Dialysis system with sensor for detection of heparin-induced thrombocytopenia

Abstract

A system includes: a dialysis machine configured to provide a dialysis treatment for a patient; at least one fluid line; a sensor disposed on the at least one fluid line, wherein the sensor is configured to obtain platelet measurements from fluid passing through the at least one fluid line; and a processing system configured to: receive the platelet measurements from the sensor; determine whether the platelet measurements are indicative of a risk of Heparin-induced thrombocytopenia (HIT) to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, provide an alert to the patient and / or a clinician based on the platelet measurements.

Description

Leydig 774120 (230066W001)DIALYSIS SYSTEM WITH SENSOR FOR DETECTION OF HEPARIN-INDUCED THROMBOCYTOPENIACROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims benefit to U.S. Provisional Patent Application No. 63 / 699,588, filed on September 26, 2024, which is hereby incorporated by reference herein.FIELD

[0002] The present application relates to the field of dialysis treatment systems, and in particular, to detecting heparin-induced thrombocytopenia in connection with dialysis treatments.BACKGROUND

[0003] Hemodialysis (HD) treatment includes extracorporeal filtration of a patient’s blood through an artificial kidney (dialyzer). As the blood moves through extracorporeal blood tubing, and especially at the blood-air interface of drip chambers and at the narrow straw inlets of the dialyzer, platelets in the blood may form clots.

[0004] Heparin is a naturally occurring compound that works as an anticoagulant. Many dialysis patients receive either a bolus of heparin before a dialysis treatment or are infused with heparin throughout a hemodialysis treatment session to ensure clotting does not occur until it is necessary to seal the blood access at the end of the treatment. Heparin is infused by the machine’s heparin pump slowly contracting a syringe filled with heparin and connected directly to the extracorporeal blood tubing. The hemodialysis machine allows the operator to select the volume and the rate of infusion.

[0005] Heparin is also used for peritoneal dialysis (PD) patients to reduce the buildup of fibrin in the patient’s peritoneum. In this context, the patient may manually inject heparin into each of the dialysis solution bags with a syringe. Then, when using an automated PD cycler, the patient sleeps while the heparinized dialysis solution is infused into the patient.

[0006] Heparin-induced thrombocytopenia (HIT) is a complication that may occur in patients exposed to heparin, for example, through HD or PD treatments. Although HIT is rare, theLeydig 774120 (230066W001) consequences thereof can be serious and life-threatening. Conventionally, HIT may be detected through costly, time-consuming blood tests.

[0007] HIT is caused by a patient’s body reacting with antibodies that bind to complexes of heparin and platelet factor 4 (PF4), activating the platelets and promoting a prothrombotic state. In the case of HIT being detected, the patient should be taken off heparin immediately to prevent further harm.

[0008] HIT is more frequently encountered with unfractionated heparin (UFH) than with low molecular weight heparin (LMWH). Up to 8% of dialysis patients receiving heparin can develop HIT, and treatment for HIT is complex and costly. Thus, it is advantageous to catch HIT reactions as early as possible to prevent further complications, but this can conventionally be done only through careful observation and blood tests.

[0009] Additionally, since dialysis patients are typically heparinized every treatment, the effect is more deleterious. Furthermore, PD patients perform their treatments at home, so it is less likely that a trained clinician will be able to immediately notice and diagnose HIT.SUMMARY

[0010] In an exemplary embodiment, the present application provides a system. The system includes: a dialysis machine configured to provide a dialysis treatment for a patient; at least one fluid line; a sensor disposed on the at least one fluid line, wherein the sensor is configured to obtain platelet measurements from fluid passing through the at least one fluid line; and a processing system configured to: receive the platelet measurements from the sensor; determine whether the platelet measurements are indicative of a risk of Heparin-induced thrombocytopenia (HIT) to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, provide an alert to the patient and / or a clinician based on the platelet measurements.

[0011] In a further exemplary embodiment, the dialysis machine is a hemodialysis machine, the at least one fluid line comprises an extracorporeal blood line, and the sensor is disposed on the extracorporeal blood line.

