Circulation support system

Abstract

An example of a cardiac pump system includes a catheter shaft having a proximal end region coupled to a handle and a distal end region coupled to a cardiac pump. The cardiac pump includes an impeller housing, a cannula, and an impeller. The cannula includes a distal end region and a proximal end region. The distal end region of the cannula is configured to be positioned in the left ventricle of the heart. Furthermore, the cardiac pump system includes a first flow sensor coupled to the cannula or catheter shaft. The first flow sensor is configured to directly sense a first velocity of blood flowing adjacent to the first flow sensor.

Description

Technical Field

[0001] The present disclosure relates to a percutaneous circulatory assist device system. More specifically, the present disclosure relates to a circulatory assist device including one or more flow sensors.

Background Art

[0002] Percutaneous circulatory assist devices such as blood pumps can provide temporary cardiac assistance in patients with reduced cardiac function or cardiac output. Such a device can be introduced percutaneously from the femoral artery, pass retrograde through the descending aorta, cross the aortic arch, pass through the aortic valve through the ascending aorta, and be delivered to the left ventricle. A percutaneous circulatory assist device can include one or more flow sensors disposed on the device to directly measure the blood flow in the vicinity thereof. Direct measurement of blood flow can facilitate derivation of the position of the assist device within the heart, the cardiac output of the heart, or other heart-related parameters. Thus, there is a continuing need to provide a circulatory assist device system including one or more flow sensors designed to provide information about the heart and / or other data related to cardiac procedures. A circulatory assist device system including one or more flow sensors designed to provide information about the heart and / or other data related to cardiac procedures is disclosed herein.

Summary of the Invention

[0003] This disclosure provides alternative designs, materials, manufacturing methods and uses for medical devices and / or medical systems. An example of a cardiac pump system includes a catheter shaft having a proximal end region coupled to a handle and a distal end region coupled to a cardiac pump, wherein the cardiac pump includes an impeller housing, a cannula and an impeller, the cannula having a distal end region and a proximal end region, and the distal end region of the cannula is configured to be positioned in the left ventricle of the heart, and the cardiac pump system further includes a first flow sensor coupled to the cannula or the catheter shaft, the first flow sensor being configured to directly sense a first velocity of blood flowing adjacent to the first flow sensor.

[0004] Alternatively or in addition to any of the above embodiments, the cardiac pump system further comprises a console coupled to the handle, the console including a processor, and the console configured to receive a first signal from the first flow sensor.

[0005] In addition to or alternative to any of the above embodiments, the cardiac pump system is configured such that the first signal corresponds to the first velocity of blood sensed by the first flow sensor. Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the processor calculates the cardiac output based on the first velocity of blood sensed by the first flow sensor.

[0006] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the first flow sensor is attached to the outer surface of the distal end region of the cannula. In an alternative or additional configuration to any of the above embodiments, the cardiac pump system is configured such that the first flow sensor is embedded within the wall of the cannula.

[0007] Alternatively or in addition to any of the above embodiments, the cardiac pump system further includes a second flow sensor, the first flow sensor of which is coupled to the cannula, and the cardiac pump system is coupled to the catheter shaft.

[0008] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the second flow sensor directly senses a second velocity of blood flowing adjacent to the second flow sensor, and the console is configured to receive a second signal from the second flow sensor, the second signal corresponding to the second velocity of blood flowing adjacent to the second flow sensor.

[0009] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the processor compares the first velocity of blood sensed by the first flow sensor with the second velocity of blood sensed by the second flow sensor.

[0010] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the processor calculates the position of the cardiac pump based on the result of comparing the first velocity of blood sensed by the first flow sensor with the second velocity of blood sensed by the second flow sensor.

[0011] Alternatively or in addition to any of the above embodiments, the cardiac pump system is positioned along the catheter shaft such that the first flow sensor is positioned distal to the subclavian artery when the distal end region of the cannula is positioned in the left ventricle.

[0012] Alternatively or in addition to any of the above embodiments, the cardiac pump system is positioned along the catheter shaft such that the first flow sensor is positioned proximal to the subclavian artery when the distal end region of the cannula is positioned in the left ventricle.

[0013] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the first flow sensor is positioned along the catheter shaft so as to be adjacent to and distal to the renal artery when the distal end region of the cannula is positioned in the left ventricle.

[0014] Alternatively or in addition to any of the above embodiments, the cardiac pump system is configured such that the first flow sensor is positioned along the catheter shaft so as to be adjacent to and proximal to the renal artery when the distal end region of the cannula is positioned in the left ventricle.

