CN113769260B

CN113769260B - Auxiliary blood pumping system

Info

Publication number: CN113769260B
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: 2024-09-27
Anticipated expiration: 2041-09-16
Also published as: WO2023040546A1; CN113769260A

Abstract

The embodiments of the present specification provide an auxiliary pumping system. The auxiliary pumping system is used for assisting pumping, 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 catheter 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 fixed with the stator side of the driving motor.

Description

Auxiliary blood pumping system

Technical Field

The present disclosure relates to the field of medical devices, and in particular, to an auxiliary blood pumping system.

Background

Heart failure patients or patients with cardiac insufficiency, the perfusion flow of their hearts is reduced relative to normal. Sustained low perfusion flow can lead to symptoms of dyspnea, dizziness, and palpitations in heart failure patients. A decrease in heart perfusion flow may also lead to hypoperfusion of multiple organs of the human body, thereby causing failure of the respective organs. For example, since a decrease in the perfusion flow of the heart may cause an insufficient perfusion pressure of the kidneys, a sustained low perfusion pressure may cause infarction of the renal cells due to ischemia, leading to renal failure. For heart failure patients, a catheter pump is usually used for auxiliary treatment, and the catheter pump is a pumping device used for being introduced into a main artery (or other vascular positions) and providing circulatory support for the heart, and can assist the heart to increase the perfusion pressure of the aorta, so that the perfusion flow of the heart is increased.

Disclosure of Invention

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

One aspect of the present specification 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; obtaining 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 catheter pump control device comprising a processor for performing a catheter pump control method according to any of the embodiments of the present description.

One aspect of the present description provides a computer-readable storage medium storing computer instructions that, when read by a processor, perform a method of controlling a catheter pump as described in any of the embodiments of the present description.

Drawings

The present specification will be further elucidated by way of example embodiments, which will be described in detail by means of the accompanying drawings. The embodiments are not limiting, in which like numerals represent like structures, wherein:

FIG. 1 is a schematic illustration of an exemplary catheter pump shown according to some embodiments of the present description;

FIG. 2 is an exploded schematic view of an exemplary catheter pump shown in accordance with some embodiments of the present disclosure;

FIG. 3 is a schematic diagram of an exemplary fairing shown in accordance with some embodiments of the present disclosure;

FIG. 4 is a schematic diagram of an exemplary fairing according to other embodiments of the present disclosure;

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

FIG. 6 is a schematic illustration of an exemplary catheter pump shown in accordance with some embodiments of the present disclosure, wherein a stent of the catheter pump is in a collapsed state;

FIG. 7 is a schematic diagram of an exemplary catheter pump according to other embodiments of the present disclosure;

FIG. 8A is a schematic diagram of an assembly of a stent and a housing of an exemplary catheter pump shown according to some embodiments of the present disclosure;

FIG. 8B is an exploded schematic view of a stent and housing of an exemplary catheter pump shown in accordance with some embodiments of the present disclosure;

FIG. 9 is a schematic diagram of an exemplary catheter pump shown according to further embodiments of the present disclosure;

FIG. 10 is a schematic diagram of an exemplary auxiliary pumping system shown in accordance with some embodiments of the present description;

FIG. 11 is a schematic illustration of an application scenario of an exemplary auxiliary pumping system shown in accordance with some embodiments of the present description;

FIG. 12 is a schematic illustration of an exemplary auxiliary 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 disclosure;

FIG. 14 is an exemplary flow chart of a target pressure differential determination method shown in accordance with some embodiments of the present disclosure;

FIG. 15 is an exemplary flowchart of a target speed determination method according to some embodiments of the present disclosure;

FIG. 16 is an exemplary flow chart of a control parameter adjustment method according to some embodiments of the present disclosure;

fig. 17 is an exemplary flowchart of a control parameter adjustment method according to still another embodiment of the present specification;

Fig. 18 is an exemplary flowchart of a control parameter adjustment method according to still another embodiment of the present disclosure;

fig. 19 is an exemplary structural schematic diagram of a control device according to 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 drive motor, 31 is a stator side, 32 is an output 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 seal, 52 is a second seal, 6 is a support, 61 is a support, 611 is a first end, 612 is a second end, 613 is a contact pin, 614 is a connection portion, 62 is a mesh support, 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 sheath, 222 is a first seal joint, 223 is a second seal joint, 224 is a third seal joint, 225 is a protection sheath, 230 is a catheter, and 240 is a vascular cable 250.

Detailed Description

In order to more clearly illustrate the technical solutions of the embodiments of the present specification, the drawings that are required to be used in the description of the embodiments will be briefly described below. It is apparent that the drawings in the following description are only some examples or embodiments of the present specification, and it is possible for those of ordinary skill in the art to apply the present specification to other similar situations according to the drawings without inventive effort. Unless otherwise apparent from the context of the language or otherwise specified, like reference numerals in the figures refer to like structures or operations.

It will be appreciated that "system," "apparatus," "unit" and/or "module" as used herein is one method for distinguishing between different components, elements, parts, portions or assemblies of different levels. However, if other words can achieve the same purpose, the words can be replaced by other expressions.

As used in this specification and the claims, the terms "a," "an," "the," and/or "the" are not specific to a singular, but may include a plurality, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that the steps and elements are explicitly identified, and they do not constitute an exclusive list, as other steps or elements may be included in a method or apparatus.

Although the specification makes various references to certain modules or units in a system according to embodiments of the specification, any number of different modules or units may be used and run on clients and/or servers. The modules are merely illustrative, and different aspects of the systems and methods may use different modules.

A flowchart is used in this specification to describe the operations performed by the system according to embodiments of the present specification. It should be appreciated that the preceding or following operations are not necessarily performed in order precisely. Rather, the steps may be processed in reverse order or simultaneously. Also, other operations may be added to or removed from these processes.

The catheter pump is a pumping device used for being guided into the aorta (or other vascular parts) of a heart failure patient and providing circulatory support for the heart of the heart failure patient, and can assist the heart to increase the perfusion pressure of the aorta so as to achieve the purpose of treating the heart failure. In some embodiments, the catheter pump may be implanted into the aorta (or other vascular site) of the human body via a delivery device such as a catheter, and the pressure differential across the catheter pump may be increased by rotation of itself, thereby increasing the perfusion pressure of the aorta and providing powered support for the failing heart.

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

Some embodiments of the present disclosure also provide a control method of a catheter pump, which may adjust a control parameter output value of a driving motor of the catheter pump according to an actual perfusion flow rate and a target perfusion flow rate of a patient, thereby improving reliability of the control parameter output value. In some embodiments, the control device may monitor the actual perfusion flow of the patient to update the control parameter output value of the drive motor, so that the control parameter output value may accurately 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 blood transfusion organ. Wherein the blood vessel may comprise an artery or a vein. Arteries may include, but are not limited to, the ascending aorta, the descending aorta, the abdominal aorta, the pulmonary aorta, etc. Veins may include, but are not limited to, the superior vena cava or inferior vena cava, and the like. The transfusion organ may include a heart. In some embodiments, the catheter pump may be implanted in the left ventricle or right ventricle. Wherein when the catheter pump is applied in the aorta connected to the left ventricle, the fluid inlet communicates with the left ventricle, the catheter pump is capable of improving the hemodynamic performance inside the heart, increasing cardiac output or being used to assist a high risk cardiac procedure; when the catheter pump is applied to the descending aorta communicated with the renal blood 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 internal parts of the superior vena cava, inferior vena cava or pulmonary artery, etc., the pressure in the blood vessel can be increased, and the blood flow perfusion can be improved. In some embodiments, the patient of the present description includes, but is not limited to, heart failure patients, renal failure patients, liver disease patients, and cerebral infarction patients, among others.

