CN113769260A

CN113769260A - Catheter pump, auxiliary blood pumping system and control method and device of catheter pump

Info

Publication number: CN113769260A
Application number: CN202111086810.XA
Authority: CN
Inventors: 周方兵; 吴向军; 闫小珅
Original assignee: Suzhou Xinling Meide Medical Technology Co ltd
Current assignee: Suzhou Xinling Meide Medical Technology Co ltd
Priority date: 2021-09-16
Filing date: 2021-09-16
Publication date: 2021-12-10
Also published as: WO2023040546A1

Abstract

The embodiment of the specification provides a catheter pump, an auxiliary blood pumping system and a control method and device of the catheter pump. The catheter pump is used for assisting in pumping blood and comprises: a housing provided with a fluid inlet and a fluid outlet; an impeller disposed within the housing for regulating a flow rate of the conduit pump; the driving motor is used for driving the impeller to rotate and comprises a stator side and an output rotating shaft, the stator side is fixed with the shell, and the output rotating shaft is fixed with the impeller; and the rectifying device is sleeved outside the output rotating shaft of the driving motor and is fixedly connected with the stator side of the driving motor.

Description

Catheter pump, auxiliary blood pumping system and control method and device of catheter pump

Technical Field

The specification relates to the technical field of medical instruments, in particular to a catheter pump, an auxiliary blood pumping system and a control method and device of the catheter pump.

Background

In patients with heart failure or cardiac insufficiency, the perfusion flow rate of the heart is reduced relative to that of normal persons. A sustained low perfusion flow may lead to symptoms of dyspnea, dizziness and palpitation in heart failure patients. A decrease in cardiac perfusion flow may also lead to hypoperfusion of various organs of the body, thereby causing failure of the respective organs. For example, because decreased perfusion flow to the heart may cause insufficient perfusion pressure in the kidneys, a sustained low perfusion pressure may cause renal cells to infarct due to ischemia, resulting in renal failure. For patients with heart failure, a catheter pump is usually used for auxiliary treatment, and the catheter pump is a pumping device for guiding into the aorta (or other vascular sites) and providing circulatory support for the heart, and can assist the heart to increase the perfusion pressure of the aorta, so as to increase the perfusion flow of the heart.

Disclosure of Invention

One aspect of the present description provides a catheter pump for assisting in pumping blood, comprising: a housing provided with a fluid inlet and a fluid outlet; an impeller disposed within the housing for regulating a flow rate of the conduit pump; the driving motor is used for driving the impeller to rotate and comprises a stator side and an output rotating shaft, the stator side is fixed with the shell, and the output rotating shaft is fixed with the impeller; and the rectifying device is sleeved outside the output rotating shaft of the driving motor and is fixedly connected with the stator side of the driving motor.

One aspect of the present description provides an auxiliary blood pumping system comprising: a catheter pump as described in any of the embodiments herein; and the control device is electrically connected with a driving motor of the catheter pump and used for sending a control command to the driving motor based on the control parameter.

One aspect of the present description provides a method of controlling a catheter pump, the method comprising: acquiring a target pressure difference curve or a target effective pressure difference of the catheter pump; acquiring a target rotating speed of a driving motor of the catheter pump; and adjusting the control parameter output value of the driving motor according to the target pressure difference curve or the target effective pressure difference and the target rotating speed.

One aspect of the present description provides a control device for a catheter pump, comprising a processor for performing a method of controlling a catheter pump according to any one of the embodiments of the present description.

One aspect of the present description provides a computer-readable storage medium storing computer instructions which, when read by a processor, cause the processor to perform a method of controlling a catheter pump according to any one of the embodiments of the present description.

Drawings

The present description will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:

FIG. 1 is a schematic view of an exemplary catheter pump shown in accordance with some embodiments herein;

FIG. 2 is an exploded schematic view of an exemplary catheter pump according to some embodiments herein;

FIG. 3 is a schematic view of an exemplary fairing, shown in accordance with some embodiments herein;

FIG. 4 is a schematic view of an exemplary fairing according to other embodiments herein;

FIG. 5 is a partial cross-sectional view of an exemplary catheter pump according to some embodiments herein;

FIG. 6 is a schematic view of an exemplary catheter pump according to some embodiments of the present disclosure, wherein a stent of the catheter pump is in a collapsed state;

FIG. 7 is a schematic view of an exemplary catheter pump according to further embodiments herein;

FIG. 8A is an assembly schematic of a bracket and a housing of an exemplary catheter pump according to some embodiments of the present description;

FIG. 8B is an exploded schematic view of a bracket and housing of an exemplary catheter pump according to some embodiments herein;

FIG. 9 is a schematic view of an exemplary catheter pump according to still further embodiments herein;

FIG. 10 is a schematic view of an exemplary auxiliary blood pumping system according to some embodiments herein;

FIG. 11 is a schematic diagram of an application scenario of an exemplary auxiliary blood pumping system according to some embodiments of the present description;

FIG. 12 is a schematic diagram illustrating an exemplary auxiliary blood pumping system according to another embodiment of the present disclosure;

FIG. 13 is an exemplary flow chart of a method of controlling a catheter pump according to some embodiments of the present description;

FIG. 14 is an exemplary flow chart of a target pressure differential determination method according to some embodiments described herein;

FIG. 15 is an exemplary flow chart of a target speed determination method according to some embodiments described herein;

FIG. 16 is an exemplary flow chart of a control parameter adjustment method according to some embodiments described herein;

FIG. 17 is an exemplary flow chart diagram of a control parameter adjustment method according to yet another embodiment of the present description;

FIG. 18 is an exemplary flow chart of a control parameter adjustment method according to yet another embodiment of the present description;

FIG. 19 is a schematic diagram of an exemplary configuration of a control device, shown in accordance with some embodiments of the present description.

In the figure, 100 is a catheter pump, 1 is a housing, a is a central axis, 11 is a fluid inlet, 12 is a fluid outlet, 13 is a head, 14 is a support rod, 2 is an impeller, 3 is a driving motor, 31 is a stator side, 32 is an output rotating shaft, 4 is a rectifying device, 41 is a core, 411 is a through hole, 412 is a small end, 413 is a large end, 42 is a blade, 43 is a mounting portion, C is a central symmetry axis, 51 is a first sealing member, 52 is a second sealing member, 6 is a bracket, 61 is a leg, 611 is a first end, 612 is a second end, 613 is a contact leg, 614 is a connecting portion, 62 is a mesh bracket, 71 is a first pressure sensor, 72 is a second pressure sensor, 73 is a third pressure sensor, 74 is a fourth pressure sensor, 200 is an auxiliary pumping system, 210 is a control device, 212 is a storage medium, 214 is a processor, 220 is a sterile protection device, 221 is a sterile sleeve bag, 222 is a first sealing joint, 223 is a second sealing joint, 224 is a third sealing joint, 225 is a protective sheath, 230 is a catheter, 240 is a cable, and 250 is a blood vessel.

Detailed Description

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only examples or embodiments of the present description, and that for a person skilled in the art, the present description can also be applied to other similar scenarios on the basis of these drawings without inventive effort. Unless otherwise apparent from the context, or otherwise indicated, like reference numbers in the figures refer to the same structure or operation.

It should be understood that "system", "device", "unit" and/or "module" as used herein is a method for distinguishing different components, elements, parts, portions or assemblies at different levels. However, other words may be substituted by other expressions if they accomplish the same purpose.

As used in this specification and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements.

Although various references are made herein to certain modules or units in a system according to embodiments of the present description, any number of different modules or units may be used and run on the client and/or server. The modules are merely illustrative and different aspects of the systems and methods may use different modules.

Flow charts are used in this description to illustrate operations performed by a system according to embodiments of the present description. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, the various steps may be processed in reverse order or simultaneously. Meanwhile, other operations may be added to the processes, or a certain step or several steps of operations may be removed from the processes.

The catheter pump is a pumping device which is used for guiding into the aorta (or other blood vessel parts) of a heart failure patient and providing circulation support for the heart of the patient, and can assist the heart to increase the perfusion pressure of the aorta, so that the aim of treating the heart failure is fulfilled. In some embodiments, the catheter pump may be implanted in the aorta (or other vascular site) of a human body via a delivery device such as a catheter, and the catheter pump may be rotated to increase the pressure differential across the catheter pump, thereby increasing the perfusion pressure of the aorta and providing powered support to the failing heart.

Some embodiments of the present description provide a catheter pump, an auxiliary blood pumping system, and a control method and apparatus of the catheter pump. In some embodiments, the catheter pump includes a fairing that can be used to relieve the catheter pump from swirling pressure exerted on blood within the vessel, and/or can mitigate the impact of blood on the vessel, and can facilitate maintaining stability of the catheter pump. In some embodiments, the auxiliary blood pumping system further comprises a control device, the control device can adjust the control parameters of the catheter pump according to the acquired signals, and compared with a scheme for setting the control parameters according to doctor experience, the control device is higher in accuracy and faster in response speed, errors in a treatment process can be reduced, and quick recovery of a patient is facilitated.

Some embodiments of the present description also provide a control method of a catheter pump, which can adjust a control parameter output value of a drive motor of the catheter pump according to an actual perfusion flow rate and a target perfusion flow rate of a patient, improving reliability of the control parameter output value. In some embodiments, the control device may monitor the actual perfusion flow rate of the patient to update the control parameter output value of the driving motor, so that the control parameter output value may precisely match the change of the physiological index of the patient, which is beneficial to the rapid rehabilitation of the patient.

In some embodiments, the catheter pump of the present description may be implanted in a blood vessel or a blood transfusion organ. The blood vessel may include an artery or a vein, among others. Arteries may include, but are not limited to, the ascending aorta, the descending aorta, the abdominal aorta, the pulmonary aorta, and the like. Veins may include, but are not limited to, the superior vena cava or inferior vena cava, and the like. The blood transfusion organ may include a heart. In some embodiments, the catheter pump may be implanted in the left ventricle or right ventricle. Wherein the fluid inlet communicates with the left ventricle when the catheter pump is applied within the aorta connected thereto, the catheter pump being capable of improving hemodynamic performance within the heart, increasing cardiac output or for assisting in high risk cardiac surgery; when the catheter pump is applied to the descending aorta communicated with renal vessels, the renal perfusion pressure in the descending aorta can be increased, and the catheter pump is used for preventing renal failure caused by acute heart failure; when the catheter pump is applied to the upper vena cava, the lower vena cava or the interior of the pulmonary artery and the like, the pressure in the blood vessel can be increased, and the blood perfusion can be improved. In some embodiments, patients of the present disclosure include, but are not limited to, heart failure patients, renal failure patients, liver disease patients, cerebral infarction patients, and the like.

FIG. 1 is a schematic diagram of an exemplary catheter pump 100 shown in accordance with some embodiments herein. Fig. 2 is an exploded schematic view of an exemplary catheter pump 100 according to some embodiments herein.

