Collapsible blood pump and interventional assembly thereof

Abstract

The application provides a foldable blood pump with high safety and small intervention size and an intervention assembly thereof, which comprises a pump head assembly and a catheter, and a pigtail pipe is connected to the distal end of the pump head assembly; a guide wire hole is formed in the proximal pipe section of the pigtail pipe, the guide wire hole penetrates the inner and outer walls of the pigtail pipe and communicates with the inner cavity, and the guide wire hole-pigtail pipe inner cavity-pigtail pipe distal end through hole constitute a guide wire guide channel. The guide wire guide channel is directly arranged on the pigtail pipe and does not pass through the inner cavity of the flexible transmission shaft in the pump head assembly and the catheter, so that 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 the damage to the vasculature and the heart tissue; on the other hand, the arrangement of the guide wire hole can also form a passageway between the perforation position and the distal end through hole, thereby avoiding the risk of thrombosis at the front end of the pigtail pipe.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a foldable blood pump and an interventional assembly thereof. BACKGROUND

[0002] The foldable blood pump for percutaneous intervention is a ventricular assist device for providing short-term cardiac assist support for patients. In use, the pump head part of the foldable blood pump spans the aortic valve, the blood inlet is located in the left ventricle, and the blood outlet is located in the ascending aorta. Through the rotation of the impeller in the pump head part, the blood in the left ventricle is pumped to the aorta to realize the function of assisting or replacing the heart to pump blood.

[0003] Due to the particularity of the foldable blood pump: the pump head assembly includes a foldable impeller and a foldable housing, a film is arranged outside the foldable housing, the film extends proximally to the catheter, the blood inlet and the blood outlet are located at two ends of the film, and during the intervention and withdrawal of the blood pump, the film and the foldable impeller and the foldable housing are in a folded state, so a guide wire cannot be used for guidance. How to safely intervene the foldable blood pump into the left ventricle through the vasculature is a difficult problem to be solved in the industry. SUMMARY

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

[0005] In order to achieve the above object, the technical scheme adopted by the present application is as follows: a foldable blood pump, comprising a pump head assembly and a catheter, a pigtail is connected to the distal end of the pump head assembly, a guide wire hole is formed on the proximal tube segment of the pigtail, the guide wire hole penetrates the inner and outer walls of the pigtail and communicates with the inner cavity, and the guide wire hole-pigtail inner cavity-pigtail distal end through hole constitute a guide wire guide channel.

[0006] Further, the pigtail comprises a curved segment at the distal end and a support segment at the proximal end, the curved segment is a bent pipe in a natural state and can be deformed under external force, the support segment is a straight pipe structure in a natural state and the hardness of the support segment is greater than that of the curved segment, and the guide wire hole is formed on the proximal tube segment of the support segment.

[0007] Further, the hole core of the guide wire hole is arranged at an angle with the normal line at this position, and the inclination direction of the guide wire hole from outside to inside is proximal to distal, and the angle between the hole core of the guide wire hole and the normal line at this position is 30°-80°.

[0008] Further, the curved segment and the support segment are connected by a transition segment, and the angle between the support segment and the transition segment in a natural state is 120°-150°, and the transition segment and the curved segment are smoothly connected.

[0009] Further, the pump head assembly comprises an inflatable shell and a foldable impeller arranged in the inflatable shell, a flexible transmission shaft passes through the catheter lumen, the proximal end of the flexible transmission shaft extends to the outside of the body and is connected with the external motor, the distal end of the flexible transmission shaft is connected with the foldable impeller and drives the foldable impeller to rotate, the inflatable shell is fixed with the pigtail through a rigid connecting piece, the proximal end of the support section is sleeved with the outer periphery of the rigid connecting piece, and the rigid connecting piece is also provided with an inclined hole at a position corresponding to the guide wire hole, the slope of the guide wire hole is equal to that of the inclined hole and the two are connected with each other.

