Foldable blood pump and intervention assembly thereof

Abstract

The foldable blood pump comprises a pump head assembly and a catheter, the far end of the pump head assembly is connected with a pigtail tube, a guide wire hole is formed in the near-side tube section of the pigtail tube, and the guide wire hole penetrates through the inner wall and the outer wall of the pigtail tube and is communicated with an inner cavity. And the guide wire hole, the inner cavity of the pigtail tube and the far-end through hole of the pigtail tube form a guide wire guide channel. The guide wire guiding channel is directly arranged on the pigtail tube and does not pass through the pump head assembly and the inner cavity of the flexible transmission shaft in the catheter, on one hand, the size of the whole flexible transmission shaft can be set to be very small, then the intervention size of the whole blood pump is reduced, and damage to a vasculature and heart tissue of the vasculature is reduced; on the other hand, the guide wire hole is formed so that a passage can be formed between the perforation position and the far-end through hole, and the risk that thrombus is formed at the front end of the pigtail tube is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a foldable blood pump and an interventional component thereof. Background Art

[0002] The percutaneous foldable blood pump is a ventricular assist device that provides short-term cardiac support to patients. When in use, the pump head of the foldable blood pump spans the aortic valve, with its blood inlet located in the left ventricle and the bleeding outlet located in the ascending aorta. The impeller in the pump head rotates to pump the blood in the left ventricle to the aorta, thus assisting or replacing the heart's pumping function.

[0003] Due to the special features of the foldable blood pump: the pump head assembly includes a foldable impeller and a foldable shell, the foldable shell is covered with a film, the proximal end of the film extends to the catheter, the blood inlet and the bleeding outlet are located at both ends of the film, and during the blood pump insertion and withdrawal process, the film, the foldable impeller, and the foldable shell are all in a folded state, so a guide wire cannot be used for guidance. How to safely insert the foldable blood pump into the left ventricle through the vascular system is a problem that needs to be solved urgently in the industry. Summary of the invention

[0004] An object of the present invention is to provide a foldable blood pump with high safety and small invasive size.

[0005] In order to achieve the above-mentioned purpose, the technical solution adopted by the present invention is: a foldable blood pump, including a pump head assembly and a catheter, the distal end of the pump head assembly is connected to a pigtail tube, a guide wire hole is opened on the proximal tube section of the pigtail tube, the guide wire hole passes through the inner and outer walls of the pigtail tube and is connected to the inner cavity, and the guide wire hole-pigtail tube inner cavity-pigtail tube distal through hole constitutes a guide wire guiding channel.

[0006] Furthermore, the pigtail tube includes a curved section at the distal end and a supporting section at the proximal end. The curved section is a curved tube in a natural state and can be deformed under the action of external force. The supporting section is a straight tube structure in a natural state and the hardness of the supporting section is greater than that of the curved section. The guide wire hole is opened on the proximal tube section of the supporting section.

[0007] Furthermore, the core of the guide wire hole is arranged at an angle to the normal line at that location, and the inclination direction of the guide wire hole from outside to inside is from the proximal side to the distal side, and the angle between the core of the guide wire hole and the normal line at that location is 30° to 80°.

[0008] Furthermore, the curved section and the supporting section are connected by a transition section. In a natural state, the angle between the supporting section and the transition section is 120° to 150°, and the transition section is smoothly connected to the curved section.

[0009] Furthermore, the pump head assembly includes an expandable shell and a foldable impeller arranged in the expandable shell, the flexible transmission shaft passes through the inner cavity of the catheter, the proximal end of the flexible transmission shaft extends outside the body and is connected to the external motor, the distal end of the flexible transmission shaft is connected to the foldable impeller and drives the foldable impeller to rotate, the expandable shell and the pigtail tube are fixed by a rigid connecting piece, the proximal end sleeve of the support section is provided with the outer periphery of the rigid connecting piece, and an inclined hole is also provided on the rigid connecting piece at a position corresponding to the guide wire hole, and the guide wire hole and the inclined hole have the same slope and are connected to each other.

