KR20010049172A - Method and apparatus for collecting blood - Google Patents

Abstract

The blood collection device includes a sample container 40, a sealing plug 41 and a needle holder 30. The specimen container 40 is made of glass and the outer surface is coated with a polymer material. The needle 21 includes a friction reducing compound. The sealing plug 41 has an internal cavity for receiving the needle and a means 73 for guiding the flow from the distribution cavity to the inside of the sample container.

Description

Blood collection method and apparatus {METHOD AND APPARATUS FOR COLLECTING BLOOD}

Blood collection and analysis is one of the most commonly used processes in the diagnosis of many diseases and ailments. Blood, which is an essential element for humans as well as animals and marine life, is mainly red blood cells in the range of 6-8 μm (microns), leukocytes that are normally 10-14 μ size but can sometimes be 19-20 μ, and additional proteins It consists of an antibody.

The power involved in taking blood includes a number of variables and the present invention, individually and in combination, allows the safe and accurate acquisition of live samples.

Blood consists of specific cell types suspended in a fluid medium called plasma. Blood is contained within a closed system of valves, pumps, passages and chambers consisting of a circulatory system. Blood is mostly composed of 45% red blood cells and 55% plasma, with gaseous carrier red blood cells suspended in the fluid plasma. Blood is pumped by the heart through the circulatory system and maintained in the fluid suspension medium in the blood vessels. Blood cells are actually small, delicate living cells that must remain in a chemically balanced fluid environment in order to function properly.

One of the many organics required to maintain healthy metabolism, potassium is the main cation in the intracellular fluid in red blood cells. The average cytoplasmic concentration of potassium in erythrocytes is at least 105 mmol / l, or about 23 times the mean serum potassium level. In addition, since the permeability of the cell membrane to potassium is very low, rapid movement of potassium in and out of the cell membrane by diffusion is not easy. Hemolytic producing blood causes elevated serum potassium levels because intracellular potassium is excreted from the ruptured red blood cells into the serum. Therefore, hemolysis loses the effect of the measured serum potassium levels.

1 is an overall cross-sectional view of a conventional blood collection device 10 used to withdraw a blood, body fluid or gas sample from a patient. The conventional blood collection device has three main parts. These include: (1) a hollow container or vacuum tube 140 sealed by a pierceable diaphragm or stopper 141 to obtain a fluid or gaseous sample, a separation holder 130 for receiving and temporarily holding the vacuumed container; And a hollow bore hypodermic needle 121 having a penetrating lumen 124 and a pointed end tip 120 and a pointed proximal tip 123.

The needle 121 is attached to the holder 130, the sharp adjacent tip 123 is present in the holder 130, and the sharp tip 120 is separated from the holder 130. The proximal end of the needle 121 typically includes an elastic cover 125 that can be perforated. The container 140 has an open end and a closed end, and within the open end of the tube 140 lies an inner chamber 143 with a removable sealing plug 141. Blood is first drawn from the patient by inserting the pointed end tip 120 of the needle 121 into the patient's blood vessel. The cover prevents the flow of blood from the distal end of the needle 121. The vacuum tube 140 is then positioned in the hollow body 135 of the holder 130 and slides forward in the holder 130 (indicated by arrow W) so that the distal end 123 of the needle 121 is moved into the vacuum tube. Stick the sealing plug 141 of 140. The sample fills the collection container 140 and is then removed from the needle holder 130.

The pressure difference between the blood of the patient flowing in the blood vessel and the negative pressure in the vacuum chamber causes the blood to quickly fall into the inner chamber 143 of the vacuum tube 140.

28 is a cross sectional view of a conventional needle 121 with an uneven inner wall 111.

FIG. 42 shows a conventional harvesting container 140 having a chamber 143 sealed by a pierceable diaphragm 141 or sealing plug.

The present invention relates to each characteristic relating to the collection of venous or arterial blood, each individual component; needle; Needle holder; Harvesting container; Sealing plug or diaphragm; It relates to the improvement of sealing plug seals and sampling adapters.

The present invention includes a number of embodiments related to blood collection, including a simple, one-piece flow diverting plug, as shown in FIGS. 3-10, whereby the specimen is collected through a hollow bore needle. It is "cushioned" in the fluid medium and fills the collection container without the high impact and shear forces inherent in standard blood sampling equipment and procedures.

The other one-piece sealing plugs described in FIGS. 11-15 and 30 impose a sample flow before entering the collection container. The two piece sealing plug and the flow control are shown in FIGS. 16-19, where the specimen first enters the intermediate or internal chamber before entering the harvesting container, and the adjustable flow rate sealing plug with the diverter shown in FIGS. 24 to 27. Allows the user to easily start, stop or change during the harvesting process.

The one-piece sealing plugs described in FIGS. 20-23 disclose reed valve means for controlling the sample flow through the sealing plug. Another one-piece sealing plug described in FIG. 32 is known permeable or already perforated membranes that regulate or divert sample flow through the sealing plug. Another one-piece, multi-chambered sealing plug shown in FIG. 33 includes a chamber or chamber and a recess for diverting the sample flow through the sealing plug.

The needle is shown in FIG. 29 and has a friction reducing coated inner wall, and the needle itself can smoothly produce the uneven and rough inner surface produced by the current manufacturing process when the metal tube is extruded to size. These improvements are designed to reduce the high shear forces placed on the blood as it is absorbed through the needle lumen. By increasing the needle diameter, shown in FIG. 31, any of the conventional sealing plugs or other sealing plugs described herein can be used.

30 describes an adjustable flow blood collection system associated with permeability, where the sample flow is controlled by the rotational movement of the container relative to the needle holder.

Two component flow diverting sealing plugs and seals are shown in FIGS. 34, 35, 40 and 41, which isolate the blood or fluid on the body from the blood donor or health manager during the blood collection process, with the sealing plug having a chamber By covering the chamber made in a predetermined position, the needle tip only penetrates the chamber and does not penetrate directly into the inner chamber of the harvesting container.

47 and 48, the other two component sealing plugs and diverters have a means for diverting the specimen radially towards the periphery of the collection container when the needle lumen is present in the chamber, the sealing plug and diverter having the needles Regardless of how it is positioned in the holder, it allows the specimen to enter the interior chamber of the collection container at the lower pole, which can be self-filled, and therefore enters the collection container in a cushioned state. The individual parts of these sealing plugs are shown in FIGS. 49-52, and different or different sized shapes can also achieve the same or similar results.

The two component sealing plug and the diverter shown in FIGS. 47 and 48 can also be manufactured as a single component which achieves the same desirable results.

The other two component sealing plugs and the diverters shown in FIGS. 38 and 39 describe a switching means for filling the container with the specimen in a manner starting from the lower cost and reduced mass of the sealing plug and the sealing cap and filling the opposite end of the container.

The blood sample needle centrifugally punctures the sealing plug and the sample flows through the circumferentially positioned diverter. Longer needles typically used to discharge the sample taken from the collection container can be bypassed by inserting away from the center of the sealing plug. Sealing plugs shall not be removed to withdraw the specimen from the collection container.

The sealing plug with the reduced chamber is shown in FIG. 36, which regulates and diverts the sample flow from the needle to the container. The reduced portion also slows the sample flow to reduce the possibility of venous destruction during the harvesting process. The sealing plug shown in FIG. 37 may be in a sealing plug or a container or adjacent filtering means; 40 and 41, with controllable deeply penetrating sealing plugs, shown in FIGS. 40 and 41, to control the longitudinal movement of the collecting container towards the needle, while the user is still in the unrestricted recovery of the container from the needle holder. Allow for easy sample flow, start, stop or change.

The containers shown in FIGS. 43 and 44 have a coating or film around the outer glass or plastic surface of the container, which reduces the chance of container breakage even if the container is dropped or squeezed during manufacture, storage or use. The container shown in FIG. 45 has a sealing plug and a coating, film or label around the middle of the container, which reduces the possibility of vacuum leakage from within the chamber.

The other two component sealing plug and the diverter shown in FIG. 46 have a sensor or probe that allows analysis of the sample without removing it from the collection container.

Sealing plugs and seals that automatically seal are described in Figures 53 and 54, where the sealing plugs are slidable relative to the shield. The container has a greater gripping force on the seal so that the axial movement of the sealing plug occurs first and the protrusion of the seal engages the sealing plug during removal and the sliding seal closes the port at the middle.

The flow indicator or viewing portion is shown in FIG. 55 and allows the user to observe the sample flow in the chamber of the sealing plug. A harvesting container with rounded ends for inserting either end into a centrifuge is shown in FIG. 56. The coupling device is shown in FIG. 57 and allows the smaller pediatric needle holder shown in FIG. 59 to be used in a standard or larger collection container. The use of smaller diameter devices allows smaller angles to be used for easier access of blood vessels during the blood collection process.

A coupling device having a flow regulating or diverting plug is shown in FIG. 58, wherein the coupling device or extension allows a smaller pediatric needle holder to be used with a larger collection container. A new harvesting container with two pierceable ends that can be used for both small and large needle holders is shown in FIG. 59. The larger end of the collection container has a rounded edge for insertion into the centrifuge. Both sealing plugs include chambers for diverting the sample flow before entering the collection container.

61-63 is shown in Figures 61-63, which equals the ambient atmospheric pressure in the collection container and the ambient atmospheric pressure before complete removal of the sealing plug from the collection container.

A sealing plug with a chamber of external access is shown in FIGS. 64 and 65. The removable cover or seal allows the specimen deposited in the chamber to be placed on the slide without using a needle to access the specimen in the container.

Sealing plugs with chambers of external access and movable seals with holes are shown in FIGS. 66-69. The movable shield allows the specimen deposited in the chamber to be placed on the slide without using a needle to access the specimen in the container.

The present invention also includes a simple, two-piece flow diffusion seal plug, shown in FIGS. 70 and 71, wherein the specimen is in a “diffusion state” in the porous medium when exiting the hollow bore needle before filling the harvest container. Another simple two piece flow diverting seal plug is shown in FIGS. 72 and 73 whereby the sample is diverted through the aperture during the sampling process. The inflatable material that makes the hole is activated by contact with the liquid and expands close to the hole so that it gets wet within minutes.

A two piece seal plug with the addition of a single conversion component to an existing conventional seal plug or the like is shown in FIG. 74. The diverting component also includes support means for protecting the sealing plug wall from breakage or movement when positioned in the tube, thereby improving the vacuum force inside the tube by maintaining proper sealing between the sealing plug and the tube. Compression radial forces are generated on the resilient sealing plug wall by an internal support or conversion component. The end diverter wall portion between the chamber and the sampling container generated in the sealing plug is positioned far enough from the blood sampling container so that the needle does not poke the wall portion when the sample is taken. The end diverter wall portion can be drilled by a longer needle that safely removes the sample taken from the container during testing and analysis without removing the sealing plug. The conversion wall portion may also comprise a soluble or separable material. The detachable wall portion can be held in place sufficiently during the harvesting process and removed by the centrifugal force generated when the harvesting container is centrifuged.

Another two piece seal plug with a support means for protecting the seal plug wall from breakage or movement when positioned in the tube is shown in FIG. 75. This invention improves the vacuum force inside the tube by maintaining proper sealing between the sealing plug and the container wall.

The two piece sealing plug is shown in FIGS. 76 and 77 and includes a conversion component that is activated when generated between the intermediate chamber of the sealing plug and the internal chamber of the harvesting tube. The valve opens when the specimen is drawn into the chamber and closes when the pressure in the chamber is approximately equal.

A sealing plug comprising a switching component with channels and slots is shown in FIGS. 78 and 79. The sample is taken through a diverter positioned circumferentially to receive the puncture blood collection needle. The channel is positioned centrifugally so that long needles are inserted into the sample taken without contact with any sample that may remain in the intermediate chamber of the seal plug and the diverter after the sample is taken.

The blood collection needle is shown in FIG. 80 and has a positive stop that holds the needle guard adjacent to the needle guard and the needle hub during the blood collection process. Compressive force is applied on the finger pad or button to selectively move the needle guard from the holding position to the protective position where the clear needle tip is safely covered as desired by the user.

Completely and comprehensively as done in the present invention, no blood sampling device is known which takes into account the fine physical properties of living blood cells during the sampling process.

