Blood pump and ventricular assist system

Abstract

The invention 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 body and a power assembly arranged on the handle 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 form and a second form, the maximum radial size of the paddle assembly in the first form is larger than the maximum radial size of the paddle assembly in the second form, and the near end of the driving assembly penetrates through the catheter to be connected with the power assembly. The power assembly can drive the paddle assembly to axially stretch out and draw back in a reciprocating mode through the driving assembly so that the paddle assembly can be switched between the first form and the second form in turn, and then the paddle assembly can conduct blood pumping operation. According to the blood pump, the operation safety can be improved 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, and in particular to a blood pump and a ventricular assist system. Background Art

[0002] Interventional catheter pumps, also known as blood pumps, are mostly used to be implanted from blood vessels into the patient's ventricles to assist the patient's heart in pumping blood from the ventricles to the arteries, thereby providing support for the patient's blood circulation. Among them, the traditional blood pump includes a pump housing, an impeller, a motor and a catheter; the motor is arranged between the pump housing and the catheter, and the impeller, as a blood pumping drive mechanism, can rotate in the pump housing under the drive of the motor, and can flow blood into the pump housing through the blood flow inlet of the pump housing and out of the blood flow outlet of the pump housing.

[0003] However, traditional blood pumps produce potential side effects such as hemolysis and thrombosis, and the surgical safety is not high. Summary of the invention

[0004] Based on this, it is necessary to provide a blood pump and ventricular assist system to address the above technical problems.

[0005] A blood pump comprising:

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

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

[0008] 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

[0009] A blood pumping drive mechanism includes a paddle assembly and a drive assembly, wherein the paddle assembly is disposed in the pump housing and has a first form and a second form, wherein the maximum radial dimension of the paddle assembly in the first form is greater than the maximum radial dimension in the second form, and the proximal end of the drive assembly passes through the catheter and is connected to the power assembly, and the power assembly can drive the paddle assembly to reciprocate axially and extend and retract through the drive assembly, so that the paddle assembly can alternately switch between the first form and the second form, thereby enabling the paddle assembly to perform a blood pumping operation.

[0010] In one embodiment, the blade assembly includes a plurality of blades connected in sequence from near to far, and in the first form, each of the blades is unfolded, and in the second form, each of the blades is folded.

[0011] In one embodiment, the maximum radial dimensions of the plurality of blades in the first form decrease sequentially along the blood pumping direction.

[0012] In one embodiment, the paddle comprises a connected closed segment and a hollow segment, the closed segment and the hollow segment are arranged in sequence along the blood pumping direction, and the radial dimension of the connection between the closed segment and the hollow segment is the largest.

[0013] In one embodiment, 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,

[0014] The hollow section includes a second frame connected to the closed section.

[0015] In one embodiment, the drive assembly includes an inner tube and an outer tube; the distal end of the outer tube is connected to the nearest paddle blade, 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 paddle blades and is connected to the farthest paddle blade, 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.

[0016] In one embodiment, the blood pump further comprises a directional shaft, the distal end of which passes through the inner tube and is connected to the distal end of the pump housing.

[0017] In one embodiment, the handle mechanism further includes a first movable component, which is movably disposed on the handle body and connected to the power component, and the first movable component can drive the power component to move relative to the handle body.

[0018] In one embodiment, the first movable component 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 component;

[0019] The first adjusting member is cooperatively connected 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 so that the first movable member drives the power assembly to move relative to the handle body.

[0020] In one embodiment, the pump housing can be retracted or expanded;

[0021] The handle mechanism also includes a second movable component, which is movably arranged 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.

[0022] In one embodiment, the pump housing includes a stent and a coating; the stent can shrink or expand to adjust the radial size of the stent, and the stent has a proximal end, a distal end opposite to the proximal end, and a middle portion located between the proximal end and the distal end; the coating is arranged in the middle portion 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 embodiment, the second movable component includes a second movable member and a second adjusting member; the second movable member is slidably disposed on the handle body, and the second movable member is connected to the proximal end of the catheter; the second adjusting member is cooperatively connected to the outer surface of the second movable member, and the second adjusting member is configured to apply force to the second movable member when rotating so that the second movable member drives the catheter to move relative to the handle body.

[0024] A ventricular assist system comprises a control module, a perfusion module and a blood pump as described in any one of the above items; the control module is connected to a power component, and the perfusion module is used to inject perfusion fluid into the blood pump.

[0025] In the above-mentioned blood pump and ventricular assist system, on the one hand, the blade assembly of the blood pumping drive mechanism can reciprocate axially and retract under the drive of the drive assembly, so as to switch itself alternately between the first form and the second form, thereby being able to perform blood pumping operations, wherein the reciprocating axial extension and reciprocating of the blade 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 appropriately increasing the maximum radial dimension of the blade assembly in the first form, the number of blades, the axial stroke of the blade assembly in the pump housing, etc., so that the blade assembly can be slightly increased or not increased. The reciprocating axial expansion and contraction frequency of the component can avoid the reciprocating axial expansion and contraction frequency of the blade component being too large, so that the reciprocating axial expansion and contraction frequency of the blade component is much lower than the high-speed rotation frequency of the impeller of the blood pump, and can also effectively reduce the shear force on blood cells. It can be seen that the blood pumping drive mechanism provided by the present application can effectively reduce the shear force on blood cells and thus greatly eliminate the risk of hemolysis; on the other hand, the present application arranges the power part on the handle mechanism instead of between the distal end of the catheter and the proximal end of the pump housing. In this way, during surgery, the power part can be placed outside the patient's body, which can avoid the power mechanism from producing wear particles and shedding in the patient's body, and can also prevent thrombosis problems caused by heat generated by the power mechanism during operation.

[0026] In summary, the blood pump and ventricular assist system provided in the present application can greatly eliminate the risk of hemolysis by changing the pumping method of the blood pumping drive mechanism, and can prevent thrombosis problems caused by operating heat by changing the position of the power component, thereby improving the safety of surgery. 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 a blood pump paddle assembly in a first form provided by an embodiment of the present application.

[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 a blood pump housing when it is extended is provided.

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

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

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

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

[0035] Fig. 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] Fig.10 for Figure 1 A schematic diagram of the structure of the blood pump when it is pushed in the body is provided.

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

[0038] Fig.12 for Figure 1An exploded schematic diagram of the handle mechanism of a blood pump is provided.