[0010] Furthermore, the rigid connector includes a first pipe segment and a second pipe segment, a step is formed between the first pipe segment and the second pipe segment, and an isolation block is provided in the inner cavity between the first pipe segment and the second pipe segment, the isolation block is arranged near the inclined hole, an external thread is provided on the outer wall of the first pipe segment near the step, the external thread and the internal thread of the support segment form a threaded locking connection, and the inclined hole is opened on the outer wall of the first pipe segment near the step.

[0011] Furthermore, the distal end of the flexible transmission shaft is connected to a hard shaft, the foldable impeller is fixed on the hard shaft, the distal end of the hard shaft is inserted into the inner cavity of the second pipe section, and a shaft sleeve is arranged between the two.

[0012] Furthermore, a plurality of protrusions are evenly and spaced apart along the circumferential direction of the outer wall of the second pipe section, a groove is formed between two adjacent protrusions, the support foot at the far end of the expandable shell is placed in the groove and forms a fixed connection, and a protective sleeve is also provided on the outer periphery of the second pipe section.

[0013] Furthermore, the outer cover of the expandable shell is provided with a flexible membrane, which extends proximally from the middle section of the expandable shell to the catheter, and the position of the distal end of the expandable shell not covered by the flexible membrane constitutes a blood inlet, and a bleeding port is opened at the proximal end of the flexible membrane corresponding to the ascending aorta.

[0014] Another object of the present invention is to provide an interventional assembly that is highly safe and easy to operate.

[0015] In order to achieve the above-mentioned object, the technical solution adopted by the present invention is: an interventional assembly, including a foldable blood pump, the interventional assembly including a constriction sleeve, a guide wire and a tearable sheath, The constricting sleeve is slidably mounted outside the foldable blood pump. When the pump head assembly slides into the constricting sleeve, the foldable blood pump is in a folded state. When the pump head assembly slides out of the constricting sleeve, the foldable blood pump is in an expanded state. A guide wire is passed between the distal end of the pigtail tube and the guide wire hole to guide the collapsible blood pump into the ventricle through the blood vessel; The tearable sheath can be partially inserted into the vascular system of the subject through the puncture port to allow the constriction sheath to pass through, and can be torn while being withdrawn from the puncture port.

[0016] In the above scheme, the guidewire guide channel is directly set on the pigtail tube without passing through the pump head assembly and the inner cavity of the flexible transmission shaft in the catheter. On the one hand, the size of the entire flexible transmission shaft can be set very small, thereby reducing the intervention size of the entire blood pump and reducing damage to the vascular system and its cardiac tissue; on the other hand, the setting of the guidewire hole can also form a passage between the perforation position and the distal through hole, avoiding the risk of thrombus formation at the front end of the pigtail tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the overall structure of the foldable blood pump; Figure 2 for Figure 1 The middle part is an enlarged schematic diagram; Figure 3 It is a schematic diagram of the structure of the foldable blood pump in a folded state; Figure 4 for Figure 3 A cross-sectional view of Figure 5 for Figure 4 A partially enlarged schematic diagram of Figure 6 is a schematic diagram of the three-dimensional structure of the rigid connector; Figure 7 is a cross-sectional view of a rigid connector; Figure 8 This is a schematic diagram of the state during guidewire intervention; Fig. 9 This is a schematic diagram of the status after guidewire intervention; Fig.10 for Figure 8 sectional view of . DETAILED DESCRIPTION

[0018] To facilitate understanding, let us first define the directions: "proximal" and "proximal" refer to the side close to the operator / doctor, and "distal" and "distal" refer to the side away from the operator / doctor, that is, the side close to the heart.

[0019] In order to highlight the excellent technical effect of the technical solution in the present invention, it is necessary to first briefly introduce the intervention methods of the foldable blood pump in the prior art. There are two most commonly used methods in the prior art: the first is to use a guidewire-free intervention method, which is difficult to operate and requires high surgical skills of the doctor; the second is to use a guidewire to penetrate the flexible transmission shaft, which results in a larger outer diameter of the flexible transmission shaft, thereby increasing the size of the entire blood pump intervention. Figure 1-Figure 10 The technical solutions and beneficial effects of the present invention are further discussed in detail.