[0010] Further, the rigid connecting piece comprises a first pipe section and a second pipe section, and the first pipe section and the second pipe section are stepped and provided with a separation block in the inner cavity between the first pipe section and the second pipe section, the separation block is arranged near the proximal side of the inclined hole, the outer wall of the first pipe section near the step is provided with an external thread, and the external thread and the internal thread of the support section form a threaded locking connection, and the inclined hole is arranged on the outer wall of the first pipe section near the step.

[0011] Further, the distal end of the flexible transmission shaft is connected with a hard shaft, the foldable impeller is fixed on the hard shaft, and the distal end of the hard shaft is inserted into the inner cavity of the second pipe section and provided with a shaft sleeve therebetween.

[0012] Further, a plurality of protrusions are uniformly and interval arranged on the outer wall of the second pipe section along the circumferential direction thereof, a groove is formed between two adjacent protrusions, the foot of the distal end of the inflatable shell is arranged in the groove and forms a fixed connection, and a protective sleeve is further arranged on the outer periphery of the second pipe section.

[0013] Further, a flexible film is arranged on the outer part of the inflatable shell, the flexible film extends proximally from the middle section of the inflatable shell to the catheter, the position of the distal end of the inflatable shell not covered by the flexible film forms a blood inlet, and the proximal end of the flexible film is provided with a blood outlet at a position corresponding to the ascending aorta.

[0014] Another object of the present application is to provide an intervention assembly with high safety and convenient operation.

[0015] In order to achieve the above object, the technical scheme adopted by the present application is as follows: an intervention assembly comprising a foldable blood pump, the intervention assembly comprising a sheath sleeve, a guide wire and a tearable sheath tube,

[0016] The sheath sleeve is slidably sleeved outside the foldable blood pump, when the pump head assembly slides into the sheath sleeve, the foldable blood pump is in a folded state, and when the pump head assembly slides out of the sheath sleeve, the foldable blood pump is in an inflated state;

[0017] The guide wire passes through between the distal end of the pigtail and the guide wire hole and guides the foldable blood pump to intervene into the heart chamber through the blood vessel;

[0018] A sheath that can be partially inserted into the vasculature of a subject through a puncture, for passage of a sheathing catheter, and that can be withdrawn through the puncture while tearing.

[0019] In the above scheme, the guide wire guide channel is directly arranged on the pigtail, and does not pass through the inner cavity of the flexible transmission shaft in the pump head assembly and the catheter. On the one hand, the size of the entire flexible transmission shaft can be set to be very small, thereby reducing the intervention size of the entire blood pump and reducing the damage to the vasculature and the heart tissue. On the other hand, the arrangement of the guide wire hole can also form a passage between the puncture position and the distal through hole, thereby avoiding the risk of thrombosis at the front end of the pigtail. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 It is a schematic diagram of the overall structure of the foldable blood pump;

[0021] Figure 2 It is a schematic diagram of the overall structure of the foldable blood pump; Figure 1 It is a partially enlarged schematic diagram;

[0022] Figure 3 It is a schematic diagram of the structure of the foldable blood pump in a folded state;

[0023] Figure 4 It is a sectional view of the foldable blood pump; Figure 3

[0024] It is a partially enlarged schematic diagram of the foldable blood pump; Figure 5 Figure 4

[0025] Figure 6 It is a schematic diagram of the structure of the rigid connecting piece;

[0026] Figure 7 It is a sectional view of the rigid connecting piece;

[0027] Figure 8 It is a schematic diagram of the state in the guide wire intervention;

[0028] Figure 9 It is a schematic diagram of the state after the guide wire intervention;

[0029] Figure 10 It is a sectional view of the foldable blood pump. Figure 8 DETAILED DESCRIPTION

[0030] For the convenience of understanding, first we define the position: "proximal" and "proximal side" refer to the side close to the operator / doctor, and "distal" and "distal side" refer to the side away from the operator / doctor, i.e. the side close to the heart.

