System and method for detection of disconnection in an extracorporeal blood circuit

Information

  • Patent Grant
  • 8535522
  • Patent Number
    8,535,522
  • Date Filed
    Friday, February 12, 2010
    15 years ago
  • Date Issued
    Tuesday, September 17, 2013
    12 years ago
Abstract
The present invention is directed to a dialysis system with a disconnection monitor for determining if a blood line connection to a patient has been disconnected. It includes a blood circuit in fluid communication with a patient and a dialysis circuit, a pressure transducer for generating a signal indicative of a pulse signal in the blood circuit, a cardiac reference signal generator for generating a signal indicative of the patient's pulse and a disconnection monitor. The disconnection monitor includes a pressure transducer data receiver for receiving the signal indicative of the pulse signal in the blood circuit, a cardiac reference signal receiver for receiving the signal indicative of the patient's pulse, and a processor for cross-correlating the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse to generate data indicative of a disconnection of the blood line connection to the patient.
Description
FIELD OF THE INVENTION

The present invention relates to medical apparatus and procedures. More particularly, the present invention relates to an apparatus and method for detection of disconnection in an extracorporeal blood circuit being used for any blood processing treatment routine.


BACKGROUND OF THE INVENTION

Vascular access for establishing an extracorporeal blood circuit is typically obtained by using a trans-dermal needle or a luer connected catheter. Usually blood processing treatment routines require establishment of extracorporeal blood circuits. Examples of blood processing treatment routines include continual renal replacement therapy such as hemodialysis wherein blood flows outside a patient's body via a set of tubes, commonly known as arterial supply line, to a dialyzer (artificial kidney) which removes waste products and excess fluids from it. Uncontaminated blood, then, flows back into the patient's body via a second set of tubes commonly referred to as venous return line.


An extracorporeal blood circuit might be disrupted while a blood processing treatment routine is in progress due to disconnection of a needle or a catheter providing vascular access. Such disruption may have serious and often fatal consequences. Needles corresponding to an arterial supply line or a venous return line of a blood circuit may disconnect due to numerous reasons, including the sudden movement of the patient undergoing the blood processing treatment. Disconnection of a supply line is relatively easy to detect by monitoring air in the supply line. In circumstances where a supply line disconnection remains undetected for some time, generally, only a slight blood loss occurs, which is equivalent to that caused by a small needle wound.


Disconnection of venous return line of an extracorporeal blood circuit is a much more alarming occurrence. The blood flow rate in most blood processing treatment routines such as hemodialysis is very high, typically around 300-400 ml/min. Hence, a disconnection of a venous return line results in blood being pumped out of a patient's body at a rapid rate. Multiple liters of hemorrhaging within a few minutes lead to serious injury and may cause death, if not detected and remedied immediately.


Detection of a return line disconnect is difficult, as most known methods are based on monitoring and detecting a change in pressure in the venous return line tubing. Return line disconnection usually occurs due to a needle pull out situation. Since, a needle typically offers the highest fluidic resistance in an extracorporeal blood circuit, a pressure change in the return line due to needle disconnect is not significant and cannot be detected easily. The pressure drop is also very low in cases where a catheter disconnects from a patient's body, causing a return line disconnection.


Hence, detection of a disconnection in a return venous blood circuit using pressure as an indicator or metric is unreliable and may result in serious injury. Further, methods using detection of air bubbles as an indication of a disconnect cannot be relied upon because a disconnect in a venous return line does not cause air to be drawn in the return line tubing.


One known method uses a detection of moisture at a needle site to detect the disconnection of a venous return line of an extracorporeal blood circuit. The method is based on an assumption that a needle pull out would cause a blood leak, thereby making the needle site wet. Various moisture sensing methods are available for use in the detection of moisture at a needle site. One such method employs optical spectrophotometry and another employs electrical conductivity measurement for moisture detection.


Moisture sensing methods require an additional apparatus, such as sensor elements to be fastened to a patient's body near the needle site. Further, such methods are based on the assumption that, after a needle pull, blood is pooled near the sensor element. However, in situations where the needle pull out is caused by a violent action, such as sudden rolling over of the patient while sleeping, the needle may cause blood flow at a distance from the sensor element. Hence, in such a situation, the moisture sensing method would provide a false negative and, at approximately 300 ml/min blood flow rate, excessive blood loss would occur in only a couple of minutes.


Another known method uses detection of certain signals from a patient's body for detection of disconnection of venous return line. This method detects changes in signals which are attributable to a needle pull out from a patient's body. One method measures electrical signals of a patient's heart through a return venous line of an extracorporeal blood circuit of the patient. In a needle pull out situation, the electrical signals are no longer detectable. This method takes advantage of the fact that blood is a good electrical conductor and the electrical signals generated by the patient's beating heart are conducted through blood carrying tubes as long as the extracorporeal blood circuit is unbroken.


However, the method fails in situations where a needle pull out occurs causing bleeding but the return venous line is intact due to fluid contact with the pool of blood. Also, efficiency of the method decreases due to the fact that the electrical activity of heart provides a very small electrical signal which, in a noisy electrical background, yields a low signal to noise ratio. Hence, loss of the signal or a failure to distinguish it from a noisy background may cause a false positive reading.


Consequently, there is need for an improved apparatus and method for detecting a disconnect in a venous return line. Further, there is also need for an apparatus and method which does not require any extra element, such as a moisture pad to be placed at the needle insertion site. Hence, there is need for an apparatus and method for detecting a disconnect in a venous return line of an extra corporeal blood circuit, which is reliable and reduces the probability the disconnection remaining undetected and causing fatal consequences.