[0020] like Figure 1As shown, a foldable blood pump includes a pump head assembly 10 and a catheter 20. The distal end of the pump head assembly 10 is connected to a pigtail tube 30. A guide wire hole 31 is provided on the proximal tube section of the pigtail tube 30. The guide wire hole 31 passes through the inner and outer walls of the pigtail tube 30 and communicates with the inner cavity. The guide wire hole 31-pigtail tube inner cavity-pigtail tube distal through hole constitutes a guide wire guiding channel. During intervention, a guide wire 70 is inserted from the guide wire hole 31, and the guide wire 70 passes through the pigtail tube inner cavity and finally leads out from the pigtail tube distal through hole, thereby achieving the purpose of the foldable blood pump being able to intervene into the human body along the guide wire 70. In the above scheme, the guidewire guide channel is directly set on the pigtail tube 30 without passing through the pump head assembly 10 and the inner cavity of the flexible transmission shaft 40 in the catheter 20. On the one hand, the size of the entire flexible transmission shaft 40 can be set very small, thereby reducing the intervention size of the entire blood pump and reducing damage to the vascular system and its cardiac tissue; on the other hand, the setting of the guidewire hole 31 can also form a passage between the perforation position and the distal through hole, avoiding the risk of thrombus formation at the front end of the pigtail tube 30.

[0021] The pigtail tube 30 includes a curved section 32 at the distal end and a support section 33 at the proximal end. The curved section 32 is a curved tube in a natural state and can be deformed under the action of external force. The support section 33 is a straight tube structure in a natural state and the hardness of the support section 33 is greater than that of the curved section 32. The guide wire hole 31 is provided on the proximal tube section of the support section 33. On the one hand, the hardness of the support section 33 is greater than that of the curved section 32, and the guide wire 70 can be guided better. On the other hand, the length of the guide channel is longer, which is also more conducive to the intervention of the blood pump.

[0022] In order to ensure smooth insertion and exit of the guide wire 70, the core of the guide wire hole 31 is arranged at an angle to the normal line there, and the guide wire hole 31 is inclined from the proximal side to the distal side from the outside to the inside. This arrangement can prevent the guide wire 70 from getting stuck, and is also conducive to the smooth outflow of blood, preventing the blood pump from entering the inner cavity of the pigtail tube 30 to form a strip of thrombus during the blood pumping process after the guide wire 70 is withdrawn.

[0023] Preferably, the angle between the core of the guide wire hole 31 and the normal line therein is 30° to 80°. The angle value can be 30°, 45°, 60°, 75°, etc., as long as the guide wire 70 can slide smoothly, and an angle that is conducive to blood flow is more preferred.

[0024] The curved section 32 and the supporting section 33 are connected by a transition section 34. In a natural state, the angle between the supporting section 33 and the transition section 34 is 120° to 150°, and the transition section 34 is smoothly connected to the curved section 32. In other words, the curved section 32 is not directly connected to the distal end of the supporting section 33. This arrangement can better adapt to the anatomical structure of the heart, improve the accuracy and safety of the operation, reduce damage, and reduce the risk of complications.

[0025] The pump head assembly 10 includes an expandable shell 11 and a foldable impeller 12 disposed in the expandable shell 11, a flexible transmission shaft 40 passes through the inner cavity of the catheter 20, the proximal end of the flexible transmission shaft 40 extends outside the body and is connected to an external motor, the distal end of the flexible transmission shaft 40 is connected to the foldable impeller 12 and drives the foldable impeller 12 to rotate, the expandable shell 11 and the pigtail tube 30 are fixed by a rigid connector 50, the proximal end of the support section 33 is provided with the outer periphery of the rigid connector 50, and an inclined hole 51 is also provided on the rigid connector 50 at a position corresponding to the guide wire hole 31, and the guide wire hole 31 and the inclined hole 51 have the same slope and are connected to each other. The basic function of the rigid connector 50 is to connect the flexible transmission shaft 40, the expandable shell 11 and the pigtail tube 30, wherein the flexible transmission shaft 40 and the rigid connector 50 form a rotational fit, and the expandable shell 11 and the pigtail tube 30 are fixed on the rigid connector 50. Since the pigtail tube 30 plays many important roles in the blood pump, one of which is to prevent the blood pump from directly contacting the ventricular wall when pumping blood at high speed, thereby effectively avoiding ventricular wall damage. This requires the pigtail tube 30 to be soft and usually made of low-hardness material. Therefore, in order to ensure the rigidity of the guide wire guide so that the blood pump can smoothly enter the left ventricle along the guide wire 70, the guide wire hole 31 is set on the pipe section that is sleeved on the support section 33 of the rigid connector 50. Correspondingly, the pipe section of the rigid connector 50 is also provided with an oblique hole 51 to improve the rigidity of the guide wire 70 inlet and outlet.

