Catheter pump

Abstract

The invention discloses a catheter pump, and relates to the technical field of medical instruments, the catheter pump comprises a function module, the function module comprises an impeller structure, the impeller structure comprises an impeller rotating shaft and an impeller, the impeller comprises a hub and a plurality of blades, the blades are arranged on the hub, a connecting part is arranged on the side wall of the impeller rotating shaft, and the connecting part is connected with the impeller rotating shaft. The hub and the connecting part are connected through integral injection molding, and the connecting part is used for limiting relative movement of the impeller. Through integral injection molding of the impeller rotating shaft and the impeller, the problem of poor binding force between the rotating shaft and the impeller in the prior art is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a catheter pump. Background Art

[0002] Percutaneous coronary intervention (PCI) is a commonly used and effective treatment for coronary heart disease. Compared with heart bypass surgery, PCI offers lower risks, less trauma, easier surgery, and faster postoperative recovery. Furthermore, PCI is also suitable for emergency treatment of acute myocardial infarction. During surgery, a blood pump provides patients with more stable blood circulation support, improving coronary artery and distal organ perfusion while reducing cardiac burden. This facilitates intraoperative stabilization of the patient's vital signs and postoperative recovery, promoting cardiac recovery.

[0003] A percutaneously implantable blood pump is a miniature blood pump whose performance is determined by its operating mode and not by the patient's physical condition. It is an active blood circulation support device. To provide adequate blood support, the pump's power output component must operate at a sufficiently high speed. However, higher speeds can lead to poor tissue hemolysis. Furthermore, research has shown that a sufficiently small delivery volume at the micropump's interventional puncture site can reduce vascular complications and improve the device's safety and effectiveness.

[0004] Based on the above clinical reality, the blood pumping device needs to meet the requirements of minimally invasive, low speed, low hemolysis and large blood pumping flow. A compressible blood pumping catheter is known. Before entering the human body, the blood pumping catheter is compressed by external force into a compressed state to achieve minimally invasive intervention. Through percutaneous surgery, it enters the designated position of the human body in a compressed state. The blood pumping catheter returns to an expanded state, making the actual blood pumping channel larger, achieving the requirements of low speed, small hemolysis and large blood pumping flow. The core component of the blood pumping catheter is the compressible impeller. However, existing compressible blood pumping catheters have many problems.

[0005] In the existing technology, the coupling force between the rotating shaft and the impeller is poor, which causes the impeller to move relative to the impeller shaft, resulting in: the impeller and the impeller shaft are out of rotation, and the impeller's work efficiency is reduced; the impeller moves back and forth, causing the impeller to scrape against the casing, increasing the risk of mechanical hemolysis. Summary of the Invention

[0006] The object of the present invention is to provide a catheter pump, which solves the problem of poor bonding force between the shaft and the impeller in the prior art by integrally injection molding the impeller shaft and the impeller.

[0007] To achieve the above object, the present invention provides the following solutions:

[0008] The present invention provides a catheter pump, including a functional module, the functional module including an impeller structure, the impeller structure including an impeller shaft and an impeller, the impeller including a hub and a plurality of blades, the plurality of blades being arranged on the hub, the side wall of the impeller shaft being provided with a connecting portion, the hub and the connecting portion being connected by integral injection molding, and the connecting portion being used to limit the relative movement of the impeller.

[0009] Preferably, it also includes a pigtail tube, an expandable stent, a shell, a multi-lumen tube and a handle module, the impeller shaft is rotatably connected to the pigtail tube, the impeller shaft is connected to the mechanical power source in the handle module through the transmission shaft in the multi-lumen tube, the expandable stent is located on the outside of the impeller structure, the distal end of the expandable stent is connected to the pigtail tube, the proximal end of the expandable stent is used to connect to the multi-lumen tube, the shell is located on the outside of the expandable stent, the shell is respectively connected to the pigtail tube and the multi-lumen tube, and the shell is provided with a blood inlet window and a bleeding window.

[0010] Preferably, a shaft step is provided at the distal end of the impeller shaft, and the impeller shaft and the pigtail tube are rotationally connected through a rotating structure. The proximal end of the rotating structure cooperates with the shaft step to axially limit the impeller shaft, thereby restricting the impeller shaft from moving toward the distal end of the catheter pump.

[0011] The present invention also provides a catheter pump, including a functional module and a fluid path module, the functional module including an impeller structure, the impeller structure including an impeller shaft and an impeller, the impeller including a hub and several blades, a rotating structure is provided between the distal end of the impeller shaft and the pigtail tube, several of the blades are arranged on the hub, the side wall of the impeller shaft is provided with a connecting portion, the hub and the connecting portion are connected by integral injection molding, and the connecting portion is used to limit the relative movement of the impeller; the fluid path module includes a multi-lumen tube, the multi-lumen tube includes a perfusion cavity, the perfusion liquid flows from the perfusion cavity to the distal end of the impeller shaft, and flows out from the gap between the impeller shaft and the rotating structure and enters the human body.

[0012] Preferably, it also includes an expandable stent, a shell and a handle module, the impeller shaft is connected to the mechanical power source in the handle module through the transmission shaft in the multi-lumen tube, the expandable stent is located on the outside of the impeller structure, the distal end of the expandable stent is connected to the pigtail tube, the proximal end of the expandable stent is used to connect to the multi-lumen tube, the shell is located on the outside of the expandable stent, the shell is respectively connected to the pigtail tube and the multi-lumen tube, and the shell is provided with a blood inlet window and a bleeding window.

[0013] Preferably, the multi-lumen tube is further provided with an outflow cavity, the perfusion cavity extends from one end of the multi-lumen tube to the other end of the multi-lumen tube, the outflow cavity extends from one end of the multi-lumen tube to the other end of the multi-lumen tube, the proximal end of the impeller shaft is connected to the distal end of the transmission shaft, a liquid path is provided in the impeller shaft, an inlet connected to the liquid path is provided on the impeller shaft, the inlet is connected with the perfusion cavity, the liquid path and the outflow cavity respectively, the perfusion liquid flows into the perfusion cavity, flows into the liquid path from the proximal end of the impeller shaft through the inlet, flows along the liquid path to the distal end of the impeller shaft, and flows out from the gap between the impeller shaft and the rotating structure and enters the human body, and at the same time, the perfusion liquid flows out from the outflow cavity.

[0014] Preferably, the multi-lumen tube includes an inner tube and an outer tube, the inner tube is coaxially arranged on the inner side of the outer tube, the perfusion cavity is arranged between the inner tube and the outer tube, the transmission shaft is located in the inner tube, and the outflow cavity is between the transmission shaft and the inner tube.

[0015] Preferably, a spring tube is provided between the transmission shaft and the inner tube.

[0016] Preferably, the proximal end of the impeller shaft is connected to the distal end of the transmission shaft via an adapter block, and the adapter block is provided with a first channel, which is communicated with the inlet, the perfusion chamber and the outflow chamber respectively.

[0017] Preferably, a protrusion is provided at the proximal end of the impeller shaft, the inlet is between adjacent protrusions, a slide groove is provided on the adapter block, the protrusion is slidably connected to the slide groove, and a second channel is formed between the inner surface of the protrusion and the surface of the slide groove, and the second channel is respectively connected to the perfusion chamber and the liquid channel.

[0018] Preferably, the second channel is also in communication with the first channel and the outflow cavity.

[0019] Preferably, a sheath cover is provided on the outer side of the connection between the proximal end of the impeller shaft and the adapter block, and the sheath cover is connected to the expandable stent and the multi-lumen tube respectively. An opening is provided on the sheath cover, and the opening can connect the distal end of the perfusion cavity and the distal end of the outflow cavity.

[0020] Preferably, the sheath cover is provided with a sheath cover limiting step, and the sheath cover limiting step cooperates with the proximal end of the impeller shaft and the proximal end of the adapter block to achieve axial limiting of the impeller shaft, thereby restricting the impeller shaft from moving toward the proximal end of the catheter pump.

[0021] Preferably, a third channel exists between the proximal end of the impeller shaft and the sheath cover, the proximal end of the third channel is communicated with the perfusion chamber, and the distal end of the third channel is communicated with the human body.

[0022] Preferably, the third channel is also in communication with the first channel and the outflow cavity.

[0023] The present invention also provides a catheter pump, including a functional module and a handle module, the functional module including an impeller structure, the impeller structure including an impeller shaft and an impeller, the impeller including a hub and a plurality of blades, the plurality of blades being arranged on the hub, the side wall of the impeller shaft being provided with a connecting portion, the hub and the connecting portion being connected by integral injection molding, the connecting portion being used to limit the relative movement of the impeller; the handle module including a transmission sealing structure, the transmission sealing structure including an external magnetic component, an internal magnetic component, a driven shaft and a sealing cover, the internal magnetic component being arranged on the driven shaft, the driven shaft being connected to the impeller shaft through a transmission shaft, the external magnetic component being arranged on the outside of the internal magnetic component, and the external magnetic component being used to connect to a mechanical power source, the sealing cover being used to isolate the internal magnetic component from the external magnetic component, and the driven shaft both rotates and moves axially relative to the sealing cover.

[0024] Preferably, it also includes a pigtail tube, an expandable stent, a shell and a liquid circuit module, the impeller shaft is rotatably connected to the pigtail tube through a rotating structure, the liquid circuit module includes a multi-lumen tube, the transmission shaft is located in the multi-lumen tube, the expandable stent is located on the outside of the impeller structure, the distal end of the expandable stent is connected to the pigtail tube, the proximal end of the expandable stent is used to connect to the multi-lumen tube, the shell is located on the outside of the expandable stent, the shell is respectively connected to the pigtail tube and the multi-lumen tube, and the shell is provided with a blood inlet window and a bleeding window.

[0025] Preferably, the handle module further includes a perfusion cavity, the perfusion cavity of the multi-cavity tube is connected to the perfusion port of the perfusion cavity, the outflow cavity of the multi-cavity tube is connected to the outflow port of the perfusion cavity, the proximal end of the multi-cavity tube is connected to the perfusion cavity and the proximal end of the perfusion cavity and the proximal end of the outflow cavity are not connected, and the sealing cover is connected to the perfusion cavity.

[0026] Preferably, the inner magnetic assembly is sleeved on the driven shaft and fixedly connected to the driven shaft, the sealing cover is arranged on the outside of the inner magnetic assembly, the outer magnetic assembly is arranged on the outside of the sealing cover, the open end of the sealing cover is used for sealing connection with the perfusion cavity, and the driven shaft and the inner magnetic assembly can both move axially along the sealing cover.

