WO2023226779A1

WO2023226779A1 - Catheter interventional heart pump

Info

Publication number: WO2023226779A1
Application number: PCT/CN2023/093576
Authority: WO
Inventors: 柯浩; 闫小珅
Original assignee: 苏州心岭迈德医疗科技有限公司
Priority date: 2022-05-24
Filing date: 2023-05-11
Publication date: 2023-11-30
Also published as: CN114984444A

Abstract

A catheter interventional heart pump (10) comprising a drainage tube (100), an impeller (200), a driving motor (300), and a catheter (400). The front end of the drainage tube (100) is provided with a fluid inlet (110), and the rear end of the drainage tube (100) is provided with a fluid outlet (120). At least one section of the drainage tube (100) comprises a spring tube (130), and the spring tube (130) has a curved shape when in a natural state. The impeller (200) is arranged within the drainage tube (100). The driving motor (300) is used for driving the impeller (200) to rotate. The driving motor (300) comprises a stator side and an output rotating shaft (320). The output rotating shaft (320) is fixedly connected to the impeller (200). The front end of the stator side is fixedly connected to the rear end of the drainage tube (100), and the rear end of the stator side is fixedly connected to the front end of the catheter (400).

Description

Catheter interventional heart pump

cross reference

This application claims priority from Chinese patent application 202210569945.X filed on May 24, 2022, the entire content of which is incorporated herein by reference.

Technical field

This specification relates to the field of medical devices, and in particular to a catheter interventional heart pump.

Background technique

In high-risk surgeries such as high-risk percutaneous coronary intervention (PCI), interventional devices (such as coronary balloons, stents, etc.) may aggravate the degree of myocardial ischemia and affect the pumping function of the ventricle, causing the patient's Insufficient cardiac output, in turn, leads to insufficient oxygen-rich blood perfusion in the coronary arteries, further aggravating myocardial ischemia, making the operation more difficult, and even leading to cardiac shock and death of the patient during the operation. Catheter interventional heart pumps are usually used for hemodynamic maintenance, which can reduce the load on the ventricles, increase the blood input of the coronary arteries, thereby improving the myocardial ischemia state, allowing patients to obtain more complete revascularization during PCI surgery. and more thorough treatment.

Contents of the invention

One embodiment of the present specification provides a catheter interventional heart pump, which includes a drainage tube, an impeller, a driving motor and a catheter; the drainage tube is provided with a fluid inlet at its front end, and a fluid outlet is provided at its rear end. At least one section of the spring tube includes a spring tube, which is in a curved shape in a natural state; the impeller is arranged in the drainage tube, and the drive motor is used to drive the impeller to rotate, and the drive motor includes a stator side and an output Rotating shaft, the output rotating shaft is fixedly connected to the impeller, the front end on the stator side is fixedly connected to the rear end of the drainage tube, and the rear end on the stator side is fixedly connected to the front end of the conduit.

In some embodiments, the front end of the drainage tube is connected to a pigtail catheter, the front end of the pigtail catheter is made of flexible material, and the front end of the pigtail catheter is curled in a natural state.

In some embodiments, the drainage tube is provided with a development ring, and the development ring is disposed at a curved portion of the drainage tube.

In some embodiments, the catheter interventional heart pump further includes a reducer tube, a suture pad and a sterile protective bag; the reducer tube, the suture pad and the sterile protective bag are connected in sequence and set on the Outside the conduit, the diameter of the reducing tube gradually increases from the front end of the reducing tube to the rear end of the reducing tube.

In some embodiments, the taper of the reducing tube is 5° to 30°.

In some embodiments, adjusting nuts are provided at both ends of the sterile protective bag, and the adjusting nuts can lock the two ends of the sterile protective bag with the catheter respectively.

In some embodiments, the catheter interventional heart pump further includes a controller configured to control the drive motor to drive the impeller to rotate.

In some embodiments, the catheter interventional heart pump further includes a first pressure sensor and/or a second pressure sensor; the first pressure sensor is disposed at the front end of the drainage tube; the second pressure sensor is disposed at the The rear end of the drainage tube.

In some embodiments, the first pressure sensor is positioned closer to the heart pump relative to the fluid inlet. Front end; the second pressure sensor is disposed closer to the front end of the heart pump relative to the fluid outlet.

In some embodiments, the controller is configured to determine the position of the drainage tube in the body according to the first pressure signal of the first pressure sensor and/or the second pressure signal of the second pressure sensor.

In some embodiments, the controller is configured to: determine a first position of the drainage tube according to the first pressure signal; determine a second position of the drainage tube according to the second pressure signal; The first position and the second position determine the position of the drainage tube within the body.

In some embodiments, the catheter interventional heart pump further includes a rectifying device, the rectifying device is sleeved on the output shaft of the driving motor through a bearing, and the rectifying device is in contact with the stator of the driving motor. Side fixed connection.

In some embodiments, the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device capable of applying positive pressure to the gap between the rectifying device and the drive motor through the catheter. Instill sealing fluid.

In some embodiments, the sealing liquid passes through the inside of the driving motor; the surface of the driving motor in contact with the sealing liquid is provided with a parylene coating.

Description of the drawings

This specification is further explained by way of example embodiments, which are described in detail by means of the accompanying drawings. These embodiments are not limiting. In these embodiments, the same numbers represent the same structures, where:

Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification;

Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification;

Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification;

Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification;

Figure 5 is a partial cross-sectional view of a catheter-interposed heart pump according to some embodiments of the present specification;

Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of this specification;

Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification;

Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification;

Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification;

Figure 10 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification;

Figure 11 is a schematic diagram of the overall structure of a catheter-intervened heart pump according to some embodiments of this specification;

Figure 12 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification;

Figure 13 is an exemplary structural schematic diagram of a controller according to some embodiments of this specification.