[0031] ​​​To highlight the superior technical effects of the present invention, it is first necessary to briefly introduce the existing interventional methods for foldable blood pumps. There are two most common existing methods: the first uses a guidewire-free intervention method, which is difficult to operate and requires a high level of surgical skill from the surgeon; the second uses a guidewire-through-the-flexible drive shaft method, resulting in a larger outer diameter of the flexible drive shaft, thus increasing the overall size of the blood pump intervention. Below, in conjunction with... Figures 1-10 The technical solution and beneficial effects of the present invention will be further discussed in detail.

[0032] like Figure 1 As 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 pig tail tube 30. A guide wire hole 31 is provided on the proximal segment of the pig tail tube 30. The guide wire hole 31 penetrates the inner and outer walls of the pig tail tube 30 and communicates with the inner lumen. The guide wire hole 31, the inner lumen of the pig tail tube, and the distal through-hole of the pig tail tube form a guide wire guiding channel. During intervention, a guide wire 70 is inserted through the guide wire hole 31, passes through the inner lumen of the pig tail tube, and finally exits from the distal through-hole of the pig tail tube, thereby enabling the foldable blood pump to be inserted into the human body along the guide wire 70. In the above scheme, the guidewire guidance channel is directly set on the pig tail tube 30, without passing through the pump head assembly 10 and the inner cavity of the flexible drive shaft 40 in the catheter 20. On the one hand, the size of the entire flexible drive 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 heart tissue; on the other hand, the setting of the guidewire hole 31 can also make the perforation position and the distal through hole form a passage, avoiding the risk of thrombosis at the front end of the pig tail tube 30.

[0033] The pigtail cannula 30 includes a curved section 32 at the distal end and a supporting section 33 at the proximal end. The curved section 32 is a bent tube in its natural state and can deform under external force. The supporting section 33 is a straight tube in its natural state, and its hardness is greater than that of the curved section 32. The guidewire hole 31 is located on the proximal section of the supporting section 33. On the one hand, the supporting section 33 is harder than the curved section 32, which allows for better guidance of the guidewire 70. On the other hand, the longer guide channel also facilitates the intervention of the blood pump.

[0034] To ensure smooth insertion and withdrawal of the guidewire 70, the core of the guidewire hole 31 is arranged at an angle to the normal at that location, and the guidewire hole 31 is inclined from the proximal side to the distal side from the outside to the inside. This arrangement prevents the guidewire 70 from getting stuck and also facilitates smooth blood flow, preventing the formation of a strip-shaped thrombus in the lumen of the pigtail tube 30 during the blood pumping process after the guidewire 70 is withdrawn.

[0035] Preferably, the angle between the hole core of the guide wire hole 31 and the normal line at the position is 30°-80°. The angle value can be 30°, 45°, 60°, 75°, etc., as long as the smooth sliding of the guide wire 70 can be realized, and more preferably the angle is beneficial to the blood flow.

[0036] The transition section 34 connects the curved section 32 and the support section 33. In the natural state, the angle between the support section 33 and the transition section 34 is 120°-150°, and the transition section 34 smoothly connects the curved section 32. That is, the curved section 32 is not directly connected to the distal end of the support 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.

[0037] The pump head assembly 10 includes an inflatable shell 11 and a foldable impeller 12 arranged in the inflatable shell 11. A flexible transmission shaft 40 passes through the lumen of the catheter 20. The proximal end of the flexible transmission shaft 40 extends to the outside of the body and is connected to an external motor. The distal end of the flexible transmission shaft 40 is connected to and drives the rotation of the foldable impeller 12. The inflatable shell 11 is fixed between the pigtail 30 by a rigid connecting piece 50. The proximal end of the support section 33 is sleeved around the outer periphery of the rigid connecting piece 50. The rigid connecting piece 50 is also provided with an inclined hole 51 at a position corresponding to the guide wire hole 31. The slope of the guide wire hole 31 is equal to that of the inclined hole 51 and they are connected to each other. The rigid connecting piece 50 has the functions of connecting the flexible transmission shaft 40, the inflatable shell 11, and the pigtail 30. The flexible transmission shaft 40 is in rotational cooperation with the rigid connecting piece 50, and the inflatable shell 11 and the pigtail 30 are fixed on the rigid connecting piece 50. The pigtail 30 has many important functions 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 damage to the ventricular wall. This requires the pigtail 30 to have softness, which is usually made of low-hardness materials. Therefore, in order to ensure the rigidity of the guide wire guide and enable the blood pump to smoothly enter the left ventricle along the guide wire 70, the guide wire hole 31 is arranged on the pipe section of the support section 33 sleeved on the rigid connecting piece 50, and the corresponding pipe section of the rigid connecting piece 50 is also provided with an inclined hole 51 to improve the rigidity of the guide wire 70 inlet and outlet.

