Massaging system for patients undergoing hemodialysis

Abstract

A system includes: a dialysis system configured to provide a dialysis treatment for a patient; an optical monitoring system in communication with the dialysis system, wherein the optical monitoring system is configured to obtain measurements of the patient's hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and a massaging system in communication with the dialysis system, wherein the massaging system is configured to provide massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

Description

Leydig 774121 (240002W001)MASSAGING SYSTEM FOR PATIENTS UNDERGOING HEMODIALYSISCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims benefit to U.S. Provisional Patent Application No. 63 / 699,897, filed on September 27 , 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 monitoring blood levels and refill rate in connection with dialysis treatments.BACKGROUND

[0003] Dialysis is the process of removing toxins and excess fluid from a patient. This is done through ultrafiltration (UF). As shown in FIG. 1, before the treatment, fluid in the patient is located in two “pools”: the extracellular pool (fluid between cells) and the intracellular pool (fluid inside saturated cells). The extracellular pool comprises interstitial fluid (the fluid around the cells and between cells and the intravascular bloodstream space) and plasma (the fluid component of blood in the intravascular bloodstream). A single-pool kinetics (Vsp) model or double-pool kinetics (Vdp) model may be used to estimate a volume of urea distribution (V).

[0004] In the past, clinicians have used higher sodium (Na+) concentration in dialysate to try to drive fluid more quickly from the intracellular pool. However, this led to patient thirst and a problematic cycle of the patient drinking more fluid and subsequently needing more fluid to be removed during a next treatment.SUMMARY

[0005] In an exemplary embodiment, the present application provides a system. The system includes: a dialysis system configured to provide a dialysis treatment for a patient; an optical monitoring system in communication with the dialysis system, wherein the optical monitoring system is configured to obtain measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and aLeydig 774121 (240002W001) massaging system in communication with the dialysis system, wherein the massaging system is configured to provide massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

[0006] In a further exemplary embodiment, the system further includes: a body composition monitor in communication with the dialysis system, wherein the body composition monitor is configured to obtain body composition measurements from the patient. The dialysis system is configured to set a target dry weight for the patient based on the body composition measurements from the patient.

[0007] In a further exemplary embodiment, running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.

[0008] In a further exemplary embodiment, the dialysis system is configured to turn off an ultrafiltration pump in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than a second profile threshold, and the massaging system is configured to massage the patient for a predetermined amount of time in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than the second profile threshold.

[0009] In a further exemplary embodiment, the optical monitoring system is further configured to obtain measurements indicative of the patient’s respective refill responses to respective massage sequences, and the massaging system is configured to generate and store a customized massage routine for the patient based on the patient’s respective refill responses to respective massage sequences.

[0010] In a further exemplary embodiment, the massaging system is configured to provide a localized massage for a local area of the patient’s body; the optical monitoring system is further configured to obtain measurements indicative of the patient’s refill response to the localized massage; and the massaging system is configured to determine whether to continue massaging the local area of the patient’s body or to move on to massage another local area of the patient’sLeydig 774121 (240002W001) body based on the obtained measurements indicative of the patient’s refill response to the localized massage.

[0011] In a further exemplary embodiment, the massaging system is configured to determine to continue massaging the local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating that there is additional movable fluid in the local area of the patient’s body.

[0012] In a further exemplary embodiment, the massaging system is configured to determine to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating a lack of remaining movable fluid in the local area of the patient’s body.

[0013] In a further exemplary embodiment, the dialysis system comprises a hemodialysis machine.

[0014] In another exemplary embodiment, the present application provides a method for massaging a dialysis patient for improving effectiveness of dialysis treatment. The method includes: providing, by a dialysis system, a dialysis treatment for the patient; obtaining, by an optical monitoring system in communication with the dialysis system, measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refdl rate for the patient during the dialysis treatment; and providing, by a massaging system in communication with the dialysis system, massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

[0015] In a further exemplary embodiment, the method further includes: obtaining, by a body composition monitor in communication with the dialysis system, body composition measurements from the patient; and setting, by the dialysis system, a target dry weight for the patient based on the body composition measurements from the patient.

