Abstract:
A novel set of flexible dialysis tube, needles, tubing and related attachments that may be used to improve the blood sampling, removal, and reinfusion process and reduce the medical hazards of such procedures for the patient. It consists in a special perforation needle over which a plastic tube is passed into the blood vessel, flexible dialysis tube remains inserted and opens gently then bends and morphs to the body structure assuring a good blood flow. A version of flexible dialysis tube may have inside valves and actuators so that bi-directional flow can be obtained following a single vessel puncture instead of two, for procedures such as hemodialysis. An exterior connection box allows a patient to connect to an external blood processing device (hemodialysis) quickly and safely. Further, the device is designed to stay in place for several days or more, further reducing the risks and discomforts of repeated vessel punctures. Some versions of the device could have a micro-sensor array embedded with the plastic tube, enabling continuous measurement of many medically significant parameters.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61,761,386 from Feb. 6, 2013 and NO International application. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a method and devices to increase the comfort and safety of intravascular access and perfusion (removal and/or reinfusion of blood or other fluid), in order to minimize its negative impact for the patient, reduce the time required for such procedures, and improve the quality of such procedures in numerous ways. 
         [0004]    Many medical procedures require prolonged or repeated large-bore intravascular access for infusion of drugs, parenteral nutrition, and hemodialysis. The present method and devices come to improve the process of vessel penetration, and the compatibility of the devices with the blood vessels and blood, among other benefits. 
         [0005]    For the many procedures that require repetitive access to the patient&#39;s blood vessels, such as hemodialysis, this method reduces the frequency of vessel perforations that are required. By reducing vessel trauma, these method and devices may reduce the many dangerous medical complications and expensive surgical interventions, suffered by dialysis and similar patients. These devices may also serve as a safe long-lived blood-port with capabilities of monitoring the perfusion process and gathering other physiologic data. 
         [0006]    2. Description of the Prior Art 
         [0007]    Historically, kidney diseases have been a major concern among human diseases. When the kidney is sufficiently impaired that a large fraction of the body&#39;s waste products and water are not removed from the blood, the life of the patient cannot be preserved unless means are provided for artificially performing the function of the impaired kidney. Various processes called “dialysis” are used to remove these waste products. 
         [0008]    The most commonly accepted practice for dialyzing a patient&#39;s blood extracorporeally requires the surgical creation of a subcutaneous, arterial-venous fistula—a conduit, also called a shunt, for a flow of blood from an artery, usually in an arm, to a vein. 
         [0009]    Thereafter, a relatively large flow of blood produces dilation of the subcutaneous venous system, giving sufficient blood flow for dialysis by venipuncture of this “shunt” with large bore needles. 
         [0010]    Normally, two hollow needles or cannulas are used to perform two venipunctures into the shunt, so that blood can be simultaneously withdrawn and (purified blood) reinfused. 
         [0011]    Conventionally, blood is withdrawn from one of the needles, pumped through a hemodialyzer and thereafter pumped back into the patient. The needles have to be substantially distant from one another to prevent recirculation of blood. 
         [0012]    The aforementioned methodology has been found to have serious disadvantages both to the patient and to the attending physicians, nurses, and technicians. The problems are particularly aggravated because most patients requiring extracorporeal hemodialysis must undergo treatment as frequently as three to four times per week. This means that if every venipuncture were completely successful, a patient 50 would need to undergo from 6 to 8 venipunctures or cannulations each week. 
         [0013]    It is well-known that the lifespan and proper function of a fistula is inversely related to the number of venipunctures. Shunts that are repeatedly subjected to the 55 trauma of venipuncture are much more susceptible to thrombophlebitis, perivascular hemorrhage, clotting and infection. In fact, it is commonly found in patients who have experienced a number of venipunctures, that the tissues surrounding the most accessible veins develop large hematomas which obscure the veins, making successful venipuncture extremely difficult. 
         [0014]    Also contributing to the problem is the fact that once one successful venipuncture is made and blood is allowed to 65 flow from the patient&#39;s body toward a hemodialyzer, the blood volume in the fistula is reduced, making the second venipuncture very difficult. It has historically been found that while most skilled physicians or technicians are able to perform the first venipuncture with little difficulty, frequently numerous attempts are necessary before a 5 second venipuncture can be performed. 
         [0015]    In addition, the multiple attempts at venipuncture often necessary to place the second needle result in worsening apprehension and anxiety on the part of both the patient and the physician, nurse, or technician attending the patient further reducing the likelihood of successful venipuncture. 
         [0016]    In order to access the blood vessels for dialysis, perfusion or other purposes, it is first necessary to penetrate the blood vessel by puncturing it with a needle, and then, if the needle itself is not to remain in place, inserting a flexible tube of some kind, most often using the lumen of the same needle used to puncture and penetrate the blood vessel. In some devices, the flexible tube covers the needle as a sheath, and remains in the vessel after the inserting needle is removed. 
         [0017]    Dialysis typically uses a special cannulation technique that requires two punctures; one up-stream collecting arterial blood entering the shunt, and another downstream, near the venous end of the shunt, for return of the purified blood. 
         [0018]    There are several existing cannulation techniques that use sharp or blunt AV Fistula or button hole needles, that when used repetitively may cause severe blood vessel damage (aneurysm, etc.) requiring medical intervention. 
         [0019]    U.S. Pat. No. 4,936,835 describes an improved needle which has a bio-absorbable gelatin cutting or puncturing tip. The gelatin&#39;s characteristic renders the needle incapable of penetration after one initial use. Additionally, the gelatin partially dissolves to leave a coating on the punctured tissue margin, which acts to minimize hemorrhaging complications. A non-bioabsorbable in-situ sheath positioned at the punctured tissue site, which compresses the tissue, alternatively addresses hemorrhaging complications. This system has the potential problems of reaction to the small amounts of chemicals introduced, as well as complications from the solid steel needle damaging the inside of the fistula, that are prevented by the present invention 
         [0020]    U.S. Pat. No. 6,962,575 82 from Nov. 8, 2005 discloses a single access dialysis needle system comprising a first cannula, a second cannula or sheath, and a barrier arranged on the outer surface of the first cannula. The distal end of the first cannula extends distal to the distal end of the second cannula or outer sheath, and the barrier is positioned between the respective distal ends. When the barrier is inflated or otherwise activated, it prevents or minimizes recirculation. This procedure has the disadvantage of a much bigger hole penetrating the fistula, and more distress to the interior of the fistula, from the two tubes and the inflated sealing barrier that are removed by the present patent. 
         [0021]    The patent US20080312577 teaches a veno-venous expandable dialysis apparatus including a blood injection needle component configured to introduce blood at a position of a first peripheral vein and a blood withdrawal needle component configured to withdraw blood at another position from a second peripheral vein, where the first position is located away from the second position. The expandable dialysis apparatus further includes a guide wire having a central axis, an expanding sheath configured circumferentially around the guide wire to form an annular lumen between a distal blood withdrawal position and a proximal extracorporeal position; and a needle disposed around the expandable sheath. The patient is still harmed by the presence of the guiding wires, as well as by the stiffness of the needles and repetition of the puncturing; these inconveniences are eliminated by the present invention, too. 
