Blood pump system and intervention guide wire

Abstract

The utility model relates to a blood pump system and an intervention guide wire. The blood pump system comprises an intervention guide wire and a blood pump. Wherein the interventional guide wire is provided with a first developing mark and a second developing mark, and the first developing mark and the second developing mark are arranged in a spaced mode in the length direction of the interventional guide wire and can be located on the two sides of a valve respectively after the interventional guide wire is pushed to a target position; the blood pump comprises a cannula assembly, the cannula assembly is provided with a near-side opening, a far-side opening and an expected positioning part located between the far-side opening and the near-side opening, and the expected positioning part is provided with a positioning developing mark; the blood pump can be pushed into the body along the intervention guide wire, and the positioning developing mark can reach the position between the first developing mark and the second developing mark. The blood pump system can improve the accuracy of being clamped by the valve at an expected position.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a blood pump system and an interventional guide wire. Background Art

[0002] A blood pump is a ventricular assist device that is percutaneously inserted into a patient's body to assist the patient in pumping blood. After this blood pump is pushed to the target position in the patient's body, the blood pump is clamped and positioned by the aortic valve or the pulmonary valve. However, during the process of pushing the blood pump, it is difficult to visually determine whether the blood pump is accurately clamped at the expected position by the aortic valve or the pulmonary valve, and there is a risk that the blood pump will fall off the aortic valve or the pulmonary valve later. Summary of the Invention

[0003] Based on this, in view of the above technical problems, it is necessary to provide a blood pump system and an interventional guide wire, aiming to improve the accuracy of the blood pump being clamped at the expected position by the valve.

[0004] In some embodiments of the present application, the blood pump system includes an interventional guide wire and a blood pump; wherein, the interventional guide wire is provided with a first imaging mark and a second imaging mark, the first imaging mark and the second imaging mark are arranged at intervals along the length direction of the interventional guide wire, and can be respectively located on both sides of the valve after the interventional guide wire is pushed to the target position; the blood pump includes an intubation assembly, the intubation assembly is provided with a proximal opening, a distal opening and an expected positioning part located between the distal opening and the proximal opening, and the expected positioning part is provided with a positioning imaging mark; the blood pump can be pushed into the body along the interventional guide wire, and the positioning imaging mark can reach between the first imaging mark and the second imaging mark.

[0005] In one embodiment, the blood pump further includes a flexible support member disposed at the distal end of the intubation assembly, the distal end of the flexible support member has a first vertex with the maximum vertical distance to the positioning imaging mark, and the vertical distance between the first vertex and the proximal edge of the positioning imaging mark is a first distance H1;

[0006] The distal end of the interventional guide wire has a second vertex with the maximum vertical distance to the first imaging mark, and the vertical distance between the second vertex and the distal edge of the first imaging mark is a second distance H2;

[0007] The second imaging mark is farther from the second vertex than the first imaging mark, and the vertical distance between the proximal edge of the second imaging mark and the second vertex is a third distance H3;

[0008] Wherein, H3 > H1 > H2.

[0009] In one embodiment, the positioning and developing mark has a first axial length L1, the first developing mark has a second axial length L2, and the second developing mark has a third axial length L3; wherein, L1 > L2; and / or, L1 > L3.

[0010] In one embodiment, a fourth axial length L4 is provided between the first developing mark and the second developing mark, and the fourth axial length L4 is 15 mm to 30 mm; and / or, the interventional guide wire is further provided with a plurality of third developing marks, the third developing marks are farther from the distal end of the interventional guide wire than the first developing mark, and the second developing mark is located between the third developing mark and the first developing mark.

[0011] In one embodiment, the cannulation assembly includes a cannula, and the cannula is pre-shaped into a curved shape; the expected positioning portion is located at the curved portion of the cannula.