[0026] The specific structure is as follows: the rigid connector 50 includes a first pipe section 52 and a second pipe section 53, and a step 54 is formed between the first pipe section 52 and the second pipe section 53. The step 54 serves as an isolation area between the first pipe section 52 and the second pipe section 53, and also constitutes an axial limit structure of the connecting parts on both sides. An isolation block 55 is provided in the inner cavity between the first pipe section 52 and the second pipe section 53, and the isolation block 55 is arranged near the proximal side of the inclined hole 51. The isolation block 55 is preferably a structure integrally formed with the rigid connector 50. For example, during machining, a non-opened structural back-end isolation block 53 is reserved in the inner cavity of the rigid connector 50 near the inclined hole 51, so that no additional sealing parts are required to prevent blood from entering the inner cavity of the second pipe section 53, because a shaft sleeve 42 is provided in the inner cavity of the second pipe section 53 to avoid blood damage, and also constitutes an axial limit structure of the hard shaft 41. An external thread 52 is provided on the outer wall of the first pipe section 52 adjacent to the step 54, and the external thread and the internal thread of the support section 33 form a threaded locking connection, and the oblique hole 51 is provided on the outer wall of the first pipe section 52 adjacent to the step 54. The support section 33 and the first pipe section 52 are connected by threads to ensure the reliability of the connection. In order to further enhance the reliability of the connection between the two, the gap between the threads can be filled with glue, which can also prevent blood from entering the gap between the threads to cause hemolysis and thrombosis.

[0027] Since the flexible transmission shaft 40 is soft, if the foldable impeller 12 is directly arranged on the flexible transmission shaft 40, the foldable impeller 12 will have a large amount of jumping. On the one hand, it will collide with the expandable shell 11 to cause damage, and on the other hand, the shear force on the blood is large, causing serious damage to the blood. In order to ensure the stability of the foldable impeller 12 during rotation, the distal end of the flexible transmission shaft 40 is connected to the hard shaft 41, and the foldable impeller 12 is fixed on the hard shaft 41. The distal end of the hard shaft 41 is inserted into the inner cavity of the second pipe section 53 and a sleeve 42 is arranged between the two. The inner cavity of the second pipe section 53 supports the distal end of the hard shaft, and the proximal end of the hard shaft 41 is also correspondingly provided with a bearing, so that both ends of the hard shaft 41 are supported by a bearing structure, thereby ensuring the stability of the rotation of the hard shaft 41, and the foldable impeller 12 arranged on its periphery rotates smoothly. On the one hand, it will not collide with the expandable shell 11 to cause damage, and on the other hand, the shear force on the blood is small, reducing blood damage. In addition, since the foldable impeller 12 rotates relatively smoothly, the blood flow rate of the entire blood pump can also be detected, which is helpful for doctors to evaluate the patient's recovery and improve the success rate of the operation.

[0028] As is known to all, the expandable shell 11 is a grid-like structure made of shape memory alloy material, including a cylindrical section in the middle and conical sections at both ends. The expandable shell 11 is folded when an external force is applied, and expands after the external force is removed. The far end of the expandable shell 11 is a plurality of divergent legs. To fix the far end of the expandable shell 11, these legs must be fixed. Therefore, a plurality of protrusions 531 are evenly and spaced along the circumferential direction of the outer wall of the second pipe section 53, and a groove is formed between two adjacent protrusions 531. The legs at the far end of the expandable shell 11 are placed in the groove and form a fixed connection. A protective cover 55 is also provided on the outer periphery of the second pipe section 53. The number of grooves is consistent with the number of legs, so that each leg is stuck in a groove, and then fixed by welding or other processes. This can not only ensure the overall shape of the expandable shell 11, but also enhance the reliability of the connection. In order to further improve the stability of the connection, a protective sleeve 55 is provided on the outer periphery of the second tube section 53. This arrangement also ensures the smoothness of the outer surface of the device, reduces damage to the blood and prevents thrombus retention.

