Integration of pulmonary artery pressure, systemic blood pressure, and LVAD pump parameters

Abstract

Systems and related methods for remotely managing care of a patient having an implanted left ventricular assist device are provided. A system for managing care of a patient having an implanted left ventricular assist device (LVAD) and an implanted pulmonary artery pressure (PAP) sensor includes a patient management server and a clinician portal. The patient management server is configured to receive PAP data and LVAD data for the patient. The PAP data is indicative of a PAP of the patient as measured via the PAP sensor implanted in the patient. The LVAD data is indicative of a measured operating parameter of the LVAD implanted in the patient. The clinician portal is configured to transmit an alert to a clinician in response to at least one of the PAP data and the LVAD data indicating a change in a hemodynamic condition of the patient.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 607,174, filed on December 7, 2023, the full disclosure of which is incorporated herein by reference in its entirety for all purposes. Background Technology

[0002] Ventricular assist devices, called VADs, are used for both short-term (i.e., days, months) and long-term (i.e., years, or a lifetime) blood circulation support, in cases where a patient's heart cannot provide enough circulation, commonly known as heart failure or congestive heart failure. According to the American Heart Association, more than five million Americans suffer from heart failure, and approximately 670,000 new cases are diagnosed each year. People with heart failure often experience shortness of breath and fatigue. Years of living with blocked and / or high blood pressure can weaken the heart, making it unable to pump enough blood into the body. As symptoms worsen, late-stage heart failure develops. Patients with heart failure can use VADs while awaiting a heart transplant or as a long-term destination therapy. Patients can also use VADs during recovery from heart surgery. Therefore, VADs can assist a weakened heart (i.e., provide partial support) or effectively replace the function of the native heart. Summary of the Invention

[0003] The following is a simplified overview of some systems and methods of this disclosure to provide a basic understanding of the systems and methods of this disclosure. This invention is not a comprehensive overview of the systems and methods of this disclosure. It is not intended to identify key / determining elements of the systems and methods of this disclosure or to depict the scope of the systems and methods of this disclosure. Its sole purpose is to present some systems and methods of this disclosure in a simplified form as a prelude to the specific embodiments presented later.

[0004] This disclosure describes systems and methods for remotely managing the care of patients with implanted ventricular assist devices (VADs). The patient may have an implanted pulmonary artery pressure sensor, via which the patient's pulmonary artery pressure is measured. The measured pulmonary artery pressure and the measured operating parameters of the VAD can be remotely accessed by a physician or clinician and can be monitored by a system designated by the physician or clinician to detect changes in the patient's hemodynamic status. Updates to the VAD's control settings and / or updates to one or more of the patient's medical prescriptions may be appropriate in response to such changes. The systems and methods described herein improve patient care by enabling more informed patient management decisions through the combination of increased patient monitoring frequency with increased data on the patient's hemodynamic status.

[0005] Therefore, in one aspect, a system for managing the care of a patient with an implanted left ventricular assist device (LVAD) and an implanted pulmonary artery pressure (PAP) sensor includes a patient management server and a clinician portal. The patient management server is configured to receive the patient's PAP data and LVAD data. The PAP data indicates the patient's PAP as measured via the implanted PAP sensor. The LVAD data indicates the measured operating parameters of the implanted LVAD. The clinician portal is configured to communicatively couple with the patient management server. The clinician portal is configured to send an alert to the clinician in response to at least one of the PAP data and LVAD data indicating a change in the patient's hemodynamic status.

[0006] The PAP of a patient can be measured intermittently over time, allowing the PAP data to indicate the trend of the patient's PAP over time. The PAP data can indicate the patient's pulmonary artery diastolic pressure (PADP), pulmonary artery mean pressure (PAMP), and heart rate.

[0007] A patient's PAP can be monitored to detect changes in the patient's hemodynamic status. For example, an alert can be sent to the clinician in response to the patient's PAP falling outside the normal operating range established by the clinician.

[0008] LVAD data can indicate blood flow-related aspects of the LVAD. For example, LVAD data can indicate at least two of the following: (a) the minimum blood flow velocity through the LVAD in each cardiac cycle of at least one cardiac cycle of the patient; (b) the average blood flow velocity through the LVAD in each cardiac cycle of at least one cardiac cycle of the patient; or (c) the magnitude of the variation in blood flow velocity through the LVAD in each cardiac cycle of at least one cardiac cycle of the patient. LVAD data can further indicate the frequency of LVAD aspiration events.

[0009] In some cases, an alarm may include a message to the clinician regarding a possible condition of the specified patient and / or LVAD. For example, an alarm may include a message to the clinician indicating that the LVAD rotation speed may be too high and / or the patient may have low blood volume, in response to a patient's PAP being below the normal operating range and the frequency of LVAD aspiration events being above the normal range. As another example, an alarm may include a message informing the clinician of possible LVAD blockage; the alarm may be triggered in response to a PAP above the normal operating range, an average blood flow velocity through the LVAD being below the normal operating range, and a variation in blood flow velocity through the LVAD being below the normal operating range. In another example, an alarm may include a message informing the clinician that the patient may have hypertension and / or high blood volume, in response to a PAP above the normal operating range, an average blood flow velocity through the LVAD being below the normal operating range, and a variation in blood flow velocity through the LVAD being above the normal operating range.

