US20230355954A1 - Wireless diagnostic system for indirect flow measurement in artificial heart pumps - Google Patents

Abstract

Systems, apparatuses, and methods are disclosed for optimizing management of one or more implanted artificial heart pumps. An example method includes wirelessly retrieving, via one or more portable diagnostic devices, data regarding the one or more implanted artificial heart pumps. The example method further includes analyzing, by a server device, performance characteristics of the one or more implanted artificial heart pumps based on the retrieved data. The example method further includes causing rendering of the performance characteristics. Corresponding apparatuses and computer program products are contemplated.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 16/161,423, filed Oct. 16, 2018, which is a continuation of U.S. application Ser. No. 15/353,926, filed Nov. 17, 2016, now U.S. Pat. No. 10,130,743, which claims the benefit of U.S. Provisional Patent Application No. 62/256,659, filed Nov. 17, 2015, the entire contents of each of which are incorporated herein by reference.
TECHNOLOGICAL FIELD
• Example embodiments of the present invention relate generally to implanted artificial heart pumps that indirectly measure flow and, more particularly, to methods and apparatuses for acquiring and analyzing data from implanted artificial heart pumps.
BACKGROUND
• In the field of artificial heart-assist technology, advances in the mechanical design of implantable circulatory pumps have been complemented by similar improvements in their external control units. These units have been designed to be increasingly sensitive to the dynamic interaction between the blood pump and the patient's heart to better provide end-users with real-time information that can be used to measure the machine's performance under particular operating parameters.
• While blood flow measurement through the artificial heart pump is most accurate when received directly from an actual probe inserted into the outflow track of the pump conduit, implanted sensors that maintain direct contact with blood can perturb its flow and activate factors within the blood that increase the risk of blood clot formation. These clots can disturb motor blade performance and cause complete machine malfunction. When this occurs, total pump replacement may be required, mandating a high-risk open chest surgery. In the United States, direct flow heart pumps are limited, by regulation, to investigational use only. Only indirect flow measurement technology is approved by the Food and Drug Administration (FDA) for widespread therapeutic use in the United States, and heart pump engineering trends are producing new indirect-flow prototypes that are more reliable and durable than previous iterations because they continue to reduce the number of high resistance areas in the interface between the pump's surface and the patient's blood. Currently, the newest “3^rdgeneration” heart pump models all estimate flow indirectly without the use of direct sensor components.
• As an alternative to the placement of direct measurement sensors in the body, heart pump performance can be indirectly estimated using engineering formulas that relate motor torque, fluid flow rate, and the pressure of fluid moved by the motor at a particular speed. For most heart pumps, the speed of the moving motor blades that propel blood forward through the heart is the one fixed variable that can be adjusted by the end-user. Because the motors are based on brushless, direct-current design, the torque they generate is directly proportional to the power they consume in electrical current. By measuring the real-time power demands of a pump, the torque variable can be estimated. Once both torque and speed variables are known, flow and pump head pressure (the difference in pressure between the inflow and outflow portions of the pump) can be estimated. Heart pumps differ from each other in certain design characteristics that cause them to react idiosyncratically when they consume power to propel blood through the circulation. As a result, each pump utilizes its own proprietary program to convert current usage to torque and to calculate the effects of blood viscosity on the motor.
• In its current design configuration, to obtain real-time flow measurements for heart pump technology based on indirect flow estimations, a portable controller must be attached to a larger monitor. Depending on the manufacturer, the monitor contains the software to display continuous flow data, either numerically alone or both numerically and in a waveform format. These monitors are cost prohibitive for individual patient use, and only intended for diagnosing and managing heart pump-related issues in hospital or clinic facilities where expert personnel are available to titrate the motor speed to optimal flow dynamics. After hospital discharge, and between outpatient clinic visits every several months, the heart pump device functions according to the most recent settings and cannot respond dynamically to any change in the patient's physiology.
• The inability to remotely discern heart pump operating variables, characterize their trends over time, and assess their interactions with the native heart represents a missed opportunity to better utilize this transformative technology. The infrequent contact between expert and patient due to logistical constraints results in a necessarily passive heart pump utilization strategy that precludes maximal titration of the heart pump to respond to the patient's changing circulatory status. High motor rotating speeds can cause greater emptying of the left heart than physiologically appropriate and precipitate suction problems between the inlet port and the heart wall, especially in low volume situations. Because patients receive limited supervision as outpatients, clinicians and engineers may enter long-term speed settings that are lower than optimal to provide a safety margin against heart pump suction complications. However, this added safety is gained at the cost of the pump's full potential to support the heart, which could be achieved with higher operating speeds. This is undesirable because heart failure is a dynamic process: either the patient's native circulatory function is improving with the support of the pump and gradually recovering lost function or it is further deteriorating as a result of intrinsic, irreversible disease—opposite trends that require divergent heart pump management strategies. Level of patient daily activity and hydration status are other variable factors that can influence the optimal operating target speed of a particular heart pump.
