Distal components and ventricular assist devices

Abstract

This application relates to a distal component and a ventricular assist device. The distal component includes an extension tube and at least two elastic arms. The extension tube includes a connecting portion, a support portion away from the connecting portion, and a main body portion connecting the connecting portion and the support portion. One end of each elastic arm is fixedly connected to the support portion. The elastic arm has an initial shape that forms an angle with the main body portion, and a first and a second retracted shape formed by deformation relative to the extension tube. In the first retracted shape, the elastic arm deflects towards the main body portion and retracts to a position adjacent to or against the main body portion. In the second retracted shape, the elastic arm deflects towards the rear side of the support portion away from the connecting portion and retracts to the rear side of the support portion. The distal component of this application can improve the positioning effect of the ventricular assist device, and its manufacturing process is simple and relatively easy to manufacture.

Description

Technical Field

[0001] This application relates to the field of cardiovascular medical devices, and in particular to distal components and ventricular assist devices. Background Technology

[0002] The distal component of traditional ventricular assist devices is typically shaped like a pig's tail. This pig-tail-shaped distal component provides poor support and positioning against the ventricular wall. Summary of the Invention

[0003] Based on this, this application provides a distal component and a ventricular assist device, which aims to solve the problem of poor positioning effect of traditional distal components.

[0004] In one embodiment, the distal component of this application includes an extension tube and at least two elastic arms; wherein the extension tube includes a connecting portion, a support portion away from the connecting portion, and a main body portion connecting the connecting portion and the support portion; one end of each elastic arm is fixedly connected to the support portion, and the elastic arm has an initial shape that forms an angle with the main body portion, and a first folded shape and a second folded shape formed by deformation relative to the extension tube.

[0005] In the first retracted state, the elastic arm deflects toward the main body and retracts to a position adjacent to or against the main body;

[0006] In the second retracted state, the elastic arm deflects toward the rear side of the support portion away from the connecting portion and retracts to the rear side of the support portion.

[0007] In one embodiment, the number of elastic arms is two, and the two elastic arms are respectively disposed on opposite sides of the main body; or, the number of elastic arms is three or more, and the elastic arms are arranged at intervals along the circumference of the main body.

[0008] In one embodiment, the length of the main body is L1, and the length of the projection of the elastic arm toward the main body is L2, where 1 / 3L1≤L2≤2 / 3L1.

[0009] In one embodiment, the elastic arm includes a fixed end connected to the support portion and an elastic segment connected to the fixed end; wherein the elastic arm extends in a straight line from the fixed end to the end of the elastic segment; or, the elastic arm extends in an arc shape from the fixed end to the end of the elastic segment.

[0010] In one embodiment, the elastic arm includes a fixed end connected to the support portion and an elastic segment connected to the fixed end; a clearance groove is provided on the outer surface of the fixed end facing away from the included angle. In one embodiment, the clearance groove has a groove wall, the groove wall is arc-shaped, and one end of the groove wall is smoothly connected to the support portion of the extension tube, and the other end of the groove wall is smoothly connected to the elastic segment.

[0011] In one embodiment, in the initial configuration, the angle between the elastic arm and the main body is greater than or equal to 15° and less than or equal to 40°.

[0012] In one embodiment, the extension tube is arranged in a straight tube shape and has a guide wire hole extending along its length direction; and / or, the extension tube is integrally formed with the elastic arm.

[0013] In one embodiment, the cross-section of the elastic arm, obtained by a plane perpendicular to its length direction, is circular, elliptical, or polygonal; and / or, at least one of the distal end face of the support and the proximal end face of the elastic arm is de-angularized to form a protective end face.

[0014] In one embodiment, a ventricular assist device is also provided, which includes a cannula assembly, an impeller, and a distal component as described in any embodiment; wherein the cannula assembly is provided with a blood inlet and a blood outlet; the impeller is disposed within the cannula assembly and close to the blood outlet; and the extension tube of the distal component is connected to the distal end of the cannula assembly.