[0010] The patient management server can be further configured to receive blood pressure data from a non-invasive measurement of the patient's mean arterial pressure (MAP). Accordingly, in some instances, alarms may include a message notifying the clinician of potential LVAD blockage in response to PAP exceeding the patient's normal operating range, average blood flow velocity through the LVAD falling below the patient's normal operating range, variation in blood flow velocity through the LVAD falling below the patient's normal operating range, and the patient's MAP falling below the patient's normal operating range. In some instances, alarms may include a message notifying the clinician of potential hypertension and / or hypervolemia in response to PAP exceeding the patient's normal operating range, average blood flow velocity through the LVAD falling below the patient's normal operating range, variation in blood flow velocity through the LVAD falling above the patient's normal operating range, and the patient's MAP falling above the patient's normal operating range.

[0011] LVAD data can indicate the blood pressure difference across the LVAD during at least one cardiac cycle in a patient. For example, an LVAD may include one or more sensors configured to generate a signal that can be processed to estimate the pressure difference of blood pumped between the inlet and outlet of the LVAD.

[0012] Optionally, clinicians can modify one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD. For example, clinicians can optionally modify the average rotation speed of the LVAD to modify the average flow rate of blood through the LVAD.

[0013] Optionally, clinicians can program automatic modification of one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD based on PAP data and / or LVAD data. For example, automatic modification of one or more control settings of the LVAD can increase the average rotational speed of the LVAD in response to an increase in the patient's PAP. As another example, automatic modification of one or more control settings of the LVAD can decrease the average rotational speed of the LVAD in response to an increase in the frequency of LVAD aspiration events. As another example, automatic modification of one or more control settings of the LVAD can increase the average rotational speed of the LVAD in response to a decrease in the average flow rate through the LVAD. As another example, automatic modification of one or more control settings of the LVAD can decrease the average rotational speed of the LVAD in response to a decrease in the magnitude of the change in inflow rate between the average flow rate through the LVAD and the minimum flow rate through the LVAD during the patient's cardiac cycle.

[0014] Optionally, clinicians can update patient medication prescriptions via a clinician portal in response to a clinician's review of PAP and / or LVAD data. Optionally, clinicians can program the automatic updating of patient medical prescriptions based on PAP and / or LVAD data.

[0015] On the other hand, a method for managing the care of a patient with an implanted left ventricular assist device (LVAD) is provided. The method includes: (a) receiving pulmonary artery pressure (PAP) data of the patient via a patient management server, the PAP data indicating the patient's pulmonary artery pressure as measured via a PAP sensor implanted in the patient; (b) receiving LVAD data of the patient via the patient management server indicating operational parameters of the LVAD implanted in the patient; and (c) transmitting an alert to a clinician via a clinician portal in response to at least one of the PAP data and LVAD data indicating a change in the patient's hemodynamic status.

[0016] To gain a more complete understanding of the nature and advantages of the systems and methods disclosed herein, reference should be made to the following detailed descriptions and accompanying drawings. Attached Figure Description

[0017] Figure 1 A simplified schematic diagram of a system for managing the care of a patient with an implanted left ventricular assist device, according to various aspects of this disclosure, is shown.

[0018] Figure 2 It shows that via can Figure 1 A graph showing the pulmonary artery pressure measured by the implanted pulmonary artery pressure sensor used in the system.

[0019] Figure 3 A graph of pulmonary artery pressure over time is shown according to various aspects of this disclosure, illustrating the response of pulmonary artery pressure exceeding an upper limit. Figure 1 An alarm was triggered in the system. Detailed Implementation

[0020] In the following description, various systems and methods of this disclosure will be described. Specific configurations and details are set forth for purposes of explanation in order to provide a thorough understanding of the systems and methods. However, it will also be apparent to those skilled in the art that the systems and methods of this disclosure may be practiced without these specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the described systems or methods.

[0021] An implanted pulmonary artery pressure (PAP) sensor can be used to measure pulmonary artery pressure in patients with an implanted left ventricular assist device (LVAD). The measured pulmonary artery pressure and LVAD data indicating the measured LVAD's operating parameters are transmitted to a patient management server for remote management of LVAD control settings by clinicians and / or algorithms, and / or management of patient medical prescriptions.