[0015] Another example of a cardiac pump system includes a console including a processor, and a cardiac pump device including a first catheter shaft having a handle coupled to the console and a proximal end region coupled to the handle and a distal end region coupled to a cardiac pump, an impeller and a cannula, wherein the cannula includes a proximal end region and a distal end region. The cardiac pump system further includes a first flow sensor coupled to the proximal end region of the cannula, wherein the first flow sensor is positioned between the impeller and the distal end region of the cannula.

[0016] Alternatively or in addition to any of the above embodiments, the first flow sensor is configured to directly sense a first velocity of blood flowing adjacent to the first flow sensor. Alternatively or in addition to any of the above embodiments, the processor is configured to calculate the cardiac output of the heart based on the first velocity of the blood sensed by the first flow sensor.

[0017] Alternatively or in addition to any of the above embodiments, the cardiac pump device further includes one or more blood inlets located in the distal end region of the cannula, the one or more blood inlets being configured to be located in the left ventricle of the heart.

[0018] Alternatively or in addition to any of the above embodiments, the present invention further includes a second flow sensor coupled to the catheter shaft. Another exemplary method for positioning a cardiac pump system in the heart involves advancing the cardiac pump device to a position adjacent to the left ventricle of the heart, the cardiac pump device comprising an impeller and a cannula including a proximal and distal end region and a first flow sensor coupled to the proximal end region of the cannula, the first flow sensor positioned between the impeller and the distal end region of the cannula. The method includes positioning the distal end region of the cannula in the left ventricle and positioning the impeller in the ascending aorta of the heart.

[0019] The above summary of embodiments is not intended to describe any or all embodiments of this disclosure. The drawings and detailed description of the invention described later provide more specific examples of these embodiments. [Brief explanation of the drawing]

[0020] [Figure 1] Figure 1 shows the percutaneous circulatory support system, including the circulatory support device, and the relative position of the circulatory support device to the patient's heart. [Figure 2] Figure 2 is a schematic block diagram of the console management system. [Figure 3] Figure 3 shows a portion of the circulatory support system shown in Figure 1, which is placed around the patient's heart. [Figure 4] Figure 4 shows a part of the circulatory support system. [Figure 5] Figure 5 is a cross-sectional view along line 4-4 in Figure 4. [Figure 6] Figure 6 shows another embodiment of a cross-sectional view along line 4-4 in Figure 4. [Figure 7] Figure 7 shows another embodiment of a cross-sectional view along line 4-4 in Figure 4. [Figure 8] Figure 8 shows a portion of the circulatory support system located within the body's blood vessels. [Figure 9]FIG. 9 is a cross-sectional view taken along line 8-8 of FIG. 8. [Figure 10] FIG. 10 shows a part of a circulatory assist system arranged adjacent to the renal artery of a patient. [Figure 11] FIG. 11 shows a part of another circulatory assist system arranged in the heart of a patient. [Figure 12] FIG. 12 shows a part of another circulatory assist system arranged in the heart of a patient.

[0021] Although the present invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. In contrast, the present invention is intended to cover all modifications, equivalents, and alternatives within the scope of the present invention as defined by the appended claims.

Mode for Carrying Out the Invention

[0022] FIG. 1 shows an example of a percutaneous circulatory system 10 including a circulatory assist device 12 arranged in the heart 14 of a patient 16. The circulatory assist device 12 may include a flexible elongated catheter shaft 20 having a first end attached to a handle 22 and a second end attached to a blood pump 24. FIG. 1 shows the blood pump 24 arranged in the left ventricle 18 of the patient 16. The blood pump 24 may be delivered (e.g., tracked) percutaneously on a guide wire to the ventricle 18. For example, the catheter shaft 20 and the blood pump 24 may be advanced following the guide wire so as to pass through the femoral artery, through the renal artery 60 and the descending aorta, over the aortic arch, through the ascending aorta 37, through the aortic valve, and reach the left ventricle 18.

[0023] Figure 1 further shows that the handle 22 may include a distal end region attached to the catheter shaft 20 and a proximal end region attached to the power cable 26. The power cable 26 may include a distal end region connected to the console 28. It is understood that the handle 22 may include one or more actuators (e.g., buttons, levers, dials, switches, etc.) designed to allow a clinician to control various functions of the blood pump 24. For example, a clinician may be able to control the speed of a motor and / or impeller located in the blood pump 24 via the operation of one or more actuators located on the handle 22.