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

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

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

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

[0043] Fig.17 for Fig.11 A schematic diagram of the handle mechanism driving the inner tube through the power assembly is provided.

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

[0045] Fig.19 A schematic diagram of the structure 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 body; 110. Main shaft; 111. Flushing section; 111a. Flushing hole; 112. First connecting section; 112a. Positioning groove; 113. Second connecting section; 120. First stopper; 130. Second stopper; 140. Housing; 150. Wiring terminal; 160. Receiving through hole; 210. First movable assembly; 211. First movable member; 211a. First central portion; 211b. First edge portion; 211c. First connecting portion; 212. First adjusting member; 220. Power assembly; 300. Second movable assembly; 310. Second movable member; 320. Second adjusting member; 10'. Blood pump driving mechanism Structure; 100', blade assembly; 110', blade; 111', closed section; 1111', first skeleton; 1111a', first support rod; 1112', flow blocking membrane; 112', hollow section; 1121', second skeleton; 1121a', second support rod; 120', connecting pipe; 200', driving assembly; 210', inner tube; 220', outer tube; 300', second developing part; 20, pump housing; P, blood flow inlet; Q, blood flow outlet; 20a, bracket; A, circular tube section; M, first reduced diameter section; C, second reduced diameter section; 20b, coating; 30, catheter; 40, directional axis; 50, flexible end; 2, control module; 3, perfusion module. DETAILED DESCRIPTION

[0048] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0049] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0050] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0051] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0052] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0053] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0054] It should be noted that the terms “distal end” and “proximal end” throughout the text are only used to indicate relative positional relationships. The “distal end” of a component refers to the end of the component that enters the patient's body first compared to the other end during normal operation and / or the end that is farther away from the operator, while the “proximal end” refers to the end that enters the patient's body later than the other end and / or the end that is closer to the operator.

[0055] Interventional catheter pumps, also known as blood pumps, are mostly used to be implanted from blood vessels into the patient's ventricles to assist the patient's heart in pumping blood from the ventricles to the arteries, thereby providing support for the patient's blood circulation. Among them, the traditional blood pump includes a pump housing, an impeller, a motor and a catheter; the motor is arranged between the pump housing and the catheter, and the impeller, as a blood pumping drive mechanism, can rotate in the pump housing under the drive of the motor, and can flow blood into the pump housing through the blood flow inlet of the pump housing and out of the blood flow outlet of the pump housing.

[0056] Among them, in order to generate sufficient centrifugal force, maintain the stability of blood flow and ensure blood perfusion efficiency, the impeller speed of traditional blood pumps is generally very high, especially the impeller of axial flow blood pumps, whose speed can be as high as 7000 to 15000 revolutions per minute (rpm). However, when the impeller rotates at high speed, the shear force generated is greater, and the degree of damage to red blood cells is greater, thereby producing potential hemolysis side effects. The longer the operation time, the greater the side effects and the higher the incidence of complications. In addition, since the motor is placed in the body, the heat generated when the motor is running will increase the chance of thrombosis. It can be seen that traditional blood pumps have potential side effects such as hemolysis and thrombosis, and the safety of surgery is not high.

[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 interventional 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+ in the figure 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 an 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 mainly used to establish a channel between the human circulatory system and the blood pump 1 and realize 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 the catheter 30 can be connected to the handle mechanism 10 by gluing or hot melting, etc., and this application does not limit this.

[0060] like Figures 3 to 6 As shown, the pump housing 20 is mainly used to contain and guide the blood flow, and is disposed 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 interventional pump, the blood flow inlet P is arranged at the distal end of the pump housing 20, and the blood flow outlet Q is arranged at the proximal end of the pump housing 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, while the blood flow outlet Q is located in the aorta; when the blood pump 1 is a right heart interventional pump, the blood flow inlet P is arranged at the proximal end of the pump housing 20, and the blood flow outlet Q is arranged at the distal end of the pump housing 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, while the blood flow outlet Q is located in the pulmonary artery.

[0061] Among them, the pump housing 20 can shrink or expand to adjust its radial size. When the blood pump 1 is inserted into the patient's body, the pump housing 20 can be shrunk first, and the radial size of the pump housing 20 becomes smaller, so that the pump housing 20 can be inserted into the sheath tube. When the pump is pushed into the patient's body, the pump housing 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 housing 20 is expanded, and the radial size of the pump housing 20 becomes larger, so that there is a larger space in the pump housing 20, which can accommodate more blood, and is also conducive to guiding blood flow, which 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 housing 20 can be adjusted accordingly according to the position and size of the aorta or pulmonary artery by shrinking or expanding the pump housing 20, ensuring that the proximal end or distal end of the pump housing 20 can be inserted into the aorta or pulmonary artery, so that blood can be pumped from the ventricle to the aorta or pulmonary artery, which can ensure the blood pumping efficiency of the blood pump 1.

[0062] It should be noted that, since the pump housing 20 can be shrunk to a smaller size, the radial dimension of the sheath tube through which the blood supply pump 1 is inserted does not need to be set larger, thereby reducing the difficulty of pushing the sheath tube into the patient's body.

[0063] The blood pumping drive mechanism 10' mainly provides power for the flow of liquid, which can promote the flow of blood, thereby realizing the blood pumping operation. Figure 1 , Figure 2 and Figure 7 As shown, the blood pumping drive mechanism 10' includes a paddle assembly 100' and a drive assembly 200'. The paddle assembly 100' is disposed in the pump housing 20 and has a first form and a second form. The maximum radial dimension of the paddle assembly 100' in the first form is greater than the maximum radial dimension in the second form. The proximal end of the drive assembly 200' passes through the catheter 30 and is connected to the power element, and can rely on the power of the power element to drive the paddle assembly 100' to reciprocate axially and extend and retract, so that the paddle assembly 100' switches alternately between the first form and the second form, thereby enabling the paddle assembly 100' to perform a blood pumping operation. Figure 8As shown, when the driving assembly 200' drives the blade assembly 100' to compress from the blood flow inlet P of the pump housing 20 toward the blood flow outlet Q, the blade assembly 100' can switch from the second form to the first form, and the radial size of the blade assembly 100' becomes larger, so that the blade assembly 100' can bring the blood at the blood flow inlet P to the blood flow outlet Q during compression, and then pump it into the patient's blood vessel; and when the driving assembly 200' drives the blade assembly 100' to extend from the blood flow outlet Q of the pump housing 20 toward the blood flow inlet P, the blade assembly 100' can switch from the first form to the second form, and the radial size of the blade assembly 100' becomes smaller, so that the blade assembly 100' will not reversely bring blood from the blood flow outlet Q to the blood flow inlet P. The blade assembly 100' repeats the above steps, that is, through reciprocating axial expansion and contraction and synchronous switching of its own form, blood perfusion can be achieved, which is similar to the irrigation principle of the ancient keel waterwheel. Figure 8 The flow direction of blood when the paddle assembly 100' switches between the first state and the second state is shown. Figure 8 The curved dashed arrows in FIG. 1 represent the flow direction of blood, and the straight broad arrows represent the extension and retraction direction of the paddle assembly 100 ′.

