Patent Application
20190343999
The present technology is generally related to blood pumps, and more particularly, to a method of controlling an impeller within a blood pump.
Mechanical Circulatory Support Devices (“MCSDs”), such as ventricular assist devices, are commonly used to assist the pumping action of a failing heart. Typically, an MCSD includes an implantable blood pump that is surgically implanted in a patient's body, the blood pump having a housing with an inlet, an outlet, and a rotor mounted therein. The inlet is connected to a chamber of the patient's heart, typically the left ventricle, whereas the outlet is connected to an artery, such as the aorta. Rotation of the rotor drives blood from the inlet towards the outlet and thus assists blood flow from the chamber of the heart into the artery. One exemplary blood pump is the MVAD® pump.
As blood flows through the blood pump, a differential pressure is created across the pump which is subject to increasing relative to a normal pressure, such as upon the existence of a suction condition or occlusion within the pump. At least one known method of controlling a rotor or impeller in response to a pump's flow rate change is provided in commonly owned U.S. Pat. No. 9,511,179B2, the disclosure of which is hereby incorporated in its entirety. For example, such disclosure describes a method of operating a blood pump using a control circuit that detects a low flow condition, characterized by a low flow rate, and commands a drive circuit of the pump to cause a momentary reduction in the pump speed in order to cure the low flow condition. In some circumstances, however, it may be harmful to wait until the low flow condition is detected before implementing corrective measures.
The present invention provides a blood pump system including an implantable blood pump having a housing including an inlet and an outlet opposite the inlet, the housing defining a housing axis extending from the inlet to the outlet, an impeller suspended within the housing and being rotational around the housing axis, and a motor for rotating the impeller. In addition, the blood pump system may include a controller including a control circuit, the control circuit being in communication with the blood pump and being configured to detect a pressure across the pump when the pressure crosses a pressure threshold, and, in response to the pressure crossing the pressure threshold, the controller being configured to displace the impeller from a first position to a second position different than the first position using a vector control method.
In another embodiment, the present invention provides a method of controlling an implantable blood pump including a housing having a proximal portion including an inlet cannula, a distal portion including an outlet, and an impeller therein, the method including detecting when a pressure in the housing exceeds a pressure threshold and executing a first vector control command to displace the impeller axially in a distal direction from a primary position to a secondary position different than the primary position in response to the pressure exceeding the pressure threshold.
In another embodiment, the present invention provides a method of controlling an implantable blood pump including a housing having a proximate portion including a mechanical stop, a distal portion opposite the proximate portion, and an impeller therein, the method including detecting when the impeller is within a hazardous distance from the mechanical stop and executing a vector control command to displace the impeller axially in a distal direction from a hazardous position to a safe position away from the mechanical stop.
The techniques of this disclosure generally relate to blood pumps, and more particularly, to a method of controlling an impeller within a blood pump.
In one aspect, the present disclosure provides a blood pump system comprising an implantable blood pump. The implantable blood pump includes a housing having an inlet and an outlet opposite the inlet. The housing is defined by a housing axis extending from the inlet to the outlet. An impeller is suspended within the housing and is rotational around the housing axis. A motor for rotating the impeller is provided. A controller including a control circuit is provided.
The control circuit being is in communication with the blood pump and is configured to detect a pressure across the pump when the pressure crosses a pressure threshold. In response to the pressure crossing the pressure threshold, the controller is configured to displace the impeller from a first position to a second position different than the first position using a vector control method.
In another aspect, the disclosure provides housing that includes an inlet cannula. The inlet cannula is defined by the inlet and an inner tube surrounded by the inlet cannula. The inner tube is defined by a mechanical stop therein, and the second position is a distance away from the mechanical stop in a direction toward the outlet.
In another aspect, the disclosure provides that the distance is between 0.1 and 1.5 mm away from the mechanical stop.
In another aspect, the disclosure provides that the vector control method is a three-phase sensorless field-oriented control method including a plurality of stator windings and a plurality of alternating currents.
In another aspect, the disclosure provides that the control circuit is configured to maintain the blood pump in the second position for a time period when the pressure crosses the pressure threshold.
In another aspect, the disclosure provides that the controller is configured to displace the impeller from the second position to the first position when the pressure crosses the pressure threshold.
In one aspect, a method of controlling an implantable blood pump includes a housing having a proximal portion including an inlet cannula, a distal portion including an outlet, and an impeller. The method further includes detecting when a pressure in the housing exceeds a pressure threshold and executing a first vector control command to displace the impeller axially in a distal direction from a primary position to a secondary position different than the primary position in response to the pressure exceeding the pressure threshold.
In another aspect, the method further includes executing a maintenance control command to maintain the impeller in the secondary position for a time period, detecting a normal pressure condition of the blood pump, and executing a second vector control command to displace the impeller axially in a proximal direction from the secondary position to the primary position when the normal pressure condition is detected.