• A device with the capability to remotely monitor disease progression in patients with implanted artificial heart pumps, including those using the indirect-flow measurement algorithms on which the great majority of heart pumps operate, could form the cornerstone of a more nuanced heart pump management strategy by facilitating expert oversight of the patient and the implanted artificial heart pump in a non-clinical setting. A system employing such a device could utilize software packages to create dynamic models of the heart pump flow patterns and the patient's cardiac performance to guide fine-tuning of speed adjustments. Such an innovation would be useful for ensuring the most satisfactory pump performance and identifying problem trends requiring early intervention to prevent severe complications, including hospitalization or death.
BRIEF SUMMARY
• Accordingly, example embodiments described herein demonstrate methods and apparatuses for the remote monitoring and assessment of implantable artificial heart pumps, including those that indirectly measure flow. Some example embodiments rely on indirect measurement of blood flow and blood pressure characteristics to guide decision-making regarding the optimum operating parameters of the machine. Because many implantable artificial heart pumps are designed for long-term use in the outpatient setting, example embodiments described herein greatly expand the oversight capability and permit more data-driven optimization of indirect flow measurement blood pumps without added interference with recipients' quality of life and independence.
• In a first aspect of the invention, a diagnostic device is contemplated that will attach to the site on the heart pump controller at the connector location designed by the manufacturer to interface directly with a supplemental monitor used in clinical settings. In normal outpatient operations, this port is either not utilized or supports a redundant connection to the external battery pack. However, as described below, this port may be used in some example embodiments to continuously query the internal heart pump's external portable controller to gather data on power consumption and other operating variables estimated by the controller using manufacturer-specific algorithms. In some embodiments, the transfer of data from the heart pump to the diagnostic device may be restricted to a single direction to protect the integrity of the system by ensuring that changes to the operating speed can only occur with manual adjustment. As described below, the diagnostic device may also be designed to record problem-event alarms that are activated by the pump controller when the estimated flow either exceeds or falls below manufacturer-specified parameters. Currently, this real-time data is inaccessible to expert decision makers during the interval period that a patient is outside of a formal medical environment.
• In another aspect of the invention, the diagnostic device may contain a wireless transmitter to send heart pump performance data to remote monitoring servers for processing and analysis. The transmission technology may, in some embodiments, have the capability to communicate across multiple wireless bandwidths, including low-power radio frequencies and those allocated by the Federal Communications Commission (FCC) for exclusive medical usage. This aspect of the invention, for the first time, allows indirect flow measurements and other pump performance characteristics to be remotely retrieved. It should be understood that in some embodiments, the heart pump controller may be itself be designed to carry out wireless transmissions, and in such embodiments, the heart pump controller can transfer the heart pump performance data to the remote monitoring servers without the need to utilize a separate diagnostic device as an intermediary.
• In another aspect of the invention, a receiving computer server at a remote site location may receive the transmitted signals from the device and use a software application to process the heart pump performance and estimate additional physiological variables using mathematical algorithms. The receiving computer may, in this regard, also arrange the data in an integrated visual platform that provides more clinical information than the raw engineering numbers heretofore generated by manufacturers' software and may present that information in a more intuitive fashion for expert end-users. As a result, this aspect of the invention may better promote best-practice clinical decisions regarding heart pump use than currently exist for indirect flow measurement machines.
• The above summary is provided merely for purposes of summarizing some example embodiments to provide a basic understanding of some aspects of the invention contemplated herein. Accordingly, it will be appreciated that the above-described embodiments are merely examples and should not be construed to narrow the scope or spirit of the invention in any way. It will be appreciated that the scope of the invention encompasses many potential embodiments in addition to those here summarized, some of which will be further described below.
BRIEF DESCRIPTION OF THE DRAWINGS
• Having thus described some example embodiments in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale.
• FIG.1 provides a schematic block diagram of an example system comprising diagnostic device in contact with a ventricular assist device and a remote server, in accordance with example embodiments described herein.
• FIGS.2A,2B,2C, and2D illustrate a series of perspective views of an example wireless diagnostic device having a hub connector designed to interface with a certain proprietary heart pump controller, in accordance with example embodiments described herein.
• FIGS.3A,3B,3C, and3D provides a multi-dimensional view of another example wireless diagnostic device with a hub connector designed to interface with an alternate proprietary heart pump controller, in accordance with example embodiments described herein.
• FIG.4 illustrates a flowchart describing example operations for analyzing data retrieved from an implanted artificial heart pump that indirectly measures flow by a diagnostic device, in accordance with example embodiments described herein.