[0024] Furthermore, Figure 1 shows that the console 28 may include one or more control knobs (e.g., buttons, knobs, dials, etc.) 30 and / or one or more display units. For example, Figure 1 shows that the console 28 may include a first display unit 32 and a second display unit 34. It is understood that the console 28 may include more than two display units. Furthermore, although Figure 1 shows the first display unit 32 and the second display unit 34 integrated into the console 28, the circulating system 10 may be designed so that either the first display unit 32 or the second display unit 34, or both the first display unit 32 and the second display unit 34, are separate and independent components of the circulating system 10. In other words, either the first display unit 32 or the second display unit 34, or both the first display unit 32 and the second display unit 34, may be independent display units separate from the console 28. In one example, the first display unit 32 and the second display unit 34 may obtain their respective data from separate sources.

[0025] In some examples, the second display unit 34 may be designed to be mounted on the console 28 and / or the first display unit 32. For example, the first display unit 32 may be integrated with the console 28, while the second display unit 34 may be mounted on a part of the console 28. In yet another example, both the first display unit 32 and the second display unit 34 may be separate and independent display units, in which case the second display unit 34 may be configured to be mounted on the first display unit 32, or the first display unit 32 may be configured to be mounted on the second display unit 34.

[0026] Figure 2 shows that the console 28 may include one or more processors 36, memory 38, and input / output units 40, along with other appropriate components. The processor 36 of the console 28 may include a single processor or two or more processors that can operate independently or in conjunction with each other (for example, a first processor 36 that outputs data / commands to a first display unit 32, and a second processor 36 that outputs data / commands to a second display unit 34). The processor 36 may be configured to execute instructions that include instructions that can be loaded into memory 38 and / or other appropriate memory. Exemplary processor components may include, but are not limited to, microprocessors, microcontrollers, multicore processors, graphical processing units, digital signal processors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), discrete circuits, and / or other appropriate types of data processing devices. In some examples, the console's processor 36 may be configured to execute program instructions. Program instructions may include, for example, firmware, microcode, or application code executed by the processor 36, the microprocessor, and / or the microcontroller. One or more processors 36 may be configured to manage different functions, each independently. They may be configured to perform the same function simultaneously (e.g., a redundant configuration). Furthermore, they may be configured such that the first processor 36 performs a predetermined function, and the second processor 36 verifies the success or failure of the result of the first processor 36's function (e.g., a command monitor system).

[0027] In some examples, the first display unit 32 may be controlled primarily by firmware control instructions of the console, and therefore may have relatively less processing power, relatively fewer instructions, and very simple communication between the processor 36 and the display unit 32 compared to the second display unit 34 (e.g., touchscreen display unit 34), which may be controlled primarily by an embedded computer having a flexible and relatively complex communication protocol.

[0028] The memory 38 of the console 28 may include a single memory section or two or more memory sections operating independently or in conjunction with each other. Exemplary types of memory may include random access memory (RAM), EEPROM, flash memory, suitable volatile memory, suitable non-volatile memory, persistent memory (e.g., read-only memory (ROM), hard disk drives, flash memory, optical disk memory, and / or other suitable persistent memory) and / or other suitable types of memory. The memory 38 may be, or may include, a non-volatile computer-readable medium.

[0029] The input / output unit 40 of the console 28 may include a single input / output section, or two or more input / output sections that operate independently or in conjunction with each other. An exemplary input / output unit 40 may be any type of communication port configured to communicate with other components of the circulation system 10. Examples of exemplary input / output unit 45 types may include wired ports, wireless ports, radio frequency (RF) ports, low-energy Bluetooth® ports, Bluetooth® ports, near-field communication (NFC) ports, HDMI® ports, Wi-Fi ports, Ethernet® ports, VGA ports, serial ports, parallel ports, component video ports, S-video ports, composite audio / video ports, DVI ports, USB ports, optical ports, and / or other suitable ports.

[0030] Figure 3 shows a blood pump 24 of a percutaneous circulatory system 10 extending from the ascending aorta 37 to the left ventricle 18 of patient 16. The blood pump 24 may include a cannula 44 having a proximal end attached to the distal end of an impeller housing 46. The proximal end 42 of the impeller housing 46 may be attached to the distal end of a catheter shaft 20. In some examples, Figure 3 shows that the blood pump 24 may be positioned within the heart 14 so that the cannula 44 passes through the aortic valve 39, thereby allowing the distal end region 41 of the cannula 44 to be positioned within the left ventricle 18. As discussed herein, the blood pump 24 may be advanced along a guidewire to the position shown in Figure 3.