[0016] In a further exemplary embodiment, running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.Leydig 774121 (240002W001)

[0017] In a further exemplary embodiment, the method further includes: turning off, by the dialysis system, an ultrafiltration pump in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than a second profile threshold; and massaging, by the massaging system, the patient for a predetermined amount of time in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than the second profile threshold.

[0018] In a further exemplary embodiment, the method further includes: obtaining, by the optical monitoring system, measurements indicative of the patient’s respective refill responses to respective massage sequences; and generating and storing, by the massaging system, a customized massage routine for the patient based on the patient’s respective refill responses to respective massage sequences.

[0019] In a further exemplary embodiment, the method further includes: providing, by the massaging system, a localized massage for a local area of the patient’s body; obtaining, by the optical monitoring system, measurements indicative of the patient’s refill response to the localized massage; and determining, by the massaging system, whether to continue massaging the local area of the patient’s body or to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage.

[0020] In a further exemplary embodiment, the method further includes: determining, by the massaging system, to continue massaging the local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating that there is additional movable fluid in the local area of the patient’s body.

[0021] In a further exemplary embodiment, the method further includes: determining, by the massaging system, to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating a lack of remaining movable fluid in the local area of the patient’s body.

[0022] In a further exemplary embodiment, the dialysis system comprises a hemodialysis machine.

[0023] In yet another exemplary embodiment, the present application provides one or more non-transitory computer-readable mediums having processor-executable instructions storedLeydig 774121 (240002W001) thereon for massaging a dialysis patient for improving effectiveness of dialysis treatment. The processor-executable instructions, when executed, facilitate performance of the following operations: providing, by a dialysis system, a dialysis treatment for the patient; obtaining, by an optical monitoring system in communication with the dialysis system, measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and providing, by a massaging system in communication with the dialysis system, massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

[0024] In a further exemplary embodiment, running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 depicts a schematic diagram of fluid shifting from an intracellular space to an intravascular space;

[0026] FIG. 2A depicts an example of an optical blood monitoring system usable in connection with a hemodialysis treatment;

[0027] FIG. 2B depicts an example of a graphical user interface (GUI) of the optical blood monitoring system of FIG. 2A showing a Profile C;

[0028] FIG. 3 depicts an example of a body composition monitor (BCM) and a massaging table usable in connection with a hemodialysis treatment in accordance with an exemplary embodiment of the present application;

[0029] FIG. 4 depicts an example of a hemodialysis machine according to the present application;

[0030] FIG. 5 depicts an example of a connected health (CH) system in accordance with an exemplary embodiment of the present application; andLeydig 774121 (240002W001)

[0031] FIGS. 6A-6B depict flowcharts illustrating processes for providing a hemodialysis treatment supplemented by treatment-enhancing massage routines according to exemplary embodiments of the present application.DETAILED DESCRIPTION

[0032] Generally-accepted urea kinetic modeling (UKM) may be used to quantify a hemodialysis (HD) treatment. According to such modeling, during HD, reduction in the urea concentration in the intracellular fluid (ICF) compartment lags behind that in the extracellular fluid (ECF) compartment, and following the treatment, a “rebound” occurs where the blood level of urea rises due to diffusion of urea from the ICF to ECF, until an equilibrium state is established. During the 30-60 minutes after extracellular fluid has been removed that it takes for the fluid to equilibrate, the patient is closely monitored to continue to remove fluid through ultrafiltration but at a reduced rate corresponding to the intracellular-to-extracellular refill rate. FIG. 2A depicts an example of an optical blood monitoring system usable in connection with a hemodialysis treatment. Removing fluid too slowly (e.g., corresponding to “profile A” of a hemodialysis treatment) extends the treatment time which frustrates patients, incurs more time and labor costs, and / or prevents adequate fluid removal in the given session. Conversely, removing fluid too fast (e.g., corresponding to “profile B” of a hemodialysis treatment) causes cramping and potential hypotensive episodes, increasing risks to the dialysis patient.