[0029] In order to ensure the foldability of the entire pump head assembly 10, the outer cover of the expandable shell 11 is provided with a flexible membrane 13, which extends proximally from the middle section of the expandable shell 11 to the catheter 20, and the position of the distal end of the expandable shell 11 not covered by the flexible membrane 13 constitutes a blood inlet a, and a bleeding port b is opened at the proximal end of the flexible membrane 13 corresponding to the ascending aorta. The inner cavity of the flexible membrane 13 constitutes a blood flow channel, and when the blood pump is working, due to the inflow of blood, the flexible membrane 13 will be propped up to form a blood flow channel.

[0030] It is impossible to insert the foldable blood pump into the left ventricle through the vascular system with only one guide wire, because the pump head assembly 10 of the foldable blood pump is in an expanded state without the action of external force, and the diameter is large at this time, and it is impossible to insert the blood vessel at all. The present invention provides an intervention assembly for inserting the foldable blood pump into the left ventricle, and the composition of the intervention assembly and the intervention method are described in detail below.

[0031] An interventional assembly includes a foldable blood pump, the interventional assembly includes a constriction sleeve 60, a guide wire 70 and a tearable sheath, The contraction sleeve 60 is slidably mounted on the outside of the foldable blood pump. When the pump head assembly 10 slides into the contraction sleeve 60, the foldable blood pump is in a folded state. When the pump head assembly 10 slides out of the contraction sleeve 60, the foldable blood pump is in an expanded state. The size of the contraction sleeve 60 is smaller than that of the aorta, so it can be easily inserted into the blood vessel. The components of the pump head assembly 10: the expandable shell 11, the foldable impeller 12 and the flexible membrane 13 are all foldable and can be constrained in the inner cavity of the contraction sleeve 60. Together with the contraction sleeve 60, the contraction sleeve 60 can be inserted into the blood vessel. During the entire intervention process, the size of the entire intervention assembly is very small due to the restraining force of the contraction sleeve 60.

[0032] The guide wire 70 passes through the distal end of the pigtail tube 30 and the guide wire hole 31 and guides the foldable blood pump to enter the ventricle through the blood vessels; for interventional medical devices, they generally need to be guided by a guide wire. It should be emphasized that in the present invention, the guide wire 70 neither passes through the inside of the pump head assembly 10, nor through the inner cavity of the flexible transmission shaft 40, nor through the inner cavity of the contraction sleeve 60. The guide wire 70 only passes through the guide wire hole 31-pigtail tube inner cavity-pigtail tube distal end through hole to form a guide wire guiding channel, which is convenient for the installation of the guide wire 70, saving the preparation time before the operation, and gaining valuable operation time for the patient.

[0033] The tearable sheath (not shown in the figure) can be partially inserted into the vascular system of the subject through the puncture port to allow the constriction sheath 60 to pass through, and can be torn while being withdrawn from the puncture port. The distal end of the tearable sheath enters the vascular system through the puncture port, and the proximal end remains outside the human body to form or establish a passage for the constriction sheath 60 to enter the vascular system.

[0034] The specific intervention method of the foldable blood pump through the intervention component includes the following steps: S1) The tearable sheath is inserted through the puncture port, the distal end of the tearable sheath enters the vascular system through the puncture port, and the proximal end remains outside the human body.

[0035] S2) Take the assembly consisting of the foldable blood pump and the constriction sleeve 60, push the foldable blood pump so that the pigtail tube 30 extends from the distal end of the constriction sleeve 60, and pass the proximal end of the guide wire 70 from the distal end of the pigtail tube 30 and out from the guide wire hole 31; after production and disinfection, the foldable blood pump will be placed in the constriction sleeve 60 as a component for packaging, which can reduce the time for placing the foldable blood pump in the constriction sleeve 60 before surgery. Of course, there are also guide wires 70 and tearable sheaths in the packaging box. At this time, the entire foldable blood pump including the pigtail tube 30 is completely constrained in the constriction sleeve 60. Before surgery, take out the foldable blood pump and the constriction sleeve 60 assembly, push the foldable blood pump so that the pigtail tube 30 extends from the distal end of the constriction sleeve 60, and pass the guide wire 70 from the guide wire hole 31-pigtail tube lumen-pigtail tube distal through hole and extend out of the distal through hole.