Standard blood collection tubes are popular in the daily blood draw process, and various additives such as anticoagulants, coagulants, waxes, reactants, and the like are included in the vacuum chamber to facilitate testing of blood samples. Essentially, all standard, single chambered vacuum tubes are designed to draw fluid or gaseous material into the vacuumed chamber at a rapid, uncontrolled rate. The single chamber vacuum tube contains a single negative pressure in the chamber 143, which causes rapid suction of fluid or gaseous material, through the small hollow bore needle lumen 124 once the sealing plug 141 is drilled by the needle. To be evacuated to the vacuumed chamber 143. As the specimen falls into the chamber 143, a large force is generated and acts on the delicate blood cells.

Since the use of a vacuumed blood collection container, which is widely known as the brand name VACUTAINER brand blood collection system, is described in FIG. 1, the remedy is a hollower needle, a new additive inside the collection container, and a tube made of plastic resin to reduce container breakage. It is limited to vacuum forces that improve the shelf life of the collection tube.

There are inherent major limitations to the use of standard, single chamber blood collection tubes. First, the non-limiting, high velocity flow rate of the sample into the chamber vacuumed through the hollow bore needle sends the sample into the empty chamber while colliding with the distant wall of the container, causing a cell membrane known as physical damage to blood cells, or even hemolysis. Cause destruction. Second, the non-limiting suction pressure of the vacuum tube often causes the patient's blood vessels to break down, and then requires the use of a syringe to obtain a sample.

The pressure difference between the patient's existing blood pressure and the sub-atmospheric pressure in the vacuumed collection container determines the speed and flow rate of the sample entering the container. The sub-atmospheric pressure in the vacuumed chamber is greatest when the sealing plug is initially punched by the needle. The specimen is released uncontrollably at high speed through the empty chamber by impinging the far wall of the container.

Moreover, standard blood sampling equipment and procedures locate detailed blood samples in uncertain environments and generate high shear forces when the samples are small and absorbed through the hollow bore needle and discharged. Shear force can hemolyze blood cells. The speed and momentum of the sample entering the vacuum container causes the sample to run across the empty chamber and into the hard, sensitive, remote wall of the collection container. The flow rate of the sample into the container is sufficient to damage and rupture many red blood cells when they collide with the container wall, causing hemolysis. Many blood cells that initially survived collisions with the distant walls of an undamaged container can be damaged by a traumatic blunt force imposed on the cell.

Of course, the main purpose of sampling is to determine the health of the patient. This is best accomplished by leaving the blood sample untouched and keeping it alive, that is to say, alive and vivid.

During the analysis, if some specimens are found damaged and heavily hemolyzed during the collection process, the workplace rejects them and orders another blood sample from the patient for analysis. Resampling incurs additional unnecessary costs for the medical device and requires the patient to be needled twice or three times.

In the history of blood collection, several attempts have been made to prevent hemolysis during the collection process. Most of the hemolysis related to the prior art is to adjust the test results during the sampling process, mainly to compensate for damage on the specimen. This "post-process" process further complicates the analysis and at best is an unclear attempt to determine the health of the sample and the patient.

The most striking attempt to prevent hemolysis during the sampling process is known from Villa-Reel US Pat. No. 4, 492, 634, where a sealing plug with a baffle extension deflects a high velocity stream of blood onto the sidewall of the collection tube. . This deflection causes brittle blood cells to collide with the side walls of the tubes. The device of the villa-reel also generates further disturbances in the harvesting pipe.

An early plate-shaped device is also known from Villa-Reel U.S. Patent No. 3,848,579, which discloses an attempt to control the flow of blood through a hollow bore hypodermic needle. The device draws blood through a small hollow bore needle into a larger diameter chamber housing the reed valve, and then guides the hollow bore needle out of the collection tube. One problem arising in the Villa-Reel's device is that opening and closing of the valve causes further disturbances and acts strongly on the living blood cells that have been detailed during the sampling process. After the sample has passed through the valve, the sample flow path is again reduced. Additional parts are also needed to manufacture this invention, thus increasing the cost.

The rate at which blood is drawn from a vessel is determined by the volume of blood in the vessel, the pressure difference between the vessel's internal pressure and the sub-atmospheric pressure in the collection tube, and the inner diameter size of the needle lumen. For example, a common 21G blood sampling needle has an inner diameter of about 0.028 inches, which allows the vacuum tube to be filled in just a few seconds.

Another problem that exists regularly during the extraction process is rupture of blood vessels. In some patients the volumetric capacity of the blood vessels is inadequate for self replenishment when blood is rapidly drawn into a standard collection container. This problem typically occurs in young, old or anxious patients. Improper replenishment of blood can lead to the use of standard, sterile syringes and hypodermic needles to debilitate blood vessels, interfere with the blood collection process, and lead to bloodshot blood samples. Syringes allow manual inhalation to be applied to the blood vessels, thus allowing the health care manager to take blood samples at a rate slow enough to normally prevent blood vessel breakdown.

Typically, if a syringe is used to take blood samples from a patient with debilitating blood vessels, the patient's blood vessels must be stabbed several times to obtain sufficient blood samples for analysis. If stabbed several times, the patient is painful and takes 5 to 15 minutes to complete it. In addition, health managers can be annoyed because they are unable to sample the required sample within the allotted time without causing excessive discomfort to the patient. The collected blood sample should then be transported to a vacuum tube for storage and testing.

In contrast, another problem is that if the vacuum in the collection container decreases or leaks over time, the shelf life of the vacuumed tube is reduced. This results from improper sealing at the surface between sealing plugs / container surfaces. Sealing is not entirely made by the inherently uneven surface in the molded or compression molded elastic material. Small voids in the sealing plug and stopper surface allow the seal to crack by atmospheric pressure and the vacuum in the container is lost over time. The area where the seal is discontinuous is known in the industry as the "gray band" area. Elastic materials are known to be sensitive to temperature fluctuations and typically shrink over time.

Since vacuum leakage is widely known when a vacuumed collection container is used first, the vacuumed collection tube is also packaged in a sealed moving container that has been vacuumed. The user opened the moving container to release the vacuum in the container and then used the collecting tube.

Reduced vacuum collection containers do not provide sufficient samples for analysis and are normally disposed of as medical waste. Then another tube should be used to take the appropriate amount of sample for analysis. Despite attempts to minimize the vacuum leakage in the container generated by the sealing plugs through the computer and using various materials, the problem of vacuum loss remains.

The present invention provides an improved sealing means at the sealing plug / container surface interface. Improved sealing means The invention can be used with conventional sealing plugs or with flow diverting, regulating or diffusion sealing plugs known in the art.

Blood samples are prepared for analysis in either of two ways, depending on the nature of the test to be performed. If it is serum to be analyzed, the elements of erythrocytes and plasma remain combined with serum. Allow the sample to coagulate and shrink overnight before following the sample.

If it is the plasma or erythrocytes to be analyzed individually, they are spun in a centrifuge to separate the erythrocytes from the plasma. Additives are contained in the collection container to retard coagulation normally.

The present invention also includes a flow divert sealing plug having a liquid active material surrounding the aperture in the fluid passage. Blood is collected and within a few minutes the liquid active material expands to close the hole. Closed holes prevent any sample remaining in the sealing plug from combining with the sample in the collecting container after the sampling process is complete.

Another test, the CBC test, is performed on whole blood immediately after the sample is taken.

Blood drawn by syringe should be transferred to a vacuum tube before analysis or centrifugation. The transfer of specimens taken from a hypodermic syringe into a vacuum tube is considered the most dangerous blood transfer process in the field of medicine today, because the health care worker must move the exposed needle containing the blood directly to the hand holding the vacuum tube. With any small miscalculation, the health manager will directly inoculate the sample blood contained in the needle lumen.

During the transfer of blood contained in the syringe and needle, the needle pierces the tube and the blood sample is passed on by a blood-congenital pathogen such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), or other 20-old blood congenital If they include pathogens, the health manager can be spread by these pathogens. Bacterial pathogens, such as enterocortica and Pseudomonas fluloresin, have been identified in recently collected blood, and if additional needle stings occur and bacteria are present in the blood, it threatens the health of the health manager.

When the health manager forcibly transfers the specimen from the syringe to the tube, the overpressure of the tube moves the sealing plug from the tube and sprays the collected blood into the workplace.

Two posters highlighting the problem of transferring blood collected in a syringe into a vacuum tube were presented at the Centers for Disease Control conference in August 1995 regarding the prevention of needle sticks. Another alternative solution to this problem is known from US Pat. No. 5,439,450, where blood is drawn by a user into a 10cc sliding sleeve syringe. This larger sized syringe has a sliding sleeve with a diameter sufficient to insert a vacuum tube into the elongated sliding sleeve to isolate the needle from the health manager's hand during transfer of blood from the syringe.

A standard blood sampling system may work properly if the patient's blood vessels are removed and have the ability to quickly replace the volume of blood collected. However, about 5% blood collection should be done with a manual syringe. This can be thought of as going through a sample of about 150 million blood samples per year.

Essentially, blood cells are living, micro "liquid balloons" containing liquid in the permeable membrane that can be damaged or even ruptured when exposed to excess force. The membrane can also be destroyed as a result of torn or Otherwise you will be traumatized.

Besides hemolysis of erythrocytes, vacuum drawing can cause other abnormalities that tend to make nonsense interpretation of the data according to visual testing of the cells. The appearance of abnormal or segmented cells, which may be regarded as an indication of disease, may actually include artifacts from the vacuum extraction process. For example, red blood cell abnormalities, such as clustering or lamination, which may otherwise signal disease, may not be a disease but can be realistically generated by a blood extraction process. A better sample of blood can be obtained if the blood collection process can be achieved without causing unnecessary trauma to the patient, the circulatory system, or the blood cells in the sample.

FIG. 2 shows a blood sample introduced into the interior cavity 143 of the blood collection container 140 of FIG. 1. As shown, when the distal end 123 of the needle 121 punctures the collection container sealing plug 141, the blood sample suddenly moves to the vacuumed cavity 143. Initially, the blood sample hits the collection container wall at high speed. Rapid collisions of the blood sample against the inner wall of the cavity 143 injure the blood sample such that hemolysis and other undesirable physical changes occur within the sample.

Even the vacuumed cavity 143 is filled, and the specimen continuously enters the tube 140 at high speed, causing gaseous disturbances with the internal fluid in the cavity 143.

In addition, it is important that small amounts or smears of blood are normally placed on the slides during the sampling process. Slide samples are used to determine the percentage of white blood cells per 100 blood cells or whole blood cell count (CBC) by visual test. The CBC test can be run manually or automatically, where the laser is for the sample and the cell count is determined by laser bounces off several cells.

The smear is obtained by pressing the collection container filled against the needle holder and removing the blood collection device from the venipuncture space with the exposed needle by forcing a small amount of blood onto the slide through the needle. Occasionally, the needle used to directly access the blood vessel is discarded and a new needle is placed on the needle holder so that the filled collection container is pressed into the needle holder to obtain a smear for the slide.

Once the needle is withdrawn from the covered venipuncture space, a new needle can be used to obtain a smear for the slide. Using other needles to obtain smears for the slides adds cost and exposes the health care manager to other sharp needles containing blood.

What is needed is an apparatus and method for taking a sample sample, such as blood or other bodily fluid or gas, with a sampling container that solves the above-mentioned problems.

The present invention discloses the following U.S. patent application, (1) U.S. Patent Application No. 60/042, 978, filed Apr. 8, 1997, entitled "Device for Regulating Blood Sample Flow into a Collection Container"; (2) United States Patent Application No. 60/055, 517, filed August 13, 1997, entitled "Blood Collection Method and Device," and (3) 1997, "Blood Collection Method and Device," Retrospective application date of US Patent Application No. 60/042, 978, filed October 17, 2005.

The present invention provides methods and apparatus for blood sampling, in particular converting, carrying, regulating, spreading or controlling fluids or samples to a sampling container, thereby reducing the incidence of hemolysis and reducing the likelihood of destroying blood vessels during the sampling process. Manual operation with blood collection devices that can minimize vessel breakage during manufacturing, use and testing, improve vacuum in sealed containers, and can be placed on slides directly from closed sampling containers with a blunt needle or without the use of needles A blood sampling needle having a needle guard.