[0033] Profiles A, B and C are discussed, for example, in U.S. Patent No. 11,596,723, which is incorporated by reference herein in its entirety. As discussed therein, it is advantageous to monitor the percentage change in blood volume (ABV %) during the course of a dialysis treatment to ensure that the treatment is safe and effective. There is a tradeoff between ultrafiltration rate (rate at which fluid is removed) versus risk of intradialytic complications (such as cramping, nausea, vomiting, lightheadedness, and hypotension).• If ABV % has a positive slope, is flat, or has a slightly negative slope, the patient's plasma refill rate is occurring at a greater rate, the same rate, or a slightly slower rate relative to the ultrafiltration rate of the dialysis treatment, which suggests that the ultrafiltration rate may be increased without immediate risk of symptoms. This corresponds to a profile where ABV % reduction is at or less than 3% per hour, and may be referred to as “Profile A.”Leydig 774121 (240002W001)• If ABV % has a steep negative slope, the patient is experiencing a rapid decrease in blood volume (corresponding to a rapid increase in hemoconcentration of red blood cells), and the ultrafiltration rate is much higher than the plasma refill rate. This suggests that the patient is at higher risk of symptoms and an intervention may be necessary. This profile, where ABV % reduction is in excess of 6.5% per hour or 15%, may be referred to as “Profile C.”• If ABV % profile has a gradual negative slope (i.e., more negative than Profile A but less negative than Profile C), the dialysis treatment is considered a good compromise for most patients between ultrafiltration rate and prevention of symptoms. This profile, where ABV % reduction is greater than 3% per hour and less than or equal to 6.5% per hour and less than or equal to 15%, may be referred to as “Profile B”.

[0034] In view of the foregoing, exemplary embodiments of the present application provide for various systems to be utilized together in connection with a hemodialysis machine to facilitate safe and efficient provision of hemodialysis treatment for a patient. The overall system may include, for example, the hemodialysis machine, an intelligent massaging system, an optical blood monitoring system, and a body composition monitor. It is understood that the term “hemodialysis machine” may encompass a dialysis machine operating in a hemodialysis (HD) mode, in a hemofiltration (HF) mode, or in a hemodiafiltration (HDF) mode. Additionally, the term “hemodialysis machine” is understood to encompass a dialysis machine that is principally or exclusively configured to perform hemodialysis, hemofiltration, or hemodiafiltration only.

[0035] Massaging can help move fluids and toxins in the body and facilitate fluid being removed more quickly and efficiently, particularly with regard to fluid that may be “trapped” in certain areas of the body, such as in the legs or feet. Massage, such as deep tissue massage, releases creatinine (a muscle enzyme), which enters circulation and is subsequently excreted. Thus, a creatinine level in the bloodstream post-massage will be temporarily higher (and detectable) until the creatinine has been excreted. Additionally, immediate shifts in fluid have been observed when a patient moves (even slightly) in a way which reduces pressure on key points of the vascular system, and this effect can also be achieved with massage. By utilizing information during treatment (such as creatinine level and / or changes in refill rate (or a lack thereof) in response to massaging certain areas of the body), the intelligent massaging system according to exemplary embodiments of the present application may determine, for example,Leydig 774121 (240002W001) whether to continue to massage a certain area of the patient (and for how long), whether to increase or decrease intensity of the massage, and / or whether to move onto another area of the patient.

[0036] The intelligent massaging system may include, for example, a table or a chair on which the patient lies down or sits, with various controllable massaging actuators (e.g., mechanical, infrasonic, or ultrasonic massage pads) disposed at various points corresponding to various parts of a patient’s body. Each massaging actuator is configured to manipulate a respective part of the patient’s body, for example, by applying force to the patient’s body in a rolling, tapping, or kneading motion. The intelligent massaging system may further include, for example, accessory devices, such as a foot massaging device having additional massaging actuators. The massaging actuators may be connected to and controllable by a processor (e.g., a controller) of the intelligent massaging system and / or may be connected to and controllable by other processors of the overall hemodialysis system (such as a processor of the optical monitoring system or of the hemodialysis machine, or of an overall processing system which obtains data from and coordinates the various devices / systems of the overall hemodialysis system).