[0015] The distal component of this application can replace traditional distal components. The distal component of this application has at least two elastic arms circumferentially arranged in the extension tube. These elastic arms have an initial shape, a first contracted shape, and a second contracted shape. When the distal component passes through the ventricular valve from the blood vessel into the ventricle, the circumferential direction of the distal component is compressed by the ventricular valve and deforms into the first contracted shape, reducing the radial dimension of the distal component and facilitating its passage through the ventricular valve. Subsequently, after the distal component has fully entered the ventricle, the elastic arms release elastic potential energy, unfold, and return to the initial shape. In the initial state, the distal component has a larger radial dimension. The elastic arms can cooperate with the support portion of the extension tube to support the ventricle wall, thereby increasing the contact area between the distal component and the ventricle wall and improving the stability of the distal component's support and positioning within the ventricle wall.

[0016] When it is necessary to remove the distal component from the ventricle, the distal component passes through the ventricular valve from the inside out. The end of the elastic arm of the distal component is held by the ventricular valve and deflects toward the rear side of the support of the extension tube to deform into the second folded state, thereby reducing the radial dimension of the distal component and making it easier to pass through and be removed from the ventricular valve.

[0017] Furthermore, since the remote component of this application can be directly demolded and formed, unlike traditional remote components which need to be thermoformed and bent into a pig tail shape after demolding, the manufacturing process of the remote component of this application is relatively simple and the processing difficulty is low. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of an embodiment of the ventricular assist device described in this application.

[0020] Figure 2 for Figure 1 An enlarged schematic diagram of point A in the illustrated embodiment.

[0021] Figure 3 for Figure 1 A schematic diagram of the structure of the remote component in the embodiment shown.

[0022] Figure 4 for Figure 3 A partial structural schematic diagram of the embodiment shown.

[0023] Figure 5 for Figure 3 A schematic diagram of one of the cross-sectional shape designs of the elastic arm in the illustrated embodiment.

[0024] Figure 6 This is a schematic diagram of a second design for the cross-sectional shape of the elastic arm in another embodiment.

[0025] Figure 7 for Figure 3 Another schematic diagram of the embodiment shown.

[0026] Figure 8 for Figure 7 A schematic cross-sectional view along the BB direction of the embodiment shown.

[0027] Figure 9 for Figure 8Another schematic diagram of the illustrated embodiment shows the elastic arm in its initial state.

[0028] Figure 10 for Figure 8 The illustrated embodiment shows the elastic arm in a first retracted state.

[0029] Figure 11 for Figure 8 The illustrated embodiment shows the elastic arm in a second retracted state.

[0030] Figure 12 A schematic diagram of the preparation of the distal component described in this application for entry into the ventricle.

[0031] Figure 13 This is a schematic diagram showing the distal component described in this application passing through the heart valve and partially entering the ventricle.

[0032] Figure 14 This is a schematic diagram showing the distal component described in this application fully entering the ventricle.

[0033] Figure 15 A schematic diagram of the preparation of the distal component described in this application for exit from the ventricle.

[0034] Figure 16 This is a schematic diagram showing the distal component described in this application completely detached from the ventricle.

[0035] Figure 17 This is a schematic diagram of another embodiment of the remote component described in this application.

[0036] Figure 18 This is a schematic diagram of another embodiment of the remote component described in this application.

[0037] Figure 19 This is a schematic diagram of another embodiment of the remote component described in this application.

[0038] Figure label:

[0039] Distal component 100, cannula assembly 200, drive device 300, catheter 400, blood vessel 500, heart valve 600, ventricle 700, ventricular assist device 800;

[0040] Extension tube 110, elastic arm 120, extension axis 130, pipe 140, protective end face 150, clearance groove 160, notch groove 161, toothed groove 162, arc area 170;

[0041] Connecting part 111, supporting part 112, main body part 113, rear side 114, socket 115;

[0042] First elastic arm 121, second elastic arm 122, fixed end 123, elastic segment 124, clearance area 125, guide wire hole 127, end 128, initial form 120A, first retracted form 120B, second retracted form 120C.

[0043] Cannula 210, inlet tube 220, blood inlet 221, outlet tube 230, blood outlet 231;

[0044] Entering direction F1, leaving direction F2, squeezing direction F3. Detailed Implementation

[0045] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0046] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0047] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0048] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0049] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0050] In related technologies, the distal end of a ventricular assist device (VAM) is typically connected to a distal component for support and positioning. Traditionally, the distal component is often pig-tail shaped. During VAM intervention, the distal component is usually threaded onto a guidewire to straighten the pig-tail shape, allowing it to pass through the ventricular valves until it is fully inside the ventricle. After guidewire withdrawal, the distal component retracts back to its initial pig-tail shape. This pig-tail shape typically only has the arched portion at the bend in contact with the ventricle for support, resulting in unstable support and poor positioning. It should be noted that the terms "distal" and "proximal" used in this application are directional terms commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator.