Although the present invention has been described by way of example, the same reference numerals are not limited by the accompanying drawings, which point to like elements.

1 is a cross-sectional view of an entire blood collection apparatus according to the related art.

FIG. 2 shows a blood sample contained in the conventional blood collection device of FIG. 1. FIG.

3 is an overall view of a sealing plug for a blood collection container having an open chamber on the side of the sealing plug.

4 shows a sealing plug of the invention comprising a sealing plug having a side of the sampling needle and a needle holder and a cross section of the collecting tube and an intermediate chamber.

5 is a side cross-sectional view of the sealing plug in the blood sampling device of FIG. 4.

FIG. 6 shows a sample contained in a collecting tube in the apparatus of FIG. 5; FIG.

7 is a side cross-sectional view of a sealing plug with one chamber.

8 is a cross-sectional view of the sealing plug of FIG. 7 inserted into the open end of the container, wherein the chamber has one or more holes or ports.

9 is an overall bottom view of the sealing plug of FIG.

10 is an overall bottom view of one embodiment of the present invention including multiple channels.

FIG. 11 illustrates another embodiment of the present invention in which the sealing plug regulates sample flow by partially obstructing or blocking the sample exiting the hollow bore of the needle lumen.

12 is an overall bottom view of the sealing plug of FIG.

13 is a cutaway view of a sealing plug in another embodiment of the present invention.

14 is a cutaway view of the sealing plug of the present invention with multiple reducing channels or holes.

15 is a cutaway view of the present invention in which the sealing plug of the sampling container includes a plurality of increasing or expanding channels.

FIG. 16 shows an embodiment of the invention wherein the sealing plug of the sampling container comprises two components. FIG.

17 is a cross-sectional view of the sealing plug shown in FIG. 16.

18 is a cross-sectional view of one embodiment of the present invention shown in a molded state.

19 shows a sealing plug with an existing hinge inserted into the open end of the harvesting container.

20 shows the sealing plug of the present invention with a reed valve.

Figure 21 shows a sealing plug of the present invention with a recessed reed valve.

FIG. 22 is a view showing the sealing plug shown in FIG. 20. FIG.

FIG. 23 is a view showing the sealing plug shown in FIG. 21; FIG.

Figure 24 illustrates another embodiment of the present invention in which the sealing plug comprises a movable component having a closed port or hole and the needle holder comprises a compression longitudinal resistance member.

FIG. 25 shows a sharp tip of a needle that engages the movable component of a sealing plug and opens a hole, wherein the tube closure and the needle holder provide a screw or friction means to direct the sample flow to the sampling container.

Fig. 26 is a sectional view of the sealing plug of the present invention with a movable component and a closing hole.

Fig. 27 is a cross sectional view of the sealing plug of the present invention with an integrally formed movable component and a closing hole;

28 is a cross-sectional view of a conventional hypodermic needle wall.

29 is a cross sectional view of a hypodermic needle wall with an inner wall coated with a friction reducer, filter or anticoagulant.

30 shows a needle tube and a vacuum tube provided with a screw or friction means for adjusting a sample flow with a sampling container.

31 is a cross sectional view of a needle with an expansion needle bore;

32 is a cross-sectional view of the harvesting container having a sealing plug and an adjacent chamber.

33 is a cross sectional view of a collecting tube having a multi-chamber sealed plug;

34 illustrates a needle holder and a sampling needle having a sampling tube of the present invention comprising a seal engaging a sealing plug, a seal having a passageway and an intermediate chamber.

FIG. 35 is a side cross-sectional view of the assembly of FIG. 34 with a needle tip in an intermediate chamber.

FIG. 36 shows the apparatus of FIG. 35 with outer sealing means and a reducing inner chamber.

37 is a partial cutaway view of a harvesting container comprising a sealing plug with one intermediate chamber and filtering means;

FIG. 38 illustrates a two pass sealing plug of the present invention in which an intermediate chamber is created by adjoining two components together. FIG.

FIG. 39 is an overall bottom view of the sealing plug of FIG. 38; FIG.

40 is a partial cross-sectional view of one embodiment of the present invention including adjustable flow regulating means.

FIG. 41 is a modified side view of the device shown in FIG. 40; FIG.

42 is a partial cutaway view of a conventional harvesting container.

43 is a cross-sectional view of one embodiment of the present invention of a harvesting container having a protective coating or film on the outer surface of the container.

FIG. 44 is a cross-sectional view of one embodiment of the present invention of a harvesting container having a protective coating or film on the outer surface of the container extending beyond the outer surface of the interface of the sealing plug and the container. FIG.

45 is a cross-sectional view of one embodiment of the present invention of a collecting container with a coating, film or label on the outer surface of the interface of the sealing plug and the container.

46 is a partial cutaway view of the present invention wherein the sealing plug of the harvesting container includes a sensor accessible to both the inside and outside of the container.

FIG. 47 shows another embodiment of the present invention with a sealing plug and a switching component.

FIG. 48 shows another embodiment of the invention with a sealing plug and a conversion component with internal recesses. FIG.

49 is a side view of a conversion component that may be coupled to a sealing plug of the present invention.

50 is a bottom view of the conversion component shown in FIG. 49;

51 is a side sectional view of the sealing plug in one embodiment of the present invention;

FIG. 52 is an overall bottom view of the sealing plug shown in FIG. 51; FIG.

FIG. 53 illustrates another embodiment of the present invention of a self-sealing sealing plug that remains at an openable end of a container.

FIG. 54 is a cross sectional view of the sealing plug of FIG. 53 showing the self-sealing sealing plug removed from the openable end of a container having a slidable seal operated on the sealing plug;

FIG. 55 shows another embodiment of a seal and a sealing plug with flow indication or viewing portion. FIG.

56 is a cross-sectional view of the harvesting container of the present invention with a rounded end.

FIG. 57 is a cross sectional view of the present invention allowing coupler or extension a large diameter harvesting container to be used in a needle holder having a smaller diameter than a large diameter container;

FIG. 58 is a cross sectional view of the present invention allowing flow control couplers or extensions for use with needle holders having a smaller diameter than larger diameter containers.

Fig. 59 is a cross sectional view of the present invention in which a single harvesting container can be used in a needle holder having a diameter of several sizes;

60 is a side view of the sealing plug of the present invention with discharge means;

FIG. 61 is an overall bottom view of the sealing plug of FIG. 60; FIG.

FIG. 62 is a sectional view of the sealing plug shown in FIG. 60, closing the open end of the collecting container; FIG.

FIG. 63 is a cross-sectional view of the sealing plug shown in FIG. 62 in which the inner chamber of the collecting container is exposed outside the container before complete removal of the sealing plug from the collecting container; FIG.

64 is a cross sectional view of the sealing plug of the present invention including a sealed chamber of external access;

FIG. 65 is a cross sectional view of the sealing plug of FIG. 64 with the chamber open; FIG.

66 is an overall side view of a sealing plug of the present invention including a movable shield with a hole;

FIG. 67 is an overall side view of the sealing plug of FIG. 66 with the hole in the movable shield positioned adjacent to the chamber of the sealing plug;

FIG. 68 is a sectional view of the movable shield and sealing plug shown in FIG. 66; FIG.

FIG. 69 is a cross-sectional view of the movable shield and the sealing plug of FIG. 67, wherein the holes of the movable shield are positioned adjacent to the chamber of the sealing plug; FIG.

70 is a side sectional view of the container with a sealing plug that includes means for diffusing fluid entering the container.

FIG. 71 shows the blood collection device of FIG. 70, showing that the sample diffuses as it enters the container.

72 is a partial side cross-sectional view of a container with a sealing plug that includes a hole with a liquid active portion.

FIG. 73 is a side sectional view of the container containing the liquid of FIG. 72 with the hole closed in the liquid active portion; FIG.

FIG. 74 is a cross-sectional view of the present invention with switching means in combination with a conventional sealing plug, wherein the switching component may also include means for improving sealing at the sealing plug / container surface interface.

75 is a cross sectional view of the present invention with means for improving sealing at a sealing plug / container surface interface.

FIG. 76 is a cross sectional view of the present invention including a sealing plug having a pressure sensitive valve actuated when a pressure differential occurs on either side of the valve; FIG.

FIG. 77 is an overall side view of the valve component of FIG. 76; FIG.

FIG. 78 is a cross sectional side view of a sealing plug with a diverter including an open channel or slot for accessing a specimen in a container with a long needle without removing the sealing plug; FIG.

FIG. 79 is a top view of the diverter of FIG. 78 including the diverter chamber separated by an open channel or slot and wall portion;

FIG. 80 shows a blood collection needle with a needle guard that can only be operated manually;

The above object is achieved by the sampling device of the present invention which is capable of regulating, limiting, controlling, switching or altering the flow of the sample in the collecting container, the vacuumed container or the syringe.

The present invention provides an improved apparatus and method for delivering a sample sample to a collection container.

In one embodiment, a sampling device is provided, which has flow diverting or regulating means for diverting or regulating the flow of the sample into the sampling container.

In one embodiment, the sampling device is provided with a needle or other fluid communication means having a colored or limited lumen that regulates the flow rate of the sample into the sampling container.

In another embodiment, a hypodermic needle or other fluid / gas communication means is provided and has a lumen bore coated with an anticoagulant such as heparin.

In yet another embodiment, a tube seal plug is provided and has flow diverting or regulating means for diverting or regulating the flow to the harvesting container. The sealing plug includes one or more openings, channels, cavities, areas or passageways that divert or control the specimen from the needle through the sealing plug. Flow diverting or regulating openings, channels, cavities, zones or passageways communicate directly with the interior cavity of the harvesting container. Flow diverting or regulating openings, channels, cavities, regions or passageways may also be coated with friction reducing agents, anticoagulants and the like used in the analysis of blood.

In another embodiment, a sealing plug is provided, which itself has flow diverting or regulating means for diverting or regulating the flow. The sealing plug is provided with one or more chambers, which may be one internal, open or intermediate chamber that diverts or regulates sample flow to the collection container. Blood or other bodily fluids or gases are introduced into the chamber of the sealing plug before being directed to the internal cavity of the collection container. The chamber may be coated with friction reducing agents, anticoagulants typically used for analysis of blood.

The sealing plug of the present invention suspends blood in the fluid medium when it is taken, thus reducing the possibility of damaging blood elements during the extraction process.

In another embodiment, the sealing plug comprises a plurality of parts that make up the sample flow diverting or regulating means. Multiple parts may be coated with friction reducing agents, anticoagulants, and the like used in the analysis of blood.

In another embodiment, the sealing plug comprises a plurality of parts that make up the sample flow diverting or regulating means, so that the intermediate chamber is created by joining the sealing plug parts together. Multiple portions may also be coated with friction reducing agents, anticoagulants, and the like, commonly used for analysis of blood.

In another embodiment, the sealing plug comprises a plurality of parts that make up the sample flow diverting or regulating means, so that the intermediate chamber is created by joining the sealing plug and the individual parts together. Multiple portions may also be coated with friction reducing agents, anticoagulants, and the like, commonly used for analysis of blood.

In another embodiment, a vacuum tube seal / plug is provided and has adjustable flow diverting or regulating means for diverting or regulating the flow to the collection container. Flow diverting or regulating part sealing plugs are contained within the container openings.

In another embodiment, a vacuum tube sealing plug is provided and the sealing plug has adjustable flow diverting or regulating means for diverting or regulating the flow. The sealing plug is more compact than the sealing plug and includes a second plug or portion that is joined by the needle during the blood draw process. The advancing needle moves the second plug or portion so that the port on the sealing plug opens and the specimen enters the collection container at a controlled rate. The second plug or portion may be coated with a friction reducing agent, an anticoagulant, or the like conventionally used for the analysis of blood.

In another embodiment, a tube seal plug, or seal closure is provided, and an adjustable flow diverting or adjustment that frictionally or screw-couples the inner portion of the sampling needle holder to allow the healthcare worker to adjust the sample flow to the collection container. Have the means. The joining part may also be coated with a friction reducer.

In one embodiment, the sealing plug includes flow diverting or regulating means for restricting the sample flow from the chamber of the sealing plug to the interior cavity of the collection container.

In another embodiment, the sealing plug includes linked flow diverting or regulating means for restricting sample flow from the sealing plug to the harvesting container.

