Combined extracorporeal and drug delivery system and method

Abstract

To provide a favorable combined extracorporeal and drug delivery system and method.SOLUTION: An extracorporeal and drug delivery system includes: (i) a renal failure therapy machine operable with a blood filter in fluid communication with an arterial line and a venous line, the machine including (a) an effluent pump for pumping an effluent from the blood filter at an effluent flowrate, and at least one of (b) a dialysis fluid pump for pumping a dialysis fluid to the blood filter at a dialysis fluid flowrate, (c) a predilution pump for pumping a replacement fluid into the arterial line at a predilution flowrate, and (d) a postdilution pump for pumping the replacement fluid into the venous line at a postdilution flowrate; (ii) an infusion pump operable to deliver an intravenous ("IV") drug to the patient at an IV drug flowrate; and (iii) a coordinating logic implementor configured to adjust the IV drug flowrate based on an amount of the IV drug removed via the effluent flowrate.SELECTED DRAWING: Figure 1

Description

[Background technology]

[0001] (Priority Claim) This application claims priority to and benefit of U.S. Provisional Application No. 62 / 946,205, filed December 10, 2019, and entitled "Combined Extracorporeal and Drug Delivery System and Method," the entire contents of which are incorporated herein by reference.

[0002] Acute kidney injury ("AKI") is more common than most people realize and is particularly underrecognized among hospitalized patients in some countries. Worldwide, 20 percent of hospitalized patients are reported to have AKI. A larger number of intensive care unit ("ICU") patients have AKI, and 15-25 percent of such patients receive some form of renal replacement therapy ("RRT"). Approximately 27 percent of pediatric and young adult ICU patients develop AKI within the first week after admission.

[0003] The main contributing factors to AKI include septic shock (approximately 47% of cases), major surgery (approximately 34% of cases), cardiogenic shock (approximately 27% of cases), hypovolemia (approximately 25% of cases), drug induction (approximately 19% of cases), hepatorenal syndrome (approximately 6% of cases), and obstructive uropathy (approximately 3% of cases).

[0004] RRT for patients with AKI includes both intermittent hemodialysis ("IHD") and continuous renal replacement therapy ("CRRT"). IHD may treat patients, for example, every other day for 3-4 hours. CRRT instead treats patients continuously using much slower blood and therapeutic fluid flow rates. Some studies have shown that CRRT is preferable to IHD for treating AKI. For example, fluid accumulation after several days in the hospital may be lower for patients receiving CRRT than for IHD. In addition, CRRT may be preferable to IHD in terms of the frequency with which patients ultimately develop chronic kidney disease ("CKD"); i.e., patients treated with CRRT are less likely to develop CKD compared to patients treated with IHD.

[0005] CRRT is performed using a CRRT machine. CRRT machines perform different types of CRRT therapies, such as slow continuous ultrafiltration ("SCUF") for fluid removal only, continuous venovenous hemodialysis ("CVVHD"), continuous venovenous hemodiafiltration ("CVVHDF"), and continuous venovenous hemofiltration ("CVVH"). CRRT machines may also perform other types of therapies, such as therapeutic plasma exchange ("TPE"), typically involving a plasma filter and multiple indications, for autoimmune diseases, etc., hemoperfusion involving an adsorption device, MARS therapy for liver support, and extracorporeal CO2 removal ("ECCO2R") using an oxygenator for pulmonary support, etc. CRRT machines also allow for different types of anticoagulation modalities, such as systemic anticoagulation (e.g., heparin) and regional citrate anticoagulation ("RCA").

[0006] Hospitalized patients with AKI often require multiple medications to treat other illnesses, delivered at precise time intervals and concentrations to ensure proper recovery. Such patients are therefore simultaneously connected to CRRT or IHD machines. Both machines remove blood from the patient and route it through filters, removing solutes, thereby upsetting the concentrations or pharmacokinetics of other therapies, drugs, or solutions being administered to the patient during the same hospital stay.

[0007] To compensate for the effects of essential extracorporeal therapies, physicians must manually calculate changes as one therapy is added or changed, potentially resulting in under- or over-delivery of medication therapy and risk to the patient. Improved overall prescription plans for treating hospitalized patients with AKI are therefore needed. Summary of the Invention [Means for solving the problem]

[0008] This disclosure describes a combined extracorporeal and drug delivery system and method that provides a coordination logic implementer that coordinates the operation of a CRRT or IHD machine (e.g., a chronic hemodialysis machine) and one or more infusion pumps to simultaneously deliver drugs to the same patient. The synchronized operations include (i) electronically and / or data-connecting all infusion and extracorporeal devices treating the patient, (ii) registering treatment settings, including blood flow rate, treatment fluid flow rate, fluid removal rate, drug type, and dosage for the drug, (iii) providing drug-related decision support to the prescribing physician for applying and targeting dosage according to generally accepted literature guidelines and taking into account patient characteristics, disease type, and condition, (iv) calculating actual dosage to reach the desired dosage and making adjustments, if necessary, to maintain the desired dosage over time, and (v) (ii) communicating flow rate or adjustment information to an operator for approval or transmitting the information to connected infusion and extracorporeal devices to automatically make adjustments to administer drugs and / or therapeutic fluids to the patient; and (iii) optionally, synchronizing with associated hospital IT systems, such as electronic medical record databases, medical monitoring, telemedicine, or operational platforms, to report therapeutic and other data, such as treatment results, type, and dose of delivered drug, caregiver notes, e.g., patient subjectivity, presence of septic or infectious conditions, and the like. Decision support for target doses may include, for example, indications of the patient's risk and probability of future conditions, e.g., regarding blood pressure changes, fluid overload, and / or cardiac problems. In this manner, synchronized operation may provide value in addition to coordination between renal failure and infusion pump operation.

[0009] Intravenous ("IV") medications delivered during CRRT or IHD therapy may include any type of antibiotic, such as vancomycin, gentamicin, cefepime, piperacillin, tazobactam, ceftazidime, avibactam, cefazolin, aztreonam, nafcillin, oxacillin, etc. Other medications include meropenem, cefepime, and fluconazole. Other medications whose dosages are overridden by renal failure therapy and therefore benefit from being synchronized with renal failure flow rates according to the present disclosure include any type of resuscitation fluid medication, systemic anticoagulant medications such as heparin or citrate, vasopressors, electrolytes, trace elements, nutritional supplements, anticonvulsants, antifungals, antineoplastic agents, neuromuscular blockers, analgesics, and / or immunosuppressants. Any medication that may be administered in combination with CRRT or IHD therapy is contemplated for the present systems and methods.

[0010] In one embodiment, the collaboration logic implementer of the present disclosure is desirably capable of interfacing with existing CRRT machines, IHD machines, and infusion pumps (including, but not limited to, large volume infusion pumps (“LVPs”), syringe pumps, bladder pumps, infusion pumps, and any other type of IV drug pump) such that the collaboration logic implementer is located external to each of the machines, e.g., resting on, connected to, or adjacent to the CRRT or IHD machine. In one preferred embodiment, the collaboration logic implementer is in electronic and / or data communication with the CRRT or IHD machine, e.g., via a wired or wireless connection. In an alternative embodiment, the collaboration logic implementer may be provided as part of, and therefore located within, the overall control unit of the CRRT or IHD machine.

[0011] In various embodiments, the collaboration logic implementer may or may not be in electronic and / or data communication with one or more infusion pumps, depending, for example, on the pump's communication capabilities. The collaboration logic implementer may be capable of wired or wireless communication with all of the infusion pumps, some of the infusion pumps, or none of the infusion pumps. When infusion pumps are connected to the collaboration logic implementer, they may be controlled automatically or in response to confirmation and configuration by an operator. When infusion pumps are not connected to the collaboration logic implementer, they may be controlled manually in response to confirmation and configuration by an operator, who may view recommendations either on the collaboration logic implementer or on a display screen of the CRRT or IHD machine.

[0012] The coordination logic implementer coordinates the operation of the CRRT or IHD machine and the infusion pump in several ways. In one method, the system considers the flow rate of IV drugs in the prescribed fluid removal or ultrafiltration calculation. The goal of CRRT or IHD therapy may be to remove fluid from the patient so that a patient suffering from AKI does not gain fluid over time. IV drugs can significantly contribute to the overall amount of fluid delivered to the patient. The IV delivery volume is considered when determining the instantaneous effluent flow rate removed by the CRRT or IHD machine. The coordination logic implementer also keeps track of when IV drugs are being delivered so that it can command higher effluent flow rates during drug delivery and lower effluent flow rates when drug delivery is discontinued. The coordination logic implementer repeats this analysis for each IV drug being delivered during CRRT or IHD therapy and combines the results when two or more drug deliveries overlap.

[0013] Another way in which the coordination logic implementer coordinates the operation of the CRRT or IHD machine and the infusion pump is to adjust one or more infusion pump administration rates to compensate for a portion of the medication intended for the patient, instead of being removed from the extracorporeal circuit as effluent via CRRT or IHD therapy. In one embodiment, an estimate is made regarding the percentage of medication in the effluent that will be removed. The estimate may be made using one or more assumptions, such as that the effluent is completely uniform with an estimate of the patient's blood volume, which may be estimated based on the patient's weight. In an alternative embodiment, the patient's blood volume may be determined prior to therapy and entered into the coordination logic implementer, for example, via a user interface associated with the coordination logic implementer, or via a user interface on the CRRT or IHD machine, which in turn relays the blood volume to the coordination logic implementer via a wired or wireless connection.