Fig. 1 is a schematic diagram of an exemplary catheter pump 100 shown in accordance with some embodiments of the present description. Fig. 2 is an exploded schematic view of an exemplary catheter pump 100 shown in accordance with some embodiments of the present description.

Referring to fig. 1, a catheter pump 100 may include a housing 1, an impeller 2, a driving motor 3, and a rectifying device 4. The impeller 2 is disposed in the housing 1, the driving motor 3 is used to drive 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 to adjust the flow pattern of the blood passing through the impeller 2, such as adjusting the turbulence pattern caused by the impeller 2, releasing the swirl pressure applied by the catheter pump 100 to the blood in the blood vessel 250, and/or reducing the impact force of the blood to 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 which fluid is allowed to flow, the housing 1 is provided with a fluid inlet 11 and a fluid outlet 12, the fluid entering the chamber from the fluid inlet 11 and exiting from the fluid outlet 12, wherein the fluid may be blood or the like within a blood vessel 250, the direction of flow of the blood may be seen in the direction indicated by arrow D in fig. 1. In some embodiments, the housing 1 may be a cylindrical housing, the inflow inlet 11 being provided at an end face of the cylindrical housing (e.g., an end face of one end), and the fluid outlet 12 being provided at a side face of the cylindrical housing (e.g., a side face of the other end). In some embodiments, the radial dimension (e.g., diameter) of the housing 1 may be in the range of 3 mm to 7mm (e.g., 3 mm, 4mm, 5 mm, 5.5 mm, 6mm, 7mm, etc.), which refers to the dimension perpendicular to the central axis a of the housing 1.

In some embodiments, impeller 2 is disposed within a chamber that allows fluid to flow therethrough for regulating the flow of catheter pump 100. In some embodiments, the impeller 2 comprises a spiral vane arranged around its rotation axis, and the impeller 2, when rotated, is capable of driving the velocity and the swirl pressure of the fluid in the housing 1 to increase, thereby outputting the fluid with higher flow velocity and pressure at the fluid outlet 12, so as to create a pressure difference between the fluid inlet 11 and the fluid outlet 12, thereby increasing 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 drive motor 3 may include a stator side 31 and an output shaft 32, the stator side 31 may be a stationary component of the drive motor 3, such as a stator core, a stator winding, a housing, etc., and the output shaft 32 may be a shaft rotatable relative 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 at an end of the housing 1 near the fluid outlet 12, and 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 the range of 3 mm to 7 mm (e.g., 3 mm, 4 mm, 5mm, 5.5 mm, 6mm, 7 mm, 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 resistance to fluid, facilitating better circulation of the fluid.

In some embodiments, the housing 1 and 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 metallic material, such as a cobalt chrome alloy, stainless steel, etc., which is strong and long-lived. In some embodiments, the housing 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, i.e. the rectifying device 4 is kept relatively stationary relative to the stator side 31, and the output rotating shaft 32 is connected with the impeller 2 through the rectifying device 4. In some embodiments, the fairing 4 may 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 shaft 32 to rotate, the output 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 swirl pressure, and after the fluid flows through the rectifying device 4, the rectifying device 4 can adjust the swirl flow form or the turbulent flow form of the fluid to a linear flow form along the blood vessel 250, thereby releasing the swirl pressure of the fluid and reducing the impact force of the fluid on the blood vessel 250.

In some embodiments, the fairing 4 is arranged at the fluid outlet 12 to facilitate fairing the fluid at the fluid outlet 12 and to slow down the fluid swirl pressure at the fluid outlet 12.

Fig. 3 is a schematic diagram of an exemplary fairing 4 shown in accordance with some embodiments of the present disclosure. Fig. 4 is a schematic diagram of an exemplary fairing 4 shown in accordance with further embodiments of the present disclosure.

Referring to fig. 3 and 4, the fairing 4 includes a core 41, and the core 41 is configured as a central symmetrical block, which refers to a block-like structure in which the core 41 can coincide with itself after being rotated by an arbitrary angle about a central symmetry axis C. In some embodiments, core 41 includes a small end 412 and a large end 413, with the cross-section from small end 412 to large end 413 increasing gradually. 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 truncated cone with the small end 412 at the top and the large end 413 at the bottom. In some embodiments, the cross-section from the small end 412 to the large end 413 may increase non-linearly, e.g. see fig. 4, the core 41 being configured as a hemisphere, the top of which is provided as the small end 412 and the bottom of which is provided as the 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 co-linear with the central symmetry axis C of the core 41. In some embodiments, referring to fig. 3, the cross-section of the mounting portion 43 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, and various fixing methods such as laser welding, adhesion, screw connection, etc. may be used, which is not limited in this specification.

In some embodiments, the core 41 is provided with a through hole 411 for avoiding the output shaft 32, the through hole 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 through hole 411 of the core 41 is larger than the diameter of the output shaft 32 of the drive motor 3.

In some embodiments, referring to fig. 3, the fairing 4 further comprises a plurality of blades 42, the plurality of blades 42 being spaced apart on the outer surface of the core 41 about the central axis of symmetry C of the core 41, the plurality of blades 42 being configured to release the swirling pressure exerted by the impeller 2 on the blood. When the fluid in the rotating fluid state or the turbulent fluid state impacts on the rectifying device 4, the blades 42 have a drainage effect on the fluid, so that the flow direction of the fluid is changed and adjusted, and the purpose of releasing the rotating pressure of the fluid is achieved.

In some embodiments, the number of blades 42 may be set as desired, for example, the number of blades 42 may be two, three, four, etc., which is not limited in this specification. In some embodiments, adjacent blades 42 may form equal angles with the central axis of symmetry C, i.e., the blades 42 may be disposed around the core 41 at equally spaced angles relative to the central axis of symmetry C. In some embodiments, adjacent blades 42 may form unequal angles with the central axis of symmetry C.

In some embodiments, the blades 42 may be arranged in a swirl-like manner on the outer surface of the core 41, and the rotation direction of the blades 42 may be opposite to the rotation direction of the vanes of the impeller 2, thereby better counteracting the swirling pressure of the fluid. In some embodiments, the blades 42 may be arranged in an arc shape at the outer surface of the core 41, and the blades 42 may have a large radius of curvature to improve the rectifying effect. In some embodiments, the vanes 42 may be disposed in a straight line on the outer surface of the core 41, i.e., the vanes 42 extend straight from the small end 412 of the core 41 to the large end 413 of the core 41, thereby regulating the flow through the fairing 4 to continue as much as possible in the direction of the central symmetry axis C of the fairing 4.

In some embodiments, in combination with fig. 1 and 3, the vanes 42 of the fairing 4 may avoid the fluid outlet 12 of the housing 1, avoiding localized shielding or plugging of the fluid outlet 12. In some embodiments, a plurality of fluid outlets 12 may be circumferentially arranged on the housing 1, the pitch 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, avoiding the fluid outlets 12.

In some embodiments, referring to fig. 4, the rectifying device 4 may not be provided with the blades 42, but directly use the surface curvature of the core 41 to buffer the impact force of the fluid, so as to perform the rectifying function.

In some embodiments, the fairing 4 may be injection molded from a plastic material to reduce the overall weight of the catheter pump 100. In some embodiments, the fairing 4 may be machined from a metallic material, such as a metallic material including, but not limited to, cobalt chrome, stainless steel, etc., which has a high strength and a long life of the fairing 4.