[0012] In one embodiment, the blood pump system further has at least one of the following features:

[0013] A first groove is provided on the outer peripheral surface of the interventional guide wire, the first developing mark is arranged in the first groove, and the outer peripheral surface of the first developing mark is flush with the outer peripheral surface of the interventional guide wire;

[0014] A second groove is provided on the outer peripheral surface of the interventional guide wire, the second developing mark is arranged in the second groove, and the outer peripheral surface of the second developing mark is flush with the outer peripheral surface of the interventional guide wire.

[0015] In one embodiment, the blood pump system further has at least one of the following features:

[0016] At least one of the positioning and developing mark, the first developing mark and the second developing mark is provided as an annular structure;

[0017] A hydrophilic coating is provided on the outer surface of at least one of the positioning and developing mark, the first developing mark and the second developing mark;

[0018] The positioning and developing mark is arranged on the outer peripheral surface of the cannulation assembly;

[0019] The first developing mark and the second developing mark are arranged on the outer peripheral surface of the interventional guide wire.

[0020] In one embodiment, the cannula assembly includes a cannula having a distal opening at its proximal end and a proximal opening at its distal end; alternatively, the cannula assembly includes a proximal tube, a distal tube, and a cannula connecting the proximal tube and the distal tube, the proximal tube having the distal opening, the distal tube having the proximal opening, and the expected positioning portion being located on the cannula.

[0021] In one embodiment, the blood pump is one of a left ventricular assist device and a right ventricular assist device; the blood pump includes an impeller and a drive motor, the impeller is rotatably disposed within the cannula assembly, the drive motor is connected to the proximal end of the cannula assembly, and the output shaft of the drive motor is fixedly connected to the impeller to be able to drive the impeller to rotate.

[0022] The present application also provides an interventional guidewire capable of guiding the blood pump into the body. The interventional guidewire is provided with a first imaging marker and a second imaging marker. The first imaging marker and the second imaging marker are arranged at intervals along the length direction of the interventional guidewire and can be respectively located on both sides of the valve after the interventional guidewire is pushed to the target position, so that the blood pump can push the positioning imaging marker on the blood pump to between the first imaging marker and the second imaging marker along the interventional guidewire.

[0023] For the above blood pump system and interventional guidewire, by providing the first imaging marker and the second imaging marker on the interventional guidewire, the first imaging marker and the second imaging marker are arranged at intervals along the length direction of the interventional guidewire, and after the interventional guidewire is pushed to the target position, the second imaging marker and the third imaging marker can be respectively located on both sides of the valve. Thus, the operator can determine that the valve is between the second imaging marker and the third imaging marker according to the positions of the second imaging marker and the third imaging marker shown by the imaging device. The blood pump system also sets a positioning imaging marker on the expected positioning portion of the cannula assembly of the blood pump. When the blood pump is pushed into the body along the interventional guidewire, when it is observed that the positioning imaging marker of the blood pump moves to between the first imaging marker and the second imaging marker, it indicates that the expected positioning portion is exactly located at the valve, so that the expected positioning portion can be accurately clamped and fixed by the valve, ensuring that the blood pump fully extends into the target position (pulmonary artery or left ventricle), enabling the distal end of the blood pump to contact and abut against the tissue in the target position, the blood pump is firmly positioned, and the risk of blood pump detachment and implantation difficulty are reduced. Description of the Drawings

[0024] Figure 1 It is a schematic structural diagram of the blood pump system provided by an embodiment of the present application during the process of pushing the blood pump using the interventional guidewire provided by an embodiment of the present application.

[0025] Figure 2 is Figure 1Schematic structural diagram of the blood pump of the provided blood pump system.

[0026] Figure 3 For Figure 1 Schematic structural diagram of the intervention guide wire of the provided blood pump system.

[0027] Figure 4 For Figure 1 Schematic structural diagram of the intervention guide wire of the provided blood pump system after being pushed in place.

[0028] Figure 5 For Figure 1 Schematic structural diagram of the blood pump of the provided blood pump system after being pushed in place.

[0029] Figure 6 For Figure 1 Schematic structural diagram of the intervention guide wire of the provided blood pump system without the first imaging marker, the second imaging marker and the third imaging marker.