In one embodiment, a sampling device is provided and has flow diverting or regulating means for diverting or regulating the flow rate of the sample into the sampling container.

In one embodiment, the sampling device is provided with a removable shield over the sealing plug that the health care manager is not exposed to the patient's blood during the collection and testing process and also facilitates the removal of the sealing plug from the collection container.

In another embodiment, a tube seal plug is provided and has flow diverting or regulating means for diverting or regulating the flow in the harvesting container. The sealing cap includes one or more openings, channels, cavities or regions that regulate the sample flow from the hollow bore needle through the sealing plug to the collection container. Flow control openings, channels, cavities, regions or passageways may also be coated with friction reducing agents, anticoagulants, and the like used in the analysis of blood.

In another embodiment, a tube seal plug is provided and has two piece flow control means for regulating flow in the harvesting container. The flow control portion is simply pushed into the sealing plug before insertion into the opening of the container.

In another embodiment, a vacuum tube sealing plug is provided and has filtration means for filtering the sample as it flows into the sealing plug.

In another embodiment, an adjustable flow diverter is provided that is provided with a vacuum tube, a sealing plug, or a sealing closure and that frictionally or threadedly engages an internal portion of the sampling needle holder that allows the healthcare worker to adjust the sample flow in the sampling container. Or an adjustment means. The binding part may be coated with a friction reducing agent, an anticoagulant or the like used in the analysis of blood.

In one embodiment, the sealing plug includes flow diverting or regulating means for restricting the sample flow from the sealing plug to the internal cavity of the harvesting container by a strainer or a reduced passage.

In another embodiment, the sealing plug includes linked flow diverting or regulating means for restricting sample flow from the sealing plug to the harvesting container.

In another embodiment, the position of the needle tip in the perforated sealing plug is provided to limit the longitudinal movement of the needle tip only within the sealing plug chamber and not into the interior chamber of the harvesting container.

In another embodiment, a collection container is provided and has an outer coating or film to increase the crush resistance of the collection container.

In one embodiment, a harvesting container is provided and has a breakable polymer, elastic or the like coating or film applied to the interface of the sealing plug and the container to reduce the likelihood of vacuum leakage in the vacuumed chamber. This embodiment also serves as an indicator to indicate signs of vacuum leakage or tampering. Breaking this seal or coating will inform the health care manager of the possibility of vacuum leakage or traces of tampering.

In another embodiment, a sampling container is provided and by having a sealing plug with a sensor accessible from the outside of the collecting container, the specimen can be analyzed without removing the sealing plug.

In another embodiment, a harvesting container is provided and has a sealing plug that seals automatically when the sealing plug is removed from the harvesting container. The sliding seal covers the inner surface of the sealing plug which comes into contact with the sample taken. The sliding seal closes the sealing plug chamber and traps any residual specimen contained within the chamber to prevent contact with the health manager.

In another embodiment, a harvesting container is provided and has a flow indication or viewing area for observing sample flow during the harvesting process.

In another embodiment, a harvesting container is provided, having a semi-circular end for inserting either end container into a centrifuge.

In another embodiment, a coupler or extension is provided and a thinner angle is available to access the insertion space by allowing a larger diameter harvesting container to be used as a smaller diameter needle holder.

In another embodiment, a flow control coupler or extension is provided and a thinner angle is available to access the insertion space by allowing a larger diameter harvesting container to be used as a smaller diameter needle holder.

In one embodiment, a single harvesting container can be used for needle holders of various diameters.

In another embodiment, a sealing plug with discharge means is provided to equalize the atmospheric pressure within the collection container with the atmospheric pressure before complete removal of the sealing plug from the collection container.

In one embodiment, the specimen is seated in a chamber of the sealing plug of external access, allowing the specimen to be placed on the slide without using a needle to access the specimen.

In another embodiment, it is used to gain access to a needle filled harvesting container with a pointed tip, and the other exposed needle end has a blunt tip that reduces the chance of needle sticking and allows the specimen to be safely placed on the slide.

In another embodiment, a container with an improved sealing plug / container surface interface is used to increase the shelf life of the vacuumed container.

In another embodiment, the sealing plug comprises a porous material that diffuses or filters the liquid to be drawn out of the container.

In another embodiment, the sealing plug with the liquid working portion allows for sampling and no sample remains in the sealing plug during the centrifugation process.

In another embodiment, the transition part with one or more holes is inserted into the hollow end of a conventional sealing plug, allowing the use of existing sealing plug mechanisms and existing containers. This embodiment reduces the overall cost of implementing the flow divert or regulation invention. The size of the hole can be made smaller than the inner diameter of the needle used to drill the sealing plug, reducing the possibility of sample flow and arterial breakdown. The process of using the reduced pore size in the converter does not take long because the flow is reduced or restricted.

The pore size may also be equal to or larger than the inner diameter region of the needle used to drill the sealing plug, allowing full flow through the needle during the sampling process. The process using the same or increased pore size in the converter will take the same time as the standard blood draw.

In one embodiment, the sealing plug with the pressure sensitive valve is actuated when a pressure difference occurs on both sides of the valve.

In another embodiment, the sealing plug is shown having a diverter with a chamber adjacent the aperture.

In another embodiment, a blood collection needle with a needle guard is shown, where the needle guard may optionally be operated by a user.

Purpose of the Invention

It is therefore an object of the present invention to provide a subcutaneous blood collection device and method that allows conversion, control, control, diffusion, or variable sample flow into a collection container.

It is another object of the present invention to provide a subcutaneous blood collection device and method that allows for regulation, control, control, opening and closing, diffusion, or variable sample flow through or within a diaphragm or plug and into a collection container.

It is yet another object of the present invention to provide a subcutaneous blood collection device and method that allows for adjustment, control, control, opening, switching, spreading or variable sample flow into a sampling container without adding any additional parts to the device.

It is yet another object of the present invention to provide a subcutaneous sampling device and method that allows regulation, control, control, opening and closing, spreading, or variable sample flow into a sampling container and functions in a similar way as in a standard blood hypodermic needle system .

It is yet another object of the present invention to provide a subcutaneous blood collection device and method that allows for regulation, control, control, opening, switching, diffusion, or variable sample flow into a sampling container adapted for automated manufacture.

Still another object of the present invention is a subcutaneous sampling device that allows regulation, control, control, opening and closing, spreading, or variable sample flow with a collection container, and which can be positioned away from the vascular-rich access space by a tube or the like; To provide a way.

It is another object of the present invention to allow for adjustment, control, control, opening, switching, spreading or variable sample flow into a harvesting container, wherein variable compression or circumferential forces allow interaction between the sealing plug and the openable port of the sealing plug. It is to provide a subcutaneous sampling device and method used to limit or control.

Another object of the present invention is to control, control, control, open and close, spread, or vary sample flow with a harvesting container, and subcutaneous specimens in which variable compressive forces are used to limit or control the interaction between the needle holder and the harvesting container. It is to provide a sampling apparatus and method.

It is also an object of the present invention to provide a subcutaneous sampling device and method that allows the sample to remain predominantly in the fluid medium and cushion the sample flow in the collection container.

It is yet another object of the present invention to provide a subcutaneous sampling device and method that allows sample flow into the harvesting container and wherein one or more diaphragms or barriers regulate, inhibit, divert or control the sample flow within the harvesting container.

It is a further object of the present invention to use flow control means in another collection or transfer process, such as transferring blood from a syringe to a collection container.

It is yet another object of the present invention to provide a sampling device that reduces the likelihood of debilitating a patient's blood or other blood vessels on the body during the sampling process.

Another object of the present invention is to reduce sample trauma during the sampling process.

It is yet another object of the present invention to provide a sampling device and method for reducing the hemolysis of a sample taken during a blood collection process.

It is a further object of the present invention to provide a flow reduction and then increase means in a sealing plug that regulates the sample flow into the collection container.

It is a further object of the present invention to provide a filtration means in a sealing plug that regulates, controls, controls, opens, switches or regulates the sample flow into the collection container.

It is a further object of the present invention to provide a sensing means in a sealed plug or container that determines the state of blood, blood elements or blood gases when blood is contained in the sampling container, sealed plug or passage.

It is another object of the present invention to provide a protective coating or film on a harvesting container to reduce the likelihood of breakage and leakage during manufacture, storage and use.

Another object of the present invention is to provide a coating or film on the collection container seal to prevent vacuum leakage of the collection container prior to use.

It is a further object of the present invention to preserve the shelf life of samples taken in the most possible state possible.

Another object of the present invention is to keep the sampled cells alive and moving until analyzed.

It is a further object of the present invention to provide a collecting container having a sealing plug which, upon removal, automatically seals the surface of the sealing plug which comes into contact with the specimen in the collecting container.

It is a further object of the present invention to provide a harvesting container having a flow display means that is visible to the user.

It is a further object of the present invention to provide a coupler that allows a larger diameter harvesting container to be used in a smaller diameter needle holder.

It is a further object of the present invention to provide a flow control coupler which allows a larger diameter harvesting container to be used for a smaller diameter needle holder.

It is a further object of the present invention to provide a single harvesting container that can be used for needle holders of different diameters.

It is a further object of the present invention to provide as close a needle access angle as possible to be parallel to the plane of the insertion space.

It is a further object of the present invention to provide a discharging means which equalizes the internal pressure and atmospheric pressure in the collection container prior to complete removal of the sealing plug from the collection container.

Another object of the present invention is to provide access to a small amount of sample from the collection container without the use of a needle to obtain the sample.

Another object of the present invention is to expose a hollow bore needle with one blunt tip to gain access to a filled container and another blunt tip to reduce the possibility of needle sticking and allow the specimen to be safely placed on the slide. To provide a needle end.

It is another object of the present invention to provide a means for diffusing a liquid entering a container.

It is a further object of the present invention to provide an improved sealing means at the sealing plug / container surface interface.

It is a further object of the present invention to provide an improved sealing means at the sealing plug / container surface interface which may comprise sample conversion, diffusion or control means.

It is a further object of the present invention to provide a sealing plug with a pressure sensitive valve means that actuates when a pressure differential occurs on either side of the valve.

It is a further object of the present invention to provide a sealing plug with adjacent channels and switching means allowing the sample to be taken in a normal manner when the blood sampling needle penetrates the sealing plug concentrically, and the chamber created by the sealing plug and the diverter. It is to provide a longer needle to obtain a sample taken for analysis which drills a sealing plug concentrically without contacting any sample remaining in the sample.

It is a further object of the present invention to provide a blood collection needle in which the needle guard can be selectively operated only by manual release means.

For simplicity, reference numerals shown herein may be compatible in the drawings and may provide various combinations of the described invention.

The objects and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings.

Apparatus and methods are described for taking a blood sample or other fluid or gaseous material on the body. In the following description, material forms, dimensions, processes and the like are described in more detail for a complete understanding of the present invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without the specific details. In other instances, well known structures and process steps have not been described in order to avoid unnecessary obscurity of the present invention. In addition, the description herein focuses primarily on the collection of blood from human patients. However, please note that this focus is for illustrative purposes only. The present invention is not limited to collecting blood from a patient, nor is it limited to collecting a sample sample.

The container used for sampling, referred to throughout this specification by reference numeral 40, is made of glass, plastic resin or compound material and is closed by a normally vacuum and perforated sealing plug. The internal cavity 43, referred to throughout the present disclosure as 43, is a void or chamber in the container 40.

Referring to FIG. 3, there is shown a full side view of a sealing plug including a chamber 61 openly connected to the side of the sealing plug. The sealing plug 41 is insertable into the open end of the container.

4 shows the sealing plug 41 in a full side view of the blood collection needle 21, showing the needle cover 25 and the container 40 in close proximity to the cross section of the needle holder 30. The collecting tube 40 has an open end and a closed end, and the inner cavity 43 is created by placing the sealing plug 41 in the open end to maintain the sub-atmospheric pressure in the pipe.