[0064] like Figure 7 As shown, the blade assembly 100' includes a plurality of blades 110' connected in sequence from near to far, and in the first form, each blade 110' is unfolded, and in the second form, each blade 110' is folded. It should be noted that when the blade assembly 100' switches between the first form and the second form, each blade 110' opens and closes successively or synchronously. In the first form, the maximum radial dimensions of each blade 110' may be the same or different, wherein the maximum radial dimension corresponding to the blade 110' with the largest radial dimension is the maximum radial dimension of the blade assembly 100' in the first form; in the second form, the maximum radial dimensions of each blade 110' may be the same or different, wherein the maximum radial dimension corresponding to the blade 110' with the largest radial dimension is the maximum radial dimension of the blade assembly 100' in the second form.

[0065] Taking into account the processing cost and the axial dimension of the pump housing 20 of the blood pump 1 , the number of the blades 110 ′ is set to 2 to 5, for example, 2, 3, 4 or 5.

[0066] like Figure 7As shown, the maximum radial dimensions of the multiple blades 110' in the first form decrease successively along the blood pumping direction. The radial dimensions of the multiple blades 110' set in this way can guide the flow of blood in the pump housing 20, and can also prevent the blood from forming vortices in the pump housing 20, thereby improving the blood pumping efficiency of the blood pump 1. It should be noted that the "blood pumping direction" in the full text refers to the flow direction of blood from the blood flow inlet P to the blood flow outlet Q of the pump housing 20. Among them, when the blood pump 1 is a left heart interventional pump, the maximum radial dimensions of the multiple blades 110' in the first form gradually decrease 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 dimensions of the multiple blades 110' in the first form gradually decrease 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 blade assembly 100' in the first form, the number of blades 110', the axial stroke of the blade assembly 100' in the pump housing 20, and the reciprocating axial telescopic frequency of the blade assembly 100'. Specifically, the greater the blood perfusion volume of the blood pump 1, the greater the maximum radial dimension of the blade assembly 100' in the first form, the number of blades 110', the axial stroke of the blade assembly 100' in the pump housing 20, and the reciprocating axial telescopic frequency of the blade assembly 100'. In other words, when pumping blood, the blood perfusion volume of the blood pump 1 can be increased by increasing at least one of the maximum radial dimension of the blade assembly 100' in the first form, the number of blades 110', the axial stroke of the blade assembly 100' in the pump housing 20, and the reciprocating axial telescopic frequency of the blade assembly 100'. In order to prevent the blade assembly 100' from having excessive shear force due to excessive reciprocating axial expansion and contraction frequency, when the blood perfusion volume of the blood pump 1 needs to be increased, the maximum radial dimension of the blade assembly 100' in the first form, the number of blades 110', and the axial stroke of the blade assembly 100' in the pump housing 20 can be appropriately increased accordingly. In this way, the reciprocating axial expansion and contraction frequency of the blade assembly 100' can be slightly increased or not increased, thereby preventing the reciprocating axial expansion and contraction frequency of the blade assembly 100' from being too large.

[0068] It can be seen that the blood pump 1 provided in the embodiment of the present application, on the one hand, the blade assembly 100' of the blood pumping drive mechanism 10' can be reciprocated axially extended and retracted under the drive of the drive assembly 200', so that it can switch between the first form and the second form alternately, and then can perform blood pumping operation, wherein the reciprocating axial extension and reciprocating of the blade assembly 100' during blood pumping 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 1; in addition, the blood perfusion volume of the blood pump 1 can be increased by appropriately increasing the maximum radial dimension of the blade assembly 100' in the first form, the number of blades 110', the axial stroke of the blade assembly 100' in the pump housing 20, etc., so that the blood perfusion volume of the blood pump 1 can be increased slightly. Or do not increase the reciprocating axial expansion and contraction frequency of the blade assembly 100', avoid the reciprocating axial expansion and contraction frequency of the blade assembly 100' being too large, so that the reciprocating axial expansion and contraction frequency of the blade assembly 100' is much lower than the high-speed rotation frequency of the impeller of the blood pump 1, and can also effectively reduce the shear force on blood cells. It can be seen that the blood pumping drive mechanism 10' provided by the present application can effectively reduce the shear force on blood cells and thus greatly eliminate the risk of hemolysis; on the other hand, the present application arranges the power component on the handle mechanism 10, instead of between the distal end of the catheter 30 and the proximal end of the pump housing 20. In this way, during surgery, the power component can be placed outside the patient's body, which can avoid the power mechanism from producing wear particles and shedding in the patient's body, and can also prevent thrombosis problems caused by heat generated by the power mechanism during operation.

[0069] In summary, the blood pump 1 provided in the present application can greatly eliminate the risk of hemolysis by changing the blood pumping mode of the blood pumping drive mechanism 10', and can prevent thrombosis problems caused by heat generation during operation by changing the position of the power component 220, thereby improving the safety of surgery. 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.

[0070] like Figure 7 and Fig. 9 As shown, in some embodiments of the present application, the paddle 110' includes a connected closed section 111' and a hollow section 112', the closed section 111' and the hollow section 112' are arranged in sequence along 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 blood flow, while the hollow section 112' is mainly used to expand or collapse the closed section 111' under the drive of the drive assembly 200'. Therefore, the paddle 110' of this structure is convenient for both driving blood flow and expanding or collapsing. Figure 7 As shown, when the blood pump 1 is a left heart interventional pump, the closed segment 111 ′ is disposed at the distal end of the hollow segment 112 ′; when the blood pump 1 is a right heart interventional pump, the closed segment 111 ′ is disposed at the proximal end of the hollow segment 112 ′.