[0030] Among them, the reference numerals in the drawings are explained as follows:

[0031] 10. Blood pump system; 100. Blood pump; 110. Cannula assembly; 111. Distal tube; 112. Proximal tube; 113. Cannula; 101. Distal opening; 102. Proximal opening; 103. Expected positioning part; 104. Positioning imaging marker; 120. Flexible support; 121. First vertex; 130. Catheter; 140. Driving motor; 200. Intervention guide wire; 210. First imaging marker; 220. Second imaging marker; 230. Third imaging marker; 201. First groove; 202. Second groove; 203. Third groove; 204. Second vertex; 300. Right atrium; 301. Inferior vena cava; 302. Superior vena cava; 303. Tricuspid valve; 304. Right ventricle; 305. Pulmonary artery; 306. Aorta; 307. Aortic valve; 308. Left ventricle; 309. Target support point. Detailed implementation manners

[0032] To make the above objects, features and advantages of the present application more obvious and understandable, the following detailed description of the specific implementation manners of the present application will be given with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0033] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the present application.

[0034] In addition, if there are terms such as "first" and "second", these terms are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if there is a term "plurality", the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0035] In the present application, unless otherwise clearly specified and limited, if there are terms such as "mounted", "connected", "connected to", "fixed", etc., these terms should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0036] In the present application, unless otherwise clearly specified and limited, if there is a description such as a first feature being "on" or "under" a second feature, the meaning may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0037] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may be an intermediate element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If present, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for illustrative purposes and do not represent the only implementation.

[0038] It should be noted that the "distal end" and "proximal end" throughout the text are only for indicating the relative position relationship. The "distal end" of a component refers to the end of the component that first enters the patient's body compared to the other end and / or the end farther from the operator during normal operation, while the "proximal end" refers to the end that enters the patient's body later compared to the other end and / or the end closer to the operator.

[0039] See Figure 4 and Figure 6 As shown in, the present application provides an interventional guide wire 200 capable of guiding the blood pump 100 into the body. The interventional guide wire 200 is provided with a first imaging marker 210 and a second imaging marker 220. The first imaging marker 210 and the second imaging marker 220 are arranged at intervals along the length direction of the interventional guide wire 200, and can be located on both sides of the valve respectively after the interventional guide wire 200 is pushed to the target position, so that the blood pump 100 can push the positioning imaging marker 104 on the blood pump 100 between the first imaging marker 210 and the second imaging marker 220 along the interventional guide wire 200.

[0040] See Figure 1 As shown in, an embodiment of the present application further provides a blood pump system 10. The blood pump system 10 includes a blood pump 100 and the interventional guide wire 200. The blood pump 100 can be threaded through the interventional guide wire 200 and enter the patient's body along the interventional guide wire 200. The blood pump 100 can be a left ventricular assist device or a right ventricular assist device.

[0041] See Figure 4 As shown in, when the blood pump 100 is a left ventricular assist device, first push the interventional guide wire 200 through the aorta 306 and cross the aortic valve 307 to enter the left ventricle 308; then thread the blood pump 100 onto the interventional guide wire 200 (see Figure 5 ), and push it along the interventional guide wire 200 into the left ventricle 308.

[0042] When the blood pump 100 is a right ventricular assist device, first insert the interventional guide wire 200 through the inferior vena cava 301 (or superior vena cava 302), right atrium 300, tricuspid valve 303, right ventricle 304, and cross the pulmonary valve into the pulmonary artery 305; then thread the blood pump 100 onto the interventional guide wire 200 and push it along the interventional guide wire 200 into the pulmonary artery 305.

[0043] Generally speaking, the diameter of the interventional guide wire 200 is very small. During the process of pushing the interventional guide wire 200, it is difficult to see whether the interventional guide wire 200 accurately reaches the target position, which is likely to affect the subsequent pushing of the blood pump.

