Patent Description:
Implantable blood pumps provide mechanical circulatory support to patients having a weakened or otherwise compromised heart. Generally, implantable blood pumps include a pumping mechanism to move blood from the heart to the rest of the body. In operation, the blood pump draws blood from a source, such as the right ventricle, left ventricle, right atrium, or left atrium of the patient's heart and impels the blood into an artery, such as the patient's ascending aorta or peripheral artery.

Patients requiring an implantable blood pump typically have underlying heart issues, such as low pulsatility. Generally, pulsatility reflects the heart's contractility and stretch, as well as the volume of blood moved by the heart. As a result of low pulsatility, medical complications can arise, including aortic leaflet fusion, ventricular and systematic thrombosis, unclear perfusion of the peripheral microcirculatory bed due to the issues related to blood flow, and the like.

Typically, Mean Arterial Pressure ("MAP") is determined in an effort to manage and prevent medical complications. MAP is generally defined as the average pressure in a patient's arteries during one cardiac cycle and may be obtained using a patient's diastolic blood pressure and systolic blood pressure. Unfortunately, it is often difficult to determine MAP in patients having low pulsatility, such as those having the implantable blood pump, because a signal strength of the patient's pulse pressure may be lower than that which is needed for an instrument to detect the patient's pressure limits, such as the diastolic blood pressure and the systolic blood pressure. For example, traditional commercial blood pressure cuffs may be unable to detect the patient's pulse pressure because the pulse signal strength is not strong enough to provide a stable blood pressure reading. As a result, the patient may be exposed to medical complications that may have otherwise been managed or prevented through accurate blood pressure measurements.

<CIT> describes a mean arterial pressure estimation. <CIT> relates to heart beat identification and pump speed synchronization.

An implantable blood pump system as defined in the appended claims is disclosed.

To aid in the understanding of the invention, herein is disclosed a method (not claimed) of operating of a blood pump implanted within a heart which includes measuring at least one from the group consisting of a current drawn by the implantable blood pump and a blood flow from the implantable blood pump during operation, correlating the at least one from the group consisting of the current and the blood flow to a systolic arterial pressure and a diastolic arterial pressure, and adjusting a speed of an impeller of the implantable blood pump relative to a predetermined speed to correspond to an increase in the at least one from the group consisting of the current and the blood flow during a systolic phase of a cardiac cycle and a decrease in the at least one from the group consisting of the current and the blood flow during a diastolic phase of the cardiac cycle.

In one aspect of this non-claimed disclosure, the method includes obtaining and recording a mean arterial pressure of the patient.

In one aspect of this non-claimed disclosure, the method includes adjusting the speed of the impeller based upon the average blood flow value.

In one aspect of this non-claimed disclosure, the set speed of the impeller is a range of <NUM> rotations per minute to <NUM> rotations per minute.

In one aspect of this non-claimed disclosure, adjusting the speed of the impeller includes increasing the speed of the impeller relative to the predetermined speed by at least <NUM> percent during the systolic phase.

In one aspect of this non-claimed disclosure, adjusting the speed of the impeller includes decreasing the speed of the impeller relative to the predetermined speed by at least <NUM> percent during the diastolic phase.

In one aspect of this non-claimed disclosure, the speed of the impeller is automatically increased relative to the predetermined speed by a controller.

In one aspect of this non-claimed disclosure, the speed of the impeller gradually increases relative to the predetermined speed between a pair of adjacent systolic phases.

In one aspect of this non-claimed disclosure, the increase in speed of the impeller between a pair of adjacent systolic phases is a step-up.

In one aspect of this non-claimed disclosure, the increase in speed of the impeller between a pair of adjacent systolic phases is a ramp-up.

In the embodiment, an implantable blood pump system includes a blood pump, an impeller in communication with the blood pump, a controller in communication with the blood pump, the controller configured to measure a current drawn by the blood pump and a blood flow from the blood pump during operation, correlate the current to a systolic arterial pressure and a diastolic arterial pressure, and adjust a speed of the impeller relative to a predetermined speed and the blood flow to correspond to an increase in the current correlated to the systolic arterial pressure and a decrease in the current correlated to the diastolic arterial pressure.