[0051] Please see Figures 1 to 3 In view of the above, this application provides a distal component 100, which can be applied to a ventricular assist device 800. Specifically, the distal component 100 is used to connect to the cannula assembly 200 of the ventricular assist device 800. The distal component 100 can solve the problem of poor positioning effect of the above-mentioned conventional distal components. In one embodiment, the distal component 100 includes an extension tube 110 and at least two elastic arms 120; the extension tube 110 includes a connecting portion 111, a support portion 112 away from the connecting portion 111, and a main body portion 113 connecting the connecting portion 111 and the support portion 112. One end of the elastic arm 120 is fixedly connected to the support portion 112, and the elastic arm 120 has an initial shape 120A that is angled with the main body portion 113, and a first closing shape 120B and a second closing shape 120C formed by deformation relative to the extension tube 110; wherein,

[0052] In the first retracted state 120B, the elastic arm 120 deflects toward the main body 113 and retracts to a position adjacent to or against the main body 113;

[0053] In the second retracted state 120C, the elastic arm 120 deflects toward the rear side of the support portion 112 away from the connecting portion 111, and retracts to the rear side of the support portion 112.

[0054] Specifically, the main body 113 is arranged in a straight tube shape; the support part 112 and the connecting part 111 are respectively connected to the two ends of the main body 113, and the connecting part 111 is used to connect with the cannula assembly 200; the support part 112 can be used to contact and abut against the ventricular wall of the heart to position the ventricular assist device in the ventricle. The number of elastic arms 120 can be two or more. The elastic arms 120 can undergo elastic deformation and deflect around the fixed end 123 of the elastic arm 120 to switch shapes.

[0055] Therefore, the distal component 100 of this application can replace the conventional distal component 100. The distal component 100 of this application has at least two elastic arms 120 arranged circumferentially in the extension tube 110. Each elastic arm 120 has an initial shape, a first contracted shape 120B, and a second contracted shape 120C. Thus, when the distal component 100 passes through the ventricular valve 600 from the blood vessel into the ventricle 700, the elastic arms 120 of the distal component 100 are compressed by the ventricular valve 600 and deformed into the first contracted shape 120B, thereby increasing the radial dimension of the distal component 100. The size is reduced, making it easier to pass through the valve 600 of the ventricle 700; subsequently, after the distal component 100 is fully inserted into the ventricle 700, the elastic arm 120 of the distal component 100 releases elastic potential energy and unfolds and returns to the initial shape 120A. The distal component 100 in the initial state has a large radial dimension, and the elastic arm 120 can work with the support part 112 of the extension tube 110 to support the inner wall of the ventricle 700, thereby increasing the contact area between the distal component 100 and the inner wall of the ventricle 700, and thus improving the stability of the support and positioning of the distal component 100 and the inner wall of the ventricle 700.

[0056] When it is necessary to remove the distal component 100 from the ventricle, the distal component 100 passes through the ventricular valve 600 from the inside out. The end of the elastic arm 120 of the distal component 100 is held by the ventricular valve 600 and deflects toward the rear side of the support portion 112 of the extension tube 110 to deform into the second retracted state 120B, thereby reducing the radial dimension of the distal component 100 and making it easier to pass through and be removed from the ventricular valve 600.

[0057] Furthermore, traditional pig-tail shaped distal components are straight tubes during demolding and require reheating and thermoforming to bend into the desired pig-tail shape after demolding. This makes the manufacturing process of such traditional distal components quite cumbersome and difficult to process. In contrast, the distal component 100 of this application can be directly demolded, without the need for thermoforming and bending into a pig-tail shape after demolding, as is the case with traditional distal components. Therefore, the manufacturing process of the distal component 100 of this application is relatively simple and less difficult to process.

[0058] In one embodiment, there are two elastic arms 120, which are respectively disposed on opposite sides of the main body 113. Specifically, the two elastic arms 120 are defined as a first elastic arm 121 and a second elastic arm 122. The first elastic arm 121, the second elastic arm 122, and the extension tube 110 cooperate to make the distal component 100 have an arrow-shaped shape, and therefore can be commonly referred to as an arrow-shaped distal component.

