectional view of sealing plug shown in FIGS. 60 and 61 with sealing plug  341  with channel  360  and chamfered bottom  365  inserted into container  340 . Channel  360  and chamfered bottom  365  closing container  340  creating an internal chamber  343 .  
         [0338]    [0338]FIG. 63 is a cross sectional view of the sealing plug shown in FIG. 62 with a channel  360  and chamfered bottom  365 , being moved from a sealing position and equalizing the internal pressure within the container  340  and chamber  343  with the ambient atmospheric pressure prior to full removal of sealing plug  341  from container  340 . The equalization of internal pressure of chamber  343  reduces exposure probability to specimen contained within container  340 .  
         [0339]    [0339]FIG. 64 is a cross sectional side view of collection container of the present invention being closed by removable sealing plug  441  with an externally accessible chamber  455  sealed by strip  475  with pull tab  476 . As a needle punctures sealing plug  441 , hollow bore of needle containing specimen enters chamber  455  depositing a small amount of specimen within chamber  455 . Specimen is collected in a normal fashion into chamber  443 . When needle is removed from sealing plug  441 , again a small amount of specimen is deposited within chamber  455 .  
         [0340]    Container  440  does not have to be opened, or does sealing plug  441  have to be punctured with a needle, or removed to obtain a small amount of specimen for visual analysis.  
         [0341]    It is dangerous to withdraw the needle uncovered and deposit the collected specimen from the sharpened tip of the needle to a slide. With the probability of the needle being covered immediately upon withdrawal from a venipuncture site to prevent a needlestick accident, this invention makes it possible to obtain a small amount of collected specimen for a slide without exposing the healthcare worker to a sharp needle with blood in or on it.  
         [0342]    Chamber  455  can be coated with an anti-clotting agent, dye or the like to facilitate visual examination of the specimen.  
         [0343]    [0343]FIG. 65 is a cross sectional side view of collection container shown in FIG. 64 being closed by removable sealing plug  441  with an externally accessible chamber  455  being opened by removal of strip  475  with pull tab  476 . Specimen deposited in chamber  455  can now be deposited onto a slide for visual examination.  
         [0344]    [0344]FIG. 66 is a full side view of a collection container of the present invention with an externally accessible chamber  543  being closed by separable and movable sealing plug  541 , with a movable external shield  550  having an aperture  575  closing container  540  creating internal cavity  543 . External shield  550  is in a first position closing external access to chamber  555  of sealing plug  541 .  
         [0345]    [0345]FIG. 67 is a full side view of a collection container shown in FIG. 66 being closed by removable sealing plug  541  with movable external shield  550 . Aperture  575  is now in a second position, relative to the first movable position, exposing chamber  555  allowing access to collected specimen deposited within chamber  555  during collection procedures. Movement of shield  550 , relative to chamber  555  of sealing plug  541  can include a third position, whereby aperture  575  would be locked in a closed position, preventing external access to chamber  555 .  
         [0346]    Container  540  does not have to be opened to gain access to collected specimen in internal cavity  543 , nor does sealing plug  541  have to be punctured with a needle, or removed to obtain a small amount of specimen for visual analysis.  
         [0347]    Chamber  555  can be coated with an anti-clotting agent, dye or the like to facilitate visual examination of the specimen.  
         [0348]    [0348]FIG. 68 is a cross sectional side view of the collection container shown in FIG. 66 having chamber  543  being closed by removable sealing plug  541  with movable external shield  550  having aperture  575  closing chamber  555  of sealing plug  541  at section  576 . External shield  550  is in a first position closing external access to chamber  555  of sealing plug  541 .  
         [0349]    As a needle moves through well  544  and punctures sealing plug  541 , the hollow bore of the needle containing specimen enters chamber  555  depositing a small amount of specimen within the chamber. The needle then fully punctures the sealing plug  541  and specimen is collected in a normal fashion into chamber  543 . When needle is removed from sealing plug  541 , again a small amount of specimen is deposited within chamber  555 .  
         [0350]    [0350]FIG. 69 is a cross sectional side view of the collection container shown in FIG. 67 having chamber  543  being closed by removable sealing plug  541  with movable external shield  550  aperture  575  in a second position exposing chamber  555  allowing access to collected specimen deposited within chamber  555  during collection procedures.  
         [0351]    Container  540  does not have to be opened, nor does sealing plug  541  have to be punctured with a needle, or removed to obtain a small amount of specimen for visual analysis.  