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, the seal being used to prevent blood from immersing into the driving motor 3 and causing failures such as rusting, leakage, short-circuiting, etc. of the driving motor 3. In some embodiments, the number of seals may be determined according to the structure and the sealing level of the drive motor 3.

In some embodiments, the seals include a first seal 51 and a second seal 52, the first seal 51 and the second seal 52 assisting with each other to increase the tightness of the drive motor 3.

In some embodiments, the first seal 51 is disposed between the rectifying device 4 and the output shaft 32 of the drive motor 3, avoiding blood from immersing into the drive motor 3 from the gap between the rectifying device 4 and the output shaft 32. In some embodiments, the first seal 51 is configured in an annular structure, the inside of the fairing 4 is formed with a receiving cavity, and the first seal 51 is disposed in the receiving cavity and is in sliding contact with the output shaft 32, such that the first seal 51 can block a gap between the output shaft 32 and the fairing 4. In some embodiments, the first seal member 51 may be made of polytetrafluoroethylene (Teflon or PTFE), so that the first seal member 51 has advantages of sealing property, high lubrication and non-tackiness, etc., and the high lubrication and non-tackiness of the first seal member 51 makes the friction force when the output shaft 32 is in sliding contact with the first seal member very small, and the loss of the output shaft 32 is very small.

In some embodiments, a second seal 52 is provided between the fairing 4 and the stator side 31 of the drive motor 3 to prevent blood from immersing into the drive motor 3 from the mounting gap of the fairing 4 and the stator side 31. In some embodiments, the second seal 52 is configured as a disk, and the disk-shaped second seal 52 includes a flat chassis that seals against an end surface of the stator side 31 of the drive motor 3 and a protrusion formed along an edge of the flat chassis that seals against a junction between the mounting portion 43 of the fairing 4 and the stator side 31, thereby improving the sealing of the junction. In some embodiments, the second seal 52 may be made of medical grade rubber, medical grade silicone, or polytetrafluoroethylene, as the description is not limited in this regard.

In some embodiments, medical silicone grease may be applied between the seal and the fairing 4, and between the seal and the drive motor 3, which acts as a lubricant and seal, for example, to reduce friction between the first seal 51 and the output shaft 32.

Fig. 6 is a schematic diagram of an exemplary catheter pump 100 according to some embodiments of the present disclosure, wherein the stent 6 of the catheter pump 100 is in a collapsed state. Fig. 7 is a schematic diagram of an exemplary catheter pump 100 according to other embodiments of the present disclosure. Fig. 8A is an assembled schematic view of the stent 6 and the housing 1 of the exemplary catheter pump 100 shown according to some embodiments of the present specification, and fig. 8B is an exploded schematic view of the stent 6 and the housing 1 of the exemplary catheter pump 100 shown according to some embodiments of the present specification. Fig. 9 is a schematic diagram of an exemplary catheter pump 100 shown in accordance with further embodiments of the present description.

Referring to fig. 1, 2, and 6 to 9, catheter pump 100 further includes a stent 6, stent 6 being used to secure housing 1 in vessel 250 or a transfusion organ, increasing the stability of catheter pump 100 relative to vessel 250 or a 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 stent 6 is less than or equal to the radial dimension of housing 1, such that catheter pump 100 can be received in catheter 230 and implanted through catheter 230 into vessel 250 or a transfusion organ; referring to fig. 1, 7 and 9, in the deployed state, at least a portion of the stent 6 has a radial dimension greater than the radial dimension of the housing 1, at which time at least a portion of the stent 6 can be used to abut against the inner wall of a blood vessel 250 (or transfusion organ) to anchor the catheter pump 100 within the blood vessel 250. 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 between 20mm and 30 mm (e.g., 20mm, 22 mm, 25 mm, 30 mm, etc.), which is not limited in this specification.

In some embodiments, the stent 6 may have a certain elasticity, enabling 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 the catheter 230). In some embodiments, the bracket 6 may be made of a memory alloy (such as nickel-titanium alloy) material, etc.

In some embodiments, referring to fig. 1, 6 and 7, the support 6 includes 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 remote from the housing 1 to form a free end, the free ends of the legs 61 being for abutment with the inner wall of the vessel 250 to secure the catheter pump 100 within the vessel 250. In the collapsed state, the legs 61 are arranged in a converging manner 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 in a radially outwardly sloping expansion from the first end 611 to the second end 612, wherein radially outwardly 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 disk, sphere, or ellipsoid shape, etc., which increases the contact area between the second end 612 of the leg 61 and the vessel wall, reduces localized stresses on the vessel wall, and avoids stabbing the vessel wall when the leg 61 is secured.

In some embodiments, referring to fig. 6, the second end 612 of the leg 61 is less distant from the central axis a of the housing 1 than the first end 611 of the leg 61, i.e., the leg 6 forms a smaller radial dimension end at the second end 612, in the collapsed state of the leg 6, which reduces the push resistance of the leg 6 in the catheter 230 or the vessel 250, thereby reducing the risk of jamming upon pushing.

In some embodiments, the legs 61 are disposed in a radially inward sloping gathering from the first end 611 to the second end 612 such that the second end 612 is less distant from the central axis a of the housing 1 than the first end 611 is from the central axis a of the housing 1, with radially inward referring to a direction proximal 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 bent section arranged such that: in the collapsed state, the second end 612 of the leg 61 is a smaller distance from the central axis a of the housing 1 than the first end 611 of the leg 61 is from the central axis a of the housing 1. Referring to fig. 1, 2 and 6, the bending section may be configured as an L-shaped bending section bent from the end of the second end 612 of the leg 61 toward the central axis a of the housing 1, the L-shaped bending section occupying a small space of the end of the second end 612 and having a strong stability. Referring to fig. 7, the bending section may be configured as a linear bending section bent from the end of the second end 612 of the leg 61 toward the central axis a of the housing 1, and the linear bending section is smoothly configured, which is advantageous in reducing the pushing resistance of the catheter pump 100 and is easy to process.

Referring to fig. 8A and 8B, in some embodiments, the bracket 6 may include a plurality of legs 61 and a connecting portion 614, and further details of the legs 61 may be seen in fig. 6 and 7 and related description, the connecting portion 614 being provided at a first end 611 of the legs 61 for connecting the legs 61 to the housing 1. In some embodiments, the connection portion 614 is configured in a cylindrical structure, and the first end 611 of the leg 61 is connected to one end of the connection portion 614, and the other end of the connection portion 614 is connected to the fluid inlet 11 of the housing 1. In some embodiments, the interior of the connection 614 forms a hollow channel 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 connection 614 may be coupled to the housing 1 by various means such as threaded connection, snap fit, adhesive, etc.

In some embodiments, the legs 61 may be made of nickel titanium alloy or the like to meet the elastic deformation capability requirements. In some embodiments, the connection portion 614 may be made of a metal material with blood compatibility, such as cobalt-chromium alloy, stainless steel, 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, catheter pump 100 further includes a head 13 and a support rod 14, one end of support rod 14 being fixed to housing 1 and the other end of support rod being fixed to head 13. In some embodiments, the support bar 14 is in the form of a linear rod with one end secured to the fluid inlet 11 of the housing 1 and the other end secured to the head 13 and providing support for the head 13. In some embodiments, the support pole 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 of the head to fluid formation.

