Blood pump and ventricular assist system

Abstract

The application relates to a blood pump and a ventricular assist system. The blood pump comprises a handle mechanism, a catheter, a pump shell and a blood pumping driving mechanism; the handle mechanism comprises a handle main body and a power assembly arranged on the handle main body; the blood pumping driving mechanism comprises a paddle assembly and a driving assembly, the paddle assembly is arranged in the pump shell and has a first mode and a second mode, the maximum radial dimension of the paddle assembly in the first mode is greater than that in the second mode, the proximal end of the driving assembly is connected with the power assembly through the catheter, the power assembly can drive the paddle assembly to reciprocate axially through the driving assembly, so that the paddle assembly is switched between the first mode and the second mode in turn, and the paddle assembly can perform a blood pumping operation. The blood pump can improve the operation safety by changing the blood pumping mode of the blood pumping driving mechanism and the position of the power assembly.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a blood pump and a ventricular assist system. BACKGROUND

[0002] The interventional catheter pump, also known as a blood pump, is usually implanted into the heart chamber of a patient from the blood vessel to assist the patient's heart to pump blood from the heart chamber to the artery, thereby providing support for the blood circulation of the patient. The conventional blood pump includes a pump shell, an impeller, a motor and a catheter. The motor is arranged between the pump shell and the catheter. The impeller, as a blood pumping driving mechanism, can rotate in the pump shell under the driving of the motor, and can flow blood into the pump shell through the blood flow inlet of the pump shell and flow out of the pump shell through the blood flow outlet of the pump shell.

[0003] However, the conventional blood pump has potential side effects such as hemolysis and thrombosis, and the safety of the operation is not high. SUMMARY

[0004] Therefore, it is necessary to provide a blood pump and a ventricular assist system to solve the above technical problems.

[0005] A blood pump comprises:

[0006] A handle mechanism, which comprises a handle body and a power assembly arranged on the handle body;

[0007] A catheter, a proximal end of which is connected to the handle body;

[0008] A pump shell, which is arranged at a distal end of the catheter and has a blood flow inlet and a blood flow outlet; and

[0009] A blood pumping driving mechanism, which comprises a paddle assembly and a driving assembly. The paddle assembly is arranged in the pump shell and has a first form and a second form. The maximum radial dimension of the paddle assembly in the first form is greater than that in the second form. The proximal end of the driving assembly passes through the catheter and is connected to the power assembly. The power assembly can drive the paddle assembly to reciprocatingly extend and retract axially through the driving assembly, so as to switch the paddle assembly between the first form and the second form, thereby enabling the paddle assembly to perform blood pumping operation.

[0010] In one embodiment, the paddle assembly comprises a plurality of paddles connected in sequence from proximal to distal. In the first form, each paddle is unfolded, and in the second form, each paddle is folded.

[0011] In one embodiment, the maximum radial dimension of the plurality of paddles in the first form decreases in sequence along the blood pumping direction.

[0012] In one of the embodiments, the paddle comprises a closed section and a hollow section connected in sequence in the blood pumping direction, and the connection between the closed section and the hollow section has the largest radial dimension.

[0013] In one of the embodiments, the closed section comprises a first skeleton and a flow blocking film, the flow blocking film is arranged on the first skeleton, and the first skeleton is connected with the hollow section; and / or,

[0014] The hollow section comprises a second skeleton, and the second skeleton is connected with the closed section.

[0015] In one of the embodiments, the driving assembly comprises an inner tube and an outer tube, the distal end of the outer tube is connected with the nearest paddle, and the proximal end of the outer tube is connected with the handle body through the catheter, the distal end of the inner tube is arranged in each paddle and connected with the farthest paddle, and the proximal end of the inner tube is connected with the power assembly through the outer tube, and the power assembly can drive the inner tube to move linearly and reciprocally.

[0016] In one of the embodiments, the blood pump further comprises a directional shaft, and the distal end of the directional shaft is connected with the distal end of the pump shell through the inner tube.

[0017] In one of the embodiments, the handle mechanism further comprises a first movable assembly, the first movable assembly is movably arranged on the handle body and connected with the power assembly, and the first movable assembly can drive the power assembly to move relative to the handle body.

[0018] In one of the embodiments, the first movable assembly comprises a first movable member and a first adjusting member, the first movable member is in sliding connection with the handle body, and the first movable member is connected with the power assembly;

[0019] The first adjusting member is in cooperative connection with the outer surface of the first movable member, and the first adjusting member is configured to apply force to the first movable member when rotating to drive the first movable member to move the power assembly relative to the handle body.

[0020] In one of the embodiments, the pump shell can be contracted or expanded;

[0021] The handle mechanism further comprises a second movable assembly, the second movable assembly is movably arranged on the handle body and located distally of the first movable assembly, the second movable assembly is connected with the proximal end of the catheter and can drive the catheter to move relative to the handle body.

[0022] In one of the embodiments, the pump housing comprises a stent and a covering film; the stent is capable of being contracted or expanded to adjust the radial size of the stent, the stent has a proximal end, a distal end opposite to the proximal end, and a middle part between the proximal end and the distal end; the covering film is arranged on the middle part of the stent, so that one of the proximal end and the distal end of the stent forms the blood flow inlet, and the other forms the blood flow outlet.

[0023] In one of the embodiments, the second movable assembly comprises a second movable member and a second adjusting member; the second movable member is slidably arranged on the handle body, and the second movable member is connected with the proximal end of the catheter; the second adjusting member is connected with the outer surface of the second movable member, and the second adjusting member is configured to apply force to the second movable member when being rotated to drive the second movable member to move the catheter relative to the handle body.

[0024] A ventricular assist system comprises a control module, a perfusion module, and the blood pump as described in any one of the above embodiments; the control module is connected with the power assembly, and the perfusion module is used for injecting perfusion liquid into the blood pump.

[0025] The blood pump and the ventricular assist system described above, on the one hand, the paddle assembly of the blood pumping driving mechanism can reciprocate axially under the driving of the driving assembly to alternately switch between the first mode and the second mode, thereby being capable of performing blood pumping operation, wherein the reciprocating axial extension and contraction of the paddle assembly when pumping blood is equivalent to reciprocating linear motion, and the shear force generated by the reciprocating linear motion is much smaller than the shear force generated by the high-speed rotation of the impeller of the existing blood pump; in addition, the blood perfusion volume of the blood pump can be increased by correspondingly and appropriately increasing the maximum radial size of the paddle assembly in the first mode, the number of paddles, the axial stroke of the paddle assembly in the pump housing, and the like, so that the frequency of the reciprocating axial extension and contraction of the paddle assembly can be increased by a small amplitude or not, so as to avoid the frequency of the reciprocating axial extension and contraction of the paddle assembly being too large, so that the frequency of the reciprocating axial extension and contraction of the paddle assembly is much lower than the high-speed rotation frequency of the impeller of the blood pump, and the shear force on the blood cells can also be effectively reduced. It can be seen that the blood pumping driving mechanism provided by the present application can effectively reduce the shear force on the blood cells and greatly eliminate the risk of hemolysis; on the other hand, the power member is arranged on the handle mechanism, rather than between the distal end of the catheter and the proximal end of the pump housing, so that the power member can be placed outside the patient's body during surgery, which can avoid the generation of wear particles in the patient's body due to the power mechanism, and can also prevent the blood clotting problem caused by the heat generated by the operation of the power mechanism, and the like.

[0026] In summary, the blood pump and ventricular assist system provided in this application can greatly eliminate the risk of hemolysis by changing the pumping method of the blood pumping drive mechanism, and by changing the position of the power component, it can prevent thrombosis problems caused by heat during operation, etc., which can improve surgical safety. At the same time, the clinical application time and stability of the product are greatly improved, and the effect of low-frequency operation and high blood perfusion can be achieved. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a schematic structural diagram of the paddle assembly of a blood pump provided in an embodiment of the present application in a first form.

[0028] Figure 2 for Figure 1 A cross-sectional view of a blood pump is provided.

[0029] Figure 3 for Figure 1 A schematic structural diagram of a pump housing of a blood pump is provided.

[0030] Figure 4 for Figure 1 A schematic diagram of the structure of the blood pump housing when it is extended is provided.

[0031] Figure 5 for Figure 1 A schematic diagram of the structure of the pump housing of the blood pump when it is contracted is provided.

