MATERIALS OF CONDUCTIVE POLYMERS AND APPLICATIONS THEREOF THAT INCLUDE MONITORING AND SUPPLY OFEFFECTIVE THERAPYCROSS REFERENCE WITH RELATED APPLICATIONS This patent application is a continuation in part of the U.S. Patent Application. No. 10/121, 006 filed April 10, 2002. BACKGROUND OF THE INVENTION The present invention generally relates to conductive polymer materials and methods for preparing and employing same. More specifically, the present invention relates to conductive polymer materials and applications thereof including monitoring of patient access disconnection, monitoring of mixing and formulation of solutions and the like during medical therapy, such as dialysis therapy. A variety of different medical treatments related to the delivery of fluid to 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 or any suitable access device inserted in the patient . For example, hemodialysis, hemofiltration and hemodiafiltration are all treatments that remove waste, toxins and excess water directly from the patient's blood. During these treatments, the patient is connected to an extracorporeal machine, and the patient's blood is pumped through the machine. Waste, toxins and excess water are removed from the patient's blood, and the blood is infused back into the patient. The needles or other suitable access devices are inserted into the vascular access of the patient in order to transfer the patient's blood to and from the extracorporeal machine. Traditional treatments of hemodialysis, hemofiltration and hemodiafiltration can last several hours and are usually performed in a treatment center approximately three or four times a week. During any of these heme treatments, displacement of the access device may occur, such as the displacement of a needle inserted in the patient's vascular access that includes a graft or arterio-venous fistula. If it is not detected immediately, this can produce a significant amount of blood loss from the patient. This risk, associated with a displacement of the needle, is considerable. In this regard, an important criterion for monitoring blood loss includes, for example, the sensitivity, specificity and response time with respect to detecting a needle displacement. With increased levels of sensitivity, specificity and response times, the detection of needle displacement can be improved and blood loss due to displacement can be minimized. Typically, patients undergoing medical treatment, such as hemodialysis, hemofiltration, or hemodiafiltration, are visually monitored in order to detect the displacement of the needle. However, the needle may not be visible to the patient or medical personnel (that is, it may be covered with a sheet) so that it could delay detection and, thus, the actions in response to being taken in view of the displacement, such as stopping the blood pump of the extracorporeal machine to minimize the loss of blood of the patient. In addition, in view of the increased quality of life, reductions observed in both morbidity and mortality and lower costs than in treatment centers, a renewed interest in heme self-care and home therapies has emerged. Such heme homemade therapies (either hemodialysis, hemofiltration or hemodiafiltration) allow both night treatments as well as daytime. During these sessions of self-care and home heme, especially during a nocturnal hemo-home session, when the patient is asleep, the risks of displacement are more considerable because the nurses or other attendants are not present to detect the displacement. Although devices that employ a variety of different sensors are available and known to detect and / or monitor a variety of different body fluids, those devices may not be properly adapted to detect the displacement of the needle. For example, known devices employing sensors that include pH, temperature and conductivity have been used to detect nocturnal enuresis and wet diaper. Additionally, devices employing pressure sensors and / or flow sensing devices are known and used during medical treatment, such as dialysis therapy, to monitor the flow of fluids including blood flow to and / or from the patient. However, these types of detection devices may not provide an adequate level of sensitivity and response if they are applied to detect the patient's blood loss due to a displacement of the needle. Although it is known that venous pressure is used to monitor the displacement of the needle, it is not very sensitive to the exit of the needle. Other devices and additional methods are generally known to monitor vascular accesses based on the electrical conductivity of the blood. For example, the PatentAustralian No. 730, 338 based on PCT Publication No. WO 99/12588 employs an electrical circuit that includes two points through which current is induced into the bloodstream through an extracorporeal circuit in a circuit closed. The electric current is induced by means of a coil that is placed around the outside of the blood circuit tubing. Thus, each coil does not make direct contact with the blood as it circulates through the pipe. In this regard, an electric current is induced in the blood circuit by an alternating current flowing through one of the coils. The second coil is then used to measure a change in the amperage of the induced current as it flows through the blood circuit. In this regard, the electric current is coupled to a blood treatment system that includes a number of high impedance components, such as a blood pump, air bubble trap, pressure clamps and / or the like. Due to the large impedance of the conductive fluid circuit (due to the peristaltic pump and other components), the induction and detection of a safe current for the patient requires a complex and impractical design of the system and the coil. Additionally, a high noise level would necessarily result from the use of such induced current levels. This can adversely impact detection sensitivity. If low currents are used, the field coil would have to be increased in size to detect such low current levels. This may not be practical in use, particularly while being applied during dialysis therapy. PCT Publication No. WO 01/47581 describes a method and a device for monitoring access to a cardiovascular system of a patient. Access monitoring employs an electrical circuit that can generate and detect a current at separate points along the blood circuit connected to the patient. Electric current is coupled to the blood using capacitive couplers each having a metal tube placed around the blood circuit tubing. In this aspect, the metal tube defines a first plate of a capacitor; the blood circuit tubing defines the dielectric; and the blood on the front of the blood circuit pipe defines the second plate of the capacitor. The generator applies a potential difference between a pair of points to generate a current in a segment of the blood circuit. A detector uses a pair of additional and separate contact points to measure the current along at least a section of the venous branch between a first contact point and the venous needle. The change in voltage (dV) can then be determined based on a measured change in current and compared to a reference range (I) to monitor access conditions. In this regard, PCT Publication No. WO 01/47581 requires a complex circuit design that uses multiple sets of capacitive couplers to monitor vascular access conditions. This can increase the cost and expense of using it. Additionally, the mere use of capacitive coupling to inject an electrical signal into the blood circuit and / or for detection purposes can be problematic. In this aspect, the signal must pass through the blood circuit tubing since the tubing acts as a dielectric of the capacitor. This can cause an excessive level of noise and / or other interference with respect to detecting changes in vascular access conditions. In this regard, it is believed that known devices, apparatuses, systems and / or methods that can be used to monitor a patient's access conditions may not be able to detect changes in access conditions, such as in response to departure. of the needle, with sufficient sensitivity and specificity to ensure the immediate detection of blood loss so that response measures can be taken to minimize blood loss. As applicable, if twenty seconds or more of time pass before blood loss due to, for example, venous needle slippage, more than 1000 milliliters in blood loss may occur at a blood flow rate of 400 ml / min, which is typical of a dialysis therapy. Thus, the ability to respond rapidly to the immediate detection of the displacement of an access device, such as a needle, of a patient to ensure patient safety is essential. In addition to displacement, other additional parameters are monitored in general to evaluate changes in them during medical procedures that include dialysis therapies. For example, temperature sensors, pressure sensors, conductivity sensors and the like are known and generally used in a variety of ways to detect and monitor changes in conditions during medical therapy. As applied to dialysis therapy and the like, a dialysis solution may be administered to a patient in a mixed form. In this regard, the degree to which the solution is mixed can have an impact on the effectiveness of the associated therapy. In dialysis therapy, the solutions may have varying pH levels that are at levels considered to be non-physiological prior to mixing, although after mixing, the final solution is required to have a pH at a physiological level necessary for effective administration and safe during therapy. In general, conductivity sensors and pH sensors are known and used. However, it is believed that known sensors may not be as effective in terms of detection capabilities and relative ease of use, particularly as they are applied during dialysis therapy. Consequently, efforts have been directed to the design of devices, devices, systems and methods to improve the monitoring of patient therapy, such as detecting changes in patient access conditions in response to the displacement of the needle, detect changes in the formulation and mixing of the solution and the like, wherein the detection is sensitive, specific and immediate in response to such changes so that the measures in response can be taken appropriately to provide the patient with effective therapy, such as dialysis. BRIEF DESCRIPTION OF THE INVENTION The present invention provides improved devices, apparatus, systems and methods that use electrically conductive materials to monitor a variety of different conditions or parameter changes associated with the administration of one or more solutions during medical therapy. In turn, this can facilitate the safe and effective administration of medical therapy, such as dialysis therapy. In one embodiment, the conductive material includes a conductive polymer material which may include, for example, a conductive polymer component or a polymer matrix and a separate conductive component that is incorporated into the polymer matrix. The conductive materials of the present invention can be used in a number of different applications. For example, conductive materials, such as conductive polymer material, can be used for monitoring the mixing and formulation of the solution. These can be used to assess whether the solution or solutions have been effectively mixed prior to administration during therapy. This can be determined by monitoring a pH change in the solution based on changes in conductivity. In this aspect, the solution can be derived from a mixture of components in solution with varying pH levels, such as between about 1.8 to about 9.2. Thus, the present invention can be used to determine whether the pH of the mixed solution remains effective before being used. The present invention provides improved devices, apparatuses, systems and methods for detecting the displacement or disconnection of an access device, such as the displacement of a needle inserted in a patient during dialysis therapy. The devices, apparatuses, systems and methods of the present invention utilize an electrical circuit with a number of electrical contacts that are in fluid contact with the fluid circuit so that an electrical signal can be injected into at least one segment that includes , for example, a circuit defined along at least a portion of the fluid driver circuit. In this regard, a direct contact measurement can be used to provide immediate detection of a change in an electrical value in response to a change in access conditions, such as a change in impedance due to the displacement of a needle or other Patient access device during medical therapy including, for example, dialysis therapy and medication delivery. An advantage of the present invention is to provide an improved device, apparatus, system and / or method for monitoring the therapy of a patient, such as to detect a patient's access disconnection, to monitor the formulation of the solution and the like. . Another advantage is to provide devices, systems and methods employing electrically conductive materials, such as conductive polymer materials for monitoring a patient's therapy, such as dialysis. A further advantage of the present invention is to provide an improved device, apparatus, system and / or method for detecting displacement of a patient access device during medical therapy including dialysis therapy. Yet another advantage of the present invention is to provide a responsive, specific and responsive device and / or apparatus for monitoring a patient's therapy, such as for detecting the disconnection of an access during self-care and home heme treatments and for monitor the mixing conditions of the solution, such as pH changes, before use. In addition, an advantage of the present invention is to provide a viable device or apparatus for allowing a patient or other non-medical personnel in a non-medical facility to administer a dialysis therapy utilizing a portion of the patient's circulatory system. In addition, an advantage of the present invention is to provide an improved device, system and method for monitoring and / or controlling a patient's blood loss. Yet another advantage of the present invention is an improved device for connecting an electrical contact to a fluid circuit that allows fluid and electrical communication between the electrical contact and the fluid flowing through the fluid circuit. Still a further advantage of the present invention is to facilitate the safe and effective administration of medical therapy, such as dialysis therapy. Advantages and additional aspects of the present invention are described in, and will be apparent from, the following Detailed Description of the Invention and the figures. BRIEF DESCRIPTION OF THE FIGURES Figure 1A illustrates a schematic view of one embodiment of the present invention showing two needles inserted in a patient through which blood flows to and from an extracorporeal system. Figure 1 B illustrates a schematic view of an embodiment of the present invention capable of detecting a displaced needle during dialysis therapy.