Referring to fig. 1, a catheter pump 100 may include a housing 1, an impeller 2, a drive motor 3, and a rectifying device 4. The impeller 2 is arranged in the housing 1, the driving motor 3 is used for driving the impeller 2 to rotate, the impeller 2 provides pumping power for the catheter pump 100 through rotation, and the rectifying device 4 is used for adjusting the flow pattern of blood passing through the impeller 2, such as adjusting the turbulent flow pattern caused by the impeller 2, releasing the swirling pressure applied to the blood in the blood vessel 250 by the catheter pump 100, and/or relieving the impact force of the blood on the blood vessel.

In some embodiments, the housing 1 may be an enclosure that provides support or protection for the impeller 2, the drive motor 3, and/or the fairing 4. In some embodiments, the housing 1 has a chamber inside for allowing fluid to flow through, and the housing 1 is provided with a fluid inlet 11 and a fluid outlet 12, the fluid enters the chamber from the fluid inlet 11 and flows out from the fluid outlet 12, wherein the fluid may be blood or the like in the blood vessel 250, and the flow direction of the blood may refer to the direction indicated by the arrow D in fig. 1. In some embodiments, the housing 1 may be a cylindrical housing, the inflow inlet 11 is disposed at an end surface (e.g., an end surface at one end) of the cylindrical housing, and the fluid outlet 12 is disposed at a side surface (e.g., a side surface at the other end) of the cylindrical housing. In some embodiments, the radial dimension (e.g., diameter) of the housing 1 can be in a range of 3 mm to 7 mm (e.g., 3 mm, 4 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, etc.), which refers to a dimension perpendicular to the central axis a of the housing 1.

In some embodiments, the impeller 2 is disposed within a chamber that allows fluid to flow therethrough for regulating the flow rate of the catheter pump 100. In some embodiments, the impeller 2 comprises a spiral vane disposed around the rotation axis thereof, and the rotation of the impeller 2 can drive the fluid inside the housing 1 to increase the speed and the revolving pressure thereof under the action of the spiral vane, so as to output the fluid with higher flow rate and pressure at the fluid outlet 12, so as to form a pressure difference between the fluid inlet 11 and the fluid outlet 12, thereby improving the perfusion flow of the blood vessel 250.

In some embodiments, a drive motor 3 is used to drive the impeller 2 in rotation. The driving motor 3 may include a stator side 31 and an output rotating shaft 32, the stator side 31 may be a stationary part of the driving motor 3, such as a stator core, a stator winding, a housing, and the like, and the output rotating shaft 32 may be a shaft that is rotatable with respect to the stator side 31.

In some embodiments, the stator side 31 of the drive motor 3 is fixed to the housing 1 and the output shaft 32 of the drive motor 3 is fixed to the impeller 2. In some embodiments, the stator side 31 is fixed to an end of the housing 1 near the fluid outlet 12, the output shaft 32 extends into the housing 1 and is fixed to the impeller 2 in the housing 1, and the rotation of the output shaft 32 can drive the impeller 2 to rotate. In some embodiments, the radial dimension of the stator side 31 may be in a range of 3 millimeters to 7 millimeters (e.g., 3 millimeters, 4 millimeters, 5 millimeters, 5.5 millimeters, 6 millimeters, 7 millimeters, etc.). In some embodiments, the radial dimension (e.g., diameter) of the stator side 31 may be equal to the radial dimension of the housing 1. In some embodiments, the radial dimension of the stator side 31 may not be equal to the radial dimension of the housing 1. In some embodiments, the radial dimension of the stator side 31 may be smaller than the radial dimension of the housing 1, thereby reducing the obstruction to the fluid, facilitating better fluid communication.

In some embodiments, the housing 1 and the impeller 2 may be injection molded from a plastic material to reduce the overall weight of the catheter pump 100. In some embodiments, the housing 1 and the impeller 2 may be machined from a metal material, for example, the metal material may include, but is not limited to, cobalt-chromium alloy, stainless steel material, etc., and the housing 1 and the impeller 2 made of the metal material have high strength and long service life. In some embodiments, the casing 1 and the impeller 2 may be made of the same material. In some embodiments, the casing 1 and the impeller 2 may be made of different materials.

In some embodiments, the rectifying device 4 is sleeved outside the output rotating shaft 32 of the driving motor 3 and is fixedly connected with the stator side 31 of the driving motor 3, namely, the rectifying device 4 is kept relatively static relative to the stator side 31, and the output rotating shaft 32 passes through the rectifying device 4 and is connected with the impeller 2. In some embodiments, the fairing 4 can cushion the impact force of the fluid and direct the direction of fluid flow. In some embodiments, when the driving motor 3 drives the output rotating shaft 32 to rotate, the output rotating shaft 32 drives the impeller 2 to rotate, so that the fluid in the housing 1 rotates along with the impeller 2 to generate a swirling pressure, and after the fluid flows through the rectifying device 4, the rectifying device 4 can adjust the rotational flow pattern or the turbulent flow pattern of the fluid to a linear flow pattern along the blood vessel 250, thereby releasing the swirling pressure of the fluid and reducing the impact force of the fluid on the blood vessel 250.

In some embodiments, the rectifying device 4 is arranged at the fluid outlet 12 to facilitate rectifying the fluid at the fluid outlet 12, relieving the fluid swirling pressure at the fluid outlet 12.

FIG. 3 is a schematic view of an exemplary fairing 4 shown in accordance with some embodiments herein. FIG. 4 is a schematic view of an exemplary fairing 4 shown in accordance with other embodiments herein.

Referring to fig. 3 and 4, the fairing 4 includes a core 41, and the core 41 is configured as a centrally symmetric block, which refers to a block structure that can coincide with the core 41 after the core 41 rotates around a central symmetry axis C by any angle. In some embodiments, core 41 includes a small end 412 and a large end 413, with the cross-section of small end 412 to large end 413 gradually increasing. In some embodiments, the cross-section from the small end 412 to the large end 413 may increase linearly, for example, referring to fig. 3, the core 41 is configured as a circular truncated cone, with the top of the circular truncated cone being the small end 412 and the bottom of the circular truncated cone being the large end 413. In some embodiments, the cross-section from small end 412 to large end 413 may increase non-linearly, for example, referring to fig. 4, core 41 is configured as a hemisphere, with the top of the hemisphere disposed as small end 412 and the bottom of the hemisphere disposed as large end 413.

In some embodiments, the small end 412 is disposed proximate the impeller 2 and the large end 413 is disposed proximate the drive motor 3. In some embodiments, the core 41 is further provided with a mounting portion 43 for fixing with the stator side 31 of the drive motor 3.

In some embodiments, the mounting portion 43 is configured as a cylinder, the mounting portion 43 is disposed at the large end 413 and the axis of the mounting portion 43 is arranged collinear with the central axis of symmetry C of the core 41. In some embodiments, referring to FIG. 3, the mounting portion 43 has a cross-section that is smaller than the cross-section of the large end 413. In some embodiments, referring to fig. 4, the cross-section of the mounting portion 43 is equal to the cross-section of the large end 413.

In some embodiments, the mounting portion 43 is fixed to the stator side 31 of the driving motor 3 by laser welding, bonding, screwing, and other fixing methods, which are not limited in this specification.

In some embodiments, the core 41 is opened with a via 411 for avoiding the output shaft 32, the via 411 penetrating from the small end 412 to the large end 413 along the central symmetry axis C. In some embodiments, the aperture of the via hole 411 of the core 41 is larger than the diameter of the output rotary shaft 32 of the drive motor 3.

In some embodiments, referring to fig. 3, the fairing 4 further comprises a plurality of vanes 42, the plurality of vanes 42 being arranged at intervals around the central symmetry axis C of the core 41 at the outer surface of the core 41, the plurality of vanes 42 serving to relieve the swirling pressure exerted by the impeller 2 on the blood. When the rotating or turbulent fluid impinges on the fairing 4, the vanes 42 act to direct the fluid, thereby changing and adjusting the direction of flow of the fluid and achieving the purpose of releasing its swirling pressure.

In some embodiments, the number of the blades 42 may be set according to requirements, for example, the number of the blades 42 may be two, three, or four, and the like, which is not limited in this specification. In some embodiments, the angles formed by adjacent blades 42 and the central symmetry axis C may be equal, i.e. the blades 42 may be arranged around the core 41 at equally spaced angles with respect to the central symmetry axis C. In some embodiments, the angles formed by adjacent blades 42 and the central axis of symmetry C may not be equal.

In some embodiments, the blades 42 may be arranged on the outer surface of the core 41 in a swirling shape, and the swirling direction of the blades 42 may be opposite to that of the rotating blades of the impeller 2, so as to better counteract the swirling pressure of the fluid. In some embodiments, the blades 42 may be arranged in an arc shape on the outer surface of the core 41, and the blades 42 may have a larger radius of curvature to improve the flow rectification effect. In some embodiments, the vanes 42 may be arranged linearly on the outer surface of the core 41, i.e., the vanes 42 extend linearly from the small end 412 of the core 41 to the large end 413 of the core 41, thereby regulating the fluid flowing through the fairing 4 to continue in the direction of the central axis of symmetry C of the fairing 4 as much as possible.

In some embodiments, with reference to fig. 1 and 3, the vanes 42 of the fairing 4 can avoid the fluid outlet 12 of the housing 1 and avoid partially blocking or plugging the fluid outlet 12. In some embodiments, a plurality of fluid outlets 12 may be circumferentially disposed on the housing 1, the spacing between adjacent fluid outlets 12 being the same as the thickness of the blades 42 of the fairing 4, the blades 42 of the fairing 4 abutting on the side of the housing 1 between adjacent fluid outlets 12, arranged avoiding the fluid outlets 12.

In some embodiments, referring to fig. 4, the fairing 4 may not have the blades 42, but may directly use the curvature of the surface of the core 41 to cushion the impact force of the fluid and provide a fairing action.

In some embodiments, the fairing 4 can be injection molded from a plastic material to reduce the overall weight of the catheter pump 100. In some embodiments, the fairing 4 can be machined from a metal material, such as, but not limited to, cobalt-chromium alloys, stainless steel materials, and the like, wherein the metal material of the fairing 4 has high strength and long service life.

Fig. 5 is a partial cross-sectional view of an exemplary catheter pump 100 shown in accordance with some embodiments of the present description.

In some embodiments, referring to fig. 5, a seal is provided between the rectifying device 4 and the driving motor 3, and the seal is used for preventing the blood from entering the driving motor 3 to cause the driving motor 3 to have faults such as rusting, electric leakage, short circuit and the like. In some embodiments, the number of sealing members may be determined according to the structure and sealing grade of the driving motor 3.

In some embodiments, the sealing elements comprise a first sealing element 51 and a second sealing element 52, the first sealing element 51 and the second sealing element 52 mutually assisting to increase the sealing of the drive motor 3.

