Patent Publication Number: US-2022211995-A1

Title: Sleep mode and do-not-disturb mode for a left ventricular assist device

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     n/a. 
     FIELD 
     The present technology is generally related to implantable blood pump systems. 
     BACKGROUND 
     Implantable blood pumps, such as Ventricular Assist Devices (VAD), generally operate at a single programmed speed. Selection of the programmed speed is a difficult trade-off for many practitioners. Setting the speed of the pump too low can result in congestion, inability to exercise, and general heart failure symptoms. Conversely, setting the speed of the pump too high can result in suction, hypertension, hemolysis, stroke, right heart failure, and arrhythmias. The high variability of patient activity throughout the day, from sleep to exertion, compounds the difficulty of finding a single speed that minimizes the adverse events. 
     Left Ventricular Assist Devices (LVAD) produce a variety of alerts to warn the patient of concerning situations. Some alerts may warn of depletion of the pump battery or pump malfunction, while other alerts may warn of the detection of suction or low pulsatility. The alerts are typically very disruptive, making sleep more difficult and risking public embarrassment for the patient. 
     SUMMARY 
     The techniques of this disclosure generally relate to systems and methods for controlling the operating speed of an implantable blood pump. 
     In one aspect, the present disclosure provides a controller for an implantable blood pump. The controller including processing circuitry configured to control an operating speed of an impeller of the implantable blood pump. The processing circuitry being further configured to control activation and deactivation of a sleep mode. During the sleep mode the processing circuitry being configured to measure a level of suction by detecting suction during a predetermined time interval, recording the time at which suction occurred during the predetermined time interval, and generating a histogram demonstrating the measured level of suction. The measured level of suction being a percentage of time the implantable blood pump experienced suction during the predetermined time interval. The processing circuitry being configured to reduce the operating speed of the impeller if the measured level of suction exceeds a predetermined threshold. 
     In another aspect, the processing circuitry is further configured to perform a preliminary reduction of the operating speed of the impeller upon activation of the sleep mode. 
     In another aspect, if the measured level of suction exceeds a predetermined threshold, the controller is configured to generate a recommendation to a clinician for adjusting the operating speed of the impeller. 
     In another aspect, the processing circuitry is configured to generate and transmit an alert signal to at least one selected from the group consisting of an external controller, a mobile device, a tablet, and a smart device when measured level of suction exceeds the predetermined threshold. 
     In another aspect, the alert signal is one selected from the group consisting of a low urgency alert and a high urgency alert. 
     In another aspect, the low urgency alert and the high urgency alert are each at least one selected from the group consisting of an audible alert notification, a visual alert notification, and a tactile alert notification. 
     In another aspect, the at least one selected from the group consisting of the external controller, the mobile device, the tablet, and the smart device is configured to silence the low urgency alert during the sleep mode. 
     In another aspect, the processing circuitry is further configured to adjust the operating speed of the impeller based on at least one selected from the group consisting of body activity, body movement, and body position. 
     In another aspect, the sleep mode is activated via the at least one selected from the group consisting of the external controller, the mobile device, the tablet, and the smart device. 
     In another aspect, the processing circuitry is also configured to measure a level of at least one selected from the group consisting of hypertension, hypotension, hemolysis, stroke, heart failure, arrhythmias, and pump failure. 
     In another aspect, a method of controlling an operating speed of an impeller disposed within an implantable blood pump. The method comprising activating a sleep mode and measuring a level of suction within the implantable blood pump by detecting suction during a predetermined time interval, recording the time at which suction occurred during the predetermined time interval, and generating a graph demonstrating the measured level of suction. The measured level of suction being a percentage of time the implantable blood pump experienced suction during the predetermined time interval. The method further comprising decreasing the operating speed of the impeller if the measured level of suction exceeds a predetermined threshold. 
     In another aspect, the sleep mode is activated at a preset time. 
     In another aspect, the operating speed of the impeller preliminarily reduced upon activation of the sleep mode. 
     In another aspect, the method further including generating a recommendation for adjusting the operating speed of the impeller based on the measured level of suction, the recommendation being transmitted to a clinician. 
     In another aspect, the method further including generating at least one selected from the group consisting of a low urgency alert and a high urgency alert if the measured level of suction exceeds the predetermined threshold. 
     In another aspect, the low urgency alert and the high urgency alert are each at least one selected from the group consisting of an audible alert notification, a visual alert notification, and a tactile alert notification 
     In another aspect, the method further including transmitting the at least one selected from the group consisting of the low urgency alert and the high urgency alert to at least one selected from the group consisting of an external controller, a mobile device, a tablet, and a smart device. 
     In another aspect, the low urgency alert is silenced via the at least one selected from the group consisting of the external controller, the mobile device, the tablet, and the smart device. 
