Blood pump distal extension, inlet window assembly, and blood pump

Abstract

This invention relates to a distal extension of a blood pump, an inlet window assembly, and a blood pump. The distal extension includes an extension tube and a protective end. The protective end is connected to one end of the extension tube. The distal extension has a guidewire channel that extends through the extension tube and the protective end, forming a first opening on the protective end that communicates with the guidewire channel. The protective end also has multiple connecting holes that communicate with the guidewire channel. Each connecting hole has a second opening located on the outer surface of the protective end. The second openings of the multiple connecting holes are spaced apart around the guidewire channel. Therefore, when the distal extension extends into the ventricle of the heart, and the first opening and the second opening on one side of the outer surface of the protective end are blocked by the inner wall of the heart, at least one second opening on the other side of the outer surface of the protective end is exposed in the ventricle, allowing blood to flow out through the guidewire channel and the second opening, reducing the formation of thrombi caused by blood remaining in the guidewire channel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a distal extension of a blood pump, an inlet window assembly, and a blood pump. Background Technology

[0002] An interventional blood pump, also known as an intracardiac blood pump or intravascular blood pump, can be inserted into a blood vessel and protruded into the patient's heart to function as a left ventricular assist device or a right ventricular assist device.

[0003] Traditional interventional blood pumps are prone to poor blood flow at the distal end, leading to thrombosis, which urgently needs to be improved. Summary of the Invention

[0004] Therefore, it is necessary to provide a distal extension of the blood pump, an inlet window assembly, and a blood pump to address the problem of poor blood flow at the distal end of the blood pump, which easily leads to thrombosis.

[0005] In a first aspect, the present invention provides a distal extension of a blood pump, comprising:

[0006] Extension tube section; and

[0007] The protective end is connected to one end of the extension tube. The distal extension of the blood pump is provided with a guidewire channel that passes through the extension tube and the protective end to form a first opening communicating with the guidewire channel on the protective end. The protective end is also provided with a plurality of connecting holes communicating with the guidewire channel. Each connecting hole has a second opening located on the outer surface of the protective end. The second openings of the plurality of connecting holes are spaced apart around the guidewire channel.

[0008] In one embodiment, a plurality of second openings are arranged around the guide wire channel, and the spacing between any two adjacent second openings is equal.

[0009] In one embodiment, each of the connecting holes also has a third opening located on the inner wall of the guide wire channel, the distance from the third opening to the first opening along the extension direction of the extension tube is L1, and the length of the protective end along the extension direction of the extension tube is L2, wherein L1≤L2 / 2.

[0010] In one embodiment, the extension tube is a flexible structure, and the stiffness of the end of the extension tube connected to the protective end is less than the stiffness of the end of the extension tube away from the protective end.

[0011] In one embodiment, the extension tube includes a first tube segment and a second tube segment, the first tube segment being connected to the protective end, and the second tube segment being located on the side of the first tube segment away from the protective end, wherein: the wall thickness of the second tube segment is greater than the wall thickness of the first tube segment; and / or, the extension tube further includes a transition section, the transition section being connected between the first tube segment and the second tube segment, and the radial dimension of the transition section gradually decreasing along the direction from the second tube segment to the first tube segment.

[0012] In one embodiment, the protective end is spherical or ellipsoidal; and / or, the maximum outer diameter of the protective end is greater than the outer diameter of the extension tube.

[0013] In a second aspect, the present invention also provides an inlet window assembly, including an inlet window and a distal extension of a blood pump as described in any of the above embodiments, wherein the inlet window is connected to one end of the extension tube opposite to the protective end.

[0014] In one embodiment, the inlet window has an inlet port for blood to flow into, the inlet port is connected to the guide wire channel, the inlet window includes a connector and an inlet tube, the connector is connected between the inlet tube and the extension tube, the inlet port is opened in the inlet tube, the connector has a docking channel connecting the inlet port and the guide wire channel, and the inlet tube does not extend beyond the outer peripheral surface of the connector.

[0015] In one embodiment, the inlet pipe includes a plurality of support columns, with two adjacent support columns forming a liquid inlet. The connector is provided with a plurality of connecting grooves, with each of the plurality of support columns corresponding to a plurality of connecting grooves. The end of each support column extends into the corresponding connecting groove and is connected to the groove wall of the corresponding connecting groove. The height difference between the outer surface of the end of the support column and the outer circumferential surface of the connector is between 0.05 mm and 0.2 mm.

[0016] And / or, along the direction from the outer surface of the inlet window to the axis of the inlet window, the size of the liquid inlet gradually decreases.

[0017] Thirdly, the present invention also provides a blood pump including an inlet window assembly as described in any of the above embodiments.

