Distal components and ventricular assist devices

Abstract

This application provides a distal component and a ventricular assist device. The distal component includes an extension tube and an elastic structure. The extension tube includes a first end for connection to a cannula assembly and a second end away from the first end. The elastic structure includes a connecting portion, a supporting portion, and an elastic portion. The connecting portion is connected to the second end. The supporting portion and the connecting portion are spaced apart along the extension axis of the extension tube. The elastic portion connects the supporting portion and the connecting portion, and the elastic portion can expand and contract radially relative to the extension axis, giving the elastic structure a natural shape and a contracted shape. This distal component can replace traditional distal components, improving the positioning effect of the ventricular assist device and simplifying the manufacturing process.

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 an elastic structure; the extension tube includes a first end and a second end away from the first end; the elastic structure includes a connecting portion, a supporting portion, and an elastic portion; wherein the connecting portion is connected to the second end; the supporting portion and the connecting portion are arranged at intervals along the extension axis of the extension tube; the elastic portion connects the supporting portion and the connecting portion, and the elastic portion is capable of expanding and contracting radially relative to the extension axis, so that the elastic structure has a natural shape and a contracted shape.

[0005] In one embodiment, the elastic portion includes at least two elastic arms arranged at intervals around the outer circumference of the extension axis, and the elastic portion achieves the expansion and contraction by radial deformation of the elastic arms.

[0006] In one embodiment, the at least two elastic arms include a first elastic arm and a second elastic arm, which are disposed on opposite sides of the extension axis; or, the at least two elastic arms include a first elastic arm, a second elastic arm and a third elastic arm, which are arranged circumferentially around the extension axis of the extension tube.

[0007] In one embodiment, the elastic arm includes a first elastic segment and a second elastic segment; the first elastic segment extends from the connecting portion toward the supporting portion and in a direction deviating from the extension axis; the second elastic segment extends from the supporting portion toward the connecting portion and in a direction deviating from the extension axis, and connects to the first elastic segment.

[0008] In one embodiment, at least one of the first elastic segment and the second elastic segment is arranged in a straight strip shape; or, at least one of the first elastic segment and the second elastic segment is arranged in an arc shape.

[0009] In one embodiment, the outer surface at the connection between the first elastic segment and the second elastic segment is set as an arc surface.

[0010] In one embodiment, a first included angle is formed between the first elastic segment and the extension axis of the extension tube, the first included angle being greater than or equal to 30° and less than or equal to 50°; and / or, a second included angle is formed between the first elastic segment and the second elastic segment, the second included angle being greater than or equal to 80° and less than or equal to 120°.

[0011] In one embodiment, at least one of the first elastic segment and the second elastic segment is provided with a clearance groove.

[0012] In one embodiment, the clearance groove is located away from the middle portion of the elastic arm; and / or, the clearance groove is located on the side of the first elastic segment or the second elastic segment facing the extension axis.

[0013] In one embodiment, the clearance groove provided on the first elastic segment is a first clearance groove. The groove wall of the first clearance groove is arc-shaped along the extension direction of the first elastic segment, and the two ends of the first clearance groove are smoothly connected to the inner side of the first elastic segment and the surface of the support facing the connecting part, respectively.

[0014] Alternatively, the clearance groove provided on the second elastic segment is a second clearance groove, the groove wall of the second clearance groove is arc-shaped along the extension direction of the second elastic segment, and the two ends of the second clearance groove are smoothly connected to the inner side of the second elastic segment and the surface of the support portion facing the connecting portion.

[0015] In one embodiment, in the natural form, the first radial width of the elastic portion to the extension axis is greater than the radius of the extension tube; in the contracted form, the second radial width of the elastic portion to the extension axis is greater than or equal to the radius of the extension tube and less than the first radial width.

[0016] In one embodiment, the first radial width is greater than or equal to 4 times the radius of the extension tube and less than 6.5 times the radius of the extension tube.

[0017] In one embodiment, the extension tube is configured as a straight tube, and the first end of the extension tube is provided with a sleeve interface for connection with the sleeve assembly; and / or, the extension tube is integrally formed with the elastic structure.

[0018] In one embodiment, the connecting portion of the elastic structure has a first guide wire hole, which communicates with the extension tube; the supporting portion of the elastic structure has a second guide wire hole, which is disposed opposite to the first guide wire hole.

[0019] In one embodiment, a ventricular assist device 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 a first end of an extension tube of the distal component is connected to the distal end of the cannula assembly.