[0012] In a further exemplary embodiment, the dialysis machine is a peritoneal dialysis machine, the at least one fluid line comprises a spent dialysate line, and the sensor is disposed on the spent dialysate line.Leydig 774120 (230066W001)

[0013] In a further exemplary embodiment, the platelet measurements include platelet size measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet size measurement to a threshold platelet size. The platelet size measurement being larger than the threshold platelet size corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

[0014] In a further exemplary embodiment, the platelet measurements include platelet count measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a respective platelet count measurement to a previous platelet count measurement or to a baseline platelet count; and determining whether a change in platelet count between the respective platelet count measurement and the previous platelet count measurement or between the respective platelet count measurement and the baseline platelet count is greater than a change threshold. The change in platelet count being larger than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

[0015] In a further exemplary embodiment, the platelet measurements include platelet count measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet count measurement to a platelet count threshold. The platelet count measurement being smaller than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

[0016] In a further exemplary embodiment, the processing system is further configured to: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, cause a heparin pump of the system to be stopped.

[0017] In a further exemplary embodiment, the processing system is further configured to: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, cause a saline flush to be initiated.

[0018] In a further exemplary embodiment, the processing system is further configured to: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, stop the dialysis treatment.

[0019] In a further exemplary embodiment, the sensor is an ultrasonic sensor.

[0020] In a further exemplary embodiment, the sensor comprises: a housing configured to be attached to the at least one fluid line; a detector disposed in the housing on a first side of the atLeydig 774120 (230066W001) least one fluid line; and an emitter disposed in the housing on a second side of the at least one fluid line opposite the first side.

[0021] In another exemplary embodiment, the present application provides a method for providing a dialysis treatment while monitoring for Heparin-induced thrombocytopenia (HIT). The method includes: providing, by a dialysis machine, dialysis treatment for a patient; obtaining, by a sensor disposed on at least one fluid line of the dialysis machine, platelet measurements from fluid passing through the at least one fluid line; determining, by a processing system, whether the platelet measurements are indicative of a risk of HIT to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, providing an alert to the patient and / or a clinician based on the platelet measurements.

[0022] In a further exemplary embodiment, the dialysis machine is a hemodialysis machine, the at least one fluid line comprises an extracorporeal blood line, and the sensor is disposed on the extracorporeal blood line.

[0023] In a further exemplary embodiment, the dialysis machine is a peritoneal dialysis machine, the at least one fluid line comprises a spent dialysate line, and the sensor is disposed on the spent dialysate line.

[0024] In a further exemplary embodiment, the platelet measurements include platelet size measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet size measurement to a threshold platelet size. The platelet size measurement being larger than the threshold platelet size corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

[0025] In a further exemplary embodiment, the platelet measurements include platelet count measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a respective platelet count measurement to a previous platelet count measurement or to a baseline platelet count; and determining whether a change in platelet count between the respective platelet count measurement and the previous platelet count measurement or between the respective platelet count measurement and the baseline platelet count is greater than a change threshold. The change in platelet count being larger than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.Leydig 774120 (230066W001)

[0026] In a further exemplary embodiment, the platelet measurements include platelet count measurements, and determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet count measurement to a platelet count threshold. The platelet count measurement being smaller than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

[0027] In a further exemplary embodiment, the method further comprises: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, causing a heparin pump of the dialysis machine to be stopped.

[0028] In a further exemplary embodiment, the method further comprises: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, causing a saline flush to be initiated.

[0029] In yet another exemplary embodiment, the present application provides one or more non-transitory computer-readable mediums having processor-executable instructions stored thereon for providing a dialysis treatment while monitoring for Heparin-induced thrombocytopenia (HIT). The processor-executable instructions, when executed, facilitate performance of the following: providing, by a dialysis machine, dialysis treatment for a patient; obtaining, by a sensor disposed on at least one fluid line of the dialysis machine, platelet measurements from fluid passing through the at least one fluid line; determining, by a processing system, whether the platelet measurements are indicative of a risk of HIT to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, providing an alert to the patient and / or a clinician based on the platelet measurements.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 depicts a diagram of an exemplary hemodialysis system including a heparin pump;

[0031] FIG. 2A depicts a diagram of an exemplary hemodialysis machine having a sensor for HIT monitoring according to an exemplary embodiment of the present application;

[0032] FIG. 2B depicts a diagram of an exemplary sensor according to an exemplary embodiment of the present application;Leydig 774120 (230066W001)