     In yet another aspect, the disclosure provides an implantable blood pump system having a sleep mode. The implantable blood pump system including an internal controller having processing circuitry configured to control an operating speed of an impeller of an implantable blood pump, and activate and deactivate the sleep mode. The sleep mode being activated at a first preset time and deactivated at a second preset time. The operating speed of the impeller being preliminarily reduced upon activation of the sleep mode. The processing circuitry being further configured to measure a level of suction. When the sleep mode is activated, the level of suction of the implantable blood pump being measured by detecting suction during a predetermined time interval, recording the time at which suction occurred during the predetermined time interval, and generating a graph demonstrating the measured level of suction. The measured level of suction being a percentage of time the implantable blood pump experienced suction during the predetermined time interval. The processing circuitry being further configured to further reduce the operating speed of the impeller if the measured level of suction exceeds a predetermined threshold and generate at least one selected from the group consisting of a low urgency alert and a high urgency alert when the measured level of suction exceeds the predetermined threshold. The low urgency alert being silenced when the sleep mode is activated. The processing circuitry being further configured to transmit the at least one selected from the group consisting of the low urgency alert and the high urgency alert to at least one selected from the group consisting of an external controller, a mobile device, a tablet, and a smart watch when the measured level of suction exceeds the predetermined threshold. 
     The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein: 
         FIG. 1  is an internal system view of an implantable blood pump with a TETS receiver source constructed in accordance with the principles of the present application; 
         FIG. 2  is an external view of a TETS transmitter, and a controller of the system shown in  FIG. 1 ; 
         FIG. 3  is a disassembled view of an exemplary blood pump constructed in accordance with the principles of the present application; 
         FIG. 4  is a block diagram showing a control system and pump of the present application; and 
         FIG. 5  is a generated graph illustrating the measured level of suction recorded by the blood pump of  FIGS. 1-4 . 
     
    
    
     DETAILED DESCRIPTION 
     It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device. 
     In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer). 
     Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements. 
     Referring now to the drawings in which like reference designators refer to like elements there is shown in  FIGS. 1 and 2  an exemplary mechanical circulatory support device (“MCSD”) constructed in accordance with the principles of the present application and designated generally as “10.” The MCSD  10  may be fully implantable within a patient, whether human or animal, which is to say there are no percutaneous connections between the implanted components of the MCSD  10  and the components outside of the body of the patient. In the configuration shown in  FIG. 1 , the MCSD  10  includes an internal controller  12  implanted within the body of the patient. The internal controller  12  includes a control circuit  13  having a processor  15  having processing circuitry configured to control operation of an implantable blood pump  14 . The internal controller  12  may include an internal power source, configured to power the components of the controller  12  and provide power to one or more implantable medical devices, for example, the implantable blood pump, such as a ventricular assist device (“VAD”) implanted within the left ventricle of the patient&#39;s heart. The power source may include a variety of different types of power sources including an implantable battery  16 . VADs may include centrifugal pumps, axial pumps, or other kinds electromagnetic pumps configured to pump blood from the heart to blood vessels to circulate around the body. One such centrifugal pump is the HVAD and is shown and described in U.S. Pat. No. 7,997,854, the entirety of which is incorporated by reference. One such axial pump is the MVAD and is shown and described in U.S. Pat. No. 8,419,609, the entirety of which is incorporated herein by reference. In an exemplary configuration, the blood pump  14  is electrically coupled to the internal controller  12  by one or more implanted conductors  18  configured to provide power to the pump  14 , relay one or more measured feedback signals from the pump  14 , and/or provide operating instructions to the pump  14 . 
     Continuing to refer to  FIGS. 1 and 2 , a receiving or internal coil  20  may also be coupled to the internal controller  12  by, for example, the one or more implanted conductors and/or cables  18 . In an exemplary configuration, the receiving coil  20  may be implanted subcutaneously proximate the thoracic cavity, although any subcutaneous position may be utilized for implanting the receiving coil  20 . The receiving coil  20  is configured to be inductively powered through the patient&#39;s skin by a transmission or external coil  22  (seen in  FIG. 2 ) disposed opposite the receiving coil  20  on the outside/exterior of the patient&#39;s body. For example, as shown in  FIG. 2 , a transmission coil  22  may be coupled to an external controller  24  having a power source, for example, a portable battery  26  carried by the patient or wall power. In one configuration, the battery  26  is configured to generate a radiofrequency signal for transmission of energy from the transmission coil  22  to the receiving coil  20 . The receiving coil  20  may be configured for transcutaneous inductive communication with the transmission coil  22  to define a transcutaneous energy transfer system (TETS) that receives power from the transmission coil  22 . Further, the controller  12  described herein may also be used with partially implantable VAD systems. In such systems, the controller  12  described herein may be used as a similarly configured external controller with percutaneous connections to the blood pump  14 . 
