Interventional artificial heart liquid path shunting structure

Abstract

The invention discloses an interventional artificial heart liquid path shunting structure, and relates to the technical field of medical instruments, the interventional artificial heart liquid path shunting structure comprises an impeller rotating shaft, a transmission shaft and a multi-cavity tube, the impeller rotating shaft is internally provided with a liquid path channel, the far end of the impeller rotating shaft is rotatably connected with a pigtail tube through a rotating structure, and the multi-cavity tube comprises a perfusion cavity and an outflow cavity; the near end of the impeller rotating shaft is connected with the far end of the transmission shaft, an inlet communicated with the liquid path channel is formed in the impeller rotating shaft, the inlet is communicated with the perfusion cavity, the liquid path channel and the outflow cavity, and perfusion liquid flows in from the perfusion cavity and flows out from the transmission shaft. The perfusate flows into the liquid path channel from the near end of the impeller rotating shaft through the inlet, flows to the far end of the impeller rotating shaft along the liquid path channel, flows out of the gap between the impeller rotating shaft and the rotating structure and then enters the human body, and meanwhile the perfusate flows out of the outflow cavity. Interface lubrication can be improved, friction is reduced, and cooling and heat dissipation can be achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an interventional artificial heart fluid path shunt structure. 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 into a compressed state by an external force to achieve minimally invasive intervention. Through percutaneous surgery, it enters the designated position of the human body in a compressed state, and 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, the existing compressible blood pumping catheter has many problems. The friction between the high-speed rotating drive shaft and the bearing / sleeve affects the safety of the device. Summary of the Invention

[0005] The purpose of the present invention is to provide an interventional artificial heart fluid path shunt structure that can increase interface lubrication, reduce friction, and provide cooling and heat dissipation.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The present invention provides an interventional artificial heart fluid path shunt structure, comprising an impeller shaft, a transmission shaft and a multi-lumen tube, wherein a fluid path is provided in the impeller shaft, the distal end of the impeller shaft is rotationally connected to a pigtail tube via a rotating structure, the multi-lumen tube comprises an infusion chamber and an outflow chamber, the proximal end of the impeller shaft is connected to the distal end of the transmission shaft, an inlet connected to the fluid path is provided on the impeller shaft, the inlet is respectively connected to the infusion chamber, the fluid path and the outflow chamber, the perfusion fluid flows into the perfusion chamber, flows into the fluid path from the proximal end of the impeller shaft through the inlet, flows along the fluid 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 fluid flows out from the outflow chamber.

[0008] 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.

[0009] 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.

[0010] 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.

[0011] Preferably, the second channel is also in communication with the first channel and the outflow cavity.

[0012] 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 multi-lumen tube.

[0013] 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.

[0014] Preferably, the third channel is also in communication with the first channel and the outflow cavity.

[0015] Preferably, a pressure measuring chamber is provided between the inner tube and the outer tube, the pressure measuring chamber is separated from the perfusion chamber by a partition, the pressure measuring chamber is not connected to the perfusion chamber, and the pressure measuring chamber is connected to the pressure measuring element and the human body respectively.

[0016] Preferably, a reflux channel is provided inside the transmission shaft, and the reflux channel is communicated with the outflow cavity.

[0017] Compared with the prior art, the present invention has achieved the following technical effects:

[0018] The interventional artificial heart fluid shunt structure of the present invention allows perfusion fluid to flow from the perfusion chamber, into the impeller shaft through the first channel, flow along the fluid channel in the impeller shaft to the distal end of the impeller shaft, and out through the gap between the impeller shaft and the rotating structure, through the blood pumping catheter into the human body, thereby increasing interface lubrication, reducing friction, and providing cooling and heat dissipation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] 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.