[0038] The specific structure is as follows: the rigid connecting piece 50 comprises a first pipe section 52 and a second pipe section 53, and a step 54 is arranged between the first pipe section 52 and the second pipe section 53, which serves as an isolation area between the first pipe section 52 and the second pipe section 53 and also constitutes an axial limiting structure of the two side connecting components. An isolation block 55 is arranged in the inner cavity between the first pipe section 52 and the second pipe section 53, and the isolation block 55 is arranged close to the proximal side of the inclined hole 51. The isolation block 55 is preferably integrally formed with the rigid connecting piece 50, for example, a structure that is not punched through in the inner cavity of the rigid connecting piece 50 close to the inclined hole 51 is reserved during machining, so that a sealing part is not needed to be additionally arranged, which prevents blood from entering the inner cavity of the second pipe section 53. Since the inner cavity of the second pipe section 53 is provided with a shaft sleeve 42, blood damage is avoided, and the shaft sleeve 42 also constitutes an axial limiting structure of the hard shaft 41. An external thread is arranged on the outer wall of the first pipe section 52 close to the step 54, and the external thread and the internal thread of the support section 33 constitute a threaded locking connection. The inclined hole 51 is arranged on the outer wall of the first pipe section 52 close to the step 54. The support section 33 and the first pipe section 52 are connected through threads, which ensures the reliability of the connection. In order to further enhance the reliability of the connection, glue can be filled in the thread gap, which also prevents blood from entering the thread gap and causing hemolysis and thrombosis.

[0039] Since the flexible transmission shaft 40 is soft, if the foldable impeller 12 is directly arranged on the flexible transmission shaft 40, the jumping amount of the foldable impeller 12 is large, which may collide with the inflatable shell 11 and cause damage, and the shear force on the blood is large, which causes serious blood damage. In order to ensure the stability of the rotation of the foldable impeller 12, the distal end of the flexible transmission shaft 40 is connected with 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 and is provided with a shaft sleeve 42 therebetween. 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 provided with a bearing, so that both ends of the hard shaft 41 are supported by bearing structures, thereby ensuring the stability of the rotation of the hard shaft 41, and the rotation of the foldable impeller 12 arranged on the outer periphery of the hard shaft 41 is stable, which avoids collision with the inflatable shell 11 and causes damage, and the shear force on the blood is small, which reduces blood damage. In addition, since the rotation of the foldable impeller 12 is relatively stable, the blood pump flow of the whole blood pump can also be detected, which is beneficial to the evaluation of the recovery of the patient by the doctor and improves the success rate of the operation.

[0040] As known, the expandable shell 11 is a grid structure made of shape memory alloy material, including a middle cylindrical section and two tapered cylindrical sections at both ends, and the expandable shell 11 is in a folded state under the action of an external force and is in an expanded state after the external force is removed. The distal end of the expandable shell 11 is provided with a plurality of divergent legs, and the distal end of the expandable shell 11 is fixed by fixing the legs. Therefore, a plurality of protrusions 531 are uniformly and spaced apart in the circumferential direction on the outer wall of the second tube section 53, and a recess is formed between adjacent two protrusions 531, the legs at the distal end of the expandable shell 11 are arranged in the recess and are fixedly connected, and a protective sleeve is further arranged on the outer periphery of the second tube section 53. The number of recesses is consistent with the number of legs, so that each leg is clamped in a recess, and then fixed by welding or other processes. In this way, the overall shape of the expandable shell 11 can be ensured, and the reliability of the connection can be enhanced. In order to further improve the stability of the connection, a protective sleeve is further arranged on the outer periphery of the second tube section 53, which also ensures the smoothness of the outer surface of the device, reduces the damage to the blood, and prevents the retention of thrombus.