     Referring now to  FIG. 3 , as mentioned above, the blood pump  14  may be, without limitation, the HVAD® pump or the MVAD® pump, having a movable element, such as an impeller  17  or a rotor, configured to rotate about axis “A” and impel blood form the heart to the rest of the body. The impeller  17  may rotate within a tube  19  extending from a proximal upstream end to a distal downstream end. The HVAD® Pump is further discussed in U.S. Pat. No. 8,512,013, the disclosure of which is incorporated herein by reference in the entirety. The MVAD® Pump is further discussed in U.S. Pat. Nos. 8,007,254 and 9,561,313, the disclosures of which are incorporated herein by reference in the entirety. 
       FIG. 4  is a block diagram of an exemplary system for controlling a pump speed and/or other operations of the implantable blood pump  14  when the blood pump  14  is in communication with the system. The blood pump  14  includes a motor  28  therein and may be a separate component or form part of the system. The system includes the controller  12  having a control circuit  13  and a processor  15  having processing circuitry configured to perform the operations of the blood pump  14 . The system may also include a memory  30  and an interface  32 , the memory  30  being configured to store information accessible by the processor  15 . Such instructions and/or data include that which is used to control the pump speed and activation/deactivation of the sleep mode. 
     Continuing to refer to  FIGS. 1-4 , the processing circuitry is configured to control the operating speed of the impeller  17  and the activation and/or deactivation of a sleep mode, which may be activated and/or deactivated at a predetermined time selected by a clinician and/or a patient. The sleep mode may also be manually activated at any time desired by the patient, clinician, and/or any other caregiver. Upon activation and deactivation of the sleep mode, the processing circuitry may perform preliminary adjustments of the operating speed of the impeller  17  such that the speed of the impeller  17  is reduced when activated and increased once deactivated. For example, when the sleep mode is activated, the operating speed of the impeller  17  may be decreased by a predetermined difference from typical operating speed (e.g., −100 RPM) or may be lowered to a pre-selected speed (e.g., 2400 RPM) determined by the clinician. Alternatively, although it has been described herein that upon activation of the sleep mode, the operating speed of the impeller  17  is reduced, the clinician or patient may also configure the processing circuitry to increase or maintain the current operating speed of the impeller  17  upon activation of the sleep mode. 
     Once sleep mode has been activated by the processing circuitry, the controller  12  receives signals from the blood pump  14  through the one or more conductors  18  which provide information to the controller  12  regarding the operating parameters of the pump  14  while the patient is sleeping. The processing circuitry is configured to periodically and/or continuously detect and record the occurrence of at least one adverse event such as suction, hypertension, hypotension, hemolysis, stroke, heart failure, arrhythmias, pump failure, and the like. In situations wherein suction is detected, suction may be the result of the operating speed of the impeller being too high, and thus may require the operating speed of the impeller  17  to be decreased. Suction events may be detected by, including but not limited to, the methods described in U.S. Pat. No. 9,492,601, U.S. Patent Publication Number 2018/0028738, and U.S. patent application Ser. No. 16/795,929, the entireties of which are expressly incorporated by reference herein. 
     The processing circuitry is configured to measure the level of suction by detecting suction during a predetermined time interval. The predetermined time interval may include 1-hour intervals of time between 9:00 pm and 7:00 am (the predetermined time interval is not restricted to 1-hour intervals and may instead be any period of time determined by the clinician and/or patient such as minutes, hours, days, weeks, months, or years). Once the sleep mode is activated at 9:00 pm, the processing circuitry is configured to detect suction. Once suction has been detected, the processing circuitry records how much suction was detected during each 1-hour interval and generates a histogram (as shown in  FIG. 5 ), or other type of graph, demonstrating the measured level of suction. The measured level of suction is indicative of a percentage of time that the pump  14  experienced suction during each 1-hour time interval. Once the measured level of suction has been recorded and included in the graphical data, it is then compared against a predetermined threshold value set by a clinician or patient. If the processing circuitry determines that the measured level of suction exceeds the predetermined threshold, the operating speed of the impeller  17  may then be reduced by the processing circuitry. 
     The predetermined threshold may be any percentage of time the pump  14  experiences suction during a particular time interval, such as between the range of 0% of the time and 100% of the time. For example, as shown in the graph of  FIG. 5 , the processing circuitry records the percentage of time per each 1-hour interval that suction is detected in the pump  14 . During hour 24 (11:00 pm-12:00 am) suction is detected for 10% of the 1-hour interval, meaning that the pump  14  experienced suction for 6 minutes during the 1-hour interval between 11:00 pm and 12:00 am. Additionally, the clinician may set any percentage of time in suction (e.g., 4%, 6%, 8%, 10%, 12%, etc.) as being the predetermined threshold. Thus, once the predetermined threshold is reached or surpassed, the processing circuitry may reduce the operating speed of the impeller  17  or generate a recommendation to the clinician or patient for reducing the operating speed. 
     Although the graph shown in  FIG. 5  represents a 24-hour time interval, the graph may also display historical data obtained over an extended period such as, for example, any period of time within the last 7-days, 14-days, 21-days, 30-days, etc., and may influence the speed of the impeller  17  upon activation of the sleep mode on the current day. The influence of historical data obtained from prior days on the generated graph may be constant (i.e., each of the last 7-days or 14-days may be weighted equally) or could be exponentially decaying (i.e., the last night in the 7-days or 14-days has the highest weighting, the night immediately prior having less weighting, and the night prior to that having even less weighting). By analyzing the historical data, the controller  12  can determine what adjustments to the operating speed of the impeller  17  may be necessary, and may either perform these adjustments automatically or may generate and transmit a recommendation to the patient and/or clinician for whether the speed of the impeller  17  should be increased and/or decreased temporarily or permanently. As a further example of how the historical data may be used, if on a Monday and following Tuesday the operating speed of the impeller  17  is reduced at 10:00 pm, the processing circuitry may utilize learning behavior to automatically reduce the operating speed of the impeller  17  to the same reduced speed either before or at 10:00 pm on the following Wednesday or any other subsequent day. 
     Further, although it has been mentioned that the sleep mode may be activated from 9:00 pm-7:00 am, the controller  12  may activate the sleep mode at any other time of the day and/or night that is determined by a clinician or the patient in order to address each patient&#39;s particular sleep schedule. The sleep mode may also be patient initiated/scheduled via the external controller  24  or the sleep mode may be initiated/scheduled remotely by a clinician using another controller, monitor, tablet, computer, or smart device. 
     In addition to adjusting the operating speed of the impeller when the predetermined threshold has been reached or exceeded, the processing circuitry is also configured to generate and transmit a low urgency alert and/or a high urgency alert to at least one of the external controller  24 , mobile device, tablet, smart watch  34 , or the like (not shown). The low and high urgency alerts may each consist of audible, visual, and/or tactile alert notifications to warn the patient of the adverse event (e.g., suction detection). The external controller  24  or the patient&#39;s mobile device, tablet, or smart watch  34  may be configured to automatically silence the low urgency alerts so that the patient is not disturbed while they are sleeping. However, high urgency alerts will not be silenced and thus will be relayed to the patient indicating that immediate attention is required. The controller  12  will determine whether the occurrence of the at least one adverse event warrants a low or high urgency alert based on the type of adverse event and its effects on the operation of the blood pump  14 . 
     Further, the controller  12  may be pre-configured by the patient or clinician to deactivate the sleep mode at a prescheduled time or after a predetermined duration of time, such as, for example, 5-10 hours. The patient may also deactivate the sleep mode at any point via the external controller  24 , mobile device, tablet, or smart watch  34 . 
     Although the sleep mode may be deactivated during the patient&#39;s waking hours, the processing circuitry may continue to detect and record the occurrences of any adverse event, such as suction, and is configured to generate additional graphical data that can be used to provide recommendations and suggestions to the clinician for adjusting the operating speed of the impeller during the patient&#39;s waking hours. 
     The processing circuitry may also be configured to monitor physiological readings of the patient, such as, for example, the following: heart rate, respiratory rate, tidal volume, EKG, body temperature, body position, body movement, etc., or any combinations thereof. By analyzing these physiological readings, the controller  12  may determine that an increase in patient activity has occurred and may automatically deactivate the sleep mode and resume normal “waking hour” operation. However, if any of these physiological readings exceed a predetermined threshold, the controller  12  may be configured to generate and transmit the low urgency alert and/or high urgency alert to the external controller  24 . The processing circuitry may also record these physiological readings in a log that is provided to the clinician. The processing circuitry may also use these detected physiological readings to generate additional graphical data to provide recommendations and suggestions to the clinician for adjusting the operating speed of the impeller  17  during the patient&#39;s waking and/or sleep hours. 
     Further, the controller  12  and processing circuitry described herein are also configured to activate a “do-not-disturb” mode which is configured to cooperate with the described sleep mode. The do-not-disturb mode automatically silences low urgency alerts so that the user or patient is not disturbed by the alert. The user may manually activate the do-not-disturb mode when desired via the external controller  24 , mobile device, tablet, or smart watch  34 , or the user and/or clinician may configure the controller  12  to automatically activate the do-not-disturb mode at particular times each day. Clinicians may also be able to remotely schedule “do-not-disturb” times for the patient remotely via the clinicians own remote controller, mobile device, tablet, or other type of smart device. However, although low urgency alerts may routinely be silenced by the do-not-disturb mode, high urgency alerts would not be silenced and thus a user would be notified of the alert and must then deactivate the alert manually via the external controller  24 , mobile device, tablet, or smart watch  34 . 
     It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.