[0044] See Figure 3 and Figure 4 In view of this, in some embodiments, the interventional guide wire 200 is provided with a first imaging marker 210. The first imaging marker 210 can be observed through an imaging device (such as X-ray), so that the position of the interventional guide wire 200 can be determined according to the position of the first imaging marker 210. For example, the first imaging marker 210 is arranged at the distal end or a position adjacent to the distal end of the interventional guide wire 200 to determine whether the distal end of the interventional guide wire 200 enters the left ventricle 308 or the pulmonary artery 305 through the first imaging marker 210.

[0045] Also see Figure 3 and Figure 4 In some embodiments, the interventional guide wire 200 is further provided with a second imaging marker 220, and the second imaging marker 220 and the first imaging marker 210 are arranged at intervals along the axial direction of the interventional guide wire 200. The second imaging marker 220 can also be observed through an imaging device (such as X-ray), so that the positions of different parts of the interventional guide wire 200 in the axial direction can be determined according to the relative positions of the second imaging marker 220 and the first imaging marker 210, or the tissues crossed by the part of the interventional guide wire 200 between the two imaging markers can be determined.

[0046] In this embodiment, the first imaging marker 210 and the second imaging marker 220 are arranged such that when the interventional guide wire 200 enters the body, the second imaging marker 220 and the third imaging marker 210 can be located on both sides of the valve respectively. Thus, the operator can determine that the valve is located between the second imaging marker 210 and the third imaging marker 220 according to the positions of the second imaging marker 210 and the third imaging marker 220 shown by the imaging device.

[0047] See Figure 1 and Figure 5, in some embodiments, the blood pump 100 includes an intubation assembly 110, which is provided with a distal opening 101, a proximal opening 102 and an expected positioning portion 103. Among them, one of the distal opening 101 and the proximal opening 102 is a blood inlet, and the other is a blood outlet; the expected positioning portion 10 refers to the portion of the intubation assembly 110 of the blood pump 10 that is expected to be clamped and fixed by a valve (aortic valve 307 or pulmonary valve) when the distal end of the blood pump 10 enters the target position and abuts against the target support point 309.

[0048] Generally speaking, when the blood pump 100 is a left ventricular assist device, after the blood pump 100 is pushed along the interventional guide wire 200 into the left ventricle 308, the distal opening 101 is located in the left ventricle 308, and the proximal opening 102 is located in the aorta 306, so that blood can enter from the distal opening 101 of the blood pump 10 and be discharged from the proximal opening 102 into the aorta 306; at this time, the expected positioning portion 103 of the intubation assembly 110 should be clamped and fixed by the aortic valve 307.

[0049] When the blood pump 100 is a right ventricular assist device 10, after the blood pump 100 is pushed along the interventional guide wire 200 into the pulmonary artery 305, the distal opening 101 is located in the pulmonary artery 305, and the proximal opening 102 is located in one of the inferior vena cava 301, the superior vena cava 302 or the right atrium 300, so that blood can enter from the proximal opening 102 of the blood pump 10 and be discharged from the distal opening 101 into the pulmonary artery 305; at this time, the expected positioning portion 103 of the intubation assembly 110 should be clamped and fixed by the pulmonary valve.

[0050] However, during the actual pushing process, it is usually not easy to directly observe the relative positions of the intubation assembly 110 of the blood pump 100 and the valve (aortic valve 307 or pulmonary valve), so it is possible to clamp the part between the expected positioning portion 103 of the intubation assembly 110 and the distal opening 101 to the valve by mistake, rather than accurately clamping it on the expected positioning portion 103. This makes the length of the part of the blood pump 100 extending into the target position (pulmonary artery 305 or left ventricle 308) shorter, and then leads to a greater risk of the blood pump 100 falling off from the valve, and the distal end of the blood pump 100 may not reach the tissue in the target position, making the positioning of the blood pump 100 unstable.