In some embodiments, a first seal 51 is provided between the rectifying device 4 and the output shaft 32 of the drive motor 3 to prevent blood from entering the drive motor 3 from a gap between the rectifying device 4 and the output shaft 32. In some embodiments, the first seal 51 is configured as an annular structure, a housing cavity is formed inside the rectifying device 4, and the first seal 51 is disposed in the housing cavity and in sliding contact with the output rotating shaft 32, so that the first seal 51 can block a gap between the output rotating shaft 32 and the rectifying device 4. In some embodiments, the first sealing member 51 may be made of polytetrafluoroethylene (Teflon or PTFE), such that the first sealing member 51 has the advantages of sealing property, high lubrication non-adhesiveness, and the like, and the high lubrication non-adhesiveness of the first sealing member 51 causes the output rotating shaft 32 to have very small friction force when in sliding contact therewith, and very small loss to the output rotating shaft 32.

In some embodiments, a second seal 52 is provided between the rectifying device 4 and the stator side 31 of the drive motor 3, avoiding blood from entering the drive motor 3 from the mounting gap of the rectifying device 4 and the stator side 31. In some embodiments, the second seal 52 is configured in a disk shape, and the disk-shaped second seal 52 includes a flat bottom plate that blocks an end surface of the stator side 31 of the driving motor 3 and a protrusion formed along an edge of the flat bottom plate that blocks a junction of the mounting portion 43 of the rectifying device 4 and the stator side 31, thereby improving sealability at the junction. In some embodiments, the second sealing element 52 may be made of medical rubber, medical silicone, or teflon, and the description is not limited thereto.

In some embodiments, a silicone grease may be applied between the seal and the rectifying device 4 and between the seal and the driving motor 3, and the silicone grease may serve to lubricate and seal, for example, to reduce friction between the first seal 51 and the output shaft 32.

Fig. 6 is a schematic view of the exemplary catheter pump 100 shown with the stent 6 of the catheter pump 100 in a collapsed state, according to some embodiments herein. FIG. 7 is a schematic view of an exemplary catheter pump 100 according to further embodiments herein. Fig. 8A is a schematic view of the assembly of the bracket 6 and the housing 1 of the exemplary catheter pump 100 according to some embodiments of the present description, and fig. 8B is a schematic view of the explosion of the bracket 6 and the housing 1 of the exemplary catheter pump 100 according to some embodiments of the present description. FIG. 9 is a schematic view of an exemplary catheter pump 100 according to still further embodiments of the present disclosure.

Referring to fig. 1, 2, 6-9, the catheter pump 100 further comprises a stent 6, the stent 6 being used to secure the housing 1 in a blood vessel 250 or a blood transfusion organ, increasing the stability of the catheter pump 100 with respect to the blood vessel 250 or the blood transfusion organ. In some embodiments, the stent 6 comprises a collapsed state and an expanded state: referring to fig. 6, in the collapsed state, the maximum radial dimension of the stent 6 is less than or equal to the radial dimension of the housing 1, so that the catheter pump 100 can be accommodated in the catheter 230 and implanted through the catheter 230 into a blood vessel 250 or a blood transfusion organ; referring to fig. 1, 7 and 9, in the deployed state, at least part of the radial dimension of the stent 6 is greater than the radial dimension of the housing 1, at which point at least part of the stent 6 can be used to abut against the inner wall of the blood vessel 250 (or blood transfusion organ) to anchor the catheter pump 100 within the blood vessel 250. Here, the radial direction refers to a direction perpendicular to the central axis a of the housing 1.

In some embodiments, the maximum radial dimension of the stent 6 in the deployed state may range from 20 mm to 30 mm (e.g., 20 mm, 22 mm, 25 mm, 30 mm, etc.), which is not limited by the present disclosure.

In some embodiments, the stent 6 may have a certain elasticity that enables it to be switched between a collapsed state and an expanded state. In some embodiments, the stent 6 may be in a collapsed state under external pressure (e.g., the restraining force of the catheter 230); the stent 6 may automatically change to the deployed state in the absence of external pressure (e.g., extending out of the catheter 230). In some embodiments, the stent 6 may be made of a memory alloy (e.g., nitinol) material or the like.

In some embodiments, referring to fig. 1, 6 and 7, the stent 6 comprises a plurality of legs 61, the legs 61 being rod-shaped having a first end 611 and a second end 612, the first end 611 being fixed opposite the fluid inlet 11, the second end 612 being distal from the housing 1 to form a free end, the free end of the legs 61 being adapted to abut the inner wall of the blood vessel 250 to fix the catheter pump 100 within the blood vessel 250. In the collapsed state, the legs 61 are arranged converging along the central axis a of the housing 1 from the first end 611 to the second end 612, and in the expanded state, the legs 61 are arranged obliquely extending radially outward from the first end 611 to the second end 612, wherein radially outward refers to a direction away from the central axis a of the housing 1.

In some embodiments, the second end 612 of the leg 61 is provided with a contact leg 613, and the contact leg 613 is configured in a shape of a disk, a sphere, an ellipsoid or the like, so as to increase the contact area between the second end 612 of the leg 61 and the vessel wall, reduce the local stress of the vessel wall, and prevent the leg 61 from stabbing the vessel wall when being fixed.

In some embodiments, referring to fig. 6, when the stent 6 is in the collapsed state, the distance between the second end 612 of the leg 61 and the central axis a of the housing 1 is smaller than the distance between the first end 611 of the leg 61 and the central axis a of the housing 1, i.e. the stent 6 forms an end with a smaller radial dimension at the second end 612, which can reduce the pushing resistance of the stent 6 in the catheter 230 or the blood vessel 250, thereby reducing the risk of jamming when pushing.

In some embodiments, the legs 61 are arranged obliquely converging radially inward from the first end 611 to the second end 612 such that the second end 612 is at a smaller distance from the central axis a of the housing 1 than the first end 611 is from the central axis a of the housing 1, radially inward being a direction close to the central axis a of the housing 1.

In some embodiments, the end of the second end 612 of the leg 61 has a bend, the bend being arranged such that: in the collapsed state, the second end 612 of the leg 61 is at a smaller distance from the central axis a of the housing 1 than the first end 611 of the leg 61 is at from the central axis a of the housing 1. Referring to fig. 1, 2 and 6, the bent segment may be configured as an L-shaped bent segment, the L-shaped bent segment is bent from the end of the second end 612 of the leg 61 toward the direction of the central axis a of the housing 1, and the L-shaped bent segment occupies a small space at the end of the second end 612 and has strong stability. Referring to fig. 7, the bent segment may be configured as a straight bent segment, which is bent from the end of the second end 612 of the leg 61 toward the central axis a of the housing 1, and the straight bent segment has a smooth configuration, which is beneficial to reduce the pushing resistance of the catheter pump 100, and is easy to machine.

Referring to fig. 8A and 8B, in some embodiments, the bracket 6 may include a plurality of legs 61 and a connecting portion 614, further details of the legs 61 may be found in fig. 6 and 7 and their associated description, the connecting portion 614 is disposed at the first end 611 of the legs 61 for connecting the legs 61 to the housing 1. In some embodiments, the connecting portion 614 is configured as a cylindrical structure, the first end 611 of the leg 61 is connected to one end of the connecting portion 614, and the other end of the connecting portion 614 is connected to the fluid inlet 11 of the housing 1. In some embodiments, the interior of the connecting portion 614 forms a hollow passage allowing fluid to flow therethrough, from which fluid, such as blood, flows to the fluid inlet 11 of the housing 1. In some embodiments, the connecting portion 614 can be connected to the housing 1 by various means such as screwing, clipping, bonding, etc.

In some embodiments, the legs 61 may be made of nitinol or the like to meet the elastic deformability requirements. In some embodiments, the connecting portion 614 may be made of a metal material with blood compatibility such as cobalt-chromium alloy, stainless steel, etc. or a polymer material with blood compatibility, so as to meet the requirements of strength and blood compatibility.

In some embodiments, referring to fig. 9, the catheter pump 100 further comprises a head 13 and a support rod 14, one end of the support rod 14 being fixed with the housing 1 and the other end being fixed with the head 13. In some embodiments, the support rod 14 is a linear rod with one end fixed to the housing 1 at the fluid inlet 11 and the other end fixed to the head 13 and providing support for the head 13. In some embodiments, the number of support rods 14 may be one or more, such as one, two, three, or four, etc. In some embodiments, the head 13 is configured as a cone to reduce resistance to advancement of the catheter pump 100 and resistance to fluid formation by the head.

In some embodiments, the support 6 includes a mesh support 62, the mesh support 62 is disposed between the head 13 and the housing 1, and one end of the mesh support 62 is fixed to the head 13 and the other end is fixed to the housing 1. In some embodiments, the mesh support 62 may be a cage-like structure made of a wire mesh that surrounds the support pole 14 (e.g., that fits over the exterior of the support pole 14). In some embodiments, the mesh stent 62 may have self-expanding properties, the mesh stent 62 may be formed in a spindle shape in the expanded state, and the spindle shape may be a shape that is expanded in the middle and closed at both ends, when the middle portion of the mesh stent 62 is used to abut against the inner wall of the blood vessel 250 to fix the catheter pump 100. Through setting up netted support 62, can increase the area of contact of support 6 and vascular inner wall, effectively avoid support 6 to cause the damage to vascular inner wall.

In some embodiments, the surface of the catheter pump 100 that can come into contact with blood is coated with a heparin coating to prevent the appearance of local thrombi. For example, the housing 1, the drive motor 3, the rectifying device 4, the impeller 2, and the holder 6 of the catheter pump 100 may be coated with a heparin coating.

In some embodiments, the catheter pump 100 further comprises a first pressure sensor 71, wherein the first pressure sensor 71 is disposed upstream of the fluid inlet 11, wherein upstream is with respect to the flow direction D of the blood, and upstream of the fluid inlet 11 may be a position opposite to the flow direction D of the blood with respect to the fluid inlet 11 as a reference point. In some embodiments, the first pressure sensor 71 may detect the blood pressure upstream of the fluid inlet 11.

In some embodiments, since the detection accuracy of the first pressure sensor 71 is affected by the possible occurrence of the turbulent flow region at the fluid inlet 11, the first pressure sensor 71 is located at a first predetermined distance range from the fluid inlet 11, so that the first pressure sensor 71 avoids the turbulent flow region, and the accuracy of the data collected by the first pressure sensor 71 is improved. In some embodiments, the first pressure sensor 71 may be disposed at a position spaced from the fluid inlet 11 by a distance in a range of 20 mm to 60 mm (e.g., 20 mm, 30 mm, 40 mm, 45 mm, 60 mm, etc.). In some embodiments, the first pressure sensor 71 may be disposed at an end of the bracket 6 remote from the housing 1. For example, referring to fig. 6 or 7, the first pressure sensor 71 may be disposed at the second end 612 of the leg 61. For another example, referring to fig. 9, the first pressure sensor 71 may be disposed at the head 13 of the catheter pump 100.