[0033] FIG. 3 depicts a flowchart illustrating an exemplary method for providing a dialysis treatment with HIT monitoring based on platelet size according to an exemplary embodiment of the present disclosure; and

[0034] FIG. 4 depicts a flowchart illustrating an exemplary method for providing a dialysis treatment with HIT monitoring based on platelet count according to an exemplary embodiment of the present disclosure; and

[0035] FIG. 5 depicts a diagram of an exemplary peritoneal dialysis machine having a sensor for HIT monitoring according to an exemplary embodiment of the present application.DETAILED DESCRIPTION

[0036] Example embodiments of the present disclosure provide a cost-effective and expeditious way for a dialysis system to detect HIT and respond quickly thereto (e.g., through automated responsive operations being taken by the hemodialysis system), allowing for better outcomes for patients affected by HIT (e.g., avoiding or mitigating severe reactions such as thrombosis, and avoiding or minimizing disruption of hemodialysis treatments).

[0037] In an example embodiment, a hemodialysis system includes a sensor (e.g., ultrasonic, optical, or other sensor) disposed on an extracorporeal blood circuit of a hemodialysis machine, wherein the sensor is configured to monitor extracorporeal blood flowing through the extracorporeal blood circuit. For example, a processing system connected to the sensor may determine, based on measurements obtained by the sensor, the presence and aggregation size of platelets in the extracorporeal blood, and in the event of detecting HIT (or indicators of HIT), trigger responsive operations such as alarms, notifications, or stoppage of heparin infusion and / or stoppage of treatment. The processing system may include a processor and may be part of the hemodialysis machine itself or otherwise be a part of a hemodialysis system, such as part of a monitoring system used in combination with the hemodialysis machine.

[0038] FIG. 1 depicts a diagram of an exemplary hemodialysis system 100 including a heparin pump. During operation of the hemodialysis system 100, a needle or catheter is placed in the patient’s wrist / arm vein, whereby blood flows out of the patient’s vein and into a dialysis tubing circuit 102. The blood is pulled along the tubing circuit 102 by a blood pump 105. The blood pump 105 pumps the blood through a dialyzer 112 where the blood is filtered. Dialyzer 112 has thousands of fine hollow fibers inducing waste and extra fluid across the fibers to permitLeydig 774120 (230066W001) the cleansed blood to continue back out into a downstream portion of the tubing circuit 102. The hemodialysis system 100 further includes a heparin pump / syringe 108, which may be operated automatically by a processing system of the hemodialysis system 100 so that heparin is continuously injected into the patient. The dialysis machine 100 may further include a display screen for displaying a graphical user interface (GUI).

[0039] FIG. 2A depicts a diagram of an exemplary hemodialysis machine 200 having a sensor 214 according to an exemplary embodiment of the present application. The sensor 214 is configured to detect the presence and aggregation size of platelets in extracorporeal blood flowing through an extracorporeal blood circuit of the hemodialysis machine 200.

[0040] In the example of FIG. 2A, the sensor 214 may be disposed on a first portion 204 of the extracorporeal blood circuit where the extracorporeal blood leaves the patient’s body and flows towards dialyzer 212. The first portion 204 includes a blood pump 205 for circulating the extracorporeal blood at a controllable flowrate, as well as a heparin syringe / pump 208 for adding heparin to the extracorporeal blood. A controller (e.g., part of a processing system of the hemodialysis machine 200), may control the blood pump 205 to set the ultrafiltration rate (UFR) and to start or stop the blood pump 205. The controller may also control the infusion of heparin via the heparin syringe / pump 208.

[0041] After the extracorporeal blood passes through the dialyzer 212, it is returned to the patient’s body through a second portion 206 of the extracorporeal blood circuit.

[0042] The hemodialysis machine 200 may further include a substitution fluid line 210. This line may be connected to various positions of the circuit depending on the use case — for example, connected to the extracorporeal blood circuit or to a saline or dialysate bolus. The line may also be used for an automatic saline flush as discussed below.