[0020] The distal component of this application can replace a traditional distal component. The distal component of this application allows the elastic part of the elastic structure to contract radially along the extension tube to a contracted state, thereby enabling the distal component to pass through the valve of the ventricle from the blood vessel and enter the ventricle. After entering the ventricle, the elastic structure releases its elastic potential energy, causing its elastic part to expand radially along the extension tube and return to its natural state. The elastic structure in its natural state has a large radial dimension, thereby increasing the contact area with the ventricle wall and improving the stability of the distal component's support and positioning with the ventricle wall.

[0021] 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

[0022] 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.

[0023] Figure 1 This is a schematic diagram of an embodiment of the ventricular assist device described in this application.

[0024] Figure 2 for Figure 1 A schematic diagram of the structure of the remote component in the embodiment shown.

[0025] Figure 3 for Figure 2 The front view of the remote component in the illustrated embodiment in its natural state.

[0026] Figure 4 for Figure 3 The remote component of the illustrated embodiment is switched to the front view in a shrunk state.

[0027] Figure 5 for Figure 3 The remote component of the illustrated embodiment switches to the main view in the expanded state.

[0028] Figure 6 for Figure 2 Another schematic diagram of the embodiment shown.

[0029] Figure 7 for Figure 6 A schematic cross-sectional view along the AA direction of the embodiment shown.

[0030] Figure 8 for Figure 2 The illustrated embodiment is a schematic diagram in which the distal component is subjected to force to approach the heart valve in preparation for entering the ventricle.

[0031] Figure 9 for Figure 2 The illustrated embodiment shows a distal component being subjected to force that breaks through the heart valve and partially enters the ventricle.

[0032] Figure 10 for Figure 2 The illustrated embodiment shows an application diagram in which the elastic structure of the distal component enters the ventricle.

[0033] Figure 11 for Figure 2 The illustrated embodiment shows a distal component subjected to force that breaks through the heart valve and partially leaves the ventricle.

[0034] Figure 12 This is a schematic diagram of another embodiment of the remote component described in this application.

[0035] Figure 13 for Figure 12 Another schematic diagram of the embodiment shown.

[0036] Figure 14 This is a schematic diagram of another embodiment of the ventricular assist device described in this application.

[0037] Figure 15 for Figure 14 A schematic diagram of the structure of the remote component in the embodiment shown.

[0038] Figure 16 for Figure 15 Another schematic diagram of the embodiment shown.

[0039] Figure 17 for Figure 16 A schematic cross-sectional view along the BB direction of the embodiment shown.

[0040] Figure 18 for Figure 16Another schematic diagram of the embodiment shown.

[0041] Figure 19 for Figure 16 Another schematic diagram of the embodiment shown.

[0042] Figure 20 for Figure 16 Another schematic diagram of the embodiment shown.

[0043] Figure 21 This is a schematic diagram of another embodiment of the remote component described in this application.

[0044] Figure label:

[0045] Distal component 100, cannula assembly 200, drive device 300, catheter 400, artery 500, heart valve 600, ventricle 700, projection plane 800, ventricular assist device 900;

[0046] Extension tube 110, first end 111, second end 112, socket 113;

[0047] Elastic structure 120, connecting part 123, supporting part 124, hollow area 125, elastic part 126, first elastic arm 127, second elastic arm 128, third elastic arm 129; middle part 1223, clearance groove 1224, first elastic section 1225, second elastic section 1226, groove wall 1227, rounded corner edge 1228;

[0048] Extension axis 130, pipe 140, first guide wire hole 160, second guide wire hole 170;

[0049] The casing body is 210, the inlet pipe is 220, and the outlet pipe is 230;

[0050] Entering direction F1, leaving direction F2, squeezing direction F3, first radial width D1, second radial width D2, third radial width D3, radius R1, first included angle α, second included angle β. Detailed Implementation

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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 900. Specifically, the distal component 100 is used to connect to the cannula assembly 200 of the ventricular assist device 900. 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 an elastic structure 120; the extension tube 110 includes a first end 111 and a second end 112 away from the first end 111; the second end 112 of the extension tube 110 is connected to the elastic structure 120. The elastic structure 120 includes a connecting portion 123, a supporting portion 124, and an elastic portion 126; wherein, the connecting portion 123 is connected to the second end 112 of the extension tube 110; the supporting portion 124 and the connecting portion 123 are arranged at intervals along the extension axis 130 of the extension tube 110; the elastic portion 126 connects the supporting portion 124 and the connecting portion 123, and the elastic portion 126 can expand and contract radially along the extension tube 110 relative to the extension axis 130, so that the elastic structure has a natural shape and a contracted shape.