The perforated sealing plug 41 comprises one or more chambers 61 and switching means 73 for diverting the specimen when the specimen enters the sealing plug. The chamber 61 is connected to the inner chamber 43 of the container 40 by one or more passages 60. The container 40 is positioned in the cavity 35 of the needle holder 30. The needle 21 has an end 23 proximate the crisp distal end 20. The distal end 20 is insertable into a blood vessel to obtain a sample sample of test blood. The proximal end 23 lies in the needle holder 30 and drills the sealing plug 41 and allows the specimen to flow out of the vessel and into the container 40 during the sampling process. The needle 21 includes a lumen 24 in open communication with each end creating a passageway from the proximal end 23 to the distal end 20. The needle cover 25 is typically used to seal the proximal end of the needle 21.

The sealing plug 41 automatically diverts the specimen from the original fluid passageway when first pierced by the needle 21, thus eliminating the possibility that the specimen will receive momentum when entering the container 40. The size of the passageway 60 is less than, equal to or greater than the area of the needle lumen. A passage 60 equal to or larger than the area of the needle lumen allows the sample to flow freely. A passage 60 smaller than the area of the needle lumen reduces and adjusts the sample without changing the sampling process.

FIG. 5 is a cross-sectional view of the container 40, the sealing plug 41 and the needle holder 30 of FIG. 4, where the container 40 is positioned in the cavity 35 of the needle holder 30.

The sealing plug 41 includes one or more chambers 61 for diverting the sample flow. In one embodiment, the chamber 61 comprises diverting means 73 in the front of the convex wall portion which regulates the sample flow from the patient to the collection container 40. The convex wall portion allows any sample remaining in the chamber 61 to flow into the container 40 before or during the centrifugation process.

One or more passageways or holes 60 are provided between the chambers 61 to fluidly communicate between the chambers 61 and the tube cavity 43. The converter 73 can include soluble materials that convert the sample during the sampling process and dissolve after the sample is taken. Soluble materials can also be used to facilitate analysis of the sample taken.

The smaller or reduced passageway 60 can adjust the volume of the sample taken to prevent arterial breakdown with respect to the standard blood collection process. The size of the other passage 60 allows to obtain various flow sampling rates without changing the technology currently used.

6 is a cross-sectional view of FIGS. 4 and 5, showing that the specimen enters the chamber 61 of the sealing plug 41 and into the container 40. The sample flow is diverted from the needle 21 by the diverter 73, the chamber 61 and the passage 60 before entering the internal cavity 43 of the harvesting container 40. The sealing plug 41 holds the specimen in the chamber 41 after collection and protects the specimen from contamination.

7 is a cross-sectional view of the sealing plug along the 7-7 axis of FIG. 9 used to close the sampling container, which controls, controls, diverts, and reduces sample flow in the sealing plug 241 during the blood collection process. And a chamber 261 and a diverter 273 for increasing, re-guiding or blocking the chamber 261, which is positioned adjacent to the recess 260.

8 is a cross-sectional view of the container 40 of the present invention including one open end, closed end and inner chamber 43. The open end is hermetically closed by a removable sealing plug 241 with a diverter 273, wherein the one or more chambers 261 and one or more grooves or voids 260 have a sealing plug 241 with the open end of the container. When positioned within and emptying the conduit 40, it creates an internal channel, port or passageway. The sealing plug 241 and the chamber 261 also have a smaller cross-sectional thickness to reduce the overmass of the plug. By reducing the size and mass of the sealing plug, the manufacturing cost is lowered.

The inner wall or chamber 261 of the container or collection tube 40 may also include coatings, additives, gels, inert polymers or other materials used in conventional procedures for collecting and analyzing blood and blood.

FIG. 9 is an overall bottom view of the sealing plug of FIG. 7 to regulate, control, divert, reduce, increase, redirect or block sample flow through one or more grooves 260 and in the sealing plug 241 during the blood collection process. And a plug plug 241 used to close the container 40. The recess 260 creates an internal channel or passage when the sealing plug 241 is positioned within the open end of the container 40 or the vacuumed tube. The sealing plug 241 includes a passage through the bottom of the diverter 273 directly from the intermediate chamber, eliminating the need to be positioned within the open end of the container or vacuumed tube to create the passage.

10 is an overall bottom view of another embodiment of a sealing plug 241, where the sealing plug 241 regulates, controls, diverts, decreases, increases, redirects or blocks the sample flow in the sealing plug 241 during the blood collection process. And a diverter 273 for the purpose of closing the container. The recess 360 creates an internal channel or passage when the sealing plug 241 is positioned within the open end of the container or the vacuumed tube.

11 is a cross-sectional view of the sampling container 40 with the inner chamber 43 and a cutaway view of the sealing plug 441, wherein the sealing plug 441 is mounted on the sealing plug 441 before the sample enters the container 40. It has a number of uniformly sized end holes or channels 467 to regulate, control or slow the flow and is used to close the container 40. Although the holes 467 are shown here as having a uniform shape, they can be inclined, irregular, curved, or the like.

FIG. 12 is an overall bottom view of the sealing plug of FIG. 11, with an elastic material sufficient to frictionally engage and seal the inner chamber of the container and one or more portions 467 to control, control or slow down the sample flow to the sealing plug 441. A sealing plug 441 that may be included.

13 is a partial cutaway view of a sealing plug in another embodiment of the present invention, comprising a plurality of internal chambers 166 for receiving end portions of tubes or needles that penetrate the sealing plug 114 and enter the chamber 166; The flow control means including a sealing plug 114 with a reduced end hole 167 for regulating or slowing down the sample flow in the sealing plug 114 before entering the connected sampling container. Although the inner chamber 166 is shown here at one depth, it may be positioned or staggered at various levels or depths to facilitate core extraction during manufacture.

14 is a partial cutaway view of the sealing plug of the present invention used to close the harvesting container, with a plurality of chambers 266 for receiving the ends of tubes or needles that penetrate the sealing plug 214 and enter the chamber 266. Flow control means comprising a sealing plug 214 having a reduced end hole 267 for adjusting or slowing down the sample flow in the sealing plug 214 before entering the sampling container to which the sample is connected. Although the inner chamber 266 is shown here at one depth, it may be positioned or staggered at various levels or depths to facilitate core extraction during manufacture.

FIG. 15 is a partial cutaway view of the sealing plug of the present invention used to close the collection container, with a plurality of chambers 366 for receiving the end of a tube or needle that penetrates the sealing plug 314 and enters the chamber 366. , Flow control means including a sealing plug 314 having an expansion end hole 367 for adjusting or delaying or increasing the sample flow in the sealing plug 314 before the sample enters the collection container. Although the inner chamber 366 is shown here at one depth, it may be staggered at various levels or depths to facilitate core extraction during manufacturing. Sample flow is increased as the needle moves further into the increment chamber 366.

FIG. 16 is an overall side view of a two piece sealing plug of the present invention used to close a container having a perforated portion 32 and a flow regulating or diverting portion 42. The flow diverting portion 42 has one or more holes 767 in the sealing plug 32 to regulate, divert or retard the sample flow when the sample exits the needle. The portion 42 is slightly smaller in diameter or size than the portion 32 for easy removal of both portions 32 and 42 from the collection container. The part 42 can also be of the same size as the part 32.

FIG. 17 is a side cross-sectional view of the two piece sealing plug shown in FIG. 16 with a perforated portion 32 and a flow regulating portion 42. The flow regulating portion 42 has a plurality of chambers 66 for receiving the end of a tube or needle that penetrates the sealing plug 42 and enters the chamber 66. The chamber 66 is connected to a plurality of end holes 767 that regulate or control the sample flow to the sealing plug 42. Although the inner chamber 66 is shown here at one depth, it may be staggered at various levels or depths to facilitate core extraction during manufacture.

18 is a cross-sectional side view of a two part sealing plug of the present invention that includes a joinable sealing plug 532 used to close a container. The sealing plug 532 is shown in an open facing shape with two connected portions, and the perforated portion 532, which is connected to the flow regulating portion 542, has a sealing plug 532 and a portion 542. When coupled to each other it has a groove 68 and a connecting means 70 for making the inner chamber. Flow control portion 542 has one or more recess chambers 68 for receiving the end of a tube or needle that penetrates sealing plug 532 and enters chamber 68. The chamber 68 is connected to a plurality of end holes 567 that regulate or divert the sample flow to the sealing plug 532 when the sample exits the needle. Although the inner chamber 68 is shown here at one depth, it may be staggered at various levels or depths to facilitate core extraction during manufacture. The open faced embodiment of the flow control sealing plug 542 allows a wide variety of flow control properties to be readily incorporated into the present invention during manufacture. The present invention is not limited to the end hole 567 and may include reduced, increased, inclined or curved shapes.

FIG. 19 is a side cross-sectional view of the two-part sealing plug 632 shown in FIG. 18, shown in a combined shape with two connecting portions 632, 642, with one perforated portion 632 being a sealing plug When the 632 and the portion 642 are coupled to each other, there is a recess 668 for making the inner chamber, a connected perforated flow control portion 642 and a connecting means 670. The perforated sealing plug 632 has one or more inner recess chambers 668 for receiving the ends of tubes or needles that penetrate the sealing plugs 632 and enter the chamber 668. Flow control portion 642 has a plurality of end holes 667 in the sealing plug 642 that control or divert the sample flow when the sample exits the needle.

Although the inner recess chamber 668 is shown here at one depth, it can be manufactured with multiple levels or depths. The sealing plug portion 632 and 642 are coupled to each other where a male pin or post 79 is shown as a female hole or portion. The engagement portion may also include an undercut or other means for fixedly attaching or engaging the sealing plug portion 632 and 642 with each other.

20 is a partial cutaway view of the sealing plug of the present invention including a one-piece punchable sealing plug 37 used to close the harvesting container, with flow control having an intermediate chamber 168 and a flow control reed valve 76. The means are shown.

FIG. 21 is a partial cutaway view of the sealing plug of the present invention including a one-piece punchable sealing plug 137 used to close the harvesting container, with chamber 268 and perforated wall portion 77 and flow control A grooved flow control means with a reed valve 176 is shown. As the needle advances into the chamber 268, the reed valve 176 allows the sample to flow into the container. The needle may be further advanced to drill the wall portion 77, allowing sample flow directly into the container during the harvesting process.

FIG. 22 includes a sealing cap 37 with a rib valve 76 in the entire bottom view of the sealing plug shown in FIG. 20.

FIG. 23 is an overall bottom view of the sealing plug shown in FIG. 21 and includes a sealing cap 137 having a recessed chamber wall 77 and a reed valve 176.

24 is a cross-sectional view of the blood collection device of the present invention prior to insertion, showing the entire view of the needle 21, and is a cross-sectional view of the needle holder 230 and the container 40, wherein the container 40 has an adjustable flow, perforation. An internal cavity 43 with a possible plug plug 83, an inner chamber 368, an openable valve or port 75, and a second plug or diverter 80 that is movable, hardly penetrating. Port 75 shown here is closed and adjacent to port or passageway 160. The needle holder 230 has a plurality of protrusions 34 for compressively resisting the axial movement of the container 40. The compressive force must be placed on the container 40 in the holder 230 to take the sample.

25 is a cross-sectional view of the blood sampling device of the present invention during the sampling process, including a needle 21, a needle holder 230, and a container 40, wherein the container 40 is an adjustable flow, pierceable sealing plug 183. ), Internal chamber 468, an openable valve or port 175 and an internal cavity 43 having a movable second plug 80 that is hardly pierceable. Once the needle 21 enters the chamber 468, the needle tip 23 engages the diverter 80 that opens the port 175, allowing the sample to flow into the interior cavity 43 of the collection tube 40. do. The port 175 opening can be reduced by partially separating the needle tip 23 from the movable plug 80. The port 175 opening can be closed completely by completely removing the needle tip 23 from the second plug 80.

The adjustable flow with respect to penetration is rotatably controlled by the friction of the sealing plug 183 or by the screw means 84 and the friction or screwing means 82 of the needle holder 330.

FIG. 26 is a side cross-sectional view of the adjustable flow sealing plug of the present invention used to close a container, used in the same way as the sealing plug shown in FIG. 25, with an intermediate chamber 568, an openable port 275 and a uniform And a pierceable sealing plug 283 having a movable plug 88 having a consistently consistent wall portion.

FIG. 27 is a side cross-sectional view of the adjustable flow seal plug of the present invention, wherein the movable, integrally molded, almost impermeable portion or stop when engaged with the intermediate chamber 668, the openable port 675 and the needle. A sealing plug 85 having a portion 81.