         [0022]    The book written by Kaufman J A, Lee M J. On “Vascular and Interventional Radiology. The Requisites” in 2004 disclosed a procedure for the placement of a dialysis catheter. They clearly stated that a strict aseptic technique must be used during insertion procedure. Chronic dialysis catheters (CDCs) are cuffed, tunneled catheters. The configuration is dual-lumen, with an arterial port for blood flow from the body, and a venous port for blood return after passing through the dialysis machine. Risk of recirculation of blood is decreased by a staggered tip design. 
         [0023]    Flow rate is an important consideration in tunneled CDC design, as faster flow rates decrease dialysis time for the patient, and this is another aspect improved by the present invention. 
         [0024]    Generally, for tunneled CDCs, the preferred veins for central access are the right internal jugular (RIJ), right external jugular (REJ), left internal jugular (LIJ), left external jugular (LEJ)—in that order. 
         [0025]    The National Kidney Foundation&#39;s Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Hemodialysis Adequacy (K/DOQI Guidelines) state that subclavian vein (SCV) catheterization should be avoided in patients with end stage renal disease (ESRD) because of the risk for central venous stenosis, with subsequent loss of the entire ipsilateral arm for vascular access. 
         [0026]    The tunnel for the CDC is created by advancement of a tunneling device through the subcutaneous tissue on the chest wall. The tunnel may be placed medially, with the exit site at a parasternal infra-clavicular location. Alternately, it may be placed laterally, with the exit site below the clavicle at the delto-pectoral groove. The cuff of the tunneled CDC acts to hold the catheter in place. In addition, it is designed to cause a fibrotic reaction, creating a physical barrier to bacteria that prevents bacterial migration and inoculation via the exit site. The cuff is positioned within the tunnel at a distance from the exit site that will facilitate removal. 
         [0027]    The present invention may use a catheter inserted in a peripheral arterio-venous shunt or large central vein as a chronic dialysis catheter, aiming to reduce the several risks associated with the existing chronic dialysis catheter systems. 
         [0028]    Hemodialysis often involves fluid removal (using ultrafiltration in the dialysis machine), because most patients with renal failure pass little or no urine and accumulate excess intravascular volume. Side effects caused by removing too much fluid and/or removing it too rapidly include low blood pressure, fatigue, chest pains, leg-cramps, nausea and headaches. These symptoms can occur during the treatment and can persist post-treatment; they are sometimes collectively referred to as the dialysis hangover or dialysis washout The severity of these symptoms is usually proportional to the amount and speed of fluid removal. However, the impact of a given amount or rate of fluid removal can vary greatly from person to person and day to day. These side effects can be avoided and/or their severity lessened by limiting fluid intake between treatments or increasing the intensity of dialysis e.g. dialyzing more often or longer per treatment than the standard three times a week, 3-4 hours per treatment schedule. The present invention limits these side effects by allowing continuous monitoring of patients&#39; parameters, using the embedded electronics, and keeping the flow rate optimal. 
         [0029]    Since hemodialysis requires access to the circulatory system, patients undergoing hemodialysis may have their blood exposed to microbes, which can lead to sepsis (infection in the blood), endocarditis, (infection on the heart valves), or osteomyelitis, (an infection within the bones). The risk of infection depends on the type of access used and many other variables. Bleeding may also occur at the access sites, again the risk varies depending on the type of access used. Infections can be minimized by strictly adhering to infection control best practices, another goal which the present patent facilitates. 
         [0030]    Daily hemodialysis is typically used by those patients who do their own dialysis at home. It is less physiologically stressful, but does require more frequent vessel access. Home hemodialysis is usually done for  2  hours at a time, six days a week. This is simple with indwelling chronic catheters, but more problematic with fistulas or grafts. The “buttonhole technique” can be used for fistulas requiring frequent access. The present invention reduces the inconvenience of repeated vascular puncture, making the patient&#39;s home procedure faster and safer. 
       SUMMARY 
       [0031]    A novel flexible dialysis tube, conceived to minimize the effects of tissue penetration, uses a combination of blood vessel friendly materials, inflicting minimal damage and being designed for multiple uses, with the possibility of remaining installed in the patient&#39;s body as a reusable plug-in fixture. In this case a connection box is added that, when activated, seals the blood vessel and cleans the tubes&#39; interior using a fluid-actuator. The connection box creates an antiseptic environment using a combination of chemical and radioactive (alpha and/or beta) active surfaces. 
         [0032]    An arterial-venous fistula needle that is used for puncturing the blood vessel having an optimized profile with a narrow cutting edge and a blunt end used to stretch the vessel with minimal cut damage, covered in a bio-compatible light plastic material that creates the tubing connection to the external dialysis or perfusion system. After the penetration is done, needle withdraws, making the flexible dialysis tube&#39;s ends open like an umbrella inside the blood vessel providing a good leak-free connection. For dialysis, two puncture points are made that provide a symmetric positioning of the flexible dialysis tubes. For the patient&#39;s comfort the plastic flexible dialysis tube bends inside and outside forming a “dog-leg” connection that applies minimum stretching on the nearby tissue and blood-vessel. If properly sealed, it may be maintained for long periods in the patient&#39;s body, preventing extra punctures. The long-term use fittings have a special insert that seals the tube and removes any extra blood remaining in the tube, to prevent any infection or static blood deterioration. The outside fixture is equipped with a sterile cover and body that make it safe for long term use. 
         [0033]    In order to further minimize the trauma to the patient, it is possible to use a special two in one type of flexible dialysis tubing that pumps the blood intake and blood output through two lumens within the one tube. To enable leaving flexible dialysis tube in the patient&#39;s body for long periods, it will contain the additional cleaning and sealing system as well as the sterile cover outside. It will also contain an actuator that will switch the blood flow from the tubes to a shortcut inside the tube inserted in the blood vessel. This technique is superior to the button hole AV Fistula cannulation method because it produces less trauma to the shunt, and reduces drastically the number of medical complications due to shunt deterioration. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0034]      FIG. 1 —Present dialysis needle, longitudinal section 
           [0035]      FIG. 2 —New AV Fistula needle&#39;s cutting end coated in flexible dialysis tube and inserted in a blood vessel 
           [0036]      FIG. 3A —New flexible dialysis tube inserted in a blood vessel in intake position and bent into the “dog-leg” position 
           [0037]      FIG. 3B —New flexible dialysis tube inserted in a blood vessel in exhaust position and bent into the “dog-leg” position 
           [0038]      FIG. 4A —Cross section of the long-term AV Fistula flexible dialysis tube with blood locking and cleaning fixtures, 
           [0039]      FIG. 4B —The sterile protection enclosure and flexible dialysis tube function control system. 
           [0040]      FIG. 5A —Longitudinal section of the “two in one” cannulation flexible dialysis tube. 
