Abstract:
An access disconnection method includes supporting a transmitter including a wireless communication apparatus, a receiver, a portion of an arterial line, a portion of a venous line and electronic circuitry by a member separate from a blood treatment machine. The method further includes operably communicating the electronic circuitry with the transmitter and the receiver, enabling transmission of a wave from the transmitter in one of the arterial and venous lines, enabling receipt of the wave by the receiver in the other of the arterial and venous lines, and enabling a disconnection output to be sent to the blood treatment machine via the electronic circuitry. The disconnection output is indicative of a change in the wave received by the receiver from the transmitter sufficient to expect that an access site disconnection of one of the arterial and venous lines has occurred.

Description:
PRIORITY CLAIM 
       [0001]    This application claims priority to and the benefit as a continuation application of U.S. Patent Application entitled, “Acoustic Access Disconnection Systems and Methods”, Ser. No. 11/673,390, filed Feb. 9, 2007, the entire contents of which are incorporated herein by reference and relied upon. 
     
    
     BACKGROUND 
       [0002]    The present disclosure relates generally to patient access disconnection systems and methods for medical treatments. More specifically, the present disclosure relates to the detection of a patient access disconnection, such as the detection of needle or catheter dislodgment during dialysis therapy. 
         [0003]      FIG. 1  illustrates a known access disconnection configuration. Blood is drawn from an arm  12  of a patient through an arterial line  14  connected the patient via an arterial needle  16 . Blood is returned to the patient, after it has been treated, via a venous line  18  and venous needle  20 . Needles  16  and  20  actually connect to a shunt  22 , which is placed in fluid communication with one of the patient&#39;s arteries and veins. Accidental disconnection of the arterial line  14  during treatment is not as serious an issue as this simply eliminates the source of blood to the blood pump. Access disconnection of venous line  18  during treatment is a serious concern because arterial line  14  keeps feeding blood to the blood pump, while venous line  18  returns blood to a location outside of the patient. 
         [0004]    A variety of different medical treatments relate to the delivery of fluid to, through and/or from a patient, such as the delivery of blood between a patient and an extracorporeal system connected to the patient via a needle or needles inserted within the patient. For example, plasmapherisis, hemodialysis, hemofiltration and hemodiafiltration are all treatments that remove waste, toxins and excess water directly from the patient&#39;s blood. During these treatments, the patient is connected to an extracorporeal circuit and machine, and the patient&#39;s blood is pumped through the circuit and machine. Waste, toxins and excess water are removed from the patient&#39;s blood, and the blood is infused back into the patient. 
         [0005]    In these treatments, needles or similar access devices are inserted into the patient&#39;s vascular system so that the patient&#39;s blood can be transported to and from the extracorporeal machine. Traditional hemodialysis, hemofiltration and hemodiafiltration treatments can last several hours and are generally performed in a treatment center about three to four times per week. In in-center treatments, patients undergoing hemodialysis, for example, are monitored visually to detect needle dislodgment. However, the needle may not be in plain view of the patient or medical staff (e.g., it may be covered by a blanket) such that it could delay detection and timely response. 
         [0006]    Moreover, in view of the increased quality of life, observed reductions in both morbidity and mortality and lower costs with respect to in-center treatments, a renewed interest has arisen for self-care and home therapies, such as home hemodialysis. Such home therapies (whether hemodialysis, hemofiltration or hemodiafiltration) can be done during the day, evening or nocturnally. If unsupervised or asleep, dislodgment risks increase because a caregiver is not present and perhaps even the patient is not aware of a dislodgment. 
         [0007]    Various systems exist for detecting needle dislodgement in hemodialysis. For example, U.S. Pat. No. 7,022,098 (“the &#39;098 Patent”) and U.S. Pat. No. 7,052,480 (“the &#39;480 Patent”), both entitled Access Disconnection Systems And Methods, and assigned to the eventual assignee of the present application, disclose access disconnection systems that measure an electrical impedance of the extracorporeal dialysis circuit connected to the vascular access needles. An external voltage or current source is used to inject a small current (e.g., less that 2.5 μ-Amp) into the blood flow. While this external current is small compared to other systems, the source still requires that measures be taken to ensure that the current does not exceed 10 μ-Amp, which is considered in the art to be a safety limit for intercardiac devices. Further, sensitivity of the impedance system can be decreased when the patient is connected to earth ground (e.g., through grounding devices found in clinics and homes). 
         [0008]    Another problem with systems that inject current into the extracorporeal circuits occurs if the dislodged needle reestablishes contact with the other needle through leaked blood. Here, the electrical parameter being sensed, e.g., impedance, may not change or not change enough to signal an access disconnection even though one has occurred. 
         [0009]    A further obstacle involves the addition of contacts to the disposable portion of the blood treatment system. Metal or otherwise conductive members placed in the disposable add a certain amount of manufacturing difficulty and cost. 
         [0010]    A need accordingly exists for improved blood access disconnection systems. 
       SUMMARY 
       [0011]    The examples described herein disclose access disconnection systems and methods applicable for example to: plasmapherisis, hemodialysis (“HD”), hemofiltration (“HF”) and hemodiafiltration (“HDF”). The access disconnection systems may also be used with continuous renal replacement therapy (“CRRT”) treatments requiring vascular access. The access disconnection examples below operate with systems having a diffusion membrane or filter, such as a dialyzer, e.g., for HD or HDF, or a hemofiliter, e.g., for HF. 
         [0012]    Moreover, each of the systems described herein may be used with clinical or home setting machines. For example, the systems may be employed in an in-center HD, HF or HDF machine, which runs virtually continuously throughout the day. Alternatively, the systems may be used in a home HD, HF or HDF machine, which is run at the patient&#39;s convenience. One such home system is described in copending U.S. patent application Ser. No. 10/982,170 (“the &#39;170 Application”), entitled “High Convection Home Hemodialysis/Hemofiltration And Sorbent System,” filed Nov. 4, 2004, assigned to the eventual assignee of the present application, the entire contents of which are incorporated herein expressly by reference. 
         [0013]    The access disconnection examples below operate with systems having a dialysate (infusate) supply, which can be a single bag or multiple bags of dialysate supply ganged together and used one after another. Further alternatively, each of the access disconnection systems shown below can be used with a machine having an on-line source, such as one or more concentrate pump configured to combine one or more concentrate with water to form dialysate on-line. On-line sources are used commonly with HD systems for example. 
         [0014]    Various non-invasive access disconnection systems are described herein. The systems by and large do not inject a voltage or current into the patient. This illuminates problems with patient grounding inherent in current inducing systems. Because the systems do not rely on the connection or disconnection of an electrical loop, they tend to be immune from the reestablishment of a conductive path with a dislodged needle and lost blood. The disclosed systems in various embodiments communicate with the dialysis machine wirelessly, e.g., through a radio frequency signal. In this manner, the systems do not add to the disposable tubing and/or cassette that the machine uses, increasing manufacturing feasibility and reducing cost. 
         [0015]    A first system uses a piezoelectric or electromagnetic transducer (referred to hereafter generally as piezoelectric for convenience) operating for example in the Mega-Hertz frequency range, which transmits ultrasound waves into tissue. The transducer&#39;s body is parallel to the tissue in one embodiment while the piezoelectric itself is at an angle to produce ultrasound components aligned with blood flow direction. 
         [0016]    Red cells in the blood stream act as reflectors for the ultrasound, echoing the wave back into the transducer. Another piezoelectric or electromagnetic crystal (referred to hereafter generally as piezoelectric for convenience) can be used to receive the echoes. Ultrasound frequency is changed as the wave reflects on the blood cells via the Doppler effect. The changes in frequency of the ultrasound signal are an indication of the speed of the reflecting cells. The first system processes the received echoes and extracts flow rate information. 
         [0017]    The first system as mentioned uses a piezoelectric transmitter and a piezoelectric receiver or a single transducer that performs both functions. Electronic circuitry is connected to the transducers or transducer to produce the excitation signals and to process the echoes. In one implementation, the electronics also include a radio frequency (“RF”) link to the hemodialysis instrument. Once the treatment has started, the ultrasound device gathers information from the blood stream. Peak speed of reflectors, pulsatile characteristics of the blood flow, turbulence in the access are some of the parameters that are monitored as described in more detail below. The access disconnection system exchanges such information with the dialysis instrument via the RF link. Venous needle dislodgement will necessarily introduce a radical change in the sensed parameters, allowing access disconnect detection. 