[0051] See Figures 1 to 3, In view of the above situation, in some embodiments, the intubation assembly 110 is provided with a positioning and imaging mark 104 at the expected positioning portion 103, and the positioning and imaging mark 104 can be observed through an imaging device (such as an X-ray). The first imaging mark 210 and the second imaging mark 220 of the interventional guide wire 200 are arranged such that after the interventional guide wire 200 enters the body, the second imaging mark 220 and the third imaging mark 210 can be located on both sides of the valve respectively, and after the blood pump 100 is pushed into place along the interventional guide wire 200, the positioning and imaging mark 104 can be located between the first imaging mark 210 and the second imaging mark 220.

[0052] To avoid repetition, the left ventricular assist device is mainly taken as an example for introduction in this article. When pushing the blood pump 100, as Figure 4 shown, first push the interventional guide wire 200 from the aorta 306 into the left ventricle 308 until it is seen from the imaging device that the first imaging mark 210 is located in the left ventricle 308 and the second imaging mark 220 is located in the aorta 306, indicating that the interventional guide wire 200 reaches the target position. At this time, it can be known that the aortic valve 307 is also correspondingly located between the first imaging mark 210 and the second imaging mark 220. Then, as Figure 5 shown, insert the proximal end of the interventional guide wire 200 located outside the body into the blood pump 100 from the distal end of the blood pump 100, and then pass through the proximal opening 102 of the blood pump 100, so that the blood pump 100 is threaded onto the interventional guide wire 200; then push the blood pump 100 along the interventional guide wire 200 into the left ventricle 308. When it is seen that the positioning and imaging mark 104 moves between the first imaging mark 210 and the second imaging mark 220, it indicates that the expected positioning portion 103 is exactly located at the aortic valve 307 and is clamped by the aortic valve 307.

[0053] It can be seen that in the blood pump system 10, by providing a first imaging marker 210 and a second imaging marker 220 on the interventional guide wire 200, the first imaging marker 210 and the second imaging marker 220 are arranged at intervals along the length direction of the interventional guide wire 200. After the interventional guide wire 200 is pushed to the target position, the second imaging marker 210 and the third imaging marker 220 can be respectively located on both sides of the valve. Thus, the operator can determine that the valve is located between the second imaging marker 210 and the third imaging marker 220 according to the positions of the second imaging marker 210 and the third imaging marker 220 shown by the imaging device. The blood pump system 10 also provides a positioning imaging marker 104 on the expected positioning part 103 of the cannula assembly 110 of the blood pump 100. When the blood pump 100 is pushed into the body along the interventional guide wire 200, when it is observed that the positioning imaging marker 104 of the blood pump 100 moves between the first imaging marker 210 and the second imaging marker 220, it indicates that the expected positioning part 103 is exactly located at the valve. Thus, the expected positioning part 103 can be accurately clamped and fixed by the valve, ensuring that the blood pump 100 fully extends into the target position (pulmonary artery 305 or left ventricle 308), so that the distal end of the blood pump 100 can contact and abut against the tissue in the target position, and the blood pump 100 is firmly positioned, reducing the risk of the blood pump 100 falling off and the implantation difficulty.

[0054] See Figure 2 and Figure 5 , in some embodiments, the blood pump 100 further includes a flexible support member 120 provided at the distal end of the cannula assembly 110. The flexible support member 120 is used to abut against an expected target support point 309 in the target position (left ventricle 308 or pulmonary artery 305). It should be noted that the target support point 309 does not specifically refer to Figure 4 and Figure 5 a listed position. The target support point 309 can be other positions that can be expected to support the flexible support member 120. After the interventional guide wire 200 reaches the target position, the proximal end of the interventional guide wire 200 located outside the body can be first inserted into the blood pump 100 through the flexible support member 120 of the blood pump 100, and then passed out through the proximal opening 102 of the proximal end of the cannula assembly 110 of the blood pump 100. Among them, the distal end of the flexible support member 120 can be set in any shape such as a pigtail shape, a circular shape, an oval shape, an arrow shape, etc.