[0022] Referring now to the accompanying drawings, in which the same reference numerals denote the same components in several views. Figure 1 A system 10 for managing patient care is illustrated, wherein a left ventricular assist device (LVAD) 12 and a pulmonary artery pressure (PAP) sensor 14 are implanted in the patient. System 10 includes a patient management server 16 and a clinician portal 18. The patient management server 16 receives LVAD data 18 from the LVAD 12 and pulmonary artery pressure (PAP) data 20 from the PAP sensor 14. Optionally, the patient management server 16 may also receive blood pressure (BP) data 22 from a non-invasive blood pressure cuff 14. The clinician portal 18 enables clinicians to monitor the LVAD data 18, PAP data 20, and / or BP data 22 for updating the control settings of the LVAD 12 and / or for updating one or more medical prescriptions for the patient. Optionally, the patient management server 16 transmits the updated control settings to the LVAD 12 and transmits one or more updated medical prescriptions to the patient.

[0023] LVAD data 18 can be measured within a suitable operating period of LVAD 12 and indicates the instantaneous power used to drive LVAD 12 during the operating period, the change in the maximum flow rate of blood through LVAD 12 for each cardiac cycle of the patient during the operating period, the change in the minimum flow rate of blood through LVAD 12 for each cardiac cycle of the patient during the operating period, the change in the average flow rate of blood through LVAD 12 for each cardiac cycle of the patient during the operating period, and the pulsatility of LVAD 12 (which can be defined as the maximum flow rate of blood through LVAD 12 minus the minimum flow rate of blood through LVAD 12 during the patient's cardiac cycle, or alternatively defined as the average flow rate of blood through LVAD 12 minus the minimum flow rate of blood through LVAD 12 during the patient's cardiac cycle). Optionally, LVAD data 18 may also include the timing and / or frequency of aspiration events of LVAD 12.

[0024] Figure 2 A graph showing pulmonary artery pressure 30 measured via PAP sensor 14 during a suitable operating period of PAP sensor 14 is presented. PAP sensor 14 can be configured to be interrogated via an interrogation signal during the operating period of PAP sensor 14 to power the measurement of pulmonary artery pressure 30 by PAP sensor 14. Accordingly, in many cases, pulmonary artery pressure 30 is measured intermittently via PAP sensor 14 (e.g., once daily over a limited time span). System 10 can be configured to process pulmonary artery pressure 30 to determine the components of PAP data 20, including the patient's pulmonary artery systolic pressure, pulmonary artery diastolic pressure, mean pulmonary artery pressure, and heart rate for each operating period of PAP sensor 14.

[0025] Patient hemodynamics and LVAD operation parameter monitoring

[0026] In one aspect, system 10 provides remote historical display / trending of patient hemodynamic parameters and LVAD operational parameters by clinical staff responsible for managing the patient, LVAD 12, and PAP sensor 14. Parameters that can be displayed and / or monitored include: 1) MAP (mmHg) (BP cuff), 2) PA systolic blood pressure (mmHg) (PAP sensor), 3) PA diastolic blood pressure (mmHg) (PAP sensor), 4) PA mean (mmHg) (PAP sensor), 5) heart rate (BPM) (PAP sensor), 6) pump power (W) (LVAD), 7) flow mean (L / min) (LVAD), 8) flow minimum (L / min) (LVAD), 9) flow maximum (L / min) (LVAD), 10) pulse rate (LVAD) (e.g., flow maximum-flow minimum or flow mean-flow minimum), and 11) aspiration event frequency (i.e., partial occlusion events) (LVAD).

[0027] Optional threshold for automatic notifications

[0028] On the other hand, system 10 can be configured to provide clinician-selectable normal operating ranges and / or thresholds for each of the measured patient hemodynamic parameters and LVAD12 operating parameters. System 10 can be configured to generate and output notifications to clinicians via clinician portal 16 when monitored parameters exceed specified normal operating ranges or specified thresholds.

[0029] Figure 3 The graph shows the pulmonary artery diastolic pressure over time, illustrating the response of pulmonary artery diastolic pressure exceeding the upper limit. Figure 1 The system triggers an alarm. Optionally, clinicians can define normal operating ranges for any suitable parameters of the PAP data 20 (e.g., PA systolic blood pressure, PA diastolic blood pressure, PA mean pressure) to trigger an alarm to the clinician via the clinician portal 16 when the monitored parameter exceeds the specified normal operating range. For example, as Figure 3 As shown, a PAPd rise alarm is generated in response to PA diastolic pressure exceeding a specified upper limit of 32.

[0030] Status notification based on combination of triggers

[0031] In addition to threshold notifications, system 10 can be configured to provide clinicians with messages regarding a specified patient's potential hemodynamic condition, which corresponds to a specific combination of the patient's hemodynamic parameters and / or LVAD 12 operating parameters. For example, when a patient has high PA diastolic pressure, low mean flow through LVAD 12, high LVAD pulsatility, and high mean atrial pressure (MAP), system 10 can automatically generate and output a message to the clinician indicating possible hypertension and / or hypervolemia. As another example, when a patient has low PA diastolic pressure and a high frequency of LVAD aspiration events, system 10 can automatically generate and output a message to the clinician indicating possible excessive pump rate and / or hypovolemia. As yet another example, system 10 can automatically generate and output a message to the clinician in response to high PA diastolic pressure, low LVAD mean flow, low LVAD pulsatility, and low MAP, warning the clinician of potential LVAD occlusion.