Figure 1C illustrates a perspective view of one embodiment of the present invention showing the detection capabilities of disconnection of an access during medical therapy administered via a single needle. Figure 2A illustrates an exploded view of an electrical contact coupling device in an embodiment of the present invention. Figure 2B illustrates a sectional side view of the coupling device of Figure 2A in one embodiment of the present invention. Figure 2C illustrates another embodiment of the coupling device of the present invention. Figure 2D illustrates another embodiment of the coupling device of the present invention showing a threaded gear between the components thereof. Figure 2E illustrates a section view of Figure 2D. Figure 3 schematically illustrates one embodiment of the present invention in relation to the processing of a measurable voltage signal to correct changes in the basic line of impedance during processing. Figure 4A schematically illustrates a hemodialysis machine in an embodiment of the present invention. Figure 4B schematically illustrates a hemodialysis machine coupled to a patient's access via a series of tubes in an embodiment of the present invention.
Figures 5A and 5B illustrate a coupler according to an embodiment of the present invention. Figure 6 illustrates a dialyzer according to one embodiment of the present invention. Figures 7A and 7B illustrate a sensor assembly according to an embodiment of the present invention. Figures 8A and 8B illustrate a one-piece sensor according to one embodiment of the present invention. Figure 9 illustrates a multiple chamber bag according to one embodiment of the present invention. Figure 1 0 illustrates a multiple chamber bag with a peelable seal according to one embodiment of the present invention.
Figure 1 1 illustrates an automated peritoneal dialysis system according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION The present invention relates generally to electrically conductive materials that can be effectively employed to monitor a patient's therapy. This can facilitate the safe and effective administration of the therapy to a patient, such as a dialysis therapy. In one embodiment, the conductive materials of the present invention include a conductive polymer material as described below in greater detail. The present invention provides medical devices, apparatus, systems and methods for detecting the disconnection of an access. More specifically, the present invention provides medical devices, apparatus, systems and methods that employ, in part, an electrical circuit with electrical contacts in fluid contact and electrical communication with a fluid circuit that allows a direct measurement of the conductivity to be used so that the displacement of a needle or other access device through which fluids flow between a patient and the fluid circuit can be detected immediately. In this regard, the loss of fluids (i.e., blood loss) due, for example, to the displacement of a needle of the patient under medical treatment, such as dialysis therapy, delivery of drugs or the like, can be controlled at minimum. In one embodiment, the conductive polymer materials of the present invention can be used to monitor the mixing and formulation of the solution to ensure effective administration of the mixed solution during therapy, such as to determine whether a pH level of the solution mixed remains effective before use. It should be appreciated that the present invention is not limited to detecting the displacement of a needle but can be used to detect the displacement or disconnection of any suitable access device. As used in this, the term "access disconnection" or other similar terms means any event or condition that may cause a loss or leakage of an electrically conductive fluid that flows along a fluid circuit connected to the patient whenever a condition can be detected. change in electrical continuity between electrical contacts coupled to the fluid circuit. It should be appreciated that a change in electrical continuity can be detected as measured by an electrical value, such as impedance, even in the absence of displacement of a patient access device. The term "access device" as used herein or other similar terms means a suitable device that can be inserted into a patient so that a fluid, including blood, can pass through and / or from the patient via the access device. The access device may include a variety of different and suitable shapes, sizes and prepared materials. Examples of an access device include needles, catheters, cannulas or the like. The access device may be composed of any suitable material including, for example, stainless steel, plastic or similar biocompatible materials. Although in the embodiment set forth below the apparatus and / or device is designed for use in a dialysis therapy, such as hemodialysis, hemofiltration or hemodiafiltration, it should be noted that the present invention can be used in a number of different medical therapies that employ a variety of different and suitable fluid systems, such as extracorporeal blood systems. For example, the invention of the present application can be used during intravenous injection which can employ the use of a simple needle inserted in the patient to deliver a medical solution or drug, blood, blood products, processed blood or the like between the patient and the fluid system. In addition, the present invention can be used in plasma exchange therapies, where a membrane is used to separate whole blood into plasma and cellular components. With respect to dialysis therapy, the present invention can be used in a variety of different therapies to treat liver failure. Dialysis therapy, as the term or similar terms throughout the text is used, means including and encompassing any and all forms of therapies that use the patient's blood to remove waste, toxins and excess water from the patient. Such therapies include both intermittent and continuous therapies, including hemodialysis, hemofiltration and hemodiafiltration, used for continuous renal replacement therapy (CRRT). These continuous therapies include slow continuous ultrafiltration (SCU F), continuous veno-venous hemofiltration (CVVH), continuous veno-hemodialysis (CVVHD) and continuous veno-venous hemodiafiltration (CVVH DF). Dialysis therapy may also include peritoneal dialysis, such as continuous biliary peritoneal dialysis, automated peritoneal dialysis, and peritoneal continuous-flow dialysis. Additionally, although the present invention, in one embodiment, can be used in methods that provide dialysis therapy for patients having chronic kidney disease or deficiency, it should be appreciated that the present invention can be used for acute dialysis needs, for example, in an emergency room facility. Finally, as one skilled in the art appreciates, intermittent forms of therapy (ie, hemofiltration, hemodialysis, hemodiafiltration) can be used in center, self / limited care as well as in home facilities. In one embodiment, the present invention includes an electrical circuit with a number of electrical contacts, preferably a pair of electrical contacts, in fluid contact and electrical communication. The electrical contacts can include any suitable device through which electrical connection can be made to the fluid circuit thereby defining a conductive path or conductive circuit there. In a modality, at least one of the electrical contacts includes a conductive polymer material as described below in greater detail. Changes in an electrical value or any suitable parameter associated with the electrical circuit can then be monitored in response to changes in access conditions as described below. In one embodiment, the electrical contact includes an electrode that can be coupled to the fluid circuit so that an electrical connection can be made in the fluid contact with the fluid flowing through the fluid circuit as discussed below. For example, a constant current or other suitable electrical signal can be injected into the fluid circuit via a pair of electrodes in contact with the fluid flowing between the electrodes to thereby define a circuit along at least a portion of the circuit of conductive fluid. A change in an electrical value, preferably impedance, can then be measured in response to an access disconnect. This can provide a direct conductivity measurement capable of detecting a change in the impedance or other suitable electrical parameter of the fluid, such as an electrically conductive fluid that includes blood, medical solutions or the like, as it flows between a patient and a blood pressure system. fluid (i.e., an extracorporeal blood system) via a needle, needles or other device (s) inserted into the patient. In this regard, the present invention can effectively detect a displacement of a needle (e.g., a venous needle and / or an arterial needle) or other access device through which blood or other suitable fluid can flow, e.g. through and from the patient, such as a blood circuit used during dialysis therapy. The detection capability of the present invention is believed to be immediate based on the measurable change in, for example, impedance of the fluid or electrically conductive fluids due to the loss of fluid resulting from the disconnection of an access device from the patient. The immediate detection capabilities of the present invention are important, particularly as it is applied to dialysis therapy where a significant amount of blood loss can occur in a relatively short period of time if the detection and response actions are delayed to stop the loss of blood that occurs. Under typical dialysis conditions, if 20 seconds or more of the time elapses before being detected and stops blood loss due to displacement, more than 100 milliliters of blood may be lost based on typical 400 milliliter blood flow regimens. /minute. Applicants have discovered that the present invention can detect disconnection of accesses, particularly in response to venous needle displacement during dialysis therapy, in addition to a high degree of sensitivity and specificity in addition to its ability to detect immediately. The direct contact measurement of the present invention is capable of detecting a change of an electrical value, preferably impedance, due to the displacement of the needle or the like as the blood flowing through the blood circuit during the therapy of dialysis. As used herein, the term "electrical value" or other similar terms means any suitable electrical parameter such as, impedance, resistance, voltage, current, rates of change thereof, and combinations thereof. The detection of a change in impedance or the like is an indication that the needle has shifted or another similar condition has occurred. It is to be noted that the detection capabilities of the present invention can also effectively detect blood loss during medical therapy resulting from disconnection in the fluid circuit, even if the needle or needles have not been displaced. In this aspect, the present invention can be used effectively to minimize in a controlled manner the blood loss of the patient based on the ability of the present invention to immediately measure a change in impedance or the like due to blood loss to a high degree of sensitivity and specificity.