[0018] The present invention provides a distal extension of a blood pump, an inlet window assembly, and a blood pump. The distal extension of the blood pump has a guidewire channel that extends through the extension tube and the protective end, thereby forming a first opening at the protective end. Furthermore, the protective end also has multiple connecting holes communicating with the guidewire channel. Each connecting hole has a second opening located on the outer surface of the protective end, and the second openings of the multiple connecting holes are spaced apart around the guidewire channel. Therefore, when the distal extension of the blood pump extends into the ventricle, and the first opening and the second opening on one side of the outer surface of the protective end are blocked by the inner wall of the ventricle, at least one second opening on the other side of the outer surface of the protective end is exposed in the ventricle. This allows blood to flow out through the guidewire channel and the second opening on the other side of the outer surface of the protective end, significantly reducing the formation of thrombi caused by blood remaining in the guidewire channel. Compared to traditional blood pump distal extensions that only have one opening at the end and one on the side, this invention provides multiple connecting holes at the protective end that communicate with the guidewire channel. The second openings of these multiple connecting holes are spaced apart around the guidewire channel. This allows blood to flow out of the guidewire channel through the other second openings even if the first opening at the end and one of the second openings on the side are blocked, thereby further reducing the formation of thrombi caused by blood remaining in the guidewire channel. Attached Figure Description

[0019] Figure 1 This is an axonometric schematic diagram of an entrance window assembly provided in an embodiment of the present invention;

[0020] Figure 2 for Figure 1 Axial view of the distal extension of the blood pump inlet window assembly shown.

[0021] Figure 3 for Figure 1 The side view of the entrance window component shown;

[0022] Figure 4 for Figure 3 The shown is a cross-sectional view of the entrance window assembly along line AA;

[0023] Figure 5 for Figure 4 A magnified view of the entrance window component at point B;

[0024] Figure 6 The entrance window assembly provided in another embodiment is in Figure 4 A magnified view of a portion at point B shown;

[0025] Figure 7 for Figure 1 An exploded view of the entrance window assembly shown;

[0026] Figure 8 for Figure 3A cross-sectional view of the entrance window assembly shown along the CC line;

[0027] Figure 9 for Figure 1 The enlarged view of the entrance window component at point D is shown.

[0028] Reference numerals: 10, Inlet window assembly; 100, Inlet window; 110, Connector; 110a, Docking channel; 111, First connecting part; 112, Second connecting part; 112a, Connecting groove; 113, Interface part; 120, Inlet pipe; 120a, Liquid inlet; 121, Support; 122, Main body; 200, Distal extension of blood pump; 210, Extension tube part; 210a, Guide wire channel; 211, First tube segment; 212, Second tube segment; 213, Transition section; 220, Protective end; 221, Connecting hole; 2212, Second opening; 2213, Third opening; 222, First opening. Detailed Implementation

[0029] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be 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 the present invention. However, the present invention can be practiced 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 the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0030] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0031] 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 invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0032] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0033] In this invention, unless otherwise explicitly 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 is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply 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 that the first feature is at a lower horizontal level than the second feature.

[0034] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0035] The inventors of this application have discovered that interventional blood pumps typically include an inlet window assembly and an outlet window assembly. The inlet window assembly is placed in the ventricle, and the outlet window assembly is placed in the aorta. By rotating the impeller at high speed, blood from the ventricle is pumped into the aorta to assist blood circulation and reduce the workload of the heart.

[0036] Traditional inlet window assemblies consist of an inlet window and a distal component. The inlet window allows blood to flow in, while the distal component, in conjunction with a guidewire, facilitates inlet window implantation. The distal component reduces potential damage to the patient's heart and vascular system during installation or adjustment of the interventional blood pump and promotes pump stability. For guidewire passage, a guidewire channel is required through the distal component. When the blood pump is inserted into the ventricle, the ventricular wall can easily encase the distal component. Furthermore, due to the heart's pacing action, myocardial movement can easily cause pump displacement. When the pump shifts from its selected operating position, repositioning is necessary. During displacement or repositioning, the distal extension can come into contact with the ventricular wall or other tissue structures, blocking the guidewire channel opening and potentially causing impaired blood flow within the distal component, ultimately leading to thrombus formation.

[0037] To address the aforementioned issues, existing technology also provides a distal component of a blood pump. In addition to having an opening for a guidewire channel at its end, the distal component also has a through hole on its side that communicates with the guidewire channel, allowing blood to flow out from both the opening and the through hole, thus reducing the likelihood of thrombosis.

[0038] However, when the blood pump is inserted into the ventricle, the final orientation of its distal components within the ventricle is uncertain. Therefore, when the aforementioned blood pump is placed in the ventricle, the openings and orifices may still be blocked, leading to the formation of thrombi.