• FIG.5 provides an illustration of a user interface provided by an example remote heart pump monitoring application that provides a visual dashboard for assessing data acquired from the heart pump and patient-related physiological estimates, in accordance with example embodiments described herein.
• FIG.6 provides an illustration of a high-level system diagram in accordance with example embodiments described herein.
DETAILED DESCRIPTION
• Some example embodiments will now be described more fully with reference to the accompanying drawings, in which some, but not all, contemplated embodiments are shown. Indeed, the contemplated inventions may be embodied in many different forms and should not be construed as limited to the example embodiments set forth herein; rather, these example embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. As used herein, “data,” “content,” “information,” and similar terms may be used interchangeably to refer to data capable of being transmitted, received, and/or stored in accordance with embodiments of the present invention. Thus, use of any such terms should not be taken to limit the spirit or scope of the present invention.
• As used herein, a “computer-readable storage medium,” which refers to a non-transitory physical storage medium (e.g., a volatile or non-volatile memory device), can be differentiated from a “computer-readable transmission medium,” which refers to an electromagnetic signal.
• As used herein, a “processor,” which may comprise, for example,microprocessor24,processor74, or the like, may be embodied in a number of different ways. For example, the processor may be embodied as one or more of various hardware processing means such as a co-processor, a microprocessor, a controller, a digital signal processor (DSP), a processing element with or without an accompanying DSP, or various other processing circuitry including integrated circuits such as, for example, an ASIC (application specific integrated circuit), an FPGA (field programmable gate array), a microcontroller unit (MCU), a hardware accelerator, a special-purpose computer chip, or the like. As such, in some embodiments, the processor may include one or more processing cores configured to perform independently. A multi-core processor may enable multiprocessing within a single physical package. Additionally or alternatively, the processor may include one or more processors configured in tandem via the bus to enable independent execution of instructions, pipelining, and/or multithreading.
• In example embodiments, the processor may be configured to execute instructions stored in a memory (e.g.,memory devices25 or77) or otherwise accessible to the processor. Alternatively or additionally, the processor may be configured to execute hard-coded functionality. Thus, for example, when the processor is embodied as an ASIC, FPGA, or the like, the processor may comprise specifically configured hardware for conducting operations described herein. Alternatively, as another example, when the processor is embodied as an executor of software instructions, the instructions may specifically configure the processor to perform the algorithms and/or operations described herein when the instructions are executed. The processor may include, among other things, a clock, an arithmetic logic unit (ALU), and logic gates configured to support operation of the processor.
• In turn, as used herein a “memory,” such asmemory devices25 and77 may be non-transitory and may include, for example, one or more volatile and/or non-volatile memories. In other words, for example, the memory may be an electronic storage device (e.g., a computer readable storage medium) comprising gates configured to store data (e.g., bits) that may be retrievable by a machine (e.g., a computing device like the processor). The memory may be configured to store information, data, content, applications, instructions, or the like, for enabling an apparatus to carry out various functions in accordance with an example embodiments described herein. For example, the memory could be configured to buffer input data for processing by the processor. Additionally or alternatively, the memory could be configured to store instructions for execution by the processor.
• Having discussed some example terminology used herein, some example embodiments of the present invention will now be described in greater detail. The following example embodiments describe methods and apparatuses for the remote monitoring and assessment of implantable artificial heart pumps without internal flow sensors. These example embodiments rely on indirect measurement of blood flow and blood pressure characteristics to guide decision-making regarding the optimum operating parameters of the machine.
• FIG.1 portrays an example comprehensiveremote monitoring system10 for an indirect-flow, implantable left ventricular assist device (LVAD)60. The system may include a remotediagnostic device20 that connects to theLVAD60, aremote server70 and an end-user device80.LVAD60 includes an inlet port that may be surgically positioned in the left ventricle of a patient's heart to receive oxygenated blood from the patient's lungs and an outflow port that may be surgically connected to the patient's aortic artery to conduit this blood to the patient's systemic circulation.LVAD60 further includes aninternal heart pump62 to drive the flow of blood from the patient's lungs through theLVAD60 to the patient's aortic artery. Depending on the particular configuration of theLVAD60, theinternal heart pump62 may comprise a rotating element supported with mechanical bearings, electromagnetic energy, or a combination thereof.
• Theinternal heart pump62 is designed to communicate with the external environment through a driveline that exits the patient's body from an incision in the patient's chest wall to accommodate the receipt of electricity from an external power supply66. Depending on the configuration of theLVAD60, the power supply66 may comprise one or more elements configured to produce the electricity that powers theinternal heart pump62. Depending on the particular configuration of theLVAD60, the power supply66 may comprise a battery that provide direct current electricity, a wall outlet or other source that provides alternating current electricity.