         [0018]    In one implementation of the first access disconnection system, the ultrasound transducer is held in place with a band via a hook and loop assembly, magnetic coupling or other buckle mechanism. The band offers tube restraining to mechanically prevent needle dislodgement. 
         [0019]    A second access disconnection system uses the propagation properties of sound in blood within the extracorporeal circuit to determine for example if the venous section of the extracorporeal circuit is connected to the patient. The second system uses at least one acoustic transducer, which generates a sound wave signal that is processed by the dialysis unit, which has access to other parameters of the treatment such as blood flow, dialysis flow, valve sequencing etc. The sound waves can be sonic, subsonic or a pressure wave emitted into the blood stream. The signals can be of any suitable frequency, could be a single frequency or multiple frequencies, it could be continuous, pulsed, modulated in amplitude, frequency or phase. The acoustic transducer can be piezoelectric, electromagnetic or any suitable type capable of converting electrical excitation into pressure waves and/or vice versa. 
         [0020]    The second access disconnection system can be implemented in at least three ways. One implementation uses two acoustic transducers, one coupled to the venous section of the extracorporeal circuit, while the other is coupled to the arterial section of the extracorporeal circuit. One of the transducers transmits an acoustic signal into the blood stream, while the other transducer receives the signal. If any of the sections becomes disconnected, the receiver no longer detects the emitted signal, triggering an alarm. The dual acoustic transducers can each perform both functions, transmit and receive, making possible an embodiment in which the dual transducers switch functions with each other. 
         [0021]    A second implementation uses either one acoustic transducer, doubling as transmitter and receiver, or two transducers, one dedicated to transmit and the other to receive. Here, both emitter and receiver are coupled to the venous section of the extracorporeal circuit. In this implementation the transmitter sends an acoustic pulse into the blood. The pulse reflects in the extracorporeal circuit interface producing a signature response. The system monitors, processes and analyzes the signature of the echo produced when the venous line is connected and yields a baseline acoustic signature response. The acoustic signature response produced when the venous line is disconnected is different from the stored pattern. Processing of the received signal detects such change and generates an alarm, pump and/or valve shutdown or occlusion as desired. 
         [0022]    A third implementation of the second access disconnection system uses passive sonar. The blood stream in the extracorporeal circuit is subjected to a series of operations that introduce acoustic waves into it. Blood pump, drip chamber, interaction with the dialyzer and the patient each create an acoustic pattern. This sound pattern constitutes an acoustic signature, e.g., in the venous line when the needle is lodged, will be different from the one when it is dislodged. The passive sonar implementation uses an acoustic transducer coupled to the venous line, which acts as a receiver. The receiver transducer monitors, processes and analyzes acoustic signals in the blood to create a baseline acoustic signature. When the pattern changes due to a venous needle dislodgement, the processing of the received signal detects this change and generates an alarm, etc. 
         [0023]    A third access disconnection/blood leak detection system uses optical sensors. It is not uncommon that a small blood leak is present around the areas at which the access needles connect to the patient&#39;s arm. This effect, however, should be limited to a small area around the access points. If the blood leak extends to a larger area, it likely indicates needle partial or full dislodgement, which must be addressed immediately. 
         [0024]    The optical system in one embodiment uses a flexible circuit having distributed optically reflective sensors. Here, flexible circuit wraps around the arm of the patient in one embodiment. In another implementation, the optical system incorporates either a rigid or semi-rigid circuit mounted on a flexible arm band made of plastic, rubber or cloth, for example. The arm band can also be disposable. In any case, the attachment mechanism can be sized and configured to be attached alternatively for blood access with another body area, such as a patient&#39;s leg, or for catheter access, e.g., in the patient&#39;s neck. 
         [0025]    The flexible circuit can be in contact with a piece of gauze covering the needle recess. For sterility the contact surface is cleaned with a disinfectant. Alternatively, the contact area is covered with a sterile disposable transparent film, which can be self-adhesive. The film is discarded after the treatment is completed. 
         [0026]    The flexible circuit can be attached to the patient using a hook and loop type of mechanism, magnetic straps, magnetic buckle or other type of releasably securable and cleanable apparatus. 
         [0027]    The reflective optical sensors in one embodiment use of a light emitting diode, such as a light source, and a photocell or phototransistor, as receiver. The emitted light has a wavelength that has is chosen so that the color of blood absorbs its energy. As long as the light illuminates a white gauze, a percentage of the light&#39;s energy is reflected towards the receiver. On the other hand, if blood on the gauze absorbs most of all of light energy, the receiver detects a considerable loss of signal and signals or alarm, etc. 
         [0028]    A local micro-controller in one embodiment gathers data from the optical sensors and reports this data via, e.g., a radio frequency link, to the dialysis instrument. In one implementation, the micro-controller remains in a sleep mode or power-save mode, which turns the optical sensors off until the dialysis instrument requests data via the radio frequency link. The micro-controller then “wakes up”, energizes the light sources, reads the optical receivers and transmits the status back to the dialysis instrument. If one (or perhaps more than one) of the sensors does not receive enough light, the processor issues a distress call and, additionally or alternatively, energizes an audible alarm. The machine takes any other appropriate action, such as shutting down a pump or clamping a line or valve. 
         [0029]    In a fourth access disconnection embodiment, the dialysis system uses the patient&#39;s cardiovascular electrical system to detect an access disconnection. Humans have an internal electrical system that controls the timing of heartbeats by regulating: heart rate and heart rhythm. Generally, the body&#39;s electrical system maintains a steady heart rate of sixty to one hundred beats per minute at rest. The heart&#39;s electrical system also increases this rate to meet the body&#39;s needs during physical activity and lowers it during sleep. 
         [0030]    In particular, the heart&#39;s electrical system controls the timing of the body&#39;s heartbeat by sending an electrical signal through cells in the heart, namely, conducting cells that carry the heart&#39;s electrical signal and muscle cells that enable the heart&#39;s chambers to contract. The generated electrical signal travels through a network of conducting cell pathways by means of a reaction that allows each cell to activate the one next to it, passing along the electrical signal in an orderly manner. As cell after cell rapidly transmits the electrical charge, the entire heart contracts in one coordinated motion, creating a heartbeat. 
         [0031]    The system of the present disclosure uses an electrocardiogram or electrogram (“ECG”) setup. In one implementation, a first electrode is attached to the venous line and a second electrode is attached to the patient. The electrodes are connected electrically to signal conditioning circuitry. The signal conditioning circuitry produces ECG signals when the arterial and venous connections are made properly. When a partial or complete access disconnection occurs with either the arterial or venous needles, electrical communication with the body&#39;s electrical system through the extracorporeal path is lost as is the ECG signal. Additional circuitry detects this dropout and sends an access disconnection signal to the blood treatment machine. 
         [0032]    Alternative ECG embodiments include the attachment of both first and second electrodes to the extracorporeal circuit. Also, blood access can be made at or close to the patient&#39;s heart, increasing sensitivity to the ECG signals, as opposed to access at the patient&#39;s arm. To that end, disclosed herein is an embodiment for a dialysis needle equipped with the electrodes used for accessing the patient&#39;s blood at or near the heart. Also disclosed herein are various embodiments for tubing having electrodes implanted either inside the tubing, within the tubing or outside the tubing. Depending on the electrode configuration, the electrodes communicate electrically with the blood directly, capacitively, inductively, or wirelessly, e.g., through radio frequency. 
         [0033]    The ECG system is also adaptable for other uses besides the detection of vascular access disconnection. The ECG signals may be further processed to calculate other physiological parameters such as heart rate variability, respiration, stroke volume, cardiac output and central blood volume. To this end, an electrical source can be added to the ECG system to measure bioimpedance. Further, a solution can be injected into the patient&#39;s body to assist in one or more of the above parameters. The ECG system can also be used to assist control of patients with heart rhythm management devices (pacemakers) via cardiac electrophysiology measurements to change cardiovascular parameters beneficially during dialysis. 