[0032] Figure 6 for Figure 1 A schematic diagram of the blood pump implanted in a patient is provided.

[0033] Figure 7 for Figure 1 A schematic structural diagram of a blood pump drive mechanism of a blood pump is provided when the blade assembly is in a first configuration.

[0034] Figure 8 for Figure 1 A schematic diagram of the blood pumping process is provided.

[0035] Figure 9 for Figure 7 A schematic structural diagram of the first and second skeletons of the blood pumping drive mechanism is provided when the blade assembly is in a first form.

[0036] Figure 10 for Figure 1 Provided is a schematic diagram of the structure of the blood pump when pushing in the body.

[0037] Figure 11 for Figure 1 A schematic structural diagram of the handle mechanism of a blood pump is provided.

[0038] Figure 12 for Figure 1An exploded view of the handle mechanism of the provided blood pump is provided.

[0039] Figure 13 Figure 1 A schematic cross-sectional view of a handle mechanism of a blood pump is provided.

[0040] Figure 14 for Figure 11 A schematic diagram of the connection structure between the first movable member of the handle mechanism and the handle body is provided.

[0041] Figure 15 for Figure 11 A schematic cross-sectional view of a first movable member of a handle mechanism is provided.

[0042] Figure 16 for Figure 11 A schematic diagram of the connection between the handle mechanism, the catheter and the inner tube is provided.

[0043] Figure 17 for Figure 11 Provided is a schematic diagram of the handle mechanism driving the inner tube through the power assembly.

[0044] Figure 18 for Figure 11 A schematic diagram of the handle mechanism provided when driving the catheter through the second movable component.

[0045] Figure 19 A schematic structural diagram of a ventricular assist device provided in another embodiment of the present application.

[0046] The reference numerals in the accompanying drawings are described as follows:

[0047] 1, blood pump; 10, handle mechanism; 100, handle main body; 110, main shaft; 111, flushing section; 111a, flushing hole; 112, first connecting section; 112a, positioning groove; 113, second connecting section; 120, first limiting piece; 130, second limiting piece; 140, shell; 150, terminal; 160, accommodating through hole; 210, first movable assembly; 211, first movable piece; 211a, first center part; 211b, first edge part; 211c, first connecting part; 212, first adjusting piece; 220, power assembly; 300, second movable assembly; 310, second movable piece; 320, second adjusting piece; 10', blood pumping driving mechanism; 100', paddle assembly; 110', paddle; 111', closed section; 1111', first framework; 1111a', first support rod; 1112', resistance film; 112', hollow section; 1121', second framework; 1121a', second support rod; 120', connecting pipe; 200', driving assembly; 210', inner pipe; 220', outer pipe; 300', second developing piece; 20, pump shell; P, blood flow inlet; Q, blood flow outlet; 20a, bracket; A, circular pipe section; M, first reduced diameter section; C, second reduced diameter section; 20b, film; 30, catheter; 40, directional shaft; 50, flexible end; 2, control module; 3, perfusion module. DETAILED DESCRIPTION

[0048] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a number of different ways beyond the specific embodiments described and it is to be understood that the present application is not limited to the specific embodiments described below.

[0049] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0050] In addition, the terms "first", "second", and the like, if any, are used herein for descriptive purposes only and should not be construed as indicating or implying relative importance or identifying the number of the indicated technical features. Thus, a feature limited to "first" or "second" can explicitly or implicitly include at least one of the features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0051] In the present application, unless otherwise explicitly specified and limited, if the terms "mounting", "connecting", "connecting", "fixing" and the like appear, these terms should be interpreted broadly. For example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0052] In the present application, unless otherwise explicitly specified and limited, if the first feature is described as "on" or "under" the second feature, etc., it can mean that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be the first feature directly above or obliquely above the second feature, or it can only mean that the first feature is higher than the second feature in horizontal height. The first feature "below", "below" and "below" the second feature can be the first feature directly below or obliquely below the second feature, or it can only mean that the first feature is lower than the second feature in horizontal height.

[0053] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on another element or there can be a middle element. If an element is considered to be "connected" to another element, it can be directly connected to another element or there can be a middle element. If present, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in the present application are only for illustrative purposes and do not represent the only implementation.

[0054] It should be noted that "distal" and "proximal" throughout the text are only for indicating relative positional relationship, the "distal" of a component refers to the end of the component that enters the patient's body first and / or is farther away from the operator during normal operation, while the "proximal" refers to the end that enters the patient's body later and / or is closer to the operator.

[0055] Interventional catheter pumps, also known as blood pumps, are often implanted into a patient's ventricles through blood vessels to assist the heart in pumping blood from the ventricles to the arteries, thereby supporting the patient's blood circulation. Traditional blood pumps consist of a pump casing, impeller, motor, and catheter. The motor is located between the pump casing and the catheter, and the impeller, driven by the motor, rotates within the pump casing, pumping blood into the pump casing through its blood inlet and out through its blood outlet.

[0056] To generate sufficient centrifugal force, maintain stable blood flow, and ensure efficient blood perfusion, the impellers of traditional blood pumps typically rotate at very high speeds, especially those of axial-flow blood pumps, which can reach speeds of around 7,000 to 15,000 revolutions per minute (rpm). However, when the impeller rotates at high speeds, the shear force generated increases, which in turn damages red blood cells, potentially leading to hemolysis. The longer the operation time, the greater the side effects and the higher the incidence of complications. Furthermore, because the motor is located within the body, the heat generated during operation can increase the risk of thrombosis. Therefore, traditional blood pumps pose potential side effects such as hemolysis and thrombosis, making surgical safety unsafe.

[0057] In this regard, an embodiment of the present application provides a blood pump that can be implanted into a patient's ventricle as an invasive catheter pump. Figure 1 and Figure 2 As shown, the blood pump 1 may include a handle mechanism 10 , a catheter 30 , a pump housing 20 and a blood pumping drive mechanism 10 ′. Figure 1 The arrow X+ indicates the direction from the proximal end to the distal end; the arrow X- indicates the direction from the distal end to the proximal end.

[0058] The handle mechanism 10 is mainly used to assist the blood pump 1 and can be held by the operator. Figure 2 As shown, the handle mechanism 10 may include a handle body 100 and a power assembly 220 disposed on the handle body 100 .

[0059] The catheter 30 is primarily used to establish a channel between the human circulatory system and the blood pump 1 and to achieve directional blood flow. The proximal end of the catheter 30 is connected to the handle body 100. The catheter 30 can be made of a medical polymer composite and can be connected to the handle mechanism 10 by gluing or hot-melting, etc., which is not limited in this application.

[0060] like Figures 3 to 6 As shown, the pump housing 20 is mainly used to accommodate and guide the flow of blood. It is located at the distal end of the catheter 30 and has a blood flow inlet P and a blood flow outlet Q. When pumping blood, blood flows into the pump housing 20 through the blood flow inlet P of the pump housing 20 and flows out from the blood flow outlet Q of the pump housing 20. Figure 3As shown, when the blood pump 1 is a left heart intervention pump, the blood flow inlet P is arranged at the distal end of the pump shell 20, and the blood flow outlet Q is arranged at the proximal end of the pump shell 20; the blood pump 1 is pushed from the aorta to the left ventricle, and the blood flow inlet P of the blood pump 1 is located in the left ventricle, and the blood flow outlet Q is located in the aorta; when the blood pump 1 is a right heart intervention pump, the blood flow inlet P is arranged at the proximal end of the pump shell 20, and the blood flow outlet Q is arranged at the distal end of the pump shell 20; the blood pump 1 is pushed from the right ventricle to the pulmonary artery, and the blood flow inlet P of the blood pump 1 is located in the right ventricle, and the blood flow outlet Q is located in the pulmonary artery.