• The driveline also enables receipt of a motor control objective from an external heart pump controller64, which may, for instance, direct a rotating element of theinternal heart pump62 to rotate at a particular speed. In turn, the rotating element of theinternal heart pump62 may be configured to adjust its power consumption either up or down to maintain this predefined rotation speed despite changes in the patient's hemodynamic or physiological status that influence the environmental propulsion favorability. At least one computer-readable storage medium may store software comprising a set of program code instructions that, when executed, causes the heart pump controller64 to continuously monitor power consumption by the rotating element of theinternal heart pump62 and to detect fluctuations that may occur over time. Moreover, the software may utilize a proprietary, machine-specific algorithm to estimate blood flow through theinternal heart pump62. This algorithm can, for instance, be based on the known engineering principle that correlates power and speed to flow, the viscosity of the patient's blood that affects fluid dynamics, and motor design idiosyncrasies.
• As noted previously, the majority of LVADs do not utilize actual flow probes that are inserted in the implanted device due to the physiological problems such probes could cause. Instead, LVADs generate indirect flow measurements based on the machine-specific computational algorithms that report the flow rate variable based on its mathematical relationship of the known, observed variable of motor speed set by the operator and certain known patient physiological characteristics such as blood viscosity to the real-time power fluctuations of the machine (e.g., in terms of the wattage pulled by the machine from the battery or other power source) as it maintains a constant set speed under dynamic hydraulic conditions. The machine-specific algorithm referenced above may, in this regard, be derived by in vitro modeling of the functioning of a given LVAD using mock fluid loops that replicate the operation of the device in a fluid-filled, circulatory environment. Specifically, by establishing a computer connection to the LVAD, the data it generates when it is in communication with the internal pump component during dynamic activity in the mock loop can be collected, then software can be used to reconstruct the unique attributes of an LVAD's machine-specific algorithm that are based on how its proprietary motor(s) is designed to propel blood through the heart. This deduced algorithm can be used to indirectly measure blood flow through a giveninternal heart pump62.
• Thediagnostic device20 may be attached to the heart pump controller64 through a compatible mechanical andelectrical connector port50, which will be described in greater detail below in connection withFIGS.2A-2D and3A-3D. As illustrated inFIGS.2A-2D and3A-3D, thediagnostic device20 is a portable and in some embodiments, hand-holdable, device that does not appreciably interfere with the controller's physical profile or with a patient's pre-existing mobility, activity level, or range of motion (it should be understood that in embodiments in which the heart pump controller64 is configured to wirelessly transmit data in lieu of adiagnostic device20 will not substantially affect the overall morphology of the heart pump controller64 itself and thus will also not interfere with a patient's pre-existing mobility, activity level, or range of motion). Once connected to the heart pump controller64 viaconnector port50, thediagnostic device20 can receive data from the heart pump controller64. In some embodiments, thisconnector port50 only allows data transfer in a downstream direction, such that data cannot be sent from thediagnostic device20 to the patient's heart pump controller64; preventing data from being uploaded to the patient's heart pump controller64 in this fashion protects the integrity of the software employed by the heart pump controller64 and, in turn, ensures that changes to the operating speed of theLVAD60 can only occur with manual adjustment. However, in other embodiments it may be conceivable that theconnector port50 allows data to be transferred in both directions. For instance, theconnector port50 may include a user authentication feature (e.g., a biometric screening element or other secure identification mechanism) that allows data to be uploaded to the heart pump controller64 by pre-authorized users.
• When thediagnostic device20 receives data from the heart pump controller64 via theconnector port50, a bus within the diagnostic device20 (e.g., LVAD data format interface and router22) stores the data in amemory device25.Microprocessor24 may remove patient-identifying information and may encrypt the data to protect health information before it is transmitted to aremote server70 for analysis.
• After processing the data, thediagnostic device20 may make the data accessible to additional devices. In this regard, the data can be transmitted using awireless transmitter28 andinternal antenna29. Thetransmitter28 may, in various embodiments, have the capability to transmit collected data using a wide variety of wireless transmission modes30 (e.g., wireless communication modes such as radio communication, optical communication, sonic communication or the like). One example transmission may communicate data using special radio frequencies designated only for medical communications. It will be understood that while wireless transmission modes are contemplated herein and illustrated inFIG.1, some example embodiments of thediagnostic device20 may additionally or alternatively interact with remote devices (e.g., remove server70) using wireline communication.
• The data that is retrieved by thediagnostic device20 and transmitted toremote server70 may include speed setting input, estimated instantaneous and average blood flow rate over a specified time interval, variable power consumption, indications regarding the incidence of any proprietary preprogrammed alarm notifications, or any other data that theLVAD60 is configured to collect. Data transmission from the wirelessdiagnostic device20 to aremote server70 would typically be configured to occur continuously to facilitate the early identification of data trends that might require intervention. In an alternative configuration, however,diagnostic device20 may be configured to transmit data periodically, on a scheduled basis, or in response to an ad hoc request initiated from theserver70.
• While not true of all embodiments contemplated herein, the functions of thediagnostic device20 may in some cases be supported by an integrated power supply26. The power supply26 in such arrangements may be configured to receive power from the heart pump controller64, regulate it to compatible voltage, and allocate the power to therouter22,processor24, andwireless transmission components28 and29.