[0043] The sensor 214 is configured to detect the formation of antibodies which bind to complexes of heparin and platelet factor 4 (PF4) in extracorporeal blood leaving the patient. The sensor 214 is capable of detecting platelets, which are typically around 2 pm in diameter, and differentiating them from other larger blood components, which are typically 6-15 pm in diameter. A processing system connected to the sensor, such as the processing system of the hemodialysis machine or another processing system that is part of the overall hemodialysis system, is configured to monitor the measurements obtained via the sensor 214 over time and to develop a patient-specific profile for the patient’s expected platelet count and / or to detect theLeydig 774120 (230066W001) presence of or an increase in platelet-affected antibodies. The processing system may monitor such information with respect to trends occurring during a treatment, as well as with respect to trends occurring over multiple treatments and, based on the measurements, can detect whether a patient may be having an adverse reaction to heparin (such as HIT) and / or whether the patient may be starting to show signs of a potential adverse reaction to heparin (such as HIT). For example, a trend towards increasing platelet aggregation sizes may indicate that the patient is trending towards HIT, such that early intervention may be performed prior to the patient developing HIT-related complications. To provide another example, an absolute platelet aggregation size that is large (e.g., 4 pm - 8 pm in diameter) may be indicative of HIT.

[0044] It will be appreciated that although the sensor 214 is depicted in FIG. 2A as being disposed in the first portion 204 of the extracorporeal blood circuit between the heparin injection point and the dialyzer 212, it may be located elsewhere on the extracorporeal blood circuit in other implementations of the present disclosure — for example, it may be disposed along the second portion 206 or it may be disposed on the first portion 204 between the heparin injection point and the patient.

[0045] FIG. 2B depicts a diagram of an exemplary sensor 214 according to an exemplary embodiment of the present application. The sensor housing 214 may include tubing guides to rigidly hold the extracorporeal blood circuit tubing (e.g., first portion 204) in place against the sensor heads. An emitter 2141 (e g., an optical or ultrasonic emitter) within the housing may emit light or ultrasonic waves through the tubing towards the detector 2142. The tubing portion may or may not include a cuvette of a predetermined size. The tubing portion may be enclosed by a door or covering or may simply fit snugly in place.

[0046] FIG. 3 depicts a flowchart illustrating an exemplary method for providing a dialysis treatment with HIT monitoring based on platelet size according to an exemplary embodiment of the present disclosure. At stage 301, the weight of the patient for dialysis treatment is determined. At stage 302, the various vital signs and clinical parameters of the patient are taken. At stage 303, the patient is connected to the dialysis machine, and the dialysis treatment starts at stage 304. While dialysis treatment is under way, a sensor monitors platelet size. If the dialysis system determines in step 306 that the platelet size is above a threshold, one or more responsive operations can be taken (stages 307a-307f). The threshold may be, for example, 4pm. Other thresholds can be used. A tiered threshold system may also be used for taking differentLeydig 774120 (230066W001) responsive operations at different thresholds. This creates automatic proportional reactions to changing patient conditions staggered in a practical escalation ladder based on severity of patient conditions.

[0047] As mentioned above, responsive operations may be taken by the dialysis system in response to detecting measurements indicative of HIT or HIT risk (e.g., based on platelet size being above a threshold). These responsive operations may include, but are not limited to, one or more of the following:• Stage 307a: Providing a notification to a clinician (e.g., through a display on the dialysis machine, or through a message sent to a user device of a clinician), whereby the notification provides relevant information regarding the measurements to the clinician (e.g., platelet aggregation size, an indication that the platelet aggregation size has increased, an amount of platelet aggregation size increase, a rate of platelet aggregation size increase, etc.) and / or an indication that the clinician should follow up with further investigation to confirm the existence of HIT or an increased risk of HIT;• Stage 307b: Recommending to a clinician to stop the heparin pump;• Stage 307c: Automatically stopping a heparin pump of the dialysis machine (in which case, further use of the heparin pump may require a clinician to override the system);• Stage 307d: Automatically stopping the hemodialysis treatment (e.g., until a clinician is able to investigate and resume the treatment based on confirming that it is safe to do so or in an appropriately modified manner);• Stage 307e: Recommending to a clinician to stop the hemodialysis treatment;• Stage 307f: Recommending to a clinician to initiate a saline flush;• Stage 307g: Automatically initiating a saline flush to reduce coagulation;• Stage 307h: Automatically stopping heparin pump and initiating saline flush; and / or• Stage 307i : Generating a report for a medical information system to facilitate a request to be made for a non-heparin anticoagulant to be used for a next treatment.