[0071] like Figure 7 As shown, the radial dimensions of the closed section 111' in the first form and the second form gradually increase along the direction of blood pumping, and the radial dimensions of the hollow section 112' in the first form and the second form gradually decrease along the direction of blood pumping. 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 deployment and folding of the blades 110'. Among them, when the blood pump 1 is a left heart interventional pump, the radial dimensions of the closed section 111' in the first form and the second form gradually decrease from near to far, and the radial dimensions of the hollow section 112' in the first form and the second form gradually increase from near to far; when the blood pump 1 is a right heart interventional pump, the radial dimensions of the closed section 111' in the first form and the second form gradually increase from near to far, and the radial dimensions of the hollow section 112' in the first form and the second form gradually decrease from near to far.

[0072] like Fig. 9 As shown, the closed section 111' includes a first frame 1111' and a flow-blocking film 1112', the flow-blocking film 1112' is covered on the first frame 1111', and the first frame 1111' is connected to the hollow section 112'. The closed section 111' of this structure can be expanded or collapsed by deformation of the first frame 1111', and the flow-blocking film 1112' is used to drive the blood to flow in the pump housing 20 in a directional manner. It can be seen that the closed section 111' of this structure is convenient for driving the flow of blood and is convenient for expansion or collapse.

[0073] like Fig. 9 As shown, the first skeleton 1111' includes a plurality of first support rods 1111a', and the plurality of first support rods 1111a' are sequentially arranged along the circumference of the blade assembly 100', and one end of the first support rod 1111a' is connected to the hollow section 112' of the same blade 110' and the hollow section 112' of the adjacent blade 110'. The first skeleton 1111' of this structure has a simple structure, is easy to produce and process, and is also easy to unfold or fold the closed section 111'. Of course, in some other embodiments, the first skeleton 1111' can be set as a grid skeleton structure.

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

[0075] The first skeleton 1111' of the structure can be formed by laser engraving, for example, laser engraving is performed on the nickel-titanium alloy tube during processing. Alternatively, the first skeleton 1111' can be formed by weaving, for example, weaving the nickel-titanium wire during processing. After the first skeleton 1111' is laser engraved or woven, it is also necessary to perform heat setting, electrochemical polishing and other processes.

[0076] The flow-blocking membrane 1112' can be made of biocompatible materials such as e-PTFE (expended polytetrafluoroethylene), TPU (Thermoplastic Polyurethanes), and nylon. The flow-blocking membrane 1112' made of such materials has a certain elasticity and can be folded or unfolded synchronously with the first frame 1111', and will not fall off the first frame 1111' due to excessive changes in the radial dimensions of the first frame 1111', thereby ensuring normal blood pumping of the blood pump 1.

[0077] The baffle film 1112' can be sewn to the first frame 1111'. Specifically, the baffle film 1112' can be sewn to the first frame 1111' using sutures made of materials such as PET (Polyethyleneterephthalate), polytetrafluoroethylene or PP (Polypropylene). Of course, the baffle film 1112' can also be set on the first frame 1111' by hot pressing.

[0078] The flow-blocking membrane 1112' may be disposed on the inner circumference of the first skeleton 1111', or on the outer circumference of the first skeleton 1111', or on the inner and outer circumferences of the first skeleton 1111'. The present application does not impose any specific limitation on this, as long as the blood flow can be effectively blocked.

[0079] Continue to see Fig. 9 , the hollow section 112' may also include a second skeleton 1121', and the second skeleton 1121' is connected to the first skeleton 1111' of the closed section 111'. Among them, the second skeleton 1121' includes a plurality of second support rods 1121a', and the plurality of second support rods 1121a' are sequentially arranged along the circumference of the blade assembly 100', and one end of the second support rod 1121a' is connected to the closed section 111' of the same blade 110' and the closed section 111' of the adjacent blade 110'. The second skeleton 1121' of this structure has a simple structure, is easy to produce and process, and is also easy to unfold or fold the closed section 111'. Of course, in some other embodiments, the second skeleton 1121' can be set as a grid skeleton structure.

[0080] The number of the second support rods 1121a' can be 8 to 16, for example, 8, 9, 10, 11, 12, 13, 14, 15 or 16, and the present application does not impose any specific restrictions on this, as long as the strength of the hollow section 112' and the smooth expansion or folding can be ensured. The diameter of the second support rod 1121a' can be 0.1 mm to 0.25 mm, for example, 0.1 mm, 0.15 mm, 0.2 mm and 0.25 mm, etc., and there is no specific restriction on this, as long as the strength of the hollow section 112' and the smooth expansion or folding can be ensured.

[0081] The second frame 1121' of the structure can be formed by laser engraving, for example, laser engraving is performed on the nickel-titanium alloy tube during processing. Alternatively, the second frame 1121' can be formed by weaving, for example, weaving the nickel-titanium wire during processing. After the second frame 1121' is laser engraved or woven, it needs to be processed by heat setting, electrochemical polishing and other processes.

[0082] The first frame 1111' is a shape memory material. When the first frame 1111' is in the initial state, the blade 110' is in the first shape. The second frame 1121' is a shape memory material. When the second frame 1121' is in the initial state, the blade 110' is in the first shape. Fig.10 As shown, when the blood pump 1 is inserted into the patient's body, the paddle assembly 100' can be placed in the pump housing 20 first, and the pump housing 20 and the paddle assembly 100' can be stretched at the same time (the paddle assembly 100' is in the second form at this time), so that the pump housing 20 can carry the paddle assembly 100' into the sheath; when pushing in the patient's body, the pump housing 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 housing 20 is unfolded, and at this time, the first frame 1111' and the second frame 1121' of the paddle 110' are also reset and unfolded, and placed in the unfolded pump housing 20 in the first form. Afterwards, the paddle assembly 100' reciprocates and axially expands and contracts to perform the blood pumping operation. It can be seen that the paddle assembly 100' of the present application can switch between the first form and the second form. When pushing in the patient's body, the paddle assembly 100' can be set to the second form with a smaller radial dimension, and the pump housing 20 can be compressed at the same time, so that the blood pump 1 can maintain a smaller radial dimension when being delivered in the body, thereby reducing the difficulty of pushing the blood pump 1 in the patient's body, and also increasing the range of blood vessels that can be intervened, thereby improving the scope of indications; in addition, the paddle 110' is in the first form in the original state, so that the paddle assembly 100' can ensure a stable maximum radial dimension when promoting blood flow, so that the blood pump 1 can pump blood stably.