[0061] The pump shell 20 can be contracted or expanded to adjust its radial size. When the blood pump 1 is inserted into the patient's body, the pump shell 20 can be contracted first, so that the radial size of the pump shell 20 becomes smaller, so that the pump shell 20 can be inserted into the sheath tube, and when it is pushed in the patient's body, the pump shell 20 is always in a compressed state due to the limitation of the sheath tube; when the blood pump 1 reaches the target position in the patient's body, the sheath tube is withdrawn, the pump shell 20 is expanded, and the radial size of the pump shell 20 becomes larger, so that the pump shell 20 has a larger space to accommodate more blood, which is also conducive to guiding the blood flow, and can ensure the blood pumping efficiency of the blood pump 1; in addition, when the blood pump 1 reaches the target position in the patient's body, the radial size of the pump shell 20 can be adjusted by contracting or expanding the pump shell 20 according to the position and size of the aorta or the pulmonary artery, so that the proximal end or the distal end of the pump shell 20 can be inserted into the aorta or the pulmonary artery, so that the blood can be pumped from the ventricle to the aorta or the pulmonary artery, and the blood pumping efficiency of the blood pump 1 can be ensured.

[0062] It should be noted that since the pump shell 20 can be contracted to a smaller size, the radial size of the sheath tube for the blood pump 1 does not need to be set too large, thereby also reducing the difficulty of pushing the sheath tube in the patient's body.

[0063] The blood pumping driving mechanism 10' mainly provides power for the flow of liquid, and can push the blood flow, thereby realizing the blood pumping operation. As shown in Figure 1 , Figure 2 and Figure 7 , the blood pumping driving mechanism 10' includes a paddle assembly 100' and a driving assembly 200'. The paddle assembly 100' is arranged in the pump shell 20 and has a first form and a second form, and the maximum radial size of the paddle assembly 100' in the first form is larger than that in the second form; the proximal end of the driving assembly 200' penetrates the catheter 30 and is connected with a power member, and can drive the paddle assembly 100' to reciprocatingly stretch and contract axially by relying on the power of the power member, so as to make the paddle assembly 100' switch between the first form and the second form in turn, thereby enabling the paddle assembly 100' to perform the blood pumping operation. As shown in Figure 8As shown, when the driving assembly 200' drives the paddle assembly 100' to compress from the blood inflow port P to the blood outflow port Q of the pump housing 20, the paddle assembly 100' can switch from the second mode to the first mode, and the radial dimension of the paddle assembly 100' becomes larger, so that the paddle assembly 100' can bring the blood at the blood inflow port P to the blood outflow port Q when compressed, and then pump into the blood vessel of the patient; and when the driving assembly 200' drives the paddle assembly 100' to elongate from the blood outflow port Q to the blood inflow port P of the pump housing 20, the paddle assembly 100' can switch from the first mode to the second mode, and the radial dimension of the paddle assembly 100' becomes smaller, so that the paddle assembly 100' will not reversely bring the blood from the blood outflow port Q to the blood inflow port P. The paddle assembly 100' repeats the above steps, that is, reciprocating axial stretching and contraction plus synchronous switching of its own mode, to realize the perfusion of blood, similar to the irrigation principle of ancient stone waterwheel. Figure 8 The flow direction of the blood when the paddle assembly 100' switches between the first mode and the second mode is shown in FIG. 2B, wherein Figure 8 The curved dotted arrow in FIG. 2B represents the flow direction of the blood, and the straight wide arrow represents the stretching and contraction direction of the paddle assembly 100'.

[0064] As shown in FIG. 1A, Figure 7 The paddle assembly 100' includes a plurality of paddles 110' connected in sequence from proximal to distal, each paddle 110' is unfolded in the first mode, and each paddle 110' is folded in the second mode. It should be noted that each paddle 110' is opened or closed in sequence or synchronously when the paddle assembly 100' switches between the first mode and the second mode. In the first mode, the maximum radial dimensions of the paddles 110' can be the same or different, wherein the maximum radial dimension corresponding to the paddle 110' with the largest radial dimension is the maximum radial dimension of the paddle assembly 100' in the first mode; in the second mode, the maximum radial dimensions of the paddles 110' can be the same or different, wherein the maximum radial dimension corresponding to the paddle 110' with the largest radial dimension is the maximum radial dimension of the paddle assembly 100' in the second mode.

[0065] Considering the processing cost and the axial dimension of the pump housing 20 of the blood pump 1, the number of paddles 110' is set to 2-5, for example, it can be set to 2, 3, 4 or 5.

[0066] As shown in FIG. 1A, Figure 7As shown, the maximum radial dimension of the plurality of paddles 110’ in the first configuration decreases in the blood pumping direction. By arranging the radial dimension of the plurality of paddles 110’ in this way, the flow of blood in the pump housing 20 can be guided, and vortex flow of blood in the pump housing 20 can be avoided, thereby improving the blood pumping efficiency of the blood pump 1. It should be noted that the “blood pumping direction” throughout the text refers to the direction of flow of blood from the blood flow inlet P to the blood flow outlet Q of the pump housing 20. When the blood pump 1 is a left heart interventional pump, the maximum radial dimension of the plurality of paddles 110’ in the first configuration gradually decreases from the distal end to the proximal end of the pump housing 20. When the blood pump 1 is a right heart interventional pump, the maximum radial dimension of the plurality of paddles 110’ in the first configuration gradually decreases from the proximal end to the distal end of the pump housing 20.

[0067] The blood perfusion volume of the blood pump 1 is related to the maximum radial dimension of the paddle assembly 100’ in the first configuration, the number of paddles 110’, the axial stroke of the paddle assembly 100’ in the pump housing 20, and the frequency of reciprocating axial extension and contraction of the paddle assembly 100’. Specifically, the greater the blood perfusion volume of the blood pump 1, the greater the maximum radial dimension of the paddle assembly 100’ in the first configuration, the number of paddles 110’, the axial stroke of the paddle assembly 100’ in the pump housing 20, and the frequency of reciprocating axial extension and contraction of the paddle assembly 100’. In other words, during blood pumping, the blood perfusion volume of the blood pump 1 can be increased by adjusting at least one of the maximum radial dimension of the paddle assembly 100’ in the first configuration, the number of paddles 110’, the axial stroke of the paddle assembly 100’ in the pump housing 20, and the frequency of reciprocating axial extension and contraction of the paddle assembly 100’. In order to avoid excessive shear force of the paddle assembly 100’ due to excessive frequency of reciprocating axial extension and contraction of the paddle assembly 100’, when it is necessary to increase the blood perfusion volume of the blood pump 1, the maximum radial dimension of the paddle assembly 100’ in the first configuration, the number of paddles 110’, and the axial stroke of the paddle assembly 100’ in the pump housing 20 can be appropriately increased, so that the frequency of reciprocating axial extension and contraction of the paddle assembly 100’ can be increased slightly or not at all, thereby avoiding excessive frequency of reciprocating axial extension and contraction of the paddle assembly 100’.

[0068] It can be seen that the blood pump 1 provided by the embodiment of the present application has the following advantages. On the one hand, the paddle assembly 100' of the blood pumping driving mechanism 10' can reciprocate axially under the driving of the driving assembly 200' to switch between the first mode and the second mode in turn, thereby being capable of performing the blood pumping operation. The reciprocating axial extension and contraction of the paddle assembly 100' during blood pumping is equivalent to reciprocating linear motion, and the shear force generated by the reciprocating linear motion is far less than the shear force generated by the high-speed rotation of the impeller of the existing blood pump 1. In addition, the blood perfusion volume of the blood pump 1 can be increased by appropriately increasing the maximum radial dimension of the paddle assembly 100' in the first mode, the number of paddles 110', the axial stroke of the paddle assembly 100' in the pump housing 20 and the like, so that the frequency of the reciprocating axial extension and contraction of the paddle assembly 100' can be increased slightly or not increased. The frequency of the reciprocating axial extension and contraction of the paddle assembly 100' is far lower than the high-speed rotation frequency of the impeller of the blood pump 1, so that the shear force on the blood cells can be effectively reduced. It can be seen that the blood pumping driving mechanism 10' provided by the present application can effectively reduce the shear force on the blood cells, thereby greatly eliminating the risk of hemolysis. On the other hand, the power member is arranged on the handle mechanism 10, rather than between the distal end of the catheter 30 and the proximal end of the pump housing 20. In this way, the power member can be arranged outside the patient's body during surgery, so that the power mechanism can avoid generating wear particles and falling off in the patient's body, and can also prevent the blood clotting problem caused by the heat generated by the operation of the power mechanism.