• FIG.2A depicts a long-axis, top-down view ofdiagnostic device20.FIG.2B depicts the same device in long-axis side view, andFIG.2C depicts the same side view with a downward tilt and medial rotation. As illustrated inFIGS.2A,2B, and2C, thediagnostic device20 includes aposterior portion30. In some embodiments, the main enclosure of theelectrical components32 is composed of injection-molded plastic, although other materials may also be considered without departing from the spirit or scope of the present invention.
• The upper portion of themain enclosure32 may include a faceplate34 (which may, in some embodiments, be polycarbonate) with display sensor data lights that indicate various things. In some embodiments, the faceplate may include three display sensor data lights to indicate whether functioning contact exists between the heart pump controller and device (e.g., viadisplay element36a), whether there is active communication between the device and a remote network (viadisplay element36b), and whether a recent alarm has been received from the controller (viaalarm display element36c), respectively. In some embodiments, a communication disruption (either between thediagnostic device20 and heart pump controller64 or between thediagnostic device20 and remote server70) or the incidence of controller alarms may be indicated with a colored light (e.g., a red light). It should be understood that whilealarm display element36cmay illustrate whether a recent alarm has been received from the controller of theLVAD60, in some embodiments,alarm display element36cmay additionally or alternatively illustrate whether an alarm condition is received fromremote server70, as described below. In contrast, normal connection andinternal heart pump62 function may be indicated with a differently colored like (e.g., a green light). As mentioned previously, thediagnostic device20 also includes a female connector port50 (which may, for instance, be rubber) having a central recessedhole52 surrounded by three symmetrically-arranged peripheral recessed holes54. Protecting theconnector port50 is an injection moldedplastic shroud40.Shroud40 may comprise ahub44, andcentral bevels42 that twist into position to secure the contact points between thediagnostic device20 and heart pump controller64.FIG.2D displays thediagnostic device20 in a short-axis frontal view, illustrating this hub and shroud configuration.
• An alternative embodiment of this diagnostic device is displayed inFIGS.3A-3D. These figures reproduce thesame device enclosure32, display elements36a-36c, andplastic connector shroud40 as displayed inFIGS.2A-2D, and in the same sequence of orientations.FIG.3D displays thediagnostic device20 in short-axis frontal view, portrayingconnector port50′ that consists of two panels comprising a male and a female component. The superior portion of the panel is comprised of sixpins52′ and an inferior portion comprised of six recessedholes54′. Accordingly,FIGS.2A-2D differ fromFIGS.3A-3D only in thatFIGS.3A-3D illustrate adifferent connector port50′ that enables thediagnostic device20 can connect to and communicate with a different type of heart pump controller64 that uses a different interface. Specifically, while theconnector port50 illustrated inFIGS.2A-2D is configured to interface with the heart pump controller64 of an HVAD system (manufactured by HeartWare), theconnector port50′ illustrated inFIGS.3A-3D is configured to interface with the heart pump controller64 of a HeartMate II LVAD (manufactured by Thoratec). However, it will be understood that whilediagnostic device20 has been illustrated inFIGS.2A-2D and3A-3D using these two particular types ofconnector ports50 and50′, other types of connector ports configured to interface with other heart pump controllers are contemplated without departing from the spirit or scope of the present invention.
• As noted previously, it should be understood that the capabilities of thediagnostic device20 may in some embodiments be added to the heart pump controller64 itself. In such embodiments, the heart pump controller may thus wirelessly transfer heart pump performance data without the need to connect to a separatediagnostic device20 that acts as an intermediary.
• Once data has been transmitted by the wireless diagnostic device20 (or, in embodiments in which the heart pump controller64 itself is able to communicate wireless, once data has been wirelessly transmitted by the heart pump controller64), it may be received by telecommunications hardware (e.g., antenna71) of aremote server70. Once received by theserver70, the data may be conveyed by a bus (e.g., data router72) to theprocessor74 for formatting and analysis, and stored in thememory device77 of theserver70 for future retrieval and use. The data can be analyzed using a variety of bioengineering algorithms to calculate the performance characteristics of theinternal heart pump62.
• For instance, in addition to remotely obtaining and monitoring LVAD flow characteristics as described above, this data can also be used to derive the difference in pressure between the outlet portion of theinternal heart pump62 in the patient's proximal ascending aorta and the inflow portion of theinternal heart pump62 in the patient's left heart chamber. As with the machine-specific algorithm referenced previously, machine-specific algorithms can illustrate pressure differences between the inlet port and outflow ports of theLVAD60. This pressure differential may be estimated, for instance, using the polynomial equations described in Table 2 in Salamonsen et al.,Response of Rotary Blood Pumps to Changes in Preload and Afterload at a Fixed Speed Setting Are Unphysiological When Compared With the Natural Heart,35 Artificial Organs E47, E49 (2011), the entire contents of which are incorporated herein by reference. Having access to this pressure difference variable is of great medical value because it represents a dynamic relationship between the heart and systemic circulation that changes according to the phase of contraction of the heart, the degree of constriction of the vasculature, and the current state of total body fluid balance. Depending on the particular software used and the configuration of adjunctive traditional non-invasive physiological measurements not specific to LVAD patients, the real-time state of total body fluid balance can be further deduced from the total pressure difference. Timely and frequent access to this information thus facilitates the judicious administration of medications to ensure that they are maintained in a healthy state of equilibrium.