[0058] Specifically, the extension tube 110 is configured as a straight tube, and the extension axis 130 passes through the center of the extension tube 110 and extends along the length of the extension tube 110. The extension axis 130 is a virtual line. The support portion 124 and the connecting portion 123 of the elastic structure 120 are arranged at intervals along the extension axis 130 of the extension tube 110, that is, a distance is separated between the support portion 124 and the connecting portion 123, forming a hollow region 125. Thus, during the process of the distal component 100 passing through the heart valve 600 and entering the ventricle, when the support portion 124 is squeezed through the heart valve 600, when the support portion 124 is subjected to the reaction force of the heart valve 600, the support portion 124 tends to move towards the connecting portion 123. At this time, the hollow region 125 can form a deformation space for the support portion 124 to move towards the connecting portion 123, thereby buffering the reaction force of the heart valve 600.

[0059] like Figure 8 and Figure 9 As shown, when a ventricular assist device is used to intervene in a patient's body, the distal component 100 contracts radially to a contracted state along the extension tube 110 via the elastic portion 126 of the elastic structure 120, allowing the distal component 100 to pass through the ventricular valves from the blood vessels and enter the ventricle 700. Figure 8 (F1 indicates the direction of entry); and after entering the ventricle 700, the elastic structure 120 releases its elastic potential energy, causing its elastic portion 126 to expand radially along the extension tube 110 to the natural shape (e.g., Figure 10 As shown, the expanded elastic structure 120 has a larger radial dimension, allowing the support portion 124 and at least a portion of the elastic portion 126 of the elastic structure 120 to contact and engage with the ventricular wall of the heart. This increases the contact area between the distal component 100 and the ventricular wall, thereby improving the stability of the distal component 100's support and positioning with the ventricular wall. Furthermore, when the reaction force of the ventricular wall on the elastic structure 120 is large, the elastic structure 120 can expand from its natural state to its expanded form. This not only buffers the reaction force but also further increases the radial dimension of the elastic structure 120, effectively increasing the contact area with the ventricular wall and significantly improving the stability of the distal component 100's support and positioning with the ventricular wall.

[0060] Furthermore, traditional pig-tail shaped distal components are straight tubes during molding 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. In contrast, the distal component 100 of this application does not require bending or coiling and can be directly demolded. Unlike traditional distal components, it does not require thermoforming and bending into a pig-tail shape after demolding. Therefore, the manufacturing process of the distal component 100 of this application is relatively simple and less difficult to process.

[0061] Please see Figure 3 and Figure 4 In one embodiment, in its natural state, the elastic structure 120 has a first radial width D1 from the elastic portion 126 to the extension axis 130 that is greater than the radius R1 of the extension tube 110, i.e., D1 > R1. In its contracted state, the elastic structure 120 has a second radial width D2 from the elastic portion 126 to the extension axis 130 that is less than the first radial width D1, i.e., D2 < D1; and the second radial width D2 may be greater than or equal to the radius R1 of the extension tube 110, i.e., D2 ≥ R1. It should be noted that the aforementioned "radial width" refers to the maximum radial dimension from the elastic portion 126 to the extension axis 130. Optionally, the first radial width D1 is greater than or equal to four times the radius of the extension tube 110 and less than six and a half times the radius of the extension tube 110, i.e., 4R1 ≤ D1 ≤ 6.5R1.

[0062] Please see Figure 5 Of course, the elastic part 126 can also have an expanded form. In the expanded form, the third radial width D3 of the elastic part 126 to the extension axis 130 is greater than the first radial width D1, that is, D3 > D1. When the distal component 100 passes through the heart valve 600 and enters the ventricle, when the support part 124 is squeezed through the heart valve 600, the support part 124 tends to move towards the connecting part 123 when it is subjected to the reaction force of the heart valve 600. At this time, the hollow area 125 can form a deformation space for the support part 124 to move towards the connecting part 123. The elastic part 126 deforms to the expanded state to buffer the reaction force of the heart valve 600 and reduce damage to the heart valve 600. Furthermore, when the elastic part 126 is fully inserted into the ventricle 700, if the support part 123 of the elastic structure 120 is held against the inner wall of the ventricle, the elastic structure 120 can also deform into the expanded form. This not only buffers the reaction force but also further expands the radial dimension of the elastic structure 120, effectively increasing the contact area with the inner wall of the ventricle and greatly improving the stability of the distal component 100 in supporting and positioning with the inner wall of the ventricle.