In some embodiments, the bracket 6 includes a mesh bracket 62, the mesh bracket 62 being disposed between the head 13 and the housing 1, one end of the mesh bracket 62 being fixed to the head 13 and the other end being fixed to the housing 1. In some embodiments, the mesh support 62 may be a cage-like structure made of wire mesh that is positioned around the support pole 14 (e.g., around the exterior of the support pole 14). In some embodiments, the mesh scaffold 62 may have a self-expanding property, the mesh scaffold 62 being formed in a spindle shape in the expanded state, the spindle shape may be a centrally expanded, two-terminal collapsed shape, with a central portion of the mesh scaffold 62 adapted to abut against an inner wall of the vessel 250 to secure the catheter pump 100. By arranging the reticular stent 62, the contact area between the stent 6 and the inner wall of the blood vessel can be increased, and the damage to the inner wall of the blood vessel caused by the stent 6 can be effectively avoided.

In some embodiments, the surface of catheter pump 100 that can be in contact with blood is coated with a heparin coating to prevent the appearance of local thrombosis. For example, the casing 1, the driving motor 3, the rectifying device 4, the impeller 2, the bracket 6, and the like of the catheter pump 100 may be coated with heparin coating.

In some embodiments, catheter pump 100 further comprises a first pressure sensor 71, first pressure sensor 71 being disposed upstream of fluid inlet 11, wherein upstream is with respect to the flow direction D of the blood, and upstream of fluid inlet 11 may be a location in a direction opposite to flow direction D of the blood with 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, the detection accuracy of the first pressure sensor 71 is affected due to the possible occurrence of turbulent flow area at the fluid inlet 11, and the first pressure sensor 71 is separated from the fluid inlet 11 by a first preset distance range, so that the first pressure sensor 71 avoids the turbulent flow area, and the accuracy of the data acquired by the first pressure sensor 71 is improved. In some embodiments, the first pressure sensor 71 may be disposed at a distance ranging from 20mm to 60 mm (e.g., 20mm, 30 mm, 40mm, 45 mm, 60 mm, etc.) from the fluid inlet 11. 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 foot 61. For another example, referring to fig. 9, a first pressure sensor 71 may be provided at the head 13 of the catheter pump 100.

In some embodiments, catheter pump 100 further includes a second pressure sensor 72, second pressure sensor 72 being disposed downstream of fluid outlet 12, wherein downstream is with respect to the direction D of the flow of blood, and downstream of fluid outlet 12 may be a location in the same direction as the direction D of the flow of blood with 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 accuracy of the detection of the second pressure sensor 72 is affected by the possible occurrence of turbulent flow areas at the fluid outlet 12, and the second pressure sensor 72 is located at a second predetermined distance from the fluid outlet 12, such that the second pressure sensor 72 avoids turbulent flow areas, thereby improving the accuracy of the data collected by the second pressure sensor 72. In some embodiments, the second predetermined distance range may be greater than the first predetermined distance range because the range of turbulent flow areas through the fluid outlet 12 of the catheter pump 100 may be greater than the range of turbulent flow areas at the fluid inlet 11. For example, the second pressure sensor 72 may be positioned at a distance from the fluid inlet 11 in the 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 provided at an outer surface of the stator side 31 of the drive motor 3. In some embodiments, the second pressure sensor 72 may be provided at an outer surface of the cable 240 that provides the electrical signal to the drive motor 3.

In some embodiments, catheter pump 100 may include both first pressure sensor 71 and second pressure sensor 72. In some embodiments, catheter pump 100 may include only first pressure sensor 71. In some embodiments, catheter pump 100 may include only second pressure sensor 72. In some embodiments, the first pressure sensor 71 and/or the 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 working 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 diagram of an exemplary auxiliary pumping system according to some embodiments of the present description.

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

In some embodiments, catheter pump 100 is used for implantation into a human blood vessel 250 and/or a blood transfusion organ, increasing the pumping pressure of blood vessel 250 and/or blood transfusion organ, and specific details of catheter pump 100 may be found in the description above.

In some embodiments, the control device 210 is configured to be disposed outside of the human body and to 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 control parameters to achieve control of the catheter pump 100. In some embodiments, the control device 210 may send control instructions to the drive motor 3 based on manually set control parameters. In some embodiments, the control device 210 may automatically determine the control parameters and send the control instructions to the driving motor 3, so that interference of human factors can be avoided. In some embodiments, the control parameters may include, but are not limited to, voltage, current, drive speed, power, etc. of the drive motor 3, and the control device 210 is capable of sending control instructions to cause the drive motor 3 to operate in accordance with the control parameters. In some alternative embodiments, the control device 210 may be integrated within the catheter pump 100.

In some embodiments, catheter pump 100 includes a first pressure sensor 71 disposed upstream of fluid inlet 11 for detecting a pressure upstream of fluid inlet 11 and generating a corresponding signal, and a second pressure sensor 72 disposed downstream of fluid outlet 12 for detecting a pressure downstream of fluid outlet 12 and generating a corresponding signal. Details regarding the first pressure sensor 71 and the second pressure sensor 72 may be found in the above description, and will not be described again here.

In some embodiments, the control device 210 may be configured to acquire signals from the first pressure sensor 71 and the second pressure sensor 72. In some embodiments, the control device 210 has signal connections (e.g., electrical connections) to the first pressure sensor 71 and the second pressure sensor 72, the first pressure sensor 71 and the second pressure sensor 72 measuring the blood pressure and sending signals to the control device 210, which control device 210 obtains 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 adjust the control parameter output value of the driving motor 3 based on a control instruction sent to the driving motor 3 by the control parameter. 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, the control device 210 may include a storage medium 212 and a processor 214. For more details on the control device 210, see fig. 19 and its associated description.

Fig. 11 is a schematic illustration of an application scenario of an exemplary auxiliary pumping system according to some embodiments of the present description.

Referring to fig. 11, auxiliary pumping system 200 may include third pressure sensor 73 and fourth pressure sensor 74 for replacing the functions of first pressure sensor 71 and second pressure sensor 72, respectively. In some embodiments, after catheter pump 100 is implanted in a body vessel 250, third pressure sensor 73 may be implanted or pierced separately upstream of catheter pump 100 and spaced apart from catheter pump 100, and likewise fourth pressure sensor 74 may be implanted or pierced separately downstream of catheter pump 100 and spaced apart from catheter pump 100. The third pressure sensor 73 and the fourth pressure sensor 74 are separated 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, turbulent flow areas around the catheter pump 100 can be avoided more easily, and the detection accuracy is improved. In some embodiments, when catheter pump 100 is placed in the descending aortic position, third pressure sensor 73 may be positioned in the radial arterial position and fourth pressure sensor 74 may be positioned in the femoral arterial position. Additional details regarding auxiliary pumping system 200 may be found in fig. 10 and its associated description.

In some embodiments, a cable 240 is connected downstream of catheter pump 100, cable 240 being connected to control device 210 for providing electrical power and control signals to 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 configured 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 take a current parameter among control parameters as a control current for driving the motor 3.

In some embodiments, the control device 210 may be configured to determine whether the catheter pump 100 is malfunctioning based on the current signal. In some embodiments, the control device 210 may preset a safe current range value (or threshold value), and after acquiring a current signal of the driving motor 3, compare the current signal with the safe current range value (or threshold value): if the current signal is within the safe current range value (or less than the threshold value), the control device 210 generates a determination that the catheter pump 100 is functioning properly; if the current signal is outside the safe current range value (or greater than the threshold value), the control device 210 generates a determination result of an abnormal operation of the catheter pump 100. In some embodiments, the control device 210 may send out an alarm message to timely service or correct when it determines that the catheter pump 100 is malfunctioning.