Among them, the reference numbers are: 10. Catheter interventional heart pump; 100. Drainage tube; 110. Fluid inlet; 120. Fluid outlet; 130. Spring tube; 140. Development ring; 150. Inlet halter; 160. Outlet halter; 200 , impeller; 300, drive motor; 310, rectifier; 311, core; 312, via hole; 313, small end; 314, big end; 315, blade; 316, mounting part; C, central symmetry axis; 320, Output shaft; 330, first seal; 340, second seal; 350, bearing; 360, sealing fluid; 400, conduit; 500, pigtail conduit; 510, first straight section; 520, curved section; 530, third Two straight sections; 600, reducer; 700, suture pad; 800, sterile protective bag; 810, adjusting nut; 900, controller; 910, first pressure sensor; 920, second pressure sensor; 930, storage Media; 940, processor.

Detailed ways

In order to explain the technical solutions of the embodiments of this specification more clearly, the accompanying drawings needed to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some examples or embodiments of this specification. For those of ordinary skill in the art, without exerting any creative efforts, this specification can also be applied to other applications based on these drawings. Other similar scenarios. Unless obvious from the locale or otherwise stated, the same reference numbers in the figures represent the same structure or operation.

As shown in this specification and claims, words such as "a", "an", "an" and/or "the" do not specifically refer to the singular and may include the plural unless the context clearly indicates an exception. Generally speaking, the terms "comprising" and "comprising" only imply the inclusion of clearly identified steps and elements, and these steps and elements do not constitute an exclusive list. The method or apparatus may also include other steps or elements.

The catheter-intervention heart pump in the embodiment of this specification may be a pumping device introduced into a heart failure patient and maintaining blood power in the heart. Catheter-involved heart pumps can be used for revascularization in cardiogenic shock due to various causes. Cardiogenic shock refers to heart pumping dysfunction, which can lead to extremely critical situations such as organ failure due to low perfusion pressure in various organs. In the application scenarios of some embodiments, the catheter-involved heart pump can be punctured into the aorta through the femoral artery or axillary artery, and then retrograde along the aorta, through the aortic arch, through the aortic valve and into the left ventricle. After accurate positioning, the catheter can be started to intervene in the heart. The pump can pump the oxygen-rich blood from the left ventricle to the ascending aorta, thereby stabilizing the patient's hemodynamics in the short term, reducing the load on the ventricle to restore myocardial and ventricular functions, and increasing the arterial blood perfusion of various organs to avoid various organ factors. Insufficient blood supply may lead to functional abnormalities or even irreversible damage. In addition, the catheter-intervention heart pump in the embodiments of this specification can also be used in other organs or blood vessels, such as the right ventricle, renal artery, cerebral blood vessels, etc. This specification does not limit this.

Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification. Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of the present specification.

As shown in FIGS. 1 and 2 , embodiments of this specification provide a catheter-intervention heart pump 10 . The catheter-intervention heart pump 10 includes a drainage tube 100 , an impeller 200 , a driving motor 300 and a catheter 400 .

In some embodiments, the drainage tube 100 can be a tube that guides the blood flow path. The drainage tube 100 is provided with a fluid inlet 110 at the front end, and the fluid outlet 120 is provided at the rear end of the drainage tube 100. Blood flows into the drainage tube 100 from the fluid inlet 110, from Fluid outlet 120 exits drain tube 100 . The front end of the drainage tube 100 refers to the end that enters the human body first during the operation, and the rear end of the drainage tube 100 refers to the end that enters the human body later during the operation. In some embodiments, the diameter of the drainage tube 100 may be in the range of 4 mm to 7 mm (such as 4 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, etc.).

In some embodiments, an inlet trap 150 is provided at the fluid inlet 110. The inlet trap 150 is in the shape of a grid, which can prevent heart tissue (such as mitral valve chordae tendineae) from being sucked into the drainage tube 100, and prevent the ventricular wall from being blocked due to negative pressure. Blocking the blood flow inlet causes the drive motor 300 to be overloaded. In some embodiments, the inlet trap 150 may be made of metal material or polymer material.

In some embodiments, an outlet trap 160 is provided at the fluid outlet 120 . At least part of the outlet trap 160 is in the shape of a grid, which can adjust the direction in which blood flows out of the fluid outlet 120 . In some embodiments, the outlet trap 160 can be integrally formed with the drainage tube 100 , that is, multiple cutouts are made on the side wall of the rear end of the drainage tube 100 to form the outlet trap 160 . In some embodiments, the outlet trap 160 can be a component independent of the drainage tube 100 and is fixed to the rear end of the drainage tube 100 by snapping, welding, bonding, or other means. In some embodiments , the outlet trap 160 can be made of metal material or polymer material.

In some embodiments, at least one section of the drainage tube 100 includes a spring tube 130. The spring tube 130 is in a curved shape in a natural state. The spring tube 130 will elastically deform under the action of an external force. After the external force disappears, the elastic restoring force will return to its natural state. In some embodiments, the drainage tube 100 may entirely include a spring tube 130, and the inner and/or outer walls of the spring tube 130 may be provided with a polymer material layer. In some embodiments, portions of drainage tube 100 include spring tube 130 . For example, a certain middle section of the drainage tube 100 includes a spring tube 130 , and the spring tube 130 constitutes a bent portion of the drainage tube 100 . In some embodiments, the drainage tube 100 may also include but is not limited to polymer braided tubes, hypotubes, etc.; the scaffold material of the drainage tube 100 may be nickel-titanium alloy.

In some embodiments, the impeller 200 of the catheter-involved heart pump 10 is disposed in the drainage tube 100 for regulating the flow rate of the catheter-involved heart pump 10 . In some embodiments, the impeller 200 includes spiral blades arranged around its rotation axis. When the impeller 200 rotates, the spiral blades can drive the fluid in the draft tube 100 to increase in speed and gyration pressure, thereby increasing the flow rate of the fluid in the draft tube 100 . The fluid outlet 120 outputs fluid with a higher flow rate and pressure to form a pressure difference between the fluid inlet 110 and the fluid outlet 120, thereby increasing the perfusion flow of the heart. In some embodiments, the impeller 200 may be made of metal materials (such as stainless steel, titanium alloy, cobalt-chromium alloy, etc.) or polymer materials (such as polyetheretherketone PEEK). In some embodiments, the impeller 200 can be manufactured by metal machining or polymer material injection molding.

In some embodiments, the driving motor 300 is used to drive the impeller 200 to rotate. The drive motor 300 includes a stator side and an output shaft 320. The stator side may be a stationary component of the drive motor 300, such as a stator core, a stator winding, a frame, etc., and the output shaft 320 may be a shaft that can rotate relative to the stator side.