           [0041]      FIG. 5B —Cross section of the “two in one” cannulation flexible dialysis tube in AA′. 
           [0042]      FIG. 6A —Longitudinal section of the “two in one” long term cannulation flexible dialysis tube. 
           [0043]      FIG. 6B —Cross section of the “two in one” long tem cannulation flexible dialysis tube in AA′. 
           [0044]      FIG. 7 —The sterile protection enclosure and functions control for the “two-in one” flexible dialysis tube. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0045]    The inventors consider that most of the problems generated by the actual dialysis and perfusion operations are due to the bad matching between the patient&#39;s tissue and the penetration tool, and therefore we develop a new method of penetration, with a more advanced tool, that uses a sharp, stiff needle inside, sheathed outside with a flexible dialysis tube with variable stiffness in harmony with the local function performed, that may bend inside the area to reduce the stress and tissue stretching as much as possible. The assembly comes as the present AV Fistula needle, and in the simplest method is used to implant two needles: one for blood outtake and one for blood inlet. 
         [0046]    The penetration is done using the steel needle, then the needle is withdrawn leaving inside a flexible dialysis tube that is bent to accommodate the patient&#39;s body, minimizing distress. If many sessions are needed, the sterile connection box may be installed over the area, in order to provide mechanical and bacteriological protection, being an antiseptic enclosure. 
         [0047]    In this case flexible dialysis tube has a more complex structure, that includes an inner balloon that inflates with liquid inside, blocking the blood to come out while opening a bypass valve inside the blood vessel switching the flow from the tube outside the body, to straight ahead along the blood vessel, This process of closing the tubing is made using a controlled back flow of sterile liquid, i.e. physiological serum, or equivalent to push the blood out of tube; then the inner balloon inflates blocking the tube. 
         [0048]    This operation assures that no residual blood remains in the tube in the interval between consecutive usages of the tube. There are some fine details that have been considered, for example when a flexible dialysis tube, resembling a plastic straw, is entering in a blood vessel against the blood flow it opens a nozzle inside that is made from stiff structure connected by soft structure that makes a tight contact with the blood vessel walls preventing any leak around it. In flexible dialysis tube opening there is an electronic sensor array that can measure the blood pressure, flow rate, pH and even the blood composition and for continuous monitoring purposes. In the case of two needles, we use one to take out blood and one to reintroduce it, leaving a gap between the needles penetration locations. A smaller bypass valve opens in order to allow some blood flow and oxygenate the tissue between the needles, maintaining the blood fresh in the segment of tube between the two flexible dialysis tubes. The exit tube has a softer parachute-like opening that prevents back flow and leakage along the blood vessel perforation. 
         [0049]    The presence of sensors inside the blood tube makes possible the real time control of the patient&#39;s pressure and the amount of fluid extracted so that post dialysis symptoms could be minimized. The sterile connection box makes possible and easy, safe and fast connection to the patient, also giving electric and optical connection to the monitoring and process instrumentation. One more step forward is reducing the number of perforations from two to one, making the blood extraction and return through the same vessel perforation. This flexible dialysis tube has a more complex structure and is developed in a single connection box. The presence of standardized connectors makes its use safe and comfortable. It also has the facility in emergency cases to be completely pulled off without leaving anything inside the blood vessel and allow the coagulation to seal the wall perforation. 
       Best Mode of the Invention 
       [0050]      FIGS. 6 and 7  shows the best mode contemplated by the inventors of a 2 in 1 AV Fistula flexible dialysis tube that has improved features. It may be bent to follow the local tissue particularities and minimize their stretching. It opens like an umbrella where the edges are opening against the flow in order to make a tight connection and prevent blood backflow or leakage. In both sides it contains micro-electronic arrays of sensors that are performing blood parameter measurements, to control in real time the equipment operation. As an example, the blood pressure indication may be used to regulate the dialysis pump for optimal perfusion. Using variable in and out pumping, the efficiency of dialysis may be improved, possibly shortening the dialysis time. It also allows the equipment to know how much fluid volume to extract to achieve the optimum volume status for the patient. 
         [0051]    The application of a connector box over flexible dialysis tube allows fast connection, safe switching of flexible dialysis tube from off position between sessions to on position and back, and the connection of the desired instrumentation to monitor the patient in real time between sessions and control the equipment operation during the session. By its nature this soft tubing, compatible with the nearby tissue, reduces drastically the thrombosis hazard and other medical complications that require complex surgical intervention. 
       How to Make the Invention 
       [0052]    As can be seen from the drawings, flexible dialysis tube improvement is the first significant advance. It starts with a smaller steel needle, with an edge partially sharpened in the tip to perforate the tissue and blood vessel, and partially with blunt rounded edge to be used to stretch the blood vessel, without piercing, in order to accelerate recovery. It will have a shoulder to protect the plastic sheathing and facilitate its penetration into the blood vessel. After the sheathing representing flexible dialysis tube penetrates inside the shunt itself, the needle is withdrawn, breaking the seals holding the entry “parachute” closed and makes it open as an umbrella in the tube, sealing on its walls. When the steel needle is withdrawn the bypass valve opens automatically and the backwards umbrella opens creating the secondary seal against the walls of the shunt. The structure is fabricated by making the profiled needle first, and then adding the plastic sheathing, that is made from polymers compatible with body tissue. 
         [0053]    Shape remembering polymers may also be used, and make them open over a certain triggering temperature, when they are warmed up by the body heat. The “umbrella” structure is achieved by pressure molding in a die that forms them in open position. Different polymers could be used to form variously rigid parts. It may also be made by fusing together primary assemblies with heat. Tubing for the various actuators and micro-cables will be put in position during the die casting process. After the plastic tubing is mounted tightly on the needle the needle end is added and sealed with the needle, and the needle is installed on the delivery box in aseptic conditions. Chemical treatment with anticoagulants inside and coagulants outside has to be performed before and after flexible dialysis tube is mounted on the needle when access to the surfaces is possible. 
         [0054]    The connection box will be delivered in modular parts that are sequentially installed on the patient&#39;s body. It contains standardized fast coupling devices for hydraulic actuators as well for the electronic sensor system. It is treated with aseptic materials that prevent bacteria growth and is sealed, possibly using pressurized argon or sterile air. 
         [0055]    There will be several types of flexible dialysis tube developed in order to meet the needs of the applications with two or one blood vessel perforation and for long term use with connector box or for immediate use without connector box, everything being in a modular structure that allows cost optimization also. 
       DETAILED DESCRIPTION OF THE DRAWINGS 
       [0056]      FIG. 1  Present dialysis needle, longitudinal section as it penetrates tissue and a blood vessel. 
         [0057]      101 —The AV Fistula needle 
         [0058]      102 —Tissue 
         [0059]      103 —Skin 
         [0060]      104 —Sub-cutaneous tissue 
         [0061]      105 —Blood vessel 
         [0062]      106 —Blood vessel wall 
         [0063]      107 —Blood flow 
         [0064]      108 —Blood flow passing outward through the needle 
         [0065]      109 —Blood flow passing through the needle bypass hole 
         [0066]      110 —Residual blood flow past the needle in the vein 
         [0067]      111 —gap between needles. 