This can facilitate the effective and safe administration of patient therapy as discussed previously. The devices and apparatuses of the present invention can include a variety of different configurations and components that depend on the applied medical therapy such as fluid loss, in particular the blood loss can be effectively monitored due to the displacement of the needle or the needles. Similar. DISCONNECTING MULTIPLE ACCESS Now, referring to Figure 1A, one embodiment of the apparatus 10 of the present invention includes a pair of electrical contacts 12 in fluid contact with a blood line assembly 14 of a blood circuit 16 . The blood circuit 16 connects a patient 18 to an extracorporeal blood system 20 connected to, for example, dialysis therapy, which includes hemodialysis, hemofiltration, hemodiafiltration, continuous renal replacement or plasma therapies or the like. The pair of electrical contacts 12 includes a first electrical contact 22 and a second electrical contact 24 which are attached to a first tube member 26 and second respective tube member 28 of the blood circuit 16. The first tube member 26 is connected to a venous needle or other suitable access device inserted in a vascular access region (not shown) of the patient. The second tube member 28 is connected to an arterial needle or the like inserted in vascular access regions (not shown) of the patient. During dialysis therapy, for example, blood flows from patient 18 through the arterial needle to extracorporeal blood system 20 including, for example, a dialysis machine, via second tube member 28 where the blood is treated. and delivery to patient 18 through the venous needle via the first tube member 26. As blood flows through the blood circuit during dialysis therapy, a constant electric current or the like generated by a controller 29 can be injected or passed into the blood flowing via the pair of electrical contacts, preferably a pair of electrodes as described below. In one embodiment, at least one additional electrode can also be used in any suitable manner. The pair of electrodes connected to the controller 29 or other suitable electronic device can then be used to measure a change in voltage in impedance through an unknown fluid (eg, blood) or other similar electrical value to detect a change in impedance or the similar across the vascular access region. In one embodiment, an electrode can be used to inject the electrical signal into the fluid circuit while the other electrode of the pair can be used to detect a change in electrical value and pass an electrical signal indicating the same to the controller for purposes of detection and processing. When at least one of the venous needle and arterial needle of the blood circuit or other suitable condition is displaced, an immediate and detectable increase in impedance or the like can be measured in comparison to the impedance or other suitable parameter measured under normal conditions of operation. It should be appreciated that the present invention as incorporated in Figure 1 A can be modified in a variety of suitable ways depending on the medical therapy as applied. For example, venous and arterial needles can be inserted into the patient's vascular access in any suitable part of the patient's body, such as the arm, forearm, upper thigh area or the like during dialysis therapy. As discussed previously, the present invention can be applied to a different variety of medical therapies including intravenous injections, plasma exchange, drug delivery, drug delivery, blood delivery and dialysis therapies (ie, hemofiltration, hemodialysis, hemodiafiltration and continuous renal replacement). As illustrated in Figure 1 B, one embodiment of an apparatusof the present invention is shown as being applied during dialysis therapy. In one embodiment, the present invention includes a venous needle 32 and an arterial needle 34 inserted in an access 36 of the patient. The venous needle 32 and the arterial needle 34 are connected to the dialysis system 35 via a number of tube members 38 connecting the various components of the dialysis system 35 including, for example, a venous drip chamber 40, a dialyzer 42, an arterial drip chamber 44 and a blood pump 46. It should be appreciated that one or more of the components of the dialysis system can be provided with a dialysis machine coupled to the blood circuit. As shown in Figure 1 B, a first electrical contact coupling device 48 and a second electrical contact coupling device 50 are placed between the dialysis system 35 and the venous needle 32 and the arterial needle 34. As used herein, the term "electrical contact coupling device", "coupling device" or other similar terms means any suitable device that can be used to connect an electrical contact to the fluid circuit. In one embodiment, the electrical contact coupling device can be used to contact the electrical contact with the fluid circuit allowing the fluid contact and the electrical connection with the fluid flowing through the fluid circuit as described. later. In one embodiment, the pair of electrical contacts, preferably a pair of electrodes, are connected to a controller 52 or other suitable electronic device. The controller can be used to inject an electronic signal via a pair of electrodes and into the blood and / or other fluid as it flows through the blood circuit. This provides a conductive circuit along which changes in electrical values or parameters can be measured. The controller 52 which is coupled to the pair of electrodes can also be used to measure this change. It should be appreciated that the controller may include a single electronic device or any number of suitable devices in electrical connection with the electrical contacts to introduce an electrical signal into the blood circuit thus defining a conductive circuit, to measure a change in an electrical parameter or value associated with the conductive circuit and / or perform any other suitable task, such as the processing of a detectable signal as discussed below. Preferably, the electrical signal is generated from a constant current that is supplied to the electrodes until a displacement occurs. The voltage across an unknown impedance of the fluid (eg blood) circulating through the blood circuit can then be measured (not shown) to detect a change in the impedance due to changes in access conditions. However, it should be appreciated that any suitable electrical parameters and changes thereof can be monitored to detect the drop of the needle or the like as discussed previously. As will be demonstrated below, the detection capabilities of the present invention are highly responsive, specific and virtually immediate response to access disconnection, such as the displacement of the needle. Additionally, the electronic circuit of the present invention is relatively simple in design so that preferably a pair of electrodes is necessary to carry out direct conductivity measurements. This can reduce the cost and effort compared to the known vascular access monitoring techniques that only employ non-invasive detection techniques, such as capacitive connectors and induction coils as previously discussed. The Applicants have found that the total measurement of the pedant ("Z") can be modeled as two global impedances in parallel with a measure ("ZD") that is produced by the pump segment., the dialyzer, the drip chamber and / or other suitable components of the dialysis system and / or the similar ones. The other component of the pedagogy ("ZP") is formed by the vascular access of the patient and associated tubing that transports blood to and from the vascular access and / or the like. In this aspect, the total impedance measurement can be characterized as a function of both ZD and ZP as follows: In spite of this parallel pedagogy, the Applicants have discovered that the electrical contacts in connection with the The controller can be used to measure a change in the impedance along the conditor circuit as blood flows through the blood circuit in response to the access disconnection, such as the displacement of the needle. If the needle travel occurs, the conductive circuit along at least a portion of the fluid circuit changes from a closed circuit to an open circuit and thus Z = ZD where ZP approaches infinity. In this regard, the direct conductivity measurement capabilities of the present invention can be used effectively to detect access disconnection. The Applicants note that the ZD component can produce a level of electrical interference associated with the high variable impedance with time of the components of a system coupled to the fluid circuit and its components which include, for example, a blood pump, a drip chamber and / or the like. The Applicants have discovered that the interference due to the ZD component can be eliminated, if necessary, effectively or at least reduced. In one embodiment, the signal associated with the detection of Z or the like can be further processed as will be discussed below. Alternatively, in one embodiment, the electrical circuit of the present invention can be designed to block or bypass one or more components of the dialysis system of the conductive circuit or the defined path along the blood circuit as described below. In this regard, accuracy, sensitivity and response can be improved with respect to the detection of access disconnection. In one embodiment, a third electrical contact point 53 can be used to effectively minimize or eliminate the interference with respect to the high impedance components coupled to the blood circuit, such as the blood pump and the like. The additional point of contact can be made in any suitable way. For example, the third contact point may be an electrode or other suitable device through which electrical continuity may be established between it and one of the electrodes of the coupling devices. In one embodiment, the third electrical contact can be attached to a fluid circuit in fluid and electrical communication with the fluid flowing therethrough. The third contact point 53 can be positioned in any suitable position along the blood circuit. Preferably, the third contact point 53 is positioned at any suitable location between the blood pump 46 and the coupled device 50 as shown in Figure 1 B. A potential equalization may be applied between the third contact point 53 and the electrode of coupling device 50. The potential is applied to a voltage which is equal to the applied potential between the electrodes of the first coupling device 48 and the second coupling device 50. This effectively causes the electric current or the like, once injected into the blood circuit, to derive one or more of the components of the dialysis system. In one embodiment, the third contact point 53 can be positioned so that the electrical current or the like effectively derives all the components of the dialysis system, as shown in Figure 1 B. DISCONNECTION OF SIMPLE ACCESS The electrical contacts of the present invention can be positioned in any suitable position in relation to the needle, needles or appropriate access device inserted in the patient. As shown in Figure 1 C, an embodiment of the present invention is shown as applied with respect to the detection of an access detection, such as the displacement of a simple access device inserted in the patient. This type of application is applied to a variety of different and appropriate medical therapies administered via a simple access device, such as a single needle, which includes intravenous infusion and dialysis therapy including hemodialysis, hemofiltration, hemodiafiltration and continuous renal replacement. As applied, an electrically conductive fluid, such as blood, a blood product, a medical fluid or the like, flows between the patient and a fluid system via a simple access device. The displacement detection of a single access device may include, for example, the detection of needle displacement during the delivery of any suitable electrically conductive fluid or fluids including, for example, blood, or medical drug or solution (ie. say, a medicament contained in an electrically conductive fluid, such as saline), processed blood, blood products, intravenous solutions, the like or combinations thereof. Delivery of fluid can be made between a suitable container, such as a blood bag or similar fluid delivery devices and a patient. In this regard, immediate detection and in response to access disconnection via the present invention can be used effectively to monitor and control the transfer of blood or a medical fluid, such as a drug or drug, during medical therapy administered via a simple needle.
As shown in Figure 1 C, one embodiment of the apparatus or device 54 of the present invention includes an access device 56; such as a needle, inserted into a blood vessel 58 in an area 60 of insertion of the patient's needle 62. The needle 56 is connected to the fluid system 63, such as a fluid infusion system, via a tube member 64 . The infusion system includes, for example, an infusion pump 66 for transferring blood or the like from a container 68 (eg, blood bag) to the patient. A first electrical contact 70 is separated apart from the needle 56 along the tube member 64 and a second electrical contact 72 is secured to the patient near the insertion zone 60. The first electrical contact 70 is in fluid contact with the fluid flowing from the delivery container 68 to the patient. In this configuration, the first and second electrical contacts, preferably electrodes, can be used to monitor changes in an electrical value, preferably impedance, in a conductive circuit formed by at least a portion of the fluid circuit as a electrical signal in it. In one embodiment, at least one electrical contact may include a conductive polymer material as described below in greater detail. The electrical contact points can be coupled to an electronic device 74 which is capable of processing a detectable signal transmitted through electrodes in response to a change in impedance or the like due to the displacement of the simple access device as described in detail later. Preferably, the electrical signal is generated by a constant current supplied to the electrodes so that a direct conductivity measurement can be conducted to detect a change in impedance or the like in response to changes in vascular access conditions, such as the displacement of the access needle. It is believed that the measured impedance, in the simple needle application, is a function of both the impedance of the fluid (i.e., blood) and the impedance as measured across the insertion zone. In this regard, the electronic device 74 can be adjusted to detect the impedance at the level equivalent to the combined impedance of all articles of the electrical path (i.e., the conductive fluid in the tube, needle, venous vessel blood stream, body tissue, impedance through the skin with respect to the electrode 72 sensor and the like). ELECTRICAL CONTACTS As previously discussed, the electrical contacts of the present invention are in fluid contact with the fluid flowing through the fluid circuit. In this regard, electrical contacts can be used to monitor changes in conditions associated with patient therapy. For example, the electrical contacts allow a direct conductivity measurement that is capable of detecting immediately, with high sensitivity and specificity, a change (for example, an increase) in impedance or the like due to the access disconnection, such as displacement of venous needle (arterial needle or both) of the blood circuit during dialysis therapy. Other types of monitoring applications include monitoring of conductivity changes in response to formulated solution as described in more detail below. It should be appreciated that the present invention can be used to monitor one or more combinations of condition changes. The electrical contacts may be composed of any suitable conductive and biocompatible material, such as, any suitable electrode material including stainless steel, other suitable conductive materials or combinations thereof. It is essential that the electrode material be biocompatible. In one embodiment, the electrical contacts include a conductive polymer material as described in greater detail below. It should be appreciated that electrical contacts can be constructed in a variety of different sizes and shapes, whose illustrative examples are described below. For example, electrical contacts can be configured or designed as a plaster electrode that includes an agent capable of expanding when it contacts moisture. The agent may include a variety of suitable materials including gels that are known to expand by volume more than ten times upon contact with moisture. In one embodiment, the plaster electrode can be used to detect fluid (i.e., blood leak) in an insertion zone of an access device inserted in a patient during the administration of medical therapy via a simple access device, such as It was previously discussed. Upon contact with the fluid, the plaster electrode will necessarily expand to such an extent that it ruptures upon contact of the electrode, thereby causing a detectable increase in impedance of fluid flowing from the fluid system to the patient via a needle. In one embodiment, one or more electrodes (not shown), such as one or more plaster electrodes as discussed previously, may be used in combination with the pair of electrical contacts as shown, for example, in Figures 1A and 1 B. For example, a plaster electrode can be attached to the patient near the insertion area of either the arterial and venous needles or both. In this regard, the plaster electrode (s) can be used to detect leakage of fluid, such as blood, from the insertion area of the access device (s). In one embodiment, a pair of electrodes is coupled to the blood circuit in an invasive manner (illustrated in Figures 2A and 2C as will be discussed below) so that the electrodes contact the blood as previously discussed. An excitation source that includes a constant current source or the like can be applied to the electrodes to inject an electrical signal into the blood circuit so that a conditor circuit is defined along which measurements can be made. direct conductivityTo ensure patient safety, the excitation source is typically isolated from the power instrument. Preferably, the excitation source produces a constant electrical current that passes through the blood via the electrodes. Any suitable amount of current can be generated for detection purposes. In one embodiment, the electrical current passed through the blood is maintained at a level of about 10 microamperes or less, preferably 5 microamperes or less. It should be appreciated that the present invention can be operated at low current levels (eg, 10 microamperes or less) so that the current level has a negligible effect, if any, on the health and safety of the patient. It should be appreciated that the impedance or other suitable parameter can be measured and calculated in a variety of different and suitable ways. For example, the amplitude, phase and / or frequency of the constant current drive source can be measured and varied during detection of a change in impedance. The impedance levels can then be detected by measuring the voltage across the electrodes. In this aspect, the amplitude, frequency and / or phase of the voltage can then be measured and used in combination with the measured amplitude, frequency and / or phase of the excitation source to calculate the blood impedance levels based on derivatives or equations that are typically used to calculate the impedance. The electrical contacts can be connected to the blood circuit in a variety of different and suitable ways. For example, the electrical contacts can be an integral component of the extracorporeal system, a disposable component that can be connected and released from the blood circuit tubing members, a reusable component that can be autoclaved between uses, or the like. ELECTRICAL CONTACT COUPLING DEVICE In one embodiment, the apparatus of the present invention includes an electrical contact coupling device that can be used to secure the electrical contacts, preferably electrodes, to the blood circuit so that the electrodes effectively contact with blood and, thus, can be used to effectively monitor changes in access conditions as previously discussed. In one embodiment, at least one of the electrical contacts includes a conductive polymer material as described below. The coupling device of the present invention can also be designed to facilitate the protection of the user against contact with a source of electrical potential. In one embodiment, the device can include a conductive element connected to a tube, through which a medical fluid can flow, wherein the conductive element has a first portion exposed to medical fluid, such as blood, and a second portion external to the fluid. tube. The coupling device of the present invention may include a variety of different and suitable configurations, components, replacement material or the like. In one embodiment, the present invention may include a device for connecting an electrical contact to a fluid conduit that provides fluid and electrical communication between the electrical contact and the fluid flowing through the fluid conduit. The device may include a first member that includes an annular portion capable of accommodating the electrical contact and a first portion of the rod connected to the annular member, wherein the portion of the rod has an open extension through the annular portion; a second member that includes a base portion with a second portion of the rod with an open extension therethrough to the notch region that allows the first member to be inserted and secured to the second member; and a contact member adapted to accommodate the first and second shank portions that allow the contact member to bump against at least a portion of the electrical contact member that allows an electrical connection to be made between the electrical contact and the contact member . Illustrative examples of the electrical contact coupling device of the present invention are described below. As illustrated in Figures 2A and 2B, the electrical contact coupling device 80 includes a probe member 82 having a cylindrical shape with an opening 84 extending therethrough. In this aspect, an electrical contact, preferably an electrode 86 having a cylindrical shape can be inserted into the opening 84 so that the electrode 86 is secured in the probe member 82. In one embodiment, the probe member 82 has a channel 85 that extends along at least a portion of the opening 84 into which the electrode 86 can be inserted into the probe member 82. A tube member, for example, of a blood tubing assembly, a tubing connector member of a dialysis machine or the like, may be inserted at both ends of the opening 84 of the probe member 82 in contact with a external portion of channel 85 that allows blood or other suitable fluids to make fluid contact with electrode 86 in any suitable manner. The electrode 86 has an opening 88 extending therethrough within which blood (not shown) or other suitable fluid can flow from the fluid circuit. In one embodiment, the diameter of the opening 88 of the electrode 86 is dimensioned to allow the flow of blood through the electrode 86 so that the blood flow levels under typical operating conditions, such as during dialysis therapy, can be maintained properly. In this aspect, the coupling device of the present invention can be easily and effectively attached to the fluid circuit, which includes a blood circuit or the like, for use during medical therapy including, for example, dialysis therapy . It should be appreciated that the coupling device 80 of the present invention can be attached to the fluid circuit in any suitable manner so that the electrical and fluid connection can be made with the fluid flowing through the fluid circuit.