[0037] FIG. 2A depicts an example of an optical blood monitoring system 200 usable in connection with a hemodialysis treatment. The optical blood monitoring system may include a sensor clip assembly 201, attachable to a blood chamber of an extracorporeal blood circuit, which is configured to monitor parameters such as hematocrit, oxygen saturation, and blood volume change. The information provided by the optical monitoring system indicates how much fluid is available for ultrafiltration (UF) during treatment and can provide relevant information and / or notifications to a clinician relating to adaptation of a UF rate during treatment (e.g., via a display 202). For example, if this optical monitoring system determines that the fluid shift in the blood is too fast, it will indicate a “C profile,” meaning that a crash (cramping / hypotensive episode) is imminent. FIG. 2B depicts an example of a graphical user interface of the optical blood monitoring system of FIG. 2A showing a C profile.

[0038] FIG. 3 depicts an example of a body composition monitor (BCM) 302 and a massaging table 330 usable in connection with a hemodialysis treatment in accordance with an exemplary embodiment of the present application. The BCM 302 is connected to the patient while the patient is on the massaging table 330, and the BCM 302 may be used to determine aLeydig 774121 (240002W001) dry weight volume for a patient using, for example, bioimpedance measurements of body tissues, allowing a determination of how much fluid can be removed from the patient during a treatment.

[0039] FIG. 4 depicts an example of a hemodialysis (HD) system 400. The HD system 400 includes an HD machine 402 to which a disposable blood component set 404 that forms a blood circuit is connected. During hemodialysis, arterial and venous patient lines 406, 408 of the blood component set 404 are connected to a patient and blood is circulated through various blood lines and components, including a dialyzer 410, of the blood component set 404. At the same time, dialysate is circulated through a dialysate circuit formed by the dialyzer 410 and dialysate lines connected to the HD machine 402. The dialysate passes through the dialyzer 410 along with the extracorporeal blood. The blood and dialysate passing through the dialyzer 410 are separated from one another by a semi-permeable structure (e.g., a semi-permeable membrane and / or semi- permeable microtubes) of the dialyzer 410. As a result of this arrangement, toxins are removed from the patient's blood and collected in the dialysate. The fdtered blood exiting the dialyzer 410 is returned to the patient. The dialysate that exits the dialyzer 410 includes toxins removed from the blood and is commonly referred to as “spent dialysate.” The spent dialysate is routed from the dialyzer 410 to a drain.

[0040] A dialysate container 424 is connected to the HD machine 402 via a dialysate supply line 426. A drain line 428 and an ultrafiltration line 429 also extend from the HD machine 402. The dialysate supply line 426, the drain line 428, and the ultrafiltration line 429 are fluidly connected to dialysate lines inside the housing 403 of the HD machine 402 that form part of the dialysate circuit. During hemodialysis, the dialysate supply line 426 carries fresh dialysate from the dialysate container 424 to the portion of the dialysate circuit located inside the HD machine 402. The blood component set 404 is secured to a module 430 attached to the front of the HD machine 402. The module 430 includes a blood pump 432 capable of driving blood through the blood circuit. The module 430 also includes various other instruments capable of monitoring the blood flowing through the blood circuit.

[0041] A drug pump 492 also extends from the front of the HD machine 402. The drug pump 492 is a syringe pump that includes a clamping mechanism configured to retain a syringe 478 of the blood component set 404. The drug pump 492 also includes a stepper motor configured to move the plunger of the syringe 478 along the axis of the syringe 478. A shaft of the stepper motor is secured to the plunger in a manner such that when the stepper motor is operated in aLeydig 774121 (240002W001) first direction, the shaft forces the plunger into the syringe 478, and when operated in a second direction, the shaft pulls the plunger out of the syringe 478. The drug pump 492 can thus be used to inject a liquid drug (e.g., heparin) from the syringe 478 into the blood circuit via a drug delivery line 474 during use, or to draw liquid from the blood circuit into the syringe 478 via the drug delivery line 474 during use. HD system 400 also includes a saline bag 476 with a respective delivery line 472.

[0042] The HD machine 402 includes a display screen 418 and a control panel 420. The display screen 418 and the control panel 420 allow an operator to input various treatment parameters to the HD machine 402 and to otherwise control the HD machine 402. The display screen 418 functions to provide information to the patient and the operator of the HD system 400. For example, the display screen 418 may display information related to a dialysis treatment to be applied to the patient, including information related to a prescription, as described above. In some embodiments, the display screen 418 is a touch screen for direct input of treatment parameters.