         [0068]      112 —Second needle that puts blood back in the vein 
         [0069]      114 —External device (dialysis or analysis) 
         [0070]      115 —Device&#39;s input tube 
         [0071]      116 —Device&#39;s output tube returns to vein 
         [0072]      117 —Blood flows recombination point 
         [0073]      FIG. 2 —New AV Fistula flexible dialysis tube needle&#39;s cutting end coated in the plastic tubing and inserted in a blood vessel 
         [0074]      201 —The AV Fistula needle 
         [0075]      202 —Profiled cutting edge 
         [0076]      203 —Blunt edge for elastic stretching the blood vessel&#39;s hole without cutting 
         [0077]      204 —Needle bump for plastic flexible dialysis tube umbrella opener activation 
         [0078]      205 —Fistula penetration hole borders 
         [0079]      206 —Blood vessel tube wall 
         [0080]      207 —Blood flow 
         [0081]      208 —Umbrella structure opening inside blood vessel 
         [0082]      209 —Umbrella structure opening inside blood vessel bump for triggering opening 
         [0083]      210 —Umbrella structure opening inside blood vessel with hinge-like structure to allow elastic opening against wall of fistula. 
         [0084]      211 —Bio-compatible plastic flexible dialysis tube. 
         [0085]      FIG. 3A —New plastic flexible dialysis tube inserted in the fistula in intake position and bent into the “dog-leg” position 
         [0086]      301 —The AV Fistula needle outside sheath of flexible dialysis tube with the needle extracted 
         [0087]      302 —Tissue 
         [0088]      303 —Skin 
         [0089]      304 —Subcutaneous tissue 
         [0090]      305 —Blood vessel 
         [0091]      306 —Blood vessel wall 
         [0092]      307 —Blood flow 
         [0093]      308 —Blood flow passing outward through the needle 
         [0094]      309 —Blood flow passing forward through the needle bypass hole 
         [0095]      310 —AV Fistula tube hole for residual blood pass through 
         [0096]      311 —Symmetry line followed by the mirrored image for blood exhaust in the blood vessel tube. 
         [0097]      FIG. 3B —New flexible dialysis tube inserted in a blood vessel in exhaust position and bended in the “dog-leg” position 
         [0098]      321 —The AV Fistula flexible dialysis tube with the needle extracted 
         [0099]      322 —Tissue 
         [0100]      323 —Skin 
         [0101]      324 —Subcutaneous tissue 
         [0102]      325 —Fistula lumen 
         [0103]      326 —Fistula wall 
         [0104]      327 —Blood flow 
         [0105]      328 —blood flow passing inward through flexible dialysis tube 
         [0106]      329 —Blood flow passing through flexible dialysis tube bypass hole 
         [0107]      330 —AV Fistula flexible dialysis tube hole for residual blood pass through 
         [0108]      331 —gap to other. 
         [0109]      FIG. 4A —Longitudinal section of the long-term AV Fistula flexible dialysis tube with blood sensing and cleaning fixtures. 
         [0110]      401 —The AV Fistula tubing sheath with the needle extracted 
         [0111]      402 —Bladder filling micro-tubing 
         [0112]      403 —Skin 
         [0113]      404 —Subcutaneous tissue 
         [0114]      405 —Fistula lumen 
         [0115]      406 —Wall of fistula 
         [0116]      407 —Blood flow 
         [0117]      408 —Inlet umbrella expansion mechanism opened in the blood vessel 
         [0118]      409 —Blood flow passing through flexible dialysis tube bypass hole 
         [0119]      410 —AV Fistula tube hole for residual blood pass through 
         [0120]      411 —Pass through blood vessel seal in open position 
         [0121]      412 —Fluid actuated sampling tube valve in off position 
         [0122]      413 —Blood vessel seal&#39;s actuating bellows 
         [0123]      414 —Micro-fluidic channel to bellows actuator 
         [0124]      415 —Bladder or balloon inflated by sterile fluid 
         [0125]      416 —Micro-electronics measurement system 
         [0126]      417 —Multi-signal micro wire cable 
         [0127]      418 —Actuator valve signal micro-tube 
         [0128]      419 —Sterile fluid input for washing flexible dialysis tube which prevents contaminants from entering the blood stream 
         [0129]      420 —Residual fluid and washing fluid eliminated by balloon 
         [0130]      FIG. 4B —The sterile protection enclosure and tubing functional control connections. 
         [0131]      430 —Skin surface 
         [0132]      431 —Needle in withdrawn position out of flexible dialysis tube 
         [0133]      432 —Bracelet holding the protection box tight on the body or other attachment method. 
         [0134]      433 —Sterile enclosure base on the body with antibacterial interface 
         [0135]      434 —Middle plastic tube penetrating the tissue 
         [0136]      435 —Middle tube connection to upper tube bellows in bent position 
         [0137]      436 —Lipper tube parallel to the skin 
         [0138]      437 —Intake tube that delivers blood from the fistula to the device outside the body 
         [0139]      438 —Intake blood flow exiting the tube 
         [0140]      439 —Standard medical coupling 
         [0141]      440 —On-off valve 
         [0142]      445 —Cleanup and sterilization tube 
         [0143]      446 —Clean-up sterilization flow where residual blood exits 
         [0144]      447 —Standard medical fitting coupling 
         [0145]      448 —On-off valve 
         [0146]      449 —Valve for penetration needle 
         [0147]      450 —Resilient sealing to prevent blood leakage 
         [0148]      451 —Valve actuator 
         [0149]      452 —Piston actuator to inflate the internal bladder. 
         [0150]      453 —Piston or diaphragm 
         [0151]      454 —Inflation fluid reservoir 
         [0152]      455 —Dual flow bellows actuator 
         [0153]      456 —Bellows actuator connector adaptor 
         [0154]      457 —Multi-contact connector board mounted to the platform 
         [0155]      458 —Multi-signal connector from the micro-electronic measurement system 
         [0156]      459 —Other signal (optical, ultrasound) connector adaptor 
         [0157]      460 —Operational platform with sealing case connected to base. 
         [0158]      FIG. 5A —Longitudinal section through the “two in one” cannulation flexible dialysis tube. 
         [0159]      500 —The penetration needle outside sheath tube with the needle extracted 
         [0160]      501 —The umbrella structure opened in the blood vessel 
         [0161]      502 —Tissue 
         [0162]      503 —Skin 
         [0163]      504 —Subcutaneous tissue 
         [0164]      505 —Fistula lumen 
         [0165]      506 —Fistula wall 
         [0166]      507 —Blood flow 
         [0167]      508 —Blood flow passing outward through flexible dialysis tube to external device 
         [0168]      509 —Blood flow returning from outside body through the return flexible dialysis tube 
         [0169]      510 —Stoma, return hole in the fistula flowing towards the body. 