[0069] In summary, the blood pump 1 provided by the present application can greatly eliminate the risk of hemolysis by changing the blood pumping mode of the blood pumping driving mechanism 10', and can prevent the blood clotting problem caused by the heat generated by the operation of the power assembly 220 by changing the position of the power assembly 220. The surgical safety can be improved, and the clinical application time and stability of the product can be greatly improved, so that the effects of low-frequency operation and high blood perfusion can be achieved.

[0070] As shown in Figure 7 and Figure 9 In some embodiments of the present application, the paddle 110' includes a closed section 111' and a hollow section 112' connected together. The closed section 111' and the hollow section 112' are arranged in sequence in the blood pumping direction, and the radial dimension of the connection between the closed section 111' and the hollow section 112' is the largest. The closed section 111' of the paddle 110' is mainly used to drive the blood flow, and the hollow section 112' is mainly used to expand or contract the closed section 111' under the driving of the driving assembly 200', so that the paddle 110' with this structure is convenient for driving the blood flow and expanding or contracting. Figure 7 As shown in Figure 7 , when the blood pump 1 is a left heart interventional pump, the closed section 111' is arranged at the distal end of the hollow section 112'. When the blood pump 1 is a right heart interventional pump, the closed section 111' is arranged at the proximal end of the hollow section 112'.

[0071] As shown in Figure 7 The radial dimension of the closed section 111' gradually increases along the blood pumping direction in both the first and second morphologies, and the radial dimension of the hollow section 112' gradually decreases along the blood pumping direction in both the first and second morphologies. The closed section 111' and the hollow section 112' of this structure are similar to two umbrella structures arranged opposite to each other, which facilitates the unfolding and folding of the paddle 110'. When the blood pump 1 is a left heart interventional pump, the radial dimension of the closed section 111' gradually decreases from proximal to distal in both the first and second morphologies, and the radial dimension of the hollow section 112' gradually increases from proximal to distal in both the first and second morphologies. When the blood pump 1 is a right heart interventional pump, the radial dimension of the closed section 111' gradually increases from proximal to distal in both the first and second morphologies, and the radial dimension of the hollow section 112' gradually decreases from proximal to distal in both the first and second morphologies.

[0072] As shown in Figure 9 The closed section 111' includes a first skeleton 1111' and a flow blocking film 1112', the flow blocking film 1112' is arranged on the first skeleton 1111', and the first skeleton 1111' is connected with the hollow section 112'. The closed section 111' of this structure can be unfolded or folded by deforming the first skeleton 1111', and the flow blocking film 1112' can be used to direct the flow of blood in the pump housing 20. Therefore, the closed section 111' of this structure facilitates the flow of blood and is convenient for unfolding or folding.

[0073] As shown in Figure 9 The first skeleton 1111' includes a plurality of first support rods 1111a', which are arranged in sequence along the circumference of the paddle assembly 100'. One end of the first support rod 1111a' is connected with the hollow section 112' of the same paddle 110' and the hollow section 112' of the adjacent paddle 110'. The first skeleton 1111' of this structure is simple in structure, convenient for production and processing, and convenient for unfolding or folding of the closed section 111'. Of course, in other embodiments, the first skeleton 1111' can be provided in a grid skeleton structure.

[0074] The number of first support rods 1111a' can be 8-16, such as 8, 9, 10, 11, 12, 13, 14, 15 or 16, without specific limitation, as long as the strength of the closed section 111' and the smooth unfolding or folding are ensured. The diameter of the first support rod 1111a' can be 0.1-0.25 mm, such as 0.1 mm, 0.15 mm, 0.2 mm and 0.25 mm, etc. The present application does not make specific limitation on this, as long as the strength of the closed section 111' and the smooth unfolding or folding are ensured.

[0075] The first skeleton 1111' of the structure can be formed by laser engraving, for example, laser engraving of a nickel-titanium alloy tube during processing. Alternatively, the first skeleton 1111' can be formed by braiding, for example, braiding of a nickel-titanium wire during processing. After the first skeleton 1111' is laser engraved or braided, it also needs to be processed by heat setting, electrochemical polishing and the like.

[0076] The flow blocking film 1112' can be a biocompatible material such as e-PTFE (expanded polytetrafluoroethylene), TPU (Thermoplastic Polyurethanes), nylon, etc. The flow blocking film 1112' of such material has a certain elasticity and can be synchronized with the first skeleton 1111' to fold or unfold, and will not fall off from the first skeleton 1111' due to the change of the radial size of the first skeleton 1111', ensuring the normal blood pumping of the blood pump 1.

[0077] The flow blocking film 1112' can be sewn on the first skeleton 1111'. Specifically, a suture line made of PET (Polyethyleneterephthalate), polytetrafluoroethylene or PP (Polypropylene) or the like can be used to sew the flow blocking film 1112' on the first skeleton 1111'. Of course, the flow blocking film 1112' can also be provided on the first skeleton 1111' by hot pressing.

[0078] The flow blocking film 1112' can be provided on the inner circumferential surface of the first skeleton 1111', or on the outer circumferential surface of the first skeleton 1111', or on the inner and outer circumferential surfaces of the first skeleton 1111'. The present application does not make specific limitation thereto as long as it can effectively seal the blood flow.

[0079] Continuing to refer to Figure 9 The hollow section 112' can also include a second skeleton 1121', which is connected to the first skeleton 1111' of the closed section 111'. The second skeleton 1121' includes a plurality of second support rods 1121a', which are arranged in sequence along the circumference of the paddle assembly 100'. One end of the second support rod 1121a' is connected to the closed section 111' of the same paddle 110' and the closed section 111' of the adjacent paddle 110'. The second skeleton 1121' of this structure is simple in structure, easy to produce and process, and also easy to unfold or fold the closed section 111'. Of course, in other embodiments, the second skeleton 1121' can be provided in a grid skeleton structure.

[0080] The number of the second support rods 1121a' can be 8-16, for example, 8, 9, 10, 11, 12, 13, 14, 15 or 16, which is not limited in the present application, as long as the strength of the hollow section 112' and the smooth unfolding or folding can be ensured. The diameter of the second support rods 1121a' can be 0.1-0.25 mm, for example, 0.1 mm, 0.15 mm, 0.2 mm and 0.25 mm, which is not limited, as long as the strength of the hollow section 112' and the smooth unfolding or folding can be ensured.

[0081] The second skeleton 1121' of the structure can be formed by laser engraving, for example, laser engraving of the nickel-titanium alloy tube during processing. Alternatively, the second skeleton 1121' can be formed by braiding, for example, braiding of the nickel-titanium wire during processing. After the second skeleton 1121' is laser engraved or braided, it also needs to be processed by heat setting, electrochemical polishing and the like.

[0082] The first skeleton 1111' is a shape memory material, and when the first skeleton 1111' is in the initial state, the paddle 110' is in the first shape. The second skeleton 1121' is a shape memory material, and when the second skeleton 1121' is in the initial state, the paddle 110' is in the first shape. As shown in Figure 10 When the blood pump 1 is inserted into the patient's body, the paddle assembly 100' can be placed into the pump shell 20 first, and at the same time, the pump shell 20 and the paddle assembly 100' are stretched (at this time, the paddle assembly 100' is in the second shape), so that the pump shell 20 can be inserted into the sheath with the paddle assembly 100'. When pushing in the patient's body, the pump shell 20 and the paddle assembly 100' are always in a compressed state due to the limitation of the sheath. When the blood pump 1 reaches the target position in the patient's body, the sheath is withdrawn, the pump shell 20 is expanded, and at this time, the first skeleton 1111' and the second skeleton 1121' of the paddle 110' also reset and expand to the first shape in the expanded pump shell 20. Then, the paddle assembly 100' reciprocates axially to pump blood. It can be seen that the paddle assembly 100' of the present application can switch between the first shape and the second shape, and when pushing in the patient's body, the paddle assembly 100' can be set to the second shape with a smaller radial size, and at the same time, the pump shell 20 is compressed, so that the blood pump 1 can maintain a smaller radial size when transported in the body, thereby reducing the difficulty of pushing the blood pump 1 in the patient's body, and also increasing the range of accessible blood vessels, thereby improving the range of indications. In addition, the paddle 110' is in the first shape in the original state, so that the paddle assembly 100' can ensure a stable maximum radial size when driving blood flow, so that the blood pump 1 can pump blood stably.

[0083] It should be noted that, Figure 10The straight broad arrow in FIG represents the radial dimension shrinking direction of the impeller assembly 100 ′ and the pump housing 20 .