[0027] Preferably, one end of the driven shaft extends out from the open end of the sealing cover and there is a gap between the driven shaft and the perfusion cavity. The gap between the driven shaft and the perfusion cavity can be connected to the outflow cavity. The other end of the driven shaft is close to the sealing end of the sealing cover. The proximal end of the impeller shaft is fixedly connected to the distal end of the transmission shaft. The movement of the driven shaft is limited by the sealing end. There are gaps between the driven shaft and the sealing cover, and between the internal magnetic assembly and the sealing cover.

[0028] Preferably, the driven shaft is a solid structure, and one end of the driven shaft is used to be connected to the transmission shaft.

[0029] Preferably, the driven shaft is a hollow structure, and the transmission shaft extends into the driven shaft.

[0030] Preferably, the transmission shaft is a hollow shaft, a reflux channel is provided inside the transmission shaft, and the reflux channel is communicated with the outflow cavity.

[0031] Preferably, the driven shaft is an optical axis.

[0032] Preferably, the driven shaft includes a first shaft portion and a second shaft portion, the first shaft portion is located inside the sealing cover, the second shaft portion is located outside the sealing cover, and a spiral structure is provided on the outside of the second shaft portion, and the rotation direction of the spiral structure is opposite to the rotation direction of the driven shaft.

[0033] Preferably, a wear-resistant insert is provided between the driven shaft and the perfusion cavity, the wear-resistant insert is fixedly connected to the perfusion cavity, the wear-resistant insert and the driven shaft can rotate relative to each other, the driven shaft is provided with a protrusion, and the wear-resistant insert cooperates with the protrusion to achieve axial limitation of the driven shaft, thereby limiting the movement of the driven shaft toward the distal end of the catheter pump.

[0034] Preferably, the handle module also includes a first diffusion stress tube, a motor housing, a second diffusion stress tube and a cable, one end of the first diffusion stress tube is connected to the multi-cavity tube, the other end of the first diffusion stress tube is connected to the perfusion cavity, the first diffusion stress tube is provided with an perfusion tube and an outflow tube, one end of the perfusion tube is communicated with the perfusion port, one end of the outflow tube is communicated with the outflow port, the motor housing is arranged on the outside of the drive motor, the motor housing and the perfusion cavity can be detachably connected, and the motor housing and the perfusion cavity are connected by a locking nut, one end of the second diffusion stress tube is connected to the motor housing, the other end of the second diffusion stress tube is connected to the cable, and one end of the cable is connected to the drive motor.

[0035] Preferably, the multi-lumen tube includes an inner tube and an outer tube, the inner tube is coaxially arranged on the inner side of the outer tube, the perfusion chamber and the pressure measuring chamber are arranged between the inner tube and the outer tube, the pressure measuring chamber and the perfusion chamber are separated by a partition, the pressure measuring chamber is not connected with the perfusion chamber, the transmission shaft is located in the inner tube, the outflow chamber is between the transmission shaft and the inner tube, the pressure measuring chamber is connected with the human body through the pressure measuring hole opened on the side wall of the outer tube, a detection chamber is provided in the perfusion chamber, the detection chamber is respectively connected with the pressure measuring chamber and the pressure measuring tube for passing the pressure measuring liquid, a pressure measuring element is provided in the detection chamber, and the pressure measuring element is used to detect the body pressure transmitted by the pressure measuring liquid.

[0036] Preferably, the connecting portion is a groove and / or a through hole.

[0037] Preferably, a liquid channel is provided in the impeller shaft, the liquid channel is communicated with the through hole, the hub passes through the through hole and forms a film layer on the inner wall of the impeller shaft.

[0038] Preferably, the impeller shaft comprises a first rigid section, a flexible section and a second rigid section which are arranged in sequence, the connecting portion is located in the flexible section, and the flexible section is bendable.

[0039] Preferably, the flexible section is a hypotube structure.

[0040] Compared with the prior art, the present invention has achieved the following technical effects:

[0041] The present invention allows the impeller structure to be axially flexible, reducing damage to the blood vessel wall during the pumping process. The impeller shaft and impeller are integrally injection-molded, and the connection portion on the impeller shaft increases the binding force between the impeller and the impeller shaft. The present invention provides stable support, and the impeller shaft and the flexible shaft use the same transmission shaft to avoid radial deflection, reduce the risk of scratching between the impeller and the housing, reduce hemolysis, and reduce the entry of particles into the body. The present invention has a simple structure, low cost, and high reliability. The present invention allows the perfusion fluid to increase interface lubrication, reduce friction, and provide cooling and heat dissipation. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0043] Figure 1 is a schematic diagram of a catheter pump of the present invention;

[0044] Figure 2Schematic diagram of the distal end of the catheter pump of the present invention (without the sheath cover and adapter block);

[0045] Figure 3 This is a schematic diagram of the connection between the housing and the multi-lumen tube of the present invention;

[0046] Figure 4 is a schematic diagram of a multi-lumen tube of the present invention;

[0047] Figure 5 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 1 ;

[0048] Figure 6 Schematic diagram of the connection between the pigtail tube and the impeller shaft of the present invention Figure 1 ;

[0049] Figure 7 Schematic diagram of the connection between the pigtail tube and the impeller shaft of the present invention Figure 2 ;

[0050] Figure 8 This is a schematic diagram of the application of the impeller structure of the present invention;

[0051] Figure 9 Schematic diagram of the impeller shaft of the present invention Figure 1 ;

[0052] Figure 10 for Figure 9 A local enlarged view of location I;

[0053] Figure 11 Schematic diagram of the impeller shaft of the present invention Figure 2 ;

[0054] Figure 12 for Figure 11 A partial enlarged view of location II;

[0055] Figure 13 Schematic diagram of the impeller shaft of the present invention Figure 3 ;

[0056] Figure 14 for Figure 13 A partial enlarged view of location III;

[0057] Figure 15 Schematic diagram of the impeller shaft of the present invention Figure 4 ;

[0058] Figure 16 for Figure 15 A partial enlarged view of point IV;

[0059] Figure 17 This is a schematic diagram of the wheel hub of the present invention passing through the through hole;

[0060] Figure 18 This is a cross-sectional view of the impeller shaft of the present invention;

[0061] Figure 19 It is a cross-sectional view of the impeller structure of the present invention;

[0062] Figure 20 This is a front view of the impeller shaft of the present invention;

[0063] Figure 21 This is a schematic diagram of the bending of the impeller shaft of the present invention;

[0064] Figure 22 Schematic diagram of the connection between the proximal end of the impeller shaft and the transmission shaft of the present invention;

[0065] Figure 23 Schematic diagram of the multi-lumen tube of the present invention Figure 1 ;

[0066] Figure 24 Schematic diagram of the flow of the perfusion liquid in the perfusion cavity, the third channel, the liquid channel and the outflow cavity of the present invention;

[0067] Figure 25 The perfusion liquid of the present invention enters the human body through the liquid channel (the impeller shaft has no shaft step);

[0068] Figure 26 Schematic diagram of the distal end of the catheter pump of the present invention (with sheath cover and adapter block);

[0069] Figure 27 Schematic diagram of the connection between the proximal end of the impeller shaft and the adapter block of the present invention;

[0070] Figure 28 A side view of the connection between the proximal end of the impeller shaft and the adapter block of the present invention;

[0071] Figure 29 Schematic diagram of the sliding connection between the proximal end of the impeller shaft and the adapter block of the present invention Figure 1 ;

[0072] Figure 30 Schematic diagram of the sliding connection between the proximal end of the impeller shaft and the adapter block of the present invention Figure 2 ;

[0073] Figure 31 Schematic diagram of the connection between the proximal end of the impeller shaft and the adapter block of the present invention;

[0074] Figure 32 This is a schematic diagram of the exterior of the impeller shaft, sheath cover, and transmission shaft of the present invention;

[0075] Figure 33 This is a schematic diagram of the interior of the impeller shaft, sheath cover and transmission shaft of the present invention;

[0076] Figure 34 This is a partial enlarged view of the impeller shaft, sheath cover and transmission shaft of the present invention;

[0077] Figure 35 A schematic diagram of the expansion stent of the present invention is shown in FIG.

[0078] Figure 36 is a schematic diagram of expansion of the expandable stent of the present invention;

[0079] Figure 37 Schematic diagram of the flow of the perfusion liquid in the perfusion cavity, the first channel, the third channel, the liquid channel and the outflow cavity of the present invention;

[0080] Figure 38 Schematic diagram of the flow of the perfusion liquid in the perfusion chamber, the first channel and the liquid channel of the present invention;

[0081] Figure 39 Schematic diagram of the flow of the perfusion liquid in the perfusion chamber and the third channel of the present invention

[0082] Figure 40 Schematic diagram of the flow of the perfusion liquid in the perfusion chamber and the outflow chamber of the present invention;

[0083] Figure 41 The sealing cover of the present invention is shown in FIG. Figure 1 ;

[0084] Figure 42 The sealing cover of the present invention is shown in FIG. Figure 2 ;

[0085] Figure 43 Schematic diagram of the connection between the sealing cover and the perfusion cavity of the present invention Figure 1 ;

[0086] Figure 44 Schematic diagram of the connection between the sealing cover and the perfusion cavity of the present invention Figure 2 ;

[0087] Figure 45 This is a schematic diagram of the connection between the inner magnetic assembly and the driven shaft of the present invention;

[0088] Figure 46 The driven shaft of the present invention moves along the axial direction of the driven shaft. Figure 1 ;

[0089] Figure 47 The driven shaft of the present invention moves along the axial direction of the driven shaft. Figure 2 ;

[0090] Figure 48 This is a schematic diagram of the driven shaft, internal magnetic assembly and sealing cover of the present invention before installation;

[0091] Figure 49 This is a schematic diagram of the driven shaft, internal magnetic assembly and sealing cover after installation of the present invention;

[0092] Figure 50 This is a schematic diagram of the external magnetic assembly and the external magnetic assembly mounting sleeve of the present invention before installation;

[0093] Figure 51 This is a schematic diagram of the outer magnetic component driving the inner magnetic component to rotate according to the present invention;

[0094] Figure 52 This is a schematic diagram of the outer magnetic component driving the inner magnetic component to rotate according to the present invention;

[0095] Figure 53 The perfusion solution of the present invention is Figure 5 Flow diagram of the transmission sealing structure;

[0096] Figure 54 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 2 ;

[0097] Figure 55 The perfusion solution of the present invention is Figure 54 Flow diagram of the transmission sealing structure;

[0098] Figure 56 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 3 ;

[0099] Figure 57 It is a partial enlarged view of the spiral structure of the present invention;

[0100] Figure 58 Schematic diagram of the driven shaft of the present invention (with a spiral structure);

[0101] Figure 59 The perfusion solution of the present invention is Figure 56 Flow diagram of the transmission sealing structure;