         [0034]    In a fifth system, a blood leak device using capacitive sensors is provided. The device includes outer layers of insulation, e.g., plastic layers. Inside, the device includes an array of capacitors. A layer of shielding is also provided inside the shielding. If a blood leak develops beneath the capacitive device, the region of capacitors sensing a dielectric change grows. If the region stops growing, a system using the capacitive device assumes a normal amount of seepage has occurred, which is distinguishable from a blood leak or needle dislodgement. If the blood leak grows large enough, the system using the capacitive device assumes that a partial or full access disconnection has occurred and causes an alarm. 
         [0035]    In any of the above described access disconnection embodiments, the circuitry for the access disconnection systems can be located locally at the patient or sensing site, remotely within the machine, or some combination thereof Depending on the location of the circuitry, the signal sent from the access disconnection system to the dialysis machine can be a steady, e.g., conditioned digital signal, an intermittent signal, a signal sent on command or some combination thereof The signal can be sent via wires or wirelessly. 
         [0036]    Further, any of the above described access disconnection/blood leak detection embodiments can be used alternatively in a redundant system with another, different type of access disconnection/blood leak system. For example, any system that looks for an electrical connection to be broken (described loosely as an access disconnection system for ease of description but in know way intending to limit the meaning of the term) can be combined with a system that looks for an electrical connection to be made (described loosely as a blood leak detection system for ease of description but in know way intending to limit the meaning of the term) to capitalize on benefits inherent with each type of system. 
         [0037]    It is therefore an advantage of the present disclosure to provide an improved access disconnection system for blood treatment machines. 
         [0038]    It is another advantage of the present disclosure to provide non-invasive access disconnection systems. 
         [0039]    It is a further advantage of the present disclosure to provide access disconnection systems that do not induce current into the patient&#39;s blood. 
         [0040]    It is still another advantage of the present disclosure to provide access disconnection systems that do not add to disposable cost or manufacture. 
         [0041]    It is still a further advantage of the present disclosure to provide access disconnection systems that circumvent problems from to electrical reconnection due to lost blood. 
         [0042]    It is yet another advantage of the present disclosure to provide an access disconnection system that yields other valuable blood parameter information. 
         [0043]    It is yet a further advantage of the present disclosure to provide access disconnection systems that are compatible with blood needle and catheter applications. 
         [0044]    Additional features and advantages are described herein, and will be apparent from, the following Detailed Description and the figures. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0045]      FIG. 1  illustrates a known arterial and venous access configuration. 
           [0046]      FIG. 2  is a sectioned elevation view showing one embodiment of an access disconnection system using ultrasound. 
           [0047]      FIG. 3  is a perspective view showing the system of  FIG. 2  and one embodiment for it to communicate with a blood treatment machine. 
           [0048]      FIG. 4  is a schematic view of one embodiment of the electronics associated with the system of  FIG. 2 . 
           [0049]      FIG. 5  is a schematic view of one simulation of the ultrasound access disconnection system of  FIG. 2 . 
           [0050]      FIG. 6  is a chart illustrating results from testing done on the simulation of  FIG. 5 . 
           [0051]      FIG. 7  is a perspective view showing one embodiment of an acoustic access disconnection system, which employs two acoustic transducers. 
           [0052]      FIG. 8  is a perspective view showing an additional embodiment of an acoustic access disconnection system, which employs active sonar, and which is system is depicted in a transmit phase. 
           [0053]      FIG. 9  is a perspective view showing either (i) a receive phase of the active sonar system of  FIG. 8  or (ii) an alternative embodiment employing a passive sonar system, wherein both systems “listen” to either (i) an echo of the active transmitted signal or (ii) the acoustic signature of the extracorporeal circuit in the passive system. 
           [0054]      FIG. 10  is a perspective view showing one embodiment of an optical access disconnection system. 
           [0055]      FIG. 11  is a perspective view showing one embodiment of a flexible circuit used with the optical access disconnection system of  FIG. 10 . 
           [0056]      FIG. 12  is a schematic elevation view representing the optical access disconnection system of  FIG. 10  in a normal state. 
           [0057]      FIG. 13  is a schematic elevation view representing the optical access disconnection system of  FIG. 10  in an access disconnection state. 
           [0058]      FIG. 14  is a perspective view showing the optical system of  FIG. 10  and one embodiment for it to communicate with a blood treatment machine. 
           [0059]      FIG. 15  is a schematic view of one embodiment of a system that uses electrocardiogram (“ECG”) signals to detect an access disconnection. 
           [0060]      FIG. 16  is a schematic view of another embodiment of a system that uses electrocardiogram (“ECG”) signals to detect an access disconnection. 
           [0061]      FIG. 17  is a plan view of one embodiment for a cardiac catheter used with the ECG system of  FIG. 16 . 
           [0062]      FIGS. 18A to 18C  illustrate various embodiments for coupling an electrical contact with the patient&#39;s blood, the embodiments capable of being used with the systems of  FIGS. 16 and 17 . 
           [0063]      FIGS. 19A and 19B  are top and side views of a capacitive sensing blood leak detection device. 
       
    
    
     DETAILED DESCRIPTION 
       [0064]    The examples described herein are applicable to any medical fluid therapy system requiring vascular access. The examples are particularly well suited for the control of kidney failure therapies, such as all forms of hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration (“HDF”) and continuous renal replacement therapies (“CRRT”) requiring vascular access. 
       Ultrasound Remote Access Disconnection Sensor 
       [0065]    Referring now to the drawings and in particular to  FIGS. 2 to 4 , an ultrasound access disconnection system  10  is illustrated.  FIG. 2  shows the details of system  10 .  FIG. 3  shows one apparatus for attaching system  10  to patient  12 .  FIG. 3  also shows one embodiment for interfacing system  10  with blood treatment or dialysis machine  100 . While system  10  refers generally to the remote apparatus connected to the patient as seen in  FIG. 2 , system  10  and indeed each of the systems described herein also includes the machine or instrument, such as a dialysis machine.  FIG. 4  shows an embodiment of the electronics (either onboard or remote electronics) associated with system  10 .  FIGS. 5 and 6  provide test results. 
         [0066]    Any of the vascular disconnection examples described herein, including system  10 , is operable with machine  100 , which can include a diffusion membrane or filter, such as a dialyzer, e.g., for HD or HDF, or a hemofiliter, e.g., for HF. Moreover, machine  100  and any of the access disconnection systems described herein may be used in clinical or home settings. For example, machine  100  and the access disconnection systems may be employed in an in-center HD machine, which runs virtually continuously throughout the day. Alternatively, they may be used in a home HD machine, which can for example be run at night while the patient is sleeping. 
         [0067]    Machine  100  in one embodiment has a dialysate (infusate) supply. Alternatively, multiple bags of dialysate supply are ganged together and used one after another. In such a case, the emptied supply bags can serve as drain or spent fluid bags. Further alternatively, machine  100  can be used with an on-line source, such as one or more concentrate pump configured to combine one or more concentrate with water to form dialysate on-line. On-line sources are used commonly with HD systems for example. 
         [0068]    Although not illustrated, machine  100  can operate with an in-line or batch heater that heats the dialysate or infusate to a desired temperature. The heater can be located upstream or downstream of a fresh supply pump for example. Machine  100  includes a dialysate air trap, which can be located at or near the heater to capture air egression from the dialysate due to heating. Likewise, the extracorporeal circuit operable with blood pump  102  also includes one or more air detector and air removal apparatus (e.g., air trap). 
         [0069]    HD, HF, HDF or CRRT machine  100  also includes blood pumping systems, shown below, which are known generally in the art, e.g., the use of one or more peristaltic blood pump. HD, HF, HDF or CRRT machine  100  also includes dialysate proportioning systems, mentioned above, which are also known and need not be described here. The &#39;534 Patent, incorporated herein by reference, describes a proportioning system for example. 
         [0070]    Machine  100  also includes an apparatus and method for knowing how much dialysate has been used for clearance and how much ultrafiltration volume has been removed. This apparatus controls and knows how much ultrafiltrate has been removed from the patient and controls the flowrate of dialysate to and from the dialyzer, extracorporeal circuit and/or hemofilter. The apparatus also ensures that the necessary amount of ultrafiltrate is removed from the patient by the end of treatment. 