[0083] It should be noted that Fig.10The straight broad arrow in denoted 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', and the connecting tube 120' 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 on 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 above structure of the blade assembly 100 ', as 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 blade 110' and is connected to the most distal blade 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 can drive 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', and when the power member drives the inner tube 210' to reciprocate linear motion, the distal end of the inner tube 210' leads each blade 110' to reciprocate axial telescope.

[0087] The inner tube 210' can be a hypotube, which not only makes the inner tube 210' flexible to facilitate pushing in curved blood vessels, but also has a certain strength to push the blades 110' to perform multiple axial expansion and contraction. The bellows can be cut by laser, and the material can be a biocompatible metal material such as nickel-titanium alloy, 316L steel, etc.

[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 the present application does not impose specific restrictions on this.

[0089] The inner diameter of the outer tube 220' may be slightly larger than the outer diameter of the inner tube 210', and may be made of a medical polymer composite material. The distal end of the outer tube 220' may be connected to the most proximal connecting tube 120' by welding, hot melting, etc., and the proximal end of the outer tube 220' may be fixed in the handle body 100 by welding, hot melting, etc., and the present application does not make specific restrictions on this.

[0090] In some embodiments of the present application, the paddle assembly 100' further includes a first developing member (not shown in the drawings) and a second developing member 300', wherein the first developing member is disposed on the proximal side of the paddle assembly 100', and the second developing member 300' is disposed on the distal side 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 developing member and the second developing member 300'. If the paddle assembly 100' is not in the preset position, for example, in the first form, the paddle assembly 100' is located between the blood flow inlet P and the blood flow outlet Q, the radial dimension of the pump housing 20 or the telescopic range 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 developing member may be disposed at the distal end of the outer tube 220' and close to the most proximal paddle 110', for example, on the most proximal connecting tube 120'. The first developing member may be made of a platinum-iridium alloy or tantalum, and may be disposed on the most proximal connecting tube 120' by laser welding or physical embedding (i.e., a groove is provided on the most proximal connecting tube 120', and the first developing member is embedded in the groove on the most proximal connecting tube 120'). The number of first developing members may be 1, 2, 3 or more, and the present application does not impose any specific limitation thereto, as long as the proximal end of the paddle assembly 100' can be effectively and accurately positioned.

[0092] The second developing member 300' can be a developing ring and is disposed at the distal end of the farthest blade 110'. The second developing member 300' can be made of platinum-iridium alloy or platinum-tungsten alloy and can be connected to the farthest blade 110' and the distal end of the inner tube 210' by laser welding, hot melting or the like.

[0093] In some embodiments of the present application, the blood pumping drive mechanism 10' further includes a first protective coating (not shown in the drawings), which is disposed on the surface of the blade assembly 100'. The first protective coating may be disposed on the inner surface and / or the outer surface of the blade assembly 100'. For example, all surfaces of the first frame 1111', the second frame 1121' and the flow-blocking film 1112' of the blade 110' are provided with the first protective coating.

[0094] The first protective coating may be an anti-thrombotic coating or a hydrophilic coating, which can effectively prevent the attachment of thrombi and reduce the probability of postoperative complications. As an example, the inner surface and the outer surface of the blade assembly 100' may both be provided with an anti-thrombotic coating, or both be provided with a hydrophilic coating, or one may be provided with an anti-thrombotic coating and the other may be provided with a hydrophilic coating.

[0095] In order to ensure that the blade assembly 100' can be directional and retractable under the drive of the inner tube 210', in some embodiments of the present application, such as Figure 1 As shown, the blood pump 11 further includes a directional shaft 40, the proximal end of the directional shaft 40 extends out of the inner tube 210', and the distal end of the directional shaft 40 passes through the paddle assembly 100' and is connected to the distal end of the pump housing 20. The paddle assembly 100' can reciprocate axially along the directional shaft 40, so that the paddle assembly 100' can pump blood in a directional manner. It should be noted here that the directional shaft 40, the inner tube 210', the outer tube 220' and the catheter 30 are arranged in sequence from the inside to the outside.

[0096] The orientation shaft 40 may be a metal flexible shaft. The distal end of the orientation shaft 40 may be exposed from the distal end of the pump housing 20 and may be connected to the distal end of the pump housing 20 by welding, hot melting, etc., and the present application does not impose any specific restrictions on this.

[0097] In some embodiments of the present application, the power component of the handle mechanism 10 may include one of a reciprocating linear motor, a cylinder, a hydraulic cylinder, and a mechanism composed of a rotary motor and a crank connecting rod.

[0098] In some embodiments of the present application, Fig.12 As shown, the handle mechanism 10 further includes a first movable assembly 210, which is movably disposed on the handle body 100 and connected to 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, thereby adjusting the initial position of the paddle assembly 100' in the pump housing 20.

[0099] Combination Fig.12 and Fig.13As shown, in some embodiments, the movable mechanism includes a first movable member 211 and a first adjusting member 212; the first movable member 211 is slidably connected to the handle body 100, and the first movable member 211 is connected to the power assembly 220; the first adjusting member 212 is cooperatively connected to the outer surface of the first movable member 211, and the first adjusting member 212 is configured to apply force to the first movable member 211 during rotation so that the first movable member 211 drives the power assembly 220 to move relative to the handle body 100. For example, the first adjusting member 212 can be configured to apply force to the first movable member 211 during forward rotation so that the first movable member 211 moves in a direction away from the handle body 100, thereby driving the power assembly 220 away from the handle body 100 through the first movable member 211; the first adjusting member 212 is also configured to apply force in the opposite direction to the first movable member 211 during reverse rotation so that the first movable member 211 moves in a direction close to the handle body 100, thereby driving the power assembly 220 close to the handle body 100 through the first movable member 211. Therefore, by cooperating with the first movable member 211, the position of the first movable member 211 relative to the handle body 100 is adjusted through the first adjusting member 212, so that the position of the power component 220 connected to the first movable member 211 relative to the handle body 100 can be flexibly adjusted, so that the initial position of the inner tube 210' connected to the power component 220 relative to the handle body 100 is adjustable, so as to improve the flexibility and adaptability of the driving handle.