In some embodiments, the output shaft 320 is fixedly connected to the impeller 200 , the front end on the stator side is fixedly connected to the rear end of the drainage tube 100 , and the rear end on the stator side is fixedly connected to the front end of the conduit 400 . Among them, the front end in the embodiment of this specification refers to the end that enters the human body first during the operation, and the rear end refers to the end that enters the human body later during the operation. When the driving motor 300 drives the output shaft 320 to rotate, the output shaft 320 drives the impeller 200 to rotate, causing the fluid in the drainage tube 100 to rotate with the impeller 200 to generate a gyrating pressure, so that the blood perfusion pressure at the fluid outlet 120 is relative to the pressure at the fluid inlet 110 Increased blood perfusion pressure.

As shown in FIG. 2 , in some embodiments, the catheter-involved heart pump 10 may further include a rectifying device 310 , which is disposed at the fluid outlet 120 for adjusting the fluid pattern at the fluid outlet 120 . In some embodiments, the rectifier device 310 is sleeved outside the output shaft 320 of the drive motor 300 and is fixedly connected to the stator side of the drive motor 300 , that is, the rectifier device 310 remains relatively stationary relative to the stator side, and the output shaft 320 passes through the rectifier. Device 310 is connected to impeller 200 . In some embodiments, the rectifying device 310 can buffer the impact force of the fluid and guide the direction of fluid flow. After the fluid in the drainage tube 100 flows through the rectifying device 310, the rectifying device 310 can adjust the rotational flow pattern or the turbulent flow pattern of the fluid. It is a flow pattern along the axis of the blood vessel, thereby releasing the gyration pressure of the fluid and reducing the impact of the fluid on the blood vessel. See Figures 3 and 4 and their associated descriptions for more details about the rectification device 310.

According to the structure of the catheter-interposed heart pump 10 in the above embodiment, it can be inserted into organs such as the heart or blood vessels, and the impeller 200 pressurizes the heart or blood vessels to increase the perfusion pressure of the organs such as the heart or blood vessels, thereby increasing the pumping function of the heart and reducing the burden on the heart. By providing the spring tube 130, the drainage tube 100 has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube 100 to guide the blood flow of the left ventricle into the aorta.

Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification. Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification.

As shown in FIGS. 3 and 4 , the rectifying device 310 includes a core 311 , which is configured as a centrally symmetrical block. The centrally symmetrical block means that the core 311 can be rotated at any angle around the central symmetry axis C and can be aligned with itself. Overlapping block structures. In some embodiments, the core 311 includes a small end 313 and a large end 314, and the cross-section from the small end 313 to the large end 314 gradually increases. In some embodiments, the cross section from the small end 313 to the large end 314 can increase linearly. For example, as shown in FIG. 3 , the core 311 is configured in a truncated cone shape, with the small end 313 at the top of the truncated cone and the large end 314 at the bottom of the truncated cone. In some embodiments, the cross section from the small end 313 to the large end 314 can increase non-linearly. For example, see FIG. 4 , the core 311 is configured as a hemisphere, the top of the hemisphere is set as the small end 313 , and the bottom of the hemisphere is set as is big endian 314.

In some embodiments, the small end 313 is disposed close to the impeller 200 and the large end 314 is disposed close to the drive motor 300 . In some embodiments, the core 311 is also provided with a mounting portion 316 for fixing to the stator side of the drive motor 300 . In some embodiments, the mounting portion 316 is configured as a cylinder, the mounting portion 316 is disposed at the large end 314 and the axis of the mounting portion 316 is co-linearly arranged with the central symmetry axis C of the core 311 . In some embodiments, referring to FIG. 3 , the cross-section of the mounting portion 316 is smaller than the cross-section of the large end 314 . In some embodiments, referring to FIG. 4 , the cross-section of the mounting portion 316 is equal to the cross-section of the large end 314 .

In some embodiments, the mounting portion 316 is fixed to the stator side of the drive motor 300, and various fixing methods such as laser welding, bonding, and threaded connection can be used, which are not limited in this specification.

In some embodiments, the core 311 is provided with a through hole 312 for avoiding the output rotating shaft 320 , and the through hole 312 extends from the small end 313 to the large end 314 along the central axis of symmetry C. In some embodiments, the diameter of the through hole 312 of the core 311 is larger than the diameter of the output shaft 320 of the drive motor 300 .

In some embodiments, referring to FIG. 3 , the rectification device 310 further includes a plurality of blades 315 , which are spacedly arranged on the outer surface of the core 311 around the central symmetry axis C of the core 311 , and are used for releasing The swirling pressure exerted by the impeller 200 on the blood. When the fluid in the rotating flow state or the turbulent flow state impacts the rectifying device 310, the blades 315 have a diversion effect on the fluid, thereby changing and adjusting the flow direction of the fluid to achieve the purpose of releasing its swirling pressure.

In some embodiments, the number of blades 315 can be set as needed. For example, the number of blades 315 can be two, three, or four, etc., which is not limited in this specification. In some embodiments, the angles formed by adjacent blades 315 and the central axis of symmetry C may be equal, that is, the blades 315 may be arranged around the core 311 at equally spaced angles relative to the central axis of symmetry C. In some embodiments, the angles formed by adjacent blades 315 with the central axis of symmetry C may be unequal.

In some embodiments, the blades 315 may be arranged in a swirling shape on the outer surface of the core 311 , and the rotation direction of the blades 315 may be opposite to the rotation direction of the blades of the impeller 200 , thereby better counteracting the swirling pressure of the fluid. In some embodiments, the blades 315 can be arranged in an arc shape on the outer surface of the core 311 , and the blades 315 can have a larger radius of curvature to improve the rectification effect. In some embodiments, the blades 315 can be arranged in a straight line on the outer surface of the core 311 , that is, the blades 315 extend straight from the small end 313 of the core 311 to the large end 314 of the core 311 , thereby adjusting the flow through the rectifying device 310 The fluid can continue to flow in the direction of the central symmetry axis C of the rectifying device 310 .