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

In some embodiments, the auxiliary pumping system 200 may include a catheter (not shown in fig. 12) via which the catheter pump 100 and cable 240 are implanted into a blood vessel 250 of a human body. As shown in fig. 12, a portion of the cable 240 may enter the body with the catheter pump 100 and another portion may be located outside the body and coupled to the control device 210. In performing an implantation procedure, catheter pump 100 is delivered to a designated location via a catheter, and then the catheter is retracted so that catheter pump 100 extends from the catheter, and stent 6 on catheter pump 100 is then deployed to secure catheter pump 100 in the designated location. In some embodiments, to avoid bacterial contamination of the catheter and cable 240 during implantation procedures and retrieval, the auxiliary pumping system 200 further includes a sterility protection 220, the sterility protection 220 being capable of sealing the catheter and cable 240 in an extracorporeal portion in a sterile environment, ensuring cleanliness of the catheter and cable 240.

In some embodiments, the sterility protection 220 can include a sterility pouch 221, a protective sheath 225, and first, second, and third seal joints 222, 223, 224. The two ends of the sterile bagging 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 connected to each other. In some embodiments, the sterile sleeve 221 and the second and third sealing joints 223, 224 may be joined by gluing or pre-buried injection molding. In some embodiments, the first sealing joint 222 is maintained sealed to the cable 240 or conduit by a seal (e.g., a gasket). The third sealing joint 224 is maintained in sealing relation to the cable 240 or conduit by a seal (e.g., a gasket).

In some embodiments, the first sealing joint 222 is a male joint and the second sealing joint 223 is a female joint, the first sealing joint 222 and the second sealing joint 223 being configured to form a seal with one another (e.g., a snap fit, a threaded connection, etc.), the protective sheath 225 may be coupled to the sterile pouch 221 via the first sealing joint 222 and the second sealing joint 223 such that the catheter and the cable 240 of the extracorporeal section may be better encased by the protective sheath 225 and the sterile pouch 221. In some embodiments, the other end of the protective sheath 225 may be implanted in the human body to further ensure the tightness of the catheter and cable 240. In some embodiments, the other end of the protective sheath 225 may be tapered in cross-section toward the head end; therefore, when the other end is implanted into a human body, the implanted opening can be effectively blocked, so that blood outflow can be prevented.

Fig. 13 is an exemplary flow chart of a method of controlling a catheter pump according to some embodiments of the present disclosure.

In some embodiments, the catheter pump control method 1200 may be used to control a catheter pump (such as the catheter pump 100 of any of the embodiments described above). In some embodiments, the catheter pump control method 1200 may be performed by the control device 210 (e.g., the processor 214). Hereinafter, the catheter pump control method 1200 will be described by taking the catheter pump disposed in the aorta as an example. It is noted that the catheter pump control method 1200 is equally applicable to situations where the catheter pump is located elsewhere. As shown in fig. 13, the catheter pump control method 300 may include:

At step 1210, a target pressure differential curve or target effective pressure differential for catheter pump 100 is obtained.

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

In some embodiments, the target effective pressure differential may be an effective value of the pressure differential desired to be achieved between upstream and downstream of catheter pump 100. In some embodiments, the effective value of the pressure difference refers to an equivalent pressure value obtained by computationally transforming the varying target pressure difference curve. In some embodiments, the target effective pressure differential may be an average (e.g., a weighted average) of the pressure differences desired to be achieved between upstream and downstream of 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 be stored in the storage medium 212. In some embodiments, processor 214 may retrieve a corresponding target pressure differential curve or target effective pressure differential from storage medium 212 based on information entered by a user. 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 patient's physiological index (e.g., heart failure level, cardiac output, etc.).

In some embodiments, the processor 214 may determine a target pressure differential profile or a target effective pressure differential of the catheter pump 100 from the target perfusion flow of the patient and the aortic actual pressure profile. In some embodiments, the processor 214 may acquire a target perfusion flow of the patient and determine an aortic pressure curve from the target perfusion flow; further, the processor 214 may acquire an actual pressure profile of the patient's aorta and determine a target pressure differential profile or a target effective pressure differential of the catheter pump based on the target pressure profile and the actual pressure profile. For more details on the target pressure difference (e.g., target pressure difference curve or target effective pressure difference) determination method, see FIG. 14 and its associated description.

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

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

In step 1230, the output value of the control parameter of the driving motor 3 is adjusted according to the target pressure difference curve or the target effective pressure difference and the target rotation 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 intended to flow) through the drive motor 3. In some embodiments, the processor 214 may adjust the current profile or current value of the control current according to the target pressure differential profile or target effective pressure differential. In some embodiments, the processor 214 may adjust the voltage value of the control voltage based on the target rotational speed.

In some embodiments, the processor 214 may adjust the current profile of the control current according to the target pressure differential profile. In some embodiments, the target pressure differential curve may represent the time-dependent variation of the auxiliary pumping pressure that catheter pump 100 needs to provide to the patient's blood, which auxiliary pumping pressure may be achieved by driving of drive motor 3 of 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 at this time, by adjusting the control current of the driving motor, the torque of the motor output shaft 32 can be adjusted, so as to adjust the auxiliary pumping pressure provided by the catheter pump. Thus, the processor 214 can adjust the current profile of the control current according to the positive correlation of 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 profile. By adjusting the control current to match the target pressure difference curve, the catheter pump can be made to accurately match the change of the physiological index (such as cardiac output) of the patient and to accurately match the periodic change of the blood vessel pressure caused by the beating period of the heart, thereby improving the effect of the catheter pump 100 in assisting the pumping of blood.

In some embodiments, the 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 be referred 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 catheter pump 100 to the patient based on the target effective pressure differential is relatively equivalent to the auxiliary pumping pressure provided by catheter pump 100 to the patient based on the target pressure differential curve (e.g., both equivalent from the perspective of an auxiliary pump blood flow over a period of time (e.g., 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 needs and to enable the pressure differential between the upstream and downstream 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 pumping effect can be achieved through a constant current value, reducing the processing and control difficulty of the control device 210.

In some embodiments, the processor 214 may adjust the voltage value of the control voltage based on the target rotational speed. In some embodiments, the greater the control voltage of the drive motor 3, the greater the rotational speed of its output. Therefore, the processor 214 can bring the rotation speed of the drive motor 3 to 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, processor 214 may determine a control parameter target value for the drive motor based on the target pressure differential curve or target effective pressure differential, and the target rotational speed; further, the processor 214 may adjust the control parameter output value of the drive motor based on the control parameter target value and the measured value.

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 control parameter adjustment value for the drive motor based on the target pressure differential curve or the target effective pressure differential, as well as 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 the actual rotational speed of the drive motor; and further 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.

For more details on the control parameter adjustment method, see 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 of the present disclosure. In some embodiments, the target pressure differential determination method 1300 may be performed by the control device 210 (e.g., the processor 214). Processor 214 may determine a target pressure differential curve or target effective pressure differential for the catheter pump based on target pressure differential determination method 1300, thereby implementing step 1210. As shown in fig. 14, the target pressure difference determination method 1300 may include:

Step 1310, a target perfusion flow of a patient is acquired.

In some embodiments, the target perfusion flow may be an amount of blood expected to be achieved per unit time through a certain cross-section of the blood vessel 250. For example, the target perfusion flow may be the amount of blood expected to be achieved per minute for a certain cross-section of the heart's injection into the main artery.