[0100] See also Figure 12 to Figure 14 As shown, in one embodiment, the first movable member 211 is sleeved outside the handle body 100 so that the first movable member 211 can slide relative to the handle body 100, and the outer surface of the first movable member 211 is provided with an external thread. The first adjusting member 212 is generally in a screw-like structure for easy rotation, and a threaded hole is provided inside the first adjusting member 212 to cooperate with the external thread on the first movable member 211, so that the first adjusting member 212 is connected to the first movable member 211 through a thread. In this embodiment, the installation position of the power assembly 220 relative to the handle body 100 can be adjusted by only changing the rotation direction of the first adjusting member 212, which is simple and efficient to operate.

[0101] Illustratively, in one embodiment, when the first adjusting member 212 is rotated clockwise, the first adjusting member 212 drives the first movable member 211 to slide in a direction away from the handle body 100 through a thread, thereby driving the power assembly 220 away from the handle body 100; when the first adjusting member 212 is rotated counterclockwise, the first adjusting member 212 drives the first movable member 211 to slide in a direction close to the handle body 100 through a thread, thereby driving the power assembly 220 close to the handle body 100, thereby achieving the adjustment of the installation position of the power assembly 220 relative to the handle body 100.

[0102] In one embodiment, the handle body 100 has a receiving hole 160; the first movable part 211 includes a first center portion 211a, a first connecting portion 211c and a first edge portion 211b, and the first center portion 211a, the first connecting portion 211c and the first edge portion 211b are connected in sequence along the radial direction of the first movable part 211, the first center portion 211a is connected to the power component 220, and the first edge portion 211b is configured to be used for matching connection with the first adjusting member 212; the first movable part 211 is configured to be inserted into the corresponding part of the handle body 100 through the first connecting portion 211c so that the first center portion 211a is located in the receiving hole 160, and the first edge portion 211b is located outside the receiving hole 160. In this embodiment, the first central portion 211a included in the first movable part 211 is arranged in the receiving hole 160, and the first edge portion 211b is arranged outside the receiving hole 160. This can not only improve the stability of the first movable part 211 and the handle body 100 after being plugged in, but also enable the first movable part 211 to slide freely relative to the handle body 100, so as to realize the movement of the power component 220 by the first movable part 211, thereby changing the installation position of the power component 220.

[0103] See also Figure 14 to Figure 15 As shown, a hollow receiving through hole 160 is provided inside the handle body 100, and a positioning groove 112a is provided on the side wall of the handle body 100. The first movable member 211 includes a first central portion 211a, a first connecting portion 211c and a first edge portion 211b which are connected in sequence from the inside to the outside. The first central portion 211a is connected to the first edge portion 211b through the first connecting portion 211c, and an external thread is provided on the outer side of the first edge portion 211b. When the first movable member 211 is connected to the handle body 100, the first movable member 211 is aligned with the end of the handle body 100 so that the first connecting portion 211c is inserted into the positioning groove 112a, and the sliding connection between the first movable member 211 and the handle body 100 can be realized.

[0104] In one embodiment, the power assembly 220 is disposed in the receiving through hole 160 and connected to the first central portion 211a, and the power assembly 220 is configured to connect to 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 disposed in the receiving through hole 160 and fixedly connected to the first central portion 211a. The inner tube 210' connected thereto is driven to move along the extension direction of the receiving through hole 160 by the power assembly 220, so that the inner tube 210' can reciprocate along the same straight line as much as possible, so as to ensure the stability when the inner tube 210' is driven to move.

[0105] In order to facilitate the expansion and contraction of the pump housing 20, Fig.12As shown, the handle mechanism 10 further includes a second movable component 300, which is movably disposed on the handle body 100 and is located at the distal end of the first movable component 210. The second movable component 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 retracted backward by controlling the second movable component 300, so that the pump housing 20 can be expanded or contracted.

[0106] In one embodiment, the second movable assembly 300 includes a second movable member 310 and a second adjusting member 320; the second movable member 310 is slidably disposed on the handle body 100, and the second movable member 310 is connected to the proximal end of the catheter 30; the second adjusting member 320 is cooperatively 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 when rotating so that the second movable member 310 drives the catheter 30 to move relative to the handle body 100. Figures 11 to 13 As shown, by changing the rotation direction of the second adjusting member 320 , the direction in which the second adjusting member 320 applies force to the second movable member 310 can be changed, and then the catheter 30 is driven to reciprocate relative to the handle body 100 through the second movable member 310 .

[0107] Further, in one embodiment, the second movable member 310 includes a second central portion, a second connecting portion, and a second edge portion, the second central 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 central portion is configured to be connected to the catheter 30, and the second edge portion is configured to be connected with the second adjusting member 320; the second movable member 310 is configured to be plugged into the corresponding portion of the handle body 100 through the second connecting portion so that the second central portion is located in the receiving through hole 160, and the second edge portion is located outside the receiving through hole 160. Figures 1 to 5 As shown, the structural form and connection method of the second movable part 310 and the second adjusting part 320 and the handle body 100 can be the same as the structural form and connection method of the first movable part 211 and the first adjusting part 212 and the handle body 100 in the above embodiment, so as to realize the sliding connection between the second movable part 310 and the handle body 100.

[0108] See also Figures 16 to 18As shown, the first movable component 210 and the second movable component 300 are arranged on the handle body 100 at intervals. The movable mechanism of the first movable component 210 is connected to the outer wall of the handle body 100, and the power component 220 is arranged in the receiving through hole 160 of the handle body 100 and connected to the inner tube 210'. The second movable component 300 is connected to the catheter 30, and the inner tube 210' extends into the interior of the catheter 30, so that the inner tube 210' and the catheter 30 can reciprocate on the same side of the handle body 100, which is convenient for using the driving handle to cooperate with multiple targets at the same time to drive a more complex blade 110' structure, thereby improving the applicable scenarios. For example,

[0109] Fig.16 , the state where the inner tube 210' is driven to approach the handle body 100 by the power assembly 220 of the first movable assembly 210 is shown;

[0110] Fig.17 2 shows a state where the inner tube 210' is driven away from the handle body 100 by the power assembly 220 of the first movable assembly 210;

[0111] Fig.18 FIG. 4 shows a state where the catheter 30 is driven to approach the handle body 100 by the second movable assembly 300 .