In some embodiments, referring to FIG. 4 , the rectifying device 310 may not be provided with blades 315 , but directly utilize the surface curvature of the core 311 to buffer the impact force of the fluid and perform a rectifying effect.

In some embodiments, the rectifying device 310 can be injection molded from plastic material to reduce the overall weight of the catheter-involved heart pump. In some embodiments, the rectifying device 310 can be machined from metal materials. For example, metal materials include but are not limited to cobalt-chromium alloys, stainless steel materials, etc. The rectifying device 310 made of metal has high strength and long service life.

Figure 5 is a partial cross-sectional view of a catheter-involved heart pump according to some embodiments of the present specification.

In some embodiments, as shown in FIG. 5 , a seal is provided between the rectifying device 310 and the drive motor 300 . The seal is used to prevent blood from infiltrating into the drive motor 300 and causing the drive motor 300 to cause rust, leakage, short circuit and other failures. In some embodiments, the number of seals may be determined according to the structure and sealing level of the drive motor 300 .

In some embodiments, the seal includes a first seal 330 and a second seal 340 that assist each other to increase the sealing performance of the drive motor 300 .

In some embodiments, the first seal 330 is disposed between the rectifying device 310 and the output rotating shaft 320 of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the gap between the rectifying device 310 and the output rotating shaft 320 . In some embodiments, the first seal 330 is configured as an annular structure, an accommodation cavity is formed inside the rectifying device 310 , the first seal 330 is disposed in the accommodation cavity and is in sliding contact with the output shaft 320 , so that the first seal The component 330 can block the gap between the output rotating shaft 320 and the rectifying device 310 . In some embodiments, the first seal 330 may be made of polytetrafluoroethylene (Teflon or PTFE), so that the first seal 330 has the advantages of sealing performance, high lubrication and non-stickiness, and the high lubrication of the first seal 330 The non-stickiness makes the friction force of the output rotating shaft 320 when it is in sliding contact with the output rotating shaft 320 very small, and the loss of the output rotating shaft 320 is very small.

In some embodiments, the second seal 340 is disposed between the rectifying device 310 and the stator side of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the installation gap between the rectifying device 310 and the stator side. In some embodiments, the second seal 340 is configured in a disc shape. The disc-shaped second seal 340 includes a flat bottom plate and a protrusion formed along the edge of the flat bottom plate. The flat bottom plate blocks the stator side of the drive motor 300 On the end surface, the protrusions block the connection between the mounting part 316 of the rectification device 310 and the stator side, thereby improving the sealing performance of the connection. In some embodiments, the second seal 340 may be made of materials such as medical rubber, medical silicone, or polytetrafluoroethylene, which is not limited in this specification.

In some embodiments, medical silicone grease can be coated between the seal and the rectifying device 310 and between the seal and the driving motor 300. The medical silicone grease plays a role in lubrication and sealing. For example, it can reduce the size of the first seal. The friction force between the component 330 and the output shaft 320.

Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of the present specification.

In some embodiments, the rectifying device 310 can be sleeved on the output shaft 320 of the drive motor 300 through the bearing 350. The arrangement of the bearing 350 can make the output shaft 320 rotate more smoothly inside the rectifying device 310, thereby improving the driving force of the output shaft 320. Stability of impeller 200 rotation. In some embodiments, the bearing 350 may be disposed between the fairing device 310 and the output shaft 320 . In some embodiments, the inner ring of the bearing 350 may be fixedly connected to the output shaft 320 , and/or the outer ring of the bearing 350 may be fixedly connected to the inner wall of the rectifying device 310 .

In some embodiments, a second seal 340 may be disposed between the rectifying device 310 and the stator side of the driving motor 300 to improve the sealing between the rectifying device 310 and the stator side of the driving motor 300 . See Figure 5 and its associated description for more details on the second seal 340.

In some embodiments, the rectifying device 310 and the driving motor 300 can be sealed by a sealing liquid 360, where the sealing liquid 360 includes but is not limited to physiological saline, glucose solution, etc. In some embodiments, the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device (not shown in the figure). The extracorporeal positive pressure infusion device can apply positive pressure to the gap between the rectifying device 310 and the drive motor 300 through the catheter 400 Instill sealing fluid. In some embodiments, sealing fluid may pass through the interior of the drive motor 300 . In some embodiments, the arrows in Figure 6 illustrate the flow path of the sealing liquid 360: the sealing liquid 360 is instilled through extracorporeal positive pressure and introduced from the catheter 400 into the driving motor 300. In the housing, it then flows from between the second seal 340 and the stator side of the drive motor 300 to the output shaft 320 , flows along the outer wall of the output shaft 320 and the rectifying device 310 to the outside of the bearing 350 , and flows from the bearing 350 to the rectifying device 310 continues to flow between the outer wall of the output shaft 320 and the rectifying device 310, and flows outward toward the organ at the position where the impeller 200 and the rectifying device 310 are butted. The gap between the rectifying device 310 and the driving motor 300 is filled with the sealing liquid 360, which can adapt to gaps of different sizes and has a good sealing effect. In some embodiments, the surface of the driving motor 300 that is in contact with the sealing liquid is provided with parylene coating. By providing the parylene coating, direct contact between the drive motor 300 and the sealing liquid can be effectively avoided, which can protect the motor and prevent the motor from contaminating the sealing liquid. In some embodiments, before assembling the catheter interventional heart pump, a parylene coating may be provided on the surface of the drive motor 300 . For example, the disassembled drive motor can be soaked in a parylene solution, so that the stator side and the output shaft of the drive motor are both covered with parylene coating. In some embodiments, the parylene coating can also be replaced by other biocompatible material coatings, which is not limited in this specification.

In some embodiments, the extracorporeal positive pressure infusion device can be implemented by a peristaltic pump or gravity. The infusion pressure can be in the range of 150 to 600mmHg, such as 200mmHg, 350mmHg, 400mmHg, 500mmHg, etc.

Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification. Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification.

As shown in Figures 1-2 and 7-8, in some embodiments, a pigtail catheter 500 is connected to the front end of the drainage tube 100. The front end of the pigtail catheter 500 is made of flexible material to avoid damage to tissues and organs. In some embodiments, the front end of the pigtail catheter 500 is curled in a natural state, and is used to assist the drainage tube 100, the driving motor 300 and other structures to enter the heart (such as entering the left ventricle), and its curled shape is not easy to fold in the left ventricle. , twisting and slipping.