[0031] Figure 3 further shows that the shaft 20 of the circulatory support device 12 may include one or more blood inlets 58 located in the distal end region 41 of the cannula 44, and one or more blood outlets 48 located along the impeller housing 46. In one example, the blood pump 24 may be located in the heart 14 such that one or more blood inlets 58 located along the distal end region 41 of the cannula 44 may be located in the left ventricle 18, and one or more blood outlets 48 located along the impeller housing 46 may be located in the ascending aorta 37.

[0032] Furthermore, the blood pump 24 may include an electric motor that drives the rotation of an impeller 33, which may be located within the impeller housing 46. In some examples, the motor may drive the rotation of the impeller 33 via electromagnetic induction. The rotating impeller 33 can draw blood from the left ventricle 18 (through one or more blood inlets 58 located in the distal end region of the cannula 44) and deliver it to the ascending aorta 37 (through one or more blood outlets 48 located along the impeller housing 46). In other words, the electric motor drives the impeller 33 to pump blood from the left ventricle 18 through the aortic valve 39 to the ascending aorta 37.

[0033] Furthermore, the circulatory support device 12 may include one or more sensors that can be coupled to the cannula 44, the impeller housing 46, and / or the catheter shaft 20. One or more sensors coupled to the cannula 44, the impeller housing 46, and / or the catheter shaft 20 may be designed to monitor blood pressure (e.g., arterial pressure, venous pressure), blood flow velocity, or other cardiac-related parameters. Furthermore, one or more sensors of the circulatory support device 12 coupled to the cannula 44, the impeller housing 46, and / or the catheter shaft 20 may be designed to monitor other parameters relating to the percutaneous circulatory system 10, the circulatory support device 12, and / or the patient 16.

[0034] Figure 3 shows that in one example, the percutaneous circulatory system 10 may include a sensor 50 (e.g., a flow sensor, a position sensor, etc.) positioned along the distal end region of the cannula 44. For example, if the sensor 50 is a flow sensor, it may be designed to sense the flow rate (e.g., blood flow velocity) of blood flowing adjacent to the sensor 50. For example, the flow sensor 50 may be designed to directly measure the velocity of blood flowing from the left ventricle 18 through the aortic valve 39 to the ascending aorta 37. Any exemplary flow sensor described herein may include optical sensors, ultrasonic sensors, electromagnetic sensors, thermal convection sensors, etc. Furthermore, in some examples where the sensor 50 is a position sensor, the sensor 50 may determine the position of the blood pump 24 relative to the left ventricle 18 and / or the aorta 37 based on a measurement of the blood flow velocity of blood flowing adjacent to the sensor 50.

[0035] Figure 3 further shows that in one example, the percutaneous circulatory system 10 may include a flow sensor 52 positioned along the distal end region of the catheter shaft 20. In some examples, the flow sensor 52 may be positioned forward of the subclavian artery 35. In other examples, the flow sensor 52 may be positioned backward of the subclavian artery 35. In other examples, the flow sensor 52 may be positioned approximately 1 to 10 centimeters from the proximal end of the impeller housing 46, or approximately 2 to 9 centimeters from the proximal end of the impeller housing 46, or approximately 3 to 7 centimeters from the proximal end of the impeller housing 46, or approximately 4 to 6 centimeters from the proximal end of the impeller housing 46, or approximately 5 centimeters from the proximal end of the impeller housing 46. The flow sensor 52 may be designed to sense the flow rate (e.g., blood flow velocity) of blood flowing adjacent to the flow sensor 52. For example, the flow sensor 52 may be designed to directly measure the velocity of blood flowing from the left ventricle 18 through the aortic valve 39 into the ascending aorta 37. Any exemplary flow sensor described herein may include optical sensors, ultrasonic sensors, electromagnetic sensors, thermal convection sensors, and the like.

[0036] Furthermore, it is understood that in some cases the flow sensor 52 may be located within the descending aorta, anterior to the celiac trunk, posterior to the celiac trunk, anterior to the renal artery and / or posterior to the renal artery.