         [0170]      511 —Bellows expand here to block flow in both directions in the Off position, between dialysis sessions. 
         [0171]      512 —Venous blood flow 
         [0172]      513 —Middle zone of the plastic tube has two tubes for the blood removal and return 
         [0173]      514 —Bellows line where the tube bends forming the “dog-leg” path 
         [0174]      515 —Flexible dialysis tube outside the body attaching to the external ports. 
         [0175]      516 —External ports, standardized connectors 
         [0176]      517 —External ports, standardized connectors 
         [0177]      518 —External device 
         [0178]      519 —Terminal fitting or valve used introduce the perforating guiding needle 
         [0179]      FIG. 5B —Cross section through the “two in one” cannulation flexible dialysis tube in the middle zone 
         [0180]      520 —The external flexible dialysis tube 
         [0181]      521 —The intake flow 
         [0182]      522 —The outtake flow 
         [0183]      523 —Semirigid hinged structure to limit the volume of the outtake flow channel 
         [0184]      524 —Semirigid membrane separating the channels 
         [0185]      FIG. 6 —Longitudinal section of the “two in one” long term cannulation flexible dialysis tube. 
         [0186]      600 —The perforation needle outside flexible dialysis tube with the needle extracted 
         [0187]      601 —The umbrella structure opened in the blood vessel 
         [0188]      602 —Tissue 
         [0189]      603 —Skin 
         [0190]      604 —Subcutaneous tissue 
         [0191]      605 —Fistula lumen 
         [0192]      606 —Fistula wall 
         [0193]      607 —Blood flow 
         [0194]      608 —Blood flow passing through flexible dialysis tube bypass hole 
         [0195]      609 —Blood flow returning from outside body through flexible dialysis tube return tube 
         [0196]      610 —Stoma, return hole in the blood vessel flowing towards the body/hart. 
         [0197]      611 —Bending expanding line where flexible dialysis tube is bellows like that expands on one side making the inner tube wall to block the input in it from the blood vessel tube. 
         [0198]      612 —Venous blood flow 
         [0199]      613 —Middle segment of flexible dialysis tube holding two tubes inside for the flow and return 
         [0200]      614 —Bellows line where the tube bends forming the “dog-leg” path 
         [0201]      615 —The final tube outside the body holding the connector fittings to the external apart. 
         [0202]      616 —Fitting For connection to external apparatus and input the blood back in the body 
         [0203]      617 —Fitting for connection the blood output to an external device 
         [0204]      618 —External device—dialyzer etc. 
         [0205]      619 —Terminal fitting used introduce the perforating guiding needle 
         [0206]      620 —Main valve—fluidic actuated 
         [0207]      621 —Dual flow separation valve in upper withdrawn position 
         [0208]      622 —Fluid channel inside the flexible dialysis tube walls 
         [0209]      623 —Elastic membrane balloon fulfilling the tubes volume with sterile liquid 
         [0210]      624 —Electric signals micro-cables from sensors and MEMS actuators 
         [0211]      625 —Dual flow separation valve actuator track 
         [0212]      626 —Pressure, temperature, flow, ph, ultrasound or optic micro-sensor array 
         [0213]      FIG. 6B —Cross section through the “two in one” cannulation flexible dialysis tube in the middle zone in the Off position 
         [0214]      630 —Flexible dialysis tube 
         [0215]      631 —The intake flow 
         [0216]      632 —The outtake flow 
         [0217]      633 —Semirigid hinged structure to limit the volume of the outtake flow channel 
         [0218]      634 —Semirigid membrane separating the channels 
         [0219]      635 —Actuator tract of the dual fluid tract separation valve 
         [0220]      636 —Micro-tube for sterile fluid balloon actuator 
         [0221]      637 —Micro cable for microelectronics transducer 
         [0222]      638 —Multi-functional capillary tubes—for optics or fluidics 
         [0223]      FIG. 7 —The sterile protection enclosure and control for the “two-in one” flexible dialysis tube. 
         [0224]      700 —Body surface 
         [0225]      701 —Needle in withdrawn position 
         [0226]      702 —Bracelet holding the protection box tight on the body surface 
         [0227]      703 —Sterile enclosure base on the body 
         [0228]      704 —Middle plastic flexible dialysis tube penetrating the tissue 
         [0229]      705 —Middle flexible dialysis tube in bent position 
         [0230]      706 —Upper flexible dialysis tube parallel to the skin 
         [0231]      707 —Intake flexible dialysis tube that delivers blood from the fistula to the external device 
         [0232]      708 —blood flow exit port 
         [0233]      709 —Standard medical coupling 
         [0234]      710 —On-Off valve 
         [0235]      711 —Port for blood flow from the external device back into the body 
         [0236]      712 —On-Off valve 
         [0237]      713 —Standard medical coupling 
         [0238]      714 —Port for blood flow from the device into the body 
         [0239]      715 —Cleanup and sterilization tube 
         [0240]      716 —Cleaning port for blood removal and sterile fluid infusion. 
         [0241]      717 —Standard medical coupling 
         [0242]      718 —On-Off valve 
         [0243]      719 —Valve for penetration needle 
         [0244]      720 —Rubber seal to prevent blood leakage 
         [0245]      721 —Vain to close port 
         [0246]      722 —Piston actuator to inflate the internal balloon 
         [0247]      723 —Piston 
         [0248]      724 —Inflation fluid reservoir 
         [0249]      725 —Dual flow bellows actuator 
         [0250]      726 —Bellows actuator connector adaptor 
         [0251]      727 —Multi-contact connector board tight on the platform 
         [0252]      728 —Multi-signal connector from the micro-electronic measurement system 
         [0253]      729 —Other signal (optical, ultrasound) connector adaptor 
         [0254]      730 —Operational platform with sealing case connected to base. 
       DETAILED DESCRIPTION 
       [0255]      FIG. 1  Presents an actual dialysis needle in longitudinal section as it penetrates tissue and a blood vessel as is currently used, The AV Fistula needle  101  is penetrating the skin  103  and the tissue nearby  104  until it reaches the upper wall of a blood vessel  105 . It is pushed forward and penetrates the nearby blood vessel wall  106  but has to go at a less acute angle inside the blood vessel to avoid further penetration through the opposite vessel wall. The blood flow  107  encounters the needle and a part passes forward through the needle  108 ; another part of blood flow passes forward through the needle bypass hole  109 , in order to maintain active circulation and avoid coagulation. To assure this, the needle has to allow a space within the vessel to allow about 5-30% of the flow to continue past it. For dialysis purposes the extracted blood is processed in a filtering machine,  114  and another needle  112  is used to return it to the blood stream,  117  also allowing for sonic passage of blood around it. 
         [0256]    The needles will be placed one after another on the same blood vessel leaving a gap  111  between. The second needle  112  that puts blood back in the vein is punched in the opposite direction making possible that the blood coming from the external device  114  (dialysis or analysis, or other) that takes the blood from the first needle through the input tube  115  and after processing places it at the output tube  116  and returns in the second needle  112  in the blood flows recombination point  117 , where it mixes with the blood left for vein&#39;s maintenance  110 . 