[0032] Remote updates of LVAD control settings and / or medication prescriptions

[0033] On the other hand, system 10 can be configured to allow clinicians to remotely update the speed settings and medication (RX) updates / recommendations of the LVAD 12 via clinician portal 16. After wireless synchronization with patient management server 16, the speed settings of the LVAD 12 can be adjusted by the controller of the LVAD 12.

[0034] LVAD automatic closed-loop control

[0035] On the other hand, System 10 can be configured to provide clinicians with the ability to program automatic (closed-loop) speed regulation of LVAD 12 based on any suitable combination of patient hemodynamic parameters measured herein and / or operating parameters measured herein from LVAD 12. System 10 can be configured to enable clinicians to tailor the control of LVAD 12 to specific patient needs / goals. For example, System 10 can be configured to enable clinicians to program closed-loop speed regulation of LVAD 12 where: 1) the speed of LVAD 12 increases with increasing diastolic lung pressure, 2) the speed of LVAD 12 decreases with increasing aspiration event frequency, 3) the speed of LVAD 12 increases with decreasing mean flow, and / or 4) the speed of LVAD 12 decreases with decreasing flow pulsatility. The relative “gain” of VAD speed with respect to parameter changes can be set by the clinician. Upper and lower limits for the overall VAD speed can be set by the clinician to ensure a safe overall speed range, regardless of algorithmic decisions (speed limits).

[0036] Optionally, the control settings for the LVAD 12 that can be updated may include the nominal rotational speed (rpm) of the LVAD 12 impeller and the low-speed limit (rpm) of the impeller. In some systems and methods in which the LVAD 12 can operate in artificial pulse mode to generate blood pressure pulses similar to those generated by the native heart, the control settings for the LVAD 12 may further include suitable pulse parameters (e.g., pulse amplitude (rpm), pulse duration (ms)).

[0037] Other variations are within the spirit of the systems and methods disclosed herein. Therefore, although the systems and methods of this disclosure are readily adaptable to various modifications and substitutions, some of the illustrated systems and methods are shown in the accompanying drawings and have been described in detail above. However, it should be understood that this is not intended to limit the systems and methods of this disclosure to the one or more specific forms disclosed, but rather, the systems and methods of this disclosure are intended to cover all modifications, substitutions, and equivalents falling within the spirit and scope of this disclosure as defined by the appended claims.

[0038] In the context of describing the systems and methods of this disclosure (especially in the context of the following claims), the terms “a,” “an,” and “the,” and similar designations are intended to be interpreted as covering both the singular and plural, unless otherwise stated herein or obviously contradicted by the context. The terms “comprising,” “having,” “including,” and “containing” should be interpreted as open-ended terms (i.e., meaning “including, but not limited to”), unless otherwise specified. The term “connected” should be interpreted as being partially or wholly included, attached to, or combined, even if some intermediary exists. The recitation of value ranges herein is intended only as a shorthand method for individually referring to each individual value falling within that range, unless otherwise stated herein, and each individual value is incorporated into this specification as if it were separately recited herein. All methods described herein may be performed in any suitable order, unless otherwise stated herein or obviously contradicted by the context. The use of any and all examples or exemplary language (e.g., “such as”) provided herein is intended only to better illustrate the systems and methods of this disclosure and does not constitute a limitation on the scope of the systems and methods of this disclosure, unless otherwise required. The language used in this specification should not be construed as indicating that any non-claimed element is necessary for implementing the systems and methods disclosed herein.

[0039] This document describes preferred systems and methods according to this disclosure, including the best modes known to the inventors for implementing systems and methods of this disclosure. Variations of these preferred systems and methods will become apparent to those skilled in the art upon reading the foregoing description. The inventors anticipate that those skilled in the art will use these variations as appropriate, and the inventors intend to practice the systems and methods of this disclosure in forms other than those specifically described herein. Correspondingly, the systems and methods of this disclosure include all modifications and equivalents to the subject matter recited in the appended claims, as permitted by applicable regulations. Furthermore, any combination of the foregoing elements in all possible variations is covered by the systems and methods of this disclosure, unless otherwise stated herein or obviously contradicted by the context.

[0040] All references cited in this document (including publications, patent applications and patents) are incorporated herein by reference as if each reference were individually and specifically indicated to be incorporated by reference and to be presented in its entirety in this document.