In another aspect, the method further includes moving the impeller axially in the distal direction away from a mechanical stop defined by an inner tube. The inner tube is surrounded by the inlet cannula.
In another aspect, the method further includes moving the impeller between 0.1 and 1.5 mm away from the mechanical stop.
In another aspect, the method further includes having the first vector control command be a three-phase sensorless field-oriented control method.
In another aspect, the method further includes reducing a speed of the impeller relative to an initial speed.
In another aspect, the method further includes maintaining the blood pump in the secondary position for a time period.
In another aspect, the method further includes determining whether a plurality of pump parameters are within a normal operating range.
In another aspect, the method further includes having the pump parameters include a flow and speed of the blood pump.
In one aspect, a method of controlling an implantable blood pump includes a housing having a proximate portion including a mechanical stop, a distal portion opposite the proximate portion, and an impeller. The method further includes detecting when the impeller is within a hazardous distance from the mechanical stop and executing a vector control command to displace the impeller axially in a distal direction from a hazardous position to a safe position away from the mechanical stop.
In another aspect, the method further includes detecting an adverse condition within the blood pump and detecting when the impeller is within the hazardous distance from the mechanical stop in response to the adverse condition.
In another aspect, the method further includes executing a maintenance control command to maintain the impeller within the safe position for a time period, detecting a clearance of the adverse condition of the blood pump, and executing a second vector control command to displace the impeller axially in a proximal direction from the safe position to a normal operating position.
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.
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:
Before describing in detail exemplary embodiments, it is noted that the claims reside primarily in combinations of system components and processing steps related to a method of controlling a blood pump. Accordingly, the system and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.
As used herein, relational terms, such as “first” and “second,” “top” and “bottom,” and the like, may be used solely to distinguish one entity or element from another entity or element without necessarily requiring or implying any physical or logical relationship or order between such entities or elements. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the concepts described herein. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes” and/or “including” when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Referring now to the drawings in which like reference designators refer to like elements there is shown in
In one configuration, the blood pump 10 includes a pump housing 12 having an inlet cannula 14 and an impeller 16 within the housing 12 to impel the blood. The inlet cannula 14 may include an inner tube 18 formed from a non-magnetic material, such as a ceramic. The inner tube 18 includes an interior surface 20 defining a cylindrical bore 22 for receiving the impeller 16 therein. The inner tube 18 may also include a cylindrical outer surface 24 configured to be surrounded by a stator 26 having one or more coils 28. A voltage may be applied to the coils 28 to produce an electromagnetic force to rotate the impeller 16, thus impelling the blood along a flow path from an upstream direction U to a downstream direction D.
The impeller 16 is configured to move in an axial direction relative to the housing 12 along a housing axis “A” that extends from the inlet cannula 14 through a lower housing portion 30 having an outlet 32 which may be proximate a volute. As discussed in further detail below, the method provided herein includes controlling the axial direction or position of the impeller 16 so as to move the impeller axially away from a mechanical stop located within the inner tube 18 during an adverse incident, such as suction or occlusion. Suction is an intermittent decrease in flow through the blood pump 10, whereas occlusion is a sustained decrease in flow through the blood pump 10.
The impeller 16 may be configured so that during rotation, the impeller 16 is levitated within the housing 12 by contactless bearings, such as magnetic bearings, hydrodynamic bearings or a combination of the two which produce a hydraulic and magnetic suspension system. For example, with reference to
With reference to
In one configuration, the control circuit 36 is coupled to the motor 34 to control operation of the motor 34, such as through one or more implanted cables. The control circuit 36 includes a processor 38, a memory 40, and an interface 42 for interfacing with the motor 34. The memory 40 stores information accessible by the processor 38, including instructions 44 that may be executed by the processor 38. The memory 40 also includes data 46 that may be retrieved, manipulated or stored by the processor 38. The memory 40 may be of any type capable of storing information accessible by the processor 38, such as a hard-drive, memory card, ROM, RAM, DVD, CD-ROM, write-capable, and read only memories. The processor 38 may be any well-known processor, such as commercially available processors. Alternatively, the processor 38 may be a dedicated controller such as an ASIC.
The data 46 may be retrieved, stored or modified by the processor 38 in accordance with the instructions 44. The data may also be formatted in any computer-readable format such as, but not limited to, binary values, ASCII or Unicode. Moreover, the data 46 may comprise any information sufficient to identify the relevant information, such as numbers, descriptive text, proprietary codes, pointers, references to data stored in other memories (including other network locations) or information that is used by a function to calculate the relevant data.