The probe member 82 also includes a rod portion 90 extending from a cylindrically shaped surface 92 of its body. The rod portion 90 has an opening 93 extending therethrough. In one embodiment, the rod portion 90 is positioned so that at least a portion of the electrode 86 is in contact with the opening 93 of the rod portion 90. In order to secure the electrode 86 to the blood circuit, the coupling device 80 includes a plug member 94 which includes a body portion 96 with an opening 98 for accepting the probe member 82 and for accepting a member. tube (not shown) of the blood circuit so that the blood makes direct contact with the electrode as it circulates through the blood circuit during dialysis therapy. In one embodiment, the plug member 94 includes a rod portion 1 00 extending from the body member 96, wherein the rod portion 100 includes an opening 1 02 extending therethrough. As the probe member 82 is inserted through the opening 98 of the body member 96, the rod portion 90 of the probe member 82 can be inserted into the opening 102 of the stem portion 100 of the limb body 96. 94 plug. In one embodiment, the plug member 94 includes a notch region 1 04 that extends along at least a portion of the body 96 of the plug member 94. In this aspect, the probe member 82 can be inserted through the opening 98 and then moved or positioned in the notch region 1 04 to secure the probe member 82 in the body 96 of the plug member 94. In one embodiment, the coupling device 80 includes an electrical contact member 106 that is inserted into the opening 102 of the rod portion 100 of the body 96 of the plug member 94 so that the contact member 106 extends through of the opening 93 of the rod portion 90 of the probe member 82 to contact at least a portion of a surface 108 of the electrode 86. The electrical contact member 106 is used to connect the electronics (not shown) of, for example, the excitation source, a signal processing device, other similar suitable electronic devices for use in monitoring and / or controlling changes in access conditions, such as the displacement of the needle. The electrical contact member 106 can be made of any suitable material, such as any suitable conductive material including, stainless steel, other similar conductive materials or combinations thereof. In order to secure the electrical contact member 106 in place, a contact retainer member 10 is inserted into the opening 102 of the rod portion 100 of an end region 12 thereof. In one embodiment, the coupling device is mounted on a machine, device or dialysis system in any suitable manner. For example, the coupling device can be mounted as an integral component of the dialysis machine. Also, the coupling device can be mounted as a separate and / or independent component that can interrelate with any of the components of the apparatus and system of the present invention. In one embodiment, the coupling device 80 can be insertable via the rod portion 1 00 of the plug member 94 to a dialysis machine or other suitable components. It should be appreciated that the electrical contact coupling device can include a variety of different and suitable material shapes, sizes and components. For example, another embodiment of the coupling device is illustrated in Figure 2C. The coupling device 1 14 in Figure 2C is similar in construction to the coupling device shown in Figures 2A and 2B. In this aspect, the coupling device 1 of Figure 2C may include, for example, a cylindrical electrode or other suitable electrical contact, a probe member for accepting the electrode and securing it in place within a plug member of the device detection. The probe member includes a portion of the rod that can be inserted into a stem portion of the plug member. An electrical contact member can be inserted into the rod portion so that it can make contact with the electrode. The coupling device of Figure 2C may also include a contact retainer member to hold the electrical contact member in place in a manner similar to the coupling device shown in Figures 2A and 2B. As shown in Figure 2C, the probe member 16 of the electrical contact coupling device 1 14 includes a handle 1 1 8 which can facilitate securing the probe member 16 within the plug member 120. The handle 1 18, as shown, has a solid shape that can facilitate the use and make-up of the coupling device 1 14. In addition, the shank portion (not shown) of the probe member 16 is larger in diameter than the shank portion of the probe member as illustrated in FIG. 2A. By increasing the size of the rod, the probe member can be inserted more easily and quickly into the plug member. In addition, the probe member is of longer length compared to the probe member as shown in Figures 2A and 2B such that the end regions 122 of the probe member 16 extend beyond a notch region 124 of the probe member. 120 member plug. This can facilitate securing the probe member in the notch region 124 of the plug member 120. In one embodiment, an opening 126 of the plug member 120 may include a further opening portion 128 to accommodate the insertion of the rod portion of the probe member 16, which has an enlarged size, therethrough. This can ensure proper alignment of the probe member with respect to the plug member before inserting the probe member into the plug member thus facilitating the insertion process.
It should be appreciated that the probe member, the socket member and the stop member contact may be composed of a variety of different and suitable materials including, for example, plastics, molded plastics, like materials or combinations thereof. The various components of the coupling device, such as the probe member, the plug member and the contact retainer member, can be accommodated in any suitable manner. For example, the components can be accommodated in soft coupling (as shown in Figures 2A and 2B), in threaded coupling (as shown in Figures 2D and 2E) and / or any suitable coupling or adjustment arrangement between them. As shown in Figures 2D and 2E, the coupling device 130 of the present invention can be made of threaded parts which are removably connected to each other to form the coupling device. The threaded parts can facilitate the securing of the electrode to the blood circuit as well as the general use thereof as described below. In one embodiment, the stem portion 132 of the body 134 of coupling device 130 has a threaded region 136 which can join insertably to a dialysis machine or other suitable mounting device in threaded engagement. This may favor the ease with which the coupling device is attached and detached from the mounting device.
As shown in Figure 2E, the stem portion 132 is threaded on both sides allowing it to be in threaded engagement with an annular member 138. The annular member 138 provides direction and support by allowing the electrical contact member 140 to abut against the electrode 142 housed in the probe member 144, as previously discussed. In one embodiment, a plate member 146 made of any suitable conductive material can be pressed against a spring 148 as the probe member 144 is secured to the body 134. At the same time, another spring 150 can be moved against the body member 140. electrical contact in contact with the retainer 152 which is inserted into an annular region of the annular member 138 to secure the electrical contact member 140 of the body 134. the spring mechanism in an embodiment of the present invention allows the parts of the device 130 coupling remain in safe coupling during use. It can also facilitate the use during the detachment of the parts for cleaning, maintenance or other suitable purpose. As discussed previously, the present nvención can be effectively used for detecting the displacement of an access device, such as a needle, inserted into a patient through which fluid can pass between the patient and a delivery system and / or fluid treatment. The present invention can be applied in a number of different applications, such as therapies or medical treatments, particularly dialysis therapies. In dialysis therapies, access devices, such as needles, are inserted into the arteries and veins of a patient to connect the blood flow to and from the dialysis machine. Under these circumstances, if the needle moves or separates from the blood circuit, particularly the venous needle, the amount of blood loss from the patient can be significant and immediate. In this aspect, the present invention can be used to controllably and effectively minimize the loss of blood of a patient due to displacement of the access device, such as during dialysis therapy including hemodialysis, hemofiltration, hemodiafiltration and continuous renal displacement. DETECTION AND SIGNAL PROCESSING As previously discussed, the electrical contacts in connection with the controller can be used to detect a change in impedance or the like in response to the output of the needle or other similar changes in access conditions. Electrical contacts can include a variety of suitable conductive materials, such as conductive polymer materials, as described below. In one embodiment, the present invention can be adapted to correct for any variations in base impedance over time. This may increase the level of sensitivity with respect to the detection capabilities of the present invention. In this regard, if the changes in the base impedance are very large and are not corrected properly, the changes in the impedance due to the displacement of the needle may not be so easily detectable, if they are detected, above the base values. From a practical point of view, there are a number of different process conditions that can influence a change in the base impedance over time. For example, a current or gradual change in the baseline may occur due to a change in characteristics, such as hematocrit, plasma protein, blood / water conductivity and / or the like, of blood or other fluid. suitable during treatment. This may arise due to changes in the level of electrolytes or other components during dialysis therapy. As illustrated in Figure 3, the present invention can process a measurable voltage signal to correct changes in the base impedance over time. This may increase the detection capabilities of the present invention, as discussed previously. In one embodiment, a current source 160 or the like generates an electric current to pass through the blood as it flows to, through and out of the patient along the extracorporeal blood circuit 162 which connects the patient , via venous and arterial needles, with the dialysis system that includes a variety of process components. The electric current is injected into the blood circuit via a first electrical contact 163a whereby a circuit or conductive path is defined along the blood circuits. Preferably, the current is maintained at a constant level until displacement occurs.