[0041] The following relate to various aspects of the designation of this invention: 1. A system for managing the care of a patient with an implanted left ventricular assist device (LVAD) and an implanted pulmonary artery pressure (PAP) sensor, the system comprising: A patient management server configured to receive patient PAP data and LVAD data, wherein the PAP data indicates the patient's PAP measured via a PAP sensor implanted in the patient's body, and wherein the LVAD data indicates the measured operating parameters of an LVAD implanted in the patient's body; and A clinician portal configured to communicatively couple with a patient management server, wherein the clinician portal is configured to send alerts to clinicians in response to at least one of PAP data and LVAD data indicating a change in the patient’s hemodynamic status. 2. According to the system of aspect 1, the patient's PAP is measured intermittently over time, such that the PAP data indicates the trend of the patient's PAP over time. 3. According to aspect 1 or 2, in which an alarm is transmitted to the clinician in response to the patient's PAP being outside the normal operating range of the PAP established by the clinician for the patient. 4. A system according to any one of aspects 1 to 3, wherein the LVAD data indicates at least two of the following: The minimum flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; The average velocity of blood flowing through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; or The magnitude of the change in blood flow velocity through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient. 5. According to the system in aspect 4, where: LVAD data indicates the frequency of LVAD aspiration events; and Alarms include messages to clinicians that the LVAD rotation speed may be too high and / or the patient may have low blood volume in response to a patient’s PAP being below the normal operating range and / or the frequency of LVAD aspiration events being above the normal range. 6. According to the system in aspect 4, wherein: Alerts include messages notifying clinicians of potential LVAD blockage; and An alarm is triggered in response to the following: PAP is higher than the patient's normal PAP range; the average blood flow velocity through the LVAD is lower than the patient's normal average blood flow velocity through the LVAD range; and the variation in blood flow velocity through the LVAD is lower than the patient's normal variation in blood flow velocity through the LVAD range. 7. According to aspect 4, the system includes an alarm that notifies the clinician of possible hypertension and / or hypervolemia in response to PAP being higher than the patient's normal PAP range, the average blood flow rate through the LVAD being lower than the patient's normal average blood flow rate through the LVAD, and the magnitude of the change in blood flow rate through the LVAD being higher than the patient's normal magnitude of the change in blood flow rate through the LVAD. 8. According to the system in aspect 4, wherein: The patient management server is further configured to receive blood pressure data, including non-invasive measurements of the patient's mean arterial pressure (MAP); and Alarms include messages notifying clinicians of potential LVAD blockage in response to PAP being higher than the patient's normal PAP range, average blood flow velocity through the LVAD being lower than the patient's normal average blood flow velocity through the LVAD, variation in blood flow velocity through the LVAD being lower than the patient's normal variation in blood flow velocity through the LVAD, and the patient's MAP being lower than the patient's normal MAP range. 9. According to the system in aspect 4, wherein: The patient management server is further configured to receive blood pressure data, including non-invasive measurements of the patient's mean arterial pressure (MAP); and Alerts include notifications to clinicians that the patient may have hypertension and / or hypervolemia in response to events such as PAP being higher than the patient's normal PAP range, average blood flow velocity through the LVAD being lower than the patient's normal average blood flow velocity through the LVAD, variation in blood flow velocity through the LVAD being higher than the patient's normal variation in blood flow velocity through the LVAD, and the patient's MAP being higher than the patient's normal MAP range. 10. According to aspect 4, the system wherein LVAD data indicate the blood pressure difference across the LVAD during at least one cardiac cycle of the patient. 11. A system according to any one of aspects 1 to 10, wherein a clinician can modify one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD. 12. A system according to any one of aspects 1 to 10, wherein a clinician can program automatic modification of one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD based on PAP data and / or LVAD data. 13. According to aspect 12, the automatic modification of one or more control settings of the LVAD increases the average rotational speed of the LVAD in response to an increase in the patient's PAP. 14. The system according to aspect 12, wherein the automatic modification of one or more control settings of the LVAD decreases the average rotational speed of the LVAD in response to an increase in the frequency of suction events of the LVAD. 15. The system according to aspect 12, wherein automatic modification of one or more control settings of the LVAD increases the average rotational speed of the LVAD in response to a decrease in the average flow velocity through the LVAD. 16. The system according to aspect 12, wherein automatic modification of one or more control settings of the LVAD decreases the average rotational speed of the LVAD in response to a decrease in the magnitude of the change in inflow rate between the average flow rate through the LVAD and the minimum flow rate through the LVAD during the patient's cardiac cycle. 