         [0071]    Machine  100  includes an enclosure  104  as seen in  FIG. 3 . Enclosure  104  varies depending on the type of treatment, whether the treatment is in-center or a home treatment, and whether the dialysate/infusate supply is a batch-type (e.g., bagged) or on-line. An in-center, on-line enclosure  104  tends to be bigger and more robust due to the additional dialysate producing equipment and the frequency of use of such machines. A home therapy enclosure  104  is desirably smaller and built so that machine  100  can be moved about one&#39;s home or for travel. 
         [0072]      FIG. 2  illustrates that system  10  includes a transducer  24 . Transducer  24  in the illustrated embodiment includes a housing  26 , which houses a piezoelectric crystal  28 . Transducer  24  transmits power from one type of system to another. In the piezoelectric embodiment, transducer  24  power is provided in the form of electricity from a piezoelectric material acted upon. System  10  includes a transducer excitation apparatus  42  as seen in  FIG. 4 , which applies an electrical field to piezoelectric crystal  28 . Piezoelectric crystal  28  undergoes mechanical deformation due to the electric field. In this manner, crystal  28  is induced to resonate (vibrate) at a certain frequency to produce ultrasonic waves. In an embodiment, the ultrasonic waves are produced in the Mega-Hertz frequency range. A layer of gel couples the waves to the patient in one embodiment. The ultrasound waves in the presence of human tissue travel through the tissue to a depth that depends on the power and frequency of the excitation. 
         [0073]    Housing  26  of transducer  24  in the illustrated embodiment is positioned in parallel with the arm and tissue of patient  12 . Crystal  28  on the other hand is placed at an angle, e.g., forty-five degrees, relative to the arm and tissue of patient  12  to produce ultrasound waves  30   a  having directional components both aligned with and perpendicular to the direction of blood flow. 
         [0074]    Blood cells  32 , e.g., red blood cells, within the blood stream serve as reflectors for the ultrasound waves, echoing waves  30   b  back towards a second piezoelectric crystal  34 . It should be appreciated however that first piezoelectric crystal  28  could perform both emitter and receiver functions, in which case second crystal  34  is not needed. In the illustrated embodiment, receiver crystal  34  is located in the same housing  26  of the same transducer  24  as is emitter crystal  28 . Alternatively, receiver crystal  34  is located in a separate transducer housing. In the illustrated embodiment, receiver crystal  34  is also mounted at an angle, e.g., forty-five degrees, relative to the arm and tissue of patient  12 . 
         [0075]    For receiver piezoelectric crystal  34 , reflected waves  30   b  apply mechanical stress to receiver crystal  34 , causing crystal  34  to become electrically charged and to vibrate at its resonant frequency creating an ultrasound wave. The reflected ultrasound waves  30   b  have a different frequency than do the emitted ultrasound waves  30   a,  an effect known as the Doppler effect. The change in frequency is dependent on the speed and direction of movement of blood cells  32  flowing though the access site. The electronics in system  10  stores software that processes the received echoes  30   b  to determine blood parameters, such as, blood flowrate of the red blood cells, peak flowrate of the reflectors, changes in blood flowrate, e.g., pulsatile characteristics of the blood flow, turbulence in the access line as described in more detail below. 
         [0076]    In the embodiment illustrated in  FIG. 3 , transducer  24  and the electronics described below are held in place via bands  36 . Bands  36  have suitable fasteners, such as VelcroTM fasteners or other type of frictionally engaging fastener, buttoned or snap-fitted fastener. Bands  36  serve a second function, namely,  FIG. 2  shows that band  36  holds transducer  24  against patient  12  via a gel  38 . Gel  38  couples the ultrasound wave into the patient&#39;s tissue. 
         [0077]      FIG. 4  shows an embodiment of the electronics associated with system  10 . A digital signal processor (“DSP”)  44 , which can include onboard random access memory (“RAM”) and read only memory (“ROM”), sends an output signal to transducer excitation apparatus  42 . Excitation apparatus  42  excites emitter crystal  28  of transducer  24  as described above. Reflected waves  30   b  cause receiver crystal  34  (or crystal  28  operating as both emitter and receiver) to vibrate and create an ultrasound wave, which is sent to signal conditioning  40 . Signal conditioning  40  in one embodiment includes an analog to digital (“A/D”) converter, which digitizes the reflected wave into a form that DSP  44  can process. Signal conditioning  40  may, in another embodiment, contain demodulation circuitry to separate the signal components in a manner useful for Doppler calculations, for example. 
         [0078]    DSP using onboard software in one embodiment detects a flow or access condition, a no-flow or full-access disconnection condition or a partial-flow or partial access disconnection condition. DSP  44  also uses the conditioned signals to detect blood flowrate, e.g., by equating a particular frequency to a particular blood flowrate. The correlation can be determined empirically and checked for repeatability. A peak frequency corresponds to peak blood flowrate. DSP  44  also detects changes in blood flowrate even when they do not rise to the level indicating an access disconnection. This information can be used to determine blood flow turbulence for example, which in turn can be used for example diagnostically to monitor or determine therapy efficiency or effectiveness. 
         [0079]    DSP  44  communicates back and forth with a remote or wireless emitter/receiver  46 , such as a radio frequency (“RF”) emitter/receiver. Other remote signals may be used alternatively, such as a microwave signal. Further alternatively, system  10  is hard-wired to machine  100  and communicates via electrical signals, e.g., 4 to 20 mA or 0 to 5 VDC signals. 
         [0080]    Machine  100  includes a wireless transmitter/receiver  48 , such as an RF transceiver. In system  10 , communicator  48  instrument  100  sends messages to and receives messages from the remote unit via communicator  46 . Communicator  48  in turn communicates back and forth with a central processing unit (“CPU”)  50  located within  100 . CPU  50  in an embodiment includes a supervisory processor that communicates via signals  56  with one or more delegate processor and circuit board or controller located within machine  100 . Transducer  24 , signal conditioning  40 , excitation apparatus  42 , DSP  44  and emitter  46  are located on a printed circuit board (“PCB”)  52  in the illustrated embodiment. PCB  52  can be located within transducer housing  26 , within a separate housing (not illustrated), or within a housing that also houses one or more transducer  24 . In an alternative embodiment, DSP  44  and its associated functionality are located and performed, respectively, at CPU  50  of machine  100 . 
         [0081]    PCB  52  also includes a battery, a power supply or a combination of both, referred to generally herein as power supply  54 . Supply  54  can be a rechargeable battery, for example. Supply  54  powers the components of PCB  52 , such as, signal conditioning, DSP  44  and wireless communicator  46 . Power supply  54  is rechargeable in an embodiment and can be coupled to an audio, visual or audiovisual alarm that alerts the patient when the power supply needs to be recharged or replaced. 
         [0082]    In the embodiment illustrated in  FIG. 4 , remote wireless communicator or transceiver  46  communicates with instrument communicator  48  via an RF signal  58 . Signal  58  can be any of the following types: an electrical signal, a radio frequency signal, a microwave signal, a continuous signal, an intermittent signal, a signal sent only upon the sensing of the change and any suitable combination thereof  FIG. 3  shows that in an embodiment signal  58  is a continuous e.g., digitalized, data stream, which CPU  50  (via RAM  42  and DSP  44  and associated functions located in machine  100 ) uses to determine blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like. If an access disconnection occurs, the frequency of reflected ultrasonic waves  30   b  changes significantly enough as does the output of corresponding signal  58  that the software within buffering RAM  42  detects a partial or full access disconnection. When the access disconnection is detected, CPU  50  via signals  56  causes other components within machine  100  to take appropriate action, e.g., causes an audio, visual or audiovisual alarm to appear on and/or be sounded from graphical user interface  106  of machine  100 . CPU also likely causes blood pump  102  to shut down. 