[0014] If the estimated drug percentage is, for example, 1 percent, the collaboration logic implementer may either increase the flow rate associated with the prescribed drug by 1 percent or recommend to the operator a flow rate set point that is 1 percent higher than the flow rate associated with the prescribed dosage. The increased IV drug flow rate, if implemented automatically or approved by the operator, may be ignored if it has a negligible effect on the effluent flow rate, taking into account the adjustments discussed above. Increasing the IV drug flow rate in this way compensates for the amount of IV drug removed via effluent removal of the CRRT or IHD machine.

[0015] In determining whether to adjust the flow rate for an IV drug, the coordination logic implementer may take into account whether the CRRT or IHD machine is actually running. For example, if the IV drug is delivered before or after CRRT or IHD treatment, the coordination logic implementer will not adjust the IV drug flow rate from the flow rate associated with the prescribed dosage. If the CRRT or IHD machine is stopped for any reason during treatment, e.g., due to an alarm, alert, supply bag change, etc., the coordination logic implementer is notified of the stoppage and may respond in multiple alternative ways, for example, (i) automatically reducing or suggesting reducing the IV drug flow rate to the flow rate associated with the prescribed dosage for the duration of the stoppage, (ii) maintaining the IV drug flow rate at an elevated rate during the stoppage but counting the additional flow rate as part of the administered dosage so that the overall drug delivery time can be reduced to meet the prescribed dosage, or (iii) completely shutting off the IV drug flow rate, e.g., if the drug is intended to accompany CRRT or IHD treatment, e.g., if the drug is an anticoagulant, phosphorus supplement, and the like.

[0016] As an alternative to, or in addition to, adjusting the IV pump flow rate so that the actual IV dose received by the patient meets the prescribed dose for the patient despite IV drug loss due to waste removal from renal failure therapy, the present systems and methods also contemplate adjusting IV drug concentrations. For example, the actual concentration of one or more IV drugs may be increased from the prescribed concentration to account for the amount of drug loss via waste removal so that the actual amount of drug absorbed by the patient meets the expected prescribed amount of drug absorbed by the patient.

[0017] The present systems and methods are contemplated to compensate for (e.g., reduce) increases in IV drug flow rate or concentration due to hemofilter clogging over time, which may reduce the amount of IV drug removal for a set effluent removal flow rate. The amount of clogging may be estimated by a pressure increase, e.g., effluent line pressure increase, correlated, e.g., experimentally, in a lookup table with a variable amount of IV drug removal reduction. The disclosed system receives increasing pressure signals over the course of treatment, invokes the lookup table, and adjusts (e.g., reduces) the percentage increase in IV drug flow rate and / or concentration accordingly.

[0018] As a further alternative, the IV fluid flow rate or concentration may be adjusted based on the amount of dilution due to the substitution fluid flow rate and / or dialysis fluid flow rate, as opposed to the waste fluid flow rate, where the adjustment may be based on the relationship between the IV fluid flow rate, substitution fluid flow rate, and / or dialysis fluid flow rate.

[0019] In another aspect of the systems and methods of the present disclosure, the chemical composition of the IV fluid, substitution fluid, and / or dialysis fluid is analyzed and overlapping chemicals or components are compared to acceptable levels to determine whether the chemical composition of the IV fluid should be adjusted or whether the combined chemical or component dosage is acceptable. If it is determined that the IV drug components need to be modified, the system outputs a revised formulation for approval and subsequent compounding, for example, by the hospital pharmacy.

[0020] At the end of, or at any suitable time throughout, the CRRT or IHD treatment and drug delivery, it is contemplated that any or all relevant treatment data may be transmitted to a hospital's electronic medical record ("EMR") database, which stores the file for the patient. To that end, it is contemplated that the collaboration logic implementer may communicate via wired or wireless communication with a hospital server or other computer storage device for the EMR database, data warehouse, or data lake.

[0021] In a typical hospital or emergency room setting, there will likely be only one CRRT or IHD machine and one or more associated infusion pumps. In such cases, there will be a dedicated coordination logic implementer for the arrangement of machines, which acts as a hub to the spoke medical machines. For example, in a more clinical setting using a hemodialysis machine for IHD, where IV drug delivery can still occur, it is considered to provide a coordination logic implementer dedicated to two or more CRRT or IHD machines and associated infusion pumps. Here, the coordination logic implementer could (i) again be a hub to all of the spoke medical machines, including the CRRT or IHD machine, or (ii) be a higher-level hub to each of the spoke CRRT or IHD machines in the cluster, which in turn are lower-level hubs to their associated spoke infusion pumps. The latter arrangement may be preferable when shorter-range wireless communication is provided.

[0022] In a first aspect of the present disclosure, which may be combined with any other aspect enumerated herein, or portions thereof, without in any way limiting the scope of the present invention in light of the disclosure herein, a renal failure therapy machine operable with (i) a hemofilter in fluid communication with an arterial line for removing blood from a patient to the hemofilter and a venous line for returning blood from the filter to the patient, the machine comprising: (a) a waste pump positioned and arranged to pump waste fluid from the hemofilter at an effluent flow rate; and (b) a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate. a pre-dilution pump positioned and arranged to pump substitution fluid into the arterial line at a pre-dilution flow rate, or a post-dilution pump positioned and arranged to pump substitution fluid into the venous line at a post-dilution flow rate; (ii) an infusion pump operable to deliver intravenous ("IV") medication to the patient at an IV medication flow rate; and (iii) a coordination logic implementer configured to determine an adjustment for the IV medication flow rate based on the amount of IV medication removed via the waste flow rate.

[0023] In a second aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, a renal failure therapy machine is a continuous kidney replacement machine, which includes a waste pump and at least two of a dialysis fluid pump, a pre-dilution pump, or a post-dilution pump.

[0024] In a third aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, a renal failure therapy machine is a hemodialysis machine, which includes a waste pump and a dialysis fluid pump.

[0025] In a fourth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, a collaboration logic implementer is provided separately from the renal failure therapy machine and the infusion pump, and the collaboration logic implementer is in wired or wireless communication with at least the renal failure therapy machine.

[0026] In a fifth aspect of the present disclosure, which may be combined with the fourth aspect in combination with any other aspect or portion thereof enumerated herein, the system is configured such that a total patient fluid input is communicated to or determined for the collaboration logic implementer by the collaboration logic implementer to determine an adjustment for the IV drug flow rate based on the amount of IV drug removed via the waste flow rate.

[0027] In a sixth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the system is configured to at least one of (i) automatically implement an adjustment for an IV drug flow rate in an infusion pump, or (ii) display the adjustment for implementation in one or more of a renal failure therapy machine, an infusion pump, or a collaborative logic implementer.

[0028] In a seventh aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaboration logic implementer is integrated into a renal failure therapy machine.

[0029] In an eighth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, an infusion pump includes a first infusion pump, the IV drug is a first IV drug, the IV drug flow rate is a first IV drug flow rate, and a second infusion pump operable to deliver a second IV drug to a patient at a second IV drug flow rate, and the collaboration logic implementer is configured to determine an adjustment for the second IV drug flow rate based on an amount of the second IV drug removed via the waste flow rate.

[0030] In a ninth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the system is configured such that the effluent flow rate may take into account adjustments for the IV drug flow rate and at least one of the dialysis fluid flow rate, the pre-dilution flow rate, or the post-dilution flow rate.

[0031] In a tenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the system is configured such that the waste flow rate takes into account a prescribed patient fluid loss rate.

[0032] In an eleventh aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the amount of IV drug removed via the waste flow rate comprises a percentage of the IV drug in the waste flow rate.

[0033] In a twelfth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaborative logic implementer is configured to determine an adjustment for the IV drug flow rate based on the amount of IV drug removed via the waste flow rate and in response to an estimate of the patient's blood volume.

[0034] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaborative logic implementer is further configured to take into account blood filter patency or clogging when determining an adjustment for the IV drug flow rate.

[0035] In a fourteenth aspect of the present disclosure, which may be combined with the thirteenth aspect in combination with any other aspect or portion thereof enumerated herein, the system is configured such that when an amount of IV drug is removed via the waste flow rate, an adjustment is made to cause the IV drug flow rate to meet the prescribed IV drug flow rate.

[0036] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof listed in this specification, the renal failure therapy machine is a first renal failure therapy machine, the infusion pump includes a second renal failure therapy machine, the first infusion pump being associated with a second infusion pump, and the collaborative logic implementer is configured to determine an adjustment for an IV drug flow rate of the second infusion pump.

[0037] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaborative logic implementer is configured to alternatively or additionally determine an adjustment to the concentration of the IV drug based on the amount of IV drug removed via the waste flow rate.

[0038] In a seventeenth aspect of the present disclosure, which may be combined with the sixteenth aspect in combination with any other aspect or portion thereof enumerated herein, the system is configured for implementation to display concentration adjustments to one or more of a renal failure therapy machine, an infusion pump, or a collaborative logic implementer.

[0039] In an eighteenth aspect of the present disclosure, which may be combined with the sixteenth aspect in combination with any other aspect or portion thereof enumerated herein, the system is configured such that as the amount of IV drug is removed via the waste flow rate, concentration adjustment causes the IV drug dose received by the patient to meet the prescribed IV drug dose.