In some embodiments, the catheter pump 100 further comprises a second pressure sensor 72, wherein the second pressure sensor 72 is disposed downstream of the fluid outlet 12, wherein the downstream is with respect to the flow direction D of the blood, and the downstream of the fluid outlet 12 may be a position in the same direction as the flow direction D of the blood with the fluid outlet 12 as a reference point. In some embodiments, the second pressure sensor 72 may detect the blood pressure downstream of the fluid outlet 12.

In some embodiments, the detection accuracy of the second pressure sensor 72 is affected by the possible occurrence of the turbulent region at the fluid outlet 12, and the second pressure sensor 72 is located at a second predetermined distance range from the fluid outlet 12, so that the turbulent region is avoided by the second pressure sensor 72, and the accuracy of the data collected by the second pressure sensor 72 is improved. In some embodiments, the second predetermined distance range may be greater than the first predetermined distance range, as the turbulent zone area through the fluid outlet 12 of the catheter pump 100 may be greater than the turbulent zone area at the fluid inlet 11. For example, the second pressure sensor 72 may be disposed at a position spaced from the fluid inlet 11 by a distance in a range of 30 mm to 70 mm (e.g., 30 mm, 40 mm, 45 mm, 60 mm, 70 mm, etc.). In some embodiments, the second pressure sensor 72 may be disposed on an outer surface of the stator side 31 of the drive motor 3. In some embodiments, the second pressure sensor 72 may be provided on an outer surface of a cable 240 that provides an electrical signal to the drive motor 3.

In some embodiments, the catheter pump 100 may include both the first pressure sensor 71 and the second pressure sensor 72. In some embodiments, the catheter pump 100 may include only the first pressure sensor 71. In some embodiments, the catheter pump 100 may include only the second pressure sensor 72. In some embodiments, first pressure sensor 71 and/or second pressure sensor 72 may be various types of pressure sensors, such as strain gauge pressure sensors, diffused silicon pressure sensors, piezoelectric pressure sensors, and the like. By providing the first pressure sensor 71 and/or the second pressure sensor 72, the fluid pressure at the upstream and/or downstream position of the catheter pump 100 can be conveniently known, so that the work condition and clinical effect of the catheter pump can be monitored, and the catheter pump can be guided to work better.

FIG. 10 is a schematic view of an exemplary auxiliary blood pumping system, according to some embodiments of the present disclosure.

Referring to fig. 10, the auxiliary pumping system 200 may be a system that provides additional blood circulation power to the heart failure patient. The auxiliary blood pumping system 200 may include the catheter pump 100 and the control device 210 described above.

In some embodiments, the catheter pump 100 is for implantation in a human blood vessel 250 and/or a blood transfusion organ to increase the pumping pressure of the blood vessel 250 and/or blood transfusion organ, and the specific details of the catheter pump 100 may be as described above.

In some embodiments, the control device 210 is adapted to be disposed outside the body and control the operation of the catheter pump 100. In some embodiments, the control device 210 is electrically connected to the drive motor 3 of the catheter pump 100, for example by a cable 240. In some embodiments, the control device 210 is configured to send control instructions to the drive motor 3 based on the control parameters to implement the control of the catheter pump 100. In some embodiments, the control device 210 may send a control command to the driving motor 3 based on a control parameter set by a human. In some embodiments, the control device 210 may automatically determine the control parameters and send control commands to the driving motor 3, so that human interference can be avoided. In some embodiments, the control parameters may include, but are not limited to, voltage, current, driving speed, power, etc. of the driving motor 3, and the control device 210 can send control instructions to operate the driving motor 3 according to the control parameters. In some alternative embodiments, the control device 210 may be integrated within the catheter pump 100.

In some embodiments, the catheter pump 100 includes a first pressure sensor 71 and a second pressure sensor 72, the first pressure sensor 71 being disposed upstream of the fluid inlet 11 for detecting the pressure upstream of the fluid inlet 11 and generating a corresponding signal, the second pressure sensor 72 being disposed downstream of the fluid outlet 12 for detecting the pressure downstream of the fluid outlet 12 and generating a corresponding signal. The details of the first pressure sensor 71 and the second pressure sensor 72 can be found in the above description, and are not repeated herein.

In some embodiments, the control device 210 may be used to acquire signals of the first pressure sensor 71 and the second pressure sensor 72. In some embodiments, the control device 210 is in signal connection (e.g., electrically connected) with the first pressure sensor 71 and the second pressure sensor 72, the first pressure sensor 71 and the second pressure sensor 72 measure blood pressure and send signals to the control device 210, and the control device 210 acquires and processes the signals.

In some embodiments, the control device 210 may adjust the control parameter output value of the drive motor 3 based on the signals of the first pressure sensor 71 and the second pressure sensor 72. In some embodiments, the control device 210 may calculate a control parameter according to the signals of the first pressure sensor 71 and the second pressure sensor 72, and based on the control parameter, send a control command to the driving motor 3, thereby adjusting the control parameter output value of the driving motor 3. In some embodiments, the control device 210 may take the value of the control parameter as the control parameter output value of the drive motor 3.

In some embodiments, control device 210 may include a storage medium 212 and a processor 214. For more details regarding the control device 210, reference may be made to fig. 19 and its associated description.

FIG. 11 is a schematic diagram illustrating an application scenario of an exemplary auxiliary blood pumping system according to some embodiments of the present disclosure.

Referring to fig. 11, the auxiliary pumping system 200 may comprise a third pressure sensor 73 and a fourth pressure sensor 74 for replacing the function of the first pressure sensor 71 and the second pressure sensor 72, respectively. In some embodiments, after the catheter pump 100 is implanted in the body vessel 250, the third pressure sensor 73 may be implanted or penetrated separately upstream of the catheter pump 100 and spaced apart from the catheter pump 100, and likewise, the fourth pressure sensor 74 may be implanted or penetrated separately downstream of the catheter pump 100 and spaced apart from the catheter pump 100. The third pressure sensor 73 and the fourth pressure sensor 74 are provided separately from the catheter pump 100, so that the structure of the catheter pump 100 can be simplified, the positions of the third pressure sensor 73 and the fourth pressure sensor 74 are not limited by the catheter pump 100, a turbulent area around the catheter pump 100 can be avoided more easily, and the detection accuracy can be improved. In some embodiments, when the catheter pump 100 is placed in a descending aorta position, the third pressure sensor 73 may be placed in a radial artery position and the fourth pressure sensor 74 may be placed in a femoral artery position. Additional details regarding the auxiliary pumping system 200 can be found in fig. 10 and its associated description.

In some embodiments, a cable 240 is connected downstream of the catheter pump 100, and the cable 240 is connected to the control device 210 for providing power and control signals to the catheter pump 100. The fourth pressure sensor 74 may be disposed in a branch vessel 250 downstream of the catheter pump 100, the branch vessel 250 avoiding the vessel 250 through which the cable 240 passes, so that the cable 240 can be prevented from affecting the detection accuracy of the fourth pressure sensor 74.

In some embodiments, the control device 210 may be used to obtain a current signal for driving the motor 3. In some embodiments, the drive motor 3 may feed back a current signal to the control device 210. In some embodiments, the control device 210 may use a current parameter among the control parameters as the control current of the drive motor 3.

In some embodiments, the control device 210 may be configured to determine whether the catheter pump 100 is operating abnormally based on the current signal. In some embodiments, the control device 210 may preset a safety current range value (or threshold value) and, after acquiring the current signal of the drive motor 3, compare the current signal with the safety current range value (or threshold value): if the current signal is within the safe current range (or less than the threshold), the control device 210 generates a determination that the catheter pump 100 is working normally; if the current signal is outside the safe current range (or greater than the threshold), the control device 210 generates a determination result that the catheter pump 100 is operating abnormally. In some embodiments, when the control device 210 determines that the catheter pump 100 is abnormally operated, it may send out an alarm message to perform timely maintenance or correction.

FIG. 12 is a schematic diagram of an application scenario of an exemplary auxiliary blood pumping system according to some embodiments of the present description.

In some embodiments, the auxiliary blood pumping system 200 may include a catheter (not shown in fig. 12) through which the catheter pump 100 and the cable 240 are implanted into a blood vessel 250 of the human body. As shown in FIG. 12, a portion of the cable 240 may be routed into the body with the catheter pump 100, and another portion may be located outside the body and connected to the control device 210. In the implantation operation, the catheter pump 100 is first transported to a designated position through the catheter, and then the catheter is withdrawn so that the catheter pump 100 extends from the catheter, and the stent 6 on the catheter pump 100 is then expanded to fix the catheter pump 100 at the designated position. In some embodiments, to avoid bacterial contamination of the catheter and cable 240 during implantation and retrieval, the auxiliary blood pumping system 200 further comprises a sterile protection device 220, wherein the sterile protection device 220 is capable of sealing the catheter and cable 240 of the extracorporeal portion in a sterile environment, ensuring cleanliness of the catheter and cable 240.

In some embodiments, sterility guard 220 can include a sterile sleeve 221, a protective sheath 225, and first, second, and third sealing joints 222, 223, 224. The two ends of the sterile sleeve bag 221 are respectively connected with a second sealing joint 223 and a third sealing joint 224, and the first sealing joint 222 is connected with one end of a protective sheath 225; the first sealing joint 222 and the second sealing joint 223 are interconnected. In some embodiments, the sterile sleeve 221 and the second and third sealing joints 223 and 224 can be connected by gluing or pre-injection molding. In some embodiments, the first sealing joint 222 is sealed from the cable 240 or conduit by a seal (e.g., a grommet). The third sealing joint 224 is sealed to the cable 240 or conduit by a seal (e.g., a grommet).

In some embodiments, the first sealing joint 222 is a male joint, the second sealing joint 223 is a female joint, the first sealing joint 222 and the second sealing joint 223 are used to connect (e.g., snap, screw, etc.) to each other to form a seal, and the protective sheath 225 and the sterile pouch 221 can be connected together through the first sealing joint 222 and the second sealing joint 223, so that the catheter and the cable 240 of the extracorporeal portion can be better covered by the protective sheath 225 and the sterile pouch 221. In some embodiments, the other end of the protective sheath 225 may be implanted into the body to further ensure the hermeticity of the catheter and cable 240. In some embodiments, the other end of the protective sheath 225 may be of a shape that tapers in cross-section toward the head end; thereby can effectively guarantee to block the plant entrance when implanting this other end human body to prevent that blood from flowing out.

FIG. 13 is an exemplary flow chart of a method of controlling a catheter pump according to some embodiments described herein.

In some embodiments, the catheter pump control method 1200 may be used to control a catheter pump (e.g., the catheter pump 100 of any of the embodiments described above). In some embodiments, the method 1200 of controlling the catheter pump may be performed by the control device 210 (e.g., the processor 214). The catheter pump control method 1200 will be described below with the catheter pump positioned in the aorta as an example. It is noted that the method 1200 for controlling a catheter pump is equally applicable to other catheter pump configurations. As shown in fig. 13, a method 300 of controlling a catheter pump may include:

in step 1210, a target pressure differential curve or a target effective pressure differential of the catheter pump 100 is obtained.