[0036] S3) Under the assistance of imaging, the guide wire 70 is inserted into the blood vessel until the distal end of the guide wire 70 reaches the left ventricle; S4) With the assistance of imaging, the assembly consisting of the foldable blood pump and the constriction sleeve 60 is inserted into the designated position through the blood vessel along the guide wire 70. At this time, the expandable shell 11 and the foldable impeller 12 in the folded state are located in the left ventricle; that is, the blood pump in the folded state is inserted into the left ventricle together with the constriction sleeve 60, thereby reducing damage to the blood vessels and heart tissues.

[0037] S5) The guide wire 70 is withdrawn to the outside of the body. The foldable blood pump can be withdrawn later without the need for a guide wire. S6) withdraw the contraction sleeve 60 into the aorta. As the contraction sleeve 60 is withdrawn, the external force on the expandable shell 11 and the foldable impeller 12 is released. The expandable shell 11 and the foldable impeller 12 are in an expanded state in the left ventricle. The bleeding port b of the flexible membrane 13 is located at the ascending aorta. At this time, the flexible membrane 13 outside the expandable shell 11 is still in a folded state. S7) The foldable blood pump is started to perform auxiliary blood pumping operation. Blood enters the flexible membrane 13 from the blood inlet a to prop up the flexible membrane to form a blood channel. Blood is ejected into the ascending aorta from the bleeding port b opened at the proximal end of the flexible membrane 13.

[0038] In summary, the present invention has at least the following beneficial technical effects: (1) The guide wire 70 passes through the inner cavity of the flexible transmission shaft 40, which reduces the diameter of the flexible transmission shaft 40 and makes the size of the entire interventional assembly small; (2) The guide wire 70 does not pass through the inner cavity of the flexible transmission shaft 40, but directly passes through the guide wire guiding channel set on the pigtail tube 30. The operation process is simple, which saves the time of inserting the guide wire 70 before the operation, thus saving time for the operation that races against time; (3) Since the guide wire 70 does not need to be inserted through the inner cavity of the flexible transmission shaft 40, the foldable blood pump and the constriction sleeve 60 can be assembled and packaged as a component when the product is packaged at the factory, which also saves the time of inserting the foldable blood pump into the constriction sleeve 40 before the operation; (4) The guide wire hole 31 is opened on the proximal side of the pigtail tube 30. The guide wire hole 31-pigtail tube inner cavity-pigtail tube distal through hole constitute a guide wire guiding channel. After the guide wire 70 is withdrawn, the guiding channel constitutes a blood flow channel, so that the blood entering the inner cavity of the pigtail tube from the distal through hole can flow out from the guide wire hole 31. In other words, the blood in the inner cavity of the pigtail tube 31 is always in a flowing state, thereby effectively avoiding the formation of thrombus strips and improving safety performance.

[0039] Of course, it is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, but also includes the same or similar structures that can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, no matter from which point of view, the embodiments should be regarded as exemplary and non-limiting, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims are included in the present invention. Any reference numerals in the claims should not be regarded as limiting the claims involved.

[0040] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A foldable blood pump, comprising a pump head assembly (10) and a catheter (20), wherein the distal end of the pump head assembly (10) is connected to a pigtail tube (30), characterized in that: A guide wire hole (31) is provided on the proximal tube section of the pigtail tube (30). The guide wire hole (31) passes through the inner and outer walls of the pigtail tube (30) and communicates with the inner cavity. The guide wire hole (31) - the inner cavity of the pigtail tube - the distal through hole of the pigtail tube constitutes a guide wire guiding channel.

2. The foldable blood pump according to claim 1, characterized in that: The pigtail tube (30) comprises a curved section (32) located at the distal end and a supporting section (33) located at the proximal end. The curved section (32) is a curved tube in a natural state and can be deformed under the action of an external force. The supporting section (33) is a straight tube structure in a natural state and the hardness of the supporting section (33) is greater than the hardness of the curved section (32). The guide wire hole (31) is provided on the proximal tube section of the supporting section (33).