[0102] Figure 60 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 4 ;

[0103] Figure 61 The perfusion solution of the present invention is Figure 60 Flow diagram of the transmission sealing structure;

[0104] Figure 62 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 5 ;

[0105] Figure 63 The perfusion solution of the present invention is Figure 62 Flow diagram of the transmission sealing structure;

[0106] Figure 64 Schematic diagram of the multi-lumen tube of the present invention Figure 2 ;

[0107] Figure 65 is a side view of the multi-lumen tube of the present invention;

[0108] Figure 66 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 6 ;

[0109] Figure 67 The perfusion solution of the present invention is Figure 66 Flow diagram of the transmission sealing structure;

[0110] Figure 68 The proximal end of the catheter pump of the present invention is shown in FIG. Figure 7 ;

[0111] Figure 69 The perfusion solution of the present invention is Figure 68 Flow diagram of the transmission sealing structure;

[0112] Figure 70 The perfusion liquid of the present invention enters the human body through the liquid channel (the impeller shaft has a shaft step);

[0113] Figure 71 Schematic diagram of the clearance between the hydraulic chamber and the rotating shaft of the present invention;

[0114] Wherein: 1-pigtail tube, 2-impeller structure, 3-expandable stent, 4-housing, 5-multi-lumen tube, 6-handle module, 7-impeller shaft, 8-impeller, 9-hub, 10-blade, 11-fluid channel, 12-drive shaft, 13-blood inlet window, 14-bleeding window, 15-rotating structure, 16-shaft step, 17-groove, 18-through hole, 19-membrane layer, 20-first rigid section, 21- Flexible section, 22-second rigid section, 23-perfusion chamber, 24-outflow chamber, 25-inlet, 26-inner tube, 27-outer tube, 28-spring tube, 29-adapter block, 30-first channel, 31-protrusion, 32-slide, 33-second channel, 34-sheath cover, 35-opening, 36-sheath cover limiting step, 37-third channel, 38-perfusion chamber, 39-pressure measuring hole, 40-drive motor , 41-external magnetic assembly, 42-inner magnetic assembly, 43-driven shaft, 44-sealing cover, 45-proximal insert, 46-external magnetic assembly mounting sleeve, 47-open end, 48-sealing end, 50-first shaft portion, 51-second shaft portion, 52-spiral structure, 53-wear-resistant insert, 54-protrusion, 55-first diffusion stress tube, 56-motor housing, 57-second diffusion stress tube, 58-cable, 59-infusion tube, 60-outflow tube, 61-locking nut, 62-pressure measuring chamber, 63-partition, 64-detection chamber, 65-pressure measuring tube, 66-pressure measuring element, 67-inner ring of bearing, 68-outer ring of bearing, 70-first connecting portion, 71-second connecting portion, 72-plug, 73-sleeve, 74-transmission line, 75-transmission line antenna, 76-hydraulic chamber, 77-rotating shaft matching clearance. DETAILED DESCRIPTION

[0115] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0116] The object of the present invention is to provide a catheter pump, which solves the problem of poor bonding force between the shaft and the impeller in the prior art by integrally injection molding the impeller shaft and the impeller.

[0117] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0118] Example 1

[0119] like Figures 1 to 5As shown: This embodiment provides a catheter pump, including a pigtail tube 1, a functional module, an expandable stent 3, a housing 4, a fluid path module and a handle module 6. The functional module includes an impeller structure 2, and the impeller structure 2 includes an impeller shaft 7 and an impeller 8. The impeller shaft 7 is used to transmit torque and drive the impeller 8 to rotate. The impeller 8 includes a hub 9 and a plurality of blades 10. The plurality of blades 10 are arranged on the hub 9. A fluid path channel 11 is provided in the impeller shaft 7. The fluid path channel 11 runs from the proximal end of the impeller shaft 7 to the distal end of the impeller shaft 7. A connecting portion is provided on the side wall of the impeller shaft 7. The hub 9 and the connecting portion are connected by integral injection molding. Used to limit the relative movement of the impeller 8, the impeller shaft 7 is rotatably connected to the pigtail tube 1, the liquid path module includes a multi-lumen tube 5, the impeller shaft 7 is connected to the drive motor 40 in the handle module 6 through the transmission shaft 12 in the multi-lumen tube 5, the expandable bracket 3 is located on the outside of the impeller structure 2, the distal end of the expandable bracket 3 is connected to the pigtail tube 1, and the proximal end of the expandable bracket 3 is used to connect with the multi-lumen tube 5, the shell 4 is located on the outside of the expandable bracket 3, and the shell 4 is respectively connected to the pigtail tube 1 and the multi-lumen tube 5. A blood inlet window 13 and a bleeding window 14 are provided on the shell 4. The blood inlet window 13 is set near the distal end of the catheter pump, and the bleeding window 14 is set near the proximal end of the catheter pump.

[0120] Specifically, if Figure 9 and Figure 10 As shown, in this embodiment, the connecting portion is a groove 17, and the portion of the hub 9 corresponding to the groove 17 is located in the groove 17 and adheres to the surface of the groove 17, thereby limiting the movement of the impeller 8. Compared with the smooth surface of the impeller shaft 7 in the prior art, this embodiment strengthens the coupling force between the impeller 8 and the impeller shaft 7 by combining the hub 9 with the groove 17. At the same time, because the connecting portion is a groove 17, the area where the connecting portion is located can have a certain degree of bending flexibility.

[0121] In this embodiment, the impeller 8 is made of a polymer material, preferably one of natural rubber, isoprene rubber or thermoplastic polyurethane.

[0122] In this embodiment, the impeller shaft 7 is made of a metal material, preferably a cobalt-chromium alloy, a nickel-titanium alloy, stainless steel (304 stainless steel or 316 stainless steel) or a tungsten alloy. The impeller shaft 71 can be hardened by DLC or surface nitriding.

[0123] In this embodiment, the connection force between the impeller shaft 7 and the impeller 8 is improved by providing a connecting portion, thereby preventing the impeller 8 and the impeller shaft 7 from moving, preventing the impeller 8 and the impeller shaft 7 from rotating out of alignment, improving the working efficiency of the impeller 8, avoiding the risk of scratching between the impeller 8 and the housing 4, reducing the occurrence of hemolysis, and reducing the entry of particles into the body.

[0124] In this embodiment, the distal end of the impeller shaft 7 and the proximal end of the pigtail tube 1 are rotatably connected via a rotating structure 15. The rotating structure 15 can be of two structures, such as Figure 7 As shown, the first rotating structure 15 is a shaft sleeve 73, which is made of ceramic. The distal end of the impeller shaft 7 is located inside the shaft sleeve 73 and is fixed to the shaft sleeve 73; Figure 6 As shown, the second rotating structure 15 is a bearing, preferably a ball bearing. The distal end of the impeller shaft 7 is located inside the inner ring 67 of the bearing and is fixed to the bearing inner ring 67. The pigtail tube 1 is located outside the outer ring 68 of the bearing and is fixed to the bearing outer ring 68. If the impeller shaft 7 is fixed to the inner ring 67 of the bearing, the impeller shaft 7 is axially fixed relative to the pigtail tube 1. If the impeller shaft 7 is engaged with the shaft sleeve 73, the impeller shaft 7 can move axially relative to the pigtail tube 1. The distal end of the impeller shaft 7 is provided with a shaft step 16. The proximal end of the rotating structure 15 cooperates with the shaft step 16 to axially limit the impeller shaft 7, restricting its movement toward the distal end of the catheter pump.

[0125] In this embodiment, Figure 23 As shown, the multi-lumen tube 5 is made of plastic materials such as polyamide and Pebax. The multi-lumen tube 5 includes an inner tube 26 and an outer tube 27. The inner tube 26 is coaxially arranged on the inner side of the outer tube 27. A perfusion cavity 23 is provided between the inner tube 26 and the outer tube 27. The transmission shaft 12 is coaxially arranged in the inner tube 26. An outflow cavity 24 is provided between the transmission shaft 12 and the inner tube 26. The transmission shaft 12 is used to transmit the driving torque. The transmission shaft 12 is made of stainless steel or cobalt-chromium-molybdenum alloy. A spring tube 28 is provided between the transmission shaft 12 and the inner tube 26. The outer wall contacts or does not contact the inner wall of the inner tube 26, the inner wall of the spring tube 28 contacts or does not contact the outer wall of the transmission shaft 12, and the spring tube 28 is made of stainless steel. The spring tube 28 is used to constrain the radial runout of the transmission shaft 12 and reduce operating vibration and noise; the perfusion chamber 23 extends from the proximal end of the multi-lumen tube 5 to the distal end of the multi-lumen tube 5, and the outflow chamber 24 extends from the proximal end of the multi-lumen tube 5 to the distal end of the multi-lumen tube 5. The distal end of the outflow chamber 24 is connected to the distal end of the perfusion chamber 23, and the proximal end of the impeller shaft 7 is connected to the distal end of the transmission shaft 12. Figure 22 As shown, the impeller shaft 7 is provided with an inlet 25 connected to the fluid channel 11. The inlet 25 is a through-hole 18 structured on the sidewall of the impeller shaft 7. The inlet 25 is connected to the perfusion chamber 23, the fluid channel 11, and the outflow chamber 24. The perfusion liquid flows into the perfusion chamber 23, flows into the fluid channel 11 from the proximal end of the impeller shaft 7 through the inlet 25, flows along the fluid channel 11 to the distal end of the impeller shaft 7, and flows out through the gap between the impeller shaft 7 and the rotating structure 15 before entering the human body. Simultaneously, the perfusion liquid flows out of the outflow chamber 24. The flow of the perfusion liquid in the catheter pump can increase interfacial lubrication, reduce friction, and provide cooling and heat dissipation.

[0126] In this embodiment, a sheath cover 34 is provided on the outside of the connection between the proximal end of the impeller shaft 7 and the distal end of the transmission shaft 12. The sheath cover 34 can be made of the same material as the impeller shaft 7 or ceramic material. There is a gap between the impeller shaft 7 and the inner side of the sheath cover 34. The fitting gap is 1-8um, preferably 1-3um, so that the impeller shaft 7 and the sheath cover 34 can rotate relative to each other. The two ends of the sheath cover 34 are respectively connected to the expandable stent 3 and the multi-lumen tube 5. An opening 35 is provided on the sheath cover 34, and the opening 35 can connect the distal end of the perfusion cavity 23 and the distal end of the outflow cavity 24.