In some embodiments, the target pressure differential profile may be a profile of the pressure differential expected to be achieved between upstream and downstream of the catheter pump 100 over time. In some embodiments, the target pressure difference curve may be a linear continuous curve, a non-linear continuous curve, or a piecewise curve, among other types of curves.

In some embodiments, the target effective pressure differential may be an effective value of the pressure differential that is desired to be achieved between upstream and downstream of the catheter pump 100. In some embodiments, the effective value of the pressure difference refers to an equivalent pressure value obtained by converting a changed target pressure difference curve through calculation. In some embodiments, the target effective pressure differential may be an average (e.g., a weighted average) of the pressure differentials expected to be achieved between upstream and downstream of the catheter pump 100.

In some embodiments, the processor 214 may obtain the target pressure differential curve or the target effective pressure differential in a variety of ways. In some embodiments, the target pressure differential curve or target effective pressure differential may be set by a user (e.g., a healthcare worker). In some embodiments, a plurality of target pressure differential curves or target effective pressure differentials may reside in the storage medium 212. In some embodiments, the processor 214 may retrieve a corresponding target pressure differential curve or target effective pressure differential from the storage medium 212 based on user input information. In some embodiments, the processor 214 may retrieve a corresponding target pressure differential curve or target effective pressure differential from the storage medium 212 based on a physiological metric of the patient (e.g., degree of heart failure, cardiac output, etc.).

In some embodiments, the processor 214 may determine a target pressure differential curve or a target effective pressure differential for the catheter pump 100 based on the target perfusion flow and the actual aortic pressure curve for the patient. In some embodiments, the processor 214 may obtain a target perfusion flow rate of the patient and determine an aortic pressure curve based on the target perfusion flow rate; further, the processor 214 may obtain an actual pressure curve of the aorta of the patient and determine a target pressure differential curve or a target effective pressure differential for the catheter pump based on the target pressure curve and the actual pressure curve. For more details regarding the method for determining a target pressure difference (e.g., a target pressure difference curve or a target effective pressure difference), reference may be made to fig. 14 and its associated description.

In step 1220, a target rotational speed of the drive motor 3 of the catheter pump 100 is obtained.

In some embodiments, the target rotation speed may be a rotation speed that the drive motor 3 is expected to reach. In some embodiments, the target rotational speed may be determined from the actual perfusion flow and the target perfusion flow of the patient. In some embodiments, processor 214 may determine the auxiliary irrigation flow rate based on the actual irrigation flow rate and the target irrigation flow rate, and determine the target rotational speed of the drive motor based on the auxiliary irrigation flow rate and the target effective differential pressure of the catheter pump. For more details on the target speed determination method, reference may be made to fig. 13 and its associated description.

And step 1230, adjusting the control parameter output value of the driving motor 3 according to the target pressure difference curve or the target effective pressure difference and the target rotating speed.

In some embodiments, the control parameters of the drive motor 3 of the catheter pump 100 may include a control current and a control voltage. Wherein the control voltage may be a voltage applied (or to be applied) across the drive motor 3; the control current may be a current flowing (or to be flowed) through the drive motor 3. In some embodiments, processor 214 may adjust the current profile or current value of the control current based on the target pressure differential profile or the target effective pressure differential. In some embodiments, the processor 214 may adjust the voltage value of the control voltage according to the target speed.

In some embodiments, processor 214 may adjust the current profile of the control current according to the target pressure differential profile. In some embodiments, the target pressure difference curve may represent a time-dependent variation of an auxiliary pumping pressure that the catheter pump 100 needs to provide for the blood of the patient, which auxiliary pumping pressure may be achieved by the drive of the drive motor 3 of the catheter pump 100. In some embodiments, when the control voltage of the driving motor 3 is constant, the rotation speed of the driving motor 3 is relatively constant, and the torque of the motor output rotating shaft 32 can be adjusted by adjusting the control current of the driving motor, so as to adjust the auxiliary pumping pressure provided by the catheter pump. Therefore, the processor 214 can adjust the current curve of the control current according to the positive correlation between the control current and the auxiliary pumping pressure at a specific voltage, so that the current variation of the driving motor 3 can satisfy the target pressure difference curve. By adjusting the control current to match the target pressure difference curve, the catheter pump can be accurately matched with the change of physiological indexes (such as cardiac output) of a patient and the periodic change of the blood vessel pressure caused by the beating period of the heart, so that the effect of assisting blood pumping of the catheter pump 100 is improved.

In some embodiments, processor 214 may adjust the current value of the control current based on the target effective pressure differential. In some embodiments, the principle of adjusting the control current based on the target effective pressure difference may refer to the principle of adjusting the current curve based on the target pressure difference curve described above. In some embodiments, the auxiliary pumping pressure provided by the catheter pump 100 to the patient based on the target effective pressure differential is relatively equivalent to the auxiliary pumping pressure provided by the catheter pump 100 to the patient based on the target pressure differential profile (e.g., equivalent from the standpoint of auxiliary pump blood flow over a period of time, such as 1 min). The processor 214 may adjust the current value of the control current to enable the torque of the drive motor 3 to meet the patient's blood pumping requirements and to enable the pressure differential between the upstream and downstream sides of the catheter pump 100 to achieve the target effective pressure differential. By adjusting the control current according to the target effective pressure difference, a relatively equivalent auxiliary blood pumping effect can be achieved through a constant current value, and the processing and control difficulty of the control device 210 is reduced.

In some embodiments, the processor 214 may adjust the voltage value of the control voltage according to the target speed. In some embodiments, the greater the control voltage of the drive motor 3, the greater the rotational speed it outputs. Therefore, the processor 214 can make the rotation speed of the drive motor 3 reach the target rotation speed by adjusting the voltage value of the control voltage.

In some embodiments, the processor 214 may obtain control parameter measurements of the drive motor. In some embodiments, the processor 214 may determine a target value of a control parameter of the drive motor based on the target pressure difference curve or the target effective pressure difference, and the target rotation speed; further, the processor 214 may adjust the output value of the control parameter of the drive motor according to the target value and the measured value of the control parameter.

In some embodiments, the processor 214 may obtain the actual pressure differential of the catheter pump. In some embodiments, the processor 214 may determine the drive motor control parameter adjustment based on the target pressure differential curve or the target effective pressure differential, and the actual pressure differential and the target rotational speed. Further, the processor 214 may adjust the control parameter output value of the drive motor according to the control parameter adjustment value. In some embodiments, the processor 214 may obtain an actual rotational speed of the drive motor; and further determining a control parameter adjusting value of the driving motor according to the target pressure difference curve or the target effective pressure difference, the actual pressure difference, the target rotating speed and the actual rotating speed.

For more details on the control parameter adjustment method, reference may be made to fig. 16-18 and their associated description.

FIG. 14 is an exemplary flow chart of a target pressure differential determination method according to some embodiments described herein. In some embodiments, the target pressure differential determination method 1300 may be performed by the control device 210 (e.g., the processor 214). The processor 214 may determine a target pressure differential curve or a target effective pressure differential for the catheter pump based on the target pressure differential determination method 1300 to implement step 1210. As shown in fig. 14, the target pressure differential determination method 1300 may include:

at step 1310, a target perfusion flow rate for the patient is obtained.

In some embodiments, the target perfusion flow rate may be the amount of blood expected to be reached per unit time through a cross-section of the blood vessel 250. For example, the target perfusion flow may be the amount of blood that the heart is expected to reach by shooting into a section of the aorta within each minute.

In some embodiments, the target perfusion flow rate may be determined by a physiological metric (e.g., degree of heart failure) based on the patient. For example, when the perfusion flow rate of a mild heart failure patient with the aid of the catheter pump 100 reaches 3.5L/min, the physiological index of the mild heart failure patient can be maintained within a normal range (e.g., the physiological indexes such as blood supply, oxygen supply, and metabolic index of each organ are maintained within a normal range), the processor 214 may determine the perfusion flow rate of 3.5L/min as the target perfusion flow rate of the patient. In some embodiments, the target perfusion flow rate may be determined according to a standard perfusion flow rate of a normal person, for example, the standard perfusion flow rate of the normal person may be 5L/min, and the control device 210 may determine the perfusion flow rate of 5L/min as the target perfusion flow rate. In some embodiments, the target perfusion flow may correspond to a physiological indicator of the patient (e.g., a degree of heart failure). For example, the storage medium 212 may store a corresponding relationship between the heart failure level of the patient and the target perfusion flow rate, and the processor 214 may retrieve the corresponding target perfusion flow rate from the storage medium 212 according to the heart failure level of the patient (e.g., input by a medical staff).

In step 1320, a target aortic pressure curve is determined based on the target perfusion flow.

In some embodiments, the target pressure profile may be a profile of blood pressure in the aorta of the patient over time that is desired to be achieved. For example, for a heart failure patient, the target pressure profile may be the pressure profile of the blood pressure that is expected to be achieved after the catheter pump 100 is used to assist in pumping blood. In particular, the target pressure profile may be a pressure profile that is desired to be achieved by blood downstream of the fluid outlet 12 of the catheter pump 100.

In some embodiments, the processor 214 may obtain a standard perfusion flow and standard pressure curve for a normal person. Based on this, the processor 214 may modify (e.g., scale down) the standard pressure curve of the normal person based on the difference or proportional relationship between the standard perfusion flow of the normal person and the target perfusion flow of the heart failure patient, thereby determining the aortic target pressure curve.

In some embodiments, the processor 214 may pre-establish the correspondence between the perfusion flow rate and the aortic pressure curve according to experimental data. For example, the processor 214 may establish a correspondence of the perfusion flow rate and the aortic pressure curve according to the measured perfusion flow rate and the measured aortic pressure curve of a plurality of historical patients. On this basis, the processor 214 may call the corresponding aortic pressure curve as the aortic target pressure curve according to the target perfusion flow.

At step 1330, an aortic actual pressure curve of the patient is obtained.

In some embodiments, the aorta actual pressure curve may be a curve of actual blood pressure in the aorta over time. In some embodiments, the actual pressure profile may be a pressure profile located upstream of the fluid inlet 11 of the catheter pump 100.

In some embodiments, the actual pressure curve may be determined from a standard pressure curve modification of a normal person. In some embodiments, the processor 214 may modify the standard pressure curve based on a deviation of a physiological metric of the patient (e.g., blood pressure) from a normal range to obtain an actual pressure curve for the patient. For example, the processor 214 may obtain a proportional relationship between the patient's blood pressure and a standard blood pressure of a normal person, and adjust the standard pressure curve (e.g., downscaling) based on the proportional relationship to obtain the actual aortic pressure curve. By correcting the standard pressure curve of a normal person to obtain an actual pressure curve, the pressure sensor does not need to be arranged on the catheter pump 100 to detect the pressure of the blood vessel 250, the structure of the catheter pump 100 and/or the auxiliary blood pumping system 200 is simplified, and the control workload of the control device 210 is reduced.