[0040] In a nineteenth aspect of the present disclosure, which may be combined with the sixteenth aspect in combination with any other aspect or portion thereof enumerated herein, the infusion pump includes a first infusion pump, the IV drug is a first IV drug, which includes a second infusion pump operable to deliver a second IV drug to the patient, and the collaborative logic implementer is configured to determine an adjustment to the concentration of the second IV drug based on an amount of the second IV drug removed via the waste flow rate.

[0041] In a twentieth aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaboration logic implementer is configured to, alternatively or in addition, determine an adjustment to the flow rate and / or concentration of an IV drug based on an amount of dilution of the IV drug due to at least one of a dialysis fluid flow rate, a pre-dilution flow rate, or a post-dilution flow rate.

[0042] In a 21st aspect of the present disclosure, which may be combined with the 20th aspect in combination with any other aspect or portion thereof enumerated herein, the amount of dilution is based on a relationship between the IV drug flow rate and at least one of the dialysis fluid flow rate, the pre-dilution flow rate, or the post-dilution flow rate.

[0043] In a twenty-second aspect of the present disclosure, which may be combined with any other aspect or portion thereof enumerated herein, the collaboration logic implementer is configured to alternatively or additionally determine whether a component of an IV drug is present in at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid, and, if applicable, determine whether a formulation adjustment should be made to the IV drug.

[0044] In a twenty-third aspect of the present disclosure, which may be combined with the twenty-second aspect in combination with any other aspect or portion thereof enumerated herein, the formulation adjustment comprises reducing or eliminating a component in the IV drug.

[0045] In a twenty-fourth aspect of the present disclosure, any of the structures, functionality, and alternatives associated with any of Figures 1-4 may be combined with any of the structures, functionality, and alternatives associated with any other of Figures 1-4.

[0046] In light of the present disclosure and the above aspects, it is therefore an advantage of the present disclosure to provide a combined extracorporeal and drug delivery system and method that reduces the workload on physicians, nurses, and caregivers.

[0047] Another advantage of the present disclosure is to provide a combined extracorporeal and drug delivery system and method that improves fluid removal accuracy.

[0048] A further advantage of the present disclosure is to provide a combined extracorporeal and drug delivery system and method that improves drug dosage delivery accuracy.

[0049] Yet another advantage of the present disclosure is that it provides a combined extracorporeal and drug delivery system and method that can be implemented with existing equipment.

[0050] A still further advantage of the present disclosure is to provide a combined extracorporeal and drug delivery system and method for modifying IV drug flow rate and / or concentration.

[0051] Yet another advantage of the present disclosure is to provide a combined extracorporeal and drug delivery system and method that modifies IV drug flow rate or concentration based on effluent removal or dilution due to, for example, substitution and / or dialysis fluid flow rate.

[0052] A still further advantage of the present disclosure is to provide a combined extracorporeal and drug delivery system and method that takes into account overlapping chemicals or components in IV drugs and replacement and / or dialysis fluids and identifies whether the amount of overlapping fluid in the IV drug is acceptable, should be reduced, or should be eliminated.

[0053] Additional features and advantages of the disclosed devices, systems, and methods will be described in, and apparent from, the following detailed description and figures. The features and advantages described herein are not all-inclusive; in particular, many additional features and advantages will become apparent to those skilled in the art in light of the figures and description. Also, any particular embodiment may not possess all of the advantages enumerated herein. Furthermore, it should be noted that the terminology used herein has been selected primarily for readability and instructional purposes, and is not intended to limit the scope of the inventive subject matter. The present specification also provides, for example, the following items: (Item 1) 1. An extracorporeal drug delivery system comprising: 1. A renal failure therapy machine operable with a blood filter in fluid communication with an arterial line for removing blood from a patient to a blood filter and a venous line for returning blood from the filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient at an IV medication flow rate; a collaboration logic implementer configured to determine an adjustment for the IV medication flow rate based on an amount of the IV medication removed via the waste flow rate; and An extracorporeal drug delivery system comprising: (Item 2) 2. The extracorporeal drug delivery system of claim 1, wherein the renal failure therapy machine is a continuous kidney replacement machine and includes the waste pump and at least two of the dialysis fluid pump, the pre-dilution pump, or the post-dilution pump. (Item 3) 2. The extracorporeal drug delivery system of item 1, wherein the renal failure therapy machine is a hemodialysis machine and includes the waste pump and the dialysis fluid pump. (Item 4) 2. The extracorporeal drug delivery system of claim 1, wherein the collaboration logic implementer is provided separately from the renal failure therapy machine and the infusion pump, and the collaboration logic implementer communicates with at least the renal failure therapy machine via wired or wireless communication. (Item 5) A total patient fluid input is communicated to or determined by the collaboration logic implementer to determine an adjustment for the IV drug flow rate based on the amount of the IV drug removed via the waste flow rate. 5. The extracorporeal drug delivery system according to item 4, configured as follows: (Item 6) 2. The extracorporeal drug delivery system of claim 1, configured to at least one of: (i) automatically implement an adjustment to the IV drug flow rate in the infusion pump; or (ii) display the adjustment for implementation in one or more of the renal failure therapy machine, the infusion pump, or the coordination logic implementer. (Item 7) Item 1, wherein the collaboration logic implementer is integrated into the renal failure therapy machine. (Item 8) 2. The extracorporeal drug delivery system of claim 1, wherein the infusion pump is a first infusion pump, the IV drug is a first IV drug, the IV drug flow rate is a first IV drug flow rate, and the infusion pump includes a second infusion pump operable to deliver a second IV drug to the patient at a second IV drug flow rate, and the coordination logic implementer is configured to determine an adjustment for the second IV drug flow rate based on an amount of the second IV drug removed via the waste flow rate. (Item 9) 2. The extracorporeal drug delivery system of claim 1, wherein the waste flow rate is configured to account for adjustments for the IV drug flow rate and at least one of the dialysis fluid flow rate, pre-dilution flow rate, or post-dilution flow rate. (Item 10) 2. The extracorporeal drug delivery system of item 1, wherein the waste flow rate is configured to take into account a prescribed patient fluid loss rate. (Item 11) 2. The extracorporeal drug delivery system of claim 1, wherein the amount of IV drug removed via the waste flow rate comprises a percentage of the IV drug in the waste flow rate. (Item 12) 2. The extracorporeal drug delivery system of claim 1, wherein the collaboration logic implementer is configured to determine an adjustment for the IV drug flow rate based on the amount of the IV drug removed via the waste flow rate and in response to an estimate of the patient's blood volume. (Item 13) Item 10. The extracorporeal drug delivery system of item 1, wherein the collaboration logic implementer is further configured to take into account blood filter patency or clogging when determining adjustments for the IV drug flow rate. (Item 14) Item 14. The extracorporeal drug delivery system of item 13, wherein the adjustment is configured to cause the IV drug flow rate to meet the prescribed IV drug flow rate when an amount of the IV drug is removed via the waste flow rate. (Item 15) Item 10. The extracorporeal drug delivery system of item 1, wherein the renal failure therapy machine is a first renal failure therapy machine, the infusion pump is a first infusion pump, and includes a second renal failure therapy machine associated with a second infusion pump, and the collaboration logic implementer is configured to determine an adjustment for the IV drug flow rate of the second infusion pump. (Item 16) 1. An extracorporeal drug delivery system comprising: 1. A renal failure therapy machine operable with a blood filter in fluid communication with an arterial line for removing blood from a patient to a blood filter and a venous line for returning blood from the filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient; and a collaboration logic implementer configured to determine an adjustment to a concentration of the IV drug based on an amount of the IV drug removed via the waste flow rate; and An extracorporeal drug delivery system comprising: (Item 17) Item 17. The extracorporeal drug delivery system of item 16, configured for implementation to display the concentration adjustment to one or more of the renal failure therapy machine, the infusion pump, or the coordination logic implementer. (Item 18) 17. The extracorporeal drug delivery system of claim 16, wherein the concentration adjustment is configured to cause the IV drug dose received by the patient to meet the prescribed IV drug dose when the amount of IV drug is removed via the waste flow rate. (Item 19) Item 17. The extracorporeal drug delivery system of item 16, wherein the infusion pump is a first infusion pump, the IV medication is a first IV medication, and the infusion pump includes a second infusion pump operable to deliver a second IV medication to the patient, and the coordination logic implementer is configured to determine an adjustment to a concentration of the second IV medication based on an amount of the second IV medication removed via the waste flow rate. (Item 20) 1. An extracorporeal drug delivery system comprising: 1. A renal failure therapy machine operable with a blood filter in fluid communication with an arterial line for removing blood from a patient to a blood filter and a venous line for returning blood from the filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient; and a collaboration logic implementer configured to determine an adjustment to the flow rate and / or concentration of the IV drug based on an amount of dilution of the IV drug due to at least one of the dialysis fluid flow rate, the pre-dilution flow rate, or the post-dilution flow rate; An extracorporeal drug delivery system comprising: (Item 21) 21. The extracorporeal drug delivery system of claim 20, wherein the amount of dilution is based on a relationship between the IV drug flow rate and at least one of the dialysis fluid flow rate, the pre-dilution flow rate, or the post-dilution flow rate. (Item 22) 1. An extracorporeal drug delivery system comprising: 1. A renal failure therapy machine operative with a blood filter in fluid communication with an arterial line for removing blood from a patient to the blood filter and a venous line for returning blood from the filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient; and a collaboration logic implementer configured to determine whether a component of the IV drug is present in at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid, and, if applicable, determine whether a formulation adjustment should be made to the IV drug; and An extracorporeal drug delivery system comprising: (Item 23) 23. The extracorporeal drug delivery system of claim 22, wherein the formulation adjustment comprises reducing or eliminating the component in the IV drug. [Brief explanation of the drawings]

[0054] [Figure 1] FIG. 1 is a perspective view of one embodiment of the combined extracorporeal and drug delivery system of the present disclosure.