[0043] The HD system 400 includes a processing module 401 (e.g., a processor). The processing module 401 is configured to communicate with the touch screen 418 and the control panel 420. The processing module 401 may be configured to receive data from the touch screen 418 and the control panel 420, as well as BCM 302, and may control the HD machine 402 based on the received data. For example, the processing module 401 can adjust the operating parameters of the HD machine 402.

[0044] FIG. 5 depicts an example of a connected health (CH) system 500 in accordance with an exemplary embodiment of the present application. The CH system includes various elements which may communicate with each other via a network (e.g., CH cloud 520). The various elements of the CH system 500 may include, for example, an HD machine 402 (e.g., in a clinical setting or at the home) with optical monitoring system, a gateway device 510, an intelligent massaging system 530 (shown in this example in the form of a massaging chair), a BCM 302, and a remote computing device 540 (e.g., capable of remote control, storage / access of electronic health records (EHR), and / or other functions). The CH cloud 520 facilitates communication and cooperation between the various different elements shown in FIG. 5 and / or with other external elements, and the CH cloud 520 may be further connected to the Internet.Leydig 774121 (240002W001)

[0045] The intelligent massaging system 530 may be implemented as a massage chair (e.g., as depicted) or in other forms (such as in the form of a massage table, or a combination of multiple massaging elements, such as a massage chair in combination with a foot massager). The intelligent massaging system 530 may further include sensors (e.g., weight and / or pressure sensors) which monitor the posture and / or position of the patient, as well as a processing system for intelligently controlling the massaging operations based on feedback from the sensors and / or based on communication with an HD system providing an ongoing HD treatment for a patient.

[0046] The intelligent massaging system 530 works together with the HD machine 502, the optical monitoring system, and the BCM 302 to provide improved HD treatments for patients. The optical monitoring system allows for determination of a double pool refdl rate for a patient undergoing HD treatment based on measuring hematocrit levels before a vibration / massage is initiated and then tracking the duration of time before the constant UF profde changes from C or B to A. This determines the extent to which the specific vibration / massage initiated has increased the available fluids via the rate of replenishment of the intravascular fluids removed by the HD treatment ultrafiltration. A short duration (e.g., five minutes or less) indicates that more fluid is available, and that more frequent massaging will keep the fluid moving. A long duration (e.g., greater than five minutes) means less fluid is available, so the intelligent massaging system will attempt to massage a different location to try to move fluid at that location. In other words, a long duration indicates that the vibration provided via a respective massaging cycle did not significantly increase the rate of replenishment.

[0047] If massage via an entire array of vibration pads of the intelligent massaging system 530 has been attempted with no change in the profile and there is still at least half an hour on the remaining treatment duration (RTD) timer, the intelligent massaging system 530 may prompt the patient to change positions. If there is less than half an hour remaining in the treatment, the vibration array may be kept inactive unless manually initiated by the user.

[0048] In an exemplary embodiment, the intelligent massaging system may learn over time efficient patterns and location sequences (tailored to specific respective patients and / or generally-applicable patterns and sequences). This information may be stored and then used for future treatments.

[0049] In an exemplary embodiment of the present application, a method for providing a hemodialysis treatment may include the following stages:Leydig 774121 (240002W001)Prior to initiating treatment:1. The intelligent massaging system is connected to the hemodialysis machine and / or a clinic medical information system (e.g., an electronic health records (EHR) system).2. The patient is assigned to the intelligent massaging system and the patient’s age and gender is noted.3. The patient lies or sits on an apparatus of the intelligent massaging system, and his / her height and weight are determined (e.g., for a patient laying down on a massaging table, a loadcell may weigh the patient and ultrasonic or laser distance sensors at either end of the table may measure the length / height of the patient). The weight distribution of the patient may also be determined and utilized to determine a massaging sequence with respect to parts of the patient (e.g., if it is determined that there is excess weight in the leg or feet area, where fluid is prone to pooling, then the massaging system may work on those parts of the patient first). With respect to the massaging sequence, different body parts may have different corresponding massage times.4. Using the height and weight information, a body composition monitor (BCM) device determines the patient’s dry weight (e.g., via a dedicated handrest and footrest of a table or chair).5. The hemodialysis machine is set with the dry weight, and an ultrafiltration goal is determined based thereon.6. The patient is connected to the hemodialysis machine via a blood access.During treatment:7. The patient’s blood flows through an extracorporeal blood circuit which is monitored by the optical monitoring system to determine a double pool refill rate. The use of an optical monitoring system for determining a double pool refill rate is discussed, for example, in U.S. Patent No. 10,881,347 and U.S. Patent Publication No. 2020 / 0086026, which are both incorporated herein by reference in their entireties.8. Based on feedback from the optical monitoring system, for example, if plasma refilling is going too slowly, the intelligent massaging system may be triggered to begin massaging a certain part of the patient (e.g., starting with one or both legs) via corresponding actuators.9. The optical monitoring system may utilize information obtained after the massaging begins to determine whether the massaging of that part of the patient is effective (e.g., with regard to stimulating shift of fluid from cellular compartment), and may stop the massage (or decrease theLeydig 774121 (240002W001) strength of the massage) of that part of the patient after a certain amount of time and / or after detecting a decrease in effectiveness to avoid unnecessary patient discomfort.