[0020] Figure 1 Schematic diagram of the catheter pump;

[0021] Figure 2 This is a schematic diagram of the invasive artificial heart fluid shunt structure of the present invention (without the sheath cover and adapter block);

[0022] Figure 3 Schematic diagram of the connection between the shell and the multi-lumen tube;

[0023] Figure 4 Schematic diagram of a multi-lumen tube;

[0024] Figure 5 The proximal end of the catheter pump Figure 1 ;

[0025] Figure 6 Schematic diagram of the connection between the pigtail tube and the impeller shaft Figure 1 ;

[0026] Figure 7 Schematic diagram of the connection between the pigtail tube and the impeller shaft Figure 2 ;

[0027] Figure 8 This is a schematic diagram of the impeller structure application;

[0028] Figure 9 Schematic diagram of the impeller shaft Figure 1 ;

[0029] Figure 10 for Figure 9 A local enlarged view of location I;

[0030] Figure 11 Schematic diagram of the impeller shaft Figure 2 ;

[0031] Figure 12 for Figure 11 A partial enlarged view of location II;

[0032] Figure 13 Schematic diagram of the impeller shaft Figure 3 ;

[0033] Figure 14 for Figure 13 A partial enlarged view of location III;

[0034] Figure 15 Schematic diagram of the impeller shaft Figure 4 ;

[0035] Figure 16 for Figure 15 A partial enlarged view of point IV;

[0036] Figure 17 This is a schematic diagram of the wheel hub passing through the through hole;

[0037] Figure 18 It is the cross-sectional view of the impeller shaft;

[0038] Figure 19 Apply a cross-section view to the impeller structure;

[0039] Figure 20 This is the main view of the impeller shaft;

[0040] Figure 21 Schematic diagram of impeller shaft bending;

[0041] Figure 22 Schematic diagram of the connection between the proximal end of the impeller shaft and the transmission shaft of the present invention;

[0042] Figure 23 Schematic diagram of the multi-lumen tube of the present invention Figure 1 ;

[0043] 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;

[0044] Figure 25 The perfusion liquid of the present invention enters the human body through the liquid channel (the impeller shaft has no shaft step);

[0045] Figure 26 This is a schematic diagram of the invasive artificial heart fluid shunt structure of the present invention (with sheath cover and adapter block);

[0046] Figure 27 Schematic diagram of the connection between the proximal end of the impeller shaft and the adapter block of the present invention;

[0047] Figure 28 A side view of the connection between the proximal end of the impeller shaft and the adapter block of the present invention;

[0048] Figure 29 Schematic diagram of the sliding between the proximal end of the impeller shaft and the adapter block Figure 1 ;

[0049] Figure 30 Schematic diagram of the sliding between the proximal end of the impeller shaft and the adapter block Figure 2 ;

[0050] Figure 31 Schematic diagram of the connection between the proximal end of the impeller shaft and the adapter block;

[0051] Figure 32 This is a schematic diagram of the exterior of the impeller shaft, sheath cover, and drive shaft;

[0052] Figure 33 This is a schematic diagram of the interior of the impeller shaft, sheath cover, and drive shaft;

[0053] Figure 34 A partial enlarged view of the impeller shaft, sheath cover, and drive shaft

[0054] Figure 35 Schematic diagram of the expansion stent contraction;

[0055] Figure 36 Schematic diagram of the expansion of the expandable stent;

[0056] 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;

[0057] 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;

[0058] Figure 39 Schematic diagram of the flow of the perfusion liquid in the perfusion chamber and the third channel of the present invention;

[0059] Figure 40 Schematic diagram of the flow of the perfusion liquid in the perfusion chamber and the outflow chamber of the present invention;

[0060] Figure 41 Indicates the sealing cover Figure 1 ;

[0061] Figure 42 Indicates the sealing cover Figure 2 ;

[0062] Figure 43 Schematic diagram of the connection between the sealing cover and the perfusion chamber Figure 1 ;

[0063] Figure 44 Schematic diagram of the connection between the sealing cover and the perfusion chamber Figure 2 ;

[0064] Figure 45 This is a schematic diagram of the connection between the internal magnetic component and the driven shaft;

[0065] Figure 46 Schematic diagram of the driven shaft moving along the axial direction Figure 1 ;

[0066] Figure 47 Schematic diagram of the driven shaft moving along the axial direction Figure 2 ;

[0067] Figure 48 This is a schematic diagram before installation of the driven shaft, internal magnet assembly and sealing cover;

[0068] Figure 49 This is a schematic diagram of the driven shaft, internal magnet assembly and sealing cover after installation;