3. The foldable blood pump according to claim 1, characterized in that: The core of the guide wire hole (31) is arranged at an angle to the normal line at that location, and the inclination direction of the guide wire hole (31) from the outside to the inside is from the proximal side to the distal side. The angle between the core of the guide wire hole (31) and the normal line at that location is 30° to 80°.

4. The foldable blood pump according to claim 5, characterized in that: The curved section (32) and the supporting section (33) are connected by a transition section (34). In a natural state, the angle between the supporting section (33) and the transition section (34) is 120° to 150°, and the transition section (34) is smoothly connected to the curved section (32).

5. The foldable blood pump according to claim 2, characterized in that: The pump head assembly (10) comprises an expandable housing (11) and a foldable impeller (12) arranged in the expandable housing (11); a flexible transmission shaft (40) passes through the inner cavity of a catheter (20); a proximal end of the flexible transmission shaft (40) extends outside the body and is connected to an external motor; a distal end of the flexible transmission shaft (40) is connected to the foldable impeller (12) and drives the foldable impeller (12) to rotate; the expandable housing (11) and the pigtail tube (30) are fixed by a rigid connector (50); a proximal end of the support section (33) is sleeved on the outer periphery of the rigid connector (50); an inclined hole (51) is also arranged on the rigid connector (50) at a position corresponding to the guide wire hole (31); the guide wire hole (31) and the inclined hole (51) have the same slope and are connected to each other.

6. The foldable blood pump according to claim 5, characterized in that: The rigid connector (50) comprises a first pipe section (52) and a second pipe section (53), a step (54) being provided between the first pipe section (52) and the second pipe section (53), and an isolation block (55) being provided in the inner cavity between the first pipe section (52) and the second pipe section (53), the isolation block (55) being arranged near the inclined hole (51), an external thread (52) being provided on the outer wall of the first pipe section (52) near the step (54), the external thread and the internal thread of the support section (33) forming a threaded locking connection, and the inclined hole (51) being provided on the outer wall of the first pipe section (52) near the step (54).

7. The foldable blood pump according to claim 6, characterized in that: The distal end of the flexible transmission shaft (40) is connected to a hard shaft (41), the foldable impeller (12) is fixed on the hard shaft (41), and the distal end of the hard shaft (41) is inserted into the inner cavity of the second pipe section (53), with a shaft sleeve (42) disposed therebetween.

8. The foldable blood pump according to claim 7, characterized in that: A plurality of protrusions (531) are evenly and spaced apart on the outer wall of the second tube section (53) along its circumferential direction, and a groove is formed between two adjacent protrusions (531). The support leg at the far end of the expandable shell (11) is placed in the groove and forms a fixed connection. A protective sleeve (55) is also provided on the outer periphery of the second tube section (53).

9. The foldable blood pump according to claim 7, characterized in that: The outer cover of the expandable shell (11) is provided with a flexible membrane (13), which extends proximally from the middle section of the expandable shell (11) to the catheter (20), and the position of the distal end of the expandable shell (11) not covered by the flexible membrane (13) constitutes a blood inlet (a), and a bleeding port (b) is opened at a position corresponding to the ascending aorta at the proximal end of the flexible membrane (13).

10. An interventional assembly, comprising the foldable blood pump according to any one of claims 1 to 9, characterized in that: The interventional assembly includes a constriction sleeve (60), a guide wire (70) and a tearable sheath. The constriction sleeve (60) is slidably mounted outside the foldable blood pump, and when the pump head assembly (10) slides into the constriction sleeve, the foldable blood pump is in a folded state, and when the pump head assembly (10) slides out to the outside, the foldable blood pump is in an expanded state; A guide wire (70) passes between the distal end of the pigtail tube (30) and the guide wire hole (31) and guides the foldable blood pump to be inserted into the ventricle through the blood vessel; The tearable sheath can be partially inserted into the vascular system of the subject through the puncture port to allow the constriction sleeve (60) to pass through, and can be torn while being withdrawn from the puncture port.

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