[0050] FIGS. 6A-6B depict flowcharts illustrating processes for providing a hemodialysis treatment supplemented by treatment-enhancing massage routines according to exemplary embodiments of the present application.

[0051] FIG. 6A depicts certain stages occurring prior to initiating hemodialysis treatment. At stage 601, the current weight of a patient is determined (e.g., from a scale). At stage 602, a BCM performs overhydration and dialysis volume measurements. At stage 603, a target dry weight is set based on the information from the BCM. At stage 604, the patient sits or lies down on a massage chair or table. At stage 605, the optical monitoring system is connected to a hemodialysis machine, and the treatment is ready to begin. At stage 606, treatment begins, and, at stage 607, treatment information (e g. Het and / or double pool refill rate) is determined. In response to the treatment information, at stage 608, a massage sequence is run via an intelligent massaging system. The blood pump of the HD machine may be turned off during the massage sequence, depending on the severity of the hematocrit check results. After the massage sequence is performed, the patient’s reaction thereto is monitored, and based on the patient’s reaction, the intelligent massaging system and / or the HD system may determine what subsequent steps are to be taken.

[0052] It will be appreciated that the stages shown in FIG. 6A are merely exemplary, and that the stages do not necessarily need to be performed in the order shown.

[0053] FIG. 6B depicts certain stages occurring during hemodialysis treatment. At stage 610, the treatment begins and a treatment clock or RTD timer is started. At stage 611, the blood pump and the ultrafiltration pump of the hemodialysis are running during the hemodialysis treatment. At stage 612, while the treatment is ongoing, a hematocrit check is performed by the optical monitoring system, and based on the trend, it is determined whether the hemodialysis treatment is currently in profile A (too slow), profile B (acceptable speed), or profile C (too fast), as well as whether or not more fluid can be moved. If in profile B according to the hematocrit check at stage 612, the treatment continues without any massaging being performed by the intelligent massaging system. If in profile A according to the hematocrit check at stage 612, the massage function is run for an amount of time at stage 613, and based on a further hematocrit check at stage 614, the process proceeds to stage 611 (if in profile A or B) or to stage 618 (if in profile C).Leydig 774121 (240002W001)

[0054] If in profile C according to the hematocrit check at stage 612, the process proceeds to stage 615, wherein the ultrafiltration pump is turned off, and stage 616, where the massage function is run for X seconds (and it will be appreciated that stages 615 and 616 may be simultaneously occurring). At stage 617, a hematocrit check is performed. If in profile A according to the hematocrit check at stage 617, the process proceeds to stage 613. If in profile B according to the hematocrit check at stage 617, the process proceeds to stage 611. If in profile C according to the hematocrit check at stage 617, the process proceeds to stage 618.

[0055] At stage 618, the time left on the treatment clock is compared to a threshold (e.g., 10 minutes), and if greater than the threshold, then the process proceeds to stage 611. If less than the threshold, then the process proceeds to stage 619, wherein it is determined whether the patient has reached the target dry weight. If yes, the treatment ends (stage 620). If no, then the process proceeds to stage 615.

[0056] It will be appreciated that the massaging by the intelligent massaging system may not be run continuously throughout the course of a long HD treatment, as the massage force and pattern of force are configured to stimulate fluid transfer and is not likely to be comfortable to the patient.