The second electrode 163b is used to detect voltage or the like along the conductive circuit and then passes a signal indicative thereof and / or changes thereof to an electronic device for detection and processing as previously discussed. The voltage signal can be measured and processed in any suitable way. In one embodiment, the signal is passed through a series of components that include a filter or filters 164 which can act to filter out noise from the signal, particularly noise derived from the rotation of the pump in order to minimize detection false negative and / or positive displacement of the needle, a rectifier 166, a peak detector 168 and an analog-to-digital converter ("ADC") 170 to digitize the signal. In this aspect, the digital signal can then be stored in a computer device (not shown) for further processing. The voltage signal is measured and processed continuously over time, with each measurement, the digitized signals are compared to evaluate changes due to changes in the baseline associated with variations in process conditions over time, such as a change in the characteristics of the blood as previously discussed. If a change in the baseline is determined, the digitized signal can be further processed to correct the change in the baseline. The voltage information is continuously sent to a control unit 172 coupled to the ADC. The control unit continuously performs a calculation to determine whether or not a change in impedance or the like has occurred in response to the displacement of the needle. In one embodiment, a displacement of an access device is detected when [V (t) - V (t-T)] > C1, where t is time, where T is the period of revolution of the blood pump, where C1 is a constant and where V (t) = l0 * Z, where l0 is current and where Z is the impedance of the line of blood which is a function of the impedance associated with the patient's vascular access and the impedance associated with various components of the dialysis system, such as the dialyzer, as discussed previously. If the disconnection of the patient from the blood circuit is detected, the control unit 172 can be used to process the signal in order to minimize the loss of blood from the patient. In one embodiment, the controller is in communication with a dialysis system applied to administer dialysis therapy which includes, for example, hemodialysis, hemofiltration, hemodiafiltration and continuous renal replacement. This communication can be either by wire (i.e., electrical communication cable), wireless communication (i.e., wireless RF interface), a pneumatic interface or the like. In this aspect, the controller can process the signal to communicate with the dialysis system or device to shut off or stop the blood pump 174 associated with the hemodialysis machine and thus effectively minimize the amount of blood loss of the patient due to the displacement of the needle during hemodialysis.
The controller can communicate with the dialysis system in a variety of other ways. For example, the controller and the hemodialysis machine can communicate to activate a venous line clamp 1 76 to prevent the flow of additional blood via the venous needle thereby minimizing the patient's blood loss. In one embodiment, the clamp of the venous line is activated by the controller and attached to or positioned relative to the venous needle so that it can hold the venous line in close proximity to the needle. Once clamped, the dialysis system is able to detect an increase in pressure and can be programmed to shut off the blood pump by detecting pressure in the blood flow line that is above a predetermined level. Alternatively, the clamp of the venous line can be connected, in a controllable way, to the dialysis system. In one embodiment, an alarm can be triggered by detecting blood loss due, for ple, to the displacement of the needle during dialysis therapy. Once activated, the alarm (that is, audio and / or visual or similar) is capable of alerting the patient, a medical caregiver (ie doctor, registered nurse or similar) and / or a non-medical caregiver ( that is, a member of the family, a friend or the like) of the blood loss due, for ple, to the displacement of the needle. The function of the alarm is particularly desirable during dialysis therapy in a non-medical facility, such as in a home installation or self-care facility where dialysis therapy is typically administered by the patient and / or a non-medical caregiver in a non-medical facility or environment, excluding a hospital or other similar medical facility. In this regard, the activation of the alarm allows, for ple, the patient to act in response to ensure that the dialysis therapy is completed, for ple, to verify that the blood pump has been automatically turned off to minimize the loss of blood. blood of the patient. Thus, the patient has the ability to act without the help of a third party (that is, to act on their own) to ensure that response measures are taken to minimize blood loss. The alarm may work, thus, to ensure patient safety during the administration of dialysis therapy, particularly when applied to heme treatments in the home, where at least a portion of the dialysis therapy may be administered while the Patient is asleep. MAQUI NA DIALYSIS As previously discussed, the present invention can be adapted for use with any fluid delivery system, treatment system or the like. In one embodiment, the present invention is adapted for use with a dialysis machine to detect disconnection of access as blood flows between the patient and the dialysis machine along a blood circuit during treatment, including, for ple, hemodialysis, hemofiltration and hemodiafiltration. The present invention can include any dialysis machine suitable for such purposes. An ple of a hemodialysis machine of the present invention is described in the patent of E. U. No. 6, 143, 181, incorporated herein by reference. In one embodiment, the dialysis machine 190 includes a mobile chassis 192 and has on the front side 1 94 thereof a common mechanism 1 96 for connecting the tubing or the like by means of which a patient can be connected to the dialysis machine. , as shown in Figure 4B. A flat touch screen 1 97, which can display various operational parameters and is provided with symbols and fields for setting the dialysis machine by means of symbols and relevant fields, respectively, on the screen that is touched, can be adjusted vertically and can be pivoted universally in the dialysis machine and can be fixed in the desired adjusted position. In one embodiment, the dialysis machine includes a chassis that has one or more connectors for connecting a patient to the dialysis machine, via a blood circuit that allows blood to flow between the patient and the dialysis machine during therapy. dialysis, wherein one or more electrical contacts are connected to the blood circuit in fluid communication with the blood allowing the detection of a change in an electrical value in response to the access disconnection as the blood flows through the blood circuit. blood that has an electrical signal that passes in it. In one embodiment, the dialysis machine of the present invention can be designed to accommodate one or more of the electrical contact coupling devices, such as a pair of coupling devices, used to detect the access disconnect, as shown in Figure 4B. For example, one or more coupling devices 198 may be attached to the front panel 194 of the dialysis machine 1 90. This can be done in any suitable way. In one embodiment, the rod portion of the coupling device is insertable mounted via a threaded fitting, a friction fitting or the like, as previously discussed. This connects the patient to the dialysis machine 1 90 via a set 202 of blood tubing. The blood tubing assembly includes a first blood line 204 and a second blood line 206. In one embodiment, the first blood line 204 is connected to the patient via an arterial needle 208 or the like through which blood from the patient 200 can flow to the dialysis machine 1 90. The second blood line 206 is then connected to the patient 200 via a venous needle 210 or the like through which fluid flows from the dialysis machine to the patient thereby defining a blood circuit. Alternatively, the first blood line and the second blood line can be coupled with the venous needle and the arterial needle, respectively. The blood lines are made of any suitable medical grade material. In this regard, the disconnection of the access, such as the displacement of an arterial needle and / or a venous needle can be detected as previously discussed. Alternatively, the coupling device can be attached to the blood tubing assembly which is then put into the dialysis machine in any suitable manner. DIALYSIS TREATMENT CENTERS As discussed previously, the present invention can be used during dialysis therapy conducted in the home and in dialysis treatment centers. Dialysis treatment centers can provide dialysis therapy to a number of patients. In this regard, the treatment centers include a number of dialysis machines to accommodate the demands of the patients. The therapy sessions in the dialysis treatment centers can be done 24 hours a day, seven days a week depending on the installation and the patient's request for its use. In one embodiment, dialysis treatment centers are provided with the ability to detect disconnection of access during dialysis therapy in accordance with one embodiment of the present invention. For example, one or more dialysis machines may be adapted for use with an electrical contact coupling device with the other components necessary to detect disconnection of the access as previously discussed. In one embodiment, the electrical contact coupling device may be directly connected to one or more of the dialysis machines of the dialysis treatment center. It should be appreciated that the apparatuses, devices, methods and / or systems in accordance with one embodiment of the present invention can be applied for use during dialysis therapy administered to one or more patients in the dialysis treatment center in any suitable manner. . In one embodiment, the treatment center may have one or more patient stations in which dialysis therapy may be performed on one or more patients each coupled to a respective dialysis machine. Any therapy in the appropriate center can be performed including, for example, hemodialysis, hemofiltration and hemodiafiltration and combinations thereof. As used herein, the term "patient station" or other similar terms means any adequately defined area of the dedicated dialysis treatment center for use during dialysis therapy. The patient station can include any number and type of appropriate equipment necessary to administer dialysis therapy. In a modality, the dialysis treatment center includes a number of patient stations in each of which dialysis therapy can be administered to one or more patients; and one or more dialysis machines located in a respective patient station. One or more of the dialysis machines may include a chassis having one or more connectors for connecting a patient to the dialysis machine via a blood circuit that allows blood to flow between the patient and the dialysis machine during therapy. dialysis, wherein a pair of electrical contacts are connected to the blood circuit in fluid communication with the blood allowing the detection of a change in an electrical value in response to the disconnection of the access as the blood flows through the circuit of blood that has an electrical signal that passes through it. As previously discussed, the access disconnect detection capabilities of the present invention can be used to monitor and control a safe and effective dialysis therapy. When moving an access device, such as a needle, from the patient, the direct conductive measurement capabilities of the present invention can be used to provide a displacement-indicative signal that can be further processed for control and / or monitoring purposes. In one embodiment, the signal can be further processed to automatically terminate dialysis therapy to minimize blood loss due to displacement as previously discussed. In addition, the signal can be processed to trigger an alarm that can alert the patient and / or medical personnel of the displacement condition to ensure that responsive measures are taken. It should be appreciated that the present invention can be modified in a variety of suitable ways to facilitate the safe and effective administration of medical therapy, including dialysis therapy. Applicants have found that the direct driving measurement capabilities of the apparatus of the present invention can immediately detect blood loss or the like due to disconnection of access, such as needle displacement, with high sensitivity and selectivity so that Measures can be taken in response to minimize blood loss due to it. The ability to act responsibly and quickly to minimize blood loss by detecting it is particularly important with respect to the displacement of the needle during hemodialysis. If it is not detected and responds immediately, the amount of blood loss can be significant. In one embodiment, the present invention is capable of taking active or responsive measures to minimize blood loss (i.e., turning off the blood pump, activating the venous line clamp, activating the alarm and / or the like) in about three seconds or less, preferably in about two to about three seconds of the immediate detection of the displacement of the needle. In addition, the controller can be used to monitor and / or control one or more treatment parameters during hemodialysis. These parameters may include, for example, the detection of blood due to the loss of blood by the displacement of the needle, the change in blood flow, the detection of air bubbles in the arterial line, the detection of movement of the sensor during the treatment, the detection and / or monitoring of electrical continuity of the sensor or other similar parameters of the treatment. In one embodiment, the controller includes an exhibitor (not shown) to monitor one or more of the parameters. Thus, the present invention can be used to promote the safe and effective administration of patient therapy, such as dialysis therapy, as discussed previously.