17. A system according to any one of aspects 1 to 10, wherein a clinician is able to update a patient’s medication prescription via a clinician portal in response to a clinician’s review of PAP data and / or LVAD data. 18. A system according to any one of aspects 1 to 10, wherein clinicians are able to program automatic updates of patients’ medical prescriptions based on PAP data and / or LVAD data. 19. A method for managing the care of a patient with an implanted left ventricular assist device (LVAD), the method comprising: The patient management server receives the patient's pulmonary artery pressure (PAP) data, which indicates the patient's pulmonary artery pressure as measured by a PAP sensor implanted in the patient's body. The patient management server receives LVAD data from the patient, indicating the operational parameters for measuring the LVAD implanted in the patient; and The clinician portal sends alerts to clinicians in response to changes in the patient’s hemodynamic status indicated by at least one of the PAP and LVAD data. 20. According to the method of aspect 19, wherein the patient’s PAP is measured intermittently over time, such that the PAP data indicate the trend of the patient’s PAP over time. 21. According to the method of aspect 19 or 20, wherein an alarm is transmitted to the clinician in response to the patient's PAP being outside the normal operating range of the PAP established for the patient by the clinician. 22. According to the method of any one of aspects 19 to 21, wherein the LVAD data indicates at least two of the following: The minimum flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; The average velocity of blood flowing through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; or The magnitude of the change in blood flow velocity through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient. 23. According to the method of aspect 22, wherein: LVAD data indicates the frequency of LVAD aspiration events; and Alarms include messages to clinicians that the LVAD rotation speed may be too high and / or the patient may have low blood volume in response to a patient's PAP being below the normal range for PAP and the frequency of LVAD aspiration events being above the normal range for LVAD aspiration events. 24. According to the method of aspect 22, wherein the alarm includes a message notifying the clinician of a possible blockage of the LVAD in response to the PAP being higher than the patient's normal operating range of PAP, the average flow rate of blood through the LVAD being lower than the patient's normal operating range of average blood flow rate through the LVAD, and the magnitude of the change in the blood flow rate through the LVAD being lower than the patient's normal operating range of magnitude of the change in the blood flow rate through the LVAD. 25. According to the method of aspect 22, wherein the alarm includes a message to the clinician that the patient may have hypertension and / or hypervolemia in response to the PAP being higher than the patient's normal operating range for PAP, the average blood flow rate through the LVAD being lower than the patient's normal operating range for the average blood flow rate through the LVAD, and the magnitude of the change in blood flow rate through the LVAD being higher than the patient's normal operating range for the magnitude of the change in blood flow rate through the LVAD. 26. The method according to aspect 22 further includes: receiving non-invasive blood pressure data of the patient's mean arterial pressure (MAP) from a patient management server, and wherein the alarm includes a message notifying the clinician of possible LVAD blockage in response to the following: the PAP is higher than the patient's normal operating range; the average blood flow velocity through the LVAD is lower than the patient's normal operating range; the magnitude of the change in blood flow velocity through the LVAD is lower than the patient's normal operating range; and the patient's MAP is lower than the patient's normal operating range. 27. The method according to aspect 22 further includes: receiving non-invasive blood pressure data of the patient's mean arterial pressure (MAP) from a patient management server, and wherein the alarm includes a message to the clinician that the patient may have hypertension and / or hypervolemia in response to the following: the PAP is higher than the patient's normal operating range; the average blood flow velocity through the LVAD is lower than the patient's normal operating range for the average blood flow velocity through the LVAD; the magnitude of the change in blood flow velocity through the LVAD is higher than the patient's normal operating range for the magnitude of the change in blood flow velocity through the LVAD; and the patient's MAP is higher than the patient's normal operating range for the MAP. 28. According to the method of aspect 22, wherein LVAD data indicate the blood pressure difference across the LVAD during at least one cardiac cycle of the patient. 29. The method according to any one of aspects 19 to 28 further includes: modifying one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD. 30. The method according to any one of aspects 19 to 28 further includes: programming automatic modification of one or more control settings of the LVAD via a clinician portal to modify the flow rate of blood through the LVAD based on PAP data and / or LVAD data. 31. According to the method of aspect 30, wherein automatic modification of one or more control settings of the LVAD increases the mean rotation speed of the LVAD in response to an increase in the patient's PAP. 32. According to the method of aspect 30, wherein the automatic modification of one or more control settings of the LVAD decreases the average rotational speed of the LVAD in response to an increase in the frequency of suction events of the LVAD. 33. According to the method of aspect 30, wherein the automatic modification of one or more control settings of the LVAD increases the average rotational speed of the LVAD in response to a decrease in the average flow velocity through the LVAD. 34. According to the method of aspect 30, wherein the automatic modification of one or more control settings of the LVAD decreases the average rotational speed of the LVAD in response to a decrease in the magnitude of the change in inflow rate between the average flow rate through the LVAD and the minimum flow rate through the LVAD during the patient's cardiac cycle. 35. The method according to any one of aspects 19 to 34 further includes: updating the patient's medication prescription via a clinician portal in response to review of PAP data and / or LVAD data by a clinician. 36. The method according to any one of aspects 19 to 34 further includes: programming the automatic updating of patients' medical prescriptions based on PAP data and / or LVAD data via a clinician portal.