[0048] In an embodiment, the responsive operations can be automatically taken in an escalation ladder as platelet size aggregates and HIT risk increases. For example, at a first threshold, stage 307a is performed (provide notification). Then, at a second higher threshold, an escalated responsive operation may be performed (e.g., 307b or 307c). Then, at a third even higher threshold, an even more escalated responsive operation may be performed (e.g., 307e).Leydig 774120 (230066W001)

[0049] In an embodiment, after certain responsive operations at stage 307h are performed (such as shutting off heparin and / or performing a saline flush), at stage 308, the sensor continues to monitor platelet size. At stage 309, the processing system monitors the patient’s reaction and change in platelet size after the responsive operation, to determine the platelet size trend after the responsive operations. For example, if the hemodialysis system is able to determine an appropriate decreasing profile trend of the platelet size, this shows the patient is responding to the shutting off of the heparin pump or to the saline flush with a reduction of signs of HIT, that may confirm that the patient was indeed affected by HIT. In this case, the monitoring system initiates an HIT diagnosis at stage 310a. On the other hand, if the continued monitoring shows no changes in response to the shutting off of heparin or to the saline flush, that may indicate that the patient is having some other issue that needs to be further investigated. The hemodialysis system can initiate such further investigation at stage 310b, including in some cases an emergency alarm.

[0050] In an embodiment, the processing system may utilize different thresholds for respective responsive operations and / or for different situations. For example, for a PD cycler utilizing a sensor, HIT may occur while a patient is sleeping, and based on detecting that the patient is asleep, the threshold for triggering an alarm may be set to be higher while the patient is asleep so as to not wake up the patient except in relatively severe or certain cases of HIT. To provide another example, in a less severe case, an HD machine or a PD cycler may remotely contact a clinician without alerting the patient, and / or the alert may be delayed (such as to the next morning in the case of a sleeping patient), and / or an adjustment can be made in connection with configuring a next treatment while no changes are made to the current treatment (e.g., a reminder may be displayed for a next treatment to not add heparin to dialysis solution bags and / or to contact a clinician).

[0051] In an embodiment, the threshold(s) may be set by a user.

[0052] In an embodiment, in addition to or alternatively to monitoring platelet aggregation size, the processing system may use the measurements to monitor platelet count, as another symptom of HIT is a reduced number of platelets. Platelet counts normally decrease by about 15% by the end of a treatment but rebound afterward. A healthy person usually has a platelet count of 150,000 to 400,000. When the number falls under 150,000, thrombocytopenia may be occurring. The processing system may thus detect whether platelet counts are decreasing over aLeydig 774120 (230066W001) selectable period of time, and if the platelet count is determined to have dropped below a certain threshold for a certain amount of time, or continues to decrease between treatments, the processing system may respond accordingly (for example, with the responsive operations discussed above).

[0053] FIG. 4 depicts another flowchart illustrating an exemplary method for providing a dialysis treatment with HIT monitoring based on platelet count according to an exemplary embodiment of the present disclosure. In this method, at stage 401, the clinician sets a platelet count threshold, for example 150,000 platelets per pL. At stage 402, an HD treatment begins with a blood pump running. At stage 403, blood flows through extracorporeal circuit past a sensor for measurement of patient platelets. At stage 404, a processing system checks if the patient has a previous measurement stored. As described above, the processing system may be part of an HIT monitoring system used in connection with a hemodialysis system or part of the HD system itself (e.g., as part of the HD machine). In an embodiment, at stage 404a, if the processing system determines no previous measurement for the patient is stored, it sets a platelet count baseline in accordance with that measurement and proceeds back to stage 403. If the processing system of the sensor does identify a previous measurement stored for the patient, at stage 405, it determines an amount of change between the current measurement and a previous measurement and checks if the amount of change (e.g., decrease) is greater than a threshold (e.g., 20%). If the amount of change (e.g., decrease) is determined by the sensor to be less than the threshold (e.g., 20%), the method proceeds to stage 406. However, if the amount of change is determined to be greater than the threshold (e.g., 20%), the processing system alerts a user (e.g., the clinician or the patient) at stage 407 (and / or further responsive operations may be performed, as discussed above in connection with FIG. 3). At stage 406, the processing system also checks if the platelet count has fallen below a threshold, such as the 150,000 platelets per pL threshold. If not, then the treatment and ongoing HIT monitoring continues (stage 403). If so, then the processing system alerts a user (e.g., the clinician or the patient) at stage 407 (and / or further responsive operations may be performed, as discussed above in connection with FIG. 3).