         [0257]    The process just described, requiring  2  punctures and  2  needles for each session of hemodialysis is traumatic for patients, particularly for their arterio-venous shunts. The needles are typically discarded as bio-hazardous waste after only one use. In this conventional process, the patients&#39; distress and their risk for vessel damage and other medical complications is higher than it needs to be. 
         [0258]      FIG. 2 —shows the new AV Fistula needle&#39;s cutting end coated in the plastic flexible dialysis tube, inserted in a blood vessel, with the more compliant material inside the blood vessel, reducing the risk of vessel damage. 
         [0259]    In this new technology the AV Fistula needle  201  has a profiled cutting edge  202  followed by a blunt edge for blood vessel&#39;s elastic stretching without cutting  203 , that is meant to assure a tight contact and elastic sealing inside the blood vessel penetration hole,  205  minimizing the blood leakage. A needle bump  204  is used for plastic flexible dialysis tube umbrella opener activation. 
         [0260]    The needle is introduced without penetrating the other side of blood vessel wall  206 . Because different patients have different size blood vessels, a dynamic adjustment to the blood vessel diameter is made by using an umbrella opening structure inside the vessel  208  that is activated by an inner bump  209  which, when pressed by the needle bump  204  triggers the breaking of a plastic seal  210 . The umbrella structure then opens inside the blood vessel to get gently tight against the walls, to form a seal. 
         [0261]    The new tube that surrounds the penetration needle is a biocompatible plastic tube  211  that is less stiff than the steel needle and harmless to the blood vessel. 
         [0262]    This feature replaces the steel needle of previous technologies with a soft plastic tube that maintains its profile and assures the maximum flow of blood. It may be made from biodegradable polyamide, but may as well be made of any type of blood and vessel compatible plastic. 
         [0263]      FIG. 3A  shows a new plastic flexible dialysis tube inserted in a blood vessel in intake position and bent in the “dog-leg” position which is another embodiment of the present invention. It is known that any bending in a fluid tube is lowering the flow limit where laminar to turbulent flow transition occurs, which in case of blood may damage the cells but, in this case with mild radius and low flow the effects are minimal. The puncturing needle is then extracted from the sheath flexible dialysis tube  301  that remains in the blood vessel  305 . Illustration shows it penetrates skin  303 , the subcutaneous tissue,  304  and the upper blood vessel wall  306  remaining sealed inside in the blood flow  307  of the fistula. Blood flow passing forward through the noodle cover  308  that is sealed tight in the blood vessel prevents any leakage in the tissue  302 . In order to prevent blood flow stagnation and deterioration a percentage of blood flow passes forward through flexible dialysis tube bypass hole  309  and the rest goes forward through the AV Fistula lumen  310 . A similar flexible dialysis tube operates to reinfuse the purified blood at the return site. 
         [0264]      FIG. 313  shows a new plastic flexible dialysis tube, as embodied in the present invention, inserted in a blood vessel in exhaust position and bent in the “dog-leg” position. 
         [0265]    The AV Fistula sheath tube with the needle extracted  321  is implanted through the skin  323  and subcutaneous tissue,  324  in the blood vessel  325  penetrating the blood vessel tube wall  326 . The blood flow  327  is reconstituting at the nominal level by joining the blood flow passing forward through flexible dialysis tube  328  and blood flow passing forward through flexible dialysis tube bypass hole  329 . In order to prevent blood clot formation a hole is provided for residual blood pass through  330 . 
         [0266]      FIG. 4A  shows a longitudinal section through the long-term AV Fistula flexible dialysis tube with blood cleaning fixtures. In order to reduce the harm inflicted by repeated perforations, plugs are developed to enable long-term use. They are built from special plastic materials, or possibly titanium coated to produce a minimal negative interaction with the tissue, and prevent tissue buildup. Studies would be needed to evaluate factors of patient preference and relative safety or multiple punctures versus the long-term, multiple use connector box attached to the patient&#39;s body. 
         [0267]    The AV Fistula flexible dialysis tube with the needle extracted  401 , showing the plastic flexible dialysis tube fitted on the body surface in the position to be sealed and have blood flow directly through it. To stop the blood flow in the tube a bladder is inflated with a sterile fluid, and gently removing the blood in the tube in such a manner that no blood will remained trapped between the inflating bladder or balloon  415  and the tube wall  401 . Bladder filling micro-tubing  402  takes the sterile liquid from a syringe and inflates the balloon to fulfill the tube&#39;s volume. 
         [0268]    Flexible dialysis tube is left in the position that penetrates the skin  403  and subcutaneous tissue  404  into the blood vessel  405 , puncturing only one blood vessel tube wall  406 —sufficient to collect the entire blood flow  407 —because while penetrated inside an input umbrella expansion mechanism opened in the blood vessel  408  is activated, opening tight to the blood vessel walls  406 . 
         [0269]    In dual-flow operation, valve  412  occludes the lumen so that no blood flow passes through flexible dialysis tube bypass hole  409 . When the device is in Off mode, valve  412  is covering the outflow passage so that all the blood passes directly through the hole  410 , resulting in a minimal dynamic pressure drop around the inserted tube. 
         [0270]    Immediately after the seal closes flexible dialysis tube, the blood cleanup procedure starts by pumping more sterile fluid into the flexible dialysis tube&#39;s bladder or balloon  415 , while sterile fluid for washing dean flexible dialysis tube  419  is pumped in. Because this device is inserted in a blood vessel lumen, a microelectronic measurement system  416 , generically called MEMS devices, can be a part of the device, enabling measurement of many types of signals through a multi-signal micro wire channel  417 . 
         [0271]    The actuator valve for the micro-tube  418  may use the same sterile liquid to inflate or dis-inflate the actuating bellows, or may use electric signal and a MEMS device as actuator. 
         [0272]    During the sealing procedure the pump is introducing sterile liquid through the micro-tube  419  that is injected immediately after the valve  412  making a volume of liquid flowing between the inflating balloon/bladder  415  and flexible dialysis tube wall  401  to contain less and less blood traces up to the moment is completely clean and the balloon fills all the volume, making the residual volume  420  be a minimum. 
         [0273]      FIG. 4B —The sterile protection enclosure and needle-tubes control system. The desired outcome is to reduce the number or punctures of the blood vessel and to use one penetration for more than 1 week, with a high level of patient comfort and safety. 
         [0274]    This requires a protection device attached to the patient&#39;s skin to keep the in-dwelling flexible dialysis tube sterile and free of any mechanical stress, ready to be connected to the dialysis machine and start the process immediately. In engineering we call such a device a connection box that will sit on the body surface  430  over the puncture zone  431 . A bracelet-like device  432  holding the protection box tight on the body part or limb is connected to a sterile enclosure  433  on the body surface. The middle plastic tube penetrating the tissue  434  is maintained in the position with middle tube connection to upper tube bellows in bent position  435  and upper tube  436  is parallel to the skin, holding the intake tube that delivers blood from the blood vessel to the device outside the body  437 . Blood flow exiting the tube  438  via a universal medical coupling  439 . Each flexible dialysis tube has an On-Off valve  440  used to seal the tube after cleaning with sterile liquid after its disconnection from the external apparatus. Reconnection can be made without introducing air bubbles. 