In some embodiments, the pigtail catheter 500 may be a hollow tubular structure that is guided into the left ventricle through a guidewire or the like. In some embodiments, the pigtail catheter 500 may be a solid soft structure, for example, made of materials such as thermoplastic urethane elastomer (Thermoplastic Urethane, TPU), polyether block polyamide, or the like.

As shown in Figure 7, in some embodiments, the pigtail catheter 500 includes a first straight section 510 and a curved section 520. The rear end of the first straight section 510 is connected to the front end of the drainage tube 100, and the front end of the first straight section 510 is connected to the front end of the drainage tube 100. The curved sections 520 are connected, and the curved section 520 is curved in an arc from the front end of the first straight section 510 toward the rear end.

As shown in FIG. 8 , in some embodiments, the pigtail catheter 500 includes a first straight section 510 , a second straight section 530 and a curved section 520 . The rear end of the first straight section 510 is connected to the front end of the drainage tube 100 . The front end of the straight section 510 is connected to the rear end of the second straight section 530 , the front end of the second straight section 530 is connected to the curved section 520 , and the curved section 520 is curved in an arc from the front end of the second straight section 530 toward the rear end. In some embodiments, the angle between the first straight line segment 510 and the second straight line segment 530 is greater than 90° and less than 180°.

Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification.

As shown in Figure 9, in some embodiments, the drainage tube 100 is provided with a developing ring 140. The developing ring 140 is disposed at a curved portion of the drainage tube 100. The developing ring 140 can be developed in an imaging device (such as an X-ray imaging device). , used to position and mark the position of the drainage tube 100 in the human body. In some embodiments, the developing ring 140 may be made of metallic materials, such as tantalum, platinum-iridium alloy, etc. By arranging the developing ring 140 at the curved part of the drainage tube 100, the position of the drainage tube 100 in the human body can be displayed more accurately; at the same time, the posture of the drainage tube 100 in the human body can be easily observed. In some alternative embodiments, the developing ring 140 may be disposed in a non-bent portion of the drainage tube 100 . In some embodiments, a plurality of developing rings 140 may be provided on the drainage tube 100 to more accurately display the position and posture of the drainage tube 100 in the human body.

Figure 10 is a partial structural diagram of a catheter-interposed heart pump according to some embodiments of this specification.

As shown in FIG. 10 , in some embodiments, the catheter interventional heart pump 10 may further include a reducing tube 600 , a suture pad 700 and a sterile protective bag 800 . In some embodiments, the reducing tube 600 , the suture pad 700 and the sterile protective bag 800 are connected in sequence and sheathed outside the catheter 400 .

In some embodiments, the diameter of the reducing tube 600 gradually increases from the front end of the reducing tube 600 to the rear end of the reducing tube 600 . In some embodiments, the reducing tube 600 can be used to stop bleeding at the opening of the blood vessel.

In some embodiments, the taper of the reducing tube 600 is 5°˜30°, for example, the taper is 5°, 10°, 15°, 18°, 20°, 25°, 30°, etc. In some embodiments, if the taper of the reducing tube 600 is too large, it will easily cause damage to the opening of the blood vessel, while if the taper is too small, it will be difficult to achieve a hemostatic effect. By setting the taper of the reducing tube 600 in the range of 5° to 30° It can not only avoid damaging the opening of blood vessels, but also has a good hemostatic effect.

In some embodiments, the diameter of the entire reducing tube 600 gradually and continuously increases from the front end to the rear end, making the reducing tube 600 a tapered pipe. In some embodiments, the diameter of the reducing tube 600 may increase in a stepwise manner from the front end to the rear end. For example, the front end section, the middle section and the rear end section of the reducing pipe 600 are all equal diameter pipes. The diameter of the front end section is smaller than the diameter of the middle section, and the diameter of the middle section is smaller than the rear end section. The diameter of the section.

In some embodiments, the suture pad 700 may be used to suture tissue (eg, skin tissue at the opening of a blood vessel) to limit movement of the catheter-involved heart pump 10 within the body.

In some embodiments, the sterile protective bag 800 is placed on the catheter 400 to prevent the catheter 400 from being contaminated by bacteria during use or recovery, thereby reducing the risk of surgical infection. In some embodiments, the sterile protective bag 800 can move axially along the catheter 400. In some embodiments, adjusting nuts 810 are provided at both ends of the sterile protective bag 800. The adjusting nuts 810 can lock the two ends of the sterile protective bag 800 with the catheter 400, thereby limiting the relative contact between the sterile protective bag 800 and the catheter. 400 axial displacement. In some embodiments, after the operation, the adjusting nuts 810 at both ends of the sterile protective bag 800 can be locked to prevent wound infection caused by instrument withdrawal. In some embodiments, an outer sheath is used to pass through the catheter 400 exposed outside the body and on the pump body during instrument retrieval, and the catheter 400 outside the body can be protected from infection by providing a sterile protective bag 800 .

Figure 11 is a schematic diagram of the overall structure of a catheter-involved heart pump according to some embodiments of this specification. Figure 12 is a partial structural schematic diagram of a catheter-involved heart pump according to some embodiments of this specification.

As shown in FIGS. 11 and 12 , the catheter interventional heart pump 10 further includes a controller 900 , and the controller 900 can be used to control the drive motor 300 to drive the impeller 200 to rotate. In some embodiments, the controller 900 may send control instructions to the drive motor 300 based on artificially set control parameters. In some embodiments, the controller 900 can automatically determine the control parameters and send control instructions to the drive motor 300, thereby avoiding interference from human factors. In some embodiments, the control parameters may include, but are not limited to, voltage, current, driving speed, power of the driving motor 300, pressure signals collected by sensors, etc.

In some embodiments, the controller 900 is arranged outside the body and is connected to the driving motor 300 via a signal signal. A part of the cable can pass through the catheter 400 into the body and be connected to the driving motor 300, and the other part is located outside the body and connected to the controller 900. . In some embodiments, the controller 900 can be powered by its own battery, or the controller 900 can be powered by a power source from the grid.