In one aspect of this embodiment, the controller may be configured to graphically record the current drawn by the blood pump before and after the speed of the impeller is adjusted relative to the predetermined speed.

According to the invention, the controller is configured to record a mean arterial pressure.

In one aspect of this embodiment, the controller is configured to automatically adjust the speed of the impeller relative to the predetermined speed.

In one aspect of this embodiment, the controller is configured to initiate a step-up, the step-up including an increase in the speed of the impeller between a pair of adjacent systolic phases.

In one aspect of this embodiment, the controller is configured to initiate a ramp-up.

In one aspect of this embodiment, the controller maintains the predetermined speed of the impeller in a range of <NUM> rotations per minute to <NUM> rotations per minute.

In one aspect of this embodiment, the controller is configured to at least one of the group consisting of measure the blood flow and estimate the blood flow over a period of time to obtain an average blood flow value and adjust the speed of the impeller based upon the average blood flow value.

In one aspect of this embodiment, the controller is configured to gradually increase the speed of the impeller between a first systolic phase and a second systolic phase, the first systolic phase and the second systolic phase adjacent to each other.

In another not claimed disclosure, a method of measuring a blood pressure of a patient having an implantable blood pump includes measuring a current drawn by the implantable blood pump during operation; measuring an average blood flow value from the implantable blood pump during operation; correlating the current to a systolic arterial pressure and a diastolic arterial pressure of a patient; adjusting a speed of an impeller of the implantable blood pump based upon the average blood flow value relative to a predetermined speed to correspond to an increase in the current, the increase corresponding to the systolic arterial pressure of a patient, and a decrease in the current, the decrease corresponding to the diastolic arterial pressure of the patient; and recording a mean arterial pressure in response to the adjustment of the speed of the impeller relative to the predetermined speed and the average blood flow value.

Before describing in detail exemplary embodiments that are in accordance with the disclosure, it is noted that components have been represented where appropriate by conventional symbols in drawings, showing only those specific details that are pertinent to understanding this embodiments of the 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," "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.

Referring now to the drawing figures in which like reference designators refer to like elements, there is shown in <FIG> an exemplary blood pump constructed in accordance with the principles of the present application and designated generally "<NUM>. " The blood pump <NUM> may be the blood pump sold under the designation HVAD® by HeartWare, Inc. , assignee of the present application. The arrangement of components, such as the magnets, electromagnetic coils, and hydrodynamic bearings used in the exemplary blood pump <NUM> and variants of the same general design are described in <CIT>; <CIT>; <CIT>; and <CIT>. The blood pump may also be that which is sold under the designation MVAD® by HeartWare, Inc. The method and system disclosed herein, however, are not limited to a particular type of blood pump.

The blood pump <NUM>, according to one embodiment of the disclosure, includes a housing <NUM> which houses the components of the blood pump <NUM>. In one configuration, the housing <NUM> includes a first portion <NUM>, a second portion <NUM>, and an inflow cannula <NUM>. The first portion <NUM> and the second portion <NUM> cooperatively define a volute-shaped chamber <NUM> having a major longitudinal axis <NUM> extending through the first portion <NUM> and inflow cannula <NUM>. The first portion <NUM> and the second portion <NUM> define an outlet <NUM> in communication with chamber <NUM>.

Referring now to <FIG>, and <FIG>, the housing <NUM> defines a continuous enclosed flow path traveling through an upstream end <NUM> to a downstream end <NUM> of the inflow cannula <NUM>, as indicated in <FIG> by the arrows U and D respectively. An impeller <NUM> is mounted within the chamber <NUM> for rotation about the axis <NUM>. The impeller <NUM> includes a permanent magnet and flow channels for transferring blood from adjacent the center of the impeller <NUM> to the periphery of the impeller <NUM>. A first stator <NUM> having at least two coils may be disposed within the first portion <NUM> such that when a current is applied to the coils, the electromagnetic forces generated by the first stator <NUM> rotate the impeller <NUM> to impel the blood. A second stator <NUM> may be disposed within the second portion <NUM> and may be configured to operate in conjunction with or independently of the first stator <NUM> to rotate the impeller <NUM>.