         [0275]    Cleanup and sterilization tube  445  enables sterilization flow with residual blood coming out  446  and a standardized medical fitting  447  and an on-off valve  448 . The tissue penetration needle pass-through valve  449  has any leakage restricted by a rubber seal.  450 , 
         [0276]    Other connectors include valve actuator  451 , a bi-directional piston actuator  452  to inflate/deflate the internal balloon,  453  from an inflation fluid reservoir  454  holding less than 1 ml. of sterile liquid. 
         [0277]    The dual flow bellows actuator  455  has a connector adaptor  456 . 
         [0278]    The electronic measurement system embedded in the flexible dialysis tube has a multi-signal connector from the electronic measurement system  458  which carries the signal to a multi-contact connector board on the platform,  457  that may also include other signal (optical, ultrasound) connectors  459 . 
         [0279]    The entire operational platform  460  with sealing case connected to base, is sealed tight preventing septic infiltration or mechanical stress to the tube. 
         [0280]      FIG. 5A —Longitudinal section through the “two in one” cannulation flexible dialysis tube that allows for the blood to be extracted and introduced through a single puncture, rather than by using two punctures as described above. 
         [0281]    The AV Fistula flexible dialysis tube, outside sheath tube  500  with the needle extracted has the umbrella structure opened in the blood vessel  501  making it tight to the walls. The intermediary segment is penetrated through the skin  503 , and the subcutaneous tissue  504  into the blood vessel  505  surrounded by the tissue  502 . The penetration is done in such a manner that only one blood vessel tube wall  506  to be perforated allowing the blood flow  507  to be entirely collected and blood flow is passing forward through the needle  508  going to the standardized connector. The blood flow returning from the dialysis machine through the needle return tube  509  where it has an opening made by a stoma, return hole in the blood vessel flowing towards the body core/heart  510 . 
         [0282]    Bent expanding line  511  where the flexible dialysis tube is bellow like that expands on one side making the inner tube wall to block the input of blood. 
         [0283]    Venous blood flow  512  is passing through middle zone of the plastic tube  513  with its two channels inside for the blood removal and return. 
         [0284]    The fitting for connection to external apparatus  516  for pumping the blood back in the body; a fitting for connecting the blood output  517  to an external device  518 ; and a terminal fitting  519  used introduce the perforating guide needle. 
         [0285]      FIG. 5B —Cross section through the “two in one” cannulation tubing middle zone. It shows the external plastic tubing  520  that contains the intake flow  521 , the outtake flow  522  which contains a semi-rigid structure to limit the volume of the outtake flow channel  523 . The elastic semi-rigid membrane separating the channels  524  to allow a large aperture for the intake flow and let a reasonable but adequate passage for the blood return coming from the external apparatus. 
         [0286]      FIG. 6  Cross section through the “two in one” long term cannulation flexible dialysis tube that is closed when the apparatus is disconnected from the body. 
         [0287]    The insertion flexible dialysis tube  600  with the needle extracted is shown. The upper skin layer  603 , the subcutaneous flesh  604 , and the fistula wall  606  which are perforated by the needle. When the needle  600  which made the perforation is extracted, the umbrella structure  601  is opened in the fistula  605  preventing any leaks into the tissue  602  and collecting all the blood flow  607  making the blood flow through flexible dialysis tube&#39;s lumen  608 . In the Off position it passes straight through the stoma  610 , returning towards the body core/heart  609 . 
         [0288]    In order to accommodate the dogleg shape the bend  611 , where the flexible dialysis tube has bellow-like membrane that expands to form 2 channels, with the second channel  612  for return flow. 
         [0289]    Middle zone of the plastic tube holding two channels inside for the blood flow and return  613 . Bellow membrane extends through the “clog-leg” segment,  614 . Segment of tubing outside the body,  615 , making connection to external apparatus,  616  and  617  (for blood ports to an external device  618  that can be a dialysis machine, etc). Another terminal fitting  619  is used to introduce the perforating guiding needle that is used when the perforation is made, and a blunt device, when the tube is removed from the patient at the end of its use. 
         [0290]    Valve attached to the bellows semi-rigid membrane  620 ,  621  directs blood flow into the dual-lumen channels or bypass channel  608 . 
         [0291]    To purge residual blood from fluid channel a micro tube runs inside its wall  622  which inflates an elastic membrane balloon with sterile liquid  623 . Electrical micro-cables  624  come along the tube wall carrying the signals from the micro-sensors  626 , that can measure blood pressure, temperature, flow, pH, etc. Such micro-cables could also control the separation valve actuator  625  if it were to be operated by a MEMS (micro-electronics mechanical system). 
         [0292]      FIG. 6B  shows a cross section through the “two in one” cannulation flexible dialysis tube in the AA′ zone when the tube is in “stand-by” mode between perfusion/dialysis sessions, that allows keeping the tube inserted in the body safely, and reduce the risk of repeated punctures. This adds some patient discomfort (from the connection box being constantly attached to the body), but reduces the risk and discomfort of repeated fistula punctures. 
         [0293]    The main plastic flexible dialysis tube  630  in the Off position has its main lumen  631  occupied with a balloon inflated with sterile liquid. The blood return channel  632  is now compressed while its lumen is washed with sterile fluid. The inflated balloon  633  compresses the semi-rigid elastic membrane  634  against the tube wall. Running inside the tubing wall we see the micro-tube  635  for bellows expansion, another for balloon filling with sterile fluid  636 , a micro cable for micro-electronics measurement array  637 , other multi-functional capillary tubes—for optics or fluidics  638 . 
         [0294]      FIG. 7  shows the sterile protection enclosure and functions control for the “two-in one” tube. 
         [0295]    The body part or hand zone  700  is shown with the needle  701  in withdrawn position out of plastic cover tubes, but along the external tube segment axis. 
         [0296]    A bracelet  702  holding the protection box tight on the body part or limb and its sterile enclosure base  703  attaching to the body. 
         [0297]    The flexible dialysis tube  704  penetrating the tissue showing tubing bend  705  and the upper tube parallel to the skin  706 . 
         [0298]    Standardized fitting,  707 ,  711 ,  715  clearly depicted on the outer cover of the connection box, makes all the connections to facilitate patient interchange and connections to various medical devices. 
         [0299]    The intake tube  707  that delivers blood from the blood vessel to the device outside the body and intake blood flow exiting the tube  708  have universal/standardized medical coupling  709  followed by On-Off valve  710  controlling blood outflow to the external device. The return port  711  for blood return also has an On-Off valve  712 , and the standardized medical coupling  713  for the blood flow from the external device back into the body  714 . 