         [0083]    In an alternative embodiment, the processing of reflected waves  30   b  is done on PCB  52 . Here, onboard DSP  44  determines blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like. DSP  44  sends this information wirelessly via transceiver  46  to CPU  50  at predetermined intervals or when CPU  50  requests such information. When an access disconnection is detected, DSP via transceiver  46  sends an alarm signal  58  to CPU  50 , which causes other components within instrument  100  to take appropriate action as described above. Thus wireless signal  58  can be a continuous signal, an intermittent signal or a signal sent only upon the sensing of the change and any suitable combination thereof 
         [0084]    In a further alternative embodiment, PCB  52  includes an audio, visual or audiovisual alarm, which alarms a patient of an access disconnection. In this embodiment, system  10  may or may not communicate with machine  100 . For example, PCB  52  can sound an alarm, while machine  100  shuts down one ore more pump and occludes or closes one or more line or valve. 
         [0085]      FIG. 5  illustrates schematically a test that has been performed using an ultrasound sensor, such as transducer  24  shown in  FIG. 2 , placed at the blood vessel of patient  12  downstream from venous needle  20  as also seen in  FIG. 2 . It should be appreciated that the systems described herein are operable with standard access needles  16  and  20  or with subclavian type catheters. As seen in  FIG. 5 , the patient&#39;s arm is modeled by a tube. The ultrasound sensor is placed over the tube. The patient&#39;s blood is modeled using saline, which an access pump pumps at approximately one liter per minute through a five hundred cubic centimeter compliance chamber, through tube (modeling the patient) and back into a source of the saline. Arterial and venous needles  16  and  20  shown schematically in  FIG. 5  are inserted or connected to the tube representing the patient&#39;s arm. The simulated extracorporeal circuit includes a blood pump, drip chamber, in combination with a pressure sensor, dialyzer and venous side pressure sensor. 
         [0086]      FIG. 6  illustrates that when the venous access  20  was dislodged from the tube, the ultrasound sensor noticed a discernable drop in flowrate of about 300 ml per minute. That is, the one liter per minute being pumped by the access pump in  FIG. 5  returned at only  700  ml per minute as sensed by the ultrasound sensor. 
       Acoustic Access Disconnection Sensor 
       [0087]    Referring now to  FIGS. 7 to 9 , various embodiments for acoustic access disconnection systems are illustrated by systems  60   a  to  60   c  (referred to herein collectively as acoustic access disconnection systems  60  or generally as acoustic access disconnection system  60 ). Access disconnection systems  60  have many similarities with ultrasound access disconnection system  10 . Both are used with machine  100  (and each of its alternative configurations discussed above), have remote signaling capability, are non-invasive, do not circulate current through the patient&#39;s blood, do not add components to the disposable cassette or tubing set, saving cost, and have additional blood parameter measurement capability. Both systems  10  and  60  use sound waves. 
         [0088]    One primary difference with systems  60  is that the transducers and associated electronics are coupled to the arterial and venous lines  14  and  18  instead of to patient  12 . This configuration may be advantageous from the standpoint that a disconnection of one of the lines  14  and  18  should produce a relatively dramatic change in reflected waves. Additional blood parameter measurements will reflect blood flow characteristics in the extracorporeal circuit rather than blood flow characteristics in the patient as with system  10 , which may be advantageous or disadvantageous. 
         [0089]    Referring now to  FIG. 7 , a dual transducer transmit/receive acoustic access system  60   a  is illustrated. Acoustic access system  60   a  includes a printed circuit board  66 , which carries transducers  62  and  64 , signal conditioning  40 , excitation apparatus  42 , DSP  44  (including onboard memory) wireless transceiver  46  and power supply  54  described above. Power supply  54  as above powers excitation apparatus  42 , DSP  44  and wireless transceiver  46 , which operate as described above for system  10 . DSP  44  communicates back and forth with remote transceiver  46 , which communicates back and forth with machine transceiver  48 . In an alternative embodiment, as with system  10  above, one or more of the apparatus and associated functionality of DSP  44  is located within machine  100 . Machine  100  as before includes wireless, e.g., RF transceiver  48  to send and to receive signals  58  to and from wireless transceiver  46 . Alternatively, machine  100  is hardwired to system  60   a  for electrical communication. 
         [0090]    In the illustrated embodiment, acoustic emitter transducer  62  through excitation apparatus  42  transmits an acoustical signal into arterial line  14 , while receiver transducer  64  receives an acoustical signal from venous line  18 . Alternatively, emitter transducer  62  transmits an acoustical signal into venous line  18 , while receiver transducer  64  receives an acoustical signal from arterial line  14 . Tranducers  62  and  64  can be of a type in which each is constructed to be one of an emitter or a receiver. Alternatively, tranducers  62  and  64  are each both transmitters and receivers. Here, the roles of tranducers  62  and  64  upon an access disconnection event can be reversed to provide a redundant check. The roles of tranducers  62  and  64  can also be switched under normal operation to test that the transducers are working properly and also to provide redundancy for other parameters for which system  60   a  detects. 
         [0091]    In an embodiment, tranducers  62  and  64  transmit and receive waves that are sonic, subsonic or pressure waves, for example, the signal can be sent in a single or in multiple frequencies. Transducer  62  can emit waves in a continuous, intermittent or pulsed manner. Further, the emitted signal can be modulated in any one or more combination of amplitude, frequency or phase. In a preferred embodiment, the signal is distinct from naturally occurring waves that receiver transducer  64  may also detect. 
         [0092]    Excitation apparatus  42  excites acoustic emitter transducer  62  to emit sound waves in a direction towards patient  12 . Acoustic receiver transducer  64  is likewise configured to receive sound waves from the patient. In this manner, the likelihood that sound waves will travel from emitter transducer  62 , around blood pump  102 , to receiver transducer  64  is minimized Further, a drip chamber located in one or both of the arterial or venous lines provides an air barrier disconnect within the extracorporeal circuit, which should minimize sound wave coupling towards the blood pump. This directional configuration also maximizes the difference in signal reception when an access disconnection. 
         [0093]    Signal conditioning  40  (e.g., an A/D converter) conditions the signal for DSP  44 . It should be appreciated that the signal conditioning can be located alternatively within DSP  44 . DSP  44  processes the conditioned signals using an onboard or a separate buffering RAM. DSP communicates with transceiver  46 , which in turn sends and receives data from instrument transceiver  48 . Transceiver  46  can alternatively be located onboard DSP  44 . In any case, DSP  44  can be configured to detect a dislodgement by measuring a loss in power of the acoustic signal during disconnection. DSP  44  could also calculate blood flowrate, peak flowrate and any of the other parameters discussed herein. 
         [0094]    If either arterial line  14  or venous line  18  becomes partially or completely dislodged from patient  12 , communication between tranducers  62  and  64  is broken or altered significantly enough that an access disconnection determination is made and any of the protective actions discussed herein, e.g., alarm, pump shutdown, valve closing, line occluding is carried out. In the illustrated embodiment, the processing of the breaking or interruption of communication between tranducers  62  and  64  is done on PCB  66 . Here, under normal operation, PCB  66  determines the power and frequency of the received signal, and potentially, blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like as described above. This information is sent wirelessly via transceiver  46  to CPU  50  of instrument  100  on a continuous basis, at predetermined intervals, or when CPU  50  requests such information. When an access disconnection is detected, DSP via emitter  46  sends an alarm signal  58  to CPU  50 , which causes other components within machine  100  to take appropriate action as described above. The wireless signal  58  can accordingly be a continuous signal, an intermittent signal, a signal sent only upon the sensing of the change and any suitable combination thereof 
         [0095]    In an alternative embodiment, the various components of PCB  66  are provided in machine  100  such as DSP  44 . Here, the RF signal  58  is a continuous data stream, which can be conditioned e.g., digitized, locally and sent to CPU  50  of machine  100 . DSP  44  now within instrument  100  uses data stream  58  to determine the power and frequency of the received signal, and potentially, blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like within machine  100 . If an access disconnection occurs, the data contained in the RF signal  58  changes enough so that the software within instrument  100  detects a partial or full access disconnection. When the access disconnection is detected, CPU  50  causes, e.g., through a delegate controller, other components within machine  100  to take appropriate protective action as described above. 