[0059] Of course, in other embodiments, the number of elastic arms 120 can be three or more, such as three elastic arms 120, four elastic arms 120, or more. In this way, the elastic arms 120 can be arranged at intervals along the circumference of the main body 113, similar to the frame of an umbrella.

[0060] Please see Figure 4 In one embodiment, the elastic arm 120 includes a fixed end 123 connected to the support portion 112 and an elastic segment 124 connected to the fixed end 123. Optionally, the elastic arm 120 extends linearly from the fixed end 123 to the end 128 of the elastic segment 124. This design allows the elastic arm 120 to cooperate with the support portion 112 and support the ventricular wall of the heart when the distal component 100 is in its initial state. The side of the elastic arm 120 has a large lateral area and can conform to the ventricular wall of the heart, thereby increasing the contact area between the distal component 100 and the ventricular wall of the heart and improving the stability of positioning.

[0061] Of course, the shape of the elastic arm 120 is not limited to this. In another embodiment, the elastic arm 120 extends in an arc shape from the fixed end 123 to the end 128 of the elastic segment 124. This design allows the outer surface of the elastic arm 120 to be arc-shaped. When the distal component 100 passes through the ventricular valve 600, the arc surface of the elastic arm 120 contacts the ventricular valve 600, allowing the ventricular valve 600 to slide along the arc surface of the elastic arm 120. This reduces damage to the ventricular valve 600 caused by the elastic arm 120 and also reduces the stiffness of the elastic arm 120, making it easier for the elastic arm 120 to contract and deform.

[0062] Please see Figure 5 In one embodiment, the cross-section S1 of the elastic arm 120, obtained by a plane perpendicular to its length direction, is circular. In another embodiment, please refer to... Figure 6 The cross-section S1 of the elastic arm 120, obtained by a plane perpendicular to its length direction, may also be elliptical. Furthermore, in other embodiments, the cross-section S1 of the elastic arm 120, obtained by a plane perpendicular to its length direction, may be polygonal (e.g., rectangular or rounded rectangle).

[0063] Please see Figure 7 and Figure 8 In one embodiment, the extension tube 110 extends in a straight tube shape. The extension tube 110 has a sleeve interface 115 at the connecting portion 111, which is used to connect to the cannula assembly 200 of the ventricular assist device 800. The extension tube 110 also has a guidewire hole 127 extending along the extension axis 130, which passes through the connecting portion 111 and the support portion 112. The guidewire hole 127 is used for the guidewire to pass through. If blood enters the guidewire hole 127, the blood will pass through the extension tube 110 of the distal component 100 and enter the cannula assembly 200 through the connecting portion 111 for output, and will not remain in the distal component 100.

[0064] In one embodiment, in the initial configuration, the angle θ between the elastic arm 120 and the main body 113 is greater than or equal to 15° and less than or equal to 40°. The angle θ can be, but is not limited to, 15°, 18°, 20°, 22°, 25°, 30°, 35°, 38°, etc. In the initial configuration, the angle θ between the elastic arm 120 and the main body 113 should not be too large. If the angle θ is too large, the elastic arm 120 may not easily deform from the initial configuration 120A to the first contracted configuration 120B, making it difficult for the distal component 100 to pass through the blood vessel through the heart valve 600 and enter the ventricle 700. Of course, the angle θ between the elastic arm 120 and the main body 113 should also not be too small. If the angle θ is too small, the elastic arm 120 may not easily deform from the initial configuration 120A to the second contracted configuration 120B, making it difficult for the distal component 100 to withdraw outward from the heart valve. Therefore, in this embodiment, in the initial state, the angle θ between the elastic arm 120 and the main body 113 should preferably be greater than or equal to 15° and less than or equal to 40°.

[0065] Please see Figure 10In the initial configuration 120A, the elastic arm 120 and the main body 13 of the extension tube 110 are arranged at an angle, and a clearance area 125 is formed between the elastic arm 120 and the main body 13. The clearance area 125 provides deformation space for the elastic arm 120, allowing the elastic arm 120 to deflect towards the main body 113 of the extension tube 110 via the clearance area 125, thereby deforming into the first retracted configuration 120B.

[0066] This can be understood as the at least two elastic arms 120 having an initial shape 120A set at an angle θ with the main body 113, and a first folding shape 120B and a second folding shape 120C formed by deformation relative to the extension tube 110.