28 is a cross sectional view of a conventional hollow bore needle 121 having a smooth outer wall and a rough inner wall.

29 is a shear cross-sectional view of the hollow bore needle of the present invention with a smooth outer wall, wherein the inner wall 211 is coated with a friction reducing lubricant 212 to reduce the rough surface of the inner wall 211. The inner wall 211 can also be manufactured in a soft fashion by mechanical or chemical means. Lubricant or filter 212 is disposed in the groove of the inner wall 211, making a smoother inner wall surface. Inner wall coating 212 also includes a material that prevents blood coagulation.

30 is a cross-sectional view of the blood sampling device of the present invention during the sampling process, which includes a needle 21, a needle holder 430 and a container 240, wherein the container 240 is sealed when the sample emerges from the needle 21. The plug 441 includes an interior cavity 43 with an inserted sealing plug 441 having a plurality of uniformly sized end holes 467 for controlling or diverting the sample flow.

The adjustable flow with respect to penetration is dependent on the rotational movement of the container 240 with respect to the needle holder 430 by means of the protrusion or threaded portion 182 of the needle holder 430 corresponding to the protrusion or threaded portion of the container 240. Is controlled by The adjustable flow with respect to penetration can also be controlled by frictional engagement of the container 240 and the needle holder 430.

31 is a cross-sectional view of the blood collection device of the present invention prior to use, with a collection container having a needle 21, a needle holder 30, an inner cavity 143, and a sealing plug 141 connected to an enlarged bore needle 321. 140.

32 is a cross-sectional view of a container of the present invention showing a perforated sealing plug 55 having a separator 29 with one or more holes or ports 867, a container 40 having an internal cavity 43, the membrane 29 makes an intermediate chamber 868 adjacent to the sealing plug 55. Membrane 29 may be permeable or impossible at least in advance in perforated portion 867.

33 is a cross-sectional view of the collecting container of the present invention showing a container 40 having an inner cavity 43, wherein the open end of the container 40 is the second chamber 69 and the inner chamber created by the diverter 973. FIG. 968 is sealed by a multi-chamber seal plug 65. Chamber 69 is connected to first chamber 968 by port, hole or passageway 72. The sample first flows into chamber 968 and then through port and passage 960 into chamber 69 into interior cavity 43. The second chamber 69 is originally a recess or channel of the sealing plug 65 and makes the chamber 69 when the sealing plug 65 is positioned within the open end of the container or vacuum tube 40.

The sealing plug 65 has a similar shape to a standard syringe piston.

FIG. 34 shows the blood collection device of the present invention prior to use with the entirety of the needle 21 and the sealing plug 51, the cross section of the needle holder 30 and the tube 40, and the cutaway of the seal 50. A perforable sealing plug 532 having a passageway 360 and an inner chamber 361 connected to the inner chamber 43 of 40. The sealing plug 532 includes one or more intermediate chambers 361 for regulating or diverting the sample flow from the needle 21 to the container 40. The seal 50 is connected to the sealing plug 532 at the interface 46 for removal from the container 40 to reduce the exposure of blood and fluid on the body to the health care manager during the collection and testing process. The seal 50 has a radially extending face covering the top of the shield 50 with a hole or opening 44 for accessing the sealing plug 532 to the needle 21. The sealing plug 51 is contained within the shield 50 extending the annular enclosing sealing plug 532.

The seal 50 facilitates easy removal of the sealing plug 532 from the container 40. The container 40 is positioned in the cavity 35 of the needle holder 30. The distal end 20 of the hollow bore needle 21 is insertable into the blood vessel to obtain a sample of test blood.

FIG. 35 is a side cross-sectional view of the collection container of FIG. 34 during use, wherein the container 40 is one or more intermediate chambers 361 for converting or maintaining the sample flow in fluid suspension once the sample is taken from the patient to the container 40. It includes a sealing plug 51 having. A passage is provided between the chamber 361 of the one or more sealing plugs 51 and the internal cavity 43 of the container 40. The sealing plug 51 has a shield 50 that facilitates easy removal of the sealing plug 51 from the container 40. The sealing plug 51 has one or more grooves 46 and protrusions or ribs 45, which may be annular or intermittent, for engagement with the sealing plug 51. The seal 50 has a groove 55 for fittingly engaging the protrusion 45 of the sealing plug 51. The seal 50 has one or more protrusions 56 that can annular or intermittently seal plug 51.

Since the chamber 361 is manufactured at a predetermined position, only the needle tip 23 penetrates into the chamber 361 and does not directly penetrate into the inner chamber 43 of the container 40. The needle tip 23 is also made longer to first penetrate the intermediate chamber 361 to allow sample flow from the needle 21 and further advance the needle tip 23 axially into the switching means 373. And stop the sample flow during the sampling process, and finally the needle tip 23 first penetrates the intermediate chamber 361 to allow sample flow from the needle 21 and further removes the needle tip 23 Axially advancing to stay in the diverting means 373, stopping the sample flow during the sampling process, and even with further axial advancement, the needle tip 23 penetrates through the diverting means 373 and directly into the container. It penetrates into the inner chamber 43 of 40 and bypasses the intermediate chamber 361 and the switching means 373 entirely and allows sample flow directly from the needle 21 to the container 40.

36 is a side cross-sectional view of the harvesting container of the present invention, with a reduced portion 62 for controlling, regulating or diverting the sample flow to the container 40 with a passage 560 connecting the intermediate chamber 561 to the inner chamber 43. Shows an intermediate chamber 561 with a lid and a container 40 with a sealing plug 541. The sealing plug 541 has an extension outer portion 22 for maintaining sub atmospheric pressure in the container 40.

FIG. 37 is a partial cutaway view of the harvesting container of the present invention having an open end and an inner chamber 43 with a sealing plug 641 used to close the container 40. The sealing plug 641 has a chamber 661 to regulate, control, divert, redirect, reduce, increase or block the sample flow to the sealing plug 641 during the blood collection process. The passage 660 connects the intermediate chamber 661 to the intermediate chamber 43. Chamber 661 has filtration means 63 to filter or control the sample flow during the blood collection process. The filtering means 63 may also comprise a soluble material. The sealing plug 641 has an extended outer portion 22 for maintaining sub atmospheric pressure in the container 40.

38 is a cross-sectional view of the harvesting container of the present invention, wherein the open end and intermediate chamber 43, one or more transition components 74 that make up the chamber 761, and the tube 40 in which the sealing plug 71 is a container or a vacuum; A container 40 having one or more recesses 760 which, when positioned within the open end of the inner channel 43, make up an inner channel, port or passageway, the open end being removable and perforated sealing plug 71 It is sealingly closed by).

The inner cavity 43, the inner wall of the tube 40, or the diverter 74 may also include coatings, additives, gels, inert polymers or other materials used in conventional procedures for collecting and analyzing blood and blood. have.

The smaller sized sealing plug 71 requires less perforable material to close the harvesting container by adding chamber 761 and other low cost conversion components 74 to create passages 760. The indicator 64 is shown on the sealing plug 71 to determine the position of the passage 760 from the sealing plug 71 to the inner chamber 43 of the container 40. The indicator 64 indicates that it is immediately adjacent to the passage 760 of the sealing plug 71. The indicator 64 may also be located at any position from the position of the passage 760, or at an immediately opposite position or 180 degrees away.

The conversion component 74 may comprise a hinge portion, which is maintained in the conversion position during the usual sampling process and is opened by the centrifugal force generated during the centrifugation process. This allows any specimen remaining in the intermediate chamber to be combined with the specimen in the inner chamber 43 of the container 40.

The diverting component 74 can also first guide the specimen directly toward the side wall of the container 40 and then directly into the inner cavity 43 which is shaped like "Z".

FIG. 39 is an overall bottom view of the sealing plug of FIG. 38 and includes a sealing plug 71 having a chamfered portion 65, an indicator 64 and a separation diverter 74. The diverter 74 may comprise a material that is soluble when activated by a wet solution such as blood.

40 is an overall cross-sectional view and a partial cutaway view of the blood sampling device of the present invention showing the sealing plug 51 partially holed by the needle 21. The blood collection device includes a container 40 having a blood collection needle 21, a needle holder 530, and a sealing plug 51 and a shield 150. Seal plug 51 is used to close container 40 and at least one intermediate with diverter 373 to regulate, divert, redirect, reduce, increase or block sample flow to seal plug 51 during the blood collection process. Has a chamber 361. The recess 360 creates an inner channel or passage when the sealing plug 51 is positioned within the open end of the container 40.

The seal 150 is a hole for the unrestricted access of the needle 21 to the sealing plug 51 and a protrusion 52 for frictionally or rotationally engaging the needle holder 530 and an inner open facing protrusion 54. Has 44. The protrusion 52 engages with the protrusion 54 during the rotational movement of the container 40 towards the needle 21 to maintain active control during the puncturing of the sealing plug 51 by the needle 21.

The adjustable flow with respect to penetration is regulated by the friction or screw engagement of the protrusions 52 of the container 40 or the shield 150 and the friction or screw engagement of the protrusions 54 of the needle holder 30.

FIG. 41 is an overall and cutaway view of the blood sampling apparatus shown in FIG. 40, showing the needle 21 having completely pierced the sealing plug 51 in which the container is rotated in a manner of being rotated 90 degrees. The blood collection device includes a container 40 having a blood collection needle 21, a needle holder 530, and a sealing plug 51 and a shield 150. Seal plug 51 is used to close container 40 and at least one intermediate with diverter 373 to regulate, divert, redirect, reduce, increase or block sample flow to seal plug 51 during the blood collection process. Has a chamber 361. The recess 360 creates an inner channel or passage when the sealing plug 51 is positioned within the open end of the container 40.

The seal 150 has a protrusion 52 for frictionally or rotationally engaging the needle holder 530 and the inner protrusion 54. The protrusion 52 engages with the protrusion 54 during the rotation or frictional movement of the container 40 towards the needle 21 to maintain active control during the puncturing of the sealing plug 51 by the needle 21. Direct axial removal of the container 40 is not limited by the open facing shape of the protrusion 54 of the needle holder 530, and the container 40 can be removed from the needle holder 530 by a straight pull motion. have.

42 is a partial cutaway view of a conventional harvesting container 140 that includes a sealing plug 141 to maintain sub atmospheric pressure within the inner chamber 143. The container 140 is usually made of either glass or shutter resistant plastic. The main limitation of using plastic as the container 140 is that the collected blood tends to react undesirably 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 organic substrate. This adds extra cost to the harvesting container.

43 is a cross-sectional view of the harvesting container of the present invention, wherein the coating or film 49 and the inner chamber 843 on the outer surface of the container 840 so that the container 840 is destroyed during manufacture, promotion and use to reduce the possibility of shuttering. And a container 840 comprising a sealing plug 33 that can be drilled to maintain sub atmospheric pressure within the shell. The coating or film 49 includes a protective material bonded to the outer surface of the container 840. The coating or film 49 keeps the collection container 840 untouched during manufacture, storage, and use.

Coating or film 49 also includes, but is not limited to, a polymeric or elastic material that can be applied or sized by a chemical, electrical, or heating process. The coating or film 49 keeps the tube in an integral fashion and securely houses the sample in the container 840 when the container is dropped or squeezed to prevent the health care manager from being exposed to blood or fluid samples on the body and to secure the workplace. Keep it. The coating or film 49 is applicable to all harvesting containers known in the present specification.

Coating 49 may be applied to the outer surface of container 840 by immersing the container in a bath of molten polymer material and then cooling the container to solidify the polymer on the outer surface. Alternatively, coating 49 may be applied by spraying molten polymer or other suitable material onto container 840 and then cooling the container. Instead of using a molten polymer, an ultraviolet curable solvent or an air curable polymer can be used.

44 is a cross-sectional view of the harvesting container of the present invention, wherein the coating or film 149 and the inner chamber are on the outer surface of the container 840 extending beyond the junction or boundary where the sealing plug 33 and the container 840 join each other. 843 includes a container 840 having a perforated sealing plug 33 that maintains a sub atmospheric pressure. The coating or film 149 improves vacuum retention in the interior chamber 843 and alerts the health care manager if there are signs of the seal touching. This is because signs of tearing, stretching or other deformation appear on the coating or film 149 when the vacuum is damaged.