         [0096]    In a further alternative embodiment, PCB  66  includes an audio, visual or audiovisual alarm, which alarms a patient of an access disconnection. In this embodiment, system  10  may or may not communicate with machine  100 . 
         [0097]    Referring now to  FIGS. 8 and 9 , an active sonar or echo system  60   b  employs either a single acoustic transducer  68 , doubling as transmitter and receiver (as illustrated), or dual transducers, one emitting and one receiving. In either case, the single or dual transducers are coupled to a single one of the extracorporeal lines, e.g, venous line  18  in one preferred embodiment (as described above venous access dislodgement is potentially more dangerous than arterial access dislodgement). 
         [0098]    Active sonar or echo system  60   b  includes a printed circuit board  70 , which carries signal conditioning  40 , excitation apparatus  42 , DSP  44 , wireless remote transceiver  46  and power supply  54  described above. Power supply  54  powers signal conditioning  40 , DSP  44  and transceiver  46 . In an alternative embodiment, as with system  10  above, one DSP  44  is located within machine  100 . Machine  100  as before includes wireless, e.g., RF, transceiver  48  to receive signals from RF emitter  46 . Alternatively, machine  100  is hardwired to system  60   b  for electrical communication. 
         [0099]    In the illustrated embodiment, acoustic emitter transducer  68  transmits an acoustical signal into the blood of venous line  18 . The signal reflects in the extracorporeal circuit lines  14 ,  18  and graft  22 , producing a signature response. Signal conditioning  40  processes the signalure response, e.g., digitizes it, and sends a digital signal to DSP  44  (which can include RAM, ROM, onboard signal conditioning and/or onboard transceiver) located either locally at PCB  70  or at machine  100 . DSP  44  analyzes the signal using onboard software in one embodiment. DSP  44  formulates a baseline acoustic signature of the reflected acoustical wave and stores such baseline signal in RAM  42 . 
         [0100]    Acoustic emitter/receiver transducer  68  is configured to emit sound waves in a direction towards patient  12 . Transducer  68  is likewise configured to receive sound waves from the patient. The likelihood that sound waves will travel from transducer  68 , around blood pump  102 , back to transducer  68  is minimal due at least in part to a drip chamber that is located between the transducer and the blood pump in the arterial blood line. This directional configuration also maximizes the difference in signal reception when an access disconnection occurs. 
         [0101]    If either arterial line  14  or venous line  18  becomes partially or completely dislodged from patient  12 , the signature response back to tranducer  68  is broken or altered significantly enough compared to the baseline acoustic signature, that an access disconnection determination is made and any of the actions discussed herein is performed, e.g., alarm, pump shutdown, valve closing, line occluding. 
         [0102]    In the illustrated embodiment, the processing of the difference between the received response and the baseline response is done at PCB  70 . Here, under normal operation, onboard DSP  44  determines the power, frequency and shape of the envelope of the received signal, and potentially, blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like. This information is sent wirelessly via DSP  44  and communicator  46  to CPU  50  continuously, at predetermined intervals, or when CPU  50  requests such information. When an access disconnection is detected, DSP  44  via communicator  46  sends an alarm signal to CPU  50 , which causes other components within machine  100  to take appropriate action as described above. The wireless signal can accordingly be a continuous signal, an intermittent signal, a signal sent only upon the sensing of the change and any suitable combination thereof 
         [0103]    In an alternative embodiment, the majority of the components of PCB  70  are provided in machine  100 . Here, the RF signal  58  is a continuous data stream, which can be conditioned, e.g., digitized, locally and sent to the CPU of machine  100 , which operates with DSP  44  and their associated functions. Data stream  58  is used to determine blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like within machine  100 . If an access disconnection occurs, the RF signal  58  is interrupted or is otherwise reduced enough that the software within buffering DSP  44  detects a partial or full access disconnection. When the access disconnection is detected, CPU  50  causes other components within machine  100  to take appropriate action as described herein. 
         [0104]    In a further alternative embodiment, PCB  70  includes an audio, visual or audiovisual alarm, which alarms a patient of an access disconnection. In this embodiment, system  10  may or may not communicate with machine  100 . 
         [0105]    Referring again to  FIG. 9 , a passive sonar or acoustic signature system  60   c  employs a single receiver transducer  64 . Transducer  64  is coupled to a single one of the extracorporeal lines, e.g, venous line  18  in one preferred embodiment (as described above venous access dislodgement is potentially more dangerous than an arterial access dislodgement). 
         [0106]    Passive sonar or acoustic signature system  60   c  includes printed circuit board  70 , which carries signal conditioning  40 , excitation apparatus  42 , DSP  44 , wireless communicator  46  and power supply  54  described above. In an alternative embodiment, as with the systems above, one or more of the apparatuses and associated functionality of DSP  44  is located within machine  100 . 
         [0107]    Passive sonar system  60   c  uses pulses generated by the system&#39;s blood pump, drip chamber, interaction with the dialyzer or other extracorporeal device. These devices create an acoustical pattern or signature response at receiver transducer  64 , similar to the signature response discussed above. Signal conditioning  40  processes the signalure response, e.g., digitalizes it, and sends a digital signal to DSP  44 , located either locally at PCB  70  or at machine  100 . DSP  44  analyzes the signal using onboard software in one embodiment. DSP  44  formulates a baseline acoustic signature of the reflected acoustical wave and stores such baseline signal in memory. 
         [0108]    If in the illustrated embodiment, venous line  18  becomes partially or completely dislodged from patient  12 , the signature response back to tranducer  68  is broken or altered significantly enough compared to the baseline acoustic signature, that an access disconnection determination is made. Any of the actions discussed herein is then performed, e.g., alarm, pump shutdown, valve closing, line occluding is carried out. 
         [0109]    In the illustrated embodiment, the processing of the difference between the received response and the baseline response is done on PCB  70  of system  60   c.  Here again, under normal operation, onboard DSP  44  determines blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like. This information is sent wirelessly via DSP  44  and transceiver  46  to CPU  50  continuously, at predetermined intervals, or when CPU  50  requests such information. When an access disconnection is detected, DSP via transceiver  46  sends an alarm signal to CPU  50 , which causes other components within machine  100  to take appropriate action as described herein. 
         [0110]    In an alternative embodiment, DSP  44  is provided in machine  100 . Here, the RF signal  58  is a continuous data stream, which can be conditioned, e.g., digitized, locally and sent to the CPU of machine  100  via RF communication. Again, data stream  58  can be used to determine blood flowrate, peak flowrate, pulsatile characteristics of the blood flow, turbulence and the like within machine  100 . If an access disconnection occurs, the RF signal  58  is interrupted or is otherwise reduced enough that the software within buffering DSP  44  detects a partial or full access disconnection. When an access disconnection is detected, CPU  50  causes, e.g., via a delegate controller, other components within machine  100  to take appropriate protective action as described above. 
         [0111]    In a further alternative embodiment, PCB  70  of system  60   c  includes an audio, visual or audiovisual alarm, which alarms a patient of an access disconnection. In this embodiment, system  10  may or may not communicate with machine  100 . 
       Optical Access Disconnection/Blood Leak Detector 
       [0112]    Referring now to  FIGS. 10 to 14 , an embodiment of an optical access disconnection/blood leak detection system  80  is illustrated. Optical access disconnection/blood leak detection system  80  takes advantage of the gauze that is normally applied to patient  12  over access needles  16  and  20 . It is not uncommon that under normal operation a small leak is present around the access points in which needles  16  and  20  connect to patient&#39;s arm  12 . The normal blood leakage however should be limited to a small area around access needles  16  and  20 . If the blood leak extends to a larger area, it likely indicates a needle dislodgement that needs to be addressed immediately. 
         [0113]      FIG. 10  illustrates that optical access disconnection/blood leak detection system  80  provides a flexible circuit  90 . Flexible circuit  90  wraps around arm  12  of the patient. In an embodiment, flexible circuit  90  is placed over the gauze pad  82  shown in  FIG. 10 , which as mentioned is placed over access needles  16  and  20 . Because the flex circuit  90  contacts gauze  82 , sterility needs to be considered. In one embodiment, flexible circuit  90  is cleaned with a disinfectant prior to being placed over gauze  82 . In an alternative embodiment, gauze  82  is covered with a sterile disposable film  84 , which can be self-adhesive. Here, film  84  is discarded after treatment is completed. Film  84 , isolates flexible circuit  90  from the contact area. 