[0067] In one embodiment, the elastic arm 120 includes a fixed end 123 connected to the support portion 112, and an elastic segment 124 connected to the fixed end 123; a clearance groove 160 is provided on the outer surface of the fixed end 123 facing away from the included angle θ. The clearance groove 160 may be a notch 161 (e.g., Figure 8 (As shown). Alternatively, the clearance groove 160 can be a toothed groove 162 (as shown). Figure 18 (As shown). This design allows the clearance groove 160 to reduce the rigidity of the fixed end 123 of the elastic arm 120, making it easier for the elastic arm 120 to bend at the fixed end 123, thus facilitating deformation of the elastic arm 120 between different shapes. Furthermore, since the distal side of the fixed end 123 is close to the distal end of the distal component 100 body, its radial dimension is minimized after deformation, making it easiest to pass through the heart valve 600.

[0068] Please see Figure 10 The elastic arm 120 has a first contracted shape 120B formed by deformation relative to the extension tube 110. In the first contracted shape 120B, the elastic arm 120 deflects toward the main body 113 and contracts to a position adjacent to or abutting the main body 113. It can be understood that when the elastic arm 120 reaches its limit near the main body 113, the elastic arm 120 contacts the main body 113, i.e., abuts against the main body 113. Specifically, when subjected to a force in the entry direction F1 and a force in the compression direction F3, the elastic arm 120 deflects toward the main body 113 and contracts to form a contracted shape. Figure 10 The first folded configuration 120B is shown.

[0069] Please see Figure 11The elastic arm 120 has a second retracted form 120C formed by deformation relative to the extension tube 110. In the second retracted form 120C, the elastic arm 120 deflects toward the rear side 114 of the support portion 112 and retracts to the rear side 114 of the support portion 112. Specifically, when subjected to a force in the departure direction F2 and a force in the compression direction F3, the elastic arm 120 deflects toward the rear side 114 of the support portion 112 and retracts to form a retracted form. Figure 11 The second folded form 120C is shown.

[0070] Please see Figure 9 Considering that the length of the elastic arm 120 should not be too short, if the length of the elastic arm 120 is too short, the positioning effect of the elastic arm 120 in conjunction with the support portion 112 on the ventricular wall may be limited after the distal component 100 passes through the heart valve; the length of the elastic arm 120 should also not be too long, if the length of the elastic arm 120 is too long, the end of the elastic arm 120 may interfere with the ventricular wall or the ventricular valve 600 after the distal component 100 passes through the heart valve 600. Therefore, in one embodiment, the length of the main body 113 is L1, the length of the projection of the elastic arm 120 toward the main body 113 is L2, and 1 / 3L1≤L2≤2 / 3L1, so that the elastic arm 120 has an optimal length. The length L2 of the projection of the elastic arm 120 toward the main body 113 can be, but is not limited to, 0.34L1, 0.40L1, 0.45L1, 0.50L1, 0.55L1, 0.60L1, or 0.65L1.

[0071] Please see Figure 12 When the distal component 100 is used, when the ventricular assist device 800 or its distal component 100 is subjected to a force in the approach direction F1, for example, when a force is applied to the distal component 100 in the approach direction F1, the distal component 100 brings the other components of the ventricular assist device 800 closer to the heart valve 600.

[0072] Please see Figure 13Continuing to apply force to the distal component 100 in the entry direction F1, when the distal component 100 overcomes the force of the heart valve 600 in the compression direction F3 and begins to enter the ventricle 700, the elastic arm 120 deflects toward the main body 113 and retracts to a position adjacent to or abutting the main body 113. That is, the first retracted form 120B formed by the deformation of the elastic arm 120 relative to the extension tube 110 allows the support portion 112 in the extension tube 110 of the distal component 100 and part of the main body 113, together with the elastic arm 120, to pass through the heart valve 600 and enter the ventricle 700. In embodiments with a clearance zone 125, the fixed end 123 of the elastic arm 120 mainly deforms at the clearance zone 125, causing the elastic segment 124, especially the end 128 of the elastic segment 124, to retract to a position adjacent to or abutting the main body 113.

[0073] Please see Figure 14 Continue to apply force to the distal component 100 in the entry direction F1 until the elastic arm 120 is fully inserted into the ventricle 700. At this time, the support portion 112 and part of the main body portion 113 in the extension tube 110 are also in the ventricle 700. Since the elastic arm 120 is no longer subjected to the force of the heart valve 600 in the compression direction F3, the elastic arm 120 returns to its initial shape 120A, so that the elastic arm 120 is stuck in the ventricle 700, so that the elastic arm 120 remains in the position inside the ventricle without the action of external force, thereby maintaining the position of the ventricular assist device.