[0084] like Figure 7 As shown, in some embodiments of the present application, the blade assembly 100' further includes at least one connecting tube 120', which is disposed between two corresponding adjacent blades 110' or at the proximal end of the nearest blade 110'. The provision of the connecting tube 120' enables all blades 110' to be integrally carved from the same nickel-titanium tube, thereby ensuring the connection strength between adjacent blades 110'. After all blades 110' are laser engraved, processes such as heat setting and electrochemical polishing are required to form the blade assembly 100'.

[0085] The number of the connecting pipes 120 ′ is set accordingly according to the number of the blades 110 ′. For example, the number of the connecting pipes 120 ′ is the same as or one less than the number of the blades 110 ′.

[0086] Based on the blade assembly 100' of the above structure, Figure 7 As shown, in some embodiments, the drive assembly 200' includes an inner tube 210' and an outer tube 220'; the distal end of the outer tube 220' is connected to the most proximal blade, and the proximal end of the outer tube 220' passes through the catheter 30 and is connected to the handle body 100; the distal end of the inner tube 210' is inserted into each paddle 110' and is connected to the most distal paddle 110', and the proximal end of the inner tube 210' passes through the outer tube 220' and is connected to the power assembly 220, and the power assembly 220 is capable of driving the inner tube 210' to reciprocate linear motion. The distal end of the outer tube 220' is used to fix the proximal end of the blade assembly 100'. When the power element drives the inner tube 210' to reciprocate linear motion, the distal end of the inner tube 210' drives each paddle 110' to reciprocate axially.

[0087] Inner tube 210' can be a hypotube, which not only provides flexibility for easy passage through curved blood vessels but also provides strength to enable paddle 110' to perform multiple axial expansion and contraction. The bellows can be laser cut and made of biocompatible metals such as nickel-titanium alloy and 316L steel.

[0088] The distal end of the inner tube 210' can be fixed to the distal end of the farthest blade 110' by welding, hot melting, etc., and the proximal end of the inner tube 210' can be connected to the power assembly 220 by welding, hot melting, etc., and this application does not impose specific restrictions on this.

[0089] The inner diameter of the outer tube 220' can be slightly larger than the outer diameter of the inner tube 210', and the outer tube 220' can be made of a medical polymer composite material. The distal end of the outer tube 220' can be connected to the proximal-most connecting tube 120' by welding, heat staking, or the like, and the proximal end of the outer tube 220' can be fixed in the handle main body 100 by welding, heat staking, or the like. The present application does not make specific limitations thereto.

[0090] In some embodiments of the present application, the paddle assembly 100' further comprises a first marker (not shown in the drawings) and a second marker 300'. The first marker is arranged at the proximal end of the paddle assembly 100', and the second marker 300' is arranged at the distal end of the paddle assembly 100'. With the assistance of imaging equipment such as X-ray fluoroscopy, the position of the paddle assembly 100' relative to the blood flow inlet P and the blood flow outlet Q of the pump housing 20 can be determined by the first marker and the second marker 300'. If the paddle assembly 100' is not in the preset position, for example, in the first shape, the paddle assembly 100' is located between the blood flow inlet P and the blood flow outlet Q, the radial size of the pump housing 20 or the extension amplitude of the paddle assembly 100' can be adjusted so that the paddle assembly 100' is not in the preset position, thereby ensuring the blood pumping efficiency of the blood pump 1.

[0091] The first marker can be arranged at the distal end of the outer tube 220' and proximal to the proximal-most paddle 110', for example, on the proximal-most connecting tube 120'. The material of the first marker can be platinum-iridium alloy or tantalum, and the first marker can be arranged on the proximal-most connecting tube 120' by laser welding or physical inlaying (i.e., a recess is formed on the proximal-most connecting tube 120', and the first marker is inlaid in the recess on the proximal-most connecting tube 120'). The number of first markers can be one, two, three, or more, and the present application does not make specific limitations thereto, as long as the proximal end of the paddle assembly 100' can be effectively and accurately positioned.

[0092] The second marker 300' can be a marker ring and can be arranged at the distal end of the distal-most paddle 110'. The material of the second marker 300' can be platinum-iridium alloy or platinum-tungsten alloy, and the second marker 300' can be connected to the distal end of the inner tube 210' and the distal-most paddle 110' by laser welding, heat staking, or the like.

[0093] In some embodiments of the present application, the blood pumping driving mechanism 10' further comprises a first protective coating (not shown in the drawings) arranged on the surface of the paddle assembly 100'. The first protective coating can be arranged on the inner surface and / or the outer surface of the paddle assembly 100'. For example, the first protective coating can be arranged on all surfaces of the first skeleton 1111', the second skeleton 1121', and the flow-blocking film 1112' of the paddle 110'.

[0094] The first protective coating can be an anti-thrombus coating or a hydrophilic coating, which can effectively prevent thrombus from adhering and reduce the probability of postoperative complications. As an example, the inner surface and the outer surface of the paddle assembly 100' can be provided with an anti-thrombus coating, or a hydrophilic coating, or one of them is provided with an anti-thrombus coating and the other is provided with a hydrophilic coating.

[0095] To ensure that the paddle assembly 100' can be oriented and telescoped under the driving of the inner tube 210', in some embodiments of the present application, as shown in Figure 1 The blood pump 11 further comprises a directional shaft 40, the proximal end of which extends out of the inner tube 210', and the distal end of which is connected to the distal end of the pump shell 20 through the paddle assembly 100'. The paddle assembly 100' can be reciprocally axially telescoped along the directional shaft 40, so that the paddle assembly 100' can be oriented to pump blood. It should be noted that the directional shaft 40, the inner tube 210', the outer tube 220' and the catheter 30 are sequentially arranged from inside to outside.

[0096] The directional shaft 40 can be a metal flexible shaft. The distal end of the directional shaft 40 can be exposed from the distal end of the pump shell 20 and can be connected to the distal end of the pump shell 20 by welding, hot melting or the like, which is not specifically limited in the present application.

[0097] In some embodiments of the present application, the power member of the handle mechanism 10 can include one of a reciprocating linear motor, a pneumatic cylinder, a hydraulic cylinder and a mechanism matched by a rotary motor and a crank connecting rod.

[0098] In some embodiments of the present application, as shown in Figure 12 The handle mechanism 10 further comprises a first movable assembly 210, which is movably arranged on the handle body 100 and connected with the power assembly 220, and the first movable assembly 210 can drive the power assembly 220 to move relative to the handle body 100. The power assembly 220 can be moved forward or backward by controlling the first movable assembly 210, so as to adjust the initial position of the paddle assembly 100' in the pump shell 20.

[0099] In combination with Figure 12 and Figure 13As shown, in some embodiments, the moving mechanism comprises a first moving member 211 and a first adjusting member 212; the first moving member 211 is in sliding connection with the handle body 100, and the first moving member 211 is connected with the power assembly 220; the first adjusting member 212 is in matching connection with the outer surface of the first moving member 211, and the first adjusting member 212 is configured to apply force to the first moving member 211 when being rotated to drive the first moving member 211 to move the power assembly 220 relative to the handle body 100. For example, the first adjusting member 212 can be configured to apply force to the first moving member 211 in a forward rotation direction to drive the first moving member 211 to move away from the handle body 100, thereby driving the power assembly 220 to move away from the handle body 100 through the first moving member 211; the first adjusting member 212 can also be configured to apply force to the first moving member 211 in a reverse rotation direction to drive the first moving member 211 to move towards the handle body 100, thereby driving the power assembly 220 to move towards the handle body 100 through the first moving member 211. In this way, the position of the first moving member 211 relative to the handle body 100 is adjusted through the matching of the first adjusting member 212 and the first moving member 211, so that the position of the power assembly 220 connected with the first moving member 211 relative to the handle body 100 can be flexibly adjusted, and the initial position of the inner tube 210' connected with the power assembly 220 relative to the handle body 100 can be adjusted, so as to improve the flexibility and adaptability of the driving handle.