[0037] In one example, the location of the blood pump 24 (including the locations of the blood inlet 58, blood outlet 48, and / or impeller 33) may be determined by comparing the blood flow velocity measurements obtained from the flow sensor 50 with those obtained from the flow sensor 52. For example, the processing unit 36 ​​of the percutaneous circulation system 10 may include an algorithm designed to receive and compare the blood flow velocity data transmitted from the flow sensor 50 with the blood flow velocity data transmitted from the flow sensor 52. It is understood that the velocity of blood passing near the flow sensor 50 may be lower than the velocity of blood passing near the flow sensor 52, since the velocity of blood passing near the flow sensor 52 may be increased (e.g., accelerated) by the impeller 33. In other words, the velocity of blood flowing out of the blood outlet 48 may be higher than the velocity of blood passing near the flow sensor 50 and the velocity of blood flowing into the blood inlet 58. Furthermore, since the distance between flow sensor 50 and flow sensor 52 is known, the processing unit 36 ​​can calculate the relative position of the impeller housing (placed between flow sensor 50 and flow sensor 52) by comparing the blood flow velocity measurement obtained from flow sensor 50 with the blood flow velocity measurement obtained from flow sensor 52.

[0038] Furthermore, it is understood that for any of the flow sensors described herein (e.g., flow sensor 50, flow sensor 52, etc.), the blood flow velocity directly measured by the specified flow sensor (e.g., flow sensor 50, flow sensor 52, etc.) may be used to calculate cardiac output. Cardiac output may be defined as the amount of blood pumped out per unit time (e.g., the volumetric flow rate of blood in the body). Cardiac output may be calculated by multiplying the stroke volume (e.g., the volume of blood flowing out of the left ventricle per beat) by the heart rate (e.g., the number of left ventricular beats per unit time).

[0039] Furthermore, it is understood that in some examples, the processing unit 36 ​​of the percutaneous circulation system 10 may include an algorithm designed to receive and compare blood flow velocity data transmitted from any of the flow sensors described herein (e.g., flow sensor 50, flow sensor 52, etc.) and to use this data to calculate the cardiac output of the heart 14. Furthermore, any of the flow sensors described herein (e.g., flow sensor 50 and flow sensor 52) may be coupled to and / or incorporate an impedance sensor, so that the impedance sensor may be used to identify (e.g., calculate) the diameter of a blood vessel adjacent to the flow sensor (e.g., ascending aorta, descending aorta, etc.). It is understood that the diameter of the blood vessel (e.g., ascending aorta, descending aorta, etc.) may be used by the processing unit 36 ​​to calculate the cardiac output of the heart 14.

[0040] Furthermore, one or more components of the percutaneous circulation system 10 may be coupled to an ultrasound system that can use ultrasound to measure the diameter of blood vessels (e.g., ascending aorta, descending aorta, etc.) adjacent to the flow sensors (e.g., flow sensors 50 and 52). The ultrasound system may communicate with the processing unit 36 ​​of the percutaneous circulation system 10. Thus, the processing unit 36 ​​of the percutaneous circulation system 10 may include an algorithm that can receive data from the ultrasound system corresponding to the diameter of blood vessels (e.g., ascending aorta, descending aorta, etc.) adjacent to the flow sensors (e.g., flow sensors 50 and 52). Furthermore, the data received from the ultrasound system may be used by the processing unit 36 ​​of the percutaneous circulation system 10 to calculate the cardiac output of the heart 14.

[0041] In yet another example, the percutaneous circulation system 10 may include a conductance catheter configured to measure the conductance of blood between two equally spaced electrodes placed in the conductance catheter, thereby allowing the volume of blood to be calculated based on the conductance measurement. Furthermore, knowing the volume of blood in a blood vessel at a given time may be used to estimate the diameter of a blood vessel adjacent to the electrodes. Thus, the processing unit 36 ​​of the percutaneous circulation system 10 may include an algorithm capable of receiving data from the conductance catheter that corresponds to the diameter of a blood vessel (e.g., ascending aorta, descending aorta, etc.). Furthermore, the data received from the conductance catheter may be used by the processing unit 36 ​​of the percutaneous circulation system 10 to calculate the cardiac output of the heart 14.

[0042] It is understood that any of the flow sensors described herein (e.g., flow sensor 50, flow sensor 52, etc.) may transmit signals to the console 28 and / or the processing unit 26 via a wireless connection (e.g., Bluetooth® connection). In other examples, any of the flow sensors described herein (e.g., flow sensor 50, flow sensor 52, etc.) may be wired to the console 28 and / or the processing unit 26.