[0074] Please see Figure 15 When the ventricular assist device needs to be removed, a force F2 in the departure direction is applied to the distal component 100, and the elastic arm 120 begins to leave the ventricle 700. The elastic arm 120 is subjected to a force F3 from the heart valve 600 in the compression direction, deforming relative to the extension tube 110 to form a second contracted state 120C. In this second contracted state 120C, the two elastic arms 120 first move away from each other and then approach each other. The elastic arms 120 deflect towards the rear side 114 of the support portion 112 and contract towards the rear side 114 of the support portion 112, allowing the distal component 100 and its elastic arm 120 to pass through the heart valve 600 and leave the ventricle 700. Figure 16 As shown, since the elastic arm 120 is no longer subjected to the force of the heart valve 600 in the compression direction F3, the elastic arm 120 returns to its initial shape 120A.

[0075] Please see Figures 1 to 16The distal component 100 described in this application includes a straight-tube-shaped extension tube 110 and two elastic arms 120. The two elastic arms 120 can be bent and change between an initial shape 120A and a deformed state, including a first folded shape 120B and a second folded shape 120C. The two elastic arms 120 can be integrally formed with the extension tube 110, or they can be formed independently and then connected to form a whole. Compared with the conventional distal component 100, this structural design allows the distal component 100 of this application to be directly formed by demolding, without the need for thermoforming bending after demolding, simplifying the manufacturing process and reducing manufacturing difficulty.

[0076] like Figure 12 As shown, when using the ventricular assist device 800, before the ventricular assist device 800 enters the ventricle 700, the distal component 100 is in its initial configuration 120A; as Figure 13 As shown, when the ventricular assist device 800 enters the ventricle 700, the two elastic arms 120 are compressed and tightened by the heart valve 600, causing the distal component 100 to radially contract and pass through the heart valve 600 in a first contracted state 120B; as Figure 14 As shown, after entering the ventricle 700, the two elastic arms 120 open and return to their initial shape 120A, and the distal component 100 is positioned by contacting and resisting the inner wall of the ventricle 700 through one of the elastic arms 120.

[0077] like Figure 15 As shown, when the ventricular assist device 800 is withdrawn from the ventricle 700, the two elastic arms 120 of the distal component 100 abut against the inner wall of the heart valve 600 and bend and deform to a second contracted state 120C, causing the distal component 100 to radially contract and pass through the heart valve 600, reducing damage to the heart valve 600. After the distal component 100 radially contracts and passes through the heart valve 600 in the second contracted state 120C and leaves the ventricle 700, it... Figure 16 As shown.

[0078] Please see Figure 17 In one embodiment, at least one of the distal end face of the support 112 and the proximal end face of the elastic arm 120 is de-angularized to form a protective end face 150. Figure 8 Unlike the illustrated embodiment, in this embodiment, the support portion 112 is extended, protruding beyond the elastic arm 120 by more than 1 / 3 L2, to provide more guiding positions for the elastic arm 120 when the distal component 100 begins to pass through the heart valve 600, so as to ensure that the elastic arm 120 undergoes the target deformation at the target position, such as the clearance area 125, and to ensure that the elastic arm 120 is retracted to a position adjacent to or against the main body portion 113 in the first retracted form 120B, so as to facilitate passing through the heart valve 600.

[0079] Please see Figure 18 In one embodiment, the elastic arm 120 includes a fixed end 123 connected to the support portion 112, and a toothed groove 160 is provided on the side of the fixed end 123 facing away from the included angle θ. See also... Figure 19 In another embodiment, the elastic arm 120 of the distal component 100 is arc-shaped, and an arc-shaped region 170 is formed on the side of the elastic arm 120 opposite to the main body 113 of the extension tube 110. The design of the arc-shaped region 170 and the clearance groove 160 makes it easy for the elastic arm 120 to bend at the fixed end 123, thereby facilitating deformation between the initial form 120A and the second retracted form 120C.