         [0114]    Arm band system  90  provides preventive action against needle dislodgement. By wrapping around the needles and tubing, flexible circuit  90  secures the needles and tubing in position and accordingly tends to prevent dislodgement. Arm band system  90  confines the connections between the fistulas and associated tubing to an area covered by flexible circuit  90 , so that the system can also detect a disconnection between the fistula and the tubing. 
         [0115]      FIG. 11  illustrates that flexible circuit  90  in one embodiment includes hooks  86   a  to  86   c,  which loop around flex circuit  90  and attach, e.g., frictionally and/or adhesively, to mating pads  88   a  to  88   c,  respectively. For example, hooks  86  (referring collectively to hooks  86   a  to  86   c ) can attach to pads  88  (referring collectively to pads  88   a  to  88   c ) via a Velcro™ type attachment, buttons, slits, folds or other types of releasably securable mechanisms. If it is found that hooks  86  and pads  88  are difficult to clean, they can be replaced in one embodiment with a more hygenic attach mechanism, such as magnetic straps and buckles. 
         [0116]    As seen in  FIGS. 10 and 11 , flexible circuit  90  includes a plurality of reflective photo sensors  92   a  to  92   e,  which are each powered via leads  94   a  to  94   e,  respectively, connecting to a power source  54 , such as a coin battery. Optical sensors  92  (referring collectively to sensors  92   a  to  92   e ) in an embodiment include a light emitting diode (“LED”) acting as the light source, and a photocell or phototransistor, acting as a light receiver. The LED and photosensor are configured for a specific wavelength that allows maximum absorption when reflected in blood. LED/Photosensor combinations such as ones used in hemodialysis blood leak detectors have been used successfully in a prototype of optical system  80 . 
         [0117]    Leads  94  (referring collectively to leads  94   a  to  94   d ) in an embodiment are trace, e.g., copper traces, that are applied in a known process to flexible circuit  90 . In an embodiment, flexible circuit  90  uses an electrically insulative material, such as a polyamide or Kapton TM  film  96 . Film  96  in an embodiment is provided in multiple plies, with leads  94  and photosensors  92  sandwiched between the multiple pliers  96 . 
         [0118]    Power supply  54  in an embodiment is also sandwiched between the multiple dielectric films  96 . Power supply  54  in one embodiment also powers a microcontroller  98 , which can include any one or more of signal conditioning  40 , RAM  52 , DSP  44  and RF emitter  46  described previously herein. Microcontroller  98  can also include an audible alarm and/or a video status indicator, such as an LED, which signals whether electronics of optical access disconnection/blood leak detection system  80  are performing properly. 
         [0119]      FIGS. 12 and 13  illustrate one embodiment for operating photoelectric system  80 . In an embodiment, light emitted from the LED of photosensor  92  has a wave length for example in the range of the blue to green of the ultraviolet wave spectrum, which is absorbed by the color of blood collected on gauze  82 . When light from sensor  92  illuminates non-bloodied or white gauze  82  shown in  FIG. 12 , a percentage of its energy reflects towards a receiver, e.g., photocell or phototransister, of photosensor  92 . In  FIG. 13  on the other hand, the presence of blood on gauze  82  absorbs most of all light energy emitted from sensor  92 , such that sensor  92  receives and detects considerably less light, e.g., a loss of signal. Accordingly, in  FIG. 13  the arrow from gauze  82  back to photosensor  92  indicating reflected light is not shown. 
         [0120]    In the embodiment illustrated in  FIG. 11 , sensors  92   a  to  92   e  are spaced a relatively far distance from access needles  16  and  20 , e.g., on the order of one inch to three inches from the needles, such that if blood reaches sensors  92 , it has traveled a distance sufficient from the access points to signal an access disconnection rather than a normal amount of blood leakage. Further, using multiple sensors  92   a  to  92   e  allows redundency to be built into the software, in which for example the software looks for multiple ones of sensors  92  to show a lack of reflection before determining that an access disconnection has occurred. Alternatively, a single sensor  92  sensing blood can be taken to indicate an access disconnection. 
         [0121]    In one implementation, two or more concentric rings of optical sensors of different diameters form a sensor array that allows the system to monitor the progress of a blood leak. One of the sensors of the internal ring (small diameter sensors) looks for a lack of reflection that, due to the sensor&#39;s small diameter, is considered insignificant. If the next ring of (larger diameter) sensors does not lose reflected light, the system determines that the leak is not serious. Should the leak become serious, it reaches the outer ring of larger diameter sensors. The system uses the time between detections in successive rings to determine the flow of the blood leakage. The spacing between rings allows estimation of the volume of blood leakage. 
         [0122]    Microcontroller  98  gathers data from optical sensors  92  and reports this data in an embodiment via RF signal  58  to dialysis machine  100 . Machine  100  can include at least one of signal conditioning  40 , DSP  44  (which can have onboard RAM and ROM as well as other apparatus and functionality as described herein), which are used to analyze signal  58 . In an alternative embodiment, microcontroller  98  includes signal conditioning, such as an analog to digital converter and/or signal summing circuitry, which can combine the outputs from each of the photosensors  92  to yield a single digitized signal  58 , which is representative of entire flex circuit  90 . In a further alternative embodiment, the software and processing is stored in microcontroller  98 , in which case signal  58  tells the machine  100  whether or not an access disconnection takes place. Again, signal  58  can be continuous, intermittent, sent only when commanded, etc. 
         [0123]    To save the power of supply  54 , microcontroller  98  in one embodiment is maintained in a sleeve or power save mode and optical sensors  92  are off until dialysis instrument  100  requests data from the radio frequency link. At this point, microcontroller  98  “wakes up”, energizes light sensors  92 , reads signals from optical receivers of sensors  92  and transmits status information back to dialysis instrument  100 . In one embodiment, again, if any of sensors  92   a  to  92   e  does not receive enough light, DSP  94  issues a distress call to machine  100  and simultaneously energizes an audio alarm. Machine  100  can cause any other suitable protective action described herein to be taken. 
       Electrocardiogram (“ECG”) Remote Access Disconnection Sensor 
       [0124]    Referring now to  FIGS. 15 ,  16 ,  17  and  18 A to  18 C, various systems are shown that detect an access disconnection using signals form an electrocardiogram (“ECG”). Generally, an ECG is a test that measures electrical signals that control the rhythm of a person&#39;s heartbeat. The heart is a muscular pump made up of four chambers, two upper chambers called atria and two lower chambers are called ventricles. A natural electrical system causes the heart muscle to contract and pump blood through the heart to the lungs and the rest of the body. 
         [0125]    Electrodes for the ECG are placed on a patient&#39;s skin to detect this natural electrical activity of the heart. In system  120  of  FIG. 15 , during dialysis therapy, a first electrode  122  is attached to venous line  18 , while a second electrode  124  is attached to the patient&#39;s skin, for example, at leg  12   a  (as shown here), arm  12   b,  or chest  12   c  of patient  12  or is alternatively connected to arterial line  14 . Electrodes  122  and  124  can be connected at venous line  18  and arterial line  14  through direct contact, capacitive coupling, inductive coupling, wireless or otherwise. Alternatively, multiple body electrodes  124  can be placed at different locations  12   a,    12   b,    12   c  of patient  12 . 
         [0126]      FIGS. 18A to 18C  show three possible arrangements for contact/blood coupling. In  FIG. 18A , electrode  122  is placed inside venous line  18  and contacts blood directly. In  FIG. 18B , electrode  122  is embedded within the wall of venous line  18  and couples to the blood, e.g., capacitively or inductively. In  FIG. 18C , electrode  122  is placed outside of venous line  18  and likewise couples to the blood, e.g., capacitively or inductively. The electrodes can be metal or of a conductive polymer material. 