[0057] In further exemplary embodiments, patient-specific reactions to various massage sequences and durations may be monitored (e.g., by the intelligent massaging system, by the HD system, and / or by some other processing system) to, over time, develop patient-specific massage routines that are specifically adapted to the specific patient.

[0058] In further exemplary embodiments, the intelligent massaging system may initiate targeted massages of local areas of the patient’s body and observe the patient’s refill reaction to the massaging sequence to that local area. This provides insights into the patient’s vascular system, such as circulatory weak points where fluid is prone to becoming “trapped.” Based on such information, the patient’s HD treatment plan may include targeting massages at the fluid flow weak points such that the patient may be maintained in profile B while running the HD treatment more rapidly.

[0059] In further exemplary embodiments, the intelligent massaging system and / or the HD system may prompt the patient and / or the clinician to incorporate certain auxiliary devices, such as smaller massage devices for targeted message, and give corrective feedback to the patient and / or clinician to correct problematic postures based on identified circulatory weak points. ForLeydig 774121 (240002W001) example, a chime or light near the calf of a patient can activate if the patient is resting too much weight below the patient’s knee. Alerts may also be provided with respect to the identified weak points, further in tandem with sensor measurements, so to avoid situations where a patient’s posture may be compounding risk of occlusion in a patient’s prior-identified problematic areas.

[0060] In further exemplary embodiments, a potassium monitoring system and / or a creatinine monitoring system may further be provided to monitor the patient’s potassium and / or creatinine levels. The monitoring system(s) may provide potassium level information and / or creatinine level information used to trigger the intelligent massaging system to turn off (or to move onto a next body part) and / or to trigger an alert if the serum potassium is significantly different between pre- and post-dialysis measurements. The monitoring system(s) may include, for example, an ultrasonic or optical sensor disposed at the extracorporeal blood circuit.

[0061] In a further exemplary embodiment, machine learning may be utilized to determine a massage pattern, length, and / or frequency for efficient shift of fluid when the extracellular compartment has drained. The determined massage pattern, length, and / or frequency may be patient-specific and stored for future treatments.

[0062] In a further exemplary embodiment, blood volume monitoring may be performed ultrasonically, for example, based on a patient’s calf that is pressed flat on a surface of the massaging apparatus (e.g., a table). The blood volume monitoring may indicate poor blood flow, which may be due to the patient occluding an artery. In response to the blood volume monitoring determining poor blood flow, the UF pump rate may be reduced, and the patient may be prompted to move. Then, once adequate blood flow is observed to be reestablished, the system may ramp up ultrafiltration again. This may provide the advantage of preventing or reducing cramping in patients.

[0063] In a further exemplary embodiment, the intelligent massaging system may be configured as one or more modules that can be used with existing dialysis chairs.

[0064] In further exemplary embodiments, the intelligent massaging system may be used in connection with peritoneal dialysis (PD) treatment systems. For example, remote monitoring of treatment parameters for an at-home PD patient may be remotely monitored, and the intelligent massaging system may be remotely controlled to provide one or more massage sequences based on the treatment parameters for the PD patient undergoing PD treatment.Leydig 774121 (240002W001)

[0065] It will be appreciated that exemplary embodiments of the present application provide for various advantages with respect to efficiency and efficacy for hemodialysis treatments, as well as providing for better health outcomes with reduced labor costs and in less time.

[0066] 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.

[0067] 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.

[0068] 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 value 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 theLeydig 774121 (240002W001) specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0069] 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

Leydig 774121 (240002W001)CLAIMS:

1. A system, comprising: a dialysis system configured to provide a dialysis treatment for a patient; an optical monitoring system in communication with the dialysis system, wherein the optical monitoring system is configured to obtain measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and a massaging system in communication with the dialysis system, wherein the massaging system is configured to provide massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

2. The system according to claim 1, further comprising: a body composition monitor in communication with the dialysis system, wherein the body composition monitor is configured to obtain body composition measurements from the patient; wherein the dialysis system is configured to set a target dry weight for the patient based on the body composition measurements from the patient.

3. The system according to claim 1, wherein running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.

4. The system according to claim 1, wherein the dialysis system is configured to turn off an ultrafiltration pump in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than a second profile threshold; andLeydig 774121 (240002W001) wherein the massaging system is configured to massage the patient for a predetermined amount of time in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than the second profile threshold.