Claims

1. A system for managing the care of a patient with an implanted left ventricular assist device (LVAD) and an implanted pulmonary artery pressure (PAP) sensor, the system comprising: A patient management server configured to receive PAP data and LVAD data of a patient, wherein the PAP data indicates the patient's PAP measured via a PAP sensor implanted in the patient's body, and wherein the LVAD data indicates the measured operating parameters of the LVAD implanted in the patient's body. as well as A clinician portal configured to communicatively couple with the patient management server, wherein the clinician portal is configured to send alerts to clinicians in response to at least one of the PAP data and the LVAD data indicating a change in the patient's hemodynamic status.

2. The system according to claim 1, wherein, The patient's PAP is measured intermittently over time, such that the PAP data indicates the trend of the patient's PAP over time.

3. The system according to claim 2, wherein, In response to the patient's PAP being outside the normal operating range of the PAP established by the clinician for the patient, an alarm is transmitted to the clinician.

4. The system according to claim 3, wherein, The LVAD data indicates at least two of the following: The minimum flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; The average flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; or The magnitude of the change in blood flow velocity through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient.

5. The system according to claim 4, wherein: The LVAD data indicates the frequency of aspiration events of the LVAD; and The alarm includes a message to the clinician that the LVAD rotation speed may be too high and / or the patient may have low blood volume in response to the patient's PAP being below the normal operating range of the patient's PAP and / or the frequency of aspiration events of the LVAD being above the normal range of the frequency of aspiration events of the LVAD.

6. The system according to claim 4, wherein: The alert includes a message notifying the clinician of a possible blockage of the LVAD; and The alarm is triggered in response to the PAP being higher than the patient's normal operating range for PAP, the average flow rate of blood through the LVAD being lower than the patient's normal operating range for the average flow rate of blood through the LVAD, and the variation in the flow rate of blood through the LVAD being lower than the patient's normal operating range for the variation in the flow rate of blood through the LVAD.

7. The system according to claim 4, wherein, The alarm includes a message to the clinician that the patient may have hypertension and / or hypervolemia in response to the PAP being higher than the patient's normal PAP range, the average blood flow rate through the LVAD being lower than the patient's normal average blood flow rate through the LVAD, and the magnitude of the change in blood flow rate through the LVAD being higher than the patient's normal range for the magnitude of the change in blood flow rate through the LVAD.

8. The system according to claim 4, wherein: The patient management server is further configured to receive blood pressure data from the patient, which is a non-invasive measurement indicating the patient's mean arterial pressure (MAP); and The alarm includes a message notifying the clinician of a possible blockage of the LVAD in response to the following: the PAP is higher than the patient's normal PAP range; the average flow rate of blood through the LVAD is lower than the patient's normal average flow rate of blood through the LVAD range; the variation in the flow rate of blood through the LVAD is lower than the patient's normal variation in the variation of the flow rate of blood through the LVAD range; and the patient's MAP is lower than the patient's normal MAP range.

9. The system according to claim 4, wherein: The patient management server is further configured to receive blood pressure data from the patient, which is a non-invasive measurement indicating the patient's mean arterial pressure (MAP); and The alarm includes a message to the clinician that the patient may have hypertension and / or hypervolemia in response to the following: the patient's PAP is higher than the normal operating range of the patient's PAP; the average flow rate of blood through the LVAD is lower than the normal operating range of the patient's average flow rate of blood through the LVAD; the magnitude of the change in the flow rate of blood through the LVAD is higher than the normal operating range of the patient's magnitude of the change in the flow rate of blood through the LVAD; and the patient's MAP is higher than the normal operating range of the patient's MAP.

10. The system according to claim 4, wherein, The LVAD data indicate the blood pressure difference across the LVAD during at least one cardiac cycle in the patient.

11. The system according to any one of claims 1 to 10, wherein, The clinician can modify one or more control settings of the LVAD via the clinician portal to modify the flow rate of blood through the LVAD.

12. The system according to any one of claims 1 to 10, wherein, The clinician can program automatic modifications to one or more control settings of the LVAD via the clinician portal to modify the flow rate of blood through the LVAD based on the PAP data and / or the LVAD data.

13. The system according to claim 12, wherein, The automatic modification of one or more control settings of the LVAD increases the average rotational speed of the LVAD in response to an increase in the patient's PAP.

14. The system according to claim 12, wherein, The automatic modification of one or more control settings of the LVAD responds to an increase in the frequency of suction events of the LVAD by reducing the average rotational speed of the LVAD.

15. The system according to claim 12, wherein, The automatic modification of one or more control settings of the LVAD responds to a decrease in the average flow velocity through the LVAD by increasing the average rotational speed of the LVAD.

16. The system according to claim 12, wherein, The automatic modification of one or more control settings of the LVAD responds to a decrease in the magnitude of the change in inflow rate between the average flow rate through the LVAD and the minimum flow rate through the LVAD during the patient's cardiac cycle, thereby reducing the average rotational speed of the LVAD.

17. The system according to any one of claims 1 to 10, wherein, The clinician can update the patient's medication prescription via the clinician portal in response to the clinician's review of the PAP data and / or the LVAD data.

18. The system according to any one of claims 1 to 10, wherein, The clinician can program the automatic updating of the patient's medical prescriptions based on the PAP data and / or the LVAD data.