In some embodiments, the target perfusion flow may be determined from a physiological index of the patient (e.g., heart failure level). For example, when the perfusion rate of a patient with mild heart failure reaches 3.5L/min with the assistance of the catheter pump 100, the physiological index thereof may be maintained within a normal range (e.g., the blood supply, oxygen supply, metabolic index, etc. of each organ are maintained within a normal range), and the processor 214 may determine the perfusion rate of 3.5L/min as the target perfusion rate of the patient. In some embodiments, the target perfusion flow may be determined from a normal person's standard perfusion flow, e.g., the normal person's standard perfusion flow may be 5L/min, and the control device 210 may determine the 5L/min perfusion flow as the target perfusion flow. In some embodiments, the target perfusion flow may correspond to a physiological index of the patient (e.g., heart failure level). For example, the storage medium 212 may have stored therein a correspondence between a heart failure level of the patient and a target perfusion rate, and the processor 214 may retrieve the corresponding target perfusion rate from the storage medium 212 based on the heart failure level of the patient (e.g., entered by a healthcare worker).

Step 1320, determining an aortic target pressure curve based on the target perfusion flow.

In some embodiments, the target pressure profile may be a profile of the desired blood pressure achieved in the patient's aorta over time. For example, for heart failure patients, the target pressure profile may be a pressure profile of the blood pressure that is desired to be achieved after the catheter pump 100 is used to assist in pumping blood. Specifically, the target pressure profile may be a pressure profile expected 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 profile for a normal person. On this basis, the processor 214 may modify (e.g., scale down) the normal person's standard pressure curve based on the difference or proportional relationship between the normal person's standard perfusion flow and the heart failure patient's target perfusion flow, thereby determining the aortic target pressure curve.

In some embodiments, processor 214 may pre-establish a perfusion flow versus aortic pressure curve based on experimental data. For example, the processor 214 may establish a perfusion flow versus aortic pressure curve from measured perfusion flow versus measured aortic pressure curves for a plurality of historic patients. On this basis, the processor 214 may invoke the corresponding aortic pressure curve as the aortic target pressure curve based on the target perfusion flow.

Step 1330, an aortic actual pressure curve of the patient is acquired.

In some embodiments, the aortic actual pressure profile may be a profile of the 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 standard pressure curve corrections of a normal person. In some embodiments, the processor 214 may modify the standard pressure curve based on deviations of the patient's physiological index (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 the normal person's standard blood pressure and adjust the standard pressure curve (e.g., scale-down) based on the proportional relationship to obtain the aortic actual pressure curve. By correcting the standard pressure curve of a normal person to obtain the actual pressure curve, a pressure sensor is not required to be arranged on the catheter pump 100 to detect the pressure of the blood vessel 250, so that 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, catheter pump 100 may include a first pressure sensor 71, first pressure sensor 71 disposed upstream of fluid inlet 11 of catheter pump 100 for detecting blood pressure upstream of fluid inlet 11 of catheter pump 100 (see fig. 6-9 and their associated description for further details regarding first pressure sensor 71). In some embodiments, auxiliary pumping system 200 may include a third pressure sensor 73; the third pressure sensor 73 may be separately implanted or pierced upstream of the catheter pump 100 and spaced apart 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 the pressure-time-varying signal acquired by the first pressure sensor 71 or the third pressure sensor 73 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 differential curve or a target effective pressure differential of the catheter pump based on the target pressure curve and the actual pressure curve.

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

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

Fig. 15 is an exemplary flowchart of a target rotational speed determination method according to some embodiments of the present description. In some embodiments, the target speed determination method 1400 may be performed by the control device 210 (e.g., the processor 214). Processor 214 may determine the target rotational speed of the drive motor based on the target rotational speed determination method, thereby implementing step 1220. As shown in fig. 15, the target rotation speed determination method 1400 may include:

Step 1410, an actual perfusion flow of the patient is acquired.

In some embodiments, the actual perfusion flow may be the actual blood volume flowing through a certain cross-section of the blood vessel 250 per unit time. For example, the actual perfusion flow may be the actual blood volume per minute injected into a cross-section of the main artery by the heart. 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 the actual perfusion flow of a normal person. For example, the actual perfusion flow of a normal person may be 5L/min, and the actual perfusion flow 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 imaging, or magnetic resonance imaging, and the processor 214 may obtain the actual perfusion flow of the patient detected by the various detection techniques.

Step 1420, a target perfusion flow of the patient is acquired.

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

In step 1430, an auxiliary perfusion flow is determined based on the actual perfusion flow and the target perfusion flow.

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

Step 1440, determining a target rotational speed of the drive motor based on the auxiliary perfusion flow and the target effective pressure differential of the catheter pump.

In some embodiments, processor 214 may determine the target rotational speed of drive motor 3 based on the auxiliary perfusion flow determined in step 1430 and the target effective pressure differential of 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 catheter pump:

(equation 1)

Where F _p is the flow rate of the catheter pump, Δp is the pressure difference of the catheter pump, ω is the rotational speed of the drive motor 3, and b ₀、b₁、b₂ is an empirical constant. From the above formula, it can be further deduced that the flow rate F _p of the catheter pump is regarded as constant (e.g., auxiliary-perfusion flow rate) and the pressure difference Δp of the catheter pump is regarded as constant (e.g., target effective pressure difference):

(equation 2)

That is to say,

(Equation 3)

Wherein, Is the auxiliary perfusion flow rate of the catheter pump,Is the target effective pressure differential of the catheter pump,Is the target rotational speed of the drive motor 3.

Processor 214 may based on equation 3, based on the auxiliary perfusion flowAnd target effective pressure differential of catheter pumpDetermining 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 is changed, 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 is gradually restored and improved (or combined with other therapeutic means) with the assistance of catheter pump 100, and the physiological indices (e.g., cardiac output) of the patient are correspondingly changed. In some embodiments, the processor 214 may monitor the actual perfusion flow of the patient, and when the actual perfusion flow changes, the processor 214 may re-execute steps 1410-1440 to update the target rotational speed based on the changed actual perfusion flow. The target rotating speed is dynamically updated by monitoring the actual perfusion flow of the patient, and then the control parameter output value of the driving motor 3 is updated, so that the auxiliary pumping action of the catheter pump 100 can be dynamically adjusted along with the actual physiological condition of the patient, the physiological requirement of the patient is met, and the rapid rehabilitation of the patient is facilitated. In some embodiments, the processor 214 may maintain the patient's target perfusion flow steady during monitoring of the patient's actual perfusion flow and dynamic updating of the target rotational speed, thereby facilitating patient-stabilized rehabilitation.

Fig. 16 is an exemplary flowchart of a control parameter adjustment method according to some embodiments of the present description. 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:

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

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

In some embodiments, the 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 between the effective pressure difference and the current value of the drive motor at a particular rotational speed (e.g., a target rotational speed) may be determined empirically in advance and stored in the storage medium 212. Processor 214 may retrieve a corresponding target current value from storage medium 212 based on the target rotational speed and the target effective pressure differential.

Step 1520, a measurement of a control parameter of the drive motor is obtained.

In some embodiments, the control parameter measurements of the drive motor 3 may include measured voltages and measured current values or measured current curves. 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.

Step 1530 adjusts the control parameter output value of the drive motor based on 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 current output curve). In some embodiments, the control parameter output value of the drive motor 3 may be adjusted by a PID (Proportion Integration Differentiation) control algorithm. Specifically, the control device 210 (e.g., the processor 214) may calculate an error between the control parameter measurement value and the control parameter target value, perform a proportional operation, an integral operation, and a differential operation on the error to obtain an updated control parameter value, control the driving motor using the updated control parameter value, and detect a 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 measurement value, continuously calculate an error between the updated control parameter measurement value and the control parameter target value, calculate the error by using a PID control algorithm, obtain an updated control parameter value, and control the driving motor 3. The control device 210 continuously repeats the above-described 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, errors caused by internal losses of the drive motor can be overcome, and the control accuracy of the control device 210 on the drive motor 3 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 current output curve) of the driving motor according to the target current curve or the target current value. The control logic is simpler and the control result is more accurate by adjusting the control voltage and then adjusting the control current.