An electrical connector <NUM> (<FIG>) is provided on the first portion <NUM> for connecting the coils to a source of power, such as a controller <NUM>, configured to be external to the patient. The controller <NUM> may include various software and hardware components for operating the blood pump <NUM>. The source of power is not limited to the controller <NUM>, however, as other sources of power may be used, such as a battery, a driveline, and the like. The controller <NUM> is arranged to apply power to the coils of the pump to create a rotating magnetic field which spins the impeller <NUM> around the axis <NUM> in a direction of rotation that is clockwise, as designated by "R," or counterclockwise. Rotation of the impeller <NUM> impels blood in a downstream direction D along the flow path to the outlet <NUM>.

The controller <NUM> may be configured to measure the current drawn by the blood pump <NUM> and/or a blood flow from the blood pump <NUM>, such as from the outlet <NUM>, during operation. The controller <NUM> may also include a standard mode in which the controller <NUM> is configured to maintain a speed of the impeller <NUM> at a predetermined speed and a blood pressure mode in which the speed of the impeller <NUM> is adjusted to raise a patient's blood pressure in an effort to measure the patient's MAP using a blood pressure measurement device.

With reference to <FIG>, the current and/or the blood flow may be measured by the controller <NUM> relative to a baseline, designated as "BL. " The measurement of the current may be determined using information associated with a resistance in the electrical connection and a voltage, or another measurement method. The measurement of the blood flow may be determined using the current, the speed of the impeller <NUM>, and the viscosity of the blood, or another measurement method.

The measurement of the current and/or the blood flow may be correlated to a systolic arterial pressure and a diastolic arterial pressure of a patient having the blood pump <NUM> implanted in the patient's heart. Said another way, the current and the blood flow measurements of the blood pump <NUM> are configured to provide real-time information about the cardiac cycle of the patient's heart. <FIG> depicts an exemplary cardiac cycle including a systolic phase, designated as "s," and a diastolic phase, designated as "d. " The amount of the current and/or the blood flow through the blood pump <NUM> is graphically depicted via a waveform when the controller <NUM> is in the standard mode, designated as "SM," and the blood pressure mode, designated as "BP.

The systolic phase may be determined as the current and/or the blood flow through the blood pump <NUM> is configured to increase relative to the baseline when the heart is contracting as the blood pump <NUM> naturally requires an increase in the current to pump the blood. The diastolic phase may be determined as the current and/or the blood flow waveform is configured to decrease when the heart transitions from the systolic phase to the diastolic phase because the blood pump <NUM> requires less current when the heart is relaxing and filling with the blood than that required during contracting. The cycle shown in <FIG> is an exemplary cycle as the amount of current and/or the blood flow through the blood pump <NUM> may vary between patients.

With reference still to <FIG>, in the standard mode, the controller <NUM> is configured to maintain the speed of the impeller <NUM> at a predetermined speed, designated as "PS. " In one configuration, the predetermined speed may be at least <NUM> revolutions per minute, such as in a range of <NUM> rotations to <NUM> rotations per minute. Additional ranges are also possible in accordance with the type of blood pump and the needs of the individual patient. When the controller <NUM> is in the standard mode, including the impeller <NUM> being set to the predetermined speed, the current and/or the blood flow may not produce an amount of arterial pressure needed to measure that patient's MAP. For example, the patient may have low pulsatility, which generally includes a pulse pressure that is too low to be measured with a blood pressure device, such as a blood pressure cuff.

With reference to <FIG> and <FIG>, in the blood pressure mode, the speed of the impeller <NUM> may be increased relative to the predetermined speed "PS," in accordance with an increase in the current and/or the blood flow during systole and may be decreased in accordance with a decrease in the current and/or blood flow during diastole, such that the speed is synchronized with the patient's cardiac cycle. The speed adjustment is configured to amplify and attenuate the arterial pressure of the patient in an effort to measure the patient's MAP using the blood pressure device.