[0055] [Figure 2] FIG. 2 is a schematic diagram of one embodiment of the combined extracorporeal and drug delivery system of the present disclosure.

[0056] [Figure 3] FIG. 3 is a schematic flow chart illustrating exemplary dose correction adjustments that may be made in accordance with the combined extracorporeal and drug delivery system of the present disclosure.

[0057] [Figure 4] FIG. 4 is a schematic diagram of one embodiment of the combined extracorporeal and drug delivery system of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0058] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Referring now to the drawings, and in particular to FIG. 1 , an embodiment of a combined extracorporeal and drug delivery system 10 of the present disclosure is illustrated. System 10 includes a renal failure therapy machine 20, such as a continuous renal replacement therapy ("CRRT") machine or an intermittent supplemental hemodialysis ("IHD") machine, and intravenous ("IV") drug infusion pumps 70, 80, and / or 90. Renal failure therapy machine 20 can perform a type of renal therapy, such as, for example, arteriovenous hemofiltration, continuous arteriovenous hemodialysis, continuous arteriovenous hemodiafiltration, continuous venovenous hemofiltration, continuous venovenous hemodialysis, continuous venovenous hemodiafiltration, slow continuous ultrafiltration, hemoperfusion, therapeutic plasma exchange, leukocytapheresis, continuous ultrafiltration with periodic intermittent supplemental hemodialysis, treatment of fluid overload, congestive heart failure, drug overdose, intoxication, immune disorders, sepsis, acid imbalance, and any combination thereof.

[0059] Renal failure therapy machine 20, in the illustrated embodiment, includes a housing 22 supported by a rolling frame 24 so that renal failure therapy machine 20 can be moved or oriented to a convenient position for operation within a hospital room or intensive care unit ("ICU"). Renal failure therapy machine 20, in the illustrated embodiment, includes scales 26a...26n, which allow the weight, and therefore the volume and flow rate, of one or more fluids, such as dialysis fluid, substitution fluid, or effluent, to be determined. For example, scale 26a, in one implementation, may be used to monitor fresh dialysis fluid flow rate, while scale 26b is used to monitor effluent flow rate. Renal failure therapy machine 20 also includes an external device 28, in the illustrated embodiment, supported by housing 22, which may include, for example, a pump, a pressure sensor, an air detector, a blood leak detector, a valve, such as a tubing pinch valve, which will be discussed in further detail.

[0060] The scales 26a...26n and all sensors of the apparatus 28 output to a control unit 30, which controls all electrically operated devices 28 of the renal failure therapy machine 20. The control unit 30, in the illustrated embodiment, includes one or more processors 32, one or more memories 34, and a video card, sound card, wireless transceiver or wired interface 36, or the like. The control unit 30 communicates with the collaboration logic implementer 100 wired or wirelessly. Any wired communication discussed herein may be via, for example, Ethernet or fiber optic connections. Any wireless communication discussed herein may be via, for example, Bluetooth, WiFi, or the like. TM , Zigbee®, Z-Wave®, wireless universal serial bus ("USB"), radio frequency ("RF"), ultrasonic, photoelectric, microwave, or infrared protocols, or via any other suitable wireless communication technology.

[0061] The renal failure therapy machine 20 also includes, in the illustrated embodiment, a graphical user interface (“GUI”) 40 that allows an operator to enter data and commands into and / or receive information from the control unit 30. The GUI 40 includes a video monitor, which may also interface with a touchscreen overlay located on the video monitor for entering commands into the control unit 30. The GUI 40 may also include one or more electromechanical input devices, such as membrane switches or other buttons. The control unit 30 may also include an audio controller for playing sound files, such as alarm or alert sounds, on one or more speakers of the renal failure therapy machine 20. While the GUI 40 is illustrated as being connected to the housing 22, it is also contemplated that the GUI 40 could be separate from the control unit 30 and communicate with it wirelessly via any of the protocols described above.

[0062] Collaborative logic implementer 100, in the illustrated embodiment, includes its own control unit 110, which in the illustrated embodiment includes one or more processors 112, one or more memories 114, a video card, a sound card, and a wireless transceiver or wired interface 116 for communicating with control unit 30 of renal failure therapy machine 20 and, if enabled, the control units of IV infusion pumps 70, 80, and / or 90.

[0063] Collaborative logic implementer 100, in the illustrated embodiment, also includes a graphical user interface ("GUI") 120, which allows an operator to enter data and commands into and / or receive information from control unit 110. GUI 120 includes a video monitor, which may also interface with a touchscreen overlay located on the video monitor for entering commands into control unit 110. GUI 120 may also include one or more electromechanical input devices, such as membrane switches or other buttons. Control unit 110 may also include an audio controller for playing sound files, such as alarm or alert sounds, on one or more speakers of collaborative logic implementer 100.

[0064] Although the collaboration logic implementer 100 is illustrated as being located adjacent to the renal failure therapy machine 20, the collaboration logic implementer 100 may alternatively be located on or connected to the renal failure therapy machine 20. In a further alternative embodiment, the collaboration logic implementer 100 is integrated within the renal failure therapy machine 20, such that the control unit 110 and its software and programming are integrated into the control unit 30. However, providing the collaboration logic implementer 100 separately from the renal failure therapy machine 20 allows the collaboration logic implementer 100 to work with existing renal failure therapy machines, perhaps with a software upgrade. It is also contemplated that the collaboration logic implementer 100 may be implemented as a stand-alone device, as part of any of the medical fluid machines, and / or as third-party hardware, and / or abstracted into software in some location (such as within an EMR, edge computing, cloud service, etc.).

[0065] IV infusion pumps 70, 80, and / or 90 each include a control unit 72, 82, and 92, respectively. Control units 72, 82, and 92 may each in turn include one or more processors, one or more memories, a video card, a sound card, and a wireless transceiver or wired interface for communicating with control unit 110 of collaborative logic implementer 100. IV infusion pumps 70, 80, and / or 90 each also include one or more pump actuators 74, 84, and 94, respectively, under the control of control unit 72, 82, 92, such as peristaltic, platen, or other types of tubing or syringe pump actuators. IV infusion pumps 70, 80, and / or 90 each also include one or more graphical user interfaces (“GUIs”) 76, 86, and 96, respectively. Each GUI 76, 86, and 96 may include a video monitor, which in turn may interface with a touchscreen overlay located on the video monitor for inputting commands into control units 72, 82, and 92, respectively. Each GUI 76, 86, and 96 may also include one or more electromechanical input devices, such as membrane switches or other buttons.

[0066] The renal failure therapy machine 20 and the external infusion pumps 70, 80, and 90 each include an address, which, in one embodiment, distinguishes the machine and pump from one another from the perspective of the collaboration logic implementer 100. The address designates the pump of the renal failure therapy machine 20 and the infusion pump 70, 80, and 90 associated with a specific patient receiving AKI or other renal failure treatment. The address prevents miscommunication between multiple renal failure therapy machines 20 and associated infusion pumps 70, 80, and 90 when multiple treatments are occurring simultaneously and, for example, in close proximity to one another, e.g., in adjacent ICUs or treatment centers. The potential for miscommunication exists to a greater extent when wireless communication is used.

[0067] The addresses described above allow information to be transferred back and forth between collaboration logic implementer 100, renal failure therapy machine 20, and infusion pumps 70, 80, and 90. For example, current therapy data may be sent to collaboration logic implementer 100 from either renal failure therapy machine 20 and one or both of infusion pumps 70, 80, and 90. Collaboration logic implementer 100 may send one or more determined operating parameters to renal failure therapy machine 20 and one or more of infusion pumps 70, 80, or 90 (i) for automatic entry and activation by respective control units 30, 72, 82, or 92, and / or (ii) for display in respective GUIs 40, 76, 86, or 96 for approval or acceptance. In a further alternative embodiment, collaborative logic implementer 100 may display one or more determined actions in its GUI 120 as an alternative to, or in addition to, a display in GUI 40 , 76 , 86 , or 96 .