         [0352]    A positive engagement means can position movable shield  550  in either a first closed position, or a second open position, reducing the probability of movable shield  550  inadvertently opening prematurely during the collection process.  
         [0353]    A needle, with one sharpened tip for puncturing a sealing plug of a filled collection container, and the other end being blunted, can also be used to deposit a smear of blood on a slide. The needle can be attachable to a needle holder described throughout this application, or can be used individually to access a collected specimen in a collection container.  
         [0354]    [0354]FIG. 70 is a cross sectional side view of the present invention having a container with sealing plug which includes a diffusing member. Sealing plug  1041  includes an external well  1044  and a porous member  1063  for diffusing a liquid entering internal chamber  1043  of container  1040  during the collection process. Sealing plug  1041  includes a chamfered bottom  1065  to facilitate insertion into container  1040 .  
         [0355]    [0355]FIG. 71 is a cross sectional side view of the container and sealing plug shown in FIG. 70 showing a specimen being diffused during delivery into container  1040 . Needle  1021  with pierceable resilient cover  1025  formed on the proximal end thereof is attached in needle holder  1030  and container  1040  is inserted in chamber  1035  of needle holder  1030 , allowing proximal end of needle  1023  to puncture sealing plug  1041  and enter porous member  1063 . Specimen exits needle  1021  and is diffused during the collection process. Sealing plug  1041  includes a chamfered bottom  1065  to facilitate insertion into container  1040 .  
         [0356]    [0356]FIG. 71A is a cross sectional side view of the container and sealing plug shown in FIG. 71 showing a specimen being diffused during delivery into container  1040 . Specimen flows through needle lumen  1024  and into or through porous member  1063  before entering cavity  1043  of container  1040 . Needle  1021  is attached in needle holder  1030  and container  1040  is inserted in chamber  1035  of needle holder  1030 , allowing proximal end of needle  1023  to puncture sealing plug  1041  and enter porous member  1063 . Specimen exits needle  1021  and is diffused during the collection process. Sealing plug  1041  includes a chamfered bottom  1065  to facilitate insertion into container  1040 .  
         [0357]    [0357]FIG. 71B is a cross sectional side view of a blood collection apparatus showing the specimen flowing through a porous regulating means  1163  within needle lumen  1124 . Specimen flows through needle lumen  1124  and into or through porous member  1163  before entering cavity  143  of conventional container  140 . Needle  1121  is attached in needle holder  1030  and container  140  is inserted in chamber  1135  of needle holder  1030 , allowing proximal end of needle  1123  to puncture conventional sealing plug  141  and enter inner chamber  143 . Specimen flows through needle  1121  and is diffused within needle lumen  1124  by porous member  1163  during the collection process. Sealing plug  141  includes a chamfered bottom  1065  to facilitate insertion into container  140 . This fluid regulating needle allows a specimen to be collected using conventional blood collection containers, yet reduces both hemolysis and vein collapse probability.  
         [0358]    [0358]FIG. 72 is a cross sectional side view of the present invention having a container with sealing plug which includes an occluding member. Sealing plug  2041  includes an external well  2044 , an inner chamber  2061 , a diverting section  2073  and an expandable, liquid-sensitive section  2063  having an open aperture which allows a liquid to pass through it, yet expands and closes within minutes after being exposed to a liquid.  
         [0359]    [0359]FIG. 73 is a cross sectional side view of FIG. 72 showing a specimen contained within container  2040  and chamber  2061  of sealing plug  2041  no longer being in fluid communication with chamber  1043  of container  1040 . Liquid-sensitive section  2063  is swollen and the aperture closed.  
         [0360]    [0360]FIG. 74 is a cross sectional side view of the present invention having a container with an existing prior art sealing plug or sealing plug  1441  with an external well  1444  which includes a diverting component  1478  having a chamber  1461  created by inserting diverter  1478  into hollow end of sealing plug  141 . Diverter  1478  having a closed end  1473 , at least one open aperture  1460  and may include at least one projection  1479  for frictionally engaging inner wall of sealing plug  141 . Diverter  1478  may include a chamfered closed end  1473  to allow specimen remaining in chamber  1461  to drain into chamber  143  of container  140  prior to, or during centrifuging or analysis. Projection  1479  may be segmented or circumferential to support wall section of sealing plug  141 , creating an improved seal at the sealing plug/container surface interface, thus reducing vacuum leakage and increasing the shelf life of the vacuum tube.  