As shown in Figure 12, in some embodiments, the catheter interventional heart pump 10 further includes a first pressure sensor 910 and/or a second pressure sensor 920; the first pressure sensor 910 and the second pressure sensor 920 include but are not limited to piezoelectric sensors. Pressure sensor, piezoresistive pressure transmitter sensors, electromagnetic pressure sensors, capacitive pressure sensors, etc. In some embodiments, the catheter-intervention heart pump 10 may include only one pressure sensor, that is, the first pressure sensor 910 or the second pressure sensor 920 . In some embodiments, the catheter-intervention heart pump 10 may include two pressure sensors, ie, a first pressure sensor 910 and a second pressure sensor 920 . By arranging the first pressure sensor 910 and/or the second pressure sensor 920, the working status of the catheter-involved heart pump 10 can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump 10 can be monitored, and the catheter can be guided accordingly. Interventional heart pump 10 works better.

In some embodiments, the first pressure sensor 910 is disposed at the front end of the drainage tube 100, and the first pressure sensor 910 can be used to detect the blood perfusion pressure at the front end of the drainage tube 100. In some embodiments, if the drainage tube 100 is inserted into the left ventricle, the first pressure sensor 910 is used to detect the blood perfusion pressure in the left ventricle; if the drainage tube 100 is inserted into the aorta, the first pressure sensor 910 is used to detect blood perfusion pressure in the left ventricle. To detect the perfusion pressure in the aorta.

In some embodiments, the first pressure sensor 910 is disposed closer to the front end of the heart pump (the catheter is inserted into the heart pump 10) relative to the fluid inlet 110 (as shown in FIG. 12), so that the first pressure sensor 910 can detect the presence of blood in the heart pump 10. The blood perfusion pressure before entering the fluid inlet 110. In some embodiments, the distance between the first pressure sensor 910 and the fluid inlet 110 may be 20 to 60 mm (such as 20 mm, 30 mm, 50 mm, 60 mm, etc.).

In some embodiments, the first pressure sensor 910 is disposed closer to the rear end of the heart pump relative to the fluid inlet 110 and is disposed close to the fluid inlet 110 . At this time, the first pressure sensor 910 can detect the blood perfusion pressure at the fluid inlet 110 .

In some embodiments, the second pressure sensor 920 is disposed at the rear end of the drainage tube 100, and the second pressure sensor 920 can be used to detect the blood perfusion pressure at the rear end of the drainage tube 100. The blood perfusion pressure at the rear end of the drainage tube 100 may be the blood pressure after the blood is pressurized through the drainage tube 100, the impeller 200 and other components.

In some embodiments, the second pressure sensor 920 is disposed closer to the front end of the heart pump relative to the fluid outlet 120 (as shown in FIG. 12 ). Since a turbulent flow area may appear at the fluid outlet 120 and affect the detection accuracy of the second pressure sensor 920, disposing the second pressure sensor 920 at the front end of the fluid outlet 120 can avoid the influence of turbulent flow at the fluid outlet 120 and improve the detection accuracy of the second pressure sensor 920. The second pressure sensor 920 detects the accuracy. In some embodiments, the distance between the second pressure sensor 920 and the fluid outlet 120 may be 30-70 mm (such as 30 mm, 40 mm, 50 mm, 70 mm, etc.). In some embodiments, as shown in FIG. 12 , the second pressure sensor 920 may be disposed on the outer surface of the outlet trap 160 .

In some embodiments, the second pressure sensor 920 may be positioned closer to the rear end of the heart pump relative to the fluid outlet 120 . In some embodiments, the second pressure sensor 920 and the fluid outlet 120 can be separated by a preset distance range (such as 3cm, 5cm, etc.), so that the second pressure sensor 920 can avoid the turbulent flow area and improve the data collected by the second pressure sensor 920. Accuracy of data.

In some embodiments, the controller 900 is configured to determine the position of the drainage tube 100 in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 . Since the blood perfusion pressures of different organs and parts of the human body are different, such as the left ventricle, aorta, veins, etc., the drainage can be determined through the pressure signals detected by the first pressure sensor 910 and the second pressure sensor 920 The position of tube 100 in the body. In some embodiments, the position of the drainage tube 100 in the body can be represented by the position of any point on the drainage tube 100 in the body. In some embodiments, the position of the drainage tube 100 within the body may be represented by the position of the imaging ring 140 on the drainage tube 100 within the body.

In some embodiments, the first pressure sensor 910 and the second pressure sensor 920 can determine the specific location of the drainage tube 100 in a certain organ or part of the body. For example, the first pressure sensor 910 enters the left ventricle with the heart pump, and different positions in the left ventricle The device has different pressures, and the specific position of the first pressure sensor 910 in the left ventricle can be determined according to the pressure value detected by the first pressure sensor 910; thus, the drainage can be further deduced according to the position of the first pressure sensor 910 on the drainage tube 100. The specific location of tube 100 within the body.

In some embodiments, the first pressure sensor 910 and the second pressure sensor 920 may also be used to determine changes in the position of the drainage tube 100 within the body. For example, if the pressure value of the first pressure sensor 910 changes significantly in a short period of time (for example, the change rate of the pressure value exceeds a set threshold), it indicates that the drainage tube 100 may suddenly move in the body, such as suddenly falling off from the left ventricle to the aorta. , at this time, the controller 900 can generate early warning information to alert the operator.

In some embodiments, the controller 900 may determine the position of the drainage tube 100 within the body based solely on the first pressure signal of the first pressure sensor 910 . In some embodiments, the controller 900 may determine the position of the drainage tube 100 within the body based solely on the second pressure signal of the second pressure sensor 920 . In some embodiments, the controller 900 may simultaneously determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 to improve the accuracy of position determination.

In some embodiments, the controller 900 (such as the processor 940) can obtain the pre-stored correspondence between the position information and the pressure value from the storage medium (such as the storage medium 930). For example, the controller 900 may obtain pre-stored pressure values corresponding to different positions in the patient's left ventricle, pressure values corresponding to different positions in the aorta, and pressure values corresponding to different positions in the veins.