In some embodiments, the actual pressure profile may be determined by sensor detection. In some embodiments, the catheter pump 100 may include a first pressure sensor 71, the first pressure sensor 71 being disposed upstream of the fluid inlet 11 of the catheter pump 100 for detecting the blood pressure upstream of the fluid inlet 11 of the catheter pump 100 (see fig. 6-9 and their associated description for further details regarding the first pressure sensor 71). In some embodiments, the auxiliary pumping system 200 may include a third pressure sensor 73; the third pressure sensor 73 may be implanted or penetrated separately upstream of the catheter pump 100 and spaced from the catheter pump 100 (see fig. 11 and its associated description for further details regarding the third pressure sensor 73). In some embodiments, the processor 214 may acquire a signal of the pressure collected by the first pressure sensor 71 or the third pressure sensor 73 over time as an actual pressure curve. The actual pressure curve detected and determined by the sensor can more accurately reflect the actual blood perfusion pressure of the patient, and the reliability of the actual pressure curve is improved, so that the target pressure difference curve or the target effective pressure difference of the catheter pump can be more accurately determined.

Step 1340, determining a target pressure difference curve or a target effective pressure difference of the catheter pump according to the target pressure curve and the actual pressure curve.

In some embodiments, the processor 214 may determine a target pressure differential curve or a target effective pressure differential for the catheter pump 100 based on the target pressure curve and the actual pressure curve in steps 1310-1330. In some embodiments, the target pressure differential curve for the catheter pump 100 may be obtained by subtracting the target pressure curve and the actual pressure curve. In some embodiments, after determining the target differential pressure profile of the catheter pump 100, the processor 214 may further match the target differential pressure profile to the heart beat cycle based on the patient's electrocardiogram signal to determine a target differential pressure profile that varies periodically over time.

In some embodiments, the processor 214 may calculate a target effective pressure differential from the target pressure differential curve. In some embodiments, processor 214 may determine a target effective pressure from the target pressure curve, determine an actual effective pressure from the actual pressure curve, and then calculate a difference between the target effective pressure and the actual effective pressure to obtain a target effective pressure difference.

FIG. 15 is an exemplary flow chart of a target speed determination method according to some embodiments described herein. In some embodiments, the target speed determination method 1400 may be performed by the control device 210 (e.g., the processor 214). The processor 214 may determine a target speed of the drive motor based on the target speed determination method to implement step 1220. As shown in fig. 15, the target speed determination method 1400 may include:

at step 1410, the actual perfusion flow rate of the patient is obtained.

In some embodiments, the actual perfusion flow may be the actual amount of blood flowing through a cross-section of the blood vessel 250 per unit time. For example, the actual perfusion flow may be the actual volume of blood per minute that the heart shoots into a section of the aorta. In some embodiments, the actual perfusion flow of the patient may be the cardiac output of the patient. In some embodiments, the actual perfusion flow of a heart failure patient is generally lower than that of a normal person. For example, the actual perfusion flow rate of a normal person may be 5L/min, and the actual perfusion flow rate of a heart failure patient may be 3L/min.

In some embodiments, the actual perfusion flow may be measured by various detection techniques, such as indicator dilution, impedance, ultrasound, or magnetic resonance imaging, and the processor 214 may obtain the actual perfusion flow of the patient detected by the various detection techniques.

At step 1420, a target perfusion flow rate for the patient is obtained.

In some embodiments, the target perfusion flow rate is generally greater than the actual perfusion flow rate and less than the standard perfusion flow rate for a normal person. For example, the actual perfusion flow rate of the heart failure patient is 3L/min, and the standard perfusion flow rate of the normal person can be 5L/min, and the target perfusion flow rate can be between 3L/min and 5L/min (such as 3.5L/min or 4L/min). In some embodiments, obtaining a target perfusion flow for the patient is similar to step 1310, and further details can be found in step 1310 and its associated description.

Step 1430, an auxiliary perfusion flow rate is determined based on the actual perfusion flow rate and the target perfusion flow rate.

In some embodiments, the auxiliary perfusion flow may be a difference between the actual perfusion flow and the target perfusion flow. For example, if the actual perfusion flow rate of a heart failure patient is 3L/min and the target perfusion flow rate is 3.5L/min, the auxiliary perfusion flow rate may be 0.5L/min. In some embodiments, the secondary perfusion flow may be achieved by the pumping action of the catheter pump 100.

At step 1440, a target rotational speed of the drive motor is determined based on the auxiliary irrigation flow rate and the target effective pressure differential of the catheter pump.

In some embodiments, the processor 214 may determine a target rotational speed of the drive motor 3 based on the auxiliary irrigation flow determined in step 1430 and the target effective pressure differential of the catheter pump 100 obtained in step 1210.

In some embodiments, the following equation 1 is satisfied between the flow rate, pressure and rotational speed of the conduit pump:

wherein, F_pIs the flow of the catheter pump, Δ P is the pressure difference of the catheter pump, ω is the drive motor3 rotational speed, b₀、b₁、b₂Is an empirical constant. According to the above formula, the flow rate F of the conduit pump_pConsidering as a constant (e.g. auxiliary perfusion flow) and considering the pressure difference ap of the catheter pump as a constant (e.g. target effective pressure difference), it can further be deduced that:

that is to say that the first and second electrodes,

wherein the content of the first and second substances,

is the auxiliary priming flow of the catheter pump,

is the target effective pressure differential for the catheter pump,

is the target rotation speed of the drive motor 3.

Processor 214 may base the auxiliary perfusion flow on equation 3

And target effective pressure difference of the catheter pump

Determining a target rotational speed of a drive motor

In some embodiments, the processor 214 may monitor the actual perfusion flow of the patient; when the actual perfusion flow rate changes, the processor 214 may update the target rotation speed according to the changed actual perfusion flow rate, and further update and adjust the control parameter output value of the driving motor.

In some embodiments, the heart function of the heart failure patient gradually recovers and improves under the assistance of the catheter pump 100 (or in combination with other treatment means), and various physiological indexes (such as cardiac output) of the patient also change accordingly. In some embodiments, the processor 214 may monitor the actual perfusion flow rate of the patient, and when the actual perfusion flow rate changes, the processor 214 may re-execute step 1410-1440 to update the target rotational speed according to the changed actual perfusion flow rate. Through monitoring the actual perfusion flow of patient dynamic update target rotational speed, and then update driving motor 3's control parameter output value, can make the auxiliary pump blood effect of catheter pump 100 follow patient's actual physiology condition and carry out dynamic adjustment, more accord with patient's physiology demand, help the patient to recover fast. In some embodiments, the processor 214 may maintain the target perfusion flow of the patient steady during the monitoring of the actual perfusion flow of the patient and the dynamic updating of the target rotational speed, thereby facilitating a steady rehabilitation of the patient.

FIG. 16 is an exemplary flow chart of a control parameter adjustment method according to some embodiments described herein. In some embodiments, the control parameter adjustment method 1500 may be performed by the control device 210 (e.g., the processor 214). Processor 214 may adjust the control parameter output value of the drive motor based on control parameter adjustment method 1500 to implement step 1230. As shown in fig. 16, the control parameter adjustment method 1500 may include:

and 1510, determining a control parameter target value of the driving motor according to the target pressure difference curve or the target effective pressure difference and the target rotating speed.

In some embodiments, the control parameter target value may be a control parameter value that the drive motor 3 is expected to reach.

In some embodiments, the control parameter target value of the drive motor 3 may include a target current curve or a target current value, and a target voltage.

In some embodiments, the processor 214 may determine a target voltage for the drive motor based on the target speed.

In some embodiments, the correspondence relationship of the control voltage of the drive motor to the rotational speed may be experimentally determined in advance and stored in the storage medium 212. The processor 214 may retrieve a corresponding target voltage from the storage medium 212 based on the target speed.

In some embodiments, the processor 214 may determine a target current profile based on the target pressure differential profile and the target speed. In some embodiments, the correspondence between the pressure difference curve and the current curve of the driving motor at a specific rotational speed (e.g., a target rotational speed) may be experimentally determined in advance and stored in the storage medium 212. The processor 214 may retrieve a corresponding target current profile from the storage medium 212 based on the target speed and the target pressure differential profile.

In some embodiments, processor 214 may determine the target current value based on the target effective pressure differential and the target rotational speed. In some embodiments, the correspondence relationship between the effective pressure difference and the current value of the driving motor at a specific rotational speed (e.g., a target rotational speed) may be experimentally determined in advance and stored in the storage medium 212. The processor 214 may retrieve a corresponding target current value from the storage medium 212 based on the target rotational speed and the target effective pressure differential.

At step 1520, control parameter measurements for the drive motor are obtained.

In some embodiments, the control parameter measurements of the drive motor 3 may comprise measured voltages as well as measured current values or measured current profiles. In some embodiments, the measured voltage and the measured current value or the measured current profile may be obtained by feedback of the drive motor 3 itself.

And step 1530, adjusting the control parameter output value of the driving motor according to the control parameter target value and the measured value.

In some embodiments, the control parameter output values of the drive motor 3 may include a voltage output value and a current output value (or a current output curve). In some embodiments, the control parameter output of the drive motor 3 may be adjusted by a pid (process Integration differentiation) control algorithm. Specifically, the control device 210 (e.g., the processor 214) may calculate an error between the measured value of the control parameter and the target value of the control parameter, perform proportional operation, integral operation, and differential operation on the error to obtain an updated control parameter value, control the driving motor using the updated control parameter value, and detect the control parameter output value of the driving motor 3. Further, the control device 210 may use the detected control parameter output value as an updated control parameter measured value, continue to calculate an error between the updated control parameter measured value and the control parameter target value, perform PID control algorithm calculation on the error to obtain an updated control parameter value, and control the drive motor 3. The control device 210 continuously repeats the above process to iteratively adjust the control parameter output value of the driving motor 3, so that the control parameter output value of the driving motor approaches or reaches the control parameter target value of the driving motor. This way, the error caused by the internal loss of the driving motor can be overcome, and the control precision of the driving motor 3 by the control device 210 can be improved.

In some embodiments, the control device 210 may first adjust the voltage output value of the driving motor 3 according to the target voltage and the measured voltage, so that the voltage output value reaches the target voltage. The control device 210 may then stop the adjustment of the voltage output value and adjust the current output value (or the current output curve) of the drive motor according to the target current curve or the target current value. By adjusting the control voltage and then adjusting the control current, the control logic is simpler and the control result is more accurate.

Fig. 17 is an exemplary flowchart of a control parameter adjustment method according to yet another embodiment of the present description. In some embodiments, control parameter adjustment method 1600 may be performed by control device 210 (e.g., processor 214). Processor 214 may adjust the control parameter output value of the drive motor based on control parameter adjustment method 1600 to implement step 1230. As shown in fig. 17, the control parameter adjustment method 1600 may include:

at step 1610, the actual pressure differential of the catheter pump 100 is obtained.