         [0127]    System  120  of  FIG. 15  shows a blood pump  102  and dialyzer  108  connected to arterial line  14  and venous line  18 . The extracorporeal circuit includes other components not illustrated here for convenience. Also, dialyzer  108  communicates with a dialysate source, e.g., bagged or on-line, an pumps that deliver dialysate to the dialyzer  108 , which again are not shown for convenience. The &#39;170 Application referenced above discloses further details concerning the extracorporeal and dialysate circuits, which are applicable to each of the systems described herein. The teachings of each of the systems described herein are also applicable to access disconnection in hemofiltration and hemodialfiltration systems. 
         [0128]    Electrodes  122  and  124  are connected electrically to signal conditioning  40  and signal processing, which can include RAM  42  and DSP  44  as has been discussed herein. Any of signal conditioning  40 , RAM  42  and DSP  44  can be located locally or remotely as desired and as discussed herein. 
         [0129]    Electrodes  122  and  124  can alternatively or additionally be connected to a machine that translates the electrical activity into an electrocardiogram, which may show: evidence of heart enlargement, signs of insufficient blood flow to the heart, signs of a new or previous injury to the heart (e.g., due to a heart attack), heart rhythm problems (arrhythmias), changes in the electrical activity of the heart caused by an electrolyte imbalance in the body, and signs of inflammation of the sac surrounding the heart (pericarditis). These parameters may be useful during dialysis as discussed in more detail below. 
         [0130]    Under normal conditions, the natural electrical signals that control the rhythm of a person&#39;s heartbeat create a signal  126  shown figuratively in  FIG. 15 . Upon an access disconnection of venous line  18  in the illustrated embodiment, signal  126  is no longer sensed because electrical communication with the body through the blood is lost. Machine  100  sees the lack of signal  126  as an access disconnection and causes any of the measures discussed herein to be taken. 
         [0131]      FIGS. 16 and 17  illustrate an alternative system  140  and catheter assembly  142  used in system  140 , respectively. In system  140  of  FIG. 16 , a cardiac catheter access at chest  12   c  of patient  12  using cardiac catheter assembly  142  is used. Cardiac access and catheter assembly  142  provide a more direct access to the heart and its associated signals than does needle access at the arm  126  of patient  12 . Cardiac access and catheter assembly  142  may be better suited for acute treatments. Here, the doctor can more directly monitor electrograms from the blood pool inside the heart and provide more or better information about the cardiac function than with typical arterial and venous access, while still dialyzing patient  12 . 
         [0132]    Catheter  146  of assembly  142  is equipped with electrodes, such as electrodes  122  and  124 , via any of the configurations shown in connection with  FIGS. 18A to 18C . Catheter assembly  142  includes an arterial access section  114  and a venous access section  118 , which connect respectively to arterial line  14  and venous line  18  of the extracorporeal circuit. Catheter assembly  142  also includes a guide wire  144  for directing catheter  146  to a desired location, e.g., directly into the patient&#39;s heart or to a desired local vein, artery or graft. 
         [0133]    In systems  120  and  140 , signal processing via DSP  44  additionally or alternatively processes signal  126  to calculate any one or more of heart rate variability, respiration, stroke volume, cardiac output and central blood volume. Further, a bioimpedance source  130  is connected to the patient, so that system  120  may make bioimpedance measurements. Additionally or alternatively, systems  120  and  140  allow for the injection of a solution into the extracorporeal circuit, which is used for pacing control for patients having implanted cardiac rhythm management devices (pacemakers). System  120  and  140  allow for key cardiovascular parameters to be monitored during dialysis, which may have beneficial effects on the dialysis therapy or be used for other purposes. 
         [0134]    Bioimpedance in general is a measure of changes in the electrical conductivity of the thorax or heart. It can for example be a measure based on pulsatile blood volume changes in the aorta. Bioimpedance is relevant to the measurement of cardiac output and circulating blood volume. 
         [0135]    In particular, thoracic electrical bioimpedance (also referred to as impedance cardiography) has been investigated as a noninvasive way to assess cardiac output and other cardiovascular functions. Changes in cardiac output are used to identify a change in the hemodynamic status of a patient or to ascertain the need for, or response to, treatment, e.g., for critically ill patients and patients at high risk for morbidity and mortality. 
         [0136]    Thoracic bioimpedance has been investigated for a variety of indications, including, evaluation of the hemodynamics of patients with suspected or known cardiovascular disease, differentiation of cardiogenic from pulmonary causes of acute dyspnea, optimization of atrioventricular interval for patients with AN sequential pacemakers, and optimization of drug therapy in patients with congestive heart failure. 
         [0137]    Any of the above parameters may be monitored either in connection with dialysis or as an additional benefit of the treatment. 
       Capacitive Blood Leak Detection System 
       [0138]      FIGS. 19A and 19B  illustrate an alternative blood leak detection device  150 , which wraps around a patient&#39;s arm in any of the manners discussed above with system  80  and covers access needles  16  and  20 . Device  150  includes an array of mini-capacitors  152  as seen best in  FIG. 19A . Waterproof, e.g., plastic, insulators  154   a  to  154   c  are placed around both sides of the capacitors. A ground or shield  156  is placed between the backside of capacitors  152  and rear insulator  154   c.    
         [0139]    Device  150  does not have to absorb blood to detect a blood leak. The presence of blood beneath mini-capacitors  152  results in a change in the dielectric field surrounding the capacitors. That is, if a wet spot develops beneath device  150 , the region of capacitors  152  sensing a dielectric change would grow. If the region stops growing, the system using device  150  (which can be any of the remote or wired systems discussed herein) assumes a normal amount of seepage has occurred, which is distinguishable from a blood leak or needle dislodgement. A small amount of seepage is a common occurrence at “needle sticks” and should not produce an alarm. If the blood leak grows large enough, the system using device  110  assumes that a partial or full access disconnection has occurred and sounds an alarm. 
       Redundant Access Disconnection/Blood Leak Detection System 
       [0140]    Certain known access disconnection systems rely on the breaking of an electrical circuit to detect an access problem. One problem with these systems is that a needle dislodging from the patient does not always break the electrical circuit. A needle can for example dislodge from the patient but direct the flow of blood over the access from which the needle has been dislodged or over the other (e.g., arterial) needle to complete or re-complete the electrical circuit. Here, blood would not be returned to the patient but no alarm would sound. 
         [0141]    Other known systems assume that a dislodged needle will direct the flow of blood onto a part of the device or system. Here, if the needle is dislodged completely and quickly from under the device, the flow of blood that is supposed to seep onto a part of the system may not (or not enough) and again no alarm is sounded. 
         [0142]    To address the above described problems, any of the above-described systems can be used in combination with one another or in combination with other types of access disconnection or blood leak detection systems. In particular, a dislodgement type system can be combined with a blood leak detection system. Optical system  80  for example is a blood leak detection system, which is particularly adept at detecting blood leaking at the access site. Another type of blood leak detection system is a conductive blanket or pad, which covers the access site in a manner similar to system  80  of  FIGS. 10 to 14 . The conductive blanket or pad includes contacts which form a closed electrical loop when contacted by blood seeping from the patient access. An additional blood leak detection system  150  is disclosed above in connection with  FIGS. 19A and 19B . 
         [0143]    Dislodgement systems, such as impedance sensing systems described in the &#39;098 and &#39;480 Patents discussed above, are particularly adept at detecting when a needle or other access instrument has become fully dislodged from the patient. Ultrasound access disconnection system  10 , acoustic systems  60   a  to  60   c  and bioimpedance system  120  are also dislodgement type systems that adeptly detect a full needle dislodgement. 
         [0144]    Accordingly, it is contemplated to combine one of each of the blood leak detection systems and needle dislodgement systems in a hybrid or redundant system, which adeptly detects either failure mode. For example, any one of the impedance systems of the &#39;098 and &#39;480 Patents, ultrasound access disconnection system  10 , acoustic systems  60   a  to  60   c  and bioimpedance system  120  (full dislodgement) can be combined with any one of the optical (system  80 ), conductive blanket or capacitive (device  150 ) blood leak detection systems, so that the manner in which the venous needle has been dislodged does not matter. The access disconnection system causes an alarm if the venous needle is dislodged quickly and falls off of the patient. The blood leak detection system causes an alarm if the venous needle is partially of fully dislodged and directs blood flow over the venous or arterial needle. 
         [0145]    It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.