In some embodiments, the controller 900 may pre-collect position information and its corresponding pressure value through the developing ring 140 . In some embodiments, the catheter-intervened heart pump 10 can be implanted into the human body and imaged by an imaging device to obtain position information of the imaging ring 140 . During the process of the catheter interventional heart pump 10 being implanted into the left ventricle from the aorta, the position of the imaging ring 140 imaged under the imaging device can be collected in real time or periodically, and the first pressure sensor of the developing ring 140 at different positions can be simultaneously recorded. a pressure signal and/or a second pressure signal from a second pressure sensor. Then, data processing is performed on the collected position, first pressure signal and/or second pressure signal to obtain the corresponding relationship between position information and pressure value. The corresponding relationship between the position information and the pressure value may be a one-to-one correspondence between the position and the pressure value, or it may be a functional relationship between the position and the pressure value obtained through a fitting algorithm.

In some embodiments, the position information of the left ventricle may be represented by spatial three-dimensional coordinates. For example, the center point of the aortic valve is used as the coordinate origin, the left-right direction of the human body is the three-dimensional coordinates. In some embodiments, the location information of the detection point in the aorta may be represented by the distance between the detection point and the aortic valve.

In some embodiments, based on the corresponding relationship between the position information and the pressure value, the controller 900 may determine that the drainage tube 100 is in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 s position. In some embodiments, the controller 900 can jointly determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920. Specific steps include:

Step 1: Determine the first position of the drainage tube 100 according to the first pressure signal.

In some embodiments, the first pressure sensor 910 can acquire the first pressure signal and feed it back to the controller 900. The controller 900 can compare the first pressure signal with a pre-stored pressure value and obtain a comparison result. If the difference between the value of the first pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), then the first pressure sensor 910 can be roughly determined is at the position corresponding to the pre-stored pressure value. According to this position, the position of the drainage tube 100 can be determined. First position. In some embodiments, the controller 900 may further calculate the precise position of the first pressure sensor 910 based on the difference between the value of the first pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the first pressure sensor 910 through the functional relationship, and the first position of the drainage tube 100 can be determined based on the position.

Step 2: Determine the second position of the drainage tube 100 according to the second pressure signal.

In some embodiments, the second pressure sensor 920 can acquire the second pressure signal and feed it back to the controller 900. The controller 900 compares the second pressure signal with a pre-stored pressure value and obtains a comparison result. If the difference between the value of the second pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), the second pressure sensor 920 can be roughly determined. is at a position corresponding to the pre-stored pressure value, and the second position of the drainage tube 100 can be determined based on this position. In some embodiments, the controller 900 may further calculate the precise position of the second pressure sensor 920 based on the difference between the value of the second pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the second pressure sensor 920 through the functional relationship, and the second position of the drainage tube 100 can be determined based on the position.

Step 3: Determine the position of the drainage tube 100 in the body based on the first position and the second position.

In some embodiments, both the first position and the second position represent the position of the drainage tube 100 in the body, and the controller 900 can select the first position or the second position as the position of the drainage tube 100 in the body. For example, if the difference between the first position and the second position is within a preset range (for example, the difference is less than 5 mm), it means that the error between the first position and the second position is small, and the controller 900 can use the first position as the drainage tube. 100 in the body, or the second position is used as the position of the drainage tube 100 in the body.

In some embodiments, the controller 900 can take an intermediate position between the first position and the second position, and determine the intermediate position as the position of the drainage tube 100 in the body, thereby effectively improving the position determination accuracy of the drainage tube 100 .

In some embodiments, after the position of the drainage tube 100 is determined in the above manner, it can be determined based on the position whether the catheter-intervention heart pump 10 is installed at the position required for treatment. For example, it can be determined whether the front end of the drainage tube 100 is installed in the left ventricle or a specific position in the left ventricle (such as the apex position of the left ventricle). In some embodiments, by determining the position of the drainage tube 100 during the operation of the heart pump, it can be determined whether the position of the heart pump deviates during the operation. If the position of the heart pump deviates, there may be a possibility that the catheter may be inserted into the heart pump 10 from the left side unexpectedly. In case of ventricular detachment and other situations, the controller 900 can send out early warning information in time, thereby reducing the user's risk.

In some embodiments, the controller 900 may also adjust the current output value, voltage output value and/or power output value of the driving motor 300 based on the signals of the first pressure sensor 910 and the second pressure sensor 920 . In some embodiments, the controller 900 can calculate and obtain control parameters based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 , and send a control instruction to the driving motor 300 based on the control parameters, thereby Adjust the current output value, voltage output value and/or power output value of the drive motor 300, etc.

In some embodiments, the controller 900 may determine whether the catheter-involved heart pump 10 is working abnormally based on the current signal of the driving motor 300 . In some embodiments, the controller 900 can preset a safe current range value (or threshold), and after acquiring the current signal of the driving motor 300, compare the current signal with the safe current range value (or threshold): if the current If the signal is within the safe current range (eg, less than the threshold), the controller 900 generates a determination result that the catheter-involved heart pump 10 is working normally; if the current signal is outside the safe current range (eg, greater than the threshold), then The controller 900 generates a determination result that the catheter-involved heart pump 10 is operating abnormally. In some embodiments, when the controller 900 determines that the catheter-involved heart pump 10 is working abnormally, it can send an alarm message so that the operator can perform timely maintenance or correction.

As shown in FIG. 13 , the controller 900 of the catheter-involved heart pump 10 may include a storage medium 930, a processor 940, and a communication bus. The processor 940 and the storage medium 930 can implement the communication process through the communication bus. The processor 940 may be used to execute the control method of the catheter-involved heart pump 10 provided by any of the above embodiments of the present application.

In some embodiments, the processor 940 may be implemented using a central processing unit, a server, a terminal device, or any other possible processing device. In some embodiments, the above-mentioned central processor, server, terminal device or other processing device can be implemented on a cloud platform. In some embodiments, the above-mentioned central processor, server or other processing device can be interconnected with various terminal devices, and the terminal device can complete information processing work or part of the information processing work.

In some embodiments, storage medium 930 (or computer-readable storage medium) may store data and/or instructions. In some embodiments, the storage medium 930 may store computer instructions, and the processor 940 (or computer) may read the computer instructions to execute the control method of the catheter-involved heart pump 10 provided in any embodiment of this specification. In some embodiments, the storage device may include mass memory, removable memory, volatile read-write memory, read-only memory (ROM), etc., or any combination thereof. In some embodiments, the storage device may be implemented on a cloud platform.