[0068] The following scenarios are considered: (i) a scenario in which communication exists between the collaboration logic implementer 100 and the renal failure therapy machine 20, and the system 10 is authorized to enable automatic entry and activation of one or more operating parameters transmitted from the collaboration logic implementer 100 to the renal failure therapy machine 20; (ii) a scenario in which communication exists between the collaboration logic implementer 100 and the infusion pump 70, 80, or 90, and the system 10 is authorized to enable automatic entry and activation of one or more operating parameters transmitted from the collaboration logic implementer 100 to the infusion pump 70, 80, or 90; and (iii) a scenario in which communication exists between the collaboration logic implementer 100 and the renal failure therapy machine 20, but the system 10 does not automatically enter and activate one or more operating parameters transmitted from the collaboration logic implementer 100 to the renal failure therapy machine 20 such that the one or more parameters are displayed to the operator as suggested parameters in one or more of the GUIs 40 or 120. Scenarios contemplated for system 10 and associated methodologies include (iv) a scenario in which communication exists between collaboration logic implementer 100 and infusion pump 70, 80, or 90, but system 10 is not authorized to enable automatic entry and activation of one or more operating parameters sent from collaboration logic implementer 100 to infusion pump 70, 80, or 90, such that the one or more parameters are displayed to the operator as suggested parameters in one or more GUIs 120, 76, 86, or 96; and (v) a scenario in which communication does not exist between collaboration logic implementer 100 and infusion pump 70, 80, or 90, such that one or more parameters determined by collaboration logic implementer 100 are displayed to the operator as suggested IV drug parameters in one or more GUIs 120 or 40 (of machine 20). In the final scenario (v), the prescribed dose or flow rate corresponding to the prescribed drug dose is first manually entered into the collaborative logic implementer 100 via the GUI 120 or into the renal failure therapy machine 20 via the GUI 40.

[0069] 1 further illustrates that system 10 contemplates that collaboration logic implementer 100 is configured to communicate, e.g., wired or wirelessly, with a hospital's electronic medical record ("EMR") database 150. In one embodiment, upon completion of CRRT or IHD treatment and associated medication delivery, any or all related treatment data is transmitted from collaboration logic implementer 100 to EMR database 150, which stores a file for the patient. Other treatment information, such as medications delivered, alarms, alerts, caregiver or operator notes entered during treatment, etc., may also be transmitted from collaboration logic implementer 100 to EMR database 150, e.g., with a date and time stamp.

[0070] Referring now to FIG. 2, system 10 is illustrated diagrammatically to show one embodiment of different types of fluid inputs that may affect the overall effluent flow rate determination. System 10 in FIG. 2 includes renal failure therapy machine 20, collaboration logic implementer 100, and infusion pumps 70, 80, and 90, as described in connection with FIG. 1. FIG. 2 also illustrates new dialysis fluid scale 26a and effluent scale 26b, as well as additional scales, namely, upstream pre-dilution scale 26c, downstream pre-dilution scale 26d, and post-dilution scale 26e, as described in connection with FIG. 1. Collaboration logic implementer 100 communicates with EMR database 150, as shown in FIG. 2.

[0071] Scales 26a-26e measure fluids residing in dialysis fluid container 52a, waste container 52b, upstream pre-dilution container 52c, downstream pre-dilution container 52d, and post-dilution container 52e, respectively. Containers 52a-52c form part of a disposable set 50, which is attached to housing 22 ( FIG. 1 ) of renal failure therapy machine 20 for treatment. Disposable set 50 also includes, in the illustrated embodiment, an arterial line 54 for removing blood from patient P, a venous line 56 for returning blood to patient P, and a drip chamber 58 located within venous line 56 for removing any air from the blood before returning it to patient P. A blood filter or dialyzer 60 separates arterial line 54 from venous line 56. Hemofilter or dialyzer 60 includes a blood compartment 60a and a dialysis fluid compartment 60b, separated by a semi-permeable membrane 62. An arterial line 54 leads to the blood compartment 60a, while a venous line 56 extends from the blood compartment 60a. Similarly, a new dialysis fluid line 64 extends from the dialysis fluid container 52a to the dialysis fluid compartment 60b, while a waste line 66 extends from the dialysis fluid compartment 60b to the waste container 52b.

[0072] In the embodiment of FIG. 2, the disposable set 50 also includes an upstream pre-dilution line 68c extending from the upstream pre-dilution container 52c to the arterial line 54, a downstream pre-dilution line 68d extending from the downstream pre-dilution container 52d to the arterial line 54, and a post-dilution line 68e extending from the post-dilution container 52e to the venous line 56.

[0073] FIG. 1 generalizes pumps, sensors, valves, and the like associated with housing 22 of renal failure therapy machine 20 as external devices 28. These external devices are illustrated in more detail in FIG. 2 to include fresh dialysis fluid pump 42b in communication with fresh dialysis fluid line 64, waste pump 42b in communication with waste line 66, upstream pre-dilution pump 42c in communication with upstream pre-dilution line 68c, downstream pre-dilution pump 42d in communication with downstream pre-dilution line 68d, and post-dilution pump 42e in communication with post-dilution line 68e. Additionally, a blood pump 44 is provided, which pumps blood from patient P along arterial line 54, through hemofilter 60, via venous line 56, and back to patient P. Multiple valves, such as venous valve 46, are provided. A level detector 48 is also provided for detecting the fluid level in drip chamber 58.

[0074] All pumps, valves, detectors, scales, sensors, and the like are under the control of or send output signals to control unit 30, as illustrated by the dashed lines in FIG. 2. FIG. 2 illustrates a CRRT embodiment for renal failure therapy machine 20. An IHD or hemodialysis embodiment for renal failure therapy machine 20 would be nearly identical, but instead (i) have online dialysis fluid generation and storage drains as opposed to reservoirs 26a and 26b, (ii) use different types of pumping and valving (e.g., peristaltic and pinch, as used for CRRT, or pneumatic and / or electromechanical for IHD), (iii) use volume or flow rate determination versus gravitational sensing for CRRT for fluid control and balance, and (iv) may not deliver therapy fluid to blood lines 54 or 56. CRRT therefore presents the most common scenario regarding the number of different types of fluids that can be input into the waste equations shown below, thereby providing support for IHD embodiments as well. However, it should be understood that the CRRT of system 10 need not use a substitution fluid or can have one or both of a pre-dilution and / or a post-dilution substitution fluid. In addition, the CRRT may or may not have a dialysis fluid flow rate. The CRRT of system 10 may have any combination of such fluid flow rates.

[0075] The flow rates associated with different pumping sources in FIG. 2 are illustrated, which is related to the Q BLOOD , Q for the new dialysis fluid flow rate DIAL , Q related to waste flow rate EFF , Q related to blood pre-pump flow rate (e.g., heparin anticoagulant) PBP , Q in terms of pre-dilution displacement fluid flow rate REP1 , Q in terms of the post-dilution displacement fluid flow rate REP2 , Q related to the drug flow rate of the infusion pump 70 D70 , Q related to the drug flow rate of the infusion pump 80 D80 , and Q for the drug flow rate of the infusion pump 90 D90 Including blood flow Q BLOOD Except forEFF When determining Q DIAL , Q PBP , Q REP1 , Q REP2 , Q D70 , Q D80 , and Q D90 Consider each of Q DIAL , Q PBP , Q REP1 , and Q REP2 is, in one embodiment, the prescribed patient fluid loss or ultrafiltration removal flow rate Q UF Q D70 , Q D80 , and Q D90 The drug for may be at a flow rate corresponding to the dose prescribed by a physician, or may be adjusted from the prescribed flow rate, as discussed in detail below.

[0076] The overall fluid balance equations for the system 10 in FIG. Q UF =Q EFF -[Q DIAL +Q PBP +Q REP1 +Q REP2 +Q D70 +Q D80 +Q D90 ] In one embodiment, Q UF =200ml / hour, Q DIAL =1000ml / hour, Q PBP =600ml / hour, Q REP1 = 800 ml / hr, and Q REP2 = 800 ml / hr. The drug flow rate is initially determined from the dosage prescribed by the physician. Dosage may be provided in terms such as mg / (kg of patient weight) over time, knowing the patient weight gives the g / hr, and knowing the density of the drug gives the ml / hr. For this example, Q D70 is 60 ml / hour, and Q D80 is 100 ml / hour, and Q D90 Assuming that the flow rate is 80 ml / hr, the above equation is substituted as follows: 200=QEFF -[1,000+600+800+800+60+100+80] 200=Q EFF -[3,440 (total patient fluid input)] Q EFF =3,640ml / hour

[0077] It is noted that the 240 ml / hr total drug components (60 + 100 + 80) in the above calculation represents 7 percent of the total patient fluid input of 3,440 ml / hr, which is relatively significant and results in an equivalent percentage increase in effluent accuracy. In one embodiment, the above calculation is performed in collaboration logic implementer 100, which is capable of obtaining all input information from all physician prescription information either (i) electronically from renal failure therapy machine 20 and / or infusion pumps 70, 80, and 90, (ii) manually entered in GUI 120, or (iii) some combination thereof.

[0078] Based on the prescribed dosage for the three drugs in infusion pumps 70, 80, and 90, the effluent Q EFF = 3,640 ml / hr, the system 10 now calculates the waste flow rate Q EFF The collaboration logic implementer 100 receives patient P's weight at the start of treatment and uses a conversion algorithm to calculate the patient's corresponding blood volume. Assuming patient P weighs 80 kg, an estimator (https: / / reference.medscape.com / calculator / estimated-blood-volume) estimates that patient P's blood volume is 6,000 ml. Knowing that 3,440 ml will be added over the next hour, the cumulative volume totals 9,440 ml. The percentage of that volume for each drug over the hour is then: (i) 60 / 9,440, or 0.63%, for the drug in infusion pump 70; (ii) 100 / 9,440, or 1.1%, for the drug in infusion pump 80; and 80 / 9,440, or 0.84%, for the drug in infusion pump 90.