[0054] In an embodiment, an ultrasonic sensor may be used in combination with an optical sensor that provides additional optical information which helps to distinguish between platelets and other blood components. In one example, the optical sensor detects growing masses ofLeydig 774120 (230066W001) platelets blocking particular frequencies of light or an overall reduction in the number of platelets at a particular frequency of light.

[0055] In an embodiment, the processing system and sensor may also be calibrated to detect bloodstream or peritoneal infections and to notify patients and / or clinicians accordingly. Detecting bloodstream or peritoneal infections can help filter out early symptoms of disease that may obscure a HIT diagnosis.

[0056] It will further be appreciated that the principles discussed herein with respect to an HD machine (e.g., regarding detection of platelet presence / aggregation size / trends and responsive operations) are also applicable to a PD cycler. In the case of a PD cycler, the sensor may be built into a spent dialysis solution drain line, as platelets move into the peritoneum as waste products and are drained during a peritoneal dialysis exchange. FIG. 5 depicts a diagram of an exemplary PD machine having a sensor 214 according to an exemplary embodiment of the present application.

[0057] Since clinicians for dialysis patients may be more focused on treating other conditions and may be prone to missing the signs of HIT and / or mistaking signs of HIT for other issues (such as heart attack), embodiments of the present disclosure provide significant advantages with respect to cost-effectively and promptly detecting HIT, which would improve treatment outcomes and also avoid misdiagnoses (and the costs associated therewith) for dialysis patients.

[0058] It will be appreciated that the principles discussed herein may also be applicable in various contexts outside of HD and PD. For example:• Ultrasonically monitoring platelet counts may be used to recognize the following secondary immune thrombocytopenia (ITP) conditions: o Viral infections (including chickenpox, parvovirus, hepatitis C, Epstein-Barr, and HIV); o Systemic lupus erythematosus (SLE); o Chronic lymphocytic leukemia (CLL); o Drug-induced immune thrombocytopenia; o Sepsis, a severe bacterial infection in blood; and o Helicobacter pylori (H. pylori), a bacteria that can live in the digestive system;• Ultrasonic monitoring may also be used for lipoprotein apheresis systems to prevent or mitigate HIT for patients who are suffering from high cholesterol;Leydig 774120 (230066W001)• Ultrasonic monitoring may also be used in blood blanks to detect sub-optimal thrombocytes during blood or plasma collection or for analysis after centrifuge separation. Thrombocytes affected by antibodies will be more dense and this can be detected ultrasonically. Also, after centrifuge separation, this ultrasonic monitoring may help provide a more clear understanding of the separated components for more efficient collection.• Ultrasonic monitoring may also be used for membrane-based total plasma exchange (TPE).• Ultrasonic monitoring may also be used for other extracorporeal therapies, such as immunoadsorption and sepsis adsorption treatment.

[0059] It will be appreciated that the execution of the various machine-implemented processes and steps described herein may occur via the execution, by one or more respective processors, of processor-executable instructions stored on one or more tangible, non-transitory computer-readable mediums (such as random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), and / or another electronic memory mechanism). Thus, for example, operations performed by a respective system as discussed herein may be carried out according to instructions stored on one or more memories and / or applications executed by one or more computing devices.

[0060] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0061] The use of the terms “a” and “an” and “the” and “at least one” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term “at least one” followed by a list of one or more items (for example, “at least one of A and B”) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate valueLeydig 774120 (230066W001) falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0062] Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

1. Leydig 774120 (230066W001)CLAIMS:

1. A system, comprising: a dialysis machine configured to provide a dialysis treatment for a patient; at least one fluid line; a sensor disposed on the at least one fluid line, wherein the sensor is configured to obtain platelet measurements from fluid passing through the at least one fluid line; and a processing system configured to: receive the platelet measurements from the sensor; determine whether the platelet measurements are indicative of a risk of Heparin- induced thrombocytopenia (HIT) to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, provide an alert to the patient and / or a clinician based on the platelet measurements.

2. The system according to claim 1, wherein the dialysis machine is a hemodialysis machine, wherein the at least one fluid line comprises an extracorporeal blood line, and the sensor is disposed on the extracorporeal blood line.