[0127] In this embodiment, Figures 41 to 52The handle module 6 includes a perfusion cavity 38, a transmission sealing structure, a drive motor 40 and a proximal insert 45. The perfusion cavity 23 of the multi-lumen tube 5 is connected to the perfusion port of the perfusion cavity 38, and the outflow cavity 24 of the multi-lumen tube 5 is connected to the outflow port of the perfusion cavity 38. The proximal insert 45 is made of metal such as stainless steel. The proximal insert 45 is sleeved on the outside of the transmission shaft 12, and there is a gap between the proximal insert 45 and the transmission shaft 12. The proximal end of the proximal insert 45 is fixedly connected to the perfusion cavity 38, and the distal end of the proximal insert 45 is sealed with the inner cavity of the multi-lumen tube 5. The proximal insert 45 serves to connect the outflow cavity 24 with the perfusion cavity. The role of the separation of the cavity 23 is to connect the proximal end of the multi-lumen tube 5 with the perfusion cavity 38 and the proximal end of the perfusion cavity 23 and the proximal end of the outflow cavity 24 are not connected. The transmission sealing structure includes an external magnetic component 41, an internal magnetic component 42, a driven shaft 43 and a sealing cover 44. The external magnetic component 41, the internal magnetic component 42, the driven shaft 43 and the sealing cover 44 are all coaxially arranged. The internal magnetic component 42 and the external magnetic component 41 are made of materials such as neodymium iron boron. The internal magnetic component 42 and the external magnetic component 41 each include a magnetic ring. The internal magnetic component 42 is sleeved on the driven shaft 43 and bonded to the driven shaft 43. The internal magnetic component 42 is used to receive magnetic torque. The sealing cover 44 is arranged on the outside of the inner magnetic component 42, the outer magnetic component 41 is arranged on the outer magnetic component mounting sleeve 46, the outer magnetic component mounting sleeve 46 is located on the inner side of the perfusion cavity 38, the outer magnetic component mounting sleeve 46 is fixedly connected to the outer magnetic ring and the output shaft of the drive motor 40 respectively, the outer magnetic component mounting sleeve 46 is used to transmit the rotational torque of the output shaft of the drive motor 40 and fix the outer magnetic ring, the outer magnetic component mounting sleeve 46 is made of engineering plastics such as Peek, PC, ABC, etc., the outer magnetic component 41 is located on the outside of the sealing cover 44, and there is a gap between the outer magnetic component 41 and the sealing cover 44, and the sealing cover 44 is made of non-metallic materials. The sealing cover 44 is made of materials such as ceramics (such as alumina, zirconia, etc.), glass, diamond, etc., or the sealing cover 44 is made of plastic, and a non-metallic wear-resistant coating is provided on the outside of the plastic. The open end 47 of the sealing cover 44 is sealed and connected to the perfusion cavity 38 by bonding, and the outer wall of the sealing cover 44 is sealed and connected to the perfusion cavity 38 by interference fit. The sealing cover 44 is used to isolate the inner magnetic component 42 and the outer magnetic component 41. The rotation of the outer magnetic component 41 drives the inner magnetic component 42 and the driven shaft 43 to rotate relative to the sealing cover 44. The driven shaft 43 and the inner magnetic component 42 can also move along the axial direction of the sealing cover 44.

[0128] In this embodiment, the handle module 6 also includes a first diffusion stress tube 55, a motor housing 56, a second diffusion stress tube 57 and a cable 58. The first diffusion stress tube 55 is made of elastic materials such as rubber, silicone or polyurethane. The distal end of the first diffusion stress tube 55 is fixedly connected to the multi-lumen tube 5, and the proximal end of the first diffusion stress tube 55 is fixedly connected to the perfusion cavity 38. The first diffusion stress tube 55 is used to reduce the stress concentration between the multi-lumen tube 5 and the perfusion cavity 38 and reduce bends. The first diffusion stress tube 55 is provided with an infusion tube 59 and an outflow tube 60. The infusion tube 59 is made of PVC or polyurethane. One end of the infusion tube 59 is connected to the infusion port. The infusion tube 59 is used to transport infusion fluid (heparin saline) into the body. The outflow tube 60 is made of PVC or polyurethane. One end of the outflow tube 60 is connected to the outflow port. The outflow tube 60 is used to transport infusion fluid (heparin saline) into the body. 0 is used to receive the liquid refluxed from the body and flow it back to the extracorporeal waste liquid bag; the motor housing 56 is arranged on the outside of the drive motor 40, and the motor housing 56 and the perfusion cavity 38 can be detachably connected, and the motor housing 56 and the perfusion cavity 38 are connected by a locking nut 61, and the locking nut 61 is made of ABS / PC material. The second diffusion stress tube 57 is located on the outside of the drive motor 40 and the inside of the drive motor 40 shell. The distal end of the second diffusion stress tube 57 is connected to the motor housing 56, and the proximal end of the second diffusion stress tube 57 is connected to the cable 58. One end of the cable 58 is connected to the drive motor 40. The cable 58 is used to provide power to the motor and transmit control and detection signals. The second diffusion stress tube 57 is made of elastic materials such as rubber, silicone or polyurethane. The second diffusion stress tube 57 is used to reduce vibration and noise during motor operation.

[0129] In this embodiment, the sealing cover 44 is integrally formed, and the sealing cover 44 includes a first connecting portion 70 and a second connecting portion 71. One end of the first connecting portion 70 is an open end 47, and the other end of the first connecting portion 70 is connected to one end of the second connecting portion 71, and the other end of the second connecting portion 71 is a closed end; the driven shaft 43 is provided with a protrusion 54, and the protrusion 54 forms a rotational connection with the first connecting portion 70 of the sealing cover 44, and the second connecting portion 71 of the sealing cover 44 forms a rotational connection with the driven shaft 43.

[0130] In this embodiment, the driven shaft 43 is a solid structure, which is formed by winding multiple strands of steel cables, and the distal end of the driven shaft 43 is used to connect with the proximal end of the transmission shaft 12; or, the driven shaft 43 is a hollow structure, which is a hollow torque spring formed by braiding multiple strands of steel cables, and the proximal end of the transmission shaft 12 extends into the driven shaft 43, and the transmission shaft 12 is a solid shaft.

[0131] In this embodiment, the distal end of the driven shaft 43 extends from the open end 47 of the sealing cover 44 and there is a gap between the driven shaft 43 and the perfusion cavity 38. The gap between the driven shaft 43 and the perfusion cavity 38 can be connected to the outflow cavity 24. The proximal end of the driven shaft 43 is close to the sealing end 48 of the sealing cover 44. There are gaps between the driven shaft 43 and the sealing cover 44, and between the internal magnetic assembly 42 and the sealing cover 44.

[0132] When the transmission sealing structure of this embodiment is in use, the driving motor 40 drives the external magnetic assembly mounting sleeve 46 to drive the external magnetic assembly 41 to rotate. Through the magnetic force cooperation between the external magnetic assembly 41 and the internal magnetic assembly 42, the external magnetic assembly 41 drives the internal magnetic assembly 42 and the driven shaft 43 to rotate, the driven shaft 43 drives the transmission shaft 12 to rotate, and the transmission shaft 12 drives the impeller shaft 7 and the impeller 8 to rotate.

[0133] The sealing cover 44 of this embodiment not only seals but also enables a rotational connection, achieving an integrated design of sealing and rotational connection. During the transmission process, the outer magnetic assembly 41 and the inner magnetic assembly 42 do not contact each other. Furthermore, the driven shaft 43 not only rotates but also moves axially. This embodiment of the transmission seal has a simple structure, high reliability, long life, and low cost.

[0134] In this embodiment, Figure 24 、 Figure 70 、 Figure 71 and Figure 53 After the perfusion liquid enters the perfusion chamber 23 through the perfusion tube 59, it is divided into two paths: one part of the perfusion liquid enters the liquid channel 11 through the inlet 25, flows to the distal end of the impeller shaft 7, and flows out through the gap between the impeller shaft 7 and the rotating structure 15 to enter the human body; the other part of the perfusion liquid flows out of the outflow chamber 24 and is divided into two paths. One path flows to the waste liquid bag through the outflow tube 60, and the other path flows into the space formed by the driven shaft 43, the internal magnetic assembly 42 and the sealing cover 44 through the gap between the driven shaft 43 and the perfusion chamber 38, and then flows out through the gap between the driven shaft 43 and the perfusion chamber 38 and is discharged through the outflow tube 60.

[0135] Example 2

[0136] The difference between this embodiment and the first embodiment is that: Figure 25As shown, in this embodiment, the distal end of the impeller shaft 7 does not have a shaft step 16, and the sheath cover 34 does not need to be provided with a sheath cover limiting step 36. The proximal end of the impeller shaft 7 is fixedly connected to the distal end of the drive shaft 12. When the expandable stent 3 changes from a contracted state to an expanded state, the distal end of the expandable stent 3 drives the pigtail tube 1, and thereby drives the rotating structure 15 to move proximally relative to the impeller shaft 7. At this time, the sheath cover limiting step 36 does not play a limiting role. Because the impeller shaft 7 is fixedly connected to the drive shaft 12, and the proximal end of the drive shaft 12 is fixedly connected to the driven shaft 43, the sealing end 48 of the sealing cover 44 limits the proximal end of the driven shaft 43, thereby limiting the impeller shaft 7 from excessive proximal movement.

[0137] Example 3

[0138] In order to solve the problem that the impeller shaft 7 cannot be bent in the prior art, in this embodiment, the impeller shaft 7 includes a first rigid section 20, a flexible section 21 and a second rigid section 22 arranged in sequence, the impeller 8 and the connecting part are both located in the flexible section 21, the connecting part is a through hole 18, and the flexible section 21 can be bent.

[0139] In this embodiment, the flexible section 21 is a hypotube structure, which can be a conventional hypotube structure. The flexible section 21 of this embodiment allows the impeller structure 2 to be axially flexible, thereby reducing damage to the blood vessel wall during the pumping process and resolving the problem of the impeller shaft 7 being non-flexible.

[0140] like Figure 17 and Figure 19 As shown: In this embodiment, the fluid channel 11 is connected to the through hole 18, and the hub 9 passes through the through hole 18 and forms a film layer 19 on the inner wall of the impeller shaft 7, thereby further improving the bonding force between the impeller 8 and the impeller shaft 7. The hub 9 covers both the inner and outer walls of the impeller shaft 7 where the through hole 18 is located. The portion of the hub 9 on the inner wall of the impeller shaft 7 contacts the inner wall of the impeller shaft 7, the portion of the hub 9 on the outer wall of the impeller shaft 7 contacts the outer wall of the impeller shaft 7, and the portion of the hub 9 at the through hole 18 contacts the side wall of the through hole 18, thereby sealing the through hole 18 and preventing leakage of the perfusion liquid. The provision of the through hole 18 further improves the bending deflection of the impeller shaft 7.