As used herein, "health care provider" or other similar terms, including, for example, "health care personnel," means an individual or individuals who are authorized, trained, experienced and / or otherwise medically qualified to practicing and / or administering medical procedures including, for example, dialysis therapy, to a patient. Examples of a health care provider include a doctor, a physician, a registered nurse or other similar health care personnel. As used herein, "non-medical care provider" or other similar terms that include, for example, "non-medical care personnel" means an individual or individuals who are generally not recognized as typical medical care providers, such as doctors. , doctors, registered nurses or the like. Examples of non-medical care providers include patients, family members, friends or other similar individuals. As used in the present "medical facility" or other similar terms including, for example, "medical facility" means an installation or facility where typically medical procedures or therapies are performed, including dialysis therapies, performed under the supervision of personnel of medical care. Examples of medical facilities include hospitals, facilities for medical treatments, such as facilities for dialysis treatment, centers for dialysis treatment, centers for hemodialysis or the like. As used in the present "non-medical facility" or other similar terms including, for example, "non-medical establishment" means an installation, center, establishment and / or environment that is not recognized as a typical medical facility, such as a hospital or the like. Examples of non-medical establishments include a home, a residence or the like. It should be appreciated that the electrode output signal can be combined with other less sensitive blood loss detection methods, such as venous pressure measurements, systemic blood pressure, the like or combinations thereof, to improve the specificity for the displacement of the needle. DRIVER POLYMER As previously discussed, the present invention provides conductive polymer materials and devices, apparatuses, systems and methods employing same. The conductive polymer material can be used in a number of different applications, such as to monitor a patient's therapy. For example, conductive polymer materials can be used to monitor patient access conditions as discussed above and as further detailed below. Other types of monitoring applications include, for example, mixing monitoring or formulating solutions as described in more detail later. The present invention contemplates the monitoring of a change or a combination of condition changes associated with the patient's therapy, such as the monitoring of patient access conditions and the solution mixing conditions, alone or in combination. In one embodiment, the conductive polymer material includes a polymer matrix and a conductive component that is incorporated into the polymer matrix. Alternatively, the conductive polymer material, in one embodiment, includes a conductive polymer component without a separate conductive component, such as stainless steel. It should be appreciated that the conductive polymer material can be made from any suitable types and amounts of materials and in any suitable manner. As discussed above, the conductive polymer can include a polymer matrix and a conductive component incorporated in the matrix. The polymer matrix can include a variety of different materials based on polymers that are suitable for use in a variety of applications, particularly including medical applications, such as dialysis therapy. In one embodiment, the polymer matrix includes polyvinyl chloride, acrylonitrile butadiene styrene, polycarbonate, acrylic, a cycloolefin copolymer, a mixture of cycloolefin copolymers, a metallocene-based polyethylene, similar polymeric materials and combinations adequate of them. The conductive component can include any suitable materials or combinations of materials that have applicable conductive properties for a number of different applications including, for example, detection of patient access disconnection during medical therapy as discussed previously, monitoring of mixing or formulating of the components of the solution to form a mixed solution, and / or other similar applications. Preferably, the conductive component includes stainless steel, fillers, carbon black, fibers thereof and / or the like. The conductive component can be sized and formed in any suitable manner so that it can be rapidly incorporated into the polymer matrix. For example, the conductive component may include conductive fibers made from any suitable material, such as stainless steel, a carboniferous material and / or the like. The fibers, in one embodiment, have an aspect ratio ranging from about 2: 1 to about 30: 1. The conductive polymer material can include any suitable amount of the conductive polymer matrix and the conductive component. This may vary depending on the application of the conductive polymer material. In one embodiment, the conductive component includes more than about 10% by weight of the conductive polymer material. Preferably, the conductive component ranges from about 10% to about 50% by weight of the conductive polymer material. It should be appreciated that more than about 50% by weight of the conductive component can be used, but provides a minimum increase, if any, in perform of the polymeric material depending on the application. Preferably, the conductive component is uniformly dispersed throughout the polymer matrix. As discussed previously, the conductive polymer material, in one embodiment, is composed of a conductive polymer component. This type of component has sufficient electrical conductivity properties so that an additional conductive component, such as stainless steel, is not required. Examples of components of the polymer coating material include polyaniline, polypyrrole, polythiophenes, polyethylenedioxythiophene, poly (p-phenylene vinylene), the like and mixtures thereof. As discussed previously, the conductive polymer material can be made in any suitable manner. In general, the conductive component is mixed with the polymer component under suitable processing conditions including temperature and pressure, for example, to form a polymer matrix with the conductive component incorporated therein. The mixing must take place in a suitable period of time and with a sufficient amount of force so that the conductive component is uniformly distributed throughout the polymer matrix. The polymer matrix incorporated with a conductive component is then configured and formed into a final product in any suitable manner. For example, the polymer matrix incorporated with the conductive component can be formed in a one piece part via an injection molding process, extrusion process, or the like under suitable processing conditions. Thus, the conductive polymer material can be easily made with manufacturing techniques, such as injection molding and extrusion. This can effectively provide cost savings to the manufacturing process that can inevitably be passed on to the consumer. The conductive polymer material can be formed in any suitable form and sized depending on the application. In a modality, the conductive polymer material is formed in an electrode or other similar electrical contact that can be used for a number of different applications, including, for example, monitoring patient access conditions and / or monitoring mixing or formulating as discussed before and described later in more detail. The conductive polymer electrode may have a variety of different and suitable configurations depending on the applications. For example, the conductive polymer electrode can be made as a coupler that can be used to join pipe to form a pipe joint, as described below. As shown in Figures 5A and 5B, the conductive polymer coupler has a generally cylindrical shape. With this configuration, the conductive polymer can easily be attached to a tube through which fluid flows, thus forming a pipe joint. As shown in Figure 5A, the coupler 220 has a member 222 extending from an inner surface 224 of the electrode 220 of the coupler. The member 222 acts as a stop for the tube 226 which is attached to the electrode so that a desired length of the pipe joint 228 can be preset. The coupler 220, as shown in Figure 5A, in one embodiment, is made by an injection molding process. As shown in Figure 5A, a first tube member 230 is attached to a first end 232 of the coupler 220 and placed or stopped by a first end 234 of the member 222. A second tube member 236 is attached to a second end 238 of the coupler 220 and stopped or positioned by a second end 240 of the member 222. This forms a pipe joint 228, such as a pipe joint that is integrated into the blood circuit and used during dialysis therapy as described in the present application. As shown in Figure 5B, the coupler 242 is formed without a member that allows the length of the pipe joint to be preset as discussed above. In this respect, the length of the pipe joint can be adjusted accordingly depending on the application. In addition, the coupler 242, as shown in Figure 5B, can be made via an extrusion process instead of an injection molding process. This may provide additional cost savings with respect to the manufacture of the coupler as compared to an injection molding process as discussed above. As shown in Figure 5B, a first tube member 244 is attached to a first end 246 of the coupler 242 and a second tube member 248 is attached to the second end 250 of the coupler 242, thus forming the joint 252 of the pipe. The tube member may be attached to the conforming polymer coupler in any suitable manner. For example, the conductive polymer material can be bonded to the pipe with solvent, heat sealing, laser welding, radio frequency sealing, or the like. The pipe can be made of any suitable material depending on the application. For example, the pipe can be made of polyvinyl chloride ("PVC"). Preferably, the PVC pipe is bonded to a conductive polymer material which is made of an acrylonitrile butadiene styrene ("ABS") polymer matrix where the conductive material based on ABS is solvent-bonded to the pipeline. PVC However, the pipe can be made from a variety of different materials depending on the application. In one embodiment, the pipe includes a non-PVC material, such as metallocene-based polyethylene polymers, cycloolefin copolymers, mixtures of cycloolefin copolymers and the like. Non-PVC materials can include any type and quantity of suitable constituents. The metallocene-based polyethylene polymers and the like, illustrative of the present invention can be found, for example, in U.S. Patent No. 6,372, 848, the disclosure of which is incorporated herein by reference. These types of non-PVC polymers can include a polymer blend having a first copolymer of ethylene and α-olefin obtained using a single site catalyst present in a weight amount from about 0% to about 99% by weight of the mixture and having a melt flow index from fractional, such as about 0.1 g / 10 minutes to about 5 g / 10 minutes, a second ethylene-α-olefin copolymer obtained using a single-site catalyst and which is present in a weight amount of the mixture from about 0% to about 99% and having a melt flow rate from more than about 5 g / 1 0 minute to about 20 g / 10 minute; and a third copolymer of ethylene and α-olefin obtained using a single site catalyst and which is present in a weight amount of the mixture from about 0% to about 99% and having a melt flow rate greater than about 20. g / 10 minute. In one embodiment, the α-olefin copolymer has a molecular weight distribution of less than about 3. The cycloolefin copolymers and mixtures thereof, illustrative of the present invention, can be found, for example, in the US patent. No. 6,255,396, the disclosure of which is incorporated herein by reference. These types of polymers, which are not PVC, can include homopolymers or copolymers of cyclic olefins or bridged polycyclic hydrocarbons as components. For example, the polymer composition includes a first component obtained by the copolymerization of a norbornene monomer and an ethylene monomer, wherein the first component is in an amount from about 1 to 99% by weight of the composition; and a second component of an ethylene-α-olefin copolymer having 6 carbons wherein the second component is in an amount from about 99% to about 1% by weight of the composition. In one embodiment, the polymer composition may include an additional component, such as a second homopolymer or copolymer of a cyclic olefin or bridged polycyclic hydrocarbon. The pipe without base in PVC and the conductive coupler without base inPVC can be joined in any suitable way to form a pipe joint. In one embodiment, the pipe and coupler without PVC base are joined via glue with solvent. As described in US Pat. Nos. 6,255, 396 and 6,372, 848. As used herein, the term "solvent bonding" or other similar terms means that the pipe may be exposed to a solvent to melt, dissolve or dissolve. fluff the pipe and then join another polymer component to form a permanent bond. Suitable solvents typically include those having a solubility parameter of less than about 20 (Mpa) 1 2. Suitable solvents may also have a molecular weight of less than about 200 g / mol. The solvent may include, for example, aliphatic hydrocarbons, aromatic hydrocarbons and mixtures thereof. As used herein, the terms "aliphatic hydrocarbon" and "aromatic hydrocarbon" are compounds that contain only carbon and hydrogen atoms. Suitable aliphatic hydrocarbons may include substituted and unsubstituted hexane, heptane, cyclohexane, cycloheptane, decalin and the like. Suitable aromatic hydrocarbons can include substituted and unsubstituted aromatic hydrocarbon solvents, such as xylene, toluene, eumeno and the like. Suitable hydrocarbon substituents may include aliphatic substituents having from 1 to 12 carbons and include propyl, ethyl, butyl, hexyl, tertiary butyl, isobutyl, the like, and combinations thereof. As discussed previously, the conductive polymer of the present invention can be constructed and arranged in a variety of different configurations, such as a conductive polymer coupler as shown in Figures 5A and 5B and discussed below. Another example includes a dialyzer head that is made of the conductive polymer according to one embodiment. Referring to Figure 6, a dialyzer 253 is generally illustrated. The dialyzer 253 includes a body member 254 that generally includes a housing 256. The housing 256 includes a core section as well as two bell members 260 placed in the body. each end of the dialyzer. Placed inside the core is a bundle 258 of fibers. The dialyzer also includes a dialysate inlet 262 and a dialysate outlet 264. Positioned at a first end 266 of the dialyzer 253 is a fluid inlet 268 and at a second end 270 there is a fluid outlet 272 defined by a fluid inlet head 274 and a fluid outlet head 276, respectively. The dialyzer 253 is connected to a dialysis blood circuit in any suitable manner. In one embodiment, the input heads 274 and outlet 276 are made of the conductive polymer material of the present invention as discussed above. The input and output ports 274 and 276 can be connected to a controller 278 so that the conductive polymer heads can be used to monitor patient access conditions as previously discussed. A variety of different head and dialyzer designs can be used. For example, U.S. Patent No. 6,623,638 and U.S. Patent Publication No. 2003/0075498 provide a number of different illustrative examples of the present invention. The disclosures of U.S. Patent No. 6,623,638 and U.S. Patent Publication No. 2003/0075498 are incorporated herein by reference. The conductive polymer of the present invention can be used in any suitable form and in a variety of different devices, apparatuses, systems and applications thereof. For example, the conductive polymer can be used to detect a change in impedance in response to the displacement of an access device, to detect a change in conductivity in response to a change in the composition of the solution and / or other suitable applications. .