In some embodiments, the catheter pump 100 includes a first pressure sensor 71 and a second pressure sensor 72, the first pressure sensor 71 being disposed upstream of the fluid inlet 11 of the catheter pump 100 for detecting a blood pressure upstream of the fluid inlet 11 of the catheter pump 100, the second pressure sensor 72 being disposed downstream of the fluid outlet 12 of the catheter pump 100 for detecting a blood pressure downstream of the fluid outlet 12 of the catheter pump 100 (see fig. 6-9 and related description above for further details regarding the first and second pressure sensors 71, 72). In some embodiments, the control device 210 may obtain pressure value signals of the first pressure sensor 71 and the second pressure sensor 72, and the actual pressure difference may be a difference between the pressure value of the second pressure sensor 72 and the pressure value of the first pressure sensor 71.

In some embodiments, the auxiliary pumping system 200 may include a third pressure sensor 73 and a fourth pressure sensor 74. In some embodiments, the third pressure sensor 73 may be implanted or penetrated separately upstream of the catheter pump 100 and spaced apart from the catheter pump 100, and the fourth pressure sensor 74 may be implanted or penetrated separately downstream of the catheter pump 100 and spaced apart from the catheter pump 100. (see FIG. 11 and its associated description for further details regarding third pressure sensor 73 and fourth pressure sensor 74). In some embodiments, the control device 210 may obtain pressure value signals of the third pressure sensor 73 and the fourth pressure sensor 74, and the actual pressure difference may be a difference between the pressure value of the fourth pressure sensor 74 and the pressure value of the third pressure sensor 73.

In some embodiments, the actual pressure differential of the catheter pump 100 may comprise an actual pressure differential curve and/or an actual effective pressure differential of the catheter pump.

And 1620, determining a control parameter adjustment value of the driving motor according to the target pressure difference curve or the target effective pressure difference, the actual pressure difference and the target rotating speed.

In some embodiments, the control parameter adjustment value may be a value of a control parameter that the drive motor 3 needs to adjust. In some embodiments, the control parameter adjustment value of the drive motor 3 may be an adjustment current curve or an adjustment current value. For example, the adjustment current value may be "increased by 0.1A". For another example, the adjustment current curve may be a curve of the current value to be adjusted at each time point with respect to time. In some embodiments, processor 214 may determine an adjustment current profile based on a difference between the target pressure differential profile and the actual pressure differential (e.g., the actual pressure differential profile). In some embodiments, processor 214 may determine the adjustment current value based on a difference between the target effective pressure difference and the actual pressure difference (e.g., the actual effective pressure difference).

In some embodiments, the correspondence between the difference between the target pressure difference curve and the actual pressure difference curve and the adjustment current curve at a specific rotational speed (e.g., target rotational speed) may be determined experimentally or empirically in advance and stored in the storage medium 212. The processor 214 may retrieve a corresponding adjustment current profile from the storage medium 212 based on a difference between the target pressure differential profile and the actual pressure differential.

In some embodiments, the correspondence between the difference between the target effective pressure difference and the actual pressure difference and the adjustment current value at a specific rotation speed (e.g., the target rotation speed) may be determined in advance through experiments or experience and stored in the storage medium 212. The processor 214 may retrieve a corresponding adjustment current value from the storage medium 212 based on a difference between the target effective pressure difference and the actual pressure difference.

And step 1630, adjusting the control parameter output value of the driving motor according to the control parameter adjustment value.

In some embodiments, the control device 210 (e.g., the processor 214) may adjust the control parameter output value of the drive motor 3 according to the control parameter adjustment value. In some embodiments, the control device 210 may adjust the input current of the driving motor 3 according to the adjustment current curve or the adjustment current value so that the actual pressure difference of the catheter pump 100 matches the target pressure difference curve or the target effective pressure difference. At this time, the first pressure sensor 71 and the second pressure sensor 72 may periodically (e.g., every 0.05 second, 0.1 second, 0.5 second, 3 seconds, etc.) detect the actual pressure difference of the catheter pump 100 and feed back the actual pressure difference to the control device 210, and the control device 210 determines the control parameter adjustment value again and further adjusts the control parameter output value based on the actual pressure difference and the target pressure difference curve or the target effective pressure difference. The control device 210 repeats the above process continuously to control the actual pressure difference of the catheter pump 100 more precisely to approach or reach the target pressure difference curve or the target effective pressure difference, so as to meet the auxiliary blood pumping requirement of the catheter pump and improve the therapeutic effect of the patient.

Fig. 18 is an exemplary flowchart of a control parameter adjustment method according to still another embodiment of the present disclosure. In some embodiments, the control parameter adjustment method 1700 may be performed by the control device 210 (e.g., the processor 214). Processor 214 may adjust the control parameter output value of the drive motor based on control parameter adjustment method 1700 to implement step 1230. As shown in fig. 18, the control parameter adjustment method 1700 may include:

step 1710, obtain the actual pressure differential of the catheter pump 100.

In some embodiments, the actual pressure differential of the catheter pump 100 may comprise an actual pressure differential curve and/or an actual effective pressure differential of the catheter pump. In some embodiments, obtaining the actual pressure differential of the catheter pump 100 is accomplished in a similar manner as step 1610, and specific details can be found in step 1610 and its associated description.

Step 1720, acquiring an actual rotating speed of the driving motor.

In some embodiments, the actual rotational speed of the drive motor 3 refers to the rotational speed of the output shaft 32. In some embodiments, the back electromotive force of the driving motor 3 is in a direct proportion relationship with the actual rotation speed, and the control device 210 may calculate the actual rotation speed based on the back electromotive force of the driving motor 3. In some embodiments, the actual rotational speed of the drive motor 3 may be measured by a sensor, which may be used to measure the rotational speed of the output shaft 32 or to measure the rotational speed of the impeller 2, since the output shaft 32 of the drive motor 3 and the impeller 2 rotate synchronously. The control device 210 may obtain the actual rotation speed of the drive motor 3 based on the signal of the sensor. In some embodiments, the sensors that measure the drive motor 3 may include, but are not limited to, a photosensor, a resolver, a hall sensor, and the like.

And step 1730, determining a control parameter adjustment value of the driving motor according to the target pressure difference curve or the target effective pressure difference, the actual pressure difference, the target rotating speed and the actual rotating speed.

In some embodiments, the control parameter adjustment value of the drive motor 3 may include an adjustment voltage value, an adjustment current curve, or an adjustment current value. For example, the adjustment voltage value may be "increased by 0.1V". In some embodiments, control device 210 may determine the adjustment voltage value based on a difference between the target rotational speed and the actual rotational speed. In some embodiments, control device 210 may determine the adjustment current profile based on a difference between the target pressure differential profile and the actual pressure differential. In some embodiments, control device 210 may determine the adjustment current value based on a difference between the target effective pressure difference and the actual pressure difference.

In some embodiments, the correspondence between the difference between the target rotational speed and the actual rotational speed and the adjustment voltage value may be determined in advance through experiments or experience, and stored in the storage medium 212. The processor 214 may retrieve a corresponding adjustment voltage value from the storage medium 212 based on a difference between the target rotational speed and the actual rotational speed.

In some embodiments, the correspondence between the difference between the target pressure difference curve and the actual pressure difference curve and the adjustment current curve at a specific rotational speed (e.g., the target rotational speed or the actual rotational speed) may be determined in advance through experiments or experience, and stored in the storage medium 212. The processor 214 may retrieve a corresponding adjustment current profile from the storage medium 212 based on the target or actual speed and the difference between the target pressure differential profile and the actual pressure differential.

In some embodiments, the correspondence between the difference between the target effective pressure difference and the actual pressure difference and the adjustment current value at a specific rotation speed (e.g., the target rotation speed or the actual rotation speed) may be determined in advance through experiments or experience and stored in the storage medium 212. The processor 214 may retrieve a corresponding adjustment current value from the storage medium 212 based on the target rotational speed or the actual rotational speed, and the difference between the target effective pressure difference and the actual pressure difference.

And step 1740, adjusting the control parameter output value of the driving motor according to the control parameter adjustment value.

In some embodiments, adjusting the control parameter output value of the drive motor based on the control parameter adjustment value is implemented in a similar manner as step 1630, and the specific details can be found in step 1630 and its associated description.

In some embodiments, the control device 210 may periodically (e.g., every 0.05 second, 0.1 second, 0.5 second, 3 seconds, etc.) acquire the actual rotational speed of the drive motor and determine the adjustment voltage value based on the difference between the target rotational speed and the actual rotational speed. The control device 210 may continuously repeat the above adjustment process to control the actual rotation speed of the driving motor to approach or reach the target rotation speed.

In some embodiments, the control device 210 may first adjust the control voltage (e.g., iteratively perform

steps

1720, 1730, and 1740) to make the actual rotational speed of the driving motor reach the target rotational speed. The control device 210 may then stop adjusting the control voltage and adjust the control current (e.g., iteratively perform

steps

1710, 1730, and 1740) such that the actual pressure differential of the catheter pump approaches or reaches the target pressure differential curve or the target effective pressure differential. By adjusting the control voltage and then adjusting the control current, the control logic is simpler and the control result is more accurate. In some alternative embodiments, the control device 210 may adjust the control current first and then adjust the control voltage. In some alternative embodiments, the control device 210 may adjust the control voltage and the control current synchronously or alternately.

FIG. 19 is a schematic diagram of an exemplary configuration of a control device, shown in accordance with some embodiments of the present description. As shown in fig. 19, the control device 210 of the catheter pump may include a storage medium 212, a processor 214, and a communication bus. The processor 214 and the storage medium 212 may implement communication procedures through a communication bus. The processor 214 may be configured to execute the method for controlling a catheter pump provided in any of the embodiments described above.

In some embodiments, processor 214 may be implemented using a central processor, a server, a terminal device, or any other possible processing device. In some embodiments, the central processor, server, terminal device, or other processing device described above may be implemented on a cloud platform. In some embodiments, the central processor, server, or other processing device may be interconnected with various terminal devices, which may perform information processing tasks or portions thereof.

In some embodiments, storage medium 212 (or computer-readable storage medium) may store data and/or instructions. In some embodiments, the storage medium 212 may store computer instructions that the processor 214 (or computer) may read to perform the method of controlling a catheter pump provided in any of the embodiments herein. In some embodiments, the storage device may include mass storage, removable storage, volatile read-write memory, read-only memory (ROM), and the like, or any combination thereof. In some embodiments, the storage device may be implemented on a cloud platform.