45 is a cross-sectional view of the harvesting container of the present invention to maintain sub-atmospheric pressure in the coating, film or label 249 and the inner chamber 843 over the junction or boundary at which the sealing plug 33 and the container 840 join each other. Container 840 having a sealing plug 33. The coating, film or label 249 improves the vacuum holding in the interior chamber 843 and alerts the health care manager if there are signs of the seal touching. This is because signs of tearing, stretching or other deformation appear on the coating or film 149 when the vacuum is damaged.

46 is a partial cutaway view of the harvesting container of the present invention, having a sensor or probe 90 accessible from the outside of the container 40 and a container having a sealing plug 31 that maintains a sub atmospheric pressure in the inner chamber 43. 40). The sample can be analyzed without removing the sealing plug 31 from the container 40.

Fig. 47 is a partial cutaway view of the harvesting container of the present invention and includes a container 40 having a diverter 78 and a sealing plug 91 that maintains a sub atmospheric pressure in the inner chamber 43, wherein the diverter is soluble or not fired. It may be constructed of a soluble material, and when attached to the sealing plug 91 creates an intermediate chamber 861 and redirects the sample flow entering the chamber 861 towards the outer periphery of the container 40. The diverter 78 is attached to the sealing plug 91 by a plurality of projections 85 engaging the sealing plug 91 in the recess 47. The annular passageway 860 causes the sample flow to sink toward the outer periphery of the harvesting container 40 or descends to the lowest end of the harvesting container 40, regardless of how the container is positioned in the needle holder. 360 degree sample conversion or any classification is accomplished by the converter 78.

The diverter 78 has a frictionally engaging recess 47 of the sealing plug 91 so that the gripping force is sufficient to maintain adhesion during the normal sampling process. All collected samples are placed in a centrifuge and spin to separate plasma from red blood cells before testing. The gripping force on the sealing plug 91 may be released during the centrifugation process. This allows any specimen remaining in the intermediate chamber 861 to be combined with the specimen in the inner chamber 43 after the harvesting process.

The diverter 78 may also include a hinge portion, which is maintained in the diverting position during the usual sampling process and is opened by the centrifugal force generated during the centrifugation process. This allows any specimen remaining in the intermediate chamber 861 to be combined with the specimen in the inner chamber 43.

48 is a partial cutaway view of the harvesting container of the present invention, including a container 40 having a diverter 178 and a sealing plug 91 for maintaining sub atmospheric pressure in the inner chamber 43, wherein the diverter includes an intermediate chamber ( 961 and has a recess to guide the sample flow entering the chamber 961 towards the outer periphery of the container 40. The diverter 178 is attached to the sealing plug 91 by a plurality of protrusions 85 that engage the sealing plug 91 in the recess 47. The diverter 178 has holes or channels 79 for discharging the sample into the intermediate chamber 961 after sampling.

The diverter 178 may be constructed of a soluble or insoluble material. The hole 79 may comprise a soluble material that blocks the hole 79 and dissolves upon exposure to liquid during the extraction process, and any sample contained in the chamber 961 by opening the hole 79 into the container 40. Allow to be empty. The annular passageway 960 causes the sample flow to sink toward the outer periphery of the collecting container 40 or descends to the lowest end of the collecting container 40.

FIG. 49 is an overall side view of the diverter of the present invention that creates an intermediate chamber that couples to a sealing plug and redirects sample flow to the outer periphery of the harvest container. The diverter 278 has a barb 79 and a plurality of protrusions 85 that engage the sealing plug.

FIG. 50 is an overall top view of the diverter shown in FIG. 49 with barb 79 extending from diverter 278 and multiple protrusions 85.

FIG. 51 is a side cross-sectional view of a sealing plug in one embodiment of the present invention and includes a punctureable sealing plug 91 having one or more recesses 47 for engaging a separating component.

FIG. 52 is an overall bottom view of the sealing plug shown in FIG. 51 and has one or more grooves 47 for engaging the separating component along the 52-52 axis. The grooves may be annular, intermittent or the like to facilitate attachment of other components to the sealing plug 91.

FIG. 53 is a partial cross-sectional view of the harvesting container of the present invention, self-sealing with a shield 17 axially slidable around a portion of the sealing plug 18 inserted at the openable end of the container 40. Sealing plug 18. The punchable sealing plug 18 has a chamber 19 formed by the diverter 13 for diverting the sample flow upon exiting the needle, shown in another figure. The passage 15 opens the inner chamber 43 of the container 40 and the chamber 19 openly.

The sealing plug 18 has an annular groove 27 housing an annular projection 16 for holding the seal 17 in a slidably coupled state with the sealing plug 18. The protrusion includes a chamfered top that assembles the sealing plug 18 easily and self-centered into the seal 17 prior to insertion into the openable end of the container 40. The sealing plug 18 and the shield 17 include an airtight portion that maintains the sub atmospheric pressure in the collection container 40.

FIG. 54 is a partial cross-sectional view of the harvesting container shown in FIG. 53 with the axially slidable shield 17 and the self-sealing sealing plug 18 removed from the openable end of the container 40. 17 automatically seals the portion of the sealing plug 18 in contact with the specimen in the container 40. The seal 17 closing the port 15 at the middle portion 59 of the seal 17 and the sealing plug 18 remains in the chamber 19 of the sealing plug 18 to prevent contact with the health care personnel. Keep any specimens stable. The specimen remaining in the chamber 19 is not the same as the specimen in the container 40 after centrifugation, and the closed end of the container 40 is located at the outer end of the centrifuge. The perforated sealing plug 18 is shown in another figure, the chamber 19 formed by the diverter 13 for diverting the sample flow upon exiting the needle, and the inner chamber 43 and chamber of the harvesting container 40. It has a passageway or a port 15 communicating with 19. The protrusion 16 of the seal 17 limits the axial movement of the sealing plug 18 when the harvesting container 40 is opened. When the shield 17 is moved to the protected position, the shield 17 does not need to close the port 15 unless the outer wall of the diverter 13 is sealed by the shield 17. The sealing plug and seal 17 include an airtight portion that maintains a sub atmospheric pressure in the collection container 40.

Once the sealing plug 18 is removed from the container 40, the greater gripping force between the inner wall of the container 40 and the outer wall of the sliding shield 17 causes the sealing plug 18 to first be shafted within the shield 17. Allow slide in the directional way. Since the sealing plug 18 is then limited to the axial movement in the shield 17 by the protrusions 16, the continuous axial force is sealed with the sealing plug 18 from the openable end of the container 40. (17) Remove both.

55 is a cross-sectional view of the harvesting container of the present invention and includes a translucent flexible shield 250 and a sealing plug 451 having a flow indicator or viewing area 99 for determining sample flow into the chamber 461. . The sample flow is diverted to the cavity 43 of the container 40 by the chamber 461 and the diverter 473 and through the passage 460 during the sampling process.

Since the container 40 and the shield 250 are made of a transparent or translucent material, the sample flow is easily observed. Since the shield 250 is not a necessary component, the sample flow can be seen through the transparent container 40 wall when the sealing plugs 451 are used individually. Flow chamber 461 is easily manufactured by standard injection molding or compression molding methods. It is desirable for the shield 250 to be as transparent as possible in order to see the sample flow fastest.

56 is a cross-sectional view of the collecting container of the present invention, the interior being vacuumed and closed by a sealing plug 37 having a semicircular outer periphery that allows any one of the ends of the container 40 to be placed in a centrifuge. It includes a container 40 having a cavity 43. The tubular shield 350 has one or more protrusions 28 for engaging one or more grooves 44 of the sealing plug 37. The seal 350 does not have an upper surface, and an insert with a diverter 173 and a chamber 161 containing specimens in both when the sealing plug 37 and the seal 350 are removed from the container 40. Around the sealed plug 37. The recessed recess 34 makes a smaller punchable portion of the sealing plug 37 to facilitate the insertion of the needle through the sealing plug 37. A sealing plug 37 having a passage 160, a chamber 161 and a diverter 173 is connected to the inner chamber 43 of the container 40. The container 40 includes a closed end shape having a square, geometric figure, ellipse or other non-circular shape.

FIG. 57 is a cross-sectional view of the blood sampling adapter of the present invention, a coupler or extension, when a standard, or larger, container 40 as shown throughout the specification is usable for the smaller pediatric needle holder 95 shown in FIG. 59. (87). The smaller diameter needle holder 95 allows smaller angles to be used to access blood vessels during the blood collection process.

The hollow bore needle attached to the smaller diameter needle holder 95 is inserted into the vessel and the sealing plug 88 of the coupler 87 is inserted into the needle holder 95. Cover 25 includes specimens in chambers 46 and 93 and needle 421 until a larger diameter harvesting container slides into coupler 87 and the sealing plug of the larger diameter container is punctured. Larger diameter collection containers can be used to sample using the smaller diameter needle holder 95 shown in FIG. Smaller diameter needle holders allow smaller angles to be used to contact the blood vessels because the center point of needle holder 95 is closer to the body surface of the patient. Coupler 87 is attached to cap 88 which may be perforated at interface 89. The smaller diameter sealing plug 48 has an outer recess 92 to prevent contact between the health care personnel and the residual sample during sampling and analysis.

58 is a cross-sectional view of the blood sampling adapter of the present invention, in which a coupler or extension 187 is shown when a standard, or larger, container 40 shown in the specification is available for a smaller diameter pediatric needle holder 95. It includes. The plug 48 has a live passage 36, a diverter 26, and a chamber 94 by inserting the plug 48 into the coupler 187.

The hollow bore needle attached to the smaller diameter needle holder 95 is inserted into the vessel and the sealing plug 48 of the coupler 187 is inserted into the needle holder 95. Cover 25 includes specimens in chambers 46 and 93 and needle 421 until a larger diameter harvesting container slides into coupler 87 and the sealing plug of the larger diameter container is punctured. Larger diameter collection containers may be used to sample using smaller diameter needle holders 95. The smaller diameter needle holder 95 allows a smaller angle to be used to contact the blood vessel because the center point of the needle holder 95 is closer to the patient's body surface. The smaller diameter sealing plug 48 has an outer recess 92 to prevent contact between the health care personnel and the residual sample during sampling and analysis. The sealing plug 48 may be removed after the sample has been taken and the blood contained in the chamber 46 may be placed on a visual test slide.

Fig. 59 is a cross-sectional view of the blood sampling device of the present invention and includes a container 39 that can be used for a standard needle holder shown as a needle holder or for a pediatric needle holder 95 of smaller diameter. The smaller diameter needle holder 95 allows a smaller angle to be used to contact the blood vessel because the center point of the needle holder 95 is closer to the patient's body surface. The smaller diameter sealing plug 98 has a passage 96, a diverter 126 and a chamber 97 for diverting the specimen from the needle 21 to the container 39. The larger diameter opposite end of the container 39 can be safely placed in a centrifuge to separate red blood cells from the plasma. The smaller diameter sealing plug 98 has an outer recess 92 to prevent contact between the health care person and the residual sample during sampling and analysis.

The larger diameter sealing plug 137 has a passage 160, a diverter 173 and a chamber 161 for diverting the specimen from the needle to the container 39. The larger diameter sealing plug 137 has an outer recess 134 to keep the health care person and the residual sample from contacting during sampling and analysis. The container 39 may comprise only one open end, so that the opposite end is closed.

Figure 60 is an overall side view of the sealing plug of the present invention and has a channel 360 for equalizing the internal and atmospheric pressure in the container prior to complete removal of the sealing plug 341 from the container. The cornered portion 365 assists in the assembly of the sealing plug 341 to the open end of the harvesting container.

FIG. 61 is an overall bottom view of the sealing plug shown in FIG. 60 and has a channel 360 for equalizing the internal and atmospheric pressure in the container prior to complete removal of the sealing plug 341 from the container. The cornered portion 365 assists in the assembly of the sealing plug 341 to the open end of the harvesting container.

FIG. 62 is a cross-sectional view of the sealing plug shown in FIGS. 60 and 61 and includes a sealing plug 341 having a chamfered portion 365 and a channel 360 inserted into the container 340. The chamfered portion 365 and the channel 360 close the container 340 to create a chamber 343.