[0043] Figure 4 shows an exemplary flow sensor (e.g., flow sensor 52) attached to the catheter shaft 20 of the circulatory support device 12. Figure 4 shows that the flow sensor 52 may be sized and shaped to allow blood to flow through its surface area without substantially hindering or disturbing the velocity and / or flow of blood. For example, Figure 4 shows that the flow sensor 52 has a substantially rectangular shape and extends along the longitudinal axis of the catheter shaft 20. However, it is understood that the sensor 52 may include any shape, including circular, elliptical, square, triangular, polygonal, star-shaped, or any combination thereof.

[0044] Figure 5 shows a cross-sectional view along line 4-4 in Figure 4. Figure 5 shows that the sensor 52 can be attached to the outer surface 51 of the catheter shaft 20. For example, Figure 5 shows that in some examples the sensor 52 may be a separate component from the catheter shaft 20, thereby allowing the sensor 52 to be attached directly to the outside of the catheter shaft 20 (for example, via adhesive).

[0045] However, Figure 6 shows another example in which the exemplary sensor 52 is embedded within the wall 53 of the catheter shaft 20. In some examples, the sensor 52 may be positioned within the wall 53 of the catheter shaft 20 during the extrusion process of the catheter shaft 20. Furthermore, in one example, the sensor 52 may include a first surface that is substantially flush with the outer surface 51 of the catheter shaft. In other examples, the sensor 52 may be positioned (for example, embedded) between the inner surface 55 and the outer surface 51 of the catheter shaft 20.

[0046] Figure 7 shows an example in which multiple sensors may be arranged along the outer surface of the catheter shaft 20. For example, Figure 7 shows three sensors 52 arranged along the outer surface 51 of the catheter shaft 20. It is understood that the sensors 52 may be arranged circumferentially at equal intervals from each other around the outer surface 51 of the catheter shaft. For example, the sensors 52a, 52b, and 52c shown in Figure 7 may be arranged circumferentially at substantially 180 degrees apart from each other. Furthermore, it is understood that the circulatory support device 12 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more sensors arranged adjacent to each other at predetermined longitudinal positions along the blood pump (e.g., cannula 44, impeller housing 46) and / or the catheter shaft 20. At predetermined longitudinal positions, the sensors may be arranged circumferentially at substantially equal intervals from each other, or they may not be at equal intervals from each other. Furthermore, one or more of the sensors described herein may be directly attached to a part of the blood pump (e.g., cannula 44, impeller housing 46) and / or to the outer surface of the catheter shaft 20, or one or more of the sensors described herein may be embedded in a part of the blood pump (e.g., cannula 44, impeller housing 46) and / or within the wall of the catheter shaft 20.

[0047] Figure 8 illustrates an example of how components of the circulatory support device 12 (e.g., cannula 44, impeller housing 46, and / or catheter shaft 20) may include one or more feature portions designed to separate the flow sensor from the vessel wall of the vessel 54 (e.g., the inner wall of the ascending aorta 37). For example, Figure 8 shows that the catheter shaft 20 may include a first projection 56a positioned adjacent to the sensor 52 and a second projection 56b positioned adjacent to the sensor 52. It can be seen from Figure 8 that the sensor 52 may be positioned between the first projection 56a and the second projection 56b. As shown in Figure 8, the first projection 56a may be positioned above the sensor 52, and the second projection 56b may be positioned below the sensor 52.

[0048] Figure 9 shows a cross-sectional view along line 8-8 in Figure 8. Figure 9 shows an example where the catheter shaft 20 has moved to approach the inner surface 55 of the blood vessel 54. For example, Figure 9 may correspond to a situation during a medical procedure where the catheter shaft 20 is pressed against the inner surface of the ascending aorta of the heart. Figure 9 further shows that the first projection 56a and the second projection 56b may come into contact with the inner surface 55 of the blood vessel 54, thereby forming a gap 57 between the flow sensor 52 and the inner surface 55 of the blood vessel 54. The gap 57 allows blood to flow across the flow sensor 52, so it is understood that the flow sensor can directly measure the velocity of blood flow adjacent to the flow sensor 52, even though the catheter shaft 20 has moved toward the inner surface 55 of the blood vessel 54.

[0049] Furthermore, it is understood that the components of the circulatory support device 12 (e.g., the cannula 44, the impeller housing 46, and / or the catheter shaft 20) may include features other than the first projection 56a and / or the second projection 56b, which are designed to form a space or gap between themselves and the flow sensor (e.g., the flow sensor 50, the flow sensor 52, etc.). This allows blood to flow through the sensor 52 even though the component has moved closer to the inner surface of the blood vessel. For example, the components of the circulatory support device 12 (e.g., the cannula 44, the impeller housing 46, and / or the catheter shaft 20) may include one or more projections, ridges, protrusions, needle-like projections, ridges, edges, steps, etc., positioned adjacent to the flow sensor to separate it from the inner surface of the blood vessel wall.