[0112] In one embodiment, the handle body 100 includes a main shaft 110, a first stopper 120 and a second stopper 130. The main shaft 110 has a receiving through hole 160. The main shaft 110 is configured to be slidably connected with the first movable member 211 and the second movable member 310. The first stopper 120 is connected to one end of the main shaft 110 to limit the first movable member 211, and the second stopper 130 is connected to the other end of the main shaft 110 to limit the second movable member 310. Figures 11 to 14 As shown, the main shaft 110 is a roughly cylindrical structure, and a receiving through hole 160 is provided inside the main shaft 110. The two ends of the main shaft 110 are respectively threadedly connected with the first stopper 120 and the second stopper 130. The main shaft 110 is arranged in the housing 140, and the housing 140 protects the main shaft 110. Therefore, the first movable member 211 and the second movable member 310 are respectively limited by the first stopper 120 and the second stopper 130, so as to ensure that the first movable member 211 and the second movable member 310 can slide freely along the main shaft 110 and do not separate from the main shaft 110.

[0113] In one embodiment, the handle body 100 also includes a shell 140 and a wiring terminal 150, and the wiring terminal 150 is arranged between the first limit member 120 and the main shaft 110. The two ends of the wiring terminal 150 are respectively threadedly connected to the first limit member 120 and the main shaft 110, and the wiring terminal 150 is used to electrically connect the power component 220 and an external power supply to power the power component 220.

[0114] See also Figure 12 to Figure 13 As shown, 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, and the flushing section 111 protrudes from the first connecting section 112 and the second connecting section 113 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, and the receiving through hole 160 runs through the flushing section 111, the first connecting section 112, and the second connecting section 113 and communicates with the flushing hole 111a. A perfusion liquid such as saline can be injected into the receiving through hole 160 through the flushing hole 111a to ensure the normal operation of the blood pump 1. Specifically, the perfusion liquid can be injected into the annular space between the outer tube 220' and the inner tube 210', wherein the walls of the directional shaft 40, the inner tube 210', and the catheter 30 can also be provided with perfusion holes, so that the perfusion liquid 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 side of the inner tube 210' can extend the power mechanism and be provided with a liquid injection head, and in this case, it is not necessary to provide a through hole on the wall of the inner tube 210'. The first connecting section 112 is configured to be slidably connected to the first movable member 211. Specifically, a positioning groove 112a is provided on the first connecting section 112 to cooperate with the first movable member 211. One end of the first connecting section 112 away from the flushing section 111 is threadedly connected to the first stopper 120. The second connecting section 113 is configured to be slidably connected to the second movable member 310. One end of the second connecting section 113 away from the flushing section 111 is connected to the second stopper 130. The flushing section 111 separates the first movable assembly 210 and the second movable assembly 300, so that the flushing function can be achieved and interference between the first movable member 211 and the second movable member 310 can be avoided.

[0115] like Figure 3 As shown, in some embodiments of the present application, the pump housing 20 includes a support 20a and a coating 20b; the support 20a can be shrunk or expanded to adjust the radial size of the support 20a, and the support 20a has a proximal end, a distal end opposite to the proximal end, and a middle part located between the proximal end and the distal end; the coating 20b is provided in the middle part of the support 20a, so that one of the proximal end and the distal end of the support 20a forms a blood flow inlet P, and the other forms a blood flow outlet Q. The pump housing 20 of this structure is easy to expand and contract.

[0116] The stent 20a can be formed by laser engraving, for example, laser engraving is performed on the nickel-titanium alloy tube when the pump housing 20 is processed. Alternatively, the stent 20a can be formed by weaving, for example, nickel-titanium wires are weaved when the pump housing 20 is processed. After the stent 20a is laser engraved or woven, it is also necessary to perform heat treatment to shape it into a mesh stent 20a.

[0117] Continue to see Figure 3 The stent 20a includes a circular tube segment A, a first diameter-reduced segment M and a second diameter-reduced segment C. The first diameter-reduced segment M is arranged at the proximal end of the circular tube segment A, and the second diameter-reduced segment C is arranged at the distal end of the circular tube segment A. The coating 20b is arranged on the circular tube segment A. The diameter of the first diameter-reduced segment M gradually increases from the proximal end to the distal end, and the diameter of the second diameter-reduced segment C gradually decreases from the proximal end to the distal end. By providing the first diameter-reduced segment M and the second diameter-reduced segment C, a guiding effect can be played on the pump housing 20 passing into or out of the sheath tube, which is beneficial to the passing in or out of the pump housing 20, and also beneficial to the contraction or expansion of the stent 20a.

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

[0119] like Figure 3 As shown, the proximal end of the coating 20b is connected to the first reduced diameter section M, and the distal end of the coating 20b is connected to the second reduced diameter section C. In this arrangement, the coating 20b covers the entire circular tube section A along the axial direction of the pump housing 20, so that there is enough space in the bracket 20a to accommodate the blood pumping drive member, so that when the blood pumping drive member moves, blood can flow in from the blood flow inlet P and flow out from the blood flow outlet Q in a direction.

[0120] The coating 20b can be made of biocompatible materials such as e-PTFE, TPU, nylon, etc. The coating 20b of such materials has a certain elasticity and can shrink or expand synchronously with the stent 20a without falling off the stent 20a due to excessive changes in the radial dimensions of the stent 20a, thereby ensuring normal blood pumping of the blood pump 1.

[0121] The coating 20b can be sutured to the bracket 20a. Specifically, the coating 20b can be sutured to the middle part of the bracket 20a using suture thread made of PET, polytetrafluoroethylene or P. Of course, the coating 20b can also be set on the middle part of the bracket 20a by hot pressing.

[0122] The coating 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. This application does not make any specific restrictions as long as it can effectively block the blood flow.

[0123] In some embodiments of the present application, the pump housing 20 further includes a third developing member (not shown in the drawings) and a fourth developing member (not shown in the drawings), the third developing member is disposed on the proximal end of the bracket 20a, and the fourth developing member is disposed on the distal end of the bracket 20a. With the assistance of imaging equipment such as X-ray fluoroscopy, the third developing member and the fourth developing member can be used to determine whether the blood pump 1 is delivered to the target position. When the left interventional blood pump 1 is delivered to the target position, the third developing member is located in the left ventricle, and the fourth developing member is located in the aorta; when the right interventional blood pump 1 is delivered to the target position, the third developing member is located in the pulmonary artery, and the fourth developing member is located in the right ventricle.