[0141] When the impeller shaft 7 and the impeller 8 are integrally injection molded, first, the cut impeller shaft 7 is placed in the mold cavity for positioning; secondly, a cylindrical and stepped axis is extended from both ends of the impeller shaft 7 into the liquid channel 11, and the gap between the axis and the inner wall of the impeller shaft 7 is used to form the part of the hub 9 inside the inner wall of the impeller shaft 7, that is, the membrane layer 19; finally, the mold cavity is removed to obtain the impeller structure 2.

[0142] Example 4

[0143] This embodiment defines the specific structure of the hypotube structure in the third embodiment, such as Figure 18 As shown, in this embodiment, the side wall of the flexible section 21 is provided with a plurality of circles of through hole 18 structures along the axial direction of the flexible section 21. Each circle of the through hole 18 structure includes a plurality of through holes 18 arranged along the circumference of the flexible section 21. The through holes 18 are discontinuous in the circumferential direction of the flexible section 21 so as to maintain the torque transmission performance of the impeller shaft 71. The through holes 18 of adjacent circles are staggered, and the shape of the through holes 18 is not limited.

[0144] Example 5

[0145] like Figure 20 and Figure 21 This embodiment further defines the fourth embodiment. In this embodiment, the through holes 18 are elongated holes. The dimension B of the connecting portions between adjacent through holes 18 in the same circle of through holes 18 is 0.05-2 mm, preferably 0.1-0.5 mm, and more preferably 0.25 mm. The dimension A of the through holes 18 along the axial direction of the flexible section 21 is 0.1-0.5 mm, preferably 0.1-0.5 mm, and more preferably 0.25 mm. In this embodiment, the maximum bending deflection W of the impeller shaft 7 is within the range of 0.1-5 mm.

[0146] In this embodiment, the presence of the through hole 18 can not only enhance the coupling force between the impeller 8 and the impeller shaft 7 , but also increase the bending deflection of the impeller shaft 7 .

[0147] Example 6

[0148] like Figures 11 to 12 As shown: In this embodiment, the through holes 18 of adjacent circles are arranged in a one-to-one correspondence, and the through holes 18 are circular holes.

[0149] Example 7

[0150] like Figures 13 and 14 As shown: The difference between this embodiment and the sixth embodiment is that, in this embodiment, the through holes 18 are circular holes, and the through holes 18 of adjacent circles are staggered.

[0151] Example 8

[0152] like Figures 15 and 16 As shown: In this embodiment, the through holes 18 include round holes and long holes. The through holes 18 in the through hole 18 structure of the same circle are all round holes, and the through holes 18 in the through hole 18 structure adjacent to it are all long holes, and the through holes 18 in adjacent circles are staggered.

[0153] Embodiment 9

[0154] The difference between this embodiment and the first embodiment is that in this embodiment, the connecting portion is a groove 17 and a through hole 18 .

[0155] Example 10

[0156] like Figures 26 to 31 As shown, this embodiment further optimizes the first embodiment. This embodiment includes a transfer block 29, which can be made of the same material as the impeller shaft 7 or a ceramic material. The proximal end of the impeller shaft 7 is connected to the distal end of the drive shaft 12 via the transfer block 29. In this embodiment, the proximal end of the impeller shaft 7 is provided with protrusions 31. Between adjacent protrusions 31 is an inlet 25, which is a notched structure. The transfer block 29 is provided with a first channel 30, which communicates with the inlet 25, the infusion chamber 23, and the outflow chamber 24, respectively.

[0157] In this embodiment, Figures 32 to 36 As shown, a sheath cover 34 is provided on the outside of the connection between the proximal end of the impeller shaft 7 and the adapter block 29. A clearance exists between the outside of the connection between the proximal end of the impeller shaft 7 and the adapter block 29 and the inside of the sheath cover 34. The clearance is 1-8 μm, preferably 1-3 μm, so that the connection between the proximal end of the impeller shaft 7 and the adapter block 29 and the sheath cover 34 can rotate relative to each other. The sheath cover 34 is provided with a sheath cover limiting step 36. The impeller shaft 7 is provided with a shaft step 16. The proximal end of the impeller shaft 7 and the adapter block 29 are axially slidably engaged. The adapter block 29 is fixedly connected to the transmission shaft 12. When the expandable stent 3 changes from a contracted state to an expanded state, the distal end of the expandable stent 3 drives the pigtail 1, which in turn drives the rotating structure 15. The rotating structure 15 drives the impeller shaft 7, which in turn drives the adapter block 29 to move proximally. The sheath cover limiting step 36 prevents the adapter block 29 from excessive proximal movement.

[0158] In this embodiment, a slide groove 32 is provided on the adapter block 29, and the protrusion 31 is slidably connected to the slide groove 32. The gap between the inner surface of the protrusion 31 and the surface of the slide groove 32 is between 0.1-0.5 mm, forming a second channel 33 between the inner surface of the protrusion 31 and the surface of the slide groove 32. The second channel 33 is connected to the perfusion chamber 23, the liquid channel 11, and the outflow chamber 24 respectively.

[0159] In this embodiment, the perfusion liquid is divided into three paths: after the perfusion liquid enters the perfusion chamber 23, a portion of the perfusion liquid enters the liquid channel 11 through the first channel 30 and the inlet 25. At the same time, a portion of the perfusion liquid enters the liquid channel 11 through the second channel 33. The perfusion liquid flows to the distal end of the impeller shaft 7 and flows out from the gap between the impeller shaft 7 and the rotating structure 15 to enter the human body; the remaining portion of the perfusion liquid flows out from the outflow chamber 24.

[0160] Example 11

[0161] like Figures 37 to 40As shown, this embodiment is further optimized based on the embodiment 10. A sheath cover 34 is provided on the outer side of the connection between the proximal end of the impeller shaft 7 and the adapter block 29. The sheath cover 34 is sealedly connected to the inner tube 26 and the outer tube 27 of the multi-lumen tube 5 respectively.

[0162] In this embodiment, there is a third channel 37 between the outer wall of the proximal end of the impeller shaft 7 and the inner wall of the sheath cover 34. The size of the third channel 37 is between 0.003-0.2 mm. The proximal end of the third channel 37 is connected to the distal ends of the perfusion chamber 23, the first channel 30, the second channel 33 and the outflow chamber 24 respectively, and the distal end of the third channel 37 is connected to the human body.

[0163] In this embodiment, an opening 35 is provided on the sheath cover 34 so that the first channel 30 , the second channel 33 , the third channel 37 , the perfusion cavity 23 and the outflow cavity 24 can communicate with each other.

[0164] In this embodiment, the perfusion liquid is divided into four paths: after the perfusion liquid enters the perfusion chamber 23, a portion of the perfusion liquid enters the liquid channel 11 through the first channel 30 and the inlet 25. At the same time, a portion of the perfusion liquid enters the liquid channel 11 through the second channel 33, flows to the distal end of the impeller shaft 7, and flows out through the gap between the impeller shaft 7 and the rotating structure 15 to enter the human body; a portion of the perfusion liquid enters the human body through the third channel 37; and another portion of the perfusion liquid flows out of the outflow chamber 24.

[0165] Example 12

[0166] like Figures 64 to 65 As shown, the difference between this embodiment and the first embodiment is that: in this embodiment, a pressure measuring chamber 62 is further provided between the inner tube 26 and the outer tube 27, and the pressure measuring chamber 62 is separated from the perfusion chamber 23 by a partition 63. The pressure measuring chamber 62 is not connected to the perfusion chamber 23, and the pressure measuring chamber 62 is connected to the human body through a pressure measuring hole 39 opened on the side wall of the outer tube 27. A plug 72 is provided at the front end of the pressure measuring hole 39 to prevent the pressure measuring chamber 62 from being connected to the perfusion chamber 23 and the outflow chamber 24. A detection chamber 64 is provided in the perfusion chamber body 38, and the detection chamber 64 is respectively connected to the pressure measuring chamber 62 and a pressure measuring tube 65 for passing a pressure measuring liquid. A pressure measuring element 66 is provided in the detection chamber 64. The pressure measuring element 66 is preferably a pressure sensor, and the pressure measuring element 66 is used to detect the body pressure transmitted by the pressure measuring liquid.

[0167] Since the perfusion cavity 38 and the motor housing 56 are detachably connected, the transmission line 74 of the pressure measuring element 66 is provided with a transmission line antenna 75 at a corresponding position.

[0168] Example 13

[0169] like Figures 54 to 55As shown, the difference between this embodiment and the first embodiment is that in this embodiment, the inner magnetic assembly 42 and the outer magnetic assembly 41 each include at least two magnetic rings. The magnetic rings in the inner magnetic assembly 42 are arranged along the axial direction of the driven shaft 43, and the magnetic rings in the outer magnetic assembly 41 are arranged along the axial direction of the driven shaft 43. By increasing the volume of the inner magnetic assembly 42 and the outer magnetic assembly 41 (for example, by increasing the length, thickness, surface area, etc.), the strength of the inner magnetic assembly 42 and the outer magnetic assembly 41 is increased, thereby increasing the magnetic torque.

[0170] Example 14

[0171] like Figures 56 to 59 As shown: The difference between this embodiment and embodiment thirteen is that: in this embodiment, the driven shaft 43 includes a first shaft portion 50 and a second shaft portion 51, the first shaft portion 50 is located inside the sealing cover 44, and the second shaft portion 51 is located outside the sealing cover 44, and a spiral structure 52 is provided on the outside of the second shaft portion 51, and the rotation direction of the spiral structure 52 is opposite to the rotation direction of the driven shaft 43. For example, if the driven shaft 43 is right-handed, the rotation direction of the spiral structure 52 is left-handed. By providing the spiral structure 52, the liquid in the space formed by the driven shaft 43, the internal magnetic component 42 and the sealing cover 44 can be promoted to flow out, thereby taking away friction heat and wear particles, avoiding the presence of blood in the space formed by the driven shaft 43, the internal magnetic component 42 and the sealing cover 44, and avoiding the coagulation of protein in the blood to hinder the rotation of the driven shaft 43 and the internal magnetic component 42.

[0172] Example 15

[0173] like Figures 60 to 61 As shown, the difference between this embodiment and the fourteenth embodiment is that in this embodiment, the drive shaft 12 is a hollow shaft, that is, a return channel is provided in the drive shaft 12, which is connected to the outflow chamber 24. The liquid is divided into two paths: one path flows from the gap between the driven shaft 43 and the perfusion chamber 38 into the space formed by the driven shaft 43, the internal magnetic assembly 42, and the sealing cover 44, and then flows out through the gap between the driven shaft 43 and the perfusion chamber 38, carrying away the friction heat between the driven shaft 43 and the sealing cover 44 before flowing out through the outflow pipe 60; the other path flows from the return channel of the drive shaft 12 into the space formed by the driven shaft 43, the internal magnetic assembly 42, and the sealing cover 44, and then flows out through the gap between the driven shaft 43 and the perfusion chamber 38.