[0041] 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, the flexible membrane 13 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 which is not covered by the flexible membrane 13 constitutes a blood inlet a, and the proximal end of the flexible membrane 13 is provided with a blood outlet b at the position 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, the flexible membrane 13 will be lifted up to form a blood flow channel due to the inflow of blood.

[0042] Only one guide wire cannot intervene the foldable blood pump into the left ventricle through the vasculature, because the pump head assembly 10 of the foldable blood pump is in an expanded state without the action of an external force, at this time the diameter is large, and it is impossible to intervene from the blood vessel. The present application provides an intervention assembly for intervening the foldable blood pump into the left ventricle, and the composition of the intervention assembly and the intervention method thereof will be described in detail below.

[0043] An intervention assembly, comprising a foldable blood pump, the intervention assembly comprising a sheath 60, a guide wire 70 and a tearable sheath tube,

[0044] The sheath 60 is slidably sleeved outside the foldable blood pump. When the pump head assembly 10 is slid into the sheath 60, the foldable blood pump is in a folded state, and when the pump head assembly 10 is slid out of the sheath 60, the foldable blood pump is in an inflated state. The size of the sheath 60 is smaller than that of the aortic blood vessel, so it can be easily intervened from the blood vessel. The components of the pump head assembly 10, including the inflatable shell 11, the foldable impeller 12 and the flexible membrane 13, are foldable and can be constrained in the inner cavity of the sheath 60 and intervened from the blood vessel together with the sheath 60. During the entire intervention process, the size of the entire intervention assembly is small due to the constraint of the sheath 60.

[0045] The guide wire 70 passes through the guide wire hole 31 of the pigtail 30 and guides the foldable blood pump to intervene in the heart chamber through the blood vessel. For an interventional medical device, a guide wire is generally needed to guide. It needs to be emphasized that in the present application, the guide wire 70 neither passes through the inside of the pump head assembly 10, nor passes through the inner cavity of the flexible transmission shaft 40, nor passes through the inner cavity of the sheath 60. The guide wire 70 only passes through the guide wire hole 31-pigtail inner cavity-pigtail distal end hole to form a guide wire guide channel, which facilitates the threading of the guide wire 70 and saves the preparation time before the operation, so as to save the precious operation time for the patient.

[0046] The tearable sheath tube (not shown in the figure) can be partially intervened into the vasculature of the subject through the puncture port, and the sheath tube can be torn and withdrawn from the puncture port when withdrawn. The distal end of the tearable sheath tube enters the vasculature through the puncture port, and the proximal end remains outside the human body, which is used to form or establish a passage for the sheath 60 to enter the vasculature.

[0047] The specific intervention method of the foldable blood pump through the intervention assembly includes the following steps:

[0048] S1) The tearable sheath tube is inserted from the puncture port, and the distal end of the tearable sheath tube enters the vasculature through the puncture port, and the proximal end remains outside the human body.

[0049] S2) Take the assembly of the foldable blood pump and the sheath 60, push the foldable blood pump so that the pigtail 30 extends out of the distal end of the sheath 60, and the proximal end of the guide wire 70 is inserted from the distal end of the pigtail 30 and passes out of the guide wire hole 31. After the production and sterilization of the foldable blood pump, the foldable blood pump is placed in the sheath 60 as an assembly for packaging, which can reduce the time of placing the foldable blood pump in the sheath 60 before the operation. Of course, the packaging box also contains the guide wire 70 and the tearable sheath tube, etc. At this time, the entire foldable blood pump including the pigtail 30 is completely constrained in the sheath 60. Before the operation, the foldable blood pump and the sheath 60 assembly are taken out, and the foldable blood pump is pushed so that the pigtail 30 extends out of the distal end of the sheath 60, and the guide wire 70 is inserted from the guide wire hole 31-pigtail inner cavity-pigtail distal end hole and extends out of the distal end hole.