         [0361]    Diverter end  1473  may include a large opening and be closed by a removable or dissolvable wall section which allows the specimen remaining in the intermediate chamber  1461  after collection to be added to the specimen in the collection container chamber  1443 . Specimen would still flow through aperture  1460  during the collection process. A dissolvable material, such as those used as additives to facilitate analysis, maybe used and dissolve within minutes of being wetted by a specimen. The diverting end  1473  would be removed from the diverter by the centrifugal forces placed on the container during the centrifuge process. Thus any specimen remaining in the intermediate chamber  1461  would be added to the specimen in the collection container. This would allow a long needle to freely access the specimen, which may be separated into plasma and red cells during the centrifuge process, enabling a pure plasma or red cell specimen to be drawn from the container for analysis.  
         [0362]    Diverter  1478  radially compresses sealing plug  1441  against collection container  1440  wall, improving seal and increasing shelf life of the container. The inner wall section of sealing plug  1441  may include an annular or segmented undercut or projection to correspondingly mate with a projection or undercut respectively, on diverter  1478 . An undercut or recess is easily moldable into elastomeric materials like rubber or rubber mixed with plastic, or other compounds.  
         [0363]    The cost of implementing this flow diverting technology is very low because existing tooling and components do not have to be modified. The assembly procedure would have to be modified and tools created for manufacturing the diverting component.  
         [0364]    [0364]FIG. 75 is a cross sectional side view of the present invention having a container with an existing prior sealing plug with an annular member which frictionally engages the inner wall section of sealing plug. The sealing plug wall section  3065  adjacent to annular member  3079  compresses and supports the wall section  3065  when the sealing plug  141  is inserted in container  140 . Annular member  3079  may be cylindrical in shape with open ends. Cylindrical configuration contacts a greater portion of sealing plug wall section, creating more surface area of contact with collection container wall. Annular member  3079  radially compresses sealing plug against collection container wall, improving the seal and increasing shelf life of the container.  
         [0365]    The use of annular member  3079  provides an improved seal at the sealing plug/container surface interface, thus reducing “gray band” regions and vacuum leakage, thus increasing the shelf life of the vacuum tube.  
         [0366]    The cost of implementing this improved sealing technology is very low because existing tooling and components do not have to be modified. The assembly procedure would have to be modified and tools created for manufacturing the annular component.  
         [0367]    [0367]FIG. 76 is a cross sectional side view of the present invention having a container with a sealing plug with a pressure sensitive valve which is activated when a pressure difference exists on either side of the valve. Sealing plug  4041 , includes an external well  4044  and projection or undercut  4062 , which may have an annular configuration, is inserted in container  4040  creating cavity  4043 . Valve  4078  is positioned in sealing plug  4041  and creates chamber  4061  which closes at interface  4075 . When sealing plug  141  is punctured by a needle and a greater pressure is created in chamber  4061 , valve  4078  opens and the area of higher pressure moves to the area of lower pressure contained in cavity  4043 . Valve  4078  also has a diverting section  4073 .  
         [0368]    [0368]FIG. 77 is a full side view of the pressure sensitive diverter or valve  4078  which is inserted in a sealing plug.  
         [0369]    [0369]FIG. 78 is a cross sectional side view of a sealing plug  5041  having a diverting component  5078  with an aperture  5060  for diverting or regulating a specimen flow, a diverting wall section  5073 , and a channel or slot  5000  for accessing a collected specimen in a container sealed by sealing plug  5041 . A long needle may be inserted through sealing plug  5041  to access the collected specimen with out contacting any specimen which may be residing in the chamber created by the coupling of sealing plug  5041  and diverter  5078 .  
         [0370]    [0370]FIG. 79 is a partial cut away view of the diverting component  5078  of FIG. 78. Diverting component  5078  having a channel or slot  5000  and chamber created by diverting wall section  5073 .  
         [0371]    [0371]FIG. 80 is a full side view of a blood collection needle with a manually activated needle guard. Blood collection needle having a hub  6015 , with a fixedly attached hollow bore needle  6010  with both the proximal and distal ends sharpened, distal end  6011  is shown here, with the proximal end covered by a puncturable boot or cover. A needle guard  6022  is releasably held adjacent to hub  6015  by a latching arm  6026  which includes a finger pad  6027  and a stop or projection  6049 . Needle guard  6022  having a needle trap  6041  which rides on the needle and moves to a protecting position when needle guard  6022  is manually released by activating the finger pad  6027 . Any longitudinal compressive force exerted by inserting needle  6010  into a patient does not activate needle guard.