[0039] To address this issue, the present invention proposes a distal extension of a blood pump, an inlet window assembly, and a blood pump. A guidewire channel extends through the extension tube and the protective end, thereby forming a first opening at the protective end. Multiple connecting holes communicating with the guidewire channel are provided at the protective end, and multiple second openings on the outer surface of the protective end are spaced apart around the guidewire channel. This ensures that when the distal extension of the blood pump extends into the ventricle, and the first opening and the second opening on one side of the outer surface of the protective end are blocked by the ventricle wall, at least one second opening on the other side of the outer surface of the protective end is exposed within the ventricle. This allows blood to flow out through the guidewire channel and the second opening, further reducing the formation of thrombi caused by blood remaining in the guidewire channel. The distal extension of the blood pump, the inlet window assembly, and the blood pump provided by the present invention will be described in detail below with reference to specific embodiments and the accompanying drawings.

[0040] Please see Figure 1 and Figure 2 It is understood that the blood pump (not shown) provided in one embodiment of the present invention includes an inlet window assembly 10, which includes a distal extension 200 of the blood pump. The inlet window assembly 10 can be conveniently implanted into the ventricle via a blood vessel through the distal extension 200 of the blood pump.

[0041] Please continue reading. Figure 1 and Figure 2 In one embodiment, the extension tube portion 210 of the distal extension member 200 of the blood pump is provided with a guide wire channel 210a, and the guide wire channel 210a passes through the extension tube portion 210 and the protective end portion 220, thereby forming a first opening 222 communicating with the guide wire channel 210a on the protective end portion 220. Furthermore, since the protective end portion 220 is also provided with a plurality of connecting holes 221 communicating with the guide wire channel 210a, each connecting hole 221 has a second opening 2212 located on the outer surface of the protective end portion 220, and the second openings 2212 of the plurality of connecting holes 221 are spaced apart around the guide wire channel 210a.

[0042] Therefore, when the distal extension 200 of the blood pump extends into the ventricle, and the first opening 222 and the second opening 2212 on one side of the outer surface of the protective end 220 are blocked by the inner wall of the ventricle, at least one second opening 2212 located on the other side of the outer surface of the protective end 220 is exposed in the ventricle, allowing blood to flow out through the guidewire channel 210a and the second opening 2212, reducing the formation of thrombi caused by blood remaining in the guidewire channel 210a. Furthermore, compared to conventional distal extensions of blood pumps that only have one opening at the end and one on the side, this invention provides multiple connecting holes 221 in the protective end 220 that communicate with the guidewire channel 210a, and the second openings 2212 of the multiple connecting holes 221 are spaced apart around the guidewire channel 210a. This allows blood to flow out of the guidewire channel 210a through the other second openings 2212 even when the first opening 222 at the end and one second opening 2212 on the side are blocked, thereby reducing the formation of thrombi caused by blood remaining in the guidewire channel 210a.

[0043] Please see Figures 1 to 4 In one embodiment, a plurality of second openings 2212 are arranged around the guidewire channel 210a, and the spacing between any two adjacent second openings 2212 is equal. This ensures that, given a fixed number of connecting holes 221, the distribution span of each second opening 2212 is sufficiently large, preventing the aggregation of multiple second openings 2212. This further reduces the possibility of the first opening 222 and multiple second openings 2212 being blocked simultaneously, thereby further reducing the probability of thrombus formation.

[0044] In one embodiment, the protective end 220 can be approximately spherical, with the lines connecting the plurality of second openings 2212 forming a circumference, and the plurality of second openings 2212 being evenly distributed on the circumference. In another embodiment, when the protective end 220 is approximately cubic, the first opening 222 is located at the top of the cube, and the number of connecting holes 221 can be four, with the second opening 2212 of each connecting hole 221 located at the center of the corresponding side peripheral surface of the cube. It is understood that when the protective end 220 has other shapes, the plurality of second openings 2212 can also be evenly arranged on the outer peripheral surface of the protective end 220.

[0045] In one embodiment, a plurality of second openings 2212 are arranged circumferentially along an axis perpendicular to the guidewire channel 210a. The plurality of second openings 2212 surround the guidewire channel 210a, and the spacing between any two adjacent second openings 2212 is equal. This ensures that not only is the spacing between each second opening 2212 sufficiently large, but also that the spacing between each second opening 2212 and the first opening 222 is sufficiently large, further reducing the possibility of the first opening 222 and the plurality of connecting holes 221 being simultaneously blocked, thereby further reducing the probability of thrombus formation.

[0046] Please see Figure 5 Each connecting hole 221 also has a third opening 2213, which is located on the inner wall of the guide wire channel 210a, that is, the third opening 2213 and the second opening 2212 are located on opposite sides of the connecting hole 221.

[0047] Please continue reading. Figures 1 to 4 In one embodiment, the outer surface of the protective end 220 is at least partially a smooth curved surface, with multiple connecting holes 221 exposed on the smooth curved surface. A smooth curved surface refers to a surface with a tangent plane at every point, and the direction of the tangent plane changes continuously with the continuous movement of points on the surface, so that the outer surface of the protective end 220 has no acute angles, right angles, or other included angles. This design facilitates the movement of the protective end 220 within blood vessels and ventricles; it also reduces the likelihood of the protective end 220 scratching the blood vessel wall and ventricular wall during implantation.