3. The system according to claim 1 , wherein the dialysis machine is a peritoneal dialysis machine, wherein the at least one fluid line comprises a spent dialysate line, and the sensor is disposed on the spent dialysate line.

4. The system according to claim 1, wherein the platelet measurements include platelet size measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet size measurement to a threshold platelet size; wherein the platelet size measurement being larger than the threshold platelet size corresponds to the platelet measurements being indicative of a risk of HIT to the patient.Leydig 774120 (230066W001)5. The system according to claim 1 , wherein the platelet measurements include platelet count measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a respective platelet count measurement to a previous platelet count measurement or to a baseline platelet count; and determining whether a change in platelet count between the respective platelet count measurement and the previous platelet count measurement or between the respective platelet count measurement and the baseline platelet count is greater than a change threshold; wherein the change in platelet count being larger than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

6. The system according to claim 1, wherein the platelet measurements include platelet count measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet count measurement to a platelet count threshold; wherein the platelet count measurement being smaller than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

7. The system according to claim 1, wherein the processing system is further configured to: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, cause a heparin pump of the system to be stopped.

8. The system according to claim 1, wherein the processing system is further configured to: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, cause a saline flush to be initiated.

9. The system according to claim 1, wherein the processing system is further configured to:Leydig 774120 (230066W001) in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, stop the dialysis treatment.

10. The system according to claim 1, wherein the sensor is an ultrasonic sensor.

11. The system according to claim 1, wherein the sensor comprises: a housing configured to be attached to the at least one fluid line; a detector disposed in the housing on a first side of the at least one fluid line; and an emitter disposed in the housing on a second side of the at least one fluid line opposite the first side.

12. A method for providing a dialysis treatment while monitoring for Heparin- induced thrombocytopenia (HIT), the method comprising: providing, by a dialysis machine, dialysis treatment for a patient; obtaining, by a sensor disposed on at least one fluid line of the dialysis machine, platelet measurements from fluid passing through the at least one fluid line; determining, by a processing system, whether the platelet measurements are indicative of a risk of HIT to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, providing an alert to the patient and / or a clinician based on the platelet measurements.

13. The method according to claim 12, wherein the dialysis machine is a hemodialysis machine, wherein the at least one fluid line comprises an extracorporeal blood line, and the sensor is disposed on the extracorporeal blood line.

14. The method according to claim 12, wherein the dialysis machine is a peritoneal dialysis machine, wherein the at least one fluid line comprises a spent dialysate line, and the sensor is disposed on the spent dialysate line.Leydig 774120 (230066W001)15. The method according to claim 12, wherein the platelet measurements include platelet size measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet size measurement to a threshold platelet size; wherein the platelet size measurement being larger than the threshold platelet size corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

16. The method according to claim 12, wherein the platelet measurements include platelet count measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a respective platelet count measurement to a previous platelet count measurement or to a baseline platelet count; and determining whether a change in platelet count between the respective platelet count measurement and the previous platelet count measurement or between the respective platelet count measurement and the baseline platelet count is greater than a change threshold; wherein the change in platelet count being larger than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

17. The method according to claim 12, wherein the platelet measurements include platelet count measurements, and wherein determining whether the platelet measurements are indicative of a risk of HIT to the patient comprises: comparing a platelet count measurement to a platelet count threshold; wherein the platelet count measurement being smaller than the change threshold corresponds to the platelet measurements being indicative of a risk of HIT to the patient.

18. The method according to claim 12, further comprising: in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, causing a heparin pump of the dialysis machine to be stopped.

19. The method according to claim 12, further comprising:Leydig 774120 (230066W001) in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, causing a saline flush to be initiated.

20. One or more non-transitory computer-readable mediums having processorexecutable instructions stored thereon for providing a dialysis treatment while monitoring for Heparin-induced thrombocytopenia (HIT), wherein the processor-executable instructions, when executed, facilitate performance of the following: providing, by a dialysis machine, dialysis treatment for a patient; obtaining, by a sensor disposed on at least one fluid line of the dialysis machine, platelet measurements from fluid passing through the at least one fluid line; determining, by a processing system, whether the platelet measurements are indicative of a risk of HIT to the patient; and in response to determining that the platelet measurements are indicative of a risk of HIT to the patient, providing an alert to the patient and / or a clinician based on the platelet measurements.

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