[0100] Referring to Figures 12 to 14 As shown, in one of the embodiments, the first moving member 211 is sleeved outside the handle body 100 so that the first moving member 211 can slide relative to the handle body 100, and the outer surface of the first moving member 211 is provided with external threads. The first adjusting member 212 has a screw-like structure as a whole to facilitate rotation, and the inner part of the first adjusting member 212 is provided with a threaded hole in matching connection with the external threads on the first moving member 211, so that the first adjusting member 212 is connected with the first moving member 211 through threads. In this embodiment, only the rotation direction of the first adjusting member 212 needs to be changed to adjust the installation position of the power assembly 220 relative to the handle body 100, which is simple and efficient to operate.

[0101] For example, in one embodiment, when the first adjusting member 212 is rotated clockwise, the first adjusting member 212 drives the first moving member 211 to slide away from the handle body 100 through threads, thereby driving the power assembly 220 to move away from the handle body 100; when the first adjusting member 212 is rotated counterclockwise, the first adjusting member 212 drives the first moving member 211 to slide towards the handle body 100 through threads, thereby driving the power assembly 220 to move towards the handle body 100, so as to adjust the installation position of the power assembly 220 relative to the handle body 100.

[0102] In one of the embodiments, the handle body 100 is provided with a receiving through hole 160; the first movable member 211 comprises a first central part 211a, a first connecting part 211c and a first edge part 211b, which are sequentially connected along the radial direction of the first movable member 211, the first central part 211a is connected with the power assembly 220, and the first edge part 211b is configured to be connected with the first adjusting member 212; the first movable member 211 is configured to be inserted with the corresponding part of the handle body 100 through the first connecting part 211c so that the first central part 211a is located in the receiving through hole 160 and the first edge part 211b is located outside the receiving through hole 160. In this embodiment, the first central part 211a of the first movable member 211 is arranged in the receiving through hole 160 and the first edge part 211b is arranged outside the receiving through hole 160, which can not only improve the stability of the first movable member 211 after being inserted with the handle body 100, but also enable the first movable member 211 to slide relative to the handle body 100, so as to drive the power assembly 220 to move and change the installation position of the power assembly 220.

[0103] Referring to Figures 14 to 15 As shown in the figure, the inside of the handle body 100 is provided with a hollow receiving through hole 160, and the side wall of the handle body 100 is provided with a positioning groove 112a. The first movable member 211 comprises a first central part 211a, a first connecting part 211c and a first edge part 211b which are sequentially connected from inside to outside, the first central part 211a is connected with the first edge part 211b through the first connecting part 211c, and the outside of the first edge part 211b is provided with external threads. When the first movable member 211 is connected with the handle body 100, the end of the first movable member 211 is aligned with the end of the handle body 100 so that the first connecting part 211c is inserted into the positioning groove 112a, and at this time the first movable member 211 and the handle body 100 are connected in a sliding manner.

[0104] In one of the embodiments, the power assembly 220 is arranged in the receiving through hole 160 and connected with the first central part 211a, and the power assembly 220 is configured to connect with the inner tube 210' and drive the inner tube 210' to move along the extension direction of the receiving through hole 160. For example, the power assembly 220 can be a linear motor, which is arranged in the receiving through hole 160 and fixedly connected with the first central part 211a. The inner tube 210' connected with the power assembly 220 is driven to move along the extension direction of the receiving through hole 160, so that the inner tube 210' can reciprocate along the same straight line as much as possible, so as to ensure the stability during driving the inner tube 210' to move.

[0105] In order to facilitate the extension and contraction of the pump shell 20, the handle body 100 is provided with a receiving through hole 160, and the first movable member 211 is arranged in the receiving through hole 160. Figure 12As shown, the handle mechanism 10 further comprises a second movable assembly 300 movably arranged on the handle body 100 and located distally to the first movable assembly 210, the second movable assembly 300 is connected to the proximal end of the catheter 30 and can drive the catheter 30 to move relative to the handle body 100. The catheter 30 can be pushed forward or withdrawn backward by controlling the second movable assembly 300, so as to expand or contract the pump shell 20,

[0106] In an embodiment, the second movable assembly 300 comprises a second movable member 310 and a second adjusting member 320; the second movable member 310 is slidably arranged on the handle body 100 and connected to the proximal end of the catheter 30; the second adjusting member 320 is connected to the outer surface of the second movable member 310, and the second adjusting member 320 is configured to apply force to the second movable member 310 to drive the catheter 30 to move relative to the handle body 100 when the second adjusting member 320 is rotated. Referring to Figures 11 to 13 As shown, by changing the rotating direction of the second adjusting member 320, the force direction applied by the second adjusting member 320 to the second movable member 310 can be changed, and then the catheter 30 is driven to reciprocate relative to the handle body 100 by the second movable member 310.

[0107] Further, in one of the embodiments, the second movable member 310 comprises a second center portion, a second connecting portion and a second edge portion, the second center portion, the second connecting portion and the second edge portion are sequentially connected along the radial direction of the second movable member 310, the second center portion is configured to connect the catheter 30, and the second edge portion is configured to be connected to the second adjusting member 320; the second movable member 310 is configured to be inserted into the handle body 100 through the second connecting portion so that the second center portion is located in the receiving through hole 160 and the second edge portion is located outside the receiving through hole 160. Referring to Figures 1 to 5 As shown, the structure and connection mode of the second movable member 310 and the second adjusting member 320 with the handle body 100 can be the same as the structure and connection mode of the first movable member 211 and the first adjusting member 212 with the handle body 100 in the above-mentioned embodiments, so as to realize the sliding connection of the second movable member 310 with the handle body 100.

[0108] Referring to Figures 16 to 18As shown, the first movable assembly 210 and the second movable assembly 300 are arranged on the handle body 100. The movable mechanism of the first movable assembly 210 is connected with the outer wall of the handle body 100, and the power assembly 220 is arranged in the receiving hole 160 of the handle body 100 and connected with the inner tube 210'. The second movable assembly 300 is connected with the guide pipe 30, and the inner tube 210' extends into the interior of the guide pipe 30, so that the inner tube 210' and the guide pipe 30 can reciprocate on the same side of the handle body 100, facilitating the driving of more complex paddle 110' structures by simultaneously driving multiple target objects with the driving handle, and improving the applicable scenarios. For example,

[0109] Figure 16 In the state shown in the first movable assembly 210, the power assembly 220 drives the inner tube 210' to approach the handle body 100;

[0110] Figure 17 In the state shown in the first movable assembly 210, the power assembly 220 drives the inner tube 210' to approach the handle body 100;

[0111] Figure 18 In the state shown in the second movable assembly 300, the guide pipe 30 is driven to approach the handle body 100.

[0112] In one embodiment, the handle body 100 includes a main shaft 110, a first limiting piece 120 and a second limiting piece 130. The main shaft 110 has a receiving hole 160, and the main shaft 110 is configured to be in sliding connection with the first movable piece 211 and the second movable piece 310. The first limiting piece 120 is connected with one end of the main shaft 110 for limiting the first movable piece 211, and the second limiting piece 130 is connected with the other end of the main shaft 110 for limiting the second movable piece 310. Referring to Figures 11 to 14 As shown, the main shaft 110 has a substantially cylindrical structure, the main shaft 110 is internally provided with the receiving hole 160, and the two ends of the main shaft 110 are respectively threadedly connected with the first limiting piece 120 and the second limiting piece 130. The main shaft 110 is arranged in the shell 140, and the shell 140 protects the main shaft 110. Thus, the first limiting piece 120 and the second limiting piece 130 limit the first movable piece 211 and the second movable piece 310 respectively, so as to ensure that the first movable piece 211 and the second movable piece 310 can freely slide along the main shaft 110 without being separated from the main shaft 110.

[0113] In one embodiment, the handle body 100 further includes a shell 140 and a wiring terminal 150. The wiring terminal 150 is arranged between the first limiting piece 120 and the main shaft 110, and the two ends of the wiring terminal 150 are respectively threadedly connected with the first limiting piece 120 and the main shaft 110. The wiring terminal 150 is used for electrically connecting the power assembly 220 and externally connecting a power supply to supply power to the power assembly 220.