The beneficial effects that may be brought by the embodiments of the present description include, but are not limited to: (1) the catheter pump comprises a rectifying device, the rectifying device can be used for releasing the convolution pressure applied by the catheter pump to blood in a blood vessel, can relieve the impact force of the blood to the blood vessel and is beneficial to maintaining the stability of the catheter pump; (2) the auxiliary blood pumping system comprises a control device, the control device can adjust the control parameters of the catheter pump according to the acquired signals, and compared with a scheme for setting the control parameters according to doctor experience, the auxiliary blood pumping system has higher accuracy, can reduce errors in the treatment process and is beneficial to quick recovery of a patient; (3) the control method of the catheter pump can adjust the control parameter output value of the drive motor of the catheter pump according to the actual perfusion flow and the target perfusion flow of the patient, thereby improving the reliability of the control parameter output value; (4) the control device can monitor the actual perfusion flow of the patient to update the control parameter output value of the driving motor, so that the control parameter output value can be accurately matched with the change of the physiological index of the patient, and the quick rehabilitation of the patient is facilitated. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.

Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing detailed disclosure is to be regarded as illustrative only and not as limiting the present specification. Various modifications, improvements and adaptations to the present description may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present specification and thus fall within the spirit and scope of the exemplary embodiments of the present specification.

Also, the description uses specific words to describe embodiments of the description. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the specification is included. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, some features, structures, or characteristics of one or more embodiments of the specification may be combined as appropriate.

Moreover, those skilled in the art will appreciate that aspects of the present description may be illustrated and described in terms of several patentable species or situations, including any new and useful combination of processes, machines, manufacture, or materials, or any new and useful improvement thereof. Accordingly, aspects of this description may be performed entirely by hardware, entirely by software (including firmware, resident software, micro-code, etc.), or by a combination of hardware and software. The above hardware or software may be referred to as "data block," module, "" engine, "" unit, "" component, "or" system. Furthermore, aspects of the present description may be represented as a computer product, including computer readable program code, embodied in one or more computer readable media.

The computer storage medium may comprise a propagated data signal with the computer program code embodied therewith, for example, on baseband or as part of a carrier wave. The propagated signal may take any of a variety of forms, including electromagnetic, optical, etc., or any suitable combination. A computer storage medium may be any computer-readable medium that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. Program code located on a computer storage medium may be propagated over any suitable medium, including radio, cable, fiber optic cable, RF, or the like, or any combination of the preceding.

Computer program code required for the operation of various portions of this specification may be written in any one or more programming languages, including an object oriented programming language such as Java, Scala, Smalltalk, Eiffel, JADE, Emerald, C + +, C #, VB.NET, Python, and the like, a conventional programming language such as C, VisualBasic, Fortran2003, Perl, COBOL2002, PHP, ABAP, a dynamic programming language such as Python, Ruby, and Groovy, or other programming languages, and the like. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or processing device. In the latter scenario, the remote computer may be connected to the user's computer through any network format, such as a Local Area Network (LAN) or a Wide Area Network (WAN), or the connection may be made to an external computer (for example, through the Internet), or in a cloud computing environment, or as a service, such as a software as a service (SaaS).

Additionally, the order in which the elements and sequences of the process are recited in the specification, the use of alphanumeric characters, or other designations, is not intended to limit the order in which the processes and methods of the specification occur, unless otherwise specified in the claims. While various presently contemplated embodiments of the invention have been discussed in the foregoing disclosure by way of example, it is to be understood that such detail is solely for that purpose and that the appended claims are not limited to the disclosed embodiments, but, on the contrary, are intended to cover all modifications and equivalent arrangements that are within the spirit and scope of the embodiments herein. For example, although the system components described above may be implemented by hardware devices, they may also be implemented by software-only solutions, such as installing the described system on an existing processing device or mobile device.

Similarly, it should be noted that in the preceding description of embodiments of the present specification, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to imply that more features than are expressly recited in a claim. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.

Finally, it should be understood that the embodiments described herein are merely illustrative of the principles of the embodiments of the present disclosure. Other variations are also possible within the scope of the present description. Thus, by way of example, and not limitation, alternative configurations of the embodiments of the specification can be considered consistent with the teachings of the specification. Accordingly, the embodiments of the present description are not limited to only those embodiments explicitly described and depicted herein.

Claims

1. A catheter pump for assisting in pumping blood, comprising:

a housing provided with a fluid inlet and a fluid outlet;

an impeller disposed within the housing for regulating a flow rate of the conduit pump;

the driving motor is used for driving the impeller to rotate and comprises a stator side and an output rotating shaft, the stator side is fixed with the shell, and the output rotating shaft is fixed with the impeller;

and the rectifying device is sleeved outside the output rotating shaft of the driving motor and is fixedly connected with the stator side of the driving motor.

2. The catheter pump according to claim 1, wherein the rectifying device includes a core configured as a centrosymmetric block, the core including a small end and a large end, the cross section from the small end to the large end gradually increasing, the small end being disposed near the impeller, the large end being disposed near the driving motor, the core being opened with a through hole for avoiding the output rotating shaft.

3. The catheter pump of claim 2, wherein the fairing device further comprises a plurality of vanes spaced about the central axis of the core at an outer surface of the core for relieving the swirling pressure exerted by the impeller on the blood.

4. The catheter pump of claim 1, wherein the fairing is disposed at the fluid outlet.

5. The catheter pump according to claim 1, wherein a first seal and a second seal are provided between the rectifying device and the drive motor, a housing chamber is formed inside the rectifying device, the first seal is provided in the housing chamber and is in sliding contact with the output rotary shaft, and the second seal is provided between the rectifying device and the stator side.

6. The catheter pump of claim 1, further comprising a stent for securing the housing in a blood vessel or a blood transfusion organ, the stent comprising a collapsed state in which a maximum radial dimension of the stent is less than or equal to a radial dimension of the housing and an expanded state in which at least a portion of the radial dimension of the stent is greater than the radial dimension of the housing.

7. The catheter pump of claim 6, wherein the bracket comprises a plurality of legs, the legs being rod-shaped having a first end fixed relative to the fluid inlet and a second end spaced away from the housing to form a free end, the second end being spaced from the central axis of the housing less than the first end in the collapsed state.

8. The catheter pump of claim 7, wherein the end of the second end has a bend, the bend being arranged such that: in the furled state, the distance between the second end and the central axis of the shell is smaller than the distance between the first end and the central axis of the shell.

9. The catheter pump of claim 7, wherein the second end is provided with a contact foot configured as a disk, sphere, or ellipsoid.

10. The catheter pump of claim 7, wherein the bracket further comprises a connecting portion configured as a cylindrical structure having a hollow channel, one end of the connecting portion being connected to the first end of the leg, the other end of the connecting portion being connected to the fluid inlet of the housing.

11. The catheter pump according to claim 6, wherein the stent comprises a mesh stent, the catheter pump further comprises a head and a support rod, one end of the support rod is fixed to the housing, the other end of the support rod is fixed to the head, the mesh stent is disposed between the head and the housing, one end of the mesh stent is fixed to the head, the other end of the mesh stent is fixed to the housing, and the mesh stent is formed into a spindle shape in an expanded state.

12. The catheter pump of claim 1, further comprising a first pressure sensor disposed upstream of the fluid inlet and a second pressure sensor disposed downstream of the fluid outlet.

13. The catheter pump of claim 12, wherein the first pressure sensor is located a first predetermined distance from the fluid inlet and the second pressure sensor is located a second predetermined distance from the fluid outlet.

14. An auxiliary blood pumping system, comprising:

the catheter pump of any one of claims 1-13;

and the control device is electrically connected with a driving motor of the catheter pump and used for sending a control command to the driving motor based on the control parameter.

15. An auxiliary pumping system as defined in claim 14,

the catheter pump includes a first pressure sensor disposed upstream of the fluid inlet and a second pressure sensor disposed downstream of the fluid outlet;

the control device is further configured to:

acquiring signals of the first pressure sensor and the second pressure sensor;

and adjusting the control parameter output value of the driving motor based on the signals of the first pressure sensor and the second pressure sensor.

16. The system of claim 14, wherein the control device is further configured to:

acquiring a current signal of the driving motor;

and judging whether the catheter pump works abnormally according to the current signal.

17. A method of controlling a catheter pump, the method comprising:

acquiring a target pressure difference curve or a target effective pressure difference of the catheter pump;

acquiring a target rotating speed of a driving motor of the catheter pump;

and adjusting the control parameter output value of the driving motor according to the target pressure difference curve or the target effective pressure difference and the target rotating speed.

18. The method of claim 17, wherein said obtaining a target pressure differential curve or a target effective pressure differential for a catheter pump comprises:

obtaining a target perfusion flow rate of a patient;

determining an aorta target pressure curve according to the target perfusion flow;

acquiring an aorta actual pressure curve of a patient;

and determining a target pressure difference curve or a target effective pressure difference of the catheter pump according to the target pressure curve and the actual pressure curve.

19. The method of controlling a catheter pump of claim 17, wherein said obtaining a target rotational speed of a drive motor comprises:

acquiring actual perfusion flow and target perfusion flow of a patient;

determining auxiliary perfusion flow according to the actual perfusion flow and the target perfusion flow;

determining a target rotational speed of a drive motor based on the auxiliary irrigation flow and a target effective pressure differential of the catheter pump.

20. The method of controlling a catheter pump of claim 19, further comprising:

monitoring an actual perfusion flow of the patient;

and when the actual perfusion flow changes, updating the target rotating speed according to the changed actual perfusion flow, and further updating and adjusting the control parameter output value of the driving motor.

21. The method of controlling a catheter pump of claim 17, further comprising: acquiring a control parameter measured value of a driving motor;

the adjusting the control parameter output value of the driving motor according to the target pressure difference curve or the target effective pressure difference and the target rotating speed comprises:

determining a control parameter target value of the driving motor according to the target pressure difference curve or the target effective pressure difference and the target rotating speed;

and adjusting the control parameter output value of the driving motor according to the control parameter target value and the control parameter measured value.

22. The method of controlling a catheter pump of claim 17, further comprising: acquiring an actual pressure difference of the catheter pump;

determining a control parameter adjusting value of a driving motor according to the target pressure difference curve or the target effective pressure difference, the actual pressure difference and the target rotating speed;

and adjusting the control parameter output value of the driving motor according to the control parameter adjustment value.

23. The method of controlling a catheter pump of claim 22, further comprising: acquiring the actual rotating speed of a driving motor;

the determining of the control parameter adjustment value of the driving motor according to the target pressure difference curve or the target effective pressure difference, and the actual pressure difference and the target rotation speed comprises:

and determining a control parameter adjusting value of a driving motor according to the target pressure difference curve or the target effective pressure difference, the actual pressure difference, the target rotating speed and the actual rotating speed.

24. The method of controlling a catheter pump of claim 17, wherein the control parameters of the drive motor include a control current and a control voltage;

adjusting the current curve or the current value of the control current according to the target pressure difference curve or the target effective pressure difference; and

and adjusting the voltage value of the control voltage according to the target rotating speed.

25. A control apparatus for a catheter pump, comprising a processor for performing the method of any of claims 17-24.

26. A computer readable storage medium storing computer instructions which, when read by a processor, cause the processor to carry out a method of controlling a catheter pump according to any of claims 17 to 24.