• In addition, the data received by theremote server70 may be conveyed via a communication network400 (e.g., the Internet) to amodem82 of an end-user device80. The end-user device80 may be configured to present a graphical user interface (e.g., computer screen/interface application100) to auser90 for viewing the performance characteristics of theinternal heart pump62. It should be understood that in some embodiments, the end-user device80 may be theremote server70, and in such embodiments, the end-user device80 need not retrieve data from theserver70 via acommunication network400.
• FIG.4 illustrates a flowchart containing a series of operations for analyzing data retrieved from an implanted artificial heart pump that indirectly measures flow. More specifically,FIG.4 provides a functional block diagram describing the analysis of data captured by the diagnostic device from the heart pump and the physiological variables that can be estimated with software applications. The data received from theinternal heart pump62 can be reconfigured and made available to the end-user90 as a management decision-support tool with prediction capabilities. The operations illustrated inFIG.4 may, for example, be performed by, with the assistance of, and/or under the control of the devices utilized in comprehensiveremote monitoring system10, which includeLVAD60,diagnostic device20,server70, and end-user device80.
• Inoperation402, the heart pump controller64 receives data representative of the fixed speed setting that is entered from theinternal heart pump62 and estimates the rate at which blood is flowing through the machine. As noted previously, given the dynamic nature of the motor's power utilization at a certain speed, the heart pump controller64 can use a proprietary algorithm to perform this estimation.
• Inoperation404, adiagnostic device20 connected to the heart pump controller64 retrieves this data from the heart pump controller64 and transmits it to aremote server70 for analysis and further processing. As one aspect of this operation, the diagnostic device may remove patient-identifying information and/or encrypt the data to protect health information before the data is transmitted to aremote server70 for analysis. It will be understood that in embodiments in which the heart pump controller64 itself can wirelessly transmit data,operation404 may instead be performed by the heart pump controller64 itself.
• Inoperation406, theremote server70 executes software (e.g.,data analysis software76, which may be stored in memory device77) to use the flow data to create real-time flow waveform graphs illustrating phasic waveforms including individual peaks and troughs representing the data retrieved from theLVAD60. It should be understood that thediagnostic device20 is configured to transmit the retrieved data to theremote server70 either prior tooperation406 or as an initial aspect ofoperation406. Moreover, it should also be understood that theremote server70 may cache specific heart pump performance characteristics using a data storage device (e.g., memory device77) for a specified period of time prior to overwriting.
• Inoperation408, theserver70 further executes software (e.g., software76) to utilize the waveform amplitude morphology over time to estimate the pump flow pulsatility (a heart pump function variable that varies according to the amount of blood in the heart's left ventricle).
• Inoperation410, theserver70 further executes software (e.g., software76) to derive the difference in pressure between the outlet portion of theinternal heart pump62 in the patient's proximal ascending aorta and the inflow portion of theinternal heart pump62 in the patient's left heart chamber. In some embodiments, the software can further use adjunctive traditional non-invasive physiological measurements not specific to LVAD patients to assess the real-time state of total body fluid balance for the patient by estimating the pressure in the patient's left heart during its relaxation phase before the beginning of each beat (a crucial physiological parameter that can be used to determine the medication regime required to optimize heart function and circulatory health).
• Inoperation412, theserver70 may further execute software (e.g., software76) to estimate the pressure difference between the arterial pressure at the distal end of the internal heart pump62 (e.g., at the outlet port) and the left ventricle pressure in the proximal end of the internal heart pump62 (e.g., the inflow port) and thus arrive at an approximation of the patient's blood pressure during the different phases of the heartbeat.
• Finally, inoperation414, after having estimated all of these cardiac indices, theserver70 may further execute software (e.g., software76) to track the changing nature of the patient's cardiovascular status and anticipate the nature of support required to optimize the function of the heart pump.
• After analysis, theserver70 may locally store the processed data and analysis results or transmit the data and results to a centralized series of data services and data storage units for subsequent access by multiple end-users90 with password clearance. In some embodiments, these end-users90 may be located at off-site locations and who may thus access the data and/or analysis results via an Internet connection andmodem82. These designated end-users90 can retrieve this data viacommunication network400 using a computer software application that further arranges the data visually on the screen in a format that is medically intuitive and will facilitate positive or negative trend recognition, as discussed in connection withFIG.5. In other embodiments, end-users90 may access the data and/or analysisresults using server70 itself (and in such embodiments, theserver70 may comprise the end-user device80, as noted previously.