SUMMARY OF THE INVENTION

The present invention is directed to a dialysis system having a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising: a blood circuit in fluid communication with a patient and a dialysis circuit; a pressure transducer in pressure communication with the blood circuit wherein the pressure transducer generates a signal indicative of a pulse signal in the blood circuit; a cardiac reference signal generator, wherein the cardiac reference signal generator detects and generates a signal indicative of the patient's pulse and a disconnection monitor. The disconnection monitor comprises a pressure transducer data receiver, wherein the pressure transducer data receiver receives the signal indicative of the pulse signal in the blood circuit; a cardiac reference signal receiver, wherein the cardiac reference signal receiver receives the signal indicative of the patient's pulse; and a processor, wherein the processor cross-correlates the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse to generate data indicative of a disconnection of the blood line connection to the patient.


Optionally, the dialysis system comprises a controller, wherein the controller triggers an alarm based upon the data indicative of a disconnection of the blood line connection to the patient. Optionally, the dialysis system comprises a controller, wherein the controller shuts down a dialysis pump based upon the data indicative of a disconnection of the blood line connection to the patient. The pressure transducer non-invasively generates a signal indicative of a pulse signal in the blood circuit. Optionally, along the length of the blood line to the patient, the pressure transducer is separated from the patient by a pinch valve and an air bubble detector.


Optionally, the cardiac reference signal generator is a pulse oximeter. Optionally, the processor cross-correlates the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse within a specified time frame. The dialysis system comprises programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump. The dialysis system comprises programmatic instructions for directing the system to capture the signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump. The processor comprises an amplifier.


In another embodiment, the present invention is directed toward a dialysis system having a manifold in data communication with a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising the disposable manifold having a blood circuit in fluid communication with a patient and a dialysis circuit; a pressure transducer integrated within the manifold and in non-invasive pressure communication with the blood circuit wherein the pressure transducer generates a signal indicative of a pulse signal in the blood circuit; a cardiac reference signal generator, wherein the cardiac reference signal generator detects and generates a signal indicative of the patient's pulse and the disconnection monitor. The disconnection monitor comprises a pressure transducer data receiver, wherein the pressure transducer data receiver receives the signal indicative of the pulse signal in the blood circuit; a cardiac reference signal receiver, wherein the cardiac reference signal receiver receives the signal indicative of the patient's pulse; and a processor, wherein the processor cross-correlates the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse to generate data indicative of a disconnection of the blood line connection to the patient.


Optionally, the dialysis system further comprises a controller, wherein the controller triggers an alarm based upon the data indicative of a disconnection of the blood line connection to the patient. The dialysis system further comprises a controller, wherein the controller shuts down a dialysis pump based upon the data indicative of a disconnection of the blood line connection to the patient. The pressure transducer non-invasively generates a signal indicative of a pulse signal in the blood circuit and wirelessly communicates the signal indicative of a pulse signal in said blood circuit to the pressure transducer data receiver. Optionally, the dialysis system, along the length of the blood line to the patient, the pressure transducer is separated from the patient by a pinch valve and an air bubble detector. Optionally, the cardiac reference signal generator is a pulse oximeter and wirelessly communicates the signal indicative of the patient's pulse to the cardiac reference signal receiver.


Optionally, the processor cross-correlates the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient's pulse within a specified time frame. Optionally, the dialysis system comprises programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump. Optionally, the dialysis system comprises programmatic instructions for directing the system to capture said signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump. Optionally, the processor comprises an amplifier.





BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described by way of embodiments illustrated in the accompanying drawings wherein:



FIG. 1 is a block diagram of a system for detecting a patient's disconnection from an extracorporeal blood circuit, in accordance with an embodiment of the present invention;



FIG. 2 is a block diagram illustration of an apparatus for detecting disconnection in a return venous blood circuit, in accordance with an embodiment of the present invention; and



FIG. 3 is a flow diagram showing exemplary steps of a method of ascertaining patient's disconnection from an extracorporeal blood circuit, in accordance with an embodiment of the present invention.





DETAILED DESCRIPTION OF THE INVENTION

The present invention describes an apparatus and method for detection of disconnection in an extracorporeal blood circuit being used for any blood processing treatment routine. Examples of blood processing treatment routines include hemodialysis, hemofiltration, ultrafiltration, apheresis, etc. Vascular access for establishing an extracorporeal blood circuit is typically obtained by using a transdermal needle or a luer connected catheter. The apparatus and method described in the present invention uses the pressure pulse produced by a patient's beating heart as an indicator of an intact needle or catheter connection to the vasculature. The pressure pulse produced by a patient's heart is small; more so, in the venous return line of an extracorporeal blood circuit. In order to detect the small pressure pulse the present invention uses cross correlation methodology wherein a reference cardiac signal is cross correlated to the pressure pulse signal.


The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Exemplary embodiments are provided only for illustrative purposes and various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.


The present invention will now be discussed in context of embodiments as illustrated in the accompanying drawings.



FIG. 1 is a block diagram of a system 100 for detecting a patient's disconnection from an extracorporeal blood circuit, in accordance with an embodiment of the present invention. System 100 comprises an incoming arterial blood circuit 102, a dialyzer 104, a dialysate circuit 106, a patient pulse pressure transducer 108, a patient cardiac signal generator 115 for reference, a disconnect monitor 120, a controller 125 and a return venous blood circuit 110. In various embodiments of the present invention, blood drawn from a patient is passed through the dialyzer 104 via the arterial blood circuit 102 and cleansed blood from the dialyzer 104 is returned to the patient via the venous blood circuit 110. Contaminated dialysate expelled from the dialyzer 104 is purified or regenerated within the dialysate circuit 106 and is pumped back into the dialyzer 104. In various embodiments of the present invention, cleansed blood is returned to a patient's body via a transdermal needle or a luer connected catheter. Blood flow rates in the return venous blood circuit 110 are typically in the range of 300-400 ml/min.


It should be appreciated that any suitable dialysis circuit can be deployed. In one preferred embodiment, the dialysis circuit 106 is embodied in a dialysis manifold, as disclosed, in U.S. patent application Ser. No. 12/324,924, filed on Nov. 28, 2008, which has been incorporated herein by reference. In one embodiment, the dialyzer 104 is equivalent to dialyzer 430 of FIG. 4 in U.S. patent application Ser. No. 12/324,924, the venous blood circuit is equivalent to the patient return line of FIG. 4 in U.S. patent application Ser. No. 12/324,924, and the patient pulse pressure transducer is incorporated proximate to Port H 422 of the manifold, such as at pressure transducer 407.


The pressure transducer 108 measures the pressure pulse of a patient undergoing the blood processing treatment routine and communicates the pulse pressure substantially continuously to the disconnect monitor 120. In one embodiment the transducer 108 is an invasive or non-invasive venous pressure sensor located anywhere in the dialysis blood line (the incoming arterial blood circuit 102 or the return venous blood circuit 110). In another embodiment, the transducer 108 is an invasive or non-invasive venous pressure sensor located specifically in a dialysis blood line between the dialyzer 104 and the patient, that is, in the return venous blood circuit 110. A non-invasive air bubble detector and/or pinch valve (not shown) are optionally located between the transducer 108 and the luer connection to the patient. In an embodiment of the present invention, the pressure transducer 108 is located in close proximity to the needle or catheter inserted in the patient's body for providing vascular access corresponding to the return venous blood circuit 110. The pressure transducer 108 is located in close proximity to the needle or catheter in order to preserve waveform fidelity. In other embodiments, the pressure transducer 108 may be connected anywhere in the return venous blood circuit 110. In an embodiment of the present invention, the pressure signal produced by the pressure transducer 108 is an alternating current (AC) signal which is not an accurate measure of vascular pressure. Hence, the pressure transducer 108 is not a high accuracy transducer.


The reference signal generator 115 communicates the patient's cardiac signal substantially continuously to the disconnect monitor 120 for reference. In an embodiment of the present invention, the reference cardiac signal is obtained from a plethysmograph connected to the same body part (such as an arm) to which the needle or catheter supplying processed blood to a patient is connected. In another embodiment of the present invention, the reference cardiac signal is obtained from a finger pulse sensor/oximeter. In various other embodiments of the present invention, the reference cardiac signal may be obtained an electro-cardiogram (ECG) signal, a real time blood pressure signal, stethoscope, arterial pressure signal from the blood withdrawal line, oximeter pulse signal, alternate site plethysmograph signal, transmissive and/or reflective plethysmograph signals, acoustic cardiac signals, wrist pulse or from any other cardiac signal source known to persons of ordinary skill in the art.


The disconnect monitor 120 detects a disruption in the return venous blood circuit 110 caused by the disconnection of a needle or catheter, from the body of a patient undergoing blood processing treatment. To detect a disconnection, the monitor 120 processes the patient pulse pressure transducer and cardiac reference signals. Persons of ordinary skill in the art would appreciate that such disconnection may be caused by the needle or catheter being pulled out of the patient's body due to any reason such as a sudden movement of the patient. The disconnect monitor 108 is described in detail with reference to FIG. 2. Controller 125 is any microprocessor known to persons of ordinary skill in the art. The function of the controller 125 is to receive processed inputs from the monitor 120 and accordingly trigger appropriate actions, when required.


Persons of ordinary skill in the art should appreciate that the pressure transducer and reference signals are communicated to the disconnect monitor 120 through transmitters incorporated into the reference signal generator and pressure transducer. The transmitter can enable a wired or wireless communication to a corresponding receiver. Similarly, data from the disconnect monitor 120 is communicated to the controller 125 through wired or wireless connection. In one embodiment, such signal communication is enabled using an appropriate wired or wireless public and/or private network such as LAN, WAN, MAN, Bluetooth networks, and/or the Internet. Also, in one embodiment the disconnect monitor 120 and controller 125 are located in proximity to each other and to the pressure transducer 108 and the cardiac reference signal generator 115. In an alternate embodiment, both or either of the disconnect monitor 120 and the controller 125 are/is located remotely from each other and/or from the rest of the components of the system 100.



FIG. 2 is a block diagram illustration of an apparatus 200 for detection of a disconnection in a return venous blood circuit, in accordance with an embodiment of the present invention. The disconnect monitor 200 comprises a pressure transducer receiver 202, a reference signal receiver 204, and a cross correlation processor 206. The transducer receiver 202 and the reference signal receiver 204 receive input signals from the pressure transducer 108 and cardiac reference signal generator 115, respectively, of FIG. 1.


The pressure pulse signal obtained by the pressure transducer receiver 202 and the reference cardiac signal obtained by the reference signal receiver 204 are stored in a local memory and further fed to the cross correlation processor 206, which in turn, computes a correlation between the two signals. The output of the processor 206 is fed into the controller 125 of FIG. 1. If the output produced by the cross correlation processor 206 indicates a correlation between the two input signals, it is inferred that the return venous blood circuit is intact. If the output produced by the cross correlation processor 206 does not indicate a correlation between the two input signals, it is inferred that the return venous blood circuit is broken due to a needle or catheter pull out, and the controller 125 of FIG. 1 triggers appropriate actions, such as sounding an indicative alarm and/or shutting down the dialysis system completely or partially.


Persons of ordinary skill in the art should note that the present invention envisages use of any cross correlation processor that links, corresponds, or otherwise creates a measurable, quantifiable, and/or predictable relationship between the pressure transducer signal and reference signal. In one embodiment of the present invention cross correlation is performed by using a lock in amplifier, such as SR 810 Lock In Amplifier manufactured by Stanford Research Systems, California. Various known techniques for cross correlation detection of very low signal to noise ratio systems, and cardiac signals may be incorporated in the cross correlation processor 206.


In various embodiments of the present invention, the cross correlation function, computed by the cross correlation processor 206, is used to measure the similarities between the two input signals, i.e. the reference cardiac signal and the pressure pulse signal. Computation of the cross correlation function comprises computation of a sum of the products of corresponding pairs of points of the two input signals, within a specified time frame or window. The computation also takes into consideration any potential phase differences between the two input signals by including a lead or lag term. The mathematical formula corresponding to a cross correlation function is represented as:








r

(
12
)




(
j
)


=


1
N






n
=
0


N
-
1






x
1



(
n
)





x
2



(

n
+
j

)










where N represents a number of samples, j represents a lag factor and x1 and x2 represent the two input signals respectively.



FIG. 3 is a flow diagram showing exemplary steps of a method of ascertaining patient's disconnection from an extracorporeal blood circuit, in accordance with an embodiment of the present invention. In operation, dialysis system software, comprising a plurality of instructions and executing on a processor, prompts a patient to first attach a cardiac signal generator (such as a finger pulse oximeter) to obtain 305 a reference signal. At this point the patient may or may not be connected to a dialysis system. Thereafter or concurrent to capturing the cardiac reference signal, the dialysis system software, comprising a plurality of instructions and executing on a processor, prompts a patient to connect to the system 100 of FIG. 1 as a result of which patient pulse pressure transducer signal is also obtained 310. Next, a cross correlation processor attempts to correlate 315 the reference and transducer signals. If no correlation can be achieved at start-up, in one embodiment, the patient is prompted to turn off 320 all or certain components or, in another embodiment, the controller 125 of the system 100 of FIG. 1 does this automatically to lower noise level. For example, shutting off the pumps of the dialysis system can lower the noise and make it easier to capture and correlate the two signals. In another embodiment, a cross-correlation is attempted before noise-generating system components, such as pumps, are turned on. Thus, lock down of a correlation is attempted before complete system start-up can be completed. In one embodiment, if no correlation is locked down, an alarm is triggered, indicating the patient dialysis system may have an anomaly.


However, if a correlation is obtained, then that correlation is substantially continually monitored 325. If there is any deviation in that correlation, an alarm is triggered 330, indicating a possible leak or, optionally, the system is shut down (completely or partially) and an attempt to re-establish the correlated signal is attempted again. In one embodiment, if the nature of the correlation change or deviates beyond or within a predefined threshold, certain system components, such as pumps, are shut down and the cross correlation processor attempts to re-establish the correlation. If the correlation cannot be re-established, then an alarm is triggered. In another embodiment, if the nature of the correlation change or deviates beyond or outside the range of a predefined threshold, certain system components, such as pumps, are shut down and an alarm is immediately triggered, before any additional attempt to re-establish the correlation.


The present invention provides certain distinct improvements over the prior art. First, unlike the prior art, the present invention is responsive if the needle is just barely pulled out or if it is removed and pulled quite some distance from the insertion site. Second, the present invention does not need any extra apparatus placed at the insertion site, such as a moisture pad. Third, by cross correlating the patients' own cardiac signal, the false negatives are greatly diminished. Fourth, the combination of pressure pulse sensing and cross correlation renders the present invention unique and capable of detecting low signal to noise ratio signals. Fifth, continuously monitoring the cross correlation status enables the system to detect small signal deviations which could potentially indicate a disconnection. Therefore, an apparatus and method for detection of disconnection in an extracorporeal blood circuit being used for any blood processing treatment routine, is provided by the present invention.


While the exemplary embodiments of the present invention are described and illustrated herein, it will be appreciated that they are merely illustrative. It will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from or offending the spirit and scope of the invention.

Claims
  • 1. A dialysis system having a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising: a. A blood circuit in fluid communication with a patient and a dialysis circuit;b. A pressure transducer in pressure communication with said blood circuit wherein said pressure transducer generates a signal indicative of a pulse signal in said blood circuit;c. A cardiac reference signal generator, wherein said cardiac reference signal generator detects and generates a signal indicative of said patient's pulse;d. The disconnection monitor comprising: i. A pressure transducer data receiver, wherein said pressure transducer data receiver receives said signal indicative of the pulse signal in said blood circuit;ii. A cardiac reference signal receiver, wherein said cardiac reference signal receiver receives said signal indicative of the patient's pulse; andiii. A processor, wherein said processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse to generate data indicative of a disconnection of the blood line connection to the patient.
  • 2. The dialysis system of claim 1 further comprising a controller, wherein said controller triggers an alarm based upon said data indicative of a disconnection of the blood line connection to the patient.
  • 3. The dialysis system of claim 1 further comprising a controller, wherein said controller shuts down a dialysis pump based upon said data indicative of a disconnection of the blood line connection to the patient.
  • 4. The dialysis system of claim 1 wherein said pressure transducer non-invasively generates a signal indicative of a pulse signal in said blood circuit.
  • 5. The dialysis system of claim 4 wherein, along the length of said blood line to said patient, said pressure transducer is separated from said patient by a pinch valve and an air bubble detector.
  • 6. The dialysis system of claim 1 wherein the cardiac reference signal generator is a pulse oximeter.
  • 7. The dialysis system of claim 1 wherein the processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse within a specified time frame.
  • 8. The dialysis system of claim 1 further comprising programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump.
  • 9. The dialysis system of claim 1 further comprising programmatic instructions for directing the system to capture said signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump.
  • 10. The dialysis system of claim 1 wherein the processor comprises an amplifier.
  • 11. A dialysis system having a manifold in data communication with a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising: a. The disposable manifold having a blood circuit in fluid communication with a patient and a dialysis circuit;b. A pressure transducer integrated within said manifold and in non-invasive pressure communication with said blood circuit wherein said pressure transducer generates a signal indicative of a pulse signal in said blood circuit;c. A cardiac reference signal generator, wherein said cardiac reference signal generator detects and generates a signal indicative of said patient's pulse;d. The disconnection monitor comprising: i. A pressure transducer data receiver, wherein said pressure transducer data receiver receives said signal indicative of the pulse signal in said blood circuit;ii. A cardiac reference signal receiver, wherein said cardiac reference signal receiver receives said signal indicative of the patient's pulse; andiii. A processor, wherein said processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse to generate data indicative of a disconnection of the blood line connection to the patient.
  • 12. The dialysis system of claim 11 further comprising a controller, wherein said controller triggers an alarm based upon said data indicative of a disconnection of the blood line connection to the patient.
  • 13. The dialysis system of claim 11 further comprising a controller, wherein said controller shuts down a dialysis pump based upon said data indicative of a disconnection of the blood line connection to the patient.
  • 14. The dialysis system of claim 11 wherein said pressure transducer non-invasively generates a signal indicative of a pulse signal in said blood circuit and wirelessly communicates said signal indicative of a pulse signal in said blood circuit to the pressure transducer data receiver.
  • 15. The dialysis system of claim 14 wherein, along the length of said blood line to said patient, said pressure transducer is separated from said patient by a pinch valve and an air bubble detector.
  • 16. The dialysis system of claim 11 wherein the cardiac reference signal generator is a pulse oximeter and wirelessly communicates said signal indicative of the patient's pulse to the cardiac reference signal receiver.
  • 17. The dialysis system of claim 11 wherein the processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient's pulse within a specified time frame.
  • 18. The dialysis system of claim 11 further comprising programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump.
  • 19. The dialysis system of claim 11 further comprising programmatic instructions for directing the system to capture said signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump.
  • 20. The dialysis system of claim 11 wherein the processor comprises an amplifier.
CROSS-REFERENCE

The present invention relies on U.S. Patent Provisional No. 61/151,912 filed on Feb. 12, 2009 for priority. The present invention is also related to a) U.S. patent application Ser. No. 12/575,450, filed on Oct. 7, 2009, b) U.S. patent application Ser. No. 12/575,449, filed on Oct. 7, 2009, c) U.S. patent application Ser. No. 12/355,102, filed on Jan. 16, 2009, d) U.S. patent application Ser. No. 12/355,128, filed on Jan. 16, 2009, e) U.S. patent application Ser. No. 12/351,969, filed on Jan. 12, 2009, f) U.S. patent application Ser. No. 12/324,924, filed on Nov. 28, 2008, g) U.S. patent application Ser. No. 12/210,080, filed on Sep. 12, 2008, h) U.S. patent application Ser. No. 12/238,055, filed on Sep. 25, 2008, i) U.S. patent application Ser. No. 12/237,914, filed on Sep. 25, 2008, j) U.S. patent application Ser. No. 12/249,090, filed on Oct. 10, 2008, k) U.S. patent application Ser. No. 12/245,397, filed on Oct. 3, 2008, l) U.S. patent application Ser. No. 12/610,032, filed on Oct. 30, 2009, and m) U.S. patent application Ser. No. 12/610,100, filed on Oct. 30, 2009. All of the aforementioned applications are herein incorporated by reference.

US Referenced Citations (289)
Number Name Date Kind
2328381 Jaffe Aug 1943 A
4071444 Ash et al. Jan 1978 A
4083777 Hutchisson Apr 1978 A
4113614 Rollo et al. Sep 1978 A
4348283 Ash Sep 1982 A
4368737 Ash Jan 1983 A
4387777 Ash Jun 1983 A
4397189 Johnson et al. Aug 1983 A
4402694 Ash et al. Sep 1983 A
4403984 Ash et al. Sep 1983 A
4413988 Handt et al. Nov 1983 A
4469593 Ishihara et al. Sep 1984 A
4477342 Allan et al. Oct 1984 A
4498902 Ash et al. Feb 1985 A
4559039 Ash et al. Dec 1985 A
4581141 Ash Apr 1986 A
4596550 Troutner Jun 1986 A
4599055 Dykstra Jul 1986 A
4606826 Sano et al. Aug 1986 A
4661246 Ash Apr 1987 A
4666598 Heath et al. May 1987 A
4680122 Barone Jul 1987 A
4683053 Polaschegg Jul 1987 A
4740755 Ogawa Apr 1988 A
4762618 Gummesson et al. Aug 1988 A
4777953 Ash et al. Oct 1988 A
4854322 Ash et al. Aug 1989 A
4861242 Finsterwald Aug 1989 A
4909713 Finsterwald et al. Mar 1990 A
4914819 Ash Apr 1990 A
4950244 Fellingham et al. Aug 1990 A
4990258 Bjare et al. Feb 1991 A
4995268 Ash et al. Feb 1991 A
4997570 Polaschegg Mar 1991 A
5002054 Ash et al. Mar 1991 A
5011607 Shinzato Apr 1991 A
5032261 Pyper Jul 1991 A
5100554 Polaschegg Mar 1992 A
5114580 Ahmad et al. May 1992 A
5147613 Heilmann et al. Sep 1992 A
5198335 Sekikawa et al. Mar 1993 A
5211643 Reinhardt et al. May 1993 A
5230341 Polaschegg Jul 1993 A
5277820 Ash Jan 1994 A
5295505 Polaschegg et al. Mar 1994 A
5304349 Polaschegg Apr 1994 A
5308315 Khuri et al. May 1994 A
5322519 Ash Jun 1994 A
5385005 Ash Jan 1995 A
D355816 Ash Feb 1995 S
5405315 Khuri et al. Apr 1995 A
5441636 Chevallet et al. Aug 1995 A
5445630 Richmond Aug 1995 A
5460493 Deniega et al. Oct 1995 A
5476444 Keeling et al. Dec 1995 A
D370531 Ash et al. Jun 1996 S
5536412 Ash Jul 1996 A
5540265 Polaschegg et al. Jul 1996 A
5577891 Loughnane et al. Nov 1996 A
5580460 Polaschegg Dec 1996 A
5614677 Wamsiedler et al. Mar 1997 A
5616305 Mathieu Apr 1997 A
5624551 Baumann et al. Apr 1997 A
5629871 Love et al. May 1997 A
5632897 Mathieu May 1997 A
5644285 Maurer Jul 1997 A
5674390 Matthews et al. Oct 1997 A
5679245 Manica Oct 1997 A
5693008 Brugger et al. Dec 1997 A
5698083 Glass Dec 1997 A
5711883 Folden et al. Jan 1998 A
5713850 Heilmann et al. Feb 1998 A
5725773 Polaschegg Mar 1998 A
5744027 Connell et al. Apr 1998 A
5782796 Din et al. Jul 1998 A
5794669 Polaschegg et al. Aug 1998 A
5858186 Glass Jan 1999 A
5906978 Ash May 1999 A
5919369 Ash Jul 1999 A
5945343 Munkholm Aug 1999 A
5947953 Ash et al. Sep 1999 A
5951870 Utterberg Sep 1999 A
5989423 Kamen et al. Nov 1999 A
5989438 Fumiyama Nov 1999 A
6042561 Ash et al. Mar 2000 A
6086753 Ericson et al. Jul 2000 A
6156007 Ash Dec 2000 A
6190349 Ash et al. Feb 2001 B1
6217540 Yazawa et al. Apr 2001 B1
6234989 Brierton et al. May 2001 B1
6254567 Treu et al. Jul 2001 B1
6264680 Ash Jul 2001 B1
6280406 Dolecek et al. Aug 2001 B1
6284131 Hogard et al. Sep 2001 B1
6287516 Matson et al. Sep 2001 B1
6303036 Collins et al. Oct 2001 B1
6332985 Sherman et al. Dec 2001 B1
6348162 Ash Feb 2002 B1
6409699 Ash Jun 2002 B1
6416293 Bouchard et al. Jul 2002 B1
6468427 Frey Oct 2002 B1
6471872 Kitaevich et al. Oct 2002 B2
6497675 Davankov Dec 2002 B1
6551513 Nikaido et al. Apr 2003 B2
6554789 Brugger et al. Apr 2003 B1
6572576 Brugger et al. Jun 2003 B2
6572641 Brugger et al. Jun 2003 B2
6579253 Brugger et al. Jun 2003 B1
6579460 Willis et al. Jun 2003 B1
6582385 Brugger et al. Jun 2003 B2
6589482 Brugger et al. Jul 2003 B1
6595943 Burbank Jul 2003 B1
6623470 Munis et al. Sep 2003 B2
6627164 Wong Sep 2003 B1
6638477 Treu et al. Oct 2003 B1
6638478 Treu et al. Oct 2003 B1
6649063 Brugger et al. Nov 2003 B2
6653841 Koerdt et al. Nov 2003 B1
6673314 Burbank et al. Jan 2004 B1
6695803 Robinson et al. Feb 2004 B1
6702561 Stillig et al. Mar 2004 B2
6730266 Matson et al. May 2004 B2
6743193 Brugger et al. Jun 2004 B2
6764460 Dolecek et al. Jul 2004 B2
6773412 O'Mahony et al. Aug 2004 B2
6818196 Wong Nov 2004 B2
6830553 Burbank et al. Dec 2004 B1
6841172 Ash Jan 2005 B1
6852090 Burbank et al. Feb 2005 B2
6872346 Stillig Mar 2005 B2
6878283 Thompson Apr 2005 B2
6899691 Bainbridge et al. May 2005 B2
6923782 O'Mahony et al. Aug 2005 B2
6955655 Burbank et al. Oct 2005 B2
6958049 Ash Oct 2005 B1
6960179 Gura Nov 2005 B2
6960328 Bortun et al. Nov 2005 B2
6979309 Burbank et al. Dec 2005 B2
7004924 Brugger et al. Feb 2006 B1
7033498 Wong Apr 2006 B2
7040142 Burbank May 2006 B2
7087033 Brugger et al. Aug 2006 B2
7101519 Wong Sep 2006 B2
7112273 Weigel et al. Sep 2006 B2
7115095 Eigler et al. Oct 2006 B2
7135156 Hai et al. Nov 2006 B2
7144386 Korkor et al. Dec 2006 B2
7147613 Burbank et al. Dec 2006 B2
7169303 Sullivan et al. Jan 2007 B2
7175809 Gelfand et al. Feb 2007 B2
7214312 Brugger et al. May 2007 B2
7226538 Brugger et al. Jun 2007 B2
7241272 Karoor et al. Jul 2007 B2
7252767 Bortun et al. Aug 2007 B2
7267658 Treu et al. Sep 2007 B2
7273465 Ash Sep 2007 B2
7276042 Polaschegg et al. Oct 2007 B2
7300413 Burbank et al. Nov 2007 B2
7309323 Gura et al. Dec 2007 B2
7337674 Burbank et al. Mar 2008 B2
7338460 Burbank et al. Mar 2008 B2
7347849 Brugger et al. Mar 2008 B2
7494590 Felding et al. Feb 2009 B2
7648476 Bock et al. Jan 2010 B2
7713226 Ash et al. May 2010 B2
7780619 Brugger et al. Aug 2010 B2
7794141 Perry et al. Sep 2010 B2
7873489 Dolgos et al. Jan 2011 B2
7886611 O'Mahony et al. Feb 2011 B2
7901376 Steck et al. Mar 2011 B2
7922898 Jonsson et al. Apr 2011 B2
7922899 Vasta et al. Apr 2011 B2
7981280 Carr et al. Jul 2011 B2
7998101 Ash Aug 2011 B2
8021319 Delnevo et al. Sep 2011 B2
8034235 Rohde et al. Oct 2011 B2
8062513 Yu et al. Nov 2011 B2
8066658 Karoor et al. Nov 2011 B2
8070707 Gelfand et al. Dec 2011 B2
8075509 Molducci et al. Dec 2011 B2
8078333 Kienman et al. Dec 2011 B2
8105260 Tonelli et al. Jan 2012 B2
20020068364 Arai et al. Jun 2002 A1
20020085951 Gelfand et al. Jul 2002 A1
20030128125 Burbank et al. Jul 2003 A1
20050070837 Ferrarini et al. Mar 2005 A1
20050131332 Kelly et al. Jun 2005 A1
20050133439 Blickhan Jun 2005 A1
20060122552 O'Mahony Jun 2006 A1
20070112297 Plahey et al. May 2007 A1
20070158249 Ash Jul 2007 A1
20070158268 DeComo Jul 2007 A1
20070161113 Ash Jul 2007 A1
20070213654 Lundtveit et al. Sep 2007 A1
20080041136 Kopelman et al. Feb 2008 A1
20080041792 Crnkovich et al. Feb 2008 A1
20080065006 Roger et al. Mar 2008 A1
20080149563 Ash Jun 2008 A1
20080195021 Roger et al. Aug 2008 A1
20080195060 Roger et al. Aug 2008 A1
20080230450 Burbank et al. Sep 2008 A1
20090079578 Dvorsky et al. Mar 2009 A1
20090080757 Roger et al. Mar 2009 A1
20090082646 Bouton Mar 2009 A1
20090082647 Busby Mar 2009 A1
20090082649 Muller et al. Mar 2009 A1
20090082653 Rohde Mar 2009 A1
20090082676 Bennison Mar 2009 A1
20090095679 Demers et al. Apr 2009 A1
20090105627 Rohde Apr 2009 A1
20090113335 Sandoe et al. Apr 2009 A1
20090312694 Bedingfield et al. Dec 2009 A1
20100312161 Jonsson et al. Dec 2010 A1
20100326916 Wrazel et al. Dec 2010 A1
20110000830 Ikeda Jan 2011 A1
20110009799 Mullick et al. Jan 2011 A1
20110028881 Basaglia Feb 2011 A1
20110028882 Basaglia Feb 2011 A1
20110041928 Volker Feb 2011 A1
20110046533 Stefani et al. Feb 2011 A1
20110054352 Ko et al. Mar 2011 A1
20110092907 Krogh et al. Apr 2011 A1
20110093294 Elahi et al. Apr 2011 A1
20110098545 Ross et al. Apr 2011 A1
20110098624 McCotter et al. Apr 2011 A1
20110098625 Masala et al. Apr 2011 A1
20110098635 Helmore et al. Apr 2011 A1
20110105877 Wilt et al. May 2011 A1
20110105981 Wagner et al. May 2011 A1
20110105983 Kelly et al. May 2011 A1
20110105984 Patel et al. May 2011 A1
20110106002 Helmore et al. May 2011 A1
20110106047 Burbank et al. May 2011 A1
20110106466 Furmanski et al. May 2011 A1
20110107251 Guaitoli et al. May 2011 A1
20110108482 Lovell May 2011 A1
20110125073 Rambod et al. May 2011 A1
20110126714 Brugger et al. Jun 2011 A1
20110132838 Curtis et al. Jun 2011 A1
20110132841 Rohde et al. Jun 2011 A1
20110137224 Ibragimov Jun 2011 A1
20110137264 Chelak Jun 2011 A1
20110139704 Choi et al. Jun 2011 A1
20110140896 Menzel Jun 2011 A1
20110141116 Dalesch et al. Jun 2011 A1
20110152739 Roncadi et al. Jun 2011 A1
20110155657 Collins et al. Jun 2011 A1
20110160649 Pan Jun 2011 A1
20110166507 Childers et al. Jul 2011 A1
20110168614 Pouchoulin et al. Jul 2011 A1
20110171713 Bluchel et al. Jul 2011 A1
20110189048 Curtis et al. Aug 2011 A1
20110208072 Pfeiffer et al. Aug 2011 A1
20110208106 Levin et al. Aug 2011 A1
20110213289 Toyoda et al. Sep 2011 A1
20110218475 Brugger et al. Sep 2011 A1
20110218487 Shang et al. Sep 2011 A1
20110226680 Jonsson et al. Sep 2011 A1
20110230814 Kopperschmidt et al. Sep 2011 A1
20110237997 Beden et al. Sep 2011 A1
20110237998 Wariar et al. Sep 2011 A1
20110240537 Ferrarini et al. Oct 2011 A1
20110240555 Ficheux et al. Oct 2011 A1
20110269167 Bene Nov 2011 A1
20110272352 Braig Nov 2011 A1
20110275984 Biewer et al. Nov 2011 A1
20110284464 Roncadi et al. Nov 2011 A1
20110297593 Kelly et al. Dec 2011 A1
20110297598 Lo et al. Dec 2011 A1
20110297599 Lo et al. Dec 2011 A1
20110300010 Jarnagin et al. Dec 2011 A1
20110300230 Peterson et al. Dec 2011 A1
20110303588 Kelly et al. Dec 2011 A1
20110303590 Childers et al. Dec 2011 A1
20110303598 Lo et al. Dec 2011 A1
20110309019 Ahrens Dec 2011 A1
20110315611 Fulkerson et al. Dec 2011 A1
20120010554 Vantard et al. Jan 2012 A1
20120018377 Tsukamoto Jan 2012 A1
20120018378 Kelly et al. Jan 2012 A1
20120022440 Childers et al. Jan 2012 A1
20120029324 Akonur et al. Feb 2012 A1
20120029937 Neftel et al. Feb 2012 A1
20120031826 Childers et al. Feb 2012 A1
20120035534 Yu et al. Feb 2012 A1
20120037550 Childers et al. Feb 2012 A1
20120043279 Kelly et al. Feb 2012 A1
20120065567 Zarate Mar 2012 A1
20120075266 Shimizu et al. Mar 2012 A1
Foreign Referenced Citations (2)
Number Date Country
2009073567 Jun 2009 WO
2010114932 Jul 2010 WO
Non-Patent Literature Citations (39)
Entry
Renal Solutions, Inc., “The Allient Sorbent Hemodialysis System Operator Manual”, RSI Part No. 207460, Revision C, 2008.
Reyes et al., “Acid-Base Derangements During Sorbent Regenerative Hemodialysis in Mechanically Ventilated Patients”, Critical Care Medicine, vol. 19, No. 4, 1991, 554-559 (col. 2, lines 17-22).
Fresenius AG, “Acumen Acute Dialysis Machine Operating Instructions”, Version 1.0, May 1996.
Cobe Laboratories, Inc., “CentrySystem 3 Dialysis Control Unit Operators Manual”, Sep. 1988.
Renal Solutions, Inc., “The Allient Sorbent Hemodialysis System Home User Manual”, 2006.
Renal Solutions, Inc., “The Allient Sorbent Hemodialysis System Operator Manual”, RSI Part No. 206948, Revision G, 2008.
Fresenius USA, Inc., “Fresenius 2008H Hemodialysis Machine”, Part No. 490005, Revision H, 1994-2001.
Renal Solutions, Inc., 510(K) for the SORB+ and HISORB+ Cartridges, Mar. 31, 2003.
CD Medical, Inc., “Operator's Manual Drake Willock 480 Ultrafiltration Control Single Patient Delivery System”, 1988.
Renal Solutions, Inc., “Dialysate Tubing Set and Dialysate Reservoir Bag for the Allient Sorbent Hemodialysis System”, Instructions, 2004.
NxStage Medical, Inc., “NxStage System One User's Guide”, Software Version 4.3, Part 1 through Part 6-20, 2006.
NxStage Medical, Inc., “NxStage System One User's Guide”, Software Version 4.3, Part 6-20 through Part C-17, 2006.
Renal Solutions, Inc., 510K for the Allient Sorbent Hemodialysis System, Dec. 17, 2004.
Manns et al., “The acu-men: A New Device for Continuous Renal Replacement Therapy in Acute Renal Failure”, Kidney International, vol. 54 (1998), 268-274.
REDY® 2000 Operator's Manual (1991) (Sorbent cartridge-based hemodialysis system).
REDY® 2000 Service Manual (1989) (Sorbent cartridge-based hemodialysis system).
Seratron™ Dialysis Control System Operations Manual (cumulative 1980).
Ward et al., “Sorbent Dialysis Regenerated Dialysis Delivery Systems”, Peritoneal Dialysis Bulletin, Chapter 8, 3(2): S41-S48 (Apr.-Jun. 1983).
Anthony J. Wing et al., “Dialysate Regeneration”, Replacement of Renal Function by Dialysis, Chapter 17, 323-340 (William Drukker et al., eds., Martinus Nijhoff Publishers, 2nd ed., 1983).
Fresenius AG, “Acumen Acute Dialysis Machine Brief Operating Instructions”, May 1996.
Renal Solutions, Special 510(k) Device Modification, Allient Sorbent Hemodialysis System, Mar. 15, 2007.
Renal Solutions, 510(K), Allient Sorbent Hemodialysis System, Dec. 2004.
Renal Solutions, Inc., Portions of 510(k) Allient Sorbent Hemodialysis System (Sections A-I), Dec. 17, 2004.
Renal Solutions, Inc., Portions of 510(k) Allient Sorbent Hemodialysis System (Allient Main Controller Software Architecture Overview), Renal Solutions, Inc., Dec. 17, 2004.
Renal Solutions, Inc., Portions of 510(k) Allient Sorbent Hemodialysis System (Sections M.3 and M.4), Renal Solutions, Inc., Dec. 17, 2004.
Fresenius USA, Inc., Portions of Operator's Manual, Fresenius 2008H, Hemodialysis Machine, (Section 1), 2001, pp. 1-27.
Fresenius USA, Inc., Portions of Operator's Manual, Fresenius 2008H, Hemodialysis Machine, (Sections 2.1 to 2.6), 2001, pp. 29-54.
Fresenius USA, Inc., Portions of Operator's Manual, Fresenius 2008H, Hemodialysis Machine, (Sections 2.8 to 2.15), 2001, pp. 55-75.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Home User Manual, 2006, Chapters 1-3.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Home User Manual, 2006, Chapters 4.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Home User Manual, 2006, Chapters 5 to end.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual, 2008, Chapters 1 to 2.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual, 2008, Chapter 3.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual, 2008, Chapter 4, 4-1 to 4-33.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual, 2008, Chapter 4, 4-34 to 4-69.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual, 2008, Chapter 5.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual Model 1500, 2008, Chapters 1 to 2.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual Model 1500, 2008, Chapter 3, 3-2 to 3-30.
Renal Solutions, Portions of the Allient Sorbent Hemodialysis System, Operator Manual Model 1500, 2008, Chapter 3, 3-31 to 3-70.
Related Publications (1)
Number Date Country
20100234786 A1 Sep 2010 US
Provisional Applications (1)
Number Date Country
61151912 Feb 2009 US