In one embodiment, the conductive polymer is part of an assembly or sensing apparatus that can be used, for example, to monitor dialysis applications as discussed in the present application. The sensor apparatus of the present invention may include a number of different configurations and designs. Two examples of such illustrative designs of the present invention are described later in Figures 7A and 7B. In Figure 7A, the pipe joint 284 which includes the conductive polymer electrode 286 attached to a pipe member 288 as described above, for example, is put in place by a fastening device 290 for the purposes of the detection capabilities associated with the sensor apparatus 291 in one embodiment. In general, the fastener 290, as shown in Figure 7A, has a cube or mass design. More specifically, the fastener 290 includes a base member 292 on which the pipe joint 284 can be placed. The base member 292 includes a first portion 294 that is made of a plastic or other suitable material. The first portion 294 defines an outer surface 296 of the base member 292. Along the outer surface 296, the first portion 294 includes two openings that are spaced apart, as shown in Figure 7A. The first opening 298 is placed on a first edge 300 of the first portion of the base and the second opening 302 is placed on a second edge 304 of the first portion of the base. The openings can be configured in any suitable manner and used for assembly purposes.
The second portion of the base member includes a conductive portion 306, as shown in Figure 7A. In one embodiment, the conductive portion 306 includes a single piece portion 308 that is made of any suitable conductive material, such as stainless steel and / or the like. As shown in Figure 7A, the conductive polymer of the pipe joint is placed against a curved edge 310 of the second portion that is substantially formed on an outer surface 312 of the conductive polymer electrode 286. The electrode is substantially cylindrical in shape. The fastener 290 also includes an arm member 314 that is pivotally attached to the base member 292, as shown in Figure 7A. The arm member 314 includes a generally curved region so that the arm 314 can be placed over the pipe joint 284 allowing it to conform substantially to the generally cylindrical surface of the pipe joint and thereby further secure the gasket 284 of the pipe. pipe in place. Another configuration of an illustrative cube design of the sensor apparatus of the present invention is shown in Figure 7B. In general, this design provides a fastener 316 as a box enclosing the pipe joint 318 where the pipe joint includes the conductive polymer electrode 320 in the form of a coupler that is attached to the pipe member 322, as shown in FIG. discussed before. The fastener 316 includes a base member 324. The base member 324 includes side portions 326, a bottom portion 328 and an opening 330 in a top portion 332. As shown in Figure 7B, the sensor apparatus 334 includes a conductor member 336 that is contained in the base member 324. The conductor member 336 may be made of any suitable material as described above. The conditor member 336 includes an annular surface 338 against which the pipe joint 318 can be placed. The sensor apparatus 334 also includes a lip 340 which is pivotally attached to the base member 324. The lip 340 has a member 342 that abuts against a portion of the pipe joint in a closed position. This secures the pipe joint in place for use. As discussed previously, the sensor apparatus of the present application can be used in a number of suitable applications. For example, the sensing apparatus can be suitably coupled to a blood circuit and used for detection purposes of disconnection of an access device as described in the present application. Another application includes monitoring the formulation of the solution, as described in more detail below. In this aspect, the sensing apparatus, as shown in Figures 7A and 7B, may be used in combination with or in place of electrical coupling devices, as illustrated in Figures 2A to 2E and is described above. Thus, the present invention can be used to monitor one or a combination of conditions, such as access to a patient and the mixing of a solution, during its use. As applied, the sensing apparatus may be connected to a controller or other similar device for detection purposes.
The controller may include one or a number of different devices that are in electrical contact with the sensor apparatus in any suitable manner. In another embodiment, the sensing apparatus may include a single part part that is made of a conductive polymer material. The single piece part can be made in any suitable manner, such as by injection molding, as described above. A number of different and suitable shapes and sizes can be formed. An illustrative example of the present invention of conductive electrode 344 of a single part part is shown in Figures 8A and 8B. In general, the conductive polymer electrode 344 is configured as a coupler that can join pipe to form a pipe joint through which fluid can flow as shown in Figures 8A and 8B. The conductive polymer electrode 344 includes a base member 346 having an annular opening 348 extending therethrough. A pipe member 350 may be attached to the ends 351 of the annular opening 348 so that the pipe joint can be formed as described above. The base member 346 includes a portion 352 of a rod extending from a portion of a surface 354 of the base member 346. This can be used to assemble or bond the conductive polymer electrode 344 to a control panel or other suitable component, such as a hemodialysis machine, as described above. The rod portion 352 defines a ring-shaped channel 356 extending from the surface 354 of the base member 346. In ring-shaped channels, an annular channel 360 extending from the surface 354 of the base 346 is also provided, as shown in Figure 8B. The rod portion can be used to provide a path through which the electrode can be in electrical contact with one or more other devices, such as a controller, in any suitable manner. The base member also includes an upper member 362 that extends from a portion of the surface 354 of the base member 346. The upper member 362 can be used to secure the stem portion 352 of the base member 346 in place for use and / or to remove the electrode after use. As shown in Figures 8A and 8B, the conductive polymer electrode 344 includes a member 366 extending from an inner surface of the annular opening 348. The member 366 acts as a stop against which the pipe can be placed to form the pipe joint. The member 366 has a generally cylindrical shape with an opening 368 through which fluid can flow. As discussed previously, the conductive polymer material of the present invention can be used in a number of different applications. In one embodiment, the conductive polymer material can be used to monitor patient access conditions, such as to detect disconnection of an access device that is inserted in a patient through which fluid flows during medical therapy. Preferably, the disconnection detection application is applied during dialysis therapy, such as during hemodialysis therapy. As applied to dialysis applications, the conductive polymer can be formed as an electrode and attached to a blood circuit for dialysis in any suitable manner. As shown in Figures 1A and 2A, and described further below, at least one of the sensors may include an electrode made with the conductive polymer material of the present invention. The sensors 22 and 24 are in electrical contact with a controller 29 and thus the conducting polymer electrode can be used for detection, monitoring and control purposes related to the dialysis therapy as described above. As shown in Figures 4A and 4B and described in the present application, the sensors 198 can be attached directly to the hemodialysis machine, wherein at least one of the sensors includes a conductive polymer electrode according to one embodiment of the present invention. The conductive polymer sensor can be configured in any suitable manner, such as the coupler and hub design (see Figures 5A, 5B, 7A and 7B), the design of the single part part (see Figures 8A and 8B) and the dialyzer head design (see Figures 8A and 8B) as described above. It should be appreciated that the present invention contemplates the use of one or a combination of different sensors to monitor medical therapy, such as conditions of patient access and solution mixing.
In one embodiment, the conductive polymer material of the present invention can be used to monitor the mixing of solutions to form a mixed solution, such as a mixed solution used during medical therapy. One type of illustrative application of the present invention for such monitoring purposes is during dialysis therapy, particularly during peritoneal dialysis. In general, the conductive polymer material can be formed as an electrode or other detection device that can effectively detect changes in conductivity associated with a dialysis solution that is administered to the patient during peritoneal dialysis. The dialysis solution can be formed from a number of components of the solution that are mixed to form a mixed solution for dialysis before administration. The components of the dialysis solution may have varying pH levels, such as fluctuating from about 1.8 to about 9.2. Once mixed, the pH of the mixed solution for dialysis should be at a physiologically acceptable level, such as fluctuating from about 6.8 to about 7.5, before being used. The pH level can be monitored in relation to changes in the conductivity level of the dialysis solution. In this regard, the conductive polymer of the present invention can be used to detect changes in the level of conductivity and, thus, can be used to determine whether the components of the solution are appropriately mixed or not to form the mixed solution for dialysis in an acceptable pH level before use. A general description of peritoneal dialysis is provided below and is illustrative of the present invention. Peritoneal dialysis uses a sterile dialysis solution, which is infused into the peritoneal cavity of a patient and placed in contact with the patient's peritoneal membrane. Waste, toxins and excess water pass from the patient's bloodstream through the peritoneal membrane to the dialysis solution. The transfer of waste, toxins and excess water from the bloodstream to the dialysis solution occurs due to diffusion and osmosis during a period of swelling as an osmotic agent in the dialysis solution creates an osmotic gradient across the membrane. brana The spent solution is subsequently drained from the patient's peritoneal cavity to remove waste, toxins and excess water from the patient. There are several types of peritoneal dialysis therapies, including ambulatory peritoneal dialysis ("CAPD") and automated peritoneal dialysis. CAPD is a manual dialysis treatment, in which the patient connects the catheter to a bag of fresh dialysis solution and manually infuses the fresh dialysis solution through a catheter or other suitable access device into the patient's peritoneal cavity. The patient disconnects the catheter from the bag of fresh dialysis solution and allows the solution to remain inside the cavity to transfer waste, toxins and excess water from the patient's blood stream to the dialysis solution. After a period of permanence, the patient drains the spent dialysis solution and then repeats the manual dialysis procedure. Pipe assemblies with "Y" connectors for the solution and drainage bags that are available can reduce the number of connections the patient must make. Pipe assemblies may include pre-assembled bags that include, for example, an empty bag and a bag filled with dialysis solution. In the CAPD, the patient performs several cycles of drainage, filling and permanence during the day, for example, approximately four times per day. Each treatment cycle, which includes draining, filling and permanence, takes approximately four hours. Automated peritoneal dialysis is similar to continuous ambulatory peritoneal dialysis because dialysis treatment includes a draining cycle, filling and permanence. However, a dialysis machine automatically performs three or more cycles of peritoneal dialysis treatment, typically at night while the patient is asleep. With automated peritoneal dialysis, an automated dialysis machine is fluidly connected to an implanted catheter. The automated dialysis machine is also fluidly connected to a source or bag of fresh dialysis solution and to a fluid drain. The dialysis machine pumps the spent dialysis solution from the peritoneal cavity, through the catheter, to the drain. The dialysis machine then pumps fresh solution of dialysis from the source, through the catheter and into the peritoneal cavity of the patient. The automated machine allows the dialysis solution to remain within the cavity so that the transfer of waste, toxins and excess water from the blood stream of the patient to the dialysis solution can take place. A computer controls the automated dialysis machine so that dialysis treatment occurs automatically when the patient is connected to the dialysis machine, for example, when the patient sleeps. That is, the dialysis system pumps automatically and sequentially fluid to the peritoneal cavity, allows permanence, pumps fluid out of the peritoneal cavity and repeats the procedure. During the treatment several cycles of drainage, filling and permanence will occur. Tam Well, is typically used a "last fill" final volume at the end of automated dialysis treatment, which remains in the peritoneal cavity of the patient when the patient disconnects from the dialysis machine for the day. Automated peritoneal dialysis relieves the patient of having to manually perform the draining, permanence and filling steps during the day. In general, the dialysis solution includes an osmotic agent, such as dextrose or other suitable constituent in any suitable amount, such as from about 1.5% to about 4.25% by weight. The dialysis solution also includes one or more electrolytes, such as sodium, calcium, potassium, magnesium chloride and / or the like in any suitable amount. The dialysis