[0050] S3) Under the assistance of imaging, the guide wire 70 is intervened from the blood vessel until the distal end of the guide wire 70 reaches the left ventricle;

[0051] S4) Under the assistance of imaging, the assembly composed of the foldable blood pump and the sheath sleeve 60 is intervened along the guide wire 70 to the designated position, at this time, the inflatable 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 intervened into the left ventricle together with the sheath sleeve 60, reducing the damage to the blood vessels and the heart tissue.

[0052] S5) The guide wire 70 is withdrawn to the outside of the body, and the withdrawal of the foldable blood pump does not need to use the guide wire again;

[0053] S5) The sheath sleeve 60 is withdrawn to the aorta, and as the sheath sleeve 60 is withdrawn, the external force on the inflatable shell 11 and the foldable impeller 12 is removed, the inflatable shell 11 and the foldable impeller 12 are in the expanded state in the left ventricle, and the blood outlet b of the flexible membrane 13 is located at the position of the ascending aorta; at this time, the flexible membrane 13 outside the inflatable shell 11 is still in the folded state

[0054] S6) The foldable blood pump is started, and the auxiliary blood pumping operation is implemented, the blood enters the flexible membrane 13 from the blood inlet a to support the flexible membrane to form a blood passage, and the blood is injected into the ascending aorta from the blood outlet b near the proximal end of the flexible membrane 13.

[0055] In summary, the present application has at least the following beneficial technical effects:

[0056] (1) The guide wire 70 passes through the inner cavity of the flexible transmission shaft 40, reducing the diameter of the flexible transmission shaft 40, so that the size of the entire intervention assembly is small;

[0057] (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 guide channel provided on the pigtail 30, the operation process is simple, and the time for preoperative guide wire 70 is saved, which saves time for the time-saving surgery;

[0058] (3) Since the guide wire 70 does not need to be arranged in the inner cavity of the flexible transmission shaft 40, the foldable blood pump and the sheath sleeve 60 can be assembled as a component for packaging when the product is packaged, which also saves the time for preoperative arrangement of the foldable blood pump into the sheath sleeve 40;

[0059] (4) The guide wire hole 31 is arranged at the proximal end of the pigtail 30, and the guide wire hole 31-pigtail inner cavity-pigtail distal end through hole constitute a guide wire guide channel, after the guide wire 70 is withdrawn, the guide channel constitutes a blood flow channel, so that the blood entering the inner cavity of the pigtail from the pigtail distal end through hole can flow out from the guide wire hole 31, that is, the blood in the inner cavity of the pigtail 31 is always in a flowing state, so that the formation of thrombosis can be effectively avoided, and the safety performance is improved.

[0060] Of course, the present application is not limited to the details of the above-described exemplary embodiments, but also includes the same or similar structures that can be implemented in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be regarded as exemplary and non-limiting, and the scope of the present application is defined by the appended claims rather than the above description, and therefore all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application. Any reference signs in the claims should not be regarded as limiting the claims involved.

[0061] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description of the specification is only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can be combined appropriately to form other embodiments that those skilled in the art can understand.