[0063] It is understood that on the projection plane 800 perpendicular to the extension axis 130 of the extension tube 110, the first radial width D1 of the elastic part 126 to the extension axis 130 determines the outer contour of the elastic structure 120, and the maximum radius R1 of the extension tube 110 determines the outer contour of the extension tube 110. The first radial width D1 of the elastic part 126 to the extension axis 130 is greater than the maximum radius R1 of the extension tube 110, that is, the outer contour of the elastic structure 120 on the projection plane 800 is greater than the outer contour of the extension tube 110 on the projection plane 800. Thus, after the distal component 100 passes through the heart valve and enters the ventricle 700, the extension tube 110 passes through the heart valve 600, that is, the extension tube 110 is located between the heart valves 600, while the elastic structure 120 is located inside the ventricle. On the projection plane 800, the elastic structure 120 or its elastic portion 126 can elastically deform, thereby expanding and contracting radially relative to the extension axis 130 of the extension tube 110. This design facilitates controlled entry into and controlled exit from the ventricle.

[0064] like Figure 3 and Figure 4 As shown, in one embodiment, the elastic portion 126 includes at least two elastic arms (such as a first elastic arm 127 and a second elastic arm 128), which are arranged at intervals along the outer circumference of the extending axis 130. Each elastic arm has a connecting portion 123 and a supporting portion 124 connected to its two ends, respectively. The elastic portion 126 expands and contracts by radial deformation of the at least two elastic arms. In other embodiments, the elastic structure 120 or its elastic portion 126 may also be configured as a hollow spherical or ellipsoidal shape, designed to contract upon passing through the heart valve 600 and expand upon entering the ventricle 700 to restore its circular shape, thereby maintaining the elastic structure 120 within the ventricle, i.e., maintaining its position after passing through the heart valve 600, thus maintaining the position of the ventricular assist device.

[0065] Please see Figures 3 to 6 The number of elastic arms is not limited here. Optionally, in this embodiment, the elastic part 126 includes two elastic arms, namely a first elastic arm 127 and a second elastic arm 128, which are respectively disposed on opposite sides of the extension axis 130. This design is beneficial for uniform force distribution.

[0066] Please see Figures 3 to 6In one embodiment, each elastic arm of the elastic portion 126 includes a first elastic segment 1225 and a second elastic segment 1226; wherein the first elastic segment 1225 extends from the connecting portion 123 toward the supporting portion 124 and in a direction deviating from the extension axis 130; the second elastic segment 1226 extends from the supporting portion 124 toward the connecting portion 123 and in a direction deviating from the extension axis 130, and connects to the first elastic segment 1225.

[0067] Specifically, the connection between the first elastic segment 1225 and the second elastic segment 1226 forms the middle portion 1223 of the elastic arm; the middle portions 1223 of each elastic arm constitute the position of the maximum outer diameter of the elastic portion 126. When the elastic structure 120 is in its natural state, the middle portion 1223 and the extension axis 130 are spaced apart by the first radial width D1; when the elastic structure 120 contracts from the natural state to the contracted state, the middle portion 1223 moves closer to the extension axis 130 along the radial direction of the extension tube 110, thereby reducing the maximum radial dimension of the elastic arm to the second radial width D2, where D2 < D1.

[0068] Please see Figure 4 In one embodiment, at least one of the first elastic segment 1225 and the second elastic segment 1226 of the elastic arm extends in a straight line. The first elastic segment 1225 and the second elastic segment 1226 intersect to form an angle. In another embodiment, at least one of the first elastic segment 1225 and the second elastic segment 1226 of the elastic arm may be arc-shaped. This makes the elastic arm smoother, less likely to collide with and damage the inner wall of the blood vessel or other tissues, and reduces harm to the patient.

[0069] Please continue reading. Figure 4 In another embodiment, the outer surface of the connection between the first elastic segment 1225 and the second elastic segment 1226 is set as an arc surface, which extends from the end of the first elastic segment 1225 away from the connecting portion 123 to the end of the second elastic segment 1226 away from the supporting portion 124. That is, the outer surface of the middle portion 1223 facing away from the hollow region 125 is set as an arc surface. This makes the outer contour at the maximum diameter of the elastic arm smoother, avoiding collision damage to the inner wall of the blood vessel or other tissues, and reducing harm to the patient.

[0070] Please also see Figure 4 In one embodiment, at least one of the first elastic segment 1225 and the second elastic segment 1226 is provided with a clearance groove 1224. In this embodiment, as shown... Figure 7As shown, both the first elastic segment 1225 and the second elastic segment 1226 are provided with the clearance groove 1224. Optionally, the clearance groove 1224 is disposed away from the middle part 1223 so that when the elastic structure contracts, the elastic arm deforms at the end near the extension axis of the extension tube, so that the entire elastic arm contracts closer to the extension axis of the extension tube, and the elastic arm contracts to the minimum radial dimension.