         [0300]    To make a safe easy procedure a cleanup and sterilization tube  715  allows sterilization fluid to be injected and residual blood to be removed  716 . Standardized medical coupling  717 , on-off valve  718  and a penetration needle pass through valve  719  equipped with rubber sealing to prevent blood leakage  720 . The tube switching from active mode where blood flows out and in through the tube back in the blood vessel is done using two inner channels that are opened by outside valve actuators  721  that may use a fluidic or electric actuation. 
         [0301]    The clean, residual blood-free blocking of the middle segment of the plastic tube is done using a sealed piston actuator  722  to inflate the internal balloon, using a piston  723 , inflation fluid reservoir  724 , and an actuator (not shown). The dual flow bellows actuator  725  is connected at a bellows actuator connector  726  on a multi-contact connector board attached to the platform  727  that may directly control the bellows. An adaptor module inside the connection box (not represented for clarity purposes), may use an external signal for controlling the tube modes: active, preparing to close and washing, closed and prepare to open. 
         [0302]    To make the operation more controllable, a multi-micro-sensor array may be is inserted in the input and output stoma of the tube, giving a plurality of physiologic signals difficult to be accessed by other means. These signals are transported to a multi-signal connector from the electronic measurement system  728  by the appropriate connectors. Other signals&#39; (optical, ultrasound) connector adaptor  729 , may be directly accessed by direct or wi-fi connection to external measurement devices. Then connection box case is connected to base  730 . 
         [0303]    The procedure contains the following steps:
       1. With the penetration needle inserted inside the plastic flexible dialysis tube the perforation of the blood vessel and cannulation is performed.   2. The perforation needle is withdrawn and the external flexible dialysis tube is bent forming the “dog-leg”, and the stoma valves are triggered to open, by breaking the inner locking micro-seals.   3. The sterile platform is stuck on the skin around the perforation site and sterilized. The connectors and actuators are installed.   4. A test actuation is done and body parameters measurement tested.   5. The external devices are connected and the tube is set on operational mode.   6. After ending the procedure, “prepare to close” mode is ordered and the separation valve is set to off, and the closing valve is set to on, making the blood bypass the flexible dialysis tube inside the fistula. The cleanup procedure starts by inserting sterile liquid simultaneously with slowly inflating the balloon, until it fills the inner volume of the tube so that no blood or sterile liquid remains inside. The procedure is finished when these are accomplished.   7. The electronic measurement devices remain on or off depending on user&#39;s need.   8. When the next dialysis, perfusion, or infusion is needed the “prepare to open” is ordered and the balloon is evacuated and withdrawn from its position against the tubing wall, the shutter valve is opened while the separation valve is on, making the apparatus ready for connection to external machines. The input and output ports may be opened and the active mode is set to On, by fully actuating the inner separation valve.   9. The infusion or blood extraction or dialysis exchanges then take place in active On mode until the end of operation when the “prepare to close” and “passive/closed” mode is set to On.   10. The cycle 5-9 may be repeated several times as necessary or as long it is safe for the patient the duration of maintaining the inserted tube in the fistula or other vessel will be established by medical need. Then the flexible dialysis tube is extracted by withdrawal, or if necessary by reintroducing a flexible obturator device to facilitate removal.   11. If only single use flexible dialysis tubes are used, comprising the stages 1,2 and 10, the operation is simpler, as they would not use the various flow directing valves or cleaning balloon additions in the more advanced devices proposed above. These devices would require the same precautions as current dual needle techniques placement to avoid blood mixing, keeping adequate residual flow in the shunt, proper diameters to assure good flow, etc.       
 
         [0315]    When flexible dialysis tube is not in use, blood ports are sealed by valves and various materials may be used in the connection box Or over the connection box to keep sterility. These would include foils of metal or plastic or gaseous additions. 
       BRIEF DESCRIPTIONS OF INVENTION 
       [0316]    The present invention refers to a set of improvements to the actual technique and apparatus of perfusion and dialysis having several stages of application that are not mutually exclusive. 
         [0317]    The main embodiment of the invention refers to the enhancement of the perfusion needle by adding a special plastic flexible dialysis tube covering the needle. The stiff needle is used for penetration and to insert flexible dialysis tube that will remain inside and shape itself to the vessel, while the stiff needle is extracted. Flexible dialysis tube has a structure that opens gently inside the blood vessel, preventing blood leaks from the vessel and bends along the body parallel with the skin to minimize patient distress. 
         [0318]    It is possible to reduce the number of perforations for a dialysis session from two to one by using a two in one flexible dialysis tube installed over a guiding needle. After it&#39;s in the vessel and the needle is withdrawn, flexible dialysis tube opens forward and backward and the initial tube becomes a dual function tube by the opening of a supplementary partition inside, so the blood comes out using one partition and is pumped back in the blood vessel using the secondary partition. 
         [0319]    Using advanced technologies, a controllable blood extraction/perfusion flexible dialysis tube may be developed which once inserted in the body may be safely maintained there for long periods, assuring it remains sterile and safe to use as a fluidic connector. One key issue is that blood that remains static in flexible dialysis tube may coagulate or deteriorate. In order to eliminate this possibility all the residual blood from a closed tube is eliminated by the help of another bladder placed on the other internal surface of the tube that may be inflated at will removing any blood or liquid trapped inside the dead-end tube. 
         [0320]    To further improve this process, blood is cleared by purging with a sterile liquid. Further, the use of embedded micro-electronics and micromechanics placed as a sensor array inside the tube could measure blood pressure, temperature, blood composition and chemical parameters, data that normally require multiple devices and blood removal to acquire. Measurement of flow and pressure inside the patient&#39;s AV shunt could possibly enable tuning of dialysis pump parameters for an optimal physiologic result. 
         [0321]    Further, the present invention proposes a connection box that would be attached to the patient&#39;s surface so that he could be connected in seconds to an external blood processing or infusion device, and through which physiologic measurements could be made continuously or as desired. 
       Examples of the Invention 
       [0322]    Thus it will be appreciated by those skilled in the art that the present invention is not restricted to the particular preferred embodiments described with reference to the drawings, and that variations can be made therein without departing from the scope of the present invention as defined in the appended claims thereof. The present invention consists in the development of a set of improved vascular access devices that could be used for cannulation and blood removal or reinfusion, or the introduction of any fluids to the circulatory system of the body for humans and animals, in customized versions, regarding gauge, length and functionalities. 
         [0323]    The application of these customized versions will extend the range of multiple usage minimizing the negative impact of the treatment on patients, and also reducing undesired collateral effects and medical complications. The use of the embedded sensors will bring progress to the practice of medicine, allowing the patient&#39;s blood pressure, temperature, flow, composition of the blood and its chemical properties to be monitored continuously and used in diagnosis and equipment control. Some derivatives of this equipment, without the function of blood and fluid transfer might be developed as implants for measurement purposes only. The application of the present invention will generate a step forward in medicine, by intensively using multi-parameter monitoring and more body-friendly invasive devices.