[0055] See Figure 1 and Figure 2 , the distal end of the flexible support member 120 has a first vertex 121, and the first vertex 121 is farther from the cannula assembly 110 than any other part of the distal end of the flexible support member 120. The first vertex 121 of the flexible support member 120 abuts against the target support point 309. Denote the perpendicular distance between the first vertex 121 and the distal edge of the positioning imaging marker 104 as the first distance H1. As Figure 5As shown, the distance from the predetermined target support point 309 in the left ventricle 308 (or pulmonary artery 305) to the aortic valve 307 (or pulmonary valve) is denoted as the fourth distance H4. In this embodiment, the first distance H1 is approximately equal to the fourth distance H4.

[0056] During the process of pushing the blood pump 100, when the positioning imaging marker 104 moves between the first imaging marker 210 and the second imaging marker 220, it indicates that the expected positioning portion 103 with the positioning imaging marker 104 is exactly clamped by the aortic valve 307. Ensure that the flexible support 120 also just abuts against the target support point 309.

[0057] It should be noted that for flexible supports 120 of different shapes, the position of the first vertex 121 is different. For example, as Figure 2 shown, when the distal end of the flexible support 120 is set to a pigtail shape, its first vertex 121 is located on the far side of the pigtail curl. In other embodiments (not shown), when the distal end of the flexible support 120 is set to a spherical (or elliptical) shape, its first vertex 121 is the distal point of the sphere (or ellipse).

[0058] Refer to Figure 3 , in some embodiments, the distal end of the interventional guide wire 200 can be set to a pigtail shape. The distal end of the interventional guide wire 200 has a second vertex 204, and the second vertex 204 is farther from the first imaging marker 210 and the second imaging marker 220 than any other part of the distal end of the interventional guide wire 200. Before the blood pump 10 enters the target position, the second vertex 204 of the interventional guide wire 200 abuts against the target support point 309 first. The first imaging marker 210 is located on the far side of the second imaging marker 220. The vertical distance between the second vertex 204 and the near-side edge 211 of the first imaging marker 210 is denoted as the second distance H2, and the second distance H2 is set to be less than the fourth distance H4, that is, H2 < H4, so that after the second vertex 204 abuts against the target support point 309, the first imaging marker 210 is located within the target position (left ventricle 308 or pulmonary artery 305). Since H1 = H4, thus H2 < H1.

[0059] Furthermore, the vertical distance between the second vertex 204 and the far-side edge 221 of the second imaging marker 220 is denoted as the third distance H3. The third distance H3 is set to be greater than the first distance H1, and the first distance H1 is set to be greater than the second distance H2, that is, H3 > H1 > H2. With such a setting, when the blood pump 100 is pushed into place along the interventional guide wire 200, it can be ensured that the positioning imaging marker 104 is just located between the first imaging marker 210 and the second imaging marker 220.

[0060] Refer to Figure 2 and Figure 3, in some embodiments, the positioning and developing mark 104 has a first axial length L1, the first developing mark 210 has a second axial length L2, and the first axial length L1 is set to be greater than the second axial length L2, i.e., L1 > L2. The second developing mark 220 has a third axial length L3, and the first axial length L1 is set to be greater than the second axial length L3, i.e., L1 > L3. With such a setting, it is beneficial to distinguish the developing marks on the cannula assembly 110 and the interventional guide wire 200, and the expected positioning portion 103 of the cannula assembly 110 can be designed to be relatively long accordingly, which is convenient for being clamped by the aortic valve 307 or the pulmonary valve.

[0061] As Figure 3 shown, in some embodiments, there is a fourth axial length L4 between the first developing mark 210 and the second developing mark 220. It can be understood that the size of the fourth axial length L4 needs to be greater than or equal to the path length across the valve so that the first developing mark 210 and the second developing mark 220 can be located on both sides of the valve. However, the path lengths across the valve for different patients vary to some extent, so the fourth axial length L4 required for different patients may be different. Therefore, the fourth axial length L4 can be designed accordingly according to the actual situation.