19. A method for managing the care of a patient with an implanted left ventricular assist device (LVAD), the method comprising: The patient management server receives pulmonary artery pressure (PAP) data from the patient, which indicates the patient's pulmonary artery pressure as measured via a PAP sensor implanted in the patient's body; The patient management server receives the patient's LVAD data, which indicates the operational parameters for measuring the LVAD implanted in the patient's body; as well as The clinician is alerted via the clinician portal in response to changes in the patient’s hemodynamic status indicated by at least one of the PAP data and LVAD data.

20. The method according to claim 19, wherein, The patient's PAP is measured intermittently over time, such that the PAP data indicates the trend of the patient's PAP over time.

21. The method according to claim 20, wherein, In response to the patient's PAP being outside the normal operating range of the PAP established by the clinician for the patient, an alarm is transmitted to the clinician.

22. The method according to claim 21, wherein, The LVAD data indicates at least two of the following: The minimum flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; The average flow rate of blood through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient; or The magnitude of the change in blood flow velocity through the LVAD during each cardiac cycle in at least one cardiac cycle of the patient.

23. The method according to claim 22, wherein: The LVAD data indicates the frequency of aspiration events of the LVAD; and The alarm includes a message to the clinician that the LVAD rotation speed may be too high and / or the patient may have low blood volume in response to the patient's PAP being below the normal operating range of the patient's PAP and the frequency of aspiration events of the LVAD being above the normal range of the frequency of aspiration events of the LVAD.

24. The method according to claim 22, wherein, The alarm includes a message notifying the clinician of a possible blockage of the LVAD in response to the PAP being higher than the patient's normal PAP range, the average flow rate of blood through the LVAD being lower than the patient's normal average flow rate of blood through the LVAD, and the variation in the flow rate of blood through the LVAD being lower than the patient's normal variation in the variation in the flow rate of blood through the LVAD.

25. The method according to claim 22, wherein, The alarm includes a message to the clinician that the patient may have hypertension and / or hypervolemia in response to the PAP being higher than the patient's normal PAP range, the average blood flow rate through the LVAD being lower than the patient's normal average blood flow rate through the LVAD, and the magnitude of the change in blood flow rate through the LVAD being higher than the patient's normal range for the magnitude of the change in blood flow rate through the LVAD.

26. The method of claim 22, further comprising: The patient management server receives non-invasive blood pressure data indicating the patient's mean arterial pressure (MAP), and the alarm includes a message notifying the clinician of possible LVAD blockage in response to the following: the MAP is higher than the patient's normal operating range; the mean flow rate of blood through the LVAD is lower than the patient's normal operating range; the variation in the flow rate of blood through the LVAD is lower than the patient's normal operating range; and the patient's MAP is lower than the patient's normal operating range.

27. The method of claim 22, further comprising: The patient management server receives non-invasive blood pressure data indicating the patient's mean arterial pressure (MAP), and wherein the alarm includes a message notifying the clinician that the patient may have hypertension and / or hypervolemia in response to the following: the MAP is higher than the patient's normal operating range; the mean flow rate of blood through the LVAD is lower than the patient's normal operating range; the magnitude of the change in the flow rate of blood through the LVAD is higher than the patient's normal operating range; and the patient's MAP is higher than the patient's normal operating range.

28. The method according to claim 22, wherein, The LVAD data indicate the blood pressure difference across the LVAD during at least one cardiac cycle in the patient.

29. The method according to any one of claims 19 to 28, further comprising: One or more control settings of the LVAD can be modified via the clinician portal to modify the flow rate of blood through the LVAD.

30. The method according to any one of claims 19 to 28, further comprising: The clinician portal is programmed to automatically modify one or more control settings of the LVAD to modify the flow rate of blood through the LVAD based on the PAP data and / or the LVAD data.

31. The method according to claim 30, wherein, The automatic modification of one or more control settings of the LVAD increases the average rotational speed of the LVAD in response to an increase in the patient's PAP.

32. The method according to claim 30, wherein, The automatic modification of one or more control settings of the LVAD responds to an increase in the frequency of suction events of the LVAD by reducing the average rotational speed of the LVAD.

33. The method according to claim 30, wherein, The automatic modification of one or more control settings of the LVAD responds to a decrease in the average flow velocity through the LVAD by increasing the average rotational speed of the LVAD.

34. The method according to claim 30, wherein, The automatic modification of one or more control settings of the LVAD responds to a decrease in the magnitude of the change in inflow rate between the average flow rate through the LVAD and the minimum flow rate through the LVAD during the patient's cardiac cycle, thereby reducing the average rotational speed of the LVAD.

35. The method of claim 19, further comprising: The patient's medication prescription is updated via the clinician portal in response to the clinician's review of the PAP data and / or the LVAD data.

36. The method of claim 19, further comprising: The automatic updating of the patient's medical prescriptions is programmed via the clinician portal based on the PAP data and / or the LVAD data.

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