Fig. 17 is an exemplary flowchart of a control parameter adjustment method according to still another embodiment of the present specification. In some embodiments, the control parameter adjustment method 1600 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 1600, thereby implementing step 1230. As shown in fig. 17, the control parameter adjustment method 1600 may include:

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

In some embodiments, catheter pump 100 includes a first pressure sensor 71 disposed upstream of fluid inlet 11 of catheter pump 100 for detecting blood pressure upstream of fluid inlet 11 of catheter pump 100 and a second pressure sensor 72 disposed downstream of fluid outlet 12 of catheter pump 100 for detecting blood pressure downstream of fluid outlet 12 of catheter pump 100 (see figures 6-9 and related description above for further details regarding first pressure sensor 71 and second pressure sensor 72). In some embodiments, the control device 210 may acquire 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, auxiliary pumping system 200 may include third pressure sensor 73 and fourth pressure sensor 74. In some embodiments, third pressure sensor 73 may be implanted or pierced separately upstream of catheter pump 100 and spaced apart from catheter pump 100, and fourth pressure sensor 74 may be implanted or pierced separately downstream of catheter pump 100 and spaced apart from catheter pump 100. (see FIG. 11 and its associated description for more details regarding the third pressure sensor 73 and the fourth pressure sensor 74). In some embodiments, the control device 210 may acquire the 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 catheter pump 100 may include an actual pressure differential curve and/or an actual effective pressure differential of the catheter pump.

Step 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 "0.1A increase". For another example, the adjustment current profile may be a profile of the current value required to be adjusted at various points in time versus time. In some embodiments, the processor 214 may determine the 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, the 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 and the adjustment current curve at a particular rotational speed (e.g., target rotational speed) may be determined empirically or empirically in advance and stored in the storage medium 212. Processor 214 may retrieve a corresponding adjusted current profile from storage medium 212 based on 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 may be determined experimentally or empirically in advance at a particular rotational speed (e.g., target rotational speed), and stored in the storage medium 212. Processor 214 may retrieve a corresponding adjusted current value from storage medium 212 based on the difference between the target effective pressure differential and the actual pressure differential.

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 driving motor 3 according to the control parameter adjustment value. In some embodiments, the control device 210 may adjust the input current to the drive motor 3 according to an adjustment current profile or adjustment current value to match the actual pressure differential of the catheter pump 100 to a target pressure differential profile or target effective pressure differential. At this time, the first pressure sensor 71 and the second pressure sensor 72 may periodically (e.g., every 0.05 seconds, 0.1 seconds, 0.5 seconds, 3 seconds, etc.) detect an actual pressure difference of the catheter pump 100 and feed back 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 continuously repeats the above process to more precisely control the actual pressure difference of the catheter pump 100 to approach or reach the target pressure difference curve or the target effective pressure difference, thereby achieving the auxiliary pumping requirement of the catheter pump and improving the treatment effect of the patient.

Fig. 18 is an exemplary flowchart of a control parameter adjustment method according to still another embodiment of the present specification. 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, thereby implementing step 1230. As shown in fig. 18, the control parameter adjustment method 1700 may include:

Step 1710, the actual pressure differential of catheter pump 100 is obtained.

In some embodiments, the actual pressure differential of catheter pump 100 may include an actual pressure differential curve and/or an actual effective pressure differential of the catheter pump. In some embodiments, the actual pressure differential of catheter pump 100 is obtained in a manner similar to that of step 1610, and specific details may be found in step 1610 and the description thereof.

At step 1720, an actual rotational speed of the drive motor is obtained.

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 counter electromotive force of the driving motor 3 is in a proportional relationship with the actual rotation speed, and the control device 210 may calculate the actual rotation speed based on the counter 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 the rotational speed of the impeller 2, since the output shaft 32 of the drive motor 3 and the impeller 2 are rotated synchronously. The control device 210 may obtain the actual rotational speed of the drive motor 3 based on the signals of the sensors. In some embodiments, the sensors measuring the drive motor 3 may include, but are not limited to, photoelectric sensors, rotary transformers, hall sensors, and the like.

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, and the actual pressure difference, the target rotational speed, and the actual rotational speed.

In some embodiments, the control parameter adjustment value of the drive motor 3 may include an adjustment voltage value, an adjustment current profile, or an adjustment current value. For example, the adjustment voltage value may be "0.1V increase". In some embodiments, the 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, the 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, the 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 adjusted voltage value may be determined experimentally or empirically in advance and stored in the storage medium 212. Processor 214 may retrieve a corresponding adjusted voltage value from 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 and the adjustment current curve at a particular rotational speed (e.g., the target rotational speed or the actual rotational speed) may be determined experimentally or empirically in advance and stored in the storage medium 212. Processor 214 may retrieve a corresponding adjusted current profile from storage medium 212 based on the target or actual rotational 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 may be determined experimentally or empirically in advance at a specific rotational speed (e.g., a target rotational speed or an actual rotational speed), and stored in the storage medium 212. Processor 214 may retrieve a corresponding adjusted current value from storage medium 212 based on the target rotational speed or the actual rotational speed, and the difference between the target effective pressure differential and the actual pressure differential.

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

In some embodiments, the adjustment of the control parameter output value of the driving motor according to the control parameter adjustment value is implemented in a similar manner to step 1630, and specific details can be found in step 1630 and related descriptions.

In some embodiments, the control device 210 may periodically (e.g., every 0.05 seconds, 0.1 seconds, 0.5 seconds, 3 seconds, etc.) obtain the actual rotational speed of the drive motor and determine the adjustment voltage value based again on the difference between the target rotational speed and the actual rotational speed. The control device 210 may continuously repeat the above-described 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) so that the actual rotational speed of the drive motor reaches the target rotational speed. Control device 210 may then cease adjusting the control voltage and adjust the control current (e.g., iteratively performing steps 1710, 1730, and 1740) such that the actual pressure differential across the catheter pump approximates or reaches the target pressure differential curve or target effective pressure differential. The control logic is simpler and the control result is more accurate by adjusting the control voltage and then adjusting the control current. 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 synchronize or alternatively adjust the control voltage and the control current.

Fig. 19 is an exemplary structural schematic diagram of a control device according to some embodiments of the present description. As shown in fig. 19, the catheter pump control device 210 may include a storage medium 212, a processor 214, and a communication bus. The processor 214 and the storage medium 212 may implement a communication process through a communication bus. The processor 214 may be used to perform the control method of the catheter pump provided by any of the above embodiments of the present application.

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 operations or portions of information processing operations.

In some embodiments, the 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 a computer) may read to perform the catheter pump control method provided by any of the embodiments of the present specification. In some embodiments, the storage device may include mass memory, removable memory, 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.

Possible benefits of embodiments of the present description include, but are not limited to: (1) The catheter pump comprises a rectifying device, wherein the rectifying device can be used for releasing the rotary pressure applied by the catheter pump to blood in a blood vessel, so that the impact force of the blood to the blood vessel can be reduced, and the stability of the catheter pump can be maintained; (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 the scheme of setting the control parameters according to the experience of doctors, the auxiliary blood pumping system has higher accuracy, can reduce errors in the treatment process, and is beneficial to the rapid recovery of patients; (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, so that the reliability of the control parameter output value is improved; (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 rapid rehabilitation of the patient is facilitated. It should be noted that, the advantages that may be generated by different embodiments may be different, and in different embodiments, the advantages that may be generated may be any one or a combination of several of the above, or any other possible advantages that may be obtained.