Possible beneficial effects brought about by the embodiments of the present application include but are not limited to: (1) The catheter-interposed heart pump can be inserted into the heart (such as the left ventricle) to increase the perfusion pressure of the heart through impeller pressurization, increase the heart's pumping function, and provide the heart with Reduce the burden on. By setting the spring tube, the drainage tube has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube to guide the blood flow of the left ventricle into the aorta; (2) The front end of the pigtail catheter It is curled in the natural state, and its curled shape is not easy to fold, twist and slip off in the heart; (3) the sterile protective bag is placed on the catheter to prevent the catheter from being contaminated by bacteria during use or recycling and reduce infection Risk; (4) By setting the first pressure sensor and/or the second pressure sensor, the working status of the catheter-involved heart pump can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump can be monitored, and guidance can be provided The catheter-intervention heart pump works better; (5) By determining the position of the drainage tube, it can be judged based on the position whether the catheter-intervention heart pump is installed at the location required for treatment. Moreover, by determining the position of the drainage tube, it can be determined whether the position has shifted during the work. If the position has shifted, the catheter may accidentally detach from the left ventricle of the heart pump. The controller can issue an early warning message in time. Reduce user risk. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the possible beneficial effects may be any one or a combination of the above, or any other possible beneficial effects.

The basic concepts have been described above. It is obvious to those skilled in the art that the above detailed disclosure is only an example and does not constitute a limitation of this specification. Although not explicitly stated herein, various modifications, improvements, and corrections may be made to this specification by those skilled in the art. Such modifications, improvements, and corrections are suggested in this specification, and therefore such modifications, improvements, and corrections remain within the spirit and scope of the exemplary embodiments of this specification.

At the same time, this specification uses specific words to describe the embodiments of this specification. For example, "one embodiment,""anembodiment," and/or "some embodiments" means a certain feature, structure, or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that “one embodiment” or “an embodiment” or “an alternative embodiment” mentioned twice or more at different places in this specification does not necessarily refer to the same embodiment. . In addition, certain features, structures or characteristics in one or more embodiments of this specification may be appropriately combined. combine.

Similarly, it should be noted that, in order to simplify the presentation of the disclosure in this specification and thereby facilitate the understanding of one or more embodiments, in the foregoing description of the embodiments of this specification, multiple features are sometimes combined into one embodiment, appendix figure or its description. However, this method of disclosure does not imply that the subject matter of the description requires more features than are mentioned in the claims. In fact, embodiments may have less than all features of a single disclosed embodiment.

Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Accordingly, by way of example and not limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to those expressly introduced and described in this specification.

Claims

A catheter interventional heart pump, which is characterized by including a drainage tube, an impeller, a driving motor and a catheter;

The front end of the drainage tube is provided with a fluid inlet, and the rear end of the drainage tube is provided with a fluid outlet. At least one section of the drainage tube includes a spring tube, and the spring tube is curved in a natural state;

The impeller is arranged in the drainage tube, and the drive motor is used to drive the impeller to rotate. The drive motor includes a stator side and an output shaft. The output shaft is fixedly connected to the impeller. The front end of the stator side It is fixedly connected to the rear end of the drainage tube, and the rear end of the stator side is fixedly connected to the front end of the conduit.
The catheter interventional heart pump according to claim 1, wherein the front end of the drainage tube is connected to a pigtail catheter, the front end of the pigtail catheter is made of flexible material, and the front end of the pigtail catheter is formed in a natural state. Curly.
The catheter interventional heart pump according to claim 1, wherein the drainage tube is provided with a developing ring, and the developing ring is arranged at a bend of the drainage tube.
The catheter interventional heart pump according to claim 1, further comprising a reducer tube, a suture pad and a sterile protective bag;

The reducer tube, the suture pad and the sterile protective bag are connected in sequence and set on the outside of the conduit. The diameter of the reducer tube is from the front end of the reducer tube to the end of the reducer tube. The back end gradually increases in size.
The catheter interventional heart pump according to claim 4, wherein the taper of the variable diameter tube is 5° to 30°.
The catheter interventional heart pump according to claim 4, wherein the two ends of the sterile protective bag are respectively provided with adjusting nuts, and the adjusting nuts can connect the two ends of the sterile protective bag to the Catheter lock.
The catheter interventional heart pump according to claim 1, further comprising a controller configured to control the drive motor to drive the impeller to rotate.
The catheter interventional heart pump according to claim 7, further comprising a first pressure sensor and/or a second pressure sensor;

The first pressure sensor is arranged at the front end of the drainage tube;

The second pressure sensor is arranged at the rear end of the drainage tube.
The catheter interventional heart pump according to claim 8, wherein the first pressure sensor is disposed closer to the front end of the heart pump relative to the fluid inlet;

The second pressure sensor is disposed closer to the front end of the heart pump relative to the fluid outlet.
The catheter interventional heart pump according to claim 7, wherein the controller is configured to: determine based on the first pressure signal of the first pressure sensor and/or the second pressure signal of the second pressure sensor. The location of the drainage tube in the body.
The catheter interventional heart pump according to claim 10, wherein the controller is configured to: determine the first position of the drainage tube according to the first pressure signal;

Determine the second position of the drainage tube according to the second pressure signal;

The position of the drainage tube in the body is determined based on the first position and the second position.
The catheter-intervention heart pump according to claim 1, characterized in that, the catheter-intervention heart pump further includes a rectification device, the rectification device is sleeved on the output shaft of the drive motor through a bearing, and the rectification device The device is fixedly connected to the stator side of the drive motor.
The catheter-intervention heart pump according to claim 12, characterized in that the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device, and the extracorporeal positive pressure infusion device can supply the rectifying device and the rectifying device through the catheter. The gap between the drive motors is filled with sealing fluid under positive pressure.
The catheter interventional heart pump according to claim 13, wherein the sealing liquid passes through the inside of the driving motor; and a parylene coating is provided on the surface of the driving motor in contact with the sealing liquid.