• In some embodiments, if the data and/or analysis results fall outside of predefined thresholds (and in this regard, these thresholds may be previously identified by clinicians or may be based on similarities between the data or analysis results and historical data or analysis results known to be associated with poor patient outcomes), an alarm condition may be transmitted back to thediagnostic device20, which may in turn alert the patient to consult a clinician for a recommended course of action. Still further, such alarm conditions may additionally or alternatively be transmitted directly to medical professionals for immediate action (such as to prepare for the arrival of the patient at a medical facility or to dispatch responders to the patient's location for more immediate treatment or to communicate to the patient the nature of the alarm or any immediate clinical interventions that the patient can make unilaterally). As noted previously, the diagnostic device20 (and/or heart pump controller64) may include an element (e.g.,alarm display element36cor the like) configured to convey information regarding the alarm condition to the patient.
• FIG.5 provides an illustration of a user interface provided by an example remote heart pump monitoring application that provides a visual dashboard for assessing data acquired from a heart pump that measures flow indirectly and patient-related physiological estimates. In some embodiments, an end-user may view this user interface using any suitable terminal (e.g., a fixed device such as a desktop, or a mobile device, such as a laptop, PDA, tablet, smartphone, or the like). The remote heart pump monitoring application may feature motion graphics and animation that includes a visual estimate of the instantaneous blood flow through the heart pump in liters per minute (L/min) per seconds of time (s)110, displayed in continuous waveform format112 over a numerical grid114 with a link to archival data116 that provides statistical analysis of flow averages and identifies the instances in which flow values occurred outside of limit parameters stipulated by the end-user90. The application may also depict a continuous graph120 of the relationship between the systemic arterial pressure122 and the left ventricular pressure124 estimates in millimeters of mercury (mmHg). The remote heart pump monitoring application may also provide a link to archived data126, including numerical trends. Another feature of the remote heart pump monitoring application may be a schematized drawing of a heart pump-cardiac unit130 with movement depictions to represent blood flow and machine function and numerical display of the real-time estimates of the left ventricular volume132 and flow through the pump134, and speed setting and power consumption136. In some embodiments, the remote heart pump monitoring application also includes additional links to particular patient-care related categories. For accessing additional useful patient information, the display may include a related grouping section140 with a link to archived patient laboratory results142, medical history144, and cardiac diagnostic imaging and dynamic studies146. For urgent medical and engineering problems, the display may include a related grouping section150 with a retrieval link to the local emergency medical services152 and physician154 and engineer156 consultation.
• FIG.6 illustrates a high-level system diagram in one example embodiment described herein. As shown inFIG.6, implanted LVAD pump machinery that measures flow indirectly (e.g., internal heart pump62) is connected through a driveline that exits the patient's body from an incision in the patient's chest wall to connect to an external heart pump controller64. In turn, adiagnostic device20 may connect to the heart pump controller64 and may wireless transmit data to a remote server (not shown), which may cause communication of a graphical interface providing the data and analysis results to an end-user in the form of avisual software application100. By virtue of the wireless connection provided by thediagnostic device20, this example embodiment facilitates the communication of data regarding the functioning of the implanted device to medical professionals and the ability to identify and react to abnormal indicators that would otherwise be undetectable outside of a medical facility. As a result, this example embodiment (and others described herein) greatly expands the oversight capability and more data-driven optimization of indirect flow measurement blood pumps without added interference with recipients' quality of life or independence.
• As described herein, example embodiments of the present invention provide a system enabling the acquisition of data generated by implanted indirect flow measurement artificial heart pumps in an outpatient setting. Heretofore, this real-time data has been inaccessible to expert decision makers during the interval period that a patient is outside of a formal medical environment, but utilizing embodiments of the present invention, indirect flow measurements and other pump performance characteristics may now be remotely retrieved. Moreover, example embodiments enable the transmission of that data for expert review and provide software applications for characterizing pump performance using a visual display feature that depicts real-time estimates of the patient's circulatory status to assess physiological needs and promote positive long-term clinical outcomes. In turn, example embodiments of the present invention promote best-practice clinical decisions regarding heart pump use than currently exist for indirect flow measurement machines.
• It will be understood that although the above example embodiments are described in connection with aheart pump62 that indirectly measures blood flow because indirect-flow devices represent the vast majority of heart pumps in use, other embodiments are also contemplated herein for remote monitoring of heart pumps that directly measure blood flow. In such embodiments, the structure and functions of thediagnostic device20 parallel those of the example embodiments discussed above, with the caveat that the data conveyed wirelessly by thediagnostic device20 is received from a different type of heart pump (with a similar caveat for embodiments where the heart pump controller is used in lieu of adiagnostic device20 to perform this wireless conveyance).
• Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although the foregoing descriptions and the associated drawings describe example embodiments in the context of certain example combinations of elements and/or functions, it should be appreciated that different combinations of elements and/or functions may be provided by alternative embodiments without departing from the scope of the appended claims. In this regard, for example, different combinations of elements and/or functions than those explicitly described above are also contemplated as may be set forth in some of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims (21)