[0071] Alternatively, the clearance groove 1224 is disposed on the side of the first elastic segment 1225 or the second elastic segment 1226 facing the extending axis. Thus, after the distal component enters the patient's body, the clearance groove 1224 is located on the inner side of the elastic structure, rather than on the outer side, which reduces the likelihood of the groove opening or edge of the clearance groove 1224 scraping against the inner wall of the blood vessel, thereby reducing damage to the patient.

[0072] Regarding the specific shape and structure of the clearance groove 1224, optionally, the clearance groove 1224 can be either a notched groove or a toothed groove. In this embodiment, the clearance groove 1224 is configured as a notched groove. The groove wall 1227 of the clearance groove 1224 can be configured as an arc-shaped groove wall (e.g., Figures 2 to 7 (as shown); or, the groove wall 1227 of the clearance groove 1224 can be set as a strip-shaped groove wall (e.g. Figure 12 and Figure 13 (As shown).

[0073] Please see Figure 7 Optionally, the clearance groove provided on the first elastic segment 1225 is defined as a first clearance groove 1224a. The groove wall 1227 of the first clearance groove 1224a is arc-shaped along the extension direction of the first elastic segment 1225, and both ends of the first clearance groove 1224a are smoothly connected to the inner side surface of the first elastic segment 1225 and the surface of the support portion 124 facing the connecting portion, respectively. This configuration can reduce the stress of the first elastic segment 1225 at the first clearance groove 1224a, which is beneficial for guiding deformation when the first elastic segment 1225 contracts, thereby controlling the deformation position of the elastic arm.

[0074] Similarly, the clearance groove provided on the second elastic segment 1226 is defined as the second clearance groove 1224b. The groove wall 1227 of the second clearance groove 1224b is arc-shaped along the extension direction of the second elastic segment 1226, and both ends of the second clearance groove 1224b are smoothly connected to the inner side surface of the second elastic segment 1226 and the surface of the support portion 124 facing the connecting portion 123. This arrangement can reduce the stress of the second elastic segment 1226 at the second clearance groove 1224b, which is beneficial for guiding deformation when the second elastic segment 1226 contracts, thereby controlling the deformation position of the elastic arm.

[0075] Please see Figure 7 In one embodiment, the extension tube 110 is a straight tube, and its first end 111 is provided with a sleeve interface 113 for connection with the sleeve assembly 200; in another embodiment, the extension tube 110 and the elastic structure 120 are integrally formed. Other embodiments follow the same principle and will not be described in detail. This design allows the distal component 100 to be directly demolded without the need for thermoforming and bending after demolding, thus simplifying the manufacturing process and reducing manufacturing difficulty; it also facilitates the rapid connection of the sleeve assembly 200.

[0076] Please see Figure 8 When using the distal component 100, a force is applied to the distal component 100 in the entry direction F1 within the artery 500, causing the distal component 100, along with other components of the ventricular assist device 900, to approach the heart valve 600. For example... Figure 9 As shown, 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 portion 126 of the elastic structure 120 contracts radially relative to the extension axis 130 of the extension tube 110 to the contracted shape. Figure 10 As shown, when the elastic structure 120 is fully inserted into the ventricle 700, the elastic portion 126 of the elastic structure 120 returns to its natural state, that is, it expands radially relative to the extension axis 130 of the extension tube 110. As a result, the distance from the elastic portion 126 to the extension axis 130 returns to the first radial width D1. At this time, the elastic portion 126 of the elastic structure 120 has a larger radial dimension, which can increase the contact surface with the inner wall of the ventricle, thereby ensuring that the elastic structure 120 can be stably supported on the inner wall of the ventricle and effectively improving the stability of positioning.

[0077] Please see Figure 11 When the ventricular assist device needs to be removed, a force in the departure direction F2 is applied to the distal component 100, and the elastic structure 120 begins to leave the ventricle 700. The elastic structure 120 overcomes the force of the heart valve 600 in the compression direction F3, and the elastic part 126 of the elastic structure 120 also contracts radially relative to the extension axis 130 of the extension tube 110, so that the elastic structure 120 leaves the ventricle 700.

[0078] Please see Figure 12 and Figure 13 In one embodiment, with Figure 7 Unlike the embodiment shown, in this embodiment, the groove walls 1227 on both sides of the clearance groove 1224 of the distal component 100 are set as strip-shaped groove walls, and the strip-shaped groove walls are parallel to the extension direction 130.

[0079] Please see Figure 13 In this embodiment, a first included angle α is formed between the first elastic segment 1225 and the extension direction 130 of the extension tube 110, and the first included angle α is 30° to 50°; in one embodiment, the first included angle α is 30°, 32°, 35°, 40°, 44°, 45°, 48° or 50°, etc.