FIG. 63 is a cross sectional view of the sealing plug shown in FIG. 62, moved from the sealed position and equalizing the internal and atmospheric pressures of the container 340 and the chamber 343 prior to complete removal of the sealing plug 341 from the collection container 340. FIG. It includes a chamfered portion 365 and the channel 360 to be. Equalizing the internal pressure of the container 340 and the chamber 343 reduces the likelihood of exposure of the specimen contained within the container 340.

64 is a cross sectional view of the harvesting container of the present invention closed by a removable sealing plug 441 having an outwardly accessible chamber 455 sealed by a strip 475 and a pull tab 476. When the needle punctures the sealing plug 441, the hollow bore of the needle containing the specimen enters the chamber 455 to place a small amount of specimen in the chamber 455. Samples are taken in chamber 443 in a normal pattern. When the needle is moved out of the sealing plug 441, again a small amount of sample is placed in the chamber 455.

In order for the container 440 to obtain a small sample for visual analysis, it must not be opened or the sealing plug 441 must be punctured or removed with a needle.

It is dangerous to remove the uncovered needle and place the sample taken from the needle's pointed tip to the slide. The needle is covered immediately upon withdrawal from the venipuncture, preventing the case of needle puncture. The present invention allows a health care manager to obtain a small amount of sample taken on a slide without being exposed to the pointed needle with blood.

Chamber 455 may be coated with an anticoagulant, a desiccant, or the like to facilitate visual testing of the specimen.

FIG. 65 is the side of the harvest container shown in FIG. 64 closed by a removable sealing plug 441 having an outwardly accessible chamber 455 opened by removal of the pull tab 476 and strip 475. It is a cross section. Specimens placed in chamber 455 can now be placed on visual test slides.

FIG. 66 is an overall side view of the harvesting container of the present invention, with an outwardly accessible chamber 543 closed by a removable and removable sealing plug 541, closing the container 540 and closing the inner cavity 543. FIG. And a movable outer shield 550 comprising a hole 575 to make. The outer shield 550 is in a first position that closes external access to the chamber 555 of the sealing plug 541.

FIG. 67 is an overall side view of the harvesting container shown in FIG. 66 closed by a removable sealing plug 541 with a movable outer shield 550. The aperture 575 is now in a second position relative to the first movable position, where the chamber 555 is exposed to allow access to the collected specimen disposed within the chamber 555 during the sampling process. Movement of the shield 550 relative to the chamber 555 of the sealing plug 541 may include a third position, and the aperture 575 is locked in a closed position to prevent external access to the chamber 555. .

The container 540 should not be opened to gain access to the sample collected in the interior cavity 543, or the sealing plug 541 should not be perforated with a needle, or removed to obtain a small sample for visual analysis. Should not.

Chamber 555 may be coated with an anticoagulant, a desiccant, or the like to facilitate visual testing of the specimen.

FIG. 68 shows a chamber (closed by a removable sealing plug 541 having a movable outer shield 550 comprising an opening 575 for closing the chamber 555 of the sealing plug 541 at the portion 576. Side cross-sectional view of the collecting container shown in FIG. 66 including 543). The outer shield 550 is in a first position that closes external access to the chamber 555 of the sealing plug 541.

As the needle moves through the recess 544 and punctures the sealing plug 541, the hollow bore of the needle containing the specimen enters the chamber 555 to place a small amount of specimen in the chamber. The needle then drills through the sealing plug 541 completely and the specimen is taken into the chamber 543 in a normal pattern. Once the needle is removed from the sealing plug 541, a small amount of sample is again placed in the chamber 555.

FIG. 69 is a side cross-sectional view of the harvesting container shown in FIG. 67, including a chamber 543 closed by a removable sealing plug 541 with a movable outer shield 550, and having a hole in the second position ( 575 exposes chamber 555 to allow access to collected specimens placed within chamber 555 during the harvesting process.

Container 540 should not be opened, or sealing plug 541 should not be punctured with a needle, or removed to obtain a small sample for visual analysis.

Aggressive engagement means may position the movable shield 550 in either the first closed position or the second open position, reducing the likelihood of inadvertently opening the movable shield 550 during the harvesting process.

A needle with one pointed tip for drilling the sealing plug of the filled sampling container and the other end exposed blunt can also be used to place a smear of blood on the slide. The needle may be attachable to the needle holder described throughout this specification, or may be used to access the collected sample in the collection container individually.

70 is a side sectional view of the present invention having a container with a sealing plug including a diffusion member. The sealing plug 1041 includes a porous member 1063 and an outer recess 1044 for diffusing liquid entering the container 1040 during the sampling process. The sealing plug 1041 includes a chamfered bottom 1065 to facilitate insertion into the container 1040.

FIG. 71 is a cross-sectional view of the container and sealing plug shown in FIG. 70 showing a specimen spread during delivery to container 1040. The needle 1021 is attached within the needle holder 1030 and the container 1040 is inserted into the chamber 1035 of the needle holder 1030 so that the proximal end 1023 of the needle penetrates the sealing plug 1041 to form a porous member. Allow 10 6 to enter. The sample exits the needle 1021 and diffuses during the sampling process. The sealing plug 1041 includes a chamfered bottom 1065 to facilitate insertion into the container 1040.

72 is a side view of the present invention including a container having a sealing plug including a closure member. The sealing plug 2041 includes an outer recess 2044, an inner chamber 2061, a transition portion 2073 and an inflatable liquid sensitive portion 2063. The liquid sensitive portion allows the penetration of the liquid but still has an open hole that expands and closes within minutes after exposure to the liquid.

FIG. 73 is a side cross-sectional view of FIG. 72 illustrating a sample contained within chamber 2041 and container 2040 of sealing plug 2041 that is not already in fluid communication with chamber 2043 of container 2040. The liquid sensitive portion 2063 swells and the hole is closed.

FIG. 74 shows a seal with an outer recess 1444 that includes a conventional seal plug, or diverter component 1478 that includes a chamber 1541 generated by inserting the diverter 1478 into the hollow end of the seal plug 1442. Side cross-sectional view of the present invention including a container having a plug (1441). The diverter 1478 has a closed end 1473 and one or more open holes 1460 and can include one or more protrusions 1473 for frictionally engaging the inner wall of the sealing plug 1441. The diverter 1478 can include a chamfered closed end 1473 that allows the specimen remaining in the chamber 1541 to exit into the chamber 1443 of the container 1440 before or during centrifugation or analysis. The protrusion 1479 may be segmented or circumferential to support the wall portion of the sealing plug 1441, improving sealing at the sealing plug / container surface interface, thus reducing vacuum leakage and increasing the shelf life of the vacuum tube.

The diverter end 1473 may include a large opening and is closed by a removable or soluble wall portion that allows the sample remaining in the intermediate chamber 1541 to be added to the sample in the collection container chamber 1443 after collection. . The sample still flows through the hole 1460 during the sampling process. Soluble materials, such as those used as additives to facilitate analysis, can be used and wetted by the sample to dissolve in minutes. The diverting end 1473 has been removed from the diverter by centrifugal forces placed on the container during the centrifugation process. Therefore any specimen remaining in the intermediate chamber 1541 could be added to the specimen in the collection container. This allows long needles to freely access the sample, can be separated into plasma and erythrocytes during the centrifugation process, and can draw pure plasma or erythrocytes from the analytical container.

The diverter 1478 compresses the sealing plug 1441 radially against the collection container 1440 wall to improve sealing and increase the shelf life of the container. The inner wall portion of the sealing plug 1441 may include an annular or segmented undercut or protrusion to mate correspondingly with each protrusion or undercut on the diverter 1478. The undercut or groove is readily moldable from an elastic material such as rubber or other compound mixed with rubber or plastic.

The cost of implementing the flow divert technique is very low because there is no need to retrofit existing instruments and components. The assembly process had to be improved and a tool had to be made to manufacture the transition parts.

75 is a side sectional view of the present invention including a container having a conventional sealing plug having an annular member frictionally engaging an inner wall portion of the sealing plug. The sealing plug wall portion 3065 adjacent to the annular member 3079 is compressed and supports the wall portion 3065 when the sealing plug 3041 is inserted into the container 3040. The annular member 3079 may be cylindrical in shape with an open end. The cylindrical shape makes contact with a larger portion of the sealing plug wall to create a larger area in contact with the harvest container wall. The annular member 3079 compresses the sealing plug radially against the harvest container wall to improve sealing and increase the shelf life of the container.

The use of the annular member 3079 improves the sealing at the sealing plug / container surface interface, reduces the "gray band" area and vacuum leakage, thus increasing the shelf life of the vacuum tube.

The cost of implementing this improved sealing technique is very low because there is no need to retrofit existing instruments and components. The assembly process had to be retrofitted and a tool had to be made to make the annular part.

FIG. 76 is a cross-sectional view of the present invention including a container having a sealing plug with a pressure sensitive valve actuated when a pressure differential occurs on either side of the valve. FIG. A sealing plug 4041, which may include an outer recess 4044 and a ridge or undercut 4042, which may have an annular shape, is inserted into the container 4040 to create a cavity 4043. The valve 4078 creates a chamber 4041 positioned within the sealing plug 4041 and closing at the interface 4075. When the sealing plug 4041 is punctured by the needle and a greater pressure is generated in the chamber 4041, the valve 4078 opens and moves to the low pressure region contained in the cavity 4043. The valve 4078 also has a diverting portion 4073.

77 is an overall side view of a pressure sensitive diverter or valve 4078 inserted in a sealing plug.

FIG. 78 shows a transition component 5078 with holes 5060 for diverting or regulating sample flow, channels or slots for accessing a sample taken in a container sealed by diverting wall portion 5073 and sealing plug 5041. A side cross-sectional view of a sealing plug 5041 that includes 5000. An elongated needle may be inserted through the sealing plug 5041 to access the sample taken without contacting any sample that may remain in the chamber generated by the coupling of the sealing plug 5041 and the diverter 5078. .

FIG. 79 is a partial cutaway view of the transition component 5078 of FIG. 78, shown at axis 79-79. The diverting component 5078 has a channel or slot 5000 and the chamber is created by the diverting wall portion 5073.

80 is a full side view of a blood collection needle with a needle guard operated only manually. The blood sampling needle has a hub 6015, with a fixedly attached hollow bore needle 6010 having both proximal and distal ends, with the distal end 6011 shown here, the proximal end being punctureable. Covered by boot or cover. Needle guard 6022 is releasably held adjacent hub 6015 by latching arm 6026 that includes finger pad 6027 and stops or protrusions 6049. Needle guard 6022 has a needle trap 6061 that is placed on the needle when manually released by operating finger pad 6027. No longitudinal compression force resulting from inserting the needle 6010 into the patient fails to actuate the needle guard 6022.

Claims (15)

As a sealing plug, An internal cavity adapted to receive the needle, And means for guiding a sample flow from the inner cavity to an outer surface of the seal plug. The sealing plug of claim 1, wherein the guide means comprises a hole connecting the inner cavity to an outer surface. The sealing plug of claim 1, wherein the guide means comprises a reed valve. The sealing plug of claim 1 wherein said guide means comprises an openable port. The sealing plug of claim 1, wherein the guide means comprises a porous member. As a sealing plug, A proximal end capable of needle-punching, The distal end, And at least one end hole shaped to receive a needle and direct a sample flow from the seal plug. As a hypodermic needle, Hollow bore formed by wall, A hypodermic needle comprising a friction reducing compound disposed on the wall. The hypodermic needle of claim 1, wherein the friction reducing compound is an anticoagulant. The hypodermic needle of claim 1, wherein the friction reducing compound is heparin. The hypodermic needle of claim 1, wherein the friction reducing compound is silicone. As a collecting container, A body having an inner chamber and an outer surface, A collection container comprising a shutter resistant coating on the outer surface of the container body. 12. A collecting container according to claim 11, wherein said body is made of glass. 12. The harvesting container of claim 11, wherein the coating is a polymeric material. A method of applying a protective coating on the outer surface of a blood collection container, The method comprises at least partially dipping the container into a bath of molten polymer material; b) cooling said harvesting container to solidify said polymeric material on said outer surface. A method of applying a protective coating on the outer surface of a blood collection container, The method comprises the steps of a) spraying a molten polymer material on the outer surface; b) cooling said harvesting container to solidify said polymeric material on said outer surface.