[0080] Please see Figure 1 This application also provides a ventricular assist device 800, which includes a cannula assembly 200, an impeller, and a distal component 100. The cannula assembly 200 has a blood inlet 221 and a blood outlet 231. The impeller is disposed within the cannula assembly 200 and close to the blood outlet 231. The first end 111 of the extension tube 110 of the distal component 100 is connected to the distal end of the cannula assembly 200. The specific structure of the distal component 100 is as described in the above embodiments. Since the ventricular assist device of this application adopts all the technical solutions of all the above embodiments, it possesses at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be elaborated further here.

[0081] In one embodiment, the ventricular assist device 800 further includes an impeller and a drive device 300; the cannula assembly 200 includes a cannula 210, an inlet tube 220, and an outlet tube 230; the inlet tube 220 has a blood inlet 221, and the inlet tube 220 connects the connecting portion 111 of the distal component 100 and the cannula 210; the outlet tube 230 has a blood outlet 231, and the outlet tube 230 connects the cannula 210 and the distal end 310 of the drive device 300; the proximal end 320 of the drive device 300 is connected to the catheter 400. The impeller is disposed within the outlet tube 230 and connected to the drive device 300, so that the impeller is driven to rotate by the drive device 300 to realize the liquid pumping function.

[0082] It should be noted that other embodiments of this application also include remote components and ventricular assist devices formed by combining the technical features of the above embodiments.

[0083] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0084] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A distal component, characterized in that, The extension tube comprises a connecting portion, a supporting portion distal to the connecting portion, and a main body portion connecting the connecting portion and the supporting portion; At least two elastic arms, one end of the elastic arms being fixedly connected with the supporting portion, the elastic arms having an initial shape in which the elastic arms are arranged at an angle with the main body portion, and a first retracted shape and a second retracted shape formed by deformation of the elastic arms relative to the extension tube; wherein, In the first retracted shape, the elastic arms are deflected towards the main body portion and retracted to a position adjacent to or abutting against the main body portion; In the second retracted shape, the elastic arms are deflected towards the rear side of the supporting portion distal to the connecting portion and retracted to the rear side of the supporting portion; The elastic arms comprise a fixed end connected with the supporting portion and an elastic segment connected with the fixed end; the fixed end is provided with a clearance groove on the outer side of the fixed end facing away from the angle. The number of the elastic arms is two, and the two elastic arms are arranged on opposite sides of the main body portion; or the number of the elastic arms is three or more, and the elastic arms are arranged at intervals along the circumference of the main body portion. The length of the main body portion is L1, the length of the projection of the elastic arms towards the main body portion is L2, and 1 / 3L1≤L2≤2 / 3L1.

2. The distal component of claim 1, wherein, The elastic arms comprise a fixed end connected with the supporting portion and an elastic segment connected with the fixed end; wherein, 3. The distal component of claim 1, wherein, The elastic arms extend in a straight line from the fixed end to the end of the elastic segment; or the elastic arms extend in an arc line from the fixed end to the end of the elastic segment.

4. The distal part according to any one of claims 1 to 3, characterized in that The clearance groove is a notch groove or a tooth-shaped groove. The clearance groove has a groove wall arranged in an arc shape, one end of the groove wall being smoothly connected with the supporting portion of the extension tube, and the other end of the groove wall being smoothly connected with the elastic segment.

5. The distal component of claim 1, wherein, In the initial shape, the angle between the elastic arms and the main body portion is greater than or equal to 15° and less than or equal to 40°.

6. The distal component of claim 1, wherein, The extension tube is arranged in a straight tube shape, the extension tube is provided with a guide wire hole extending in the length direction of the extension tube; and / or the extension tube is integrally formed with the elastic arms.

7. The distal part according to any one of claims 1 to 3, wherein The cross section of the elastic arms taken by a plane perpendicular to the length direction of the elastic arms is arranged in a circular shape, an elliptical shape or a polygonal shape; and / or at least one of the distal end face of the supporting portion and the proximal end face of the elastic arms is subjected to a corner rounding treatment to form a protective end face.

8. The distal part according to any one of claims 1 to 3, characterized in that The extension tube comprises a connecting portion, a supporting portion distal to the connecting portion, and a main body portion connecting the connecting portion and the supporting portion; 9. The distal part according to any one of claims 1 to 3, wherein The impeller is arranged in the housing assembly and is close to the blood outlet; and 10. A ventricular assist device, characterized by The distal end component of any one of claims 1 to 9; wherein the connecting portion of the extension tube of the distal end component is connected with the distal end of the housing assembly. ​ ​ ​ ​

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