solution may also include other constituents, such as buffers including lactate and bicarbonate, or the like, and other constituents, such as stabilizers. The dialysis solution can be made from multiple components of the solution which can vary in the amounts and types of constituents thereof and have varying pH levels. A variety of different and suitable types of multi-part dialysis solutions can be used. For example, a bicarbonate-based solution of multiple parts can be found in the patent application of E. U. 09 / 955,248, entitled SOLUTION IS DE DIÁLI SIS PERITONEAL BALANCED BI OQUÍM ICAM ENTE, filed on September 17, 2001, the description of which is incorporated herein by reference. An example of a multi-part lactate-based solution can be found in the patent application of E. U. No. 10 / 628,065, entitled DIALYSIS SOLUTIONS WITH REDUCED LEVELS OF GLUCOSE DEGRADATION PRODUCTS, filed July 25, 2003, the disclosure of which is incorporated herein by reference. Another example of a bicarbonate-based solution can be found in patent application US No. 1 0 / 044.234 entitled solution is BASED THERAPIES FOR BAKING Diali SIS, filed January 1st of January 2002 as further described in U.S. Patent No. 6,309,673, the disclosures of which are incorporated herein by reference. The bicarbonate-based solution can be made from components of the solution having varying pH conditions, such as under moderate and extreme pH conditions. In a modality, the components of the solution can vary in pH from about 1.0 to about 10.0. Once mixed, the desired pH of the mixed solution is at an acceptable physiological level, such as between about 6.5 and about 7.6 (ie, close to the pH of the blood). For example, under conditions of moderate pH, the bicarbonate-based solution can be formulated by mixing a bicarbonate concentrate with a pH ranging from about 7.2 to about 7.9, preferably from about 7.4 to about 7.6, and an electrolyte concentrate with a pH that ranges from about 3.0 to about 5.0. Under conditions of extreme pH, for example, the bicarbonate concentrate has a pH that can range from about 8.6 to about 9.5 and is mixed with an electrolyte concentrate having a pH from about 1.7 to about 2.2. A variety of different and suitable acidic and / or basic agents can be used to adjust the pH of the bicarbonate and / or electrolyte concentrates. For example, a variety of inorganic acids and bases may be used, such as hydrochloric acid, sulfuric acid, nitric acid, hydrogen bromide, hydrogen iodide, sodium hydroxide, the like or combinations thereof. The components of the solution, such as the electrolyte concentrate and the dextrose concentrate, can be mixed in the bag of the solution and then administered as a mixed solution to the patient during peritoneal dialysis. An illustrated example of a multi-chamber container containing separately the solution components of a dialysis solution according to the embodiment of the present invention is shown in Figure 9. It should be noted that the components of the solutions of dialysis of the present invention can be housed or contained in any suitable manner such that dialysis solutions can be prepared and administered effectively. In one embodiment, the present invention includes a multi-part dialysis solution in which two or more parts are formulated and stored separately and then mixed just before use. A variety of containers can be used to house the various parts of the dialysis solution, such as separate containers (ie, flasks or bags) that are connected by an appropriate fluid communication mechanism. In one embodiment, a multi-chamber container or bags can be used to house the separate components of the solution including, for example, a dextrose concentrate and a buffer concentrate. In one embodiment, the separate components are mixed into the multi-chamber bag before use, such as applied during peritoneal dialysis. Figure 9 illustrates a container suitable for storing, formulating, mixing and administering a dialysis solution, such as during an ambulatory continuous peritoneal dialysis, according to one embodiment of the present invention. The multi-chamber bag 380 has a first chamber 382 and a second chamber 384. The interior of the container is divided by a seal 386 by heat in the two chambers. It should be appreciated that the container can be divided into separate chambers by any suitable seal. In one embodiment, the container can be divided into separate chambers, such as two or more chambers, by a detachable seal. With the use of a removable seal, a brittle connector or other suitable connector would not be required to mix the components of the solution within the multi-chamber bag. An example of a multi-chamber bag for solution including a peelable seal is disclosed in U.S. Patent No. 6,319,243, the disclosure of which is incorporated herein by reference. As shown in Figure 10, a container 388 includes at least three cameras 390, 392 and 394. Chambers 390, 392 and 394 are designed for the separate storage of liquids and / or solutions, which can be mixed within the container to form a mixed solution ready for use. It should be appreciated that more or less than three cameras can be used. Removable seals 396 and 398 are provided between chambers 390, 392 and 394, respectively. Examples of peelable seals can be found in the patent application of E. U. No. 08/033, 233 filed March 16, 1993, entitled "REMOVABLE STAMP AND CONTAINER HAVING THE SAME", the description of which is incorporated herein by reference. The removable seals allow the selective opening of the chambers to allow the selective mixing of the liquids contained in them. The container 388 may also include tubular orifices, such as the tubular holes 400, 402 and 404, as shown in Figure 1. The tubular orifices are mounted in the container to allow fluid communication with the container and specifically with the container. the chambers 390, 392 and 394. For this purpose, the tubular orifices 400, 402 and 404 may include a membrane that is pierced, for example, by means of a cannula or a tip or an administration set to deliver the contents of the container to the container. patient. It should be appreciated that more or less than three holes can be used. As shown in Figure 9, the multi-chamber container 380 has a brittle or brittle connector 406 for sealingly attaching the first chamber 382 to the second chamber 384 in place of a peelable seal. To mix the solution within the multi-chamber bag 380, the fragile or brittle 406 connector is broken. The first container or chamber 382 includes two orifice tubes 408 of suitable sizes and lengths. It should be appreciated that more or less than two orifice tubes can be used. One of the orifice tubes, for example, may be used to add other constituents to the first chamber 382 during the formulation of the solution of the present invention, if necessary. The remaining orifice tube, for example, can be used to adaptively couple the first chamber 382 to the patient via a patient administration line (not shown), be used to add other additional components or the like. The second container or chamber 384 has a single hole tube 41 0 extending therefrom. In one embodiment, the orifice tube 410 is connected to a line for administration to the patient through which a solution can flow to the patient once the solution is mixed, as described below. In one embodiment, the product transfer within the multi-chamber bag 380 can be initiated from the first chamber 382 to the second chamber 384 so that the components of each chamber can be properly mixed to form the dialysis solution of the present Nvention In one embodiment, a dextrose concentrate 412 is contained in the first chamber 382 and a buffer concentrate 414 is contained in the second chamber 384. It should be appreciated that any suitable type or number of solution components can be separated with a bag of multiple chambers and then mixed to form a mixed solution before administration to the patient. Illustrative examples of peritoneal dialysis solutions include those described in the patent applications of E. U. Nos. 09 / 955,298 and 1 / 628,065 and the patent of E. U. No. 6, 309,673 as described above. The first chamber 382 is smaller in volume than the second chamber 384 so that the components of each chamber can be mixed properly once the transfer of the first chamber to the second chamber has occurred. Thus, the multi-chamber bag 380 can accommodate at least two component parts of the solution which after mixing will result in a ready-to-use dialysis solution. An example of the multi-chamber container is set forth in the U. No. 5 patent., 431, 496, the description of which is incorporated herein by reference. The multi-chamber bag can be made of a gas permeable material, such as polypropylene, polyvinyl chloride or the like. It should be appreciated that the multi-chamber bag can be manufactured from a variety of different and suitable materials and configured in a number of suitable ways so that the dialysis solutions of the present invention can be effectively formulated and administered to the patient during a medical therapy in any suitable way. For example, the first chamber may be of larger volume than the second chamber and is further adapted so that the dialysis solution of the present invention can be rapidly made and administered effectively to the patient. In one embodiment, the dialysis solution is contained and administered from a multi-chamber bag for solution during peritoneal dialysis, such as during CAPD. The solution bag can include multiple chambers each containing separate components of the dialysis solution before mixing them as discussed above. This may be necessary to maintain separation of the incompatible solution components prior to mixing for stability, sterility, effectiveness or the like associated with the dialysis solution before use. In another embodiment, the components of the solution can be prepared and stored in separate containers and then mixed via a mixing device before use, as applied during automated peritoneal dialysis. As shown in Figure 11, a first component of the solution, such as a dextrose concentrate 416, and a second component of the solution, such as a buffer concentrate 420, are stored in the respective containers or bags 422 and 424 which are fluidly connected to a mixing device 426 suitable for use during automated peritoneal dialysis, an example of which uses the ADM IX HOM ECHOICE by BAXTER I NTERNATI ONAL, I NC. In addition to the first and second components, a first bag 428 and the last bag 430 filled with a suitable solution may also be used during dialysis therapy as is generally known. In one embodiment, an effective amount of the first component 416 of the solution and the second component 420 of the solution of each respective container and to a heater bag 432 are extracted where the components of the solution (e.g., dextrose and buffer concentrates) can be mixed and heated before infusion to a patient 434 during dialysis therapy. As shown further in Figure 11, a drainage line 436 is coupled to the mixing device 426 from which the patient's waste fluids can be removed during therapy. In accordance with one embodiment of the present invention, the conductive polymer material can be used as a sensor to monitor the formulation of the solution, such as during peritoneal dialysis. For example, the conductive polymer sensor 438 may be attached to a tube 440 through which the mixed dialysis solution flows to the patient from the multi-chamber solution bag 380, as shown in FIG. 9. The sensor 438 of FIG. The conductive polymer is in electrical contact with a controller 442 or other similar device so that a change in the conductivity of the mixed dialysis solution that is fed to the patient can be monitored. Based on the conductivity level, the pH level of the mixed solution can be monitored to determine if the components of the solution (eg, dextrose concentrate and buffer concentrate) have been mixed appropriately and sufficiently to form the solution. dialysis before use. IF the dialysis solution is not properly mixed, the conductivity level will exist above or below a base conductivity level that is generally associated with a desired pH level of a dialysis solution that is ready to be used. As discussed previously, the desired pH of the mixed dialysis solution is maintained at an acceptable physiological level, such as between about 6.5 and about 7.6 before use. Based on this information, adjustments can be made to the process so that the chemistry of the solution of the dialysis solution is modified for appropriate use. This can facilitate the safe and effective use of the solution during its use, such as during dialysis therapy. As shown in Figure 11, the conductive polymer sensor 444 of the present invention can be applied during automated peritoneal dialysis. More specifically, the conductive polymer sensor 444 of the present invention can be attached to the tube member 446 through which a dialysis solution flows to the patient. The dialysis solution is a product of the mixing of the components of the solution that are stored in separate solution bags as previously discussed. The conductive polymer sensor 444 or other similar device can be connected in electrical contact to a controller 448 or other similar device so that the level of conductivity and thus the pH level of the solution that is administered to the patient can be monitored as discussed previously. Optionally, at least one additional conductive polymer sensor 450 in one embodiment may also be used as shown in Figure 11. In this regard, the additional sensor (s) can be used to monitor the conductivity level of the components of the solution before mixing. This can be used to evaluate whether the components of the solution are maintained at desired pH levels based on a conductivity measurement as discussed above. It should be understood that various changes and modifications to the currently 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 invention and without diminishing its intended advantages. Therefore, it is intended that such changes and modifications be covered by the appended claims.