[0048] Furthermore, since the outer surface of the protective end 220 is curved, the orientation and position of the various connecting holes 221 spaced apart on the protective end 220 can have greater differences. This further reduces the probability that the first opening 222 and each connecting hole 221 will be blocked simultaneously. In other words, by differentiating the opening positions of each connecting hole 221, the guidewire channel 210a can be connected to the extension tube 210 externally through at least one connecting hole 221, ensuring smooth blood flow in the guidewire channel 210a and reducing the probability of thrombosis.

[0049] It is understandable that a smooth curved surface is less likely to be completely fitted than a flat surface. Therefore, in this embodiment, the various connecting holes 221 on the outer surface of the protective end 220 have more differentiated positions and orientations, making it less likely that the first opening 222 and multiple connecting holes 221 will be blocked at the same time.

[0050] Please see Figure 2 In one embodiment, the protective end 220 may be spherical or hemispherical. In this case, the connecting holes 221 may be spaced apart circumferentially on the protective end 220. In this embodiment, the outer surface of the protective end 220 is a smooth spherical surface, making it less likely that all the connecting holes 221 on the protective end 220 will be blocked simultaneously. Please refer to... Figure 5 In this embodiment, each connecting hole 221 can be opened radially along the smooth spherical surface. Of course, Figure 5 This is just one example of the connection holes 221. Each connection hole 221 is not limited to being opened radially along the smooth spherical surface, but can also be opened in other directions on the protective end 220 to meet the differentiated needs of multiple connection holes 221.

[0051] Please see Figure 6 In another embodiment, the protective end 220 may be ellipsoidal, having a major axis and a minor axis. Compared to an ellipsoidal shape, the protective end 220 is spherical, which allows the protective end 220 of the same volume to have the largest cross-sectional area along the extension direction perpendicular to the extension tube portion 210. That is, compared to an ellipsoidal protective end, the spherical protective end 220 can have a larger outer diameter, thereby facilitating a larger first opening of the connecting hole 221 on the outer peripheral surface of the protective end 220, which facilitates blood flow through the connecting hole 221 and further reduces thrombus formation.

[0052] In another embodiment, the protective end 220 may be semi-ellipsoidal. In this case, the outer surface of the protective end 220 is a smooth ellipsoidal surface, and the first opening 222 and the various connecting holes 221 opened on the protective end 220 are less likely to be blocked simultaneously. In other embodiments, the protective end 220 may also be spindle-shaped. It is understood that the above description of the shape of the protective end 220 is only an example, and the outer surface of the protective end 220 may also be designed as other smooth curved surfaces, which will not be elaborated here.

[0053] In one embodiment, the number of connecting holes 221 can be 3, 4, 5, or 6, etc. Of course, the number of connecting holes 221 can also be set to other numbers according to actual needs.

[0054] Please see Figure 5In one embodiment, the maximum outer diameter of the protective end 220 is greater than the outer diameter of the extension tube 210. This configuration allows the protective end 220 to have a larger surface area, facilitating greater variation in the positions of the various connecting holes 221. Furthermore, since the maximum outer diameter of the protective end 220 is greater than the outer diameter of the extension tube 210, the portion of the protective end 220 protruding from the extension tube 210 can abut against tissue structures such as trabeculae within the heart, facilitating overall positional stability of the inlet window assembly 10 relative to the heart.

[0055] Please see Figure 5 In one embodiment, the transition connection between the protective end 220 and the extension tube 210 is provided with a rounded corner, that is, the protective end 220 and the extension tube 210 are connected by a rounded corner to reduce capillary action at the connection point and the potential for blood to be absorbed, thus reducing the likelihood of blood clotting and thrombus formation at the connection point. In another embodiment, a hydrophobic material can also be provided at the transition connection between the protective end 220 and the extension tube 210 to further reduce blood retention at the transition connection point, thereby reducing thrombus formation.

[0056] In one embodiment, a drainage slope 230 may be provided between the protective end 220 and the extension tube 210. The drainage slope 230 guides blood from the outer peripheral surface of the protective end 220 to the outer peripheral surface of the extension tube 210, reducing blood retention at the junction between the protective end 220 and the extension tube 210, thereby reducing the occurrence of thrombosis. The drainage slope 230 may be tangent to the outer peripheral surface of the protective end 220 to improve the drainage effect of the drainage slope 230 and further reduce the occurrence of thrombosis.