[0174] Example 16

[0175] The difference between this embodiment and the first embodiment is that in this embodiment, the inner magnetic assembly 42 and the outer magnetic assembly 41 each include at least two magnetic rings, the magnetic rings in the inner magnetic assembly 42 are nested in sequence along the radial direction of the driven shaft 43, and the magnetic rings in the outer magnetic assembly 41 are nested in sequence along the radial direction of the driven shaft 43.

[0176] Example 17

[0177] The difference between this embodiment and embodiment 1 is that: in this embodiment, the inner magnetic component 42 and the outer magnetic component 41 both include a plurality of magnetic strips uniformly arranged along the circumference of the driven shaft 43, and the number of magnetic strips of the inner magnetic component 42 is the same as or different from the number of magnetic strips of the outer magnetic component 41.

[0178] Example 18

[0179] like Figures 62 to 69 As shown, the difference between this embodiment and embodiments 12 to 17 is that: in this embodiment, the shaft step 16 is not provided on the impeller shaft 7, and a wear-resistant insert 53 is provided between the driven shaft 43 and the perfusion cavity 38. The wear-resistant insert 53 is made of ceramic material, such as alumina, zirconia, etc. The wear-resistant insert 53 is fixedly connected to the perfusion cavity 38. When the driven shaft 43 rotates, the wear-resistant insert 53 and the driven shaft 43 form a bearing fit and can rotate relative to each other. The wear-resistant insert 53 cooperates with the protrusion 54 to achieve axial limitation of the driven shaft 43, thereby limiting the movement of the driven shaft 43 toward the distal end of the catheter pump.

[0180] The impeller structure 2 of the present invention is axially bendable, reducing damage to the blood vessel wall during the pushing process of the catheter pump; the impeller shaft 7 and the impeller 8 are integrally injection-molded, and the binding force between the impeller 8 and the impeller shaft 7 is increased by the connecting part on the impeller shaft 7; this embodiment has a stable support, and the impeller shaft 7 is a continuous shaft, avoiding the problem of radial deflection caused by the use of multi-section shafts in the impeller shaft in the prior art, reducing the risk of scratching between the impeller 8 and the housing 4, reducing hemolysis, and reducing the entry of particles into the body; this embodiment has a simple structure, low cost, and high reliability.

[0181] Example 19

[0182] After in-depth and extensive research, the applicant found that most interventional instruments (such as intravascular blood pumping devices, intracardiac blood pumping devices, thrombus aspiration catheters, rotary grinding thrombus crushing catheters, etc.) that are operated through minimally invasive surgery and transmit torque in the human body through a flexible transmission shaft (such as the transmission shaft 12) or drive the functional unit of the distal section of the flexible transmission shaft (such as the impeller structure 2, the thrombus crushing basket, the grinding blade, etc.) to rotate (such as driving the impeller 8 to rotate) are faced with the technical problem that the functional unit and its fixed rotating shaft (such as the impeller shaft 7 to which the impeller 8 on the impeller structure 2 is fixed) interact with other structures (such as the pigtail tube 1, the sheath cover 34, the expandable stent 3) under working conditions (such as interface friction, unstable collision), resulting in wear and tear of the precipitated particles entering the body / vascular blood.

[0183] The aforementioned technical problems are particularly significant and difficult to resolve in some interventional instruments that require shaft support assemblies at both ends or one end of the shaft, and the shaft support assemblies have functions including radial support and thrust support. The shaft support assembly includes a radial support member and an axial thrust support member; the shaft is configured to pass through the axis of a functional element (such as an impeller 8) and is fixedly connected to the functional element; the radial support member is configured to reduce the radial movement of the functional unit by maintaining the shaft of the functional unit at a given radial position; the purpose of the axial thrust support member is to resist the axial force acting on the functional unit, hinder the axial movement of the shaft, and thereby reduce or suppress the axial position change of the functional unit. In some specific applications (such as axial flow blood pumping), in addition to radial support, the rotating shaft of the functional unit must also be equipped with axial thrust support (for example, an axial flow pump, which is different from the principle of a centrifugal pump, has blades that are subjected to force from the fluid when in operation, that is, the fluid pushes the blades in a direction opposite to its own movement direction); in some specific applications, the axial thrust support structure of the functional unit in the interventional instrument can be set on an external driving component (for example, in the embodiment, the impeller shaft 7 is fixedly connected to the transmission shaft 12, and the proximal end of the transmission shaft 12 is fixedly connected to the driven shaft 43, thereby migrating the axial thrust support structure to the external driving component), or it can be set on the rotating shaft of the functional unit in the body (for example, in the embodiment, a shaft step 16 is provided at the distal end of the impeller shaft 7, and the proximal end of the rotating structure 15 cooperates with the shaft step 16 to achieve axial limitation of the impeller shaft 7, thereby limiting the movement of the impeller shaft 7 toward the distal end of the catheter pump); however, when the axial thrust support structure is set in the body, the precipitation of particles due to interface friction and wear is not desired.

[0184] In existing fluid circuit design technologies, lubrication of the axial thrust bearing interface is often neglected, allowing particles precipitated from friction and wear at the interface to enter the body / blood vessels; other existing technologies strengthen and harden the shaft support assembly and the shaft end for wear resistance.

[0185] The present invention provides a method for suppressing wear and precipitation of particles on the moving joint surface of the distal section of an interventional instrument. The core idea of ​​the method is: using hydraulic suspension to suspend the rotating shaft so that the rotating shaft and the rotating shaft support assembly are in a non-contact or near-non-contact state, so as to reduce the contact area of ​​the moving joint surface between the rotating shaft and the rotating shaft support assembly. The specific method is: a hydraulic chamber is set at the moving joint surface between the rotating shaft and the rotating shaft support assembly (that is, the rotating shaft and the rotating shaft support assembly are clearance-fitted) for filling with liquid; the hydraulic chamber is provided with a liquid injection port and an outflow port; the liquid injection port and the outflow port are set in the rotating shaft, or the rotating shaft support assembly, or the fitting gap between the rotating shaft and the rotating shaft support assembly; liquid (such as physiological saline or other medically acceptable perfusion fluid) is injected into the hydraulic chamber through the injection port until the outflow port overflows / seeps / flows out the liquid; and the liquid pressure in the hydraulic chamber is adjusted so that the rotating shaft is supported radially and / or axially by the liquid in the hydraulic chamber and separated from the rotating shaft support assembly. It can be understood that this method has been applied and practiced in the first embodiment of the present invention; that is, the perfusion liquid enters the perfusion chamber 23 through the perfusion tube 59 and is divided into two paths. A part of the perfusion liquid enters the liquid channel 11 through the inlet 25 and flows to the distal end of the impeller shaft 7 (such as Figures 70-71 , hydraulic chamber 76), and flows out from the gap between the impeller shaft 7 and the rotating structure 15 (such as Figures 70-71 , shaft fitting clearance 77), enters the human body; when the injection flow rate / flow rate / pressure and other parameters of the perfusion fluid are adjusted in vitro, the hydraulic pressure in the hydraulic chamber can be affected to achieve the desired inhibition of friction and wear on the interface of the distal functional unit in the interventional device and the precipitation of particles; the role of the sleeve or bearing is reduced or replaced by hydraulic support.

[0186] Furthermore, the shaft support assembly includes a radial support member and an axial thrust support member; a hydraulic chamber is provided at the moving interface between the radial support member and the shaft; and a hydraulic chamber is provided at the moving interface between the axial thrust support member and the shaft; the two hydraulic chambers are interconnected. Furthermore, an inlet is provided on an end face or side face of the shaft, and an outlet is provided within the clearance between the radial support member and the shaft (i.e., the clearance between the radial support member and the shaft serves as the outlet). Furthermore, the hydraulic pressure in the hydraulic chamber is greater than the hydraulic pressure outside the outlet.

[0187] Based on the aforementioned method for inhibiting wear and precipitation of particles on the distal end joint surface of an interventional device, the applicant also provides:

[0188] An interventional instrument includes a functional unit for rotational operation, a flexible transmission shaft, a catheter and a handle structure; the functional unit includes a rotating shaft and a functional element fixed to the rotating shaft; the catheter is slender and its proximal end is connected to the handle structure, and the distal end of the catheter is provided with a rotating shaft support structure that can provide radial support and axial thrust support for the rotating shaft; the flexible transmission shaft is passed through the catheter, its distal end is connected to the rotating shaft, and its proximal end is connected to the handle structure to transmit the torque output by the handle structure to the rotating shaft; the functional unit can perform a limited axial displacement relative to the rotating shaft support structure; a hydraulic chamber is provided between the motion coupling surface between the rotating shaft support structure and the rotating shaft, which can enable the rotating shaft to be supported by liquid in the radial and / or axial directions to separate from the motion coupling surface of the rotating shaft support structure, and the hydraulic chamber has a liquid injection port and an outflow port.

[0189] Furthermore, the functional unit of the interventional instrument is one of an axial flow impeller structure, an embolism crushing basket structure, and a rotational grinding structure.

[0190] Furthermore, the interventional instrument also includes an infusion liquid circuit, the liquid inlet and outlet of the infusion liquid circuit are arranged at the proximal section of the catheter near the handle structure; the rotating shaft is configured as a hollow channel or has an axial hole; the infusion liquid circuit is connected to the injection port of the hydraulic chamber through the channel or hole of the rotating shaft.

[0191] Furthermore, the catheter of the interventional instrument is a multi-lumen tube, and the flexible transmission shaft and the perfusion liquid path are arranged in different lumens in the catheter.

[0192] Furthermore, the interventional instrument also includes an outer cover structure (such as an expandable stent 3) for supporting and maintaining the cavity for the functional unit; the rotating shaft support structure is configured at the distal end section of the rotating shaft; the distal end section of the outer cover structure is fixedly connected to the rotating shaft support structure, and the proximal end section of the outer cover structure is fixedly connected to the distal end section of the catheter.

[0193] Furthermore, the interventional instrument also includes a distal support structure (such as a pigtail tube 1), the rotating shaft support structure and the distal support structure are integrated, the distal section of the outer cover structure is fixedly connected to the proximal section of the distal support structure, and the proximal section of the outer cover structure is fixedly connected to the distal section of the catheter.

[0194] Furthermore, the interventional device is used to pump blood through the heart or to aspirate blood clots in the blood vessel cavity.