The control circuit 36 includes hardware and software for controlling the various aspects of the operation of the motor 34. The control circuit 36 may be coupled to the motor 34 through the interface 42 to collect at least some of data 46 from the motor 34. For example, the data 46 may include one or more electrical current measurements 48 of the motor windings of the stator 26 (
The instructions 44 stored in the memory 40 may include one or more instruction sets or modules, for performing certain operations in accordance with the present disclosure. One such module may be a motor control module 52 for controlling operation of the motor 34 (e.g., increasing or decreasing current supplied to the motor), such as in accordance with the FOC routines described herein. The instructions may also include one or more motor monitor modules 54 for monitoring operation of the motor 34. Examples of motor control and monitoring modules may be found in the commonly owned and copending U.S. patent application Ser. Nos. 13/355,297, 13/951,302, 14/294,448, 14/950,467, 62/266,871 and 62/271,618, the disclosures of which are incorporated herein by reference in their entireties. The control circuit 36 may be disposed within a controller 56 which is connected to a power supply 58.
Referring now to
In one configuration, the method begins with step 60 and proceeds directly to step 62 of detecting when a pressure in the housing 12 across the blood pump 10 exceeds a pressure threshold. The pressure threshold may be predetermined using blood pump parameters, such as speed and flow, and is indicative of a high-pressure or adverse condition, such as suction or occlusion. The pressure detection may be determined using the controller 56, the control circuit 36, and one or more modules within the control circuit 36. For example, a method of operating a blood pump using a control circuit that detects a low flow condition is described in commonly owned U.S. Patent Pub. No. 2012/0245681, the disclosure of which is hereby incorporated in the entirety. In addition, commonly owned U.S. Pat. No. 9,427,508, the disclosure of which is hereby incorporated in the entirety, discloses a method of determining whether a high-pressure condition is present in the blood pump based on determined flow rate. For example, a differential pressure value greater than a predetermined threshold pressure value may be indicative of a high-pressure condition across the pump. In lieu of or in addition to detecting the pressure threshold, step 62 may include detecting when the pump flow is outside of a designated range and/or the use of one or more sensors to measure and obtain information associated with the blood pump parameters.
With reference to
In one configuration, the first vector control command is executed using a vector control method, such as the three-phase sensorless field-oriented control method described above including the set of three stator windings and the set of three alternating currents. In other configurations, the vector control method may be an alternative variable-frequency drive (VFD) control method.
As shown in
The mechanical stop 76 is configured to limit axial displacement of the impeller 16 within the inner tube 18. In one configuration, the mechanical stop 76 may be formed as a portion of the inner tube 18, located closer to the inlet 74 than the outlet 32, having a diameter smaller than a remaining diameter of the inner tube 18. In other words, the mechanical stop 76 may be a slope, indentation, or the like, which creates a narrow portion of the inner tube 18 configured to prevent the impeller 16 from traveling beyond the mechanical stop 76 toward the inlet 74. In other configurations, the mechanical stop 76 may be a piece of material coupled to the interior surface 20 of the inner tube 18.
Moving the impeller 16 away from the mechanical stop 76 is configured to reduce the pressure in the housing 12, prevent pressure buildup, and/or prevent the impeller 16 from contacting the mechanical stop 76 during pressure build up or the high-pressure condition while maintaining hydraulic performance.
In one configuration, the controller 56 may be configured to reduce a speed of the impeller 16 relative to an initial speed, such as when the pressure crosses the pressure threshold. The relative amount of the speed reduction may be a preselected reaction speed sufficient to reduce the pressure buildup across the blood pump 10. The preselected reaction speed may be stored in the memory 40 of the controller 56.
In step 66 (
Referring to
With reference to
The method of detecting the hazardous distance may be executed using the methods and components described above with respect to the pressure detection. For example, the controller 56 may be configured to detect that the impeller 16 is within the hazardous distance using the control circuit 36 and one or more modules and/or sensors. An alarm may be triggered in response to the controller 56 detecting that the pressure has exceeded the pressure threshold and/or upon detecting that the impeller 16 is located at the hazardous position 88.
In step 84, the method may include executing a vector control command, such as the first vector control command described above, to displace the impeller 17 axially in the distal direction from the hazardous position 88 to a safe position 90 away from the mechanical stop 76. The safe position 90 may be a same or similar position as the second position 72 (
In one configuration, the method may include executing the maintenance control command to maintain the impeller 16 in the safe position for a time period, such as until the controller 56 detects that the adverse or high-pressure condition has cleared. In the safe position, the speed of the impeller 16 may also be reduced. Once the controller 56 detects a clearance of the adverse condition, the controller 56 may be configured to execute a second vector control command, such as that described above, to displace the impeller 16 axially in the proximal direction from the safe position 90 to a normal operating position which may be the first position 70 (
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.
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.
This application claims the benefit of U.S. Application Serial No. 62/669525, filed May 10, 2018.
| Number | Date | Country | |
|---|---|---|---|
| 62669525 | May 2018 | US |