1.-80. (canceled)

81. A system for managing external heart pump controllers, the system comprising:

a plurality of external heart pump controllers, each external heart pump controller associated with a respective implanted artificial heart pump;

a plurality of portable diagnostic devices; and

one or more server devices,

wherein a first portable diagnostic device of the plurality of portable diagnostic devices is physically attached via a connector port to a first external heart pump controller of the plurality of external heart pump controllers,

wherein the first portable diagnostic device is configured to receive data from the first external heart pump controller,

wherein the first portable diagnostic device is configured to transmit the data to a first server device of the one or more service devices via a wireless transmitter of the first portable diagnostic device, and

wherein the data transmitted from the first portable diagnostic device is indicative of one or more performance characteristics of the implanted artificial heart pump associated with the first external heart pump controller.

82. The system ofclaim 81, wherein the first server device is configured to:

receive the data transmitted from the first portable diagnostic device;

analyze the one or more performance characteristics of the implanted artificial heart pump associated with the first external heart pump controller; and

diagnose one or more faults of the implanted artificial heart pump associated with the first external heart pump controller based on the analyzed one or more performance characteristics.

83. The system ofclaim 82, further comprising:

one or more end-user devices,

wherein the first server device is configured to transmit the analyzed one or more performance characteristics to at least one end-user device of the one or more end-user devices for review by one or more designated end-users.

84. The system ofclaim 81, wherein the implanted artificial heart pump associated with the first external heart pump controller indirectly measures blood flow of a patient in which the artificial heart pump is implanted.

85. The system ofclaim 81, wherein at least the first external heart pump controller is incapable of wireless data transmissions.

86. The system ofclaim 81, wherein the connector port of the first portable diagnostic device is configured to facilitate transmission of the data from the first external heart pump controller to the first portable diagnostic device.

87. The system ofclaim 86, wherein the connector port of the first portable diagnostic device is configured to restrict transmission of the data from the first portable diagnostic device to the first external heart pump controller.

88. The system ofclaim 81, wherein the first portable diagnostic device receives electrical power from the first external heart pump controller.

89. The system ofclaim 81, wherein a second portable diagnostic device of the plurality of portable diagnostic devices is configured to receive data from a second external heart pump controller of the plurality of external heart pump controllers,

wherein the second portable diagnostic device is configured to transmit the data to the first server device via a wireless transmitter of the second portable diagnostic device, and

wherein the data transmitted from the second portable diagnostic device is indicative of one or more performance characteristics of the implanted artificial heart pump associated with the second external heart pump controller.

90. The system ofclaim 89, wherein the first server device is configured to route the data received from the first portable diagnostic device and the second portable diagnostic device into separate data streams representing the respective implanted artificial heart pumps being monitored.

91. A method for managing an external heart pump controller of an implanted artificial heart pump, the method comprising:

receiving, at a portable diagnostic device, data from the external heart pump controller, wherein the portable diagnostic device is physically attached to the external heart pump controller via a connector port; and

transmitting the data from the portable diagnostic device to a server device via a wireless transmitter of the portable diagnostic device, wherein the data transmitted from the portable diagnostic device is indicative of one or more performance characteristics of the implanted artificial heart pump.

92. The method ofclaim 91, further comprising:

receiving, at the server device, the data transmitted from the portable diagnostic device;

analyzing, by the server device, the one or more performance characteristics of the implanted artificial heart pump; and

diagnosing one or more faults of the implanted artificial heart pump based on the analyzed one or more performance characteristics.

93. The method ofclaim 92, further comprising:

transmitting, by the server device, the analyzed one or more performance characteristics to one or more end-user devices for review by one or more designated end-users.

94. The method ofclaim 91, wherein the implanted artificial heart pump indirectly measures blood flow of a patient in which the artificial heart pump is implanted.

95. The method ofclaim 91, wherein the external heart pump controller is incapable of wireless data transmissions.

96. The method ofclaim 91, wherein the connector port is configured to facilitate transmission of the data from the external heart pump controller to the portable diagnostic device.

97. The method ofclaim 96, wherein the connector port is configured to restrict transmission of the data from the portable diagnostic device to the external heart pump controller.

98. The method ofclaim 81, wherein the portable diagnostic device receives electrical power from the external heart pump controller.

99. The method ofclaim 81, further comprising:

receiving, at a second portable diagnostic device, data from a second external heart pump controller, wherein the second portable diagnostic device is physically attached to the second external heart pump controller via a second connector port; and

transmitting the data from the second portable diagnostic device to the server device via a wireless transmitter of the second portable diagnostic device, wherein the data transmitted from the second portable diagnostic device is indicative of one or more performance characteristics of an implanted artificial heart pump associated with the second external heart pump.

100. The method ofclaim 99, further comprising:

routing, via the server device, the data received from the first portable diagnostic device and the second portable diagnostic device into separate data streams representing the respective implanted artificial heart pumps being monitored.

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