[0069] Figure 50 This is a schematic diagram of the external magnetic assembly and the external magnetic assembly mounting sleeve before installation;

[0070] Figure 51 This is a schematic diagram of the outer magnetic component driving the inner magnetic component to rotate;

[0071] Figure 52 This is a schematic diagram of the outer magnetic component driving the inner magnetic component to rotate;

[0072] Figure 53 For perfusion fluid Figure 5 Flow diagram of the transmission sealing structure;

[0073] Figure 54 The proximal end of the catheter pump Figure 2 ;

[0074] Figure 55 For perfusion fluid Figure 54 Flow diagram of the transmission sealing structure;

[0075] Figure 56 The proximal end of the catheter pump Figure 3 ;

[0076] Figure 57 This is a partial enlarged view of the spiral structure;

[0077] Figure 58 Schematic diagram of the driven shaft (with a spiral structure);

[0078] Figure 59 For perfusion fluid Figure 56 Flow diagram of the transmission sealing structure;

[0079] Figure 60The proximal end of the catheter pump Figure 4 ;

[0080] Figure 61 For perfusion fluid Figure 60 Flow diagram of the transmission sealing structure;

[0081] Figure 62 The proximal end of the catheter pump Figure 5 ;

[0082] Figure 63 For perfusion fluid Figure 62 Flow diagram of the transmission sealing structure;

[0083] Figure 64 Schematic diagram of the multi-lumen tube of the present invention Figure 2 ;

[0084] Figure 65 is a side view of the multi-lumen tube of the present invention;

[0085] Figure 66 The proximal end of the catheter pump Figure 6 ;

[0086] Figure 67 For perfusion fluid Figure 66 Flow diagram of the transmission sealing structure;

[0087] Figure 68 The proximal end of the catheter pump Figure 7 ;

[0088] Figure 69 For perfusion fluid Figure 68 Flow diagram of the transmission sealing structure;

[0089] Figure 70 The perfusion fluid enters the human body through the liquid channel (the impeller shaft has a shaft step);

[0090] Figure 71 It is a schematic diagram of the clearance between the hydraulic chamber and the rotating shaft;

[0091] 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

[0092] 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.

[0093] The purpose of the present invention is to provide an interventional artificial heart fluid path shunt structure that can increase interface lubrication, reduce friction, and provide cooling and heat dissipation.

[0094] 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.

[0095] Example 1

[0096] like Figure 2 、 Figures 22 to 25As shown, this embodiment provides an interventional artificial heart fluid path shunt structure, including an impeller shaft 7, an impeller 8, a transmission 12 and a multi-lumen tube 5. The impeller 8 is arranged on the outside of the impeller shaft 7. The impeller 8 and the impeller shaft 7 are formed by co-injection molding. The hub of the impeller 8 realizes radial sealing of the impeller shaft 7 to prevent the perfusion fluid from leaking from the impeller shaft 7. The impeller shaft 7 is a hollow structure. A fluid path channel 11 is provided in the impeller shaft 7. The fluid path channel 11 runs from the distal end of the impeller shaft 7 to the proximal end of the impeller shaft 7. The distal end of the impeller shaft 7 is rotatably connected to the pigtail tube 1 through a rotating structure. The rotating structure is preferably a sleeve 73 or a bearing. The multi-lumen tube 5 includes a perfusion chamber 23 and an outflow chamber 24. The perfusion chamber 23 and the outflow chamber 24 The cavities 24 extend from the proximal end of the multi-lumen tube 5 to the distal end of the multi-lumen tube 5. The transmission 12 is located in the outflow cavity 24. The proximal end of the impeller shaft 7 is connected to the distal end of the transmission 12. An inlet 25 connected to the liquid channel 11 is provided on the impeller shaft 7. The inlet 25 is a through-hole structure provided on the side wall of the impeller shaft 7. The inlet 25 is connected to the perfusion cavity 23, the liquid channel 11 and the outflow cavity 24 respectively. The perfusion liquid flows into the perfusion cavity 23, flows into the liquid channel 11 of the impeller shaft 7 through the inlet 25, flows along the liquid channel 11 in the impeller shaft 7 to the distal end of the impeller shaft 7, and flows out from the gap between the impeller shaft 7 and the rotating structure and enters the human body, which can increase interface lubrication, reduce friction, and cool and dissipate heat.