[0079] Collaboration logic implementer 100 then increases the actual flow rate for each infusion pump 70, 80, and 90 so that the medication received by the patient over the course of one hour achieves the prescribed dosage. In the example, the flow rate for pump 70 would increase from 60 ml / hour to 60.38 ml / hour (a 0.63% increase). The flow rate for pump 80 would increase from 100 ml / hour to 101 ml / hour (a 1.1% increase). The flow rate for pump 90 would increase from 80 ml / hour to 80.67 ml / hour (a 0.84% ​​increase). Assuming the flow rate adjustments are relatively small, as is the case here, the waste flow rate Q EFF The calculations for Q do not need to be performed again. However, for larger drug flow rate adjustments, the system 10 may calculate Q in the manner described above. EFF However, drug flow rate adjustments from a drug perspective are important because the patient is currently receiving the prescribed amount of the drug.

[0080] In determining whether to adjust the flow rate for an IV drug, collaboration logic implementer 100 may consider whether CRRT or IHD machine 20 is actually running. For example, if an IV drug is delivered before or after CRRT or IHD treatment, collaboration logic implementer 100 will not adjust or suggest adjusting the IV drug flow rate from the flow rate associated with the prescribed dosage. If CRRT or IHD machine 20 is stopped for any reason during treatment, e.g., due to an alarm, alert, supply bag change, etc., machine 20 will communicate this (e.g., wired or wirelessly) to collaboration logic implementer 100, which will select one of several alternative methods, e.g., (i) automatically causing or suggesting a reduction in at least one infusion pump 70, 80, 90 its IV drug flow rate as described herein for the duration of the stoppage; (ii) reducing overall drug delivery time. , maintaining at least one IV drug flow rate at an increased rate during the shutdown so that the prescribed dosage can be met, but counting the additional flow rate as part of the administered dosage and communicating it to at least one infusion pump 70, 80, 90 or its operator, or (iii) reacting by completely shutting off one or more infusion pumps 70, 80, 90, for example, if the drug is intended to accompany CRRT or IHD therapy, e.g., if the drug is an anticoagulant, phosphate supplement, and the like.

[0081] In one embodiment, all enabled communications are bidirectional so that collaboration logic implementer 100 will know when one or more infusion pumps 70, 80, 90 are operating during operation of renal failure therapy machine 20. In one embodiment, logic implementer 100 periodically polls (e.g., every second, every few seconds, or every fraction of a second) the control units 72, 82, 92 of infusion pumps 70, 80, 90, respectively, as to whether they are currently in pumping mode. The control units 72, 82, 92 respond appropriately to control unit 110 of collaboration logic implementer 100, which reacts accordingly. EFFIn the above example for determining Q, the logic implementer 100 may determine Q during operation of the renal failure therapy machine 20. D70 is 60 ml / hour, and Q D80 is 100 ml / hour, and Q D90 is 80 ml / hour, (i) when the infusion pump 70 starts / stops pumping, Q EFF (ii) automatically increasing / decreasing Q by 60 ml / hr when the infusion pump 80 starts / stops pumping. EFF (iii) automatically increase / decrease Q when the infusion pump 90 starts / stops pumping. EFF would suggest increasing / decreasing or increasing / decreasing by 80 ml / hr.

[0082] To the extent that starting or stopping pumping of any one of the infusion pumps 70, 80, 90 significantly affects the total patient fluid input (3,440 ml / hr in the above example), the coordination logic implementer 100 is configured to adjust or suggest adjusting upward or downward the flow rate of any other currently active infusion pumps 70, 80, 90. In this manner, the system 10 is configured to adjust the operation of any of the infusion pumps 70, 80, 90 based on the current state (e.g., pumping vs. not pumping) of any of the other infusion pumps 70, 80, 90.

[0083] The above example involves adjusting the IV drug flow rate to compensate for the portion of the prescribed drug that is absorbed by the patient and therefore removed from the patient as waste fluid from the renal failure therapy instead of being treated. Another method for compensating for waste removal according to the present disclosure is to adjust the concentration of the IV drug so that the amount of drug actually absorbed by the patient matches that prescribed. In the above example, (i) the amount or percentage of IV drug lost by infusion pump 70 over one hour is 0.63%, (ii) the amount of IV drug lost by infusion pump 80 over one hour is 1.1%, while (iii) the amount of IV drug lost by infusion pump 90 over one hour is 0.84%. Therefore, collaboration logic implementer 100 may be contemplated to make a recommendation to a physician, technician, machine operator, etc. to increase the concentration of the IV drug by the lost percentage so that the patient receives the prescribed amount of each IV drug despite losing a portion of the drug to waste fluid removal from the renal failure therapy. In one embodiment, (i) if the concentration of the IV drug in infusion pump 70 is 20% by volume, the concentration is increased by 0.63% to 20.13% by volume; (ii) if the concentration of the IV drug in infusion pump 80 is 10% by volume, the concentration is increased by 1.1% to 10.11% by volume; and (iii) if the concentration of the IV drug in infusion pump 90 is 12% by volume, the concentration is increased by 0.84% ​​to 12.1% by volume.

[0084] The above example illustrates a formulation where the flow rate is not adjusted, i.e., Q D70 However, the flow rate remains at 60 ml / hour, and Q D80 However, the flow rate remains at 100 ml / hour, and Q D90 Assume that the flow rate remains at 80 ml / hr. In another alternative embodiment, the coordination logic implementer 100 of the system 10 is contemplated to provide a combination of adjusted flow rate and adjusted concentration such that the prescribed dose is met even if a portion of the IV drug is removed via the waste stream.

[0085] Many hospitals have sophisticated complex systems or units capable of achieving highly accurate concentrations, such as those defined above. Adjusting the concentration flow rate can be advantageous, for example, when the prescribed flow rate is at the maximum allowable flow rate for the drug and / or infusion pump 70, 80, 90. Concentration adjustment may require the collaboration logic implementer 100 to suggest to a physician or caregiver, etc., that a concentration change should be made, as opposed to an automatic concentration adjustment, so that the physician or caregiver, etc., may order an IV drug having the adjusted concentration from the hospital pharmacy. As with any suggestions from the collaboration logic implementer 100 discussed herein, the suggestions may be provided audibly, visually, or audiovisually in the GUI 40 of the renal failure therapy machine 20, the GUI 120 of the collaboration logic implementer 100, and / or any one or more of the GUIs 76, 86, and 96 of the associated infusion pumps 70, 80, 90.

[0086] 3 summarizes the above-described adjustments (automatic or suggested) determined by collaboration logic implementer 100 of system 10. In one embodiment, the method is implemented in control unit 110 of collaboration logic implementer 100. At oval 212, method 210 begins. At block 214, control unit 110 adjusts the IV drug pump flow rate (e.g., Q D70 , Q D80 , and Q D90 ) is calculated as illustrated above, EFF ) and waste flow rate (Q EFF ) into the overall equation for

[0087] In block 216, the control unit 110 (i) calculates the IV drug flow rate (Q) using the calculated waste flow rate and the patient's blood volume in the manner described above. D70 , Q D80 , Q D90) determine a percentage adjustment for each IV drug, and / or (ii) determine a concentration adjustment for the IV drug in the infusion pump 70, 80, 90 in the manner described above. The adjustment may be implemented automatically or suggested to the caregiver, as discussed herein.

[0088] At diamond 218, the control unit 110 adjusts the IV drug flow rate (Q D70 , Q D80 , Q D90 ), taken collectively, the waste flow rate (Q EFF ) calculations. "Significant" means that the currently calculated waste flow rate (Q EFF IV drug flow rate (Q) as a percentage of D70 , Q D80 , Q D90 ) to a threshold percentage (e.g., 0.5%). If the percentage adjustment meets or exceeds the threshold percentage, the effect is considered "significant," according to diamond 218. In the example above, Q EFF is determined to be 3,640 ml / hr, while (i) the flow rate for pump 70 is adjusted from 60 ml / hr to 60.38 ml / hr, (ii) pump 80 is adjusted from 100 ml / hr to 101 ml / hr, and pump 90 is adjusted from 80 ml / hr to 80.67 ml / hr. The total or collective adjustment of the IV pumps is 2.05 ml / hr (0.38 ml / hr + 1.00 ml / hr + 0.67 ml / hr), which is the current calculated Q of 3,640 ml / hr. EFF As a percentage of , this is 0.06%, which is well below an exemplary threshold percentage (e.g., 0.5%).

[0089] The percentage adjustment for IV drug flow rate is calculated using the effluent flow rate (Q) as determined at diamond 218. EFF ), the method 210 returns to block 214 and calculates the waste flow rate (Q EFF) and returns to block 216 to update the flow rate adjustment for the IV pump. The loop between diamond 218 and blocks 214 and 216 updates the waste flow rate (Q) so that the percentage adjustment for the IV drug flow rate is determined in diamond 218. EFF ), at which point method 210 proceeds to block 220. In block 220, control unit 110 automatically implements or suggests to the caregiver the adjustment determined in block 216 in any of the manners described herein. In diamond 222, method 210 ends.