[0114] Referring to Figures 12 to 13 As shown in the drawings, in one embodiment, the main shaft 110 includes a flushing section 111, a first connecting section 112 and a second connecting section 113, the flushing section 111 is connected between the first connecting section 112 and the second connecting section 113, the flushing section 111 protrudes in the radial direction of the main shaft 110 to separate the first movable part 211 and the second movable part 310. The flushing section 111 is provided with a flushing hole 111a, the accommodation through hole 160 penetrates the flushing section 111, the first connecting section 112 and the second connecting section 113 and communicates with the flushing hole 111a, and perfusion fluid such as saline can be injected into the accommodation through hole 160 through the flushing hole 111a to ensure the normal operation of the blood pump 1. Specifically, perfusion fluid can be injected into the annular space between the outer tube 220' and the inner tube 210', wherein the perfusion hole can also be provided on the wall of the directional shaft 40, the inner tube 210' and the catheter 30, so that the perfusion fluid between the outer tube 220' and the inner tube 210' can flow into the directional shaft 40, the inner tube 210' or the catheter 30. Of course, the proximal end of the inner tube 210' can extend out of the power mechanism and be provided with a liquid injection head, at this time, the through hole can not be provided on the wall of the inner tube 210'. The first connecting section 112 is configured to be in sliding connection with the first movable part 211, and specifically, the first connecting section 112 is provided with a positioning groove 112a matched with the first movable part 211, and the end of the first connecting section 112 away from the flushing section 111 is in threaded connection with the first limiting part 120. The second connecting section 113 is configured to be in sliding connection with the second movable part 310, and the end of the second connecting section 113 away from the flushing section 111 is connected with the second limiting part 130. By separating the first movable assembly 210 and the second movable assembly 300 through the flushing section 111, not only the flushing function can be realized, but also the interference between the first movable part 211 and the second movable part 310 can be avoided.

[0115] As Figure 3 shown, in some embodiments of the present application, the pump shell 20 includes a stent 20a and a covering 20b; the stent 20a can be contracted or expanded to adjust the radial size of the stent 20a, the stent 20a has a proximal end, a distal end opposite to the proximal end and a middle part between the proximal end and the distal end; the covering 20b is arranged at the middle part of the stent 20a, so that one of the proximal end and the distal end of the stent 20a forms a blood flow inlet P, and the other forms a blood flow outlet Q. The pump shell 20 with the above structure is convenient to stretch and retract.

[0116] The stent 20a can be made by laser engraving, for example, the nickel-titanium alloy tube is laser engraved during the processing of the pump shell 20. Alternatively, the stent 20a can be made by braiding, for example, the nickel-titanium wire is braided during the processing of the pump shell 20. After the stent 20a is laser engraved or braided, it still needs to be heat treated to be shaped into a net-shaped stent 20a.

[0117] With reference to the drawings Figure 3 , the stent 20a comprises a circular tube segment A, a first reduced diameter segment M and a second reduced diameter segment C, the first reduced diameter segment M is arranged at the proximal end of the circular tube segment A, and the second reduced diameter segment C is arranged at the distal end of the circular tube segment A; the covering 20b is arranged on the circular tube segment A. The diameter of the first reduced diameter segment M gradually increases from the proximal end to the distal end, and the diameter of the second reduced diameter segment C gradually decreases from the proximal end to the distal end. By arranging the first reduced diameter segment M and the second reduced diameter segment C, the pump shell 20 can be guided when penetrating into or out of the sheath, which is beneficial to the penetration or out of the pump shell 20, and also beneficial to the contraction or expansion of the stent 20a.

[0118] The proximal end of the first reduced diameter segment M has a first through hole, and the distal end of the second reduced diameter segment C has a second through hole. The first through hole and the second through hole are provided for the penetrating of the intervention guide wire, so that the blood pump 1 can be pushed forward along the intervention guide wire in the sheath.

[0119] As shown in Figure 3 , the proximal end of the covering 20b is connected with the first reduced diameter segment M, and the distal end of the covering 20b is connected with the second reduced diameter segment C. In this way, the covering 20b covers the entire circular tube segment A along the axial direction of the pump shell 20, so that there is enough space in the stent 20a to accommodate the blood pumping driving member, so that when the blood pumping driving member moves, blood can flow into the blood flow inlet P and flow out of the blood flow outlet Q.

[0120] The covering 20b can be made of biocompatible materials such as e-PTFE, TPU, nylon, etc. The covering 20b made of such materials has a certain elasticity, which can be synchronized with the contraction or expansion of the stent 20a, and will not fall off from the stent 20a due to the change of the radial size of the stent 20a, thereby ensuring the normal blood pumping of the blood pump 1.

[0121] The covering 20b can be sewn on the stent 20a. Specifically, a suture line made of PET, polytetrafluoroethylene or P, etc. can be used to sew the covering 20b on the middle part of the stent 20a. Of course, the covering 20b can also be arranged on the middle part of the stent 20a by hot pressing.

[0122] The covering 20b can be arranged on the inner circumferential surface of the middle part of the stent 20a, or on the outer circumferential surface of the middle part of the stent 20a, or on the inner and outer circumferential surfaces of the middle part of the stent 20a, which is not limited in the present application as long as it can effectively seal the blood flow.

[0123] In some embodiments of the present application, the pump housing 20 further comprises a third marker (not shown in the drawings) and a fourth marker (not shown in the drawings), the third marker is arranged on the proximal end of the stent 20a, and the fourth marker is arranged on the distal end of the stent 20a. With the aid of imaging equipment such as X-ray fluoroscopy, it can be determined whether the blood pump 1 is delivered to the target position through the third marker and the fourth marker. When the left interventional blood pump 1 is delivered to the target position, the third marker is located in the left ventricle, and the fourth marker is located in the aorta; when the right interventional blood pump 1 is delivered to the target position, the third marker is located in the pulmonary artery, and the fourth marker is located in the right ventricle.

[0124] The material of the third marker can be platinum-iridium alloy or platinum-tungsten alloy, which can be arranged on the proximal end of the stent 20a by laser welding or physical inlaying (i.e. a groove is formed on the stent 20a, and the third marker is inlaid in the groove on the stent 20a). The number of the third marker can be one, two, three or more, which is not specifically limited in the present application, as long as it can effectively and accurately position the pump housing 20.

[0125] The material of the fourth marker can also be platinum-iridium alloy or platinum-tungsten alloy, which can also be arranged on the distal end of the stent 20a by laser welding or physical inlaying. The number of the fourth marker can be one, two, three or more, which is not specifically limited in the present application, as long as it can effectively and accurately position the pump housing 20.

[0126] In some embodiments of the present application, the pump housing 20 further comprises a second protective coating (not shown in the drawings), which is arranged on the surface of the stent 20a and / or the covering film 20b. The protective coating can be an antithrombotic coating or a hydrophilic coating, which can effectively prevent thrombus adhesion and also reduce the probability of postoperative complications. As an example, the inner and outer surfaces of the stent 20a can be provided with an antithrombotic coating, or a hydrophilic coating, or one of them is provided with an antithrombotic coating and the other is provided with a hydrophilic coating; the inner and outer surfaces of the covering film 20b can be provided with an antithrombotic coating, or a hydrophilic coating, or one of them is provided with an antithrombotic coating and the other is provided with a hydrophilic coating.

[0127] In some embodiments of the present application, as shown in Figure 3 The pump housing 20 further comprises a flexible tip 50 arranged at the distal end of the stent 20a. The flexible tip 50 can abut against the inner wall of the tissue to position the distal end of the blood pump 1, and when the blood pump 1 is pushed, the flexible tip 50 can also protect the blood vessel. The flexible tip 50 can be a pigtail shape, a spherical shape, an arrowhead shape or a prismatic tube structure. As an example, the distal end of the inner tube 210' of the drive assembly 200' protrudes from the flexible tip 50 and is fixedly connected with the flexible tip 50.

[0128] The flexible end 50 can be made of medical silicone or polyurethane mixed with a developing material, which makes the flexible end 50 soft and has a developing function, and can also locate the position of the blood pump 1.