[0062] Optionally, the fourth axial length L4 is 15 mm to 30 mm, i.e., 15 mm ≤ L4 ≤ 30 mm. With such a setting, it can be ensured that the part of the interventional guide wire 200 between the second developing mark 220 and the second developing mark 220 can cross the valve, so that after the interventional guide wire 200 reaches the target position, the first developing mark 210 and the second developing mark 220 can be located on both sides of the valve respectively.

[0063] When the interventional guide wire 200 is applied to intervene in the left ventricle 308, the first developing mark 210 and the second developing mark 220 are located on both sides of the aortic valve 307, so that the first developing mark 210 is located in the left ventricle 308 and the second developing mark 220 is located in the aorta 306. When the interventional guide wire 200 is applied to intervene in the right ventricle 304, the first developing mark 210 and the second developing mark 220 are located on both sides of the pulmonary valve, so that the first developing mark 210 is located in the pulmonary artery 305 and the second developing mark 220 is located in the right ventricle 304.

[0064] The value of the fourth axial length L4 can be, but is not limited to, 15 mm, 20 mm, 25 mm, 30 mm, etc.

[0065] Optionally, the outer peripheral surface of the positioning and developing mark 104 can be flush with the outer peripheral surface of the expected positioning part 103. This can avoid the formation of sharp edges between the positioning and developing mark 104 and the cannula assembly 110, prevent scratching of the inner wall of the blood vessel or the inner wall of the ventricle when the blood pump 100 is implanted, and also avoid the occurrence of hemolysis.

[0066] The positioning and developing mark 104 can be a metal coating or a vulcanized layer containing developing powder. The outer surface of the positioning and developing mark 104 can be provided with a hydrophilic coating, which can play a lubricating role, reduce the friction between the positioning and developing mark 104 and the inner wall of the blood vessel, and facilitate the pushing of the blood pump 100; moreover, it can also meet the requirements of biocompatibility and help improve the safety performance of the blood pump 100.

[0067] The positioning and developing mark 104 can be set as an annular structure. The positioning and developing mark 104 can be sprayed on the outer peripheral surface of the cannula assembly 110. In other embodiments, the cannula assembly 110 includes a cannula 113, and the tube wall of the cannula 113 includes a flexible inner layer, a flexible outer layer, and an elastic support layer located between the flexible inner layer and the flexible outer layer; therefore, the positioning and developing mark 104 can also be provided between the flexible inner layer and the flexible outer layer.

[0068] As Figure 6 shown, in some embodiments, a first groove 201 is provided on the outer peripheral surface of the interventional guide wire 200, and a first developing mark 210 is provided in the first groove 201. It should be noted that the first groove 201 is not necessarily provided, and the first developing mark 210 can also be directly provided on the outer surface of the interventional guide wire 200.

[0069] Among them, the outer peripheral surface of the first developing mark 210 can be flush with the outer peripheral surface of the interventional guide wire 200. This can avoid the formation of protrusions or sharp edges at the position where the first developing mark 210 is provided on the outer peripheral surface of the interventional guide wire 200, so that the overall diameter of the outer peripheral surface of the interventional guide wire 200 is smaller and smoother, prevent scratching of the blood pump 100 and scratching of the inner wall of the blood vessel and the inner wall of the ventricle, and also avoid the occurrence of hemolysis.

[0070] The first developing mark 210 can be set as an annular structure. The annular first developing mark 210 is convenient for the developing device to determine the position of the first developing mark 210. It can be understood that the first groove 201 is provided in a circle on the interventional guide wire 200 along the circumferential direction of the interventional guide wire 200. Of course, in some other embodiments, the first developing marks 210 can also be arranged at intervals along the circumferential direction of the interventional guide wire 200, and correspondingly, the first grooves 201 are also arranged in multiple along the circumferential direction of the interventional guide wire 200 and correspond to the first developing marks 210 one by one.