While the basic concepts have been described above, it will be apparent to those skilled in the art that the foregoing detailed disclosure is by way of example only and is not intended to be limiting. Although not explicitly described herein, various modifications, improvements, and adaptations to the present disclosure may occur to one skilled in the art. Such modifications, improvements, and modifications are intended to be suggested within this specification, and therefore, such modifications, improvements, and modifications are intended to be included within the spirit and scope of the exemplary embodiments of the present invention.

Meanwhile, the specification uses specific words to describe the embodiments of the specification. Reference to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic is associated with at least one embodiment of the present description. Thus, it should be emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various positions in this specification are not necessarily referring to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of the present description may be combined as suitable.

Furthermore, those skilled in the art will appreciate that the various aspects of the specification can be illustrated and described in terms of several patentable categories or circumstances, including any novel and useful procedures, machines, products, or materials, or any novel and useful modifications thereof. Accordingly, aspects of the present 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 a "data block," module, "" engine, "" unit, "" component, "or" system. Furthermore, aspects of the specification may take the form of a computer product, comprising computer-readable program code, embodied in one or more computer-readable media.

The computer storage medium may contain a propagated data signal with the computer program code embodied therein, for example, on a baseband or as part of a carrier wave. The propagated signal may take on a variety of forms, including electro-magnetic, optical, etc., or any suitable combination thereof. 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 through any suitable medium, including radio, cable, fiber optic cable, RF, or the like, or a combination of any of the foregoing.

Computer program code necessary for operation of portions of the present description 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 language, visualBasic, fortran2003, perl, COBOL2002, PHP, ABAP, dynamic programming languages such as Python, ruby and Groovy, or other programming languages and the like. The program code may execute entirely on the user's computer or 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 form of network, 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 the use of services such as software as a service (SaaS) in a cloud computing environment.

Furthermore, the order in which the elements and sequences are processed, the use of numerical letters, or other designations in the description are not intended to limit the order in which the processes and methods of the description are performed unless explicitly recited in the claims. While certain presently useful inventive embodiments have been discussed in the foregoing disclosure, by way of various examples, it is to be understood that such details are merely illustrative 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 included within the spirit and scope of the embodiments of the present disclosure. For example, while the system components described above may be implemented by hardware devices, they may also be implemented solely by software solutions, such as installing the described system on an existing processing device or mobile device.

Likewise, it should be noted that in order to simplify the presentation disclosed in this specification and thereby aid in understanding one or more inventive embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof. This method of disclosure does not imply that the subject matter of the present description requires more features than are set forth in the claims. Indeed, less than all of the features of a single embodiment disclosed above.

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

Claims

1. An auxiliary pumping system comprising a catheter pump and a control device, the control device comprising a processor configured to perform a method comprising:

Acquiring a target pressure differential curve of the catheter pump, comprising: obtaining a target perfusion flow of a patient; determining an aortic target pressure curve according to the target perfusion flow; acquiring an aortic actual pressure curve of a patient; determining a target pressure difference curve of the catheter pump according to the target pressure curve and the actual pressure curve;

Obtaining a target rotational speed of a drive motor of the catheter pump, comprising: acquiring an actual perfusion flow and a target perfusion flow of a patient; determining an 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 perfusion flow and a target effective pressure differential of the catheter pump;

obtaining a control parameter measured value of a driving motor; the control parameters of the driving motor comprise control current and control voltage;

According to the target pressure difference curve and the target rotating speed, adjusting the control parameter output value of the driving motor, including: determining a control parameter target value of the driving motor according to the target pressure difference curve and the target rotating speed; adjusting a control parameter output value of the driving motor according to the control parameter target value and the control parameter measurement value; or adjusting a current curve or a current value of the control current according to the target pressure difference curve; and adjusting the voltage value of the control voltage according to the target rotating speed;

Monitoring an actual perfusion flow of the patient;

when the actual perfusion flow changes, the target rotating speed is updated according to the changed actual perfusion flow, and then the control parameter output value of the driving motor is updated and adjusted.

2. The auxiliary pumping system of claim 1, wherein the control device further comprises: acquiring the actual pressure difference of the catheter pump;

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

Determining a control parameter adjustment 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.

3. The auxiliary pumping system of claim 2, wherein the control device further comprises: acquiring the actual rotating speed of a driving motor;

The 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 comprises:

and 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.

4. The auxiliary pumping system of claim 1, wherein the catheter pump 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 catheter 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.

5. The auxiliary pumping system of claim 4, wherein the rectifying device comprises a core configured as a centrally symmetrical block, the core comprising 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 proximate the impeller and the large end being disposed proximate the drive motor, the core being provided with a through hole for avoidance of the output shaft.

6. The auxiliary pumping system of claim 5, wherein the fairing further comprises a plurality of vanes spaced about a central axis of the core at an outer surface of the core, the plurality of vanes configured to release the swirling pressure exerted by the impeller on the blood.

7. The auxiliary pumping system of claim 4, wherein the rectifying device is disposed at the fluid outlet.

8. The auxiliary pumping system of claim 4, wherein a first seal and a second seal are disposed between the fairing and the drive motor, the fairing having a receiving chamber formed therein, the first seal disposed in the receiving chamber and in sliding contact with the output shaft, the second seal disposed between the fairing and the stator side.

9. The auxiliary pumping system of claim 4, wherein the catheter pump further comprises a stent for securing the housing in a blood vessel or 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.

10. The auxiliary pumping system of claim 9, wherein the support includes a plurality of legs, the legs being rod-shaped having a first end and a second end, the first end being fixed relative to the fluid inlet, the second end being remote from the housing to form a free end, the second end being less than the first end from the central axis of the housing in the collapsed state.

11. The auxiliary pumping system of claim 10, wherein an end of the second end has a bend configured such that: in the collapsed state, the second end is less from the central axis of the housing than the first end.

12. The auxiliary pumping system of claim 10, wherein the second end is provided with a contact foot configured as a disk, sphere, or ellipsoid.

13. The auxiliary pumping system of claim 10, wherein the bracket further comprises a connection portion configured as a cylindrical structure having a hollow passage, one end of the connection portion being connected to the first end of the leg, the other end of the connection portion being connected to the fluid inlet of the housing.

14. The auxiliary pumping system of claim 9, wherein the stent comprises a mesh stent, the catheter pump further comprising a head and a support rod, one end of the support rod being fixed to the housing and the other end being fixed to the head, the mesh stent being disposed between the head and the housing, one end of the mesh stent being fixed to the head and the other end being fixed to the housing, the mesh stent being formed in a spindle shape in a deployed state.

15. The auxiliary pumping system of claim 4, wherein the catheter pump further comprises a first pressure sensor disposed upstream of the fluid inlet and a second pressure sensor disposed downstream of the fluid outlet.

16. The auxiliary pumping system of claim 15, wherein the first pressure sensor is a first predetermined distance range from the fluid inlet and the second pressure sensor is a second predetermined distance range from the fluid outlet.

17. The auxiliary pumping system of claim 15, wherein the control device is electrically connected to a drive motor of the catheter pump, the control device configured to send control instructions to the drive motor based on control parameters.

18. The auxiliary pumping system of claim 15, wherein 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.

19. The auxiliary pumping system of claim 4, wherein the control device is further configured to:

Acquiring a current signal of the driving motor;

judging whether the catheter pump works abnormally or not according to the current signal.

20. A computer readable storage medium storing computer instructions which, when read by a processor, assist the pumping system control processor of any of claims 1-19.