In one configuration, the amount of the speed adjustment may be determined using information associated with the blood flow of the blood pump <NUM>, such as an average blood flow value over time. As shown in <FIG>, the speed of the impeller <NUM> may be adjusted to various speeds until the average blood flow measured before and after the blood pressure mode is equal to the average blood flow value during the blood pressure mode, designated as "AFV," so as not to affect the patient's MAP. When the average blood flow value is maintained during the blood pressure mode, the amplified arterial pressure during the speed increase may be balanced by the attenuated arterial pressure during the speed decrease so as to maintain an energy content of the arterial pressure waveform constant during the blood pressure mode. In other words, by maintaining a zero-relative change in the average blood flow value through the blood pump <NUM> during the standard mode compared to the blood pressure mode, the patient's mean arterial pressure will not be affected by the speed adjustment.

In order to obtain the average blood flow value, the controller <NUM> may be configured to measure and/or estimate the blood flow over a period of time, such as ten to twenty-minute intervals, hourly, daily, or the like. The average blood flow value may also be determined using a data-table corresponding to the individual patient or another measurement method, such as adjusting the speed of the impeller <NUM> to various intervals and thereafter measuring the blood flow through the blood pump <NUM> until the average blood flow value is maintained.

As shown in <FIG> and <FIG>, the selective adjustment of the speed of the impeller <NUM> is designated as "SP," and the corresponding increase and decrease in the current and/or blood flow waveform is designated as "BP. " In one configuration, the decrease in speed of the impeller <NUM> is configured to cause the current and/or blood flow waveform in the blood pressure mode to drop below the current and/or blood flow waveform in the standard mode. The increase and the decrease in speed relative to the predetermined speed may be plus or minus <NUM> percent, or as otherwise established in accordance with the patient's cardiac cycle. In one configuration, as shown in <FIG>, the increase in speed may be a step-up, which may include a relatively instantaneous increase in the speed of the impeller <NUM> during a diastolic phase between a pair of adjacent systolic phases. Alternatively, the controller <NUM> may be configured to perform a ramp-up (not shown), which is a relatively gradual increase in the speed of the impeller <NUM> between the pair of adjacent systolic phases.

With reference again to <FIG>, the amplification in the arterial pressure is graphically represented by an increase in a peak length of the current and/or the blood flow waveform during the blood pressure mode, designated as P1, in comparison to a length of the peak in the standard mode, designated as P2. As shown, the current and/or the blood flow waveform and correlated arterial pressure is configured to be higher when the controller <NUM> is in the blood pressure mode, as a result of the speed adjustment, than that which occurs during the standard mode when the speed is predetermined. Accordingly, the patient's blood pressure may be measured in the blood pressure mode when the arterial pressure is amplified.

With reference to <FIG>, a graph is depicted showing an exemplary cardiac cycle in a computer simulation including an aortic pressure, designated as "AP," and a ventricular pressure, designated as "VP," before and after the speed of the impeller <NUM> is increased relative to the predetermined speed in an effort to raise the patient's arterial pressure such that MAP can be determined. The controller <NUM> may be configured to adjust the speed and record the corresponding aortic and ventricular pressures. The aortic pressure before the increase in speed is designed as "B" and is configured to be lower than the aortic pressure after the increase in speed, which is designated as "A. " The ventricular pressure is configured to remain constant, regardless of the speed adjustment. The graph disclosed in <FIG> is not intended to be limiting as additional methods of recordation may also be used, such as line graphs, bar graphs, charts, and the like.

Claim 1:
An implantable blood pump system, comprising:
a blood pump (<NUM>);
an impeller (<NUM>) in communication with the blood pump; and
a controller (<NUM>) in communication with the blood pump, the controller (<NUM>) configured to:
measure a current drawn by the blood pump and a blood flow from the blood pump during operation;
correlate the current to a systolic arterial pressure and a diastolic arterial pressure; and
adjust a speed (SP) of the impeller relative to a predetermined speed (PS) and the blood flow to correspond to an increase in the current correlated to the systolic arterial pressure and a decrease in the current correlated to the diastolic arterial pressure,
characterized in that
the controller (<NUM>) is configured to record a mean arterial pressure (MAP).