[0071] The first imaging marker 210 can be a metal coating or a sulfurized layer containing imaging powder. A hydrophilic coating can be provided on the outer surface of the first imaging marker 210. The hydrophilic coating can not only play a lubricating role, reducing the frictional force between the first imaging marker 210 and the inner wall of the blood vessel and between the first imaging marker 210 and the inner wall of the blood pump 100, facilitating the pushing of the interventional guide wire 200 and the blood pump 100; moreover, it can also meet the biocompatibility requirements, contributing to improving the safety performance of the interventional guide wire.

[0072] As Figure 6 shown, in some embodiments, a second groove 202 is provided on the outer peripheral surface of the interventional guide wire 200, and the second imaging marker 220 is disposed in the second groove 202. It should be noted that the second groove 202 is not necessarily provided, and the second imaging marker 220 can also be directly disposed on the outer surface of the interventional guide wire 200.

[0073] Wherein, the outer peripheral surface of the second imaging marker 220 can be flush with the outer peripheral surface of the interventional guide wire 200. This can avoid forming protrusions or edges at the position where the second imaging marker 220 is provided on the outer peripheral surface of the interventional guide wire 200, so that the overall diameter of the outer peripheral surface of the interventional guide wire 200 is small and smooth, avoiding scratching the blood pump 100 and scratching the inner wall of the blood vessel and the inner wall of the ventricle, and also avoiding the occurrence of hemolysis.

[0074] The second imaging marker 220 can be provided as an annular structure. The annular second imaging marker 220 is conducive to the imaging device to determine the position of the second imaging marker 220. It can be understood that the second groove 202 is provided in a circle on the interventional guide wire 200 along the circumferential direction of the interventional guide wire 200. Of course, in some other embodiments, the second imaging markers 220 can also be provided at intervals along the circumferential direction of the interventional guide wire 200, and correspondingly, the second grooves 202 are also provided in multiple along the circumferential direction of the interventional guide wire 200 and correspond to the second imaging markers 220 one by one.

[0075] The second imaging marker 220 can be a metal coating or a sulfurized layer containing imaging powder. A hydrophilic coating can be provided on the outer surface of the second imaging marker 220. The hydrophilic coating can play a lubricating role, reducing the frictional force between the second imaging marker 220 and the inner wall of the blood vessel and between the second imaging marker 220 and the inner wall of the blood pump 100, facilitating the pushing of the interventional guide wire 200 and the blood pump 100; moreover, it can also meet the biocompatibility requirements, contributing to improving the safety performance of the interventional guide wire.

[0076] When pushing the interventional guide wire 200, some parts of the interventional guide wire 200 need to be bent. In order to locate the bent part of the interventional guide wire 200, as Figure 3As shown, in some embodiments, the first development mark 210 is located distally of the second development mark 220; the intervention guide wire 200 is further provided with a plurality of third development marks 230, and the second development mark 220 is located between the third development marks 230 and the first development mark 210.

[0077] The third development marks 230 can also be observed by a development device (such as an X-ray), so that the position of the bent portion of the intervention guide wire 200 can be determined according to the position shown by the third development marks 230. For example, the bending condition of the intervention guide wire 200 when passing through the aorta 306, or the bending condition of the intervention guide wire 200 when passing from the inferior vena cava 301 (or inferior vena cava 302), through the right atrium 300, tricuspid valve 303, right ventricle 304 to the pulmonary valve.

[0078] Regarding the number of the third development marks 230 arranged axially on the intervention guide wire 200, it can be set accordingly according to requirements, such as 1, Figure 2 2 shown, or more.

[0079] As Figure 6 shown, in an embodiment, a third groove 203 is provided on the outer peripheral surface of the intervention guide wire 200, and the third development mark 230 is embedded in the third groove 203. It should be noted that the third groove 203 is not necessarily provided, and the third development mark 230 can also be directly provided on the outer surface of the intervention guide wire 200.

[0080] Wherein, the outer peripheral surface of the third development mark 230 can be flush with the outer peripheral surface of the intