Patent Publication Number: US-11639722-B2

Title: Pressure/flow characteristic modification of a centrifugal pump in a ventricular assist device

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/173,589, filed Oct. 29, 2018, which is a continuation of U.S. patent application Ser. No. 15/352,141, filed Nov. 15, 2016, now U.S. Pat. No. 10,117,983, issued Nov. 6, 2018, which claims priority to U.S. Provisional Application No. 62/255,774, filed Nov. 16, 2015, which is hereby incorporated by reference in its entirety, for all purposes, as if fully set forth herein. 
    
    
     BACKGROUND OF THE INVENTION 
     Centrifugal pumps have flatter head pressure-flow (HQ) curve characteristics when compared to axial flow pumps. Due to these flatter HQ curve characteristics, centrifugal pumps provide a lower head pressure as the flow approaches to zero than axial flow pumps when operated in fixed (constant) speed mode. In certain instances, the aortic pressure may momentarily exceed the pump head pressure and result in a low or even retrograde flow through the pump during diastole. A low centrifugal pump flow in diastole may reduce its ventricular unloading capability. 
     One possible solution is to employ an axial pump instead of the centrifugal pump in the ventricular assist device.  FIG.  1    shows the differences between centrifugal and axial pump HQ curves (head pressure versus flow). There are, however, tradeoffs between axial flow and centrifugal flow pumps. For example, some axial flow pumps are associated with increased likelihood of suction events at lower flow conditions and lower maximum pump flow in systole. Additionally, some clinicians may have a preference for a more sensitive pump with a relatively steeper HQ curve. 
     Yet another possible solution would be to detect systolic and diastolic phases of the cardiac cycle and adjust pump speed accordingly to provide higher pump pressure during low flow conditions, reducing the likelihood of suction events. But this approach requires special sensors and controllers to very reliably detect the characteristics of the cardiac cycle, and may not even work in low pulsatility conditions which may be present in the case of a severely impaired ventricle. Embodiments of the invention provide solutions which overcome these and other problems. 
     BRIEF DESCRIPTION OF THE INVENTION 
     In one embodiment, a ventricular assist device is disclosed. The ventricular assist device may include a centrifugal pump and a controller. The controller may be configured to cause the centrifugal pump to operate at a first speed above a predetermined flow rate. The controller may also be configured to cause the centrifugal pump to operate at a second speed below the predetermined flow rate, wherein the predetermined flowrate is indicative of a crossover point between systole and diastole phases of a person&#39;s cardiac cycle. 
     In another embodiment, a method of controlling a centrifugal pump in a ventricular assist device of a person is disclosed. The method may include causing the centrifugal pump to operate at a first speed above a predetermined flow rate. The method may also include causing the centrifugal pump to operate at a second speed below the predetermined flow rate. The predetermined flowrate may be indicative of a crossover point between systole and diastole phases of the person&#39;s cardiac cycle. 
     In another embodiment, a controller for operating a centrifugal pump in a ventricular assist device of a person is disclosed. The controller may include one or more processors. The one or more processors may be configured to execute instructions stored on a non-transitory medium. The instructions may be executable to cause a centrifugal pump to operate at a first speed above a predetermined flow rate. The instructions may also be executable to cause the centrifugal pump to operate at a second speed below the predetermined flow rate. The predetermined flowrate may be indicative of a crossover point between systole and diastole phases of the person&#39;s cardiac cycle. 
     In another embodiment, a non-transitory machine readable medium having instructions stored thereon for operating a centrifugal pump in a ventricular assist device of a person is disclosed. The instructions may be executable by one or more processors to cause a centrifugal pump to operate at a first speed above a predetermined flow rate. The instructions may also be executable to cause the centrifugal pump to operate at a second speed below the predetermined flow rate. The predetermined flowrate may be indicative of a crossover point between systole and diastole phases of a person&#39;s cardiac cycle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention is described in conjunction with the appended figures: 
         FIG.  1    is a graph showing the head pressure flow curve characteristics (head pressure versus flow) of centrifugal and axial pumps; 
         FIG.  2    is a schematic of a system for controlling a blood pump in accordance with embodiments of the present invention; 
         FIG.  3    is a graph showing the head pressure flow curve characteristics (head pressure versus flow) of a centrifugal pump controlled in a manner of one embodiment of the invention; 
         FIG.  4    is a block diagram of one embodiment of the invention for controlling a centrifugal pump to produce the head pressure flow curve shown in  FIG.  3   ; 
         FIG.  5    is a graph showing torque current (IQ) over the cardiac cycle of a patient having a ventricular assist device with a centrifugal pump being operated in two different manners, one according to embodiments of the present invention; and 
         FIG.  6    is a block diagram of an exemplary computer system capable of being used in at least some portion of the apparatuses or systems of the present invention, or implementing at least some portion of the methods of the present invention. 
     
    
    
     In the appended figures, similar components and/or features may have the same numerical reference label. Further, various components of the same type may be distinguished by following the reference label by a letter that distinguishes among the similar components and/or features. If only the first numerical reference label is used in the specification, the description is applicable to any one of the similar components and/or features having the same first numerical reference label irrespective of the letter suffix. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The ensuing description provides exemplary embodiments only, and is not intended to limit the scope, applicability or configuration of the disclosure. Rather, the ensuing description of the exemplary embodiments will provide those skilled in the art with an enabling description for implementing one or more exemplary embodiments. It being understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope of the invention as set forth in the appended claims. 
     For example, any detail discussed with regard to one embodiment may or may not be present in all contemplated versions of that embodiment. Likewise, any detail discussed with regard to one embodiment may or may not be present in all contemplated versions of other embodiments discussed herein. Finally, the absence of discussion of any detail with regard to embodiment herein shall be an implicit recognition that such detail may or may not be present in any version of any embodiment discussed herein. 
     Specific details are given in the following description to provide a thorough understanding of the embodiments. However, it will be understood by one of ordinary skill in the art that the embodiments may be practiced without these specific details. For example, circuits, systems, networks, processes, and other elements in the invention may be shown as components in block diagram form in order not to obscure the embodiments in unnecessary detail. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail in order to avoid obscuring the embodiments. 
     Also, it is noted that individual embodiments may be described as a process which is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process may be terminated when its operations are completed, but could have additional steps not discussed or included in a figure. Furthermore, not all operations in any particularly described process may occur in all embodiments. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination corresponds to a return of the function to the calling function or the main function. 
     The term “machine-readable medium” includes, but is not limited to transitory and non-transitory, portable or fixed storage devices, optical storage devices, wireless channels and various other mediums capable of storing, containing or carrying instruction(s) and/or data. A code segment or machine-executable instructions may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a class, or any combination of instructions, data structures, or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing and/or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable means including memory sharing, message passing, token passing, network transmission, etc. 
     Furthermore, embodiments of the invention may be implemented, at least in part, either manually or automatically. Manual or automatic implementations may be executed, or at least assisted, through the use of machines, hardware, software, firmware, middleware, microcode, hardware description languages, or any combination thereof. When implemented in software, firmware, middleware or microcode, the program code or code segments to perform the necessary tasks may be stored in a machine readable medium. A processor(s) may perform the necessary tasks. 
     For convenience in explanation and accurate definition in the appended claims, the terms “up” or “upper,” “down” or “lower,” “inside” and “outside” are used to describe features of the present invention with reference to the positions of such features as displayed in the figures. 
     With reference to  FIG.  2    the placement of an exemplary pump  205  in the cardiovascular system will now be described. In various embodiments, the design concept  200  includes pump  205  connected to the left ventricle  210  of a heart  225 . Blood is typically drawn into left ventricle  210  from left atrium  250  and expelled to the ascending aorta through aortic valve  220 . In the exemplary system, blood from left ventricle  210  is drawn into an inflow of pump  205  and driven through an outflow graft to aorta  265 . In the exemplary embodiment, pump  205  is implanted at or near the apex  255  of left ventricle  210 . The flow through exemplary pump  205  is estimated using pump parameters which include power/current, speed (RPM) and a flow map, which allows transformation of inputs like power/current and speed to flow based on the pump flow characteristics curves (e.g. HQ head pressure-flow curves). Heart  225  includes pulmonary valve  230 , tricuspid valve  235 , mitral valve  240 , right atrium  245 , and left atrium  250 . Pulmonary artery  260 , aorta  265 , vena cavae  270 , and pulmonary vein  275  are also shown in  FIG.  2   . Blocks representing pulmonary circulation  280  and systemic circulation  285  are also shown. A controller  290  may execute operation of pump  205  as will be understood by one of skill in the art from the description herein. 
     In embodiments of the present invention, pump speed may be controlled such that it operates at a first speed above a predetermined flow rate of blood through the pump, and at a second speed below the predetermined flow rate through the pump. A clinician may set the predetermined flow rate to correspond with a flowrate indicative of a crossover point between the patient&#39;s systolic and diastolic cardiac phases. In this manner, the pressure generated by the pump may be increased during the diastolic phase, when pressure generated by the patient&#39;s heart on its own is at its lowest. The first speed may represent a minimum operating speed for the pump. 
       FIG.  3    shows an HQ curve (head pressure versus flow) of a centrifugal pump operated in accordance with such embodiments of the invention using the exemplary system shown in  FIG.  4   . While the centrifugal pump is operated at a first speed in high flow situations (e.g., in systole), the pump is operated at a higher, second speed, in low flow situations (e.g., in diastole), and thereby simulates the properties of an axial flow pump in low flow situations (e.g., in diastole). Thus, as shown in  FIG.  5   , by operating a centrifugal pump in this manner, pressure generated may be increased during diastole when compared to operating the centrifugal pump in a conventional manner at a constant set speed across both systole and diastole. 
     Thus, in one embodiment a method may be provided for controlling a centrifugal pump in a ventricular assist or other device. This method may be conducted by pump controller  290 . Pump controller  290  may include a processor and a non-transitory readable medium as discussed further herein. 
     The method may include causing the centrifugal pump to operate at a first speed above a predetermined flow rate, and causing the centrifugal pump to operate at a second speed below the predetermined flow rate. The first speed may be a minimum set operating speed of the centrifugal pump. The second speed may be greater than the first speed. 
     When the centrifugal pump is operating at the first speed, a motor of the centrifugal pump may be operating at a variable current but at a constant speed, where the constant speed may be a speed within a certain RPM range, or within 5%, 10%, or other range of the clinician set speed. When the centrifugal pump is operating at the second speed, the motor of the centrifugal pump may be operating at a constant current and/or voltage, so as to maintain a constant back electromotive force (emf), left ventricular pressure, pulmonic pressure, and/or aortic pressure. 
     To determine when to switch between the first speed and the second speed, the method may include determining an estimated flow rate through the pump based at least in part on a measured current of a motor of the centrifugal pump. The estimated flow rate may then be compared to the predetermined flow rate set by the clinician. In other embodiments, an actual flow rate may be determined with a flow measurement sensor, and then compared to the predetermined flow rate. In some embodiments, the method may also include detecting or identifying a suction event in the centrifugal pump and reducing a speed of the centrifugal pump to alleviate the suction event. 
     Additional related publications discuss ventricular assist device control schemes and devices which may be applicable to some or all of the disclosed embodiments herein. These publications include U.S. Patent Application Publication Nos. 2014/0323796, 2016/0058930, 2016/0058929, and 2016/0228628 and U.S. Pat. Nos. 7,862,501, 8,096,935, 8,870,552, and 9,039,595. The disclosure of each of the aforementioned patent application publications and patents are hereby incorporated by reference, for all purposes, as if fully set forth herein. 
       FIG.  6    is a block diagram illustrating an exemplary computer system  600  in which embodiments of the present invention may be implemented. This example illustrates a computer system  600  such as may be used, in whole, in part, or with various modifications, to provide the functions of pump controller  290  and/or other components of the invention such as those discussed above. For example, various functions of pump controller  290  may be controlled by the computer system  600 , including, merely by way of example, determining a flow rate through pump  205 , causing pump  205  to operate at a constant speed, causing pump  205  to operate at a variable speed, etc. 
     The computer system  600  is shown comprising hardware elements that may be electrically coupled via a bus  690 . The hardware elements may include one or more central processing units  610 , one or more input devices  620  (e.g., a mouse, a keyboard, etc.), and one or more output devices  630  (e.g., a display device, a printer, etc.). The computer system  600  may also include one or more storage device  640 . By way of example, storage device(s)  640  may be disk drives, optical storage devices, solid-state storage device such as a random access memory (“RAM”) and/or a read-only memory (“ROM”), which can be programmable, flash-updateable and/or the like. 
     The computer system  600  may additionally include a computer-readable storage media reader  650 , a communications system  660  (e.g., a modem, a network card (wireless or wired), an infra-red communication device, Bluetooth™ device, cellular communication device, etc.), and working memory  680 , which may include RAM and ROM devices as described above. In some embodiments, the computer system  600  may also include a processing acceleration unit  670 , which can include a digital signal processor, a special-purpose processor and/or the like. 
     The computer-readable storage media reader  650  can further be connected to a computer-readable storage medium, together (and, optionally, in combination with storage device(s)  640 ) comprehensively representing remote, local, fixed, and/or removable storage devices plus storage media for temporarily and/or more permanently containing computer-readable information. The communications system  660  may permit data to be exchanged with a network, system, computer and/or other component described above. 
     The computer system  600  may also comprise software elements, shown as being currently located within a working memory  680 , including an operating system  684  and/or other code  688 . It should be appreciated that alternate embodiments of a computer system  600  may have numerous variations from that described above. For example, customized hardware might also be used and/or particular elements might be implemented in hardware, software (including portable software, such as applets), or both. Furthermore, connection to other computing devices such as network input/output and data acquisition devices may also occur. 
     Software of computer system  600  may include code  688  for implementing any or all of the function of the various elements of the architecture as described herein. For example, software, stored on and/or executed by a computer system such as system  600 , can provide the functions of pump controller  290 , and/or other components of the invention such as those discussed above. Methods implementable by software on some of these components have been discussed above in more detail. In other embodiments, the methods described herein may be implemented in hardware besides a microprocessor. For example, the methods described herein may be conducted on an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA). 
     The systems and methods described herein provide several advantages over existing approaches. By combining properties of a centrifugal pump in a high flow region (i.e. in systole) and properties of an axial flow pump in a low flow region (i.e. in diastole) the system potentially improves hemodynamics and increases assistance for the failing heart. The present inventions may also improve ventricular unloading and/or the capacity to support patients during exercise and other high capacity periods. 
     The invention has now been described in detail for the purposes of clarity and understanding. However, it will be appreciated that certain changes and modifications may be practiced within the scope of this disclosure and the appended claims.