[0050] Figure 10 shows that the circulatory support device 12 may include a flow sensor (substantially equivalent in form and function to any of the flow sensors described herein) positioned adjacent to the renal artery 60. For example, Figure 10 shows that a flow sensor 62 may be attached to the catheter shaft 20 and positioned forward of the renal artery 60. Figure 10 shows that a flow sensor 64 may be attached to the catheter shaft 20 and positioned backward of the renal artery 60. The flow sensors 62, 64 may be designed and operate similarly to any of the exemplary flow sensors described herein (e.g., sensors 50, 52). For example, the flow sensors 62, 64 may be designed to directly measure the velocity of blood passing in their vicinity. Furthermore, velocity data collected by sensors 62, 64 may be used by the processing unit 36 ​​to calculate the position of the circulatory support device 12 within the blood vessel and / or to calculate the cardiac output of the heart 14, as described herein.

[0051] Figure 11 shows that, in some cases, the percutaneous circulation system 10 may further include a flow sensing unit designed to follow and advance along the catheter shaft 20. For example, Figure 11 shows that the percutaneous circulation system 10 may include a secondary sensor assembly 66, which includes a sensor housing 68 and a flow sensor 70 positioned along its distal end region. It is understood that the sensor housing 68 may include a lumen sized to allow the catheter shaft 20 to pass through. Therefore, the catheter assembly 66 (including the sensor housing 68 and the flow sensor 70) may move (e.g., slide) relative to the catheter shaft 20 and / or the blood pump 24 (including the cannula 44 and the impeller housing 46), thereby allowing the flow sensor 70 to be positioned in a predetermined location within a blood vessel (e.g., the aorta) relative to the flow sensor 50, the flow sensor 52 (which may or may not be included in the exemplary system shown in Figure 11), the impeller 33, the impeller housing 46, the cannula 44, the blood inlet 58, the blood outlet 48, or any other component of the system 10.

[0052] In one example, the catheter assembly 66 may further include a push wire 67 connected to the catheter shaft 68. In one example, the push wire 67 may be attached to the outer surface of the sensor housing 68. The push wire 67 may be designed to facilitate the follow-through movement of the sensor housing 68 along the catheter shaft 20. For example, the push wire 67 may apply a force to the sensor housing 68 that facilitates pushing the sensor housing 68 along the catheter shaft 20 to a desired position within the blood vessel.

[0053] Furthermore, it is understood that the flow sensor 70 may be designed and may operate similarly to any of the exemplary flow sensors described herein (e.g., sensors 50, 52, 62, 64). For example, the flow sensor 70 may be designed to directly measure the velocity of blood passing in its vicinity. Furthermore, velocity data collected by the sensor 70 may be used by the processing unit 36 ​​to calculate the position of the circulatory support device 12 within a blood vessel and / or to calculate the cardiac output of the heart 14, as described herein.

[0054] Figure 12 shows that, in some cases, the percutaneous circulation system 10 may further include a flow sensing assembly separate from the components of the circulatory support device 12. For example, Figure 12 shows that the percutaneous circulation system 10 may include a separate sensing assembly 70, which includes a sensor housing 72 and a flow sensor 74 positioned along its distal end region. It is understood that the sensor housing 72 may include a lumen sized to allow the passage of a guidewire 76 (separate from the guidewire used to position the blood pump 24). Thus, the movable (e.g., sliding) sensing assembly 70 (including the sensor housing 72 and the flow sensor 74) may be positioned alongside and in a predetermined positional relationship to the guidewire 76 and / or the blood pump 24 (including the cannula 44 and the impeller housing 46). This allows the flow sensor 74 to be positioned in a predetermined location within a blood vessel (e.g., the aorta) relative to the flow sensor 50, the flow sensor 52 (which may or may not be included in the exemplary system shown in Figure 12), the impeller 33, the impeller housing 46, the cannula 44, the blood inlet 58, the blood outlet 48, or any other component of the system 10.