Claims

1. A collapsible blood pump comprising a pump head assembly (10) and a catheter (20), a distal end of the pump head assembly (10) being connected to a pigtail (30), characterized in that: The pigtail (30) is provided with a guide wire hole (31) on the proximal tube segment, the guide wire hole (31) penetrates the inner and outer walls of the pigtail (30) and communicates with the inner cavity, and the guide wire hole (31)-pigtail inner cavity-pigtail distal end through hole constitute a guide wire guide channel; The pigtail (30) comprises a curved segment (32) at the distal end and a support segment (33) at the proximal end, the curved segment (32) is a bent pipe in the natural state and can be deformed under external force, and the support segment (33) is a straight pipe structure in the natural state and the hardness of the support segment (33) is greater than that of the curved segment (32), and the guide wire hole (31) is arranged on the proximal tube segment of the support segment (33). The pump head assembly (10) comprises an inflatable shell (11) and a foldable impeller (12) arranged in the inflatable 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 to the outside of the body and is connected with an external motor, the distal end of the flexible transmission shaft (40) is connected with the foldable impeller (12) and drives the foldable impeller (12) to rotate, and the inflatable shell (11) and the pigtail (30) are fixed by a rigid connecting piece (50), the proximal end of the support segment (33) is sleeved with the outer periphery of the rigid connecting piece (50), and the rigid connecting piece (50) is also provided with an inclined hole (51) at a position corresponding to the guide wire hole (31), the slope of the guide wire hole (31) is equal to that of the inclined hole (51) and they are connected with each other. The rigid connecting piece (50) comprises a first tube segment (52) and a second tube segment (53), a step (54) is arranged between the first tube segment (52) and the second tube segment (53), an isolation block (55) is arranged in the inner cavity between the first tube segment (52) and the second tube segment (53), the isolation block (55) is arranged near the proximal side of the inclined hole (51), an external thread is arranged on the outer wall of the first tube segment (52) near the step (54), and the external thread and the internal thread of the support segment (33) form a thread locking connection, and the inclined hole (51) is arranged on the outer wall of the first tube segment (52) near the step (54).

2. The collapsible blood pump of claim 1, wherein: The hole core of the guide wire hole (31) is arranged at an angle with the normal line at this position, and the inclination direction of the guide wire hole (31) from outside to inside is proximal to distal, and the angle between the hole core of the guide wire hole (31) and the normal line at this position is 30°-80°.

3. The collapsible blood pump of claim 1, wherein: The curved segment (32) and the support segment (33) are connected by a transition segment (34), and the angle between the support segment (33) and the transition segment (34) is 120°-150° in the natural state, and the transition segment (34) is smoothly connected with the curved segment (32).

4. The collapsible blood pump of claim 3, wherein: The distal end of the flexible transmission shaft (40) is connected with a hard shaft (41), 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 tube segment (53), and a shaft sleeve (42) is arranged between the hard shaft (41) and the second tube segment (53).

5. The collapsible blood pump of claim 4, wherein: The outer wall of the second pipe section (53) is uniformly and spacedly provided with a plurality of protrusions (531) along the circumferential direction thereof, a recess is formed between two adjacent protrusions (531), the foot of the distal end of the inflatable shell (11) is arranged in the recess and fixedly connected, and a protective sleeve is further arranged on the outer periphery of the second pipe section (53).

6. The collapsible blood pump of claim 5, wherein: The outer part of the inflatable shell (11) is covered with a flexible membrane (13), the flexible membrane (13) extends proximally from the middle part of the inflatable shell (11) to the catheter (20), the position of the distal end of the inflatable shell (11) which is not covered by the flexible membrane (13) constitutes a blood inlet (a), and the proximal end of the flexible membrane (13) is provided with a blood outlet (b) at the position corresponding to the ascending aorta.

7. An interventional assembly comprising the collapsible blood pump of any one of claims 1-6, characterized by: The intervention assembly comprises a constriction sleeve (60), a guide wire (70) and a tearable sheath tube, The constriction sleeve (60) is slidably sleeved outside the foldable blood pump, when the pump head assembly (10) slides into the inside of the constriction sleeve (60), the foldable blood pump is in a folded state, and when the pump head assembly (10) slides out to the outside of the constriction sleeve (60), the foldable blood pump is in an inflated state; The guide wire (70) passes through the distal end of the pigtail (30) and the guide wire hole (31) and guides the foldable blood pump to be intervened into the heart chamber through the blood vessel; The tearable sheath tube can be partially intervened into the vasculature of the subject through the puncture port, the constriction sleeve (60) passes through the tearable sheath tube, and the tearable sheath tube can be torn and withdrawn from the puncture port when being withdrawn.

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