[0195] Example 20

[0196] After in-depth and extensive research, the applicant has also discovered that for most interventional devices requiring shaft rotation, the shaft's bending performance (i.e., its ability to adapt to different turning radii while navigating tortuous vascular structures) and rotational stability (i.e., its ability to maintain the axis without oscillation or deflection under the rotation of a loaded functional element) are two difficult performance characteristics to achieve simultaneously. Furthermore, the robustness of the connection between the shaft and the functional element is also a major safety concern for interventional devices. Excellent bending performance requires the shaft to possess good flexible bending deformation capabilities, while good rotational stability requires the shaft to possess good moment resistance (i.e., shaft rigidity). In existing technologies, such as cardiac pumping devices or thrombus aspiration devices, the shaft length is often compressed and shortened to achieve both bending and rotational stability, and double-end / side radial supports / limits are abandoned in favor of single-end / side radial supports / limits. This results in technical problems: the reduced connection surface between the functional element and the shaft significantly reduces the robustness of the connection, and the anti-interference performance of the entire functional unit is reduced. To this end, the present invention provides a method for strengthening the shaft of an interventional instrument. The core idea of ​​this method is: using two materials with different properties to perform an embedded configuration with complementary elasticity and rigidity, so as to achieve a balanced improvement in the bending and rotational stability of the shaft, while also improving the firmness of the connection between the shaft and the functional element; for example, an elastic polymer material is embedded in the outer surface of the metal shaft in the direction of the shaft center (axis) (it can also be understood as: a part of the metal shaft body is replaced by the elastic polymer material from the outer surface facing the axis center). The specific method is: on a metal shaft with two end faces and an outer side surface, a plurality of grooves or through holes are etched from the outer side of the shaft in the direction of the axis; the grooves or through holes are arranged in an array along the axis and circumference of the shaft to change the deflection of the metal shaft; the outer surface of the shaft is filled with elastic polymer material in these arrayed grooves or through holes, and the elastic polymer material is adhered to the wall of the groove or through hole. It is understood that this method has been applied and practiced in Examples 1 to 9 of the present invention; that is, the groove 17 or through-hole 18 of the impeller shaft 7 on the impeller structure 2 is filled with the hub 9. The metal shaft, after its deflection is modified and embedded with the elastic polymer material, can suppress the deflection and oscillation of the shaft from its axis during rotation due to the elastic pulling and compression of the elastic polymer material in the groove or through-hole by the metal wall to which it adheres. This allows the shaft to quickly correct its deflection after being disturbed by a bending moment to maintain its rotational stability.

[0197] Furthermore, the elastic polymer material filling each groove or through hole overflows the metal outer side of the metal shaft and accumulates to form an elastic polymer coating layer (such as the hub 9) with a continuous outer side.

[0198] Furthermore, the elastic polymer coating is molded into a three-dimensional contour structure (eg, blade 10 ) having the function of a pump blade.

[0199] Furthermore, the metal shaft is configured as a hollow metal tube shaft; the wall of the hollow metal tube shaft is etched to form a gap penetrating the inner and outer wall surfaces of the tube wall; the elastic polymer material is filled into the gap and overflows the gap to form a continuous elastic polymer coating layer (such as the film layer 19 and the hub 9) on the inner and outer wall surfaces of the tube wall; and the elastic polymer coating layer is adhered to the metal tube wall surface. It is understood that the integral injection molding process in Example 1 is only one of the means by which the present invention achieves the combination of the metal shaft and the elastic polymer material.

[0200] Furthermore, the hollowed-out slits of the metal tube shaft are arranged at intervals along the axial direction of the metal tube shaft and staggered along the circumferential direction; or, they extend spirally along the central axis of the metal tube shaft.

[0201] Furthermore, in the axial direction of the metal tube shaft, only the middle section is etched and hollowed out with a gap, while the two end sections have no hollowed-out gaps.

[0202] The "rotating shaft", "metal rotating shaft" and "metal tube rotating shaft" mentioned in this embodiment all refer to shafts used to fixedly support functional elements such as impellers, blades, mesh baskets, rotary grinding blades, etc., and to transmit torque to these functional elements; they can be shafts that are independent of the flexible transmission shaft (used to drive the source or handle structure to transmit torque to the functional unit, referred to as the "flexible transmission shaft" in this embodiment), or they can be shafts that are integrated with the flexible transmission shaft.

[0203] Based on the aforementioned method for strengthening the rotating shaft of an interventional device provided by the present invention, the applicant also provides:

[0204] A functional unit of an interventional instrument, the functional unit comprising a functional element for rotational operation, a metal shaft for supporting the functional element and transmitting torque to the functional element; the functional element comprising a body and a base which are integrated with each other; the outer side surface of the metal shaft is provided with grooves or through holes along the circumferential direction for changing the bending deflection of the metal shaft; the grooves or through holes are arranged in an axial array along the metal shaft, or are set in an axial spiral along the metal shaft; the base of the functional element is made of elastic polymer material; a portion of the base of the functional element is embedded in the groove or through hole of the metal shaft and adheres to the wall of the groove or through hole; the functional element is fixed to the metal shaft through the base; the body of the functional element is a three-dimensional contour structure having the function of a pump blade.

[0205] Furthermore, the metal shaft is a hollow metal tube shaft.

[0206] Furthermore, a portion of the functional element base passes through the through hole of the metal tube rotating shaft, forming a continuous layered structure on the inner wall surface of the metal tube rotating shaft.

[0207] Furthermore, the body of the functional element is a blade, and the base of the functional element is a hub.

[0208] Furthermore, the metal tube shaft includes a first rigid section, a flexible section, and a second rigid section which are sequentially arranged. The through hole is located in the flexible section, and the flexible section is bendable.

[0209] Example 21

[0210] A blood pumping device comprises a functional unit for pumping blood, a flexible transmission shaft, a catheter and a handle structure; the functional unit comprises a metal rotating shaft and an impeller; the metal rotating shaft is used to support the impeller and transmit torque to the impeller; the catheter is slender and its proximal end is connected to the handle structure, and the distal end of the catheter is provided with a rotating shaft supporting structure that can provide radial support for the metal rotating shaft; the flexible transmission shaft is passed through the catheter, its distal end is connected to the metal rotating shaft, and its proximal end is connected to the handle structure to transmit the torque output by the handle structure to the metal rotating shaft; the functional unit can perform a limited axial displacement relative to the rotating shaft supporting structure; the impeller comprises a hub and blades; the outer side surface of the metal rotating shaft is provided with grooves or through holes along the circumferential direction for changing the bending deflection of the metal rotating shaft; the grooves or through holes are arranged in an axial array along the axial direction of the metal rotating shaft, or are spirally arranged along the axial direction of the metal rotating shaft; the hub is made of elastic polymer material; a part of the hub is embedded in the groove or through hole of the metal rotating shaft and adheres to the wall of the groove or through hole; the impeller is fixed to the metal rotating shaft through the hub.

[0211] Furthermore, a portion of the hub passes through the through hole of the metal tube shaft, forming a continuous layered structure on the inner wall surface of the metal tube shaft.

[0212] Furthermore, the metal tube shaft includes a first rigid section, a flexible section, and a second rigid section which are sequentially arranged. The through hole is located in the flexible section, and the flexible section is bendable.

[0213] Furthermore, the shaft support structure at the distal end of the catheter also includes an axial thrust support function. The first rigid section or the second rigid section of the metal tube shaft is provided in the shaft support structure with axial thrust support.

[0214] Furthermore, a hydraulic chamber is provided between the moving joint surface between the rotating shaft support structure and the first rigid section or the second rigid section, which can enable the metal rotating shaft to be supported by liquid in the radial and / or axial direction to separate from the moving joint surface of the rotating shaft support structure, and the hydraulic chamber has a liquid injection port and an outflow port.

[0215] Furthermore, the blood pumping device also includes an infusion liquid circuit, the liquid inlet and outlet of the infusion liquid circuit are arranged at the proximal section of the catheter near the handle structure; the metal rotating shaft is configured as a hollow channel or has an axial hole; the infusion liquid circuit is connected to the injection port of the hydraulic chamber through the channel or hole of the metal rotating shaft.

[0216] Furthermore, the catheter of the blood pumping device is a multi-lumen tube, and the flexible transmission shaft and the perfusion liquid path are arranged in different lumens in the catheter.

[0217] Furthermore, the blood pumping device also includes an outer cover structure (such as an expandable stent 3) for supporting and maintaining the cavity for the functional unit; the shaft support structure is arranged at the distal end section of the metal shaft; the distal end section of the outer cover structure is fixedly connected to the shaft support structure, and the proximal end section of the outer cover structure is fixedly connected to the distal end section of the catheter.

[0218] Furthermore, the blood pumping device also includes a distal support structure (such as a pigtail tube 1), the rotating shaft support structure and the distal support structure are integrated, the distal section of the outer cover structure is fixedly connected to the proximal section of the distal support structure, and the proximal section of the outer cover structure is fixedly connected to the distal section of the catheter.

[0219] In the present invention, the proximal end refers to the end close to the doctor, and the distal end refers to the end away from the doctor.

[0220] This specification uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A catheter pump, characterized in that: It includes a functional module, which includes an impeller structure, the impeller structure includes an impeller shaft and an impeller, the impeller includes a hub and a plurality of blades, the plurality of blades are arranged on the hub, the side wall of the impeller shaft is provided with a connecting portion, the hub and the connecting portion are connected by integral injection molding, and the connecting portion is used to limit the relative movement of the impeller.

2. The catheter pump according to claim 1, wherein: It also includes a pigtail tube, an expandable stent, a shell, a multi-lumen tube and a handle module. The impeller shaft is rotatably connected to the pigtail tube. The impeller shaft is connected to the mechanical power source in the handle module through a transmission shaft in the multi-lumen tube. The expandable stent is located on the outside of the impeller structure. The distal end of the expandable stent is connected to the pigtail tube. The proximal end of the expandable stent is used to connect to the multi-lumen tube. The shell is located on the outside of the expandable stent. The shell is respectively connected to the pigtail tube and the multi-lumen tube. The shell is provided with a blood inlet window and a bleeding window.

3. The catheter pump according to claim 2, characterized in that: A shaft step is provided at the distal end of the impeller shaft, and the impeller shaft is rotationally connected to the pigtail tube through a rotating structure. The proximal end of the rotating structure cooperates with the shaft step to axially limit the impeller shaft, thereby restricting the impeller shaft from moving toward the distal end of the catheter pump.