5. The system according to claim 1, wherein the optical monitoring system is further configured to obtain measurements indicative of the patient’s respective refill responses to respective massage sequences; and wherein the massaging system is configured to generate and store a customized massage routine for the patient based on the patient’s respective refill responses to respective massage sequences.

6. The system according to claim 1, wherein the massaging system is configured to provide a localized massage for a local area of the patient’s body; wherein the optical monitoring system is further configured to obtain measurements indicative of the patient’s refill response to the localized massage; and wherein the massaging system is configured to determine whether to continue massaging the local area of the patient’s body or to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage.

7. The system according to claim 6, wherein the massaging system is configured to determine to continue massaging the local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating that there is additional movable fluid in the local area of the patient’s body.

8. The system according to claim 6, wherein the massaging system is configured to determine to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating a lack of remaining movable fluid in the local area of the patient’s body.Leydig 774121 (240002W001)9. The system according to claim 1 , wherein the dialysis system comprises a hemodialysis machine.

10. A method for massaging a dialysis patient for improving effectiveness of dialysis treatment, comprising: providing, by a dialysis system, a dialysis treatment for the patient; obtaining, by an optical monitoring system in communication with the dialysis system, measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and providing, by a massaging system in communication with the dialysis system, massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

11. The method according to claim 10, further comprising: obtaining, by a body composition monitor in communication with the dialysis system, body composition measurements from the patient; and setting, by the dialysis system, a target dry weight for the patient based on the body composition measurements from the patient.

12. The method according to claim 10, wherein running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.

13. The method according to claim 10, further comprising:Leydig 774121 (240002W001) turning off, by the dialysis system, an ultrafiltration pump in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than a second profile threshold; and massaging, by the massaging system, the patient for a predetermined amount of time in response to obtaining data from the optical monitoring system indicative of the dialysis treatment progressing faster than the second profile threshold.

14. The method according to claim 10, further comprising: obtaining, by the optical monitoring system, measurements indicative of the patient’s respective refill responses to respective massage sequences; and generating and storing, by the massaging system, a customized massage routine for the patient based on the patient’s respective refill responses to respective massage sequences.

15. The method according to claim 10, further comprising: providing, by the massaging system, a localized massage for a local area of the patient’s body; obtaining, by the optical monitoring system, measurements indicative of the patient’s refill response to the localized massage; and determining, by the massaging system, whether to continue massaging the local area of the patient’s body or to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage.

16. The method according to claim 15, further comprising: determining, by the massaging system, to continue massaging the local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response to the localized massage indicating that there is additional movable fluid in the local area of the patient’s body.

17. The method according to claim 15, further comprising: determining, by the massaging system, to move on to massage another local area of the patient’s body based on the obtained measurements indicative of the patient’s refill response toLeydig 774121 (240002W001) the localized massage indicating a lack of remaining movable fluid in the local area of the patient’s body.

18. The method according to claim 10, wherein the dialysis system comprises a hemodialysis machine.

19. One or more non-transitory computer-readable mediums having processorexecutable instructions stored thereon for massaging a dialysis patient for improving effectiveness of dialysis treatment, wherein the processor-executable instructions, when executed, facilitate performance of the following operations: providing, by a dialysis system, a dialysis treatment for the patient; obtaining, by an optical monitoring system in communication with the dialysis system, measurements of the patient’s hematocrit, oxygen saturation and / or blood volume change during the dialysis treatment, wherein the measurements are indicative of a double pool refill rate for the patient during the dialysis treatment; and providing, by a massaging system in communication with the dialysis system, massaging for the patient during the dialysis treatment, wherein providing massaging for the patient includes running a massage sequence taking into account the measurements obtained by the optical monitoring system.

20. The one or more non-transitory computer-readable mediums according to claim 19, wherein running the massage sequence includes: obtaining data from the optical monitoring system indicative of the dialysis treatment progressing slower than a first profile threshold; and massaging, by a massaging apparatus of the massaging system, the patient for a predetermined amount of time in response to the obtained data being indicative of the dialysis treatment progressing slower than the first profile threshold.

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