[0080] like Figure 13 As shown, a second included angle β is formed between the first elastic segment 1225 and the second elastic segment 1226, and the second included angle β is between 80° and 120°. In one embodiment, the first included angle α is 80°, 83°, 85°, 90°, 92°, 95°, 100°, 110°, 112°, 118°, or 120°, etc. The angle settings of the first included angle α and the second included angle β are beneficial for controlling the deformation position and degree of deformation of the elastic arm of the elastic structure 120, so that the elastic structure 120 or its elastic part 126 can pass through the heart valve 600 and enter and exit the ventricle 700.

[0081] It is understood that if the first elastic segment 1225 is set to an arc shape, the first included angle α refers to the angle formed between the connecting line between the two ends of the first elastic segment 1225 and the extension direction 130 of the extension tube 110. If the second elastic segment 1226 is set to an arc shape, the second included angle β refers to the angle formed between the connecting line between the two ends of the second elastic segment 1226 and the first elastic segment 1225. If both the first elastic segment 1225 and the second elastic segment 1226 are set to arc shapes, the second included angle β refers to the angle formed between the connecting line between the two ends of the first elastic segment 1225 and the connecting line between the two ends of the second elastic segment 1226.

[0082] Please see Figure 14 and Figure 15 In another embodiment, with Figure 1 Unlike the illustrated embodiment, the elastic portion 126 of the elastic structure 120 of the distal component 100 includes three elastic arms: a first elastic arm 127, a second elastic arm 128, and a third elastic arm 129. These three elastic arms are arranged circumferentially around the extension axis 130 of the extension tube 110. Optionally, the first elastic arms 127, 128, and 129 are arranged at equal intervals around the extension axis 130 of the extension tube 110, i.e., uniformly arranged. Of course, in other embodiments, the first elastic arms 127, 128, and 129 may also be arranged at non-equal intervals around the extension axis 130 of the extension tube 110. In other embodiments, the elastic portion 126 may also include other numbers of elastic arms. With this design, the elastic structure 120 can contract during use, thus easily passing through the heart valve, and the elastic structure 120 can expand, thus maintaining its position after passing through the heart valve, thereby maintaining the position of the ventricular assist device.

[0083] In one embodiment, the number of elastic arms is at least three; each elastic arm is evenly distributed relative to the extension direction 130. The outer edges of the elastic arms are rounded. In one embodiment, the extension tube 110 is a straight tube.

[0084] Please see Figure 17 and Figure 18 In one embodiment, the connecting portion 123 of the elastic structure 120 is provided with a first guide wire hole 160, which is connected to the extension tube 110; the supporting portion 124 of the elastic structure 120 is provided with a second guide wire hole 170, which is disposed opposite to the first guide wire hole 160.

[0085] Please see Figure 19 and Figure 20 Based on any of the above embodiments, the elastic arm includes a first elastic segment 1225 and a second elastic segment 1226 arranged sequentially; the first elastic segment 1225 and the second elastic segment 1226 are integrally formed; wherein, the first elastic segment 1225 is connected to the connecting portion 123, the second elastic segment 1226 is connected to the supporting portion 124, and the intermediate portion 1223 connects the first elastic segment 1225 and the second elastic segment 1226. The elastic arm has a rounded edge 1228, that is, the edge of the elastic arm is rounded to protect biological tissue.

[0086] Please see Figure 15In this embodiment, the first elastic segments 1225 of each elastic arm converge to form the connecting portion 123, and the second elastic segments 1226 of each elastic arm converge to form the supporting portion 124; that is, the first elastic segments 1225 of each elastic arm converge to form the connecting portion 123 at their ends away from the middle portion 1223, and the second elastic segments 1226 of each elastic arm converge to form the supporting portion 124 at their ends away from the middle portion 1223. Furthermore, in this embodiment, the connecting portion 123, the elastic arm, and the supporting portion 124 are integrally formed. This structural design not only enables the positioning of the ventricular assist device but also allows for direct molding without the need for thermoforming and bending after molding, thus simplifying the manufacturing process and reducing manufacturing difficulty.

[0087] In one embodiment, the elastic arm of the distal component 100 may also be configured in other shapes, such as Figure 21 As shown, the elastic arm is configured as an arc.

[0088] The following will continue to combine Figures 1 to 21 This application describes the ventricular assist device 900 and its distal component 100. As mentioned above, this application provides two solutions: a distal component 100 with two elastic arms and a distal component 100 with three elastic arms. In practical applications, it is not limited to these two solutions.