[0090] Dashed block 217 illustrates an option for method 210 in which hemofilter 60 (e.g., dialyzer or hemofilter) patency or lifespan is considered. In both CRRT and IHD, dialyzers or hemofilters 60 are known to slowly clog over time, which can reduce the rate of drug removal even though the flow rate is set as a constant in the renal failure therapy machine 20. The amount of clog may be estimated by sensing pressure in one or more of the effluent line 66, the arterial line 54, and / or the venous line 56. For example, if pressure in the effluent line 66 builds up over the course of therapy, it may be assumed to result from a clogged hemofilter 60. The pressure buildup may be correlated, e.g., empirically, with a percentage reduction in drug removal. The correlation, in one embodiment, is stored as a look-up table in the control unit 110 of the collaborative logic implementer 100. Here, as the collaboration logic implementer 100 receives increasing pressure signals from the pressure sensor associated with the waste line 66 over the course of treatment, the collaboration logic implementer 100 finds the corresponding percentage decrease in drug removal from the lookup table and reduces the percentage adjustment for the IV drug flow rate and / or IV drug concentration determined in block 216 as appropriate.

[0091] Method 210 adjusts the IV drug flow rate based on the fact that a patient undergoing renal failure therapy treatment may be subjected to fluid removal in the form of ultrafiltration as waste fluid. It is envisioned that such fluid removal may also remove a portion of one or more IV drugs that are otherwise intended to treat the patient. Method 210 highlights two methods for adjusting IV drug removal due to waste fluid removal. However, the present disclosure focuses on adjusting the IV drug flow rate (Q EFF It should be understood that other methods for compensating for IV drug removal or dilution without involving IV drug removal or dilution are also contemplated.

[0092] In one alternative method, the IV drug flow rate, Q D70 , Q D80 , and Q D90 (and / or concentration), but instead, the drug is diluted before the substitution fluid flow rate Q REP1 and Q in terms of the post-dilution displacement fluid flow rate REP2 where the IV drug flow rate Q is adjusted (or is proposed to be adjusted by the collaborative logic implementer 100) based on the amount of IV drug diluted by D70 , Q D80 , and Q D90 Q may be increased, for example, by a percentage equal to the drug flow rate divided by the total displacement fluid flow rate plus the drug flow rate. For example, using the same exemplary flow rate data from above, Q REP1 is 800 ml / hour, and Q REP2が , 800 ml / hour, and Q D70 is 60 ml / hour, and Q D80 But 100ml / hour and Q D90 If the flow rate is 80 ml / hour, then (i) Q D70 is increased by 60 ml / hr / (800 ml / hr + 800 ml / hr + 60 ml / hr) or 3.6%, and (ii) Q D80 is increased by 100 ml / hr / (800 ml / hr + 800 ml / hr + 100 ml / hr) or 5.9%, while (iii) Q D90is increased by 80 ml / hr / (800 ml / hr + 800 ml / hr + 80 ml / hr) or 4.8%. Therefore, to compensate for the fact that the three IV medications were diluted by the pre-dilution and post-dilution replacement fluid flow rates during treatment, Q D70 The flow rate of Q is increased from 60 ml / hour to 62.2 ml / hour (by 3.6%). D80 The flow rate of Q is increased from 100 ml / hour to 106 ml / hour (by 5.9%). D90 The flow rate is increased from 80 ml / hr to 83.8 ml / hr (by 4.8%). It should be understood that one skilled in the art may determine other methods for compensating for IV drug dilution due to substitution fluid flow rate other than the exemplary compensation described above, and that the IV drug concentration may alternatively or additionally be adjusted due to IV drug dilution as described above.

[0093] As is known, pre-dilution and post-dilution substitution fluids are used in hemofiltration ("HF") and hemodiafiltration ("HDF") treatments for either CRRT or IHD. In HF, the dialysis fluid flow rate Q DIAL HD and HDF are performed using a dialysis fluid flow rate Q DIAL In theory, the dialysis fluid flow rate Q does not add to the patient's total blood volume due to the fact that the dialysis fluid flow is passed along the outside of the dialyzer membrane, whose tiny hollow fiber pores block the dialysis fluid from entering the blood side of the membrane. In such a case, the dialysis fluid flow rate Q DIAL does not dilute the IV drug flow rate. However, with high flux dialyzers, it is likely that a percentage of the dialysis fluid will migrate, even if unexpectedly, into the extracorporeal circuit and therefore into the patient's blood volume. If the amount of migration becomes significant enough, the exemplary Q of 1,000 ml / hr discussed above may be exceeded. DIAL In contrast, for example, in the case of chronic HD, where the dialysis fluid flow rate is specified in ml / min, IV drug flow dilution due to dialysis fluid flow rate may be apparent. In such situations, IV drug flow dilution due to dialysis fluid flow rate may be compensated for in the same manner (flow rate and / or concentration) as described above for the pre-dilution and post-dilution substitution fluids.

[0094] In compensating for IV drug flow dilution due to dialysis fluid flow rate, the collaboration logic implementer 100 estimates the amount or flow rate of dialysis fluid migrating from the dialysis fluid compartment of the dialyzer into the blood compartment of the dialyzer. EST ) may take into account, and therefore vary due to, any one or more of: amount of dialyzer membrane flux or opening, blood flow rate, dialysis fluid flow rate, the relationship between blood flow rate and dialysis fluid flow rate, the pressure of the blood flow through the dialyzer, the pressure of the dialysis fluid flow through the dialyzer, and / or the relationship between the pressure of the blood flow and the dialysis fluid flow through the dialyzer (e.g., transmembrane pressure). EST Once established, the IV drug flow rate Q D70 , Q D80 , and Q D90 For example, Q EST The IV drug flow rate may be increased (or suggested to be increased via the collaboration logic implementer) by a percentage equal to the drug flow rate divided by the +drug flow rate. As with any suggestion from collaboration logic implementer 100 discussed herein, the IV drug flow rate suggestion here may be provided audibly, visually, or audiovisually in any one or more of GUI 40 of renal failure therapy machine 20, GUI 120 of collaboration logic implementer 100, and / or GUIs 76, 86, and 96 of associated infusion pumps 70, 80, 90.

[0095] In a further alternative aspect of the present disclosure, the chemical formulation of an IV drug is modified, for example, due to chemical overlap with the formulation of the pre-dilution substitution fluid, post-dilution substitution fluid, and / or dialysis fluid. As discussed above, many hospitals have sophisticated compounding systems or units capable of achieving highly accurate concentrations. Therefore, it is possible to adjust the chemical composition of the IV drug to avoid overlap of certain chemicals with those of the renal therapy substitution fluid or dialysis fluid. For example, the renal therapy substitution fluid and the IV drug fluid may both contain phosphate. System 10 is now configured to examine both phosphate doses to determine whether they may coexist or whether modifications to the IV drug phosphate component composition need to be made.

[0096] When both renal therapy replacement and IV medication fluid therapy fluids are provided to a patient during the same hospital treatment (either directly at the same time or in sufficient proximity to each other so that phosphate or other overlapping components from the two sources are simultaneously present in the patient), the coordination logic implementer 100 of system 10 is preferably configured to (i) understand the chemical composition of both the renal therapy replacement fluid and the IV medication, (ii) identify and combine the doses or flow rates of overlapping components or chemicals in the renal therapy replacement fluid and the IV medication, (iii) determine, for each overlapping component or chemical, whether the combined dose or flow rate exceeds a maximum dose or flow rate, or whether the dose or flow rate of the component or chemical should not exceed that of the IV medication prescription at all, and (iv) if the amount of a component or chemical in the renal therapy replacement fluid should be reduced or eliminated, notify the system 10 and / or a hospital pharmacy clinician, physician, or other user so that the IV medication may be so modified, and so considered. As with any suggestions from the collaborative logic implementer 100 discussed herein, the IV drug component suggestions may here be provided audibly, visually, or audiovisually in any one or more of the GUI 40 of the renal failure therapy machine 20, the GUI 120 of the collaborative logic implementer 100, and / or the GUIs 76, 86, and 96 of the associated infusion pumps 70, 80, 90.

[0097] In one embodiment, the prescribed dose of phosphate for patient P is X mg / (kg (patient weight) x time) and is administered with renal replacement fluid (Q REP1 +Q REP2) is X / 3, and the dose of phosphate that patient P actually receives should not exceed the prescribed dose. Here, control unit 110 of collaboration logic implementer 100 (i) receives and understands the prescribed dose of phosphate for patient P (X mg / kg (patient's weight) × time), (ii) receives and understands that the actual dose of phosphate should not exceed the prescribed dose, (iii) receives and understands the patient's weight (e.g., measured prior to treatment and delivered directly, wired or wirelessly, to collaboration logic implementer 100), and is therefore able to determine X, (iv) receives and understands the chemical components of substitution fluid 1 and / or substitution fluid 2 (if one or both are used), (v) receives and understands the prescribed flow rates of substitution fluid 1 and / or substitution fluid 2, and (vi) calculates the dose of substitution fluid 1 and / or substitution fluid 2 given the substitution fluid chemical components and patient P's weight. (vii) offset (or eliminate) the amount of phosphate in the IV medication knowing the replacement fluid dose to achieve the prescribed dose, and (viii) communicate an updated chemical formulation for the IV medication with the offset amount of the phosphate component in any manner discussed herein. In the above example, the IV medication component is changed from an X mg / (kg (patient weight) × hr) dose of phosphate to a 2X / 3 mg / (kg (patient weight) × hr) dose of phosphate such that when delivered in combination with Replacement Fluid 1 and / or Replacement Fluid 2, each having an X / 3 mg / (kg (patient weight) × hr) dose of phosphate, the resulting dose of phosphate delivered is the prescribed dose of X mg / (kg (patient weight) × hr).