[0124] The third developing member can be made of platinum-iridium alloy or platinum-tungsten alloy, and can be arranged on the proximal end of the bracket 20a by laser welding or physical inlay (i.e., a groove is provided on the bracket 20a, and the third developing member is inlaid in the groove on the bracket 20a). The number of the third developing members can be 1, 2, 3 or more, and this application does not impose any specific restrictions, as long as the pump housing 20 can be effectively and accurately positioned.

[0125] The fourth developing member may also be made of a platinum-iridium alloy or a platinum-tungsten alloy, and may also be disposed on the distal end of the bracket 20a by laser welding or physical inlay. The number of the fourth developing member may be 1, 2, 3 or more, and this application does not impose any specific limitation, as long as the pump housing 20 can be effectively and accurately positioned.

[0126] In some embodiments of the present application, the pump housing 20 further includes a second protective coating (not shown in the drawings), which is disposed on the surface of the stent 20a and / or the coating 20b. The protective coating may be an anti-thrombotic coating or a hydrophilic coating, which can effectively prevent the attachment of thrombi and also reduce the probability of postoperative related complications. As an example, the inner and outer surfaces of the stent 20a may both be provided with an anti-thrombotic coating, or both may be provided with a hydrophilic coating, or one may be provided with an anti-thrombotic coating and the other may be provided with a hydrophilic coating; the inner and outer surfaces of the coating 20b may both be provided with an anti-thrombotic coating, or both may be provided with a hydrophilic coating, or one may be provided with an anti-thrombotic coating and the other may be provided with a hydrophilic coating.

[0127] In some embodiments of the present application, Figure 3 As shown, the pump housing 20 also includes a flexible end 50, which is disposed at the distal end of the bracket 20a. The flexible end 50 can abut against the inner wall of the tissue to position the distal end of the blood pump 1, and the flexible end 50 can also protect the blood vessel when the blood pump 1 is pushed. The flexible end 50 can be a pigtail-shaped, spherical, arrow-shaped or prism-shaped tube structure. As an example, the distal end of the inner tube 210' of the drive assembly 200' extends from the flexible end 50 and is fixedly connected to the flexible end 50.

[0128] The flexible end 50 may be made of materials such as medical silicone or polyurethane mixed with a developing material, which makes the flexible end 50 have a certain degree of softness and 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 pump 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 blades 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' has 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, Fig.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 in any one of the above items; the control module 2 is connected to the power assembly 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 embodiment of the present application, on the one hand, the blade assembly 100' of the blood pumping drive mechanism 10' can be reciprocated axially extended and retracted under the drive of the drive assembly 200', so that it can switch between the first form and the second form alternately, and then can perform blood pumping operation, wherein the reciprocating axial extension and reciprocating of the blade assembly 100' during blood pumping 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 1; in addition, the blood perfusion volume of the blood pump 1 can be increased by appropriately increasing the maximum radial dimension of the blade assembly 100' in the first form, the number of blades 110', the axial stroke of the blade assembly 100' in the pump housing 20, etc., so that the blood perfusion volume of the blood pump 1 can be increased slightly. Or do not increase the reciprocating axial expansion and contraction frequency of the blade assembly 100', avoid the reciprocating axial expansion and contraction frequency of the blade assembly 100' being too large, so that the reciprocating axial expansion and contraction frequency of the blade assembly 100' is much lower than the high-speed rotation frequency of the impeller of the blood pump 1, and can also effectively reduce the shear force on blood cells. It can be seen that the blood pumping drive mechanism 10' provided by the present application can effectively reduce the shear force on blood cells and thus greatly eliminate the risk of hemolysis; on the other hand, the present application arranges the power component on the handle mechanism 10, instead of between the distal end of the catheter 30 and the proximal end of the pump housing 20. In this way, during surgery, the power component can be placed outside the patient's body, which can avoid the power mechanism from producing wear particles and shedding in the patient's body, and can also prevent thrombosis problems caused by heat generated by the power mechanism during operation.

[0138] In summary, the ventricular assist system provided in the present application can greatly eliminate the risk of hemolysis by changing the pumping mode of the blood pumping drive mechanism 10', and can prevent thrombosis problems caused by heat generation during operation by changing the position of the power component 220, thereby improving the safety of surgery. 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.

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

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

[0141] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0142] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A blood pump, characterized in that: include: A handle mechanism, the handle mechanism comprising a handle body and a power assembly arranged 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 includes a paddle assembly and a drive assembly, wherein the paddle assembly is disposed in the pump housing and has a first form and a second form, wherein the maximum radial dimension of the paddle assembly in the first form is greater than the maximum radial dimension in the second form, and the proximal end of the drive assembly passes through the catheter and is connected to the power assembly, and the power assembly can drive the paddle assembly to reciprocate axially and extend and retract through the drive assembly, so that the paddle assembly can alternately switch between the first form and the second form, thereby enabling the paddle assembly to perform a blood pumping operation.

2. The blood pump according to claim 1, characterized in that The blade assembly includes a plurality of blades connected in sequence from near to far. In the first form, each of the blades is unfolded, and in the second form, each of the blades is folded.

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

4. The blood pump according to claim 2, characterized in that 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.

5. The blood pump according to claim 4, characterized in that 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 frame connected to the closed section.

6. The blood pump according to claim 2, characterized in that: The driving assembly includes an inner tube and an outer tube; the distal end of the outer tube is connected to the nearest paddle blade, 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 paddle blades and is connected to the farthest paddle blade, 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 in a linear motion.

7. The blood pump according to claim 6, characterized in that The blood pump further comprises a directional shaft, the distal end of which passes through the inner tube and is connected to the distal end of the pump housing.

8. The blood pump according to any one of claims 1 to 7, characterized in that: The handle mechanism further comprises a first movable component, which is movably disposed on the handle body and connected to the power component, and the first movable component can drive the power component to move relative to the handle body.

9. The blood pump according to claim 8, characterized in that The first movable component 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 component; The first adjusting member is cooperatively connected 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 so that the first movable member drives the power assembly to move relative to the handle body.

10. The blood pump according to any one of claims 1 to 7, characterized in that The pump housing can be retracted or expanded; The handle mechanism also includes a second movable component, which is movably arranged 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.

11. The blood pump according to claim 10, 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, a distal end opposite to the proximal end, and a middle part located between the proximal end and the distal end; the coating is arranged in the middle part of the bracket so that one of the proximal end and the distal end of the bracket forms the blood flow inlet, and the other forms the blood flow outlet.

12. The blood pump according to claim 10, 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.

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

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