[0089] like Figures 1 to 13 The diagram shows the distal component 100 of a dual-elastic arm system. The distal component 100 includes an extension tube 110, a connecting portion 123, a support portion 124, a first elastic arm 127, and a second elastic arm 128. The first elastic arm 127 and the second elastic arm 128 can elastically deform, changing between a natural state and a deformed state. Compared to conventional distal components, the distal component 100 of this application can be directly demolded without the need for post-demolding thermoforming bending, simplifying the manufacturing process and reducing manufacturing difficulty.

[0090] like Figure 8 As shown, when the ventricular assist device 900 is used, the distal component 100 is in its natural state when the ventricular assist device 900 enters the ventricle; when the distal component 100 passes through the heart valve 600, as... Figure 9 or Figure 11 As shown, the two elastic arms are compressed and tightened by the heart valve 600 in the compression direction F3, causing the distal component 100 to radially contract to a contracted state, so as to facilitate passage through the heart valve 600. After entering the ventricle, the two elastic arms open and return to their natural state, and the distal component 100 is positioned by contacting and resisting the ventricle wall through at least one elastic arm. The same applies during withdrawal.

[0091] In this embodiment, the extension tube 110, the connecting part 123, the supporting part 124, the first elastic arm 127, and the second elastic arm 128 can be integrally formed, or they can be formed independently and then connected into one piece.

[0092] Both elastic arms include a second elastic segment 1226 and a first elastic segment 1225, with a second included angle β formed between the second elastic segment 1226 and the first elastic segment 1225. The range of the second included angle β is selectable from 80° to 120°. The range of the first included angle α between the first elastic segment 1225 and the extension tube 110 is selectable from 30° to 50°.

[0093] At least one of the second elastic segment 1226 and the first elastic segment 1225 is provided with a clearance groove 1224 to facilitate the bending and deformation of the elastic arm of the elastic part 126. The clearance groove 1224 of the second elastic segment 1226 is located near the second end 112 of the extension tube 110, and the clearance groove 1224 of the first elastic segment 1225 is located near the support part 124, so that the radial dimension of the distal part 100 is minimized after deformation. The clearance groove 1224 can be a notch or a toothed groove, etc. For example... Figures 2 to 7 In the illustrated embodiment, the clearance groove 1224 has an arc-shaped groove wall 1227.

[0094] Figure 12 and Figure 13 In the illustrated embodiment, the groove wall 1227 of the clearance groove 1224 is configured as a strip-shaped groove wall, which extends along the axial direction of the extension tube 110 and is consistent with the blood flow direction. The outer surface of the connection between the second elastic segment 1226 and the first elastic segment 1225 of the elastic arm is provided with a rounded corner.

[0095] like Figures 14 to 20 The distal component 100 of the three elastic arms is shown. The elastic part 126 of the distal component 100 has a first elastic arm 127, a second elastic arm 128 and a third elastic arm 129. The first elastic arm 127 to the third elastic arm 129 are arranged at intervals along the same circumference. In this embodiment, they are arranged at equal intervals.

[0096] like Figure 21 The distal component 100 of the double elastic arm is shown, and is similar to the front component. Figures 1 to 20 Unlike the distal component 100 shown, in this embodiment, the elastic arm of the distal component 100 can also be configured with other shapes, such as an arc shape, to protect biological tissue. Such a distal component 100 not only enables the positioning of the ventricular assist device 900, but also has a simple manufacturing process and low manufacturing difficulty.

[0097] In one embodiment, the distal component 100 includes a linear extension tube 110, a connecting portion 123, a supporting portion 124, and at least two elastic arms that can elastically deform and change between a natural state and a deformed state. In a dual-elastic-arm distal component 100, the two elastic arms are arranged opposite each other; in a triple-elastic-arm distal component 100, the three elastic arms are arranged at equal intervals along the same circumference. Each elastic arm includes a second elastic segment 1226 and a first elastic segment 1225, forming a second included angle β between the second elastic segment 1226 and the first elastic segment 1225; the elastic arm can also be arc-shaped, smoothly passing through the heart valve 600. At least one of the second elastic segment 1226 and the first elastic segment 1225 has a clearance structure to facilitate bending and deformation of the elastic arm, and the outer edge of the elastic arm is rounded. The distal component 100 has opposing first guidewire holes 160 and second guidewire holes 170.

[0098] Please see Figure 1 or Figure 14 This application also provides a ventricular assist device 900, 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.

[0099] In one embodiment, the ventricular assist device 900 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 first end 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.

[0100] 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.

[0101] 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.