[0057] Please see Figure 4 In one embodiment, the diameter of the first opening 222 is equal to the diameter of the plurality of connecting holes 221. Thus, the flow rate into the guidewire channel 210a is the same or nearly the same for both the first opening 222 and each connecting hole 221. That is, the apertures of the first opening 222 and each connecting hole 221 are uniform, so that the blood flow rate in the guidewire channel 210a changes less when the first opening 222 or each connecting hole 221 is blocked. For example, the aperture range of the first opening 222 and each connecting hole 221 is 0.8mm-1.2mm. This allows the extension tube 210 to have sufficient wall thickness and sufficient weight for both the extension tube 210 and the protective end 220 to bend, reducing damage caused by the extension tube 210 contacting the vessel wall or ventricular wall, and facilitating its movement within the blood vessel. This allows the distal extension of the blood pump 200 to better adapt to tortuous blood vessels and the complex structure of the ventricle.

[0058] In other embodiments, the aperture of the connecting hole 221 can also be varied. For example, along the outer peripheral surface of the protective end 220 to the central axis of the protective end 220, the aperture of the connecting hole 221 gradually decreases. That is, the aperture of the connecting hole 221 on the outer peripheral surface of the protective end 220 is larger than the aperture of the connecting hole 221 on the inner wall of the guide wire channel 210a. In other words, the aperture of the second opening 2212 is larger than the aperture of the third opening 2213, making the connecting hole 221 approximately funnel-shaped, which facilitates increasing the flow of blood to the connecting hole 221, thereby reducing the occurrence of thrombosis.

[0059] Please see Figure 5 In one embodiment, along the extending direction of the extension tube 210, the distance from the third opening 2213 to the first opening 222 is L1, and the length of the protective end 220 along the extending direction of the extension tube 210 is L2, wherein L1 ≤ L2 / 2, that is, the distance from each third opening 2213 to the first opening 222 is less than half the length of the protective end 220 along the extending direction of the extension tube 210. In this embodiment, the plurality of third openings 2213 may be located at the same height, that is, the distance from the third opening 2213 to the first opening 222 is a fixed value. In other embodiments, the plurality of third openings 2213 may also have a height difference.

[0060] L1 ≤ L2 / 2, meaning the third opening 2213 is located on the protective end 220 near the location of the first opening 222. This arrangement reduces the distance between the first opening 222 and the third opening 2213 in the extending direction of the extension tube 210. When the first opening 222 is blocked, although blood can flow into the protective end 220 through the connecting hole 221, some blood will still flow towards the first opening 222. If the distance between the first opening 222 and the third opening 2213 in the extending direction of the extension tube 210 is too long, some of the blood flowing towards the first opening 222 may remain in the area between the first opening 222 and the third opening 2213, forming a thrombus. By setting L1 ≤ L2 / 2, the probability of this happening can be reduced. The extending direction of the extension tube 210 is shown in [reference needed]. Figure 5 The standard number is Q.

[0061] Please see Figures 1 to 4In one embodiment, the extension tube 210 is a flexible structure. The stiffness of the end of the extension tube 210 connected to the protective end 220 is less than the stiffness of the end of the extension tube 210 away from the protective end 220. That is, the stiffness of the distal end of the extension tube 210 is less than the stiffness of the proximal end of the extension tube 210. Thus, the distal end of the extension tube 210 can naturally bend due to its lower stiffness, thereby better adapting to tortuous blood vessels and the complex structure of the ventricle. This reduces damage caused by the extension tube 210 contacting the blood vessel wall or ventricular wall, and facilitates its movement within the blood vessel. The stiffness of the extension tube 210 refers to its ability to resist elastic deformation; lower stiffness makes elastic deformation easier, while higher stiffness makes elastic deformation less likely.

[0062] It is understandable that the terms “distal” and “proximal” used in this article are directional terms, which are commonly used in the field of interventional medical devices. “Distal” refers to the end that is far away from the operator during the operation, while “proximal” refers to the end that is close to the operator during the operation.

[0063] Please continue reading. Figures 1 to 4 In one embodiment, the extension tube 210 includes a first tube segment 211 and a second tube segment 212. The first tube segment 211 is connected to the protective end 220, and the second tube segment 212 is located on the side of the first tube segment 211 away from the protective end 220, that is, the first tube segment 211 is located at the distal end, and the second tube segment 212 is located at the proximal end.

[0064] In this embodiment, the wall thickness of the second pipe segment 212 is greater than the wall thickness of the first pipe segment 211. That is, in this embodiment, by setting the wall thickness of the first pipe segment 211 to be less than the wall thickness of the second pipe segment 212, the stiffness of the distal end of the extension pipe portion 210 is made less than the stiffness of the proximal end of the extension pipe portion 210. It is understood that, with the same material, the thinner the wall thickness of the extension pipe portion 210, the easier it is to undergo elastic deformation, i.e., the lower its stiffness.

[0065] Furthermore, the outer diameter of the proximal end of the extension tube 210 can be set to be larger than the outer diameter of the distal end of the extension tube 210, and the inner diameter of the proximal end of the extension tube 210 can be the same as or almost the same as the inner diameter of the distal end of the extension tube 210, so that the wall thickness of the proximal end of the extension tube 210 is greater than the wall thickness of the distal end of the extension tube 210. This setting can ensure that the radial dimensions are the same or almost the same throughout the extension direction of the guidewire channel 210a, which facilitates blood flow.