4. A catheter pump, characterized in that: It includes a functional module and a fluid path module, the functional module includes an impeller structure, the impeller structure includes an impeller shaft and an impeller, the impeller includes a hub and several blades, a rotating structure is provided between the distal end of the impeller shaft and the pigtail tube, several blades are provided on the hub, the side wall of the impeller shaft is provided with a connecting portion, the hub and the connecting portion are connected by integral injection molding, and the connecting portion is used to limit the relative movement of the impeller; the fluid path module includes a multi-lumen tube, the multi-lumen tube includes a perfusion cavity, the perfusion liquid flows from the perfusion cavity to the distal end of the impeller shaft, and flows out from the gap between the impeller shaft and the rotating structure and enters the human body.

5. The catheter pump according to claim 4, characterized in that: It also includes an expandable stent, a shell and a handle module. The impeller shaft is connected to the mechanical power source in the handle module through the transmission shaft in the multi-lumen tube. The expandable stent is located on the outside of the impeller structure. The distal end of the expandable stent is connected to the pigtail tube. The proximal end of the expandable stent is used to connect to the multi-lumen tube. The shell is located on the outside of the expandable stent. The shell is respectively connected to the pigtail tube and the multi-lumen tube. The shell is provided with a blood inlet window and a bleeding window.

6. The catheter pump according to claim 5, characterized in that: The multi-lumen tube is further provided with an outflow cavity, the perfusion cavity extends from one end of the multi-lumen tube to the other end of the multi-lumen tube, the outflow cavity extends from one end of the multi-lumen tube to the other end of the multi-lumen tube, the proximal end of the impeller shaft is connected to the distal end of the transmission shaft, a liquid path is provided in the impeller shaft, an inlet connected to the liquid path is provided on the impeller shaft, the inlet is connected with the perfusion cavity, the liquid path and the outflow cavity respectively, the perfusion liquid flows into the perfusion cavity, flows into the liquid path from the proximal end of the impeller shaft through the inlet, flows along the liquid path to the distal end of the impeller shaft, and flows out from the gap between the impeller shaft and the rotating structure and enters the human body, and at the same time, the perfusion liquid flows out from the outflow cavity.

7. The catheter pump according to claim 6, characterized in that: The multi-lumen tube includes an inner tube and an outer tube, the inner tube is coaxially arranged on the inner side of the outer tube, the perfusion cavity is arranged between the inner tube and the outer tube, the transmission shaft is located in the inner tube, and the outflow cavity is between the transmission shaft and the inner tube.

8. The catheter pump according to claim 7, characterized in that: A spring tube is provided between the transmission shaft and the inner tube.

9. The catheter pump according to claim 6, characterized in that: The proximal end of the impeller shaft is connected to the distal end of the transmission shaft via an adapter block. The adapter block is provided with a first channel, which is communicated with the inlet, the perfusion chamber and the outflow chamber respectively.

10. The catheter pump according to claim 9, characterized in that: A protrusion is provided at the proximal end of the impeller shaft, and the inlet is located between adjacent protrusions. A slide groove is provided on the adapter block, and the protrusion is slidably connected to the slide groove. A second channel is formed between the inner surface of the protrusion and the surface of the slide groove, and the second channel is respectively connected to the perfusion chamber and the liquid channel.

11. The catheter pump according to claim 10, characterized in that: The second channel is also in communication with the first channel and the outflow cavity.

12. The catheter pump according to claim 9, wherein: A sheath cover is provided on the outer side of the connection between the proximal end of the impeller shaft and the adapter block, and the sheath cover is connected to the expandable stent and the multi-lumen tube respectively. An opening is provided on the sheath cover, and the opening can connect the distal end of the perfusion cavity and the distal end of the outflow cavity.

13. The catheter pump according to claim 12, wherein: The sheath cover is provided with a sheath cover limiting step, and the sheath cover limiting step cooperates with the proximal end of the impeller shaft and the proximal end of the adapter block to achieve axial limiting of the impeller shaft, thereby restricting the impeller shaft from moving toward the proximal end of the catheter pump.

14. The catheter pump according to claim 12, wherein: A third channel is provided between the proximal end of the impeller shaft and the sheath cover, the proximal end of the third channel is communicated with the perfusion cavity, and the distal end of the third channel is communicated with the human body.

15. The catheter pump according to claim 14, characterized in that: The third channel is also in communication with the first channel and the outflow cavity.

16. A catheter pump, characterized in that: It includes a functional module and a handle module, the functional module includes an impeller structure, the impeller structure includes an impeller shaft and an impeller, the impeller includes a hub and a plurality of blades, the plurality of blades are arranged on the hub, the side wall of the impeller shaft is provided with a connecting part, the hub and the connecting part are connected by integral injection molding, and the connecting part is used to limit the relative movement of the impeller; the handle module includes a transmission sealing structure, the transmission sealing structure includes an external magnetic component, an internal magnetic component, a driven shaft and a sealing cover, the internal magnetic component is arranged on the driven shaft, the driven shaft is connected to the impeller shaft through a transmission shaft, the external magnetic component is arranged on the outside of the internal magnetic component, and the external magnetic component is used to connect to a mechanical power source, the sealing cover is used to isolate the internal magnetic component and the external magnetic component, and the driven shaft rotates and moves axially relative to the sealing cover.

17. The catheter pump according to claim 16, wherein: It also includes a pigtail tube, an expandable stent, a shell and a liquid circuit module. The impeller shaft is rotatably connected to the pigtail tube through a rotating structure. The liquid circuit module includes a multi-lumen tube. The transmission shaft is located in the multi-lumen tube. The expandable stent is located on the outside of the impeller structure. The distal end of the expandable stent is connected to the pigtail tube. The proximal end of the expandable stent is used to connect to the multi-lumen tube. The shell is located on the outside of the expandable stent. The shell is respectively connected to the pigtail tube and the multi-lumen tube. The shell is provided with a blood inlet window and a bleeding window.

18. The catheter pump according to claim 17, wherein: The handle module also includes a perfusion cavity, the perfusion cavity of the multi-cavity tube is connected to the perfusion port of the perfusion cavity, the outflow cavity of the multi-cavity tube is connected to the outflow port of the perfusion cavity, the proximal end of the multi-cavity tube is connected to the perfusion cavity and the proximal end of the perfusion cavity and the proximal end of the outflow cavity are not connected, and the sealing cover is connected to the perfusion cavity.

19. The catheter pump according to claim 18, wherein: The inner magnetic assembly is sleeved on the driven shaft and fixedly connected to the driven shaft, the sealing cover is arranged on the outside of the inner magnetic assembly, and the outer magnetic assembly is arranged on the outside of the sealing cover. The open end of the sealing cover is used to be sealed and connected to the perfusion cavity, and the driven shaft and the inner magnetic assembly can both move axially along the sealing cover.

20. The catheter pump according to claim 19, wherein: One end of the driven shaft extends out from the open end of the sealing cover and there is a gap between the driven shaft and the perfusion cavity. The gap between the driven shaft and the perfusion cavity can be connected to the outflow cavity. The other end of the driven shaft is close to the sealing end of the sealing cover. The proximal end of the impeller shaft is fixedly connected to the distal end of the transmission shaft. The movement of the driven shaft is limited by the sealing end. There are gaps between the driven shaft and the sealing cover, and between the internal magnetic assembly and the sealing cover.

21. The catheter pump according to claim 16, wherein: The driven shaft is a solid structure, and one end of the driven shaft is used to be connected to the transmission shaft.

22. The catheter pump according to claim 16, wherein: The driven shaft is a hollow structure, and the transmission shaft extends into the driven shaft.

23. The catheter pump according to claim 18, wherein: The transmission shaft is a hollow shaft. A reflux channel is provided inside the transmission shaft, and the reflux channel is communicated with the outflow cavity.

24. The catheter pump according to claim 16, wherein: The driven shaft is an optical axis.

25. The catheter pump according to claim 16, wherein: The driven shaft includes a first shaft portion and a second shaft portion, the first shaft portion is located inside the sealing cover, the second shaft portion is located outside the sealing cover, a spiral structure is provided on the outer side of the second shaft portion, and the rotation direction of the spiral structure is opposite to the rotation direction of the driven shaft.

26. The catheter pump according to claim 18, wherein: A wear-resistant insert is provided between the driven shaft and the perfusion cavity, the wear-resistant insert is fixedly connected to the perfusion cavity, the wear-resistant insert and the driven shaft can rotate relative to each other, the driven shaft is provided with a protrusion, and the wear-resistant insert cooperates with the protrusion to achieve axial limitation of the driven shaft, thereby limiting the movement of the driven shaft toward the distal end of the catheter pump.

27. The catheter pump according to claim 18, wherein: The handle module also includes a first diffusion stress tube, a motor housing, a second diffusion stress tube and a cable. One end of the first diffusion stress tube is connected to the multi-cavity tube, and the other end of the first diffusion stress tube is connected to the perfusion cavity. The first diffusion stress tube is provided with an perfusion tube and an outflow tube. One end of the perfusion tube is communicated with the perfusion port, and one end of the outflow tube is communicated with the outflow port. The motor housing is arranged on the outside of the drive motor, and the motor housing and the perfusion cavity can be detachably connected, and the motor housing and the perfusion cavity are connected by a locking nut. One end of the second diffusion stress tube is connected to the motor housing, and the other end of the second diffusion stress tube is connected to the cable, and one end of the cable is connected to the drive motor.

28. The catheter pump according to claim 18, wherein: The multi-lumen tube includes an inner tube and an outer tube, the inner tube is coaxially arranged on the inner side of the outer tube, the perfusion chamber and the pressure measuring chamber are arranged between the inner tube and the outer tube, the pressure measuring chamber and the perfusion chamber are separated by a partition, the pressure measuring chamber is not connected to the perfusion chamber, the transmission shaft is located in the inner tube, the outflow chamber is between the transmission shaft and the inner tube, the pressure measuring chamber is connected to the human body through the pressure measuring hole opened on the side wall of the outer tube, a detection chamber is provided in the perfusion chamber, the detection chamber is respectively connected with the pressure measuring chamber and the pressure measuring tube for passing the pressure measuring liquid, a pressure measuring element is provided in the detection chamber, and the pressure measuring element is used to detect the body pressure transmitted by the pressure measuring liquid.

29. The catheter pump according to claim 1, 4 or 16, characterized in that: The connecting portion is a groove and / or a through hole.

30. The catheter pump according to claim 29, wherein: A liquid channel is provided in the impeller shaft, the liquid channel is communicated with the through hole, the hub passes through the through hole and forms a film layer on the inner wall of the impeller shaft.

31. The catheter pump according to claim 29, wherein: The impeller shaft includes a first rigid section, a flexible section, and a second rigid section that are sequentially arranged. The connecting portion is located in the flexible section, and the flexible section is bendable.

32. The catheter pump according to claim 31, wherein: The flexible section is a hypotube structure.

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