[0055] In one example, the catheter assembly 70 may further include a push wire 75 coupled to the sensor housing 72. In one example, the push wire 75 may be attached to the outer surface of the sensor housing 72. The push wire 75 may be designed to facilitate the follow-through of the sensor housing 72 along the guide wire 76. For example, the push wire 75 may add columnar strength to the sensor housing 72, facilitating its advance along the guide wire 76 to a desired position within the blood vessel.

[0056] Furthermore, it is understood that the flow sensor 74 may be designed and operate similarly to any of the exemplary flow sensors described herein (e.g., sensors 50, 52, 62, 64, 70). For example, the flow sensor 74 may be designed to directly measure the velocity of blood passing in its vicinity. Furthermore, velocity data collected by the sensor 74 may be used by the processing unit 36 ​​to calculate the position of the circulatory support device 12 within a blood vessel and / or to calculate the cardiac output of the heart 14, as described herein.

[0057] It should be understood that this disclosure is illustrative in many respects. Modifications may be made, in particular, to details relating to shape, dimensions, and process sequence, without departing from the scope of this disclosure. This may include, to an appropriate extent, the use of any feature in one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined by the language in which the attached claims are expressed.

Claims

1. It is a heart pump system, A catheter shaft having a proximal end region connected to a handle and a distal end region connected to a cardiac pump, wherein the cardiac pump includes an impeller housing, a cannula, and an impeller, the cannula includes a distal end region and a proximal end region, and the distal end region of the cannula is configured to be positioned in the left ventricle of the heart, A first flow sensor, which is coupled to the cannula or the catheter shaft, is configured to directly sense a first velocity of blood flowing adjacent to the first flow sensor. Heart pump system.

2. The system further comprises a console coupled to the handle, the console including a processor, and the console configured to receive a first signal from the first flow sensor. The cardiac pump system according to claim 1.

3. The first signal corresponds to the first velocity of blood sensed by the first flow sensor, The cardiac pump system according to claim 1 or 2.

4. The processor is configured to calculate the cardiac output of the heart based on the first velocity of the blood sensed by the first flow sensor. A cardiac pump system according to any one of claims 1 to 3.

5. The first flow sensor is attached to the outer surface of the distal end region of the cannula. A cardiac pump system according to any one of claims 1 to 4.

6. The first flow sensor is embedded in the wall of the cannula. A cardiac pump system according to any one of claims 1 to 4.

7. The first flow sensor is coupled to the cannula, and the cardiac pump system further includes a second flow sensor coupled to the catheter shaft. A cardiac pump system according to any one of claims 2 to 6.

8. The second flow sensor is configured to directly sense a second velocity of blood flowing adjacent to the second flow sensor, and the console is configured to receive a second signal from the second flow sensor, the second signal corresponding to the second velocity of blood flowing adjacent to the second flow sensor. The cardiac pump system according to claim 7.

9. The processor is configured to compare the first velocity of the blood sensed by the first flow sensor with the second velocity of the blood sensed by the second flow sensor. A cardiac pump system according to any one of claims 7 to 9.

10. The processor is configured to calculate the position of the heart pump based on the result of comparing the first velocity of blood sensed by the first flow sensor with the second velocity of blood sensed by the second flow sensor. A cardiac pump system according to any one of claims 7 to 9.

11. The first flow sensor is positioned along the catheter shaft such that when the distal end region of the cannula is positioned in the left ventricle, it is positioned distal to the subclavian artery. A cardiac pump system according to any one of claims 1 to 10.

12. The first flow sensor is positioned along the catheter shaft such that when the distal end region of the cannula is positioned in the left ventricle, it is positioned proximal to the subclavian artery. A cardiac pump system according to any one of claims 1 to 11.

13. The first flow sensor is positioned along the catheter shaft such that, when the distal end region of the cannula is positioned in the left ventricle, it is adjacent to the renal artery and distal to the renal artery. The cardiac pump system according to any one of claims 1 to 12.

14. The first flow sensor is positioned along the catheter shaft such that, when the distal end region of the cannula is positioned in the left ventricle, it is adjacent to the renal artery and proximal to the renal artery. A cardiac pump system according to any one of claims 1 to 13.

15. It is a heart pump system, A console including a processor, A cardiac pump device comprising a handle connected to the console, a first catheter shaft having a proximal end region connected to the handle and a distal end region connected to the cardiac pump, an impeller, and a cannula, wherein the cannula includes a proximal end region and a distal end region, A first flow sensor coupled to the proximal end region of the cannula, the first flow sensor being positioned between the impeller and the distal end region of the cannula, comprises Heart pump system.

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