[0098] The control unit 110 of the collaboration logic implementer 100 may alternatively be programmed to allow patient P to receive an additional X / 3 mg / (kg (patient's weight) x hour) dose of phosphate from substitution fluid 1 and / or substitution fluid 2. Or, the control unit 110 of the collaboration logic implementer 100 may determine that the dose of phosphate from substitution fluid 1 and / or substitution fluid 2 exceeds that of the prescribed dose of the IV medication, in which case the control unit 110 of the collaboration logic implementer 100 generates an alarm or alert in any of the manners and to any of the destinations discussed herein. The above teachings of using substitution fluids apply equally to dialysis fluids, assuming that a quantifiable amount of dialysis fluid migrates into the extracorporeal circuit, as discussed above. It should be understood that the composition of substitution fluid 1 and / or substitution fluid 2 may be modified instead of or in addition to modifying the composition of the IV medication, for example, if the substitution fluid is performed online at or near renal failure therapy machine 20. However, this is often the case when replacement fluids are pre-made, bagged, and sterilized. The previous paragraph applies to any overlapping chemical or component and is in no way limited to phosphates.

[0099] Referring now to FIG. 4, an embodiment of system 10 operates in the manner described above and shows a single coordination logic implementer 100 with multiple clusters of renal failure therapy machines 20 and their associated infusion pumps 70, 80, 90. In one embodiment, logic implementer 100 is the hub for all spoke renal failure therapy machines 20 and all spoke infusion pumps 70, 80, 90, which is the case in FIGS. 1 and 2. FIG. 4 illustrates an alternative embodiment, in which coordination logic implementer 100 is shown as a higher-level hub for each of the spoke CRRT or IHD machines 20 in its cluster, which in turn are lower-level hubs for their associated spoke infusion pumps 70, 80, 90. Coordination logic implementer 100 communicates with EMR database 150 as illustrated in FIG. 4. The arrangement of FIG. 4 may be preferable when shorter-range wireless communication is provided. Here, for example, (i) treatment parameters or conditions are communicated from the infusion pumps 70, 80, 90 to the collaboration logic implementer 100 via the corresponding renal failure therapy machine 20, and (ii) operating parameters (automatic or suggested) are determined in the collaboration logic implementer 100 and communicated therefrom to the infusion pumps 70, 80, 90 via the renal failure therapy machine 20.

[0100] As used in this specification, including the claims, the term "and / or" is a conjunction that is either inclusive or exclusive. Thus, the term "and / or" either indicates the presence of two or more items in a group, or indicates that a choice may be made from an alternative group.

[0101] The many features and advantages of the present disclosure are apparent from the written description, and thus, the appended claims are intended to cover all such features and advantages of the present disclosure. Moreover, since numerous modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to the exact construction and operation as shown and described. Therefore, the described embodiments should be considered as illustrative rather than restrictive, and the present disclosure should not be limited to the details given herein, but should be defined by the following claims and their full scope of equivalents, whether foreseeable or unforeseeable now or in the future.

Claims

1. An extracorporeal drug delivery system, comprising:

1. A renal failure therapy machine, the renal failure therapy machine being operative with a blood filter, the blood filter being in fluid communication with an arterial line for removing blood from a patient to the blood filter and a venous line for returning blood from the blood filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump pre-dilution substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump post-dilution substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient; a collaboration logic implementer configured to determine when a component of the IV drug is present in at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid, and, if applicable, determine whether a formulation adjustment should be made to the IV drug; and An extracorporeal drug delivery system comprising:

2. The extracorporeal drug delivery system of claim 1, wherein the formulation adjustment includes reducing the component in the IV drug or eliminating the component from the IV drug.

3. An extracorporeal drug delivery system as described in claim 1, wherein the component includes phosphate.

4. The collaborative logic implementer determines whether the formulation adjustment should be made to the IV drug. determining or receiving information indicating a first dose of the component in the IV medication; determining or receiving information indicative of a second dose of the component in the at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid; combining the first dose and the second dose of the component; determining that the formulation adjustment should be made to the IV drug when the combination of the first dose and the second dose exceeds a maximum or prescribed dose; The extracorporeal drug delivery system of claim 1 , wherein the determination is made by:

5. The extracorporeal drug delivery system of claim 4, wherein the collaborative logic implementer is configured to determine the formulation adjustment by reducing the amount of the component in the IV drug based on the second dose of the component in at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid.

6. The extracorporeal drug delivery system of claim 5, wherein the collaborative logic implementer is configured to transmit information indicating the formulation adjustment to a pharmacy server.

7. The extracorporeal drug delivery system of claim 5, wherein the collaborative logic implementer is configured to display information indicating the formulation adjustment within a graphical user interface shown on a display screen of the renal failure therapy machine.

8. The collaborative logic implementer is configured to calculate the second dose of the component. determining or receiving information indicative of a chemical composition of the components in the at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid; determining or receiving information indicative of the respective dialysis fluid flow rates, the pre-dilution flow rates, and / or the post-dilution flow rates; determining or receiving information indicative of a weight of the patient; calculating the second dose of the component using the patient's weight, the chemical composition of the component, and the respective dialysis fluid flow rate, pre-dilution flow rate, and / or post-dilution flow rate; The extracorporeal drug delivery system of claim 4 , configured to determine by:

9. The extracorporeal drug delivery system of claim 1, wherein the renal failure therapy machine is a continuous kidney replacement machine and includes the waste pump and at least two of the dialysis fluid pump, the pre-dilution pump, or the post-dilution pump.

10. The extracorporeal drug delivery system of claim 1, wherein the renal failure therapy machine is a hemodialysis machine and includes the waste pump and the dialysis fluid pump.

11. An extracorporeal drug delivery system as described in claim 1, wherein the collaborative logic implementer is provided separately from the renal failure therapy machine and the infusion pump, and the collaborative logic implementer communicates with at least the renal failure therapy machine via wired or wireless communication.

12. The extracorporeal drug delivery system of claim 1, wherein the collaborative logic implementer is integrated into the renal failure therapy machine.

13. An extracorporeal drug delivery system comprising:

1. A renal failure therapy machine, the renal failure therapy machine being operative with a blood filter, the blood filter being in fluid communication with an arterial line for removing blood from a patient to the blood filter and a venous line for returning blood from the blood filter to the patient, the renal failure therapy machine comprising: a waste pump positioned and arranged to pump waste fluid from the hemofilter at a waste flow rate; a dialysis fluid pump positioned and arranged to pump dialysis fluid to the hemofilter at a dialysis fluid flow rate; a pre-dilution pump positioned and arranged to pump pre-dilution substitution fluid into the arterial line at a pre-dilution flow rate; or a post-dilution pump positioned and arranged to pump post-dilution substitution fluid into the venous line at a post-dilution flow rate; with at least one of a renal failure therapy machine including: an infusion pump operable to deliver an intravenous ("IV") medication to the patient; a collaboration logic implementer configured to determine when a component of the IV medication is present in at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid, and, if applicable, generate an alarm when a combination of the component of the IV medication and the component in the at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid exceeds a maximum dose or a prescribed dose; An extracorporeal drug delivery system comprising:

14. The extracorporeal drug delivery system of claim 13, wherein the collaborative logic implementer is configured to transmit information indicative of the alarm to a server.

15. The extracorporeal drug delivery system of claim 13, wherein the collaborative logic implementer is configured to display information indicating the alarm within a graphical user interface shown on a display screen of the renal failure therapy machine or the infusion pump.

16. The extracorporeal drug delivery system of claim 13, wherein the component comprises a phosphate.

17. The collaborative logic implementer determines when the alarm should be generated. determining or receiving information indicating a first dose of the component in the IV medication; determining or receiving information indicative of a second dose of the component in the at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid; combining the first dose and the second dose of the component; determining that the alarm should be generated when the combination of the first dose and the second dose exceeds the maximum dose or the prescribed dose; The extracorporeal drug delivery system of claim 13, wherein the determination is made by:

18. The collaborative logic implementer, determining or receiving information indicative of a chemical composition of the components in the at least one of the dialysis fluid, the pre-dilution substitution fluid, or the post-dilution substitution fluid; determining or receiving information indicative of the respective dialysis fluid flow rates, the pre-dilution flow rates, and / or the post-dilution flow rates; determining or receiving information indicative of a weight of the patient; calculating the second dose of the component using the patient's weight, the chemical composition of the component, and the respective dialysis fluid flow rate, pre-dilution flow rate, and / or post-dilution flow rate; 20. The extracorporeal drug delivery system of claim 17, configured to determine by:

19. The extracorporeal drug delivery system of claim 13, wherein the renal failure therapy machine is a continuous kidney replacement machine and includes the waste pump and at least two of the dialysis fluid pump, the pre-dilution pump, or the post-dilution pump.

20. The extracorporeal drug delivery system described in claim 13, wherein the renal failure therapy machine is a hemodialysis machine and includes the waste pump and the dialysis fluid pump.

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