[0066] Please see Figure 2In one embodiment, the extension tube 210 further includes a transition section 213. The transition section 213 connects the first tube section 211 and the second tube section 212. Along the direction from the second tube section 212 to the first tube section 211, the radial dimension of the transition section 213 gradually decreases. In this way, the change in the outer diameter of the extension tube 210 can be smoothly transitioned, avoiding the step-like structure formed by abrupt changes in the outer diameter of the extension tube 210, and reducing the probability of a step-like structure potentially scratching the human body or obstructing the movement of the entrance window assembly 10.

[0067] Specifically, the radial dimension of the transition section 213 near its proximal end is equal to the radial dimension of the extension tube 210 near its proximal end; the radial dimension of the transition section 213 near its distal end is equal to the radial dimension of the extension tube 210 at its distal end.

[0068] Of course, in some embodiments, the overall radial dimension of the extension pipe section 210 can be gradually reduced along the direction from the second pipe section 212 to the first pipe section 211, that is, the overall structure of the extension pipe section 210 is similar to the structure of the transition section 213 described above. This arrangement can also avoid the step-like structure with abrupt change in outer diameter of the extension pipe section 210.

[0069] In one embodiment, the extension tube 210 may also be configured as a non-homogeneous structure. For example, the density of the material near the extension tube 210 may be greater than the density of the material at the distal end of the extension tube 210. This also allows the stiffness of the near end of the extension tube 210 to be greater than the stiffness of the distal end. That is, by adjusting the materials at the near and far ends of the extension tube 210, the stiffness of the near end of the extension tube 210 can be made greater than the stiffness of the distal end, allowing the distal end of the extension tube 210 to naturally bend due to its lower stiffness.

[0070] In one embodiment, the distal extension 200 of the blood pump includes a radiopaque material. The radiopaque material refers to a material that can be visualized under X-ray irradiation. Thus, by using X-rays, the location of the distal extension 200 within the human body can be determined, facilitating the positioning of the blood pump and ensuring its implantation in the desired location within the body.

[0071] Of course, in one embodiment, a contrast ring (not shown in the figure, the same below) can also be nested outside the distal extension 200 of the blood pump. The contrast ring can also determine the position of the distal extension 200 of the blood pump, and indirectly determine the position of the inlet window assembly 10 and the blood pump as a whole. In this embodiment, the contrast ring can be fitted onto the extension tube 210, and the outer surface of the contrast ring and the outer surface of the extension tube 210 are on the same curved surface. In this way, the probability of the contrast ring protruding from the extension tube 210 and scratching human tissue, or the probability of obstructing the movement of the inlet window assembly 10, is reduced. At the same time, it can also reduce the probability of the contrast ring being recessed in the extension tube 210 to form a groove-like structure, causing blood to accumulate and form a thrombus.

[0072] Please see Figure 7 In one embodiment, the inlet window assembly 10 further includes an inlet window 100. The inlet window 100 is connected to the end of the extension tube 210 opposite to the protective end 220. In other words, the inlet window 100 is located proximally, while the distal extension 200 of the blood pump is located distally. It is understood that the guidewire channel 210a within the extension tube 210, in conjunction with the guidewire, facilitates movement within the blood vessel. By positioning the distal extension 200 of the blood pump distal to the inlet window 100, the property of the distal extension 200's ease of movement within the blood vessel allows the inlet window 100 to also move conveniently within the blood vessel.

[0073] Please refer to it again. Figure 1 In one embodiment, the outer diameter of the protective end 220 is smaller than the outer diameter of the inlet window 100. This arrangement facilitates the movement of the distal extension 200 of the blood pump within the blood vessel.

[0074] Please see Figure 4 and Figure 7 In one embodiment, the inlet window 100 has an inlet 120a for blood to flow into, and the inlet 120a communicates with the guidewire channel 210a. This arrangement allows the guidewire to pass through the inlet 120a into the guidewire channel 210a, assisting the movement of the inlet window assembly 10 and the entire blood pump within the body. Furthermore, the blood can flow between the inlet 120a and the guidewire channel 210a without easily forming blood clots.

[0075] Combination Figure 8 The size of the inlet 120a gradually decreases from the outside to the inside of the inlet window 100, along the direction from the outer surface of the inlet window 100 to the axis of the inlet window 100. With this configuration, the inlet 120a can be roughly funnel-shaped, which facilitates the guidance of blood from the inlet 120a into the inlet tube 120.

[0076] Please see Figure 7 and combined Figure 4In one embodiment, the inlet window 100 includes a connector 110 and an inlet tube 120, with the connector 110 connecting the inlet tube 120 and the extension tube portion 210. An inlet port 120a is formed in the inlet tube 120, and the connector 110 has a docking channel 110a communicating with the inlet port 120a and the guidewire channel 210a. Thus, the guidewire can enter the guidewire channel 210a from the inlet port 120a through the docking channel 110a. Similarly, blood can form a flowing blood flow within the inlet port 120a, the docking channel 110a, and the guidewire channel 210a, making it less prone to clotting and forming a thrombus.

[0077] Please combine Figure 9 The inlet tube 120 does not extend beyond the outer peripheral surface of the connector 110. This allows the connector 110 to protect the inlet tube 120 when the blood pump is inserted into the ventricle, reducing the risk of impact between the connection point and external objects, and improving the stability of the connection. Furthermore, ensuring the inlet tube 120 does not extend beyond the outer peripheral surface of the connector 110 also prevents the connection point from scratching the ventricle wall.

[0078] Please see Figure 7 In one embodiment, the inlet pipe 120 includes a plurality of supports 121, with two adjacent supports 121 forming a liquid inlet 120a. Specifically, the inlet pipe 120 also includes a main body 122, with one end of each of the plurality of supports 121 connected to the distal end of the main body 122, and the other end of each of the plurality of supports 121 connected to a connector 110. Thus, two adjacent supports 121, the main body 122, and the connector 110 together form the liquid inlet 120a.

[0079] The connector 110 is provided with multiple connecting grooves 112a, and multiple supports 121 correspond to multiple connecting grooves 112a respectively. The end of each support 121 extends into the corresponding connecting groove 112a and is connected to the groove wall of the corresponding connecting groove 112a. The height difference H between the outer surface of the end of the support 121 and the outer peripheral surface of the connector 110 is between 0.05mm and 0.2mm. This ensures that the connecting groove 112a can protect the end of the support 121 while preventing blood from accumulating in the connecting groove 112a and forming a thrombus.

[0080] In one embodiment, the support column 121 and the groove wall of the connecting groove 112a can be connected by welding or bonding.

[0081] Of course, in some embodiments, the support column 121 can be integrally formed with the connector 110, that is, the inlet pipe 120 and the connector 110 are integrally formed.

[0082] In one embodiment, the inner edge of the inlet 120a, the outer edge of the inlet 120a, and the joint between the support 121 and the connector 110 can all be provided with rounded corners to avoid sharp edges and reduce damage to the blood.

[0083] In one embodiment, the main body 122 is located at the proximal end and is used to connect to the exit window assembly (not shown).

[0084] Please refer to it again. Figure 7 In one embodiment, the connector 110 includes a first connecting portion 111 and a second connecting portion 112 connected to each other. The first connecting portion 111 is located distally relative to the second connecting portion 112, and the second connecting portion 112 is located proximally relative to the first connecting portion 111. Along the direction from the extension tube 210 to the inlet tube 120, the radial dimension of the first connecting portion 111 gradually increases, meaning the first connecting portion 111 can be approximately tapered. It is understood that the radial dimension of the inlet tube 120 is larger than the radial dimension of the extension tube 210. The approximately tapered shape of the first connecting portion 111 allows for a smooth transition between the extension tube 210 and the inlet tube 120, preventing any radial dimension bulge between them and ensuring a smooth transition between the outer surfaces of the extension tube 210 and the inlet tube 120.

[0085] Please continue reading. Figure 7 In one embodiment, at least a portion of the second connecting portion 112 is located within the inlet pipe 120. The radial dimension of the second connecting portion 112 gradually decreases along the direction from the extension pipe portion 210 to the inlet pipe 120, meaning the second connecting portion 112 is approximately hemispherical. This arrangement facilitates the guidance of blood into the liquid outlet 120a. Figure 9 Specifically, the connecting groove 112a may be formed on the second connecting part 112.

[0086] Please continue reading. Figure 7 In one embodiment, the connector 110 further includes an interface portion 113, which is connected to the end of the first connecting portion 111 away from the second connecting portion 112, i.e., the interface portion 113 is connected to the distal end of the first connecting portion 111. The interface portion 113 extends into the extension tube portion 210 and connects to it. In other words, the extension tube portion 210 is fitted over the interface portion 113. This facilitates a smooth transition between the outer surface of the extension tube portion 210 and the outer surface of the first connecting portion 111.

[0087] In one embodiment, the interface portion 113 is detachably connected to the extension tube portion 210. This facilitates the removal of the distal extension 200 of the blood pump from the connector 110 for replacement. Specifically, the distal extension 200 of the blood pump and the connector 110 can be connected by threads. Of course, the distal extension 200 of the blood pump and the connector 110 can also be detachably connected in other ways.

[0088] In summary, the blood pump distal extension 200, inlet window assembly 10, and blood pump provided by the present invention have a guide wire channel 210a that extends through the extension tube portion 210 and the protective end portion 220, thereby enabling the formation of a first opening 222 communicating with the guide wire channel 210a on the protective end portion 220. Furthermore, the protective end portion 220 is also provided with a plurality of connecting holes 221 communicating with the guide wire channel 210a. Each connecting hole 221 has a second opening 2212 located on the outer surface of the protective end portion 220, and the second openings 2212 of the plurality of connecting holes 221 are spaced apart around the guide wire channel 210a. Therefore, when the distal extension 200 of the blood pump extends into the ventricle, and the first opening 222 and the second opening 2212 on one side of the outer surface of the protective end 220 are blocked by the inner wall of the ventricle, at least one second opening 2212 located on the other side of the outer surface of the protective end 220 is exposed in the ventricle, allowing blood to flow out through the guidewire channel 210a and the second opening 2212, reducing the formation of thrombi caused by blood remaining in the guidewire channel 210a. Compared to the conventional method where the distal extension of the blood pump only has one opening at the end and one on the side, the present invention provides multiple connecting holes 221 in the protective end 220 that communicate with the guidewire channel 210a, and the second openings 2212 of the multiple connecting holes 221 are spaced around the guidewire channel 210a. This allows blood to flow out from the guidewire channel 210a through the other second openings 2212 even when the first opening 222 at the end and one second opening 2212 on the side are blocked, thereby further reducing the formation of thrombi caused by blood remaining in the guidewire channel 210a.

[0089] 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.

[0090] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A distal extension of a blood pump, characterized in that, include: Extension tube section; and The protective end is connected to one end of the extension tube, and the end of the extension tube facing away from the protective end is used to connect to the inlet window of the blood pump. The distal extension of the blood pump is provided with a guidewire channel that penetrates the extension tube and the protective end, forming a first opening on the protective end that communicates with the guidewire channel. The protective end also has multiple connecting holes that communicate with the guidewire channel. Each connecting hole has a second opening located on the outer surface of the protective end, and the second openings of the multiple connecting holes are spaced apart around the guidewire channel. Each connecting hole also has a third opening located on the inner wall of the guidewire channel. Along the extension direction of the extension tube, the distance from the third opening to the first opening is L1, and the length of the protective end along the extension direction of the extension tube is L2, where L1 ≤ L2 / 2. The diameter of the second opening is larger than the diameter of the third opening; along the outer peripheral surface of the protective end to the central axis of the protective end, the diameter of the connecting hole gradually decreases, making the connecting hole funnel-shaped.

2. The distal extension of the blood pump according to claim 1, characterized in that, A plurality of second openings are arranged around the guide wire channel, and the spacing between any two adjacent second openings is equal.

3. The distal extension of the blood pump according to claim 1, characterized in that, The outer surface of the protective end is at least partially a smooth curved surface, and the connecting hole is exposed on the smooth curved surface.

4. The distal extension of the blood pump according to claim 1, characterized in that, The extension tube is a flexible structure, and the stiffness of the end of the extension tube connected to the protective end is less than the stiffness of the end of the extension tube away from the protective end.

5. The distal extension of the blood pump according to any one of claims 1-4, characterized in that, The extension tube includes a first tube segment and a second tube segment. The first tube segment is connected to the protective end, and the second tube segment is located on the side of the first tube segment opposite to the protective end. The wall thickness of the second pipe section is greater than that of the first pipe section; and / or, the extension pipe section further includes a transition section connected between the first pipe section and the second pipe section, wherein the radial dimension of the transition section gradually decreases along the direction from the second pipe section to the first pipe section.

6. The distal extension of the blood pump according to any one of claims 1-4, characterized in that, The protective end is spherical or ellipsoidal; and / or, the maximum outer diameter of the protective end is greater than the outer diameter of the extension tube.

7. An entrance window assembly, characterized in that, It includes an inlet window and a distal extension of the blood pump as described in any one of claims 1-6, wherein the inlet window is connected to one end of the extension tube opposite to the protective end.

8. The entrance window assembly according to claim 7, characterized in that, The inlet window has an inlet port for blood to flow in. The inlet port is connected to the guide wire channel. The inlet window includes a connector and an inlet tube. The connector is connected between the inlet tube and the extension tube. The inlet port is located in the inlet tube. The connector has a docking channel connecting the inlet port and the guide wire channel. The inlet tube does not extend beyond the outer circumferential surface of the connector.

9. The entrance window assembly according to claim 8, characterized in that, The inlet pipe includes multiple support columns, with two adjacent support columns forming one liquid inlet. The connector is provided with multiple connecting grooves, with each of the multiple support columns corresponding to a multiple connecting groove. The end of each support column extends into the corresponding connecting groove and connects to the groove wall of the corresponding connecting groove. The height difference between the outer surface of the end of the support column and the outer circumferential surface of the connector is between 0.05 mm and 0.2 mm. And / or, along the direction from the outer surface of the inlet window to the axis of the inlet window, the size of the liquid inlet gradually decreases.

10. A blood pump, characterized in that, Includes the entrance window assembly as described in any one of claims 7 to 9.

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