[0097] Specifically, in this embodiment, 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 chamber 23 is provided between the inner tube 26 and the outer tube 27. The transmission 12 is coaxially arranged in the inner tube 26. There is an outflow chamber 24 between the transmission 12 and the inner tube 26. The distal end of the outflow chamber 24 is connected to the distal end of the perfusion chamber 23. A reflux channel can be provided inside the transmission 12, and the reflux channel is connected to the outflow chamber 24.

[0098] In this embodiment, the perfusion liquid is divided into two paths: the perfusion liquid enters from the perfusion chamber 23, a portion 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 from the gap between the impeller shaft 7 and the rotating structure to enter the human body; the other portion of the perfusion liquid flows out from the outflow chamber 24.

[0099] Example 2

[0100] like Figure 23 、 Figures 25 to 28 、 Figures 37 to 40As shown, this embodiment further optimizes the first embodiment. This embodiment includes a connecting block 29, which connects the proximal end of the impeller shaft 7 to the distal end of the transmission 12. 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 connecting block 29 is provided with a first channel 30, which communicates with the inlet 25, the perfusion chamber 23, and the outflow chamber 24.

[0101] The adapter block 29 is provided with a chute 32, into which the protrusion 31 is slidably connected. The clearance between the inner surface of the protrusion 31 and the surface of the chute 32 is between 0.1 and 0.5 mm, forming a second channel 33 between the inner surface of the protrusion 31 and the surface of the chute 32. The second channel 33 is connected to the perfusion chamber 23, the liquid channel 11, and the outflow chamber 24.

[0102] In this embodiment, the perfusion liquid is divided into three paths: the perfusion liquid enters from the perfusion cavity 23, a portion of the perfusion liquid enters the liquid path channel 11 through the first channel 30 and the inlet 25, and at the same time, a portion of the perfusion liquid enters the liquid path 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 to enter the human body; the remaining portion of the perfusion liquid flows out from the outflow cavity 24.

[0103] Example 3

[0104] like Figure 23 、 Figures 25 to 28 、 Figures 37 to 40 As shown, this embodiment is further optimized based on the second embodiment. 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.

[0105] 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.

[0106] 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.

[0107] In this embodiment, the perfusion liquid is divided into four paths: the perfusion liquid enters from the perfusion cavity 23, a portion of the perfusion liquid enters the liquid path channel 11 through the first channel 30 and the inlet 25, and at the same time, a portion of the perfusion liquid enters the liquid path 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 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 from the outflow cavity 24.

[0108] Example 4

[0109] like Figures 64 to 65 As shown, in this embodiment, a pressure measuring chamber 62 is further provided between the inner tube 26 and the outer tube 27. 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. The pressure measuring chamber 62 is connected to the pressure measuring element. The pressure measuring chamber 62 is connected to the human body through the pressure measuring hole 39 opened on the side wall of the outer tube 27.

[0110] The above-mentioned embodiments 1 to 4 are specifically applied as follows:

[0111] Application Example 1

[0112] like Figures 1 to 5 As shown: This application example 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.

[0113] Specifically, if Figure 9 and Figure 10As shown, in this application example, the connection 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 application example 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 connection portion is a groove 17, the area where the connection portion is located can have a certain degree of bending deflection.

[0114] In this application example, the impeller 8 is made of a polymer material, preferably one of natural rubber, isoprene rubber or thermoplastic polyurethane.

[0115] In this application example, 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.

[0116] In this application example, a connecting portion is provided to enhance the coupling force between the impeller shaft 7 and the impeller 8, thereby preventing the impeller 8 and the impeller shaft 7 from moving and disengaging from the impeller 8 and the impeller shaft 7, 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.

[0117] In this application example, 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.

[0118] In this application example, Figure 23As 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.

[0119] In this application example, 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.

[0120] In this application example, 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.

[0121] In this application example, 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. 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.

[0122] In this application example, 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.

[0123] In this application example, 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.

[0124] In this application example, 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.

[0125] When the transmission sealing structure of this application example is used, 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.

[0126] The sealing cap 44 of this application example 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 application example has a simple transmission seal structure, high reliability, long life, and low cost.

[0127] In this application example, 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.

[0128] Application Example 2

[0129] The difference between this application example and application example 1 is that: Figure 25As shown, in this application example, 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, thereby driving 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.

[0130] Application Example 3

[0131] In order to solve the problem that the impeller shaft 7 cannot be bent in the prior art, in this application example, 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.

[0132] In this application example, the flexible section 21 is a hypotube structure, which can be a hypotube structure known in the prior art. The flexible section 21 of this application example allows the impeller structure 2 to be axially flexible, reducing damage to the blood vessel wall during the pumping process and resolving the problem of the impeller shaft 7 being non-flexible.

[0133] like Figure 17 and Figure 19 As shown: In this application example, the liquid 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, so that the bonding force between the impeller 8 and the impeller shaft 7 is further improved. 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 the leakage of the perfusion liquid. The provision of the through hole 18 further improves the bending deflection of the impeller shaft 7.

[0134] 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.

[0135] Application Example 4

[0136] This application example defines the specific structure of the hypotube structure in the corresponding use case 3, such as Figure 18 As shown, in this application example, the side wall of the flexible segment 21 is provided with a plurality of circles of through hole 18 structures along the axial direction of the flexible segment 21. The through hole 18 structure of each circle includes a plurality of through holes 18 arranged along the circumference of the flexible segment 21. The through holes 18 are discontinuous in the circumferential direction of the flexible segment 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.

[0137] Application Example 5

[0138] like Figure 20 and Figure 21 As shown, this application example is further limited by Example 4. In this application example, the through holes 18 are elongated holes. The dimension B of the connecting portion 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 application example, the maximum bending deflection W of the impeller shaft 7 is within the range of 0.1-5 mm.

[0139] In this application example, 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 .

[0140] Application Example 6

[0141] like Figures 11 to 12 As shown: In this application example, the through holes 18 of adjacent circles are arranged in a one-to-one correspondence, and the through holes 18 are round holes.

[0142] Application Example 7

[0143] like Figures 13 and 14 As shown: The difference between this application example and application example six is ​​that in this application example, the through holes 18 are circular holes, and the through holes 18 of adjacent circles are staggered.

[0144] Application Example 8

[0145] like Figures 15 and 16 As shown: In this application example, 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.

[0146] Application Example 9

[0147] The difference between this application example and the first application example is that in this application example, the connecting portion is a groove 17 and a through hole 18 .

[0148] Application Example 10

[0149] like Figures 26 to 31 As shown, this application example further optimizes the first application example. This application example includes an adapter 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 adapter block 29. In this application example, the proximal end of the impeller shaft 7 is provided with a protrusion 31. Between adjacent protrusions 31 is an inlet 25, which has a notched structure. The adapter 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.

[0150] In this application example, 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.

[0151] In this application example, the adapter block 29 is provided with a slide groove 32, 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. A second channel 33 is formed 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.

[0152] In this application example, 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.

[0153] Application Example 11

[0154] like Figures 37 to 40As shown, this application example is further optimized based on application example 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.

[0155] In this application example, 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.

[0156] In this application example, 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.

[0157] In this application example, 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. 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; a portion of the perfusion liquid enters the human body through the third channel 37; and another portion of the perfusion liquid flows out from the outflow chamber 24.

[0158] Application Example 12

[0159] like Figures 64 to 65 As shown, the difference between this application example and application example 1 is that: in this application example, 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.

[0160] 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.

[0161] Application Example 13

[0162] like Figures 54 to 55As shown, the difference between this application example and application example 1 is that in this application example, 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.

[0163] Application Example 14

[0164] like Figures 56 to 59 As shown: The difference between this application example and application example thirteen is that: in this application example, 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 setting 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.

[0165] Application Example 15

[0166] like Figures 60 to 61 As shown, the difference between this application example and application example fourteen is that in this application example, 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 frictional 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.

[0167] Application Example 16

[0168] The difference between this application example and application example 1 is that in this application example, the inner magnetic component 42 and the outer magnetic component 41 each include at least two magnetic rings, and the magnetic rings in the inner magnetic component 42 are nested in sequence along the radial direction of the driven shaft 43, and the magnetic rings in the outer magnetic component 41 are nested in sequence along the radial direction of the driven shaft 43.

[0169] Application Example 17

[0170] The difference between this application example and application example 1 is that in this application example, 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.

[0171] Application Example 18

[0172] like Figures 62 to 69 As shown, the difference between this application example and application examples 12 to 17 is that: in this application example, 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.

[0173] The impeller structure 2 of the present invention is bendable in the axial direction, reducing the damage to the blood vessel wall caused by the catheter pump during the pushing process; 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 application example 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 application example has a simple structure, low cost and high reliability.

[0174] Application Example 19

[0175] 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.

[0176] 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 application example, 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 application example, the distal end of the impeller shaft 7 is provided with a shaft step 16, 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.

[0177] 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.

[0178] 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 application example 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.

[0179] 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.

[0180] 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:

[0181] 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.

[0182] 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.

[0183] 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.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] Furthermore, the interventional device is used to pump blood through the heart or to aspirate blood clots in the blood vessel cavity.

[0188] Application Example 20

[0189] 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 Application 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.

[0190] 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.

[0191] Furthermore, the elastic polymer coating is molded into a three-dimensional contour structure (eg, blade 10 ) having the function of a pump blade.

[0192] 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 film layer 19 and 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 Application 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.

[0193] 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.

[0194] 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.

[0195] The "rotating shaft", "metal rotating shaft" and "metal tube rotating shaft" mentioned in this application example 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 application example), or they can be shafts that are integrated with the flexible transmission shaft.

[0196] Based on the aforementioned method for strengthening the rotating shaft of an interventional device provided by the present invention, the applicant also provides:

[0197] 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.

[0198] Furthermore, the metal shaft is a hollow metal tube shaft.

[0199] 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.

[0200] Furthermore, the body of the functional element is a blade, and the base of the functional element is a hub.

[0201] 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.

[0202] Application Example 21

[0203] 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.

[0204] 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.

[0205] 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.

[0206] 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.

[0207] 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.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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.

[0213] 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. An interventional artificial heart fluid shunt structure, characterized by: The invention comprises an impeller shaft, a transmission shaft and a multi-lumen tube, wherein a liquid path is provided in the impeller shaft, the distal end of the impeller shaft is rotationally connected to the pigtail tube through a rotating structure, the multi-lumen tube comprises an infusion chamber and an outflow chamber, the proximal end of the impeller shaft is connected to the distal end of the transmission shaft, an inlet communicating with the liquid path is opened on the impeller shaft, the inlet is communicated with the infusion chamber, the liquid path and the outflow chamber respectively, the infusion liquid flows into the infusion chamber, 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 infusion liquid flows out from the outflow chamber.

2. The invasive artificial heart fluid shunt structure according to claim 1, 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.

3. The invasive artificial heart fluid shunt structure according to claim 1, 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.

4. The invasive artificial heart fluid shunt structure according to claim 3, 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.

5. The invasive artificial heart fluid shunt structure according to claim 4, characterized in that: The second channel is also in communication with the first channel and the outflow cavity.

6. The invasive artificial heart fluid shunt structure according to claim 3, characterized in that: 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 multi-lumen tube.

7. The invasive artificial heart fluid shunt structure according to claim 6, characterized in that: 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.

8. The invasive artificial heart fluid shunt structure according to claim 7, characterized in that: The third channel is also in communication with the first channel and the outflow cavity.

9. The invasive artificial heart fluid shunt structure according to claim 2, characterized in that: A pressure measuring chamber is further provided between the inner tube and the outer tube. The pressure measuring chamber is separated from the perfusion chamber by a partition. The pressure measuring chamber is not connected to the perfusion chamber, and is connected to the pressure measuring element and the human body respectively.

10. The invasive artificial heart fluid shunt structure according to claim 2, characterized in that: A reflux channel is provided inside the transmission shaft, and the reflux channel is communicated with the outflow cavity.

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