[0102] 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, used in a ventricular assist device, characterized in that, The remote component includes: An extension tube, the extension tube including a first end and a second end remote from the first end; and An elastic structure includes a connecting portion, a supporting portion, and an elastic portion; wherein the connecting portion is connected to the second end; the supporting portion and the connecting portion are spaced apart along the extension axis of the extension tube; the elastic portion connects the supporting portion and the connecting portion, and the elastic portion is capable of expanding and contracting radially relative to the extension axis, thereby giving the elastic structure a natural shape and a contracted shape; the elastic structure is capable of releasing its elastic potential energy to allow the elastic portion to expand radially along the extension tube to the natural shape; In its natural state, the maximum radial dimension of the elastic portion from the extension axis is a first radial width; in its contracted state, the maximum radial dimension of the elastic portion from the extension axis is a second radial width, the second radial width being smaller than the first radial width. When the distal component passes through the heart valve, the elastic portion of the elastic structure is compressed by the heart valve and contracts radially along the extension tube to the contracted shape; and after entering the ventricle, the elastic structure releases its elastic potential energy, causing the elastic portion to expand radially along the extension tube to the natural shape.

2. The remote component according to claim 1, characterized in that, The elastic part includes at least two elastic arms, which are arranged at intervals around the outer circumference of the extension axis. The elastic part expands and contracts by radial deformation of the elastic arms.

3. The remote component according to claim 2, characterized in that, The at least two elastic arms include a first elastic arm and a second elastic arm, which are respectively located on opposite sides of the extension axis; or, The at least two elastic arms include a first elastic arm, a second elastic arm, and a third elastic arm, which are arranged circumferentially around the extension axis of the extension tube.

4. The remote component according to claim 2, characterized in that, The elastic arm includes a first elastic segment and a second elastic segment; the first elastic segment extends from the connecting portion toward the supporting portion and in a direction deviating from the extension axis; the second elastic segment extends from the supporting portion toward the connecting portion and in a direction deviating from the extension axis, and connects to the first elastic segment.

5. The remote component according to claim 4, characterized in that, At least one of the first elastic segment and the second elastic segment is arranged in a straight strip shape; or, at least one of the first elastic segment and the second elastic segment is arranged in an arc shape.

6. The remote component according to claim 4, characterized in that, The outer surface at the connection between the first elastic segment and the second elastic segment is set as an arc surface.

7. The remote component according to any one of claims 4 to 6, characterized in that, The first elastic segment forms a first included angle with the extension axis of the extension tube, the first included angle being greater than or equal to 30° and less than or equal to 50°; and / or, A second included angle is formed between the first elastic segment and the second elastic segment, the second included angle being greater than or equal to 80° and less than or equal to 120°.

8. The remote component according to any one of claims 4 to 6, characterized in that, At least one of the first elastic segment and the second elastic segment is provided with a clearance groove.

9. The remote component according to claim 8, characterized in that, The clearance groove is located away from the middle part of the elastic arm; and / or, the clearance groove is located on the side of the first elastic segment or the second elastic segment facing the extension axis.

10. The remote component according to claim 9, characterized in that, The clearance groove provided on the first elastic segment is the first clearance groove. The groove wall of the first clearance groove is arc-shaped along the extension direction of the first elastic segment, and the two ends of the first clearance groove are smoothly connected to the inner side of the first elastic segment and the surface of the support facing the connecting part, respectively. Alternatively, the clearance groove provided on the second elastic segment is a second clearance groove, the groove wall of the second clearance groove is arc-shaped along the extension direction of the second elastic segment, and the two ends of the second clearance groove are smoothly connected to the inner side of the second elastic segment and the surface of the support portion facing the connecting portion.

11. The remote component according to any one of claims 1 to 6, characterized in that, In the natural form, the first radial width is greater than the radius of the extension tube; in the contracted form, the second radial width is greater than or equal to the radius of the extension tube.

12. The remote component according to claim 11, characterized in that, The first radial width is greater than or equal to 4 times the radius of the extension tube and less than 6.5 times the radius of the extension tube.

13. The remote component according to any one of claims 1 to 6, characterized in that, The extension tube is configured as a straight tube, and the first end of the extension tube is provided with a sleeve interface for connection with the sleeve assembly; and / or, the extension tube is integrally formed with the elastic structure.

14. The remote component according to any one of claims 1 to 6, characterized in that, The connecting portion of the elastic structure has a first guide wire hole, which communicates with the extension tube; the supporting portion of the elastic structure has a second guide wire hole, which is disposed opposite to the first guide wire hole.

15. A ventricular assist device, characterized in that, include: A cannula assembly having a blood inlet and a blood outlet; An impeller is disposed within the cannula assembly and near the blood outlet; as well as The distal component as claimed in any one of claims 1 to 14; wherein a first end of the extension tube of the distal component is connected to the distal end of the sleeve assembly.

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