[0129] In summary, the blood pump 1 provided in this application has the following effects:

[0130] 1. Its unique reciprocating blood pumping blade 110' design is different from the existing axial flow spiral impeller structure. It can greatly eliminate shear force during operation, which can effectively reduce the risk of hemolysis, making the operation safer and longer in service life;

[0131] 2. The overall structure and processing cost of the impeller 110' and the pump housing 20 are relatively stable and low, with a high feasibility; they are simple and easy to operate, effectively reducing costs while also improving safety and reliability;

[0132] 2. The sizes of the impeller 110' and the pump housing 20 are adjustable, and the overall size can be designed to be smaller, reducing the occurrence of complications and expanding the scope of indications;

[0133] 4. The built-in multiple blades 110' design and the adjustable reciprocating frequency of the external power mechanism can provide better hemodynamics, that is, higher blood flow;

[0134] 5. The opening and closing action of the built-in multiple blades 110' exerts minimal shear force on the blood, and there is no continuous noise caused by the high-speed operation of the axial flow pump motor, which has less impact on the patient;

[0135] 6. The surfaces of the built-in paddle 110' and the pump housing 20 are coated with a protective coating, which can effectively prevent the adhesion of blood clots and reduce the occurrence of related complications.

[0136] On the other hand, Figure 19 As shown, another embodiment of the present application provides a ventricular assist system, which includes a control module 2, a perfusion module 3 and a blood pump 1 as described above; the control module 2 is connected to the power component 220, and the perfusion module 3 is used to inject perfusion fluid into the blood pump 1.

[0137] The ventricular assist system provided by the embodiments of the present application, on the one hand, the paddle assembly 100' of the blood pumping driving mechanism 10' can be driven by the driving assembly 200' to reciprocate axially to switch between the first mode and the second mode in turn, thereby being capable of performing blood pumping operation, wherein the reciprocating axial extension and contraction of the paddle assembly 100' during blood pumping is equivalent to reciprocating linear motion, and the shear force generated by the reciprocating linear motion is far less than the shear force generated by the high-speed rotation of the impeller of the existing blood pump 1; in addition, the blood perfusion volume of the blood pump 1 can be increased by appropriately increasing the maximum radial dimension of the paddle assembly 100' in the first mode, the number of paddles 110', the axial stroke of the paddle assembly 100' in the pump housing 20 and the like, so that the reciprocating axial extension and contraction frequency of the paddle assembly 100' can be increased slightly or not increased, so as to avoid that the reciprocating axial extension and contraction frequency of the paddle assembly 100' is too large, so that the reciprocating axial extension and contraction frequency of the paddle assembly 100' is far lower than the high-speed rotation frequency of the impeller of the blood pump 1, and the shear force on the blood cells can also be effectively reduced. It can be seen that the blood pumping driving mechanism 10' provided by the present application can effectively reduce the shear force on the blood cells and greatly eliminate the risk of hemolysis; on the other hand, the power member is arranged on the handle mechanism 10, rather than between the distal end of the catheter 30 and the proximal end of the pump housing 20, so that during the operation, the power member can be placed outside the patient's body, so as to avoid that the power mechanism generates wear particles and falls off in the patient's body, and also prevent the blood clotting problem caused by the heat generated by the operation of the power mechanism and the like.

[0138] In summary, the ventricular assist system provided by the present application can greatly eliminate the risk of hemolysis by changing the blood pumping mode of the blood pumping driving mechanism 10', and can prevent the blood clotting problem caused by the heat generated by the operation and the like by changing the position of the power assembly 220, so as to improve the safety of the operation, and the clinical application time and stability of the product are greatly improved, so as to achieve the effect of low-frequency operation and high blood perfusion.

[0139] The control module 2 mainly controls the power output and signal acquisition control of the power assembly 220 of the blood pump 1, for example, the pumped blood pressure can be acquired, and a display touch screen and embedded control software can be provided. As an example, the distal end of the outer tube 220' is provided with a pressure sensor, and the pressure sensor is close to the blood flow outlet Q of the pump housing 20. The pressure sensor can acquire the pumped blood pressure, and the observation and reading can be performed through the control module 2.

[0140] The perfusion module 3 can continuously and stably perfuse physiological saline and the like into the blood pump 1 through a certain pressure control device to achieve the effect of stable working output.

[0141] Any combination of the technical features in the above-described embodiments can be made, and for the sake of brevity, not all possible combinations are described, however, it is to be understood that the application embraces all such possible combinations.

[0142] The above-described embodiments only express several implementation manners of the application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the patent scope of the application. It should be pointed out that, for ordinary skilled persons in the art, some modifications and improvements can be made without departing from the concept of the application, and these all belong to the protection scope of the application. Therefore, the patent protection scope of the application should be subject to the appended claims.

Claims

1. A blood pump, characterized in that: include: A handle mechanism, the handle mechanism comprising a handle body and a power assembly provided on the handle body; a catheter, the proximal end of which is connected to the handle body; a pump housing, the pump housing being disposed at the distal end of the catheter and having a blood flow inlet and a blood flow outlet; and a blood pumping drive mechanism comprising a paddle assembly and a drive assembly, wherein the paddle assembly is disposed in the pump housing and has a first shape and a second shape, wherein the maximum radial dimension of the paddle assembly in the first shape is greater than the maximum radial dimension in the second shape, wherein the proximal end of the drive assembly passes through the catheter and is connected to the power assembly, wherein the power assembly can drive the paddle assembly to reciprocate axially and extend and retract via the drive assembly, so that the paddle assembly alternately switches between the first shape and the second shape, thereby enabling the paddle assembly to perform a blood pumping operation; The blade assembly includes a plurality of blades connected in sequence from near to far, each of the blades being unfolded in the first configuration and each of the blades being folded in the second configuration; The paddle comprises a connected closed section and a hollow section, the closed section and the hollow section are arranged in sequence along the blood pumping direction, and the radial dimension of the connection between the closed section and the hollow section is the largest.

2. The blood pump according to claim 1, characterized in that The maximum radial dimensions of the plurality of blades in the first form decrease sequentially along the blood pumping direction.

3. The blood pump according to claim 1, wherein The closed section includes a first frame and a flow-blocking film, the flow-blocking film is covered on the first frame, and the first frame is connected to the hollow section; and / or, The hollow section includes a second skeleton connected to the closed section.

4. The blood pump according to claim 1, wherein The drive assembly includes an inner tube and an outer tube; the distal end of the outer tube is connected to the proximal paddle, and the proximal end of the outer tube passes through the catheter and is connected to the handle body; the distal end of the inner tube is passed through each of the paddles and is connected to the distalmost paddle, and the proximal end of the inner tube passes through the outer tube and is connected to the power assembly, and the power assembly can drive the inner tube to reciprocate linear motion.

5. The blood pump according to claim 4, characterized in that The blood pump further includes a directional shaft, the distal end of which passes through the inner tube and is connected to the distal end of the pump housing.

6. The blood pump according to any one of claims 1 to 5, characterized in that The handle mechanism further includes a first movable component, which is movably disposed on the handle body and connected to the power component. The first movable component can drive the power component to move relative to the handle body.

7. The blood pump according to claim 6, characterized in that The first movable assembly includes a first movable member and a first adjusting member; the first movable member is slidably connected to the handle body, and the first movable member is connected to the power assembly; The first adjusting member is cooperatively connected to the outer surface of the first movable member. The first adjusting member is configured to apply force to the first movable member when rotating so that the first movable member drives the power assembly to move relative to the handle body.

8. The blood pump according to claim 6, characterized in that The pump housing can be contracted or expanded; The handle mechanism also includes a second movable component, which is movably provided on the handle body and located distal to the first movable component. The second movable component is connected to the proximal end of the catheter and can drive the catheter to move relative to the handle body.

9. The blood pump according to claim 8, characterized in that The pump housing includes a bracket and a coating; the bracket can be contracted or expanded to adjust the radial size of the bracket, and the bracket has a proximal end portion, a distal end portion opposite to the proximal end portion, and a middle portion located between the proximal end portion and the distal end portion; the coating is arranged in the middle portion of the bracket so that one of the proximal end portion and the distal end portion of the bracket forms the blood flow inlet, and the other forms the blood flow outlet.

10. The blood pump according to claim 8, characterized in that The second movable component includes a second movable part and a second adjusting part; the second movable part is slidably provided on the handle body, and the second movable part is connected to the proximal end of the catheter; the second adjusting part is cooperatively connected to the outer surface of the second movable part, and the second adjusting part is configured to apply force to the second movable part when rotating so that the second movable part drives the catheter to move relative to the handle body.

11. A ventricular assist system, characterized in that: It comprises a control module, a perfusion module and the blood pump according to any one of claims 1 to 10; the control module is connected to the power assembly, and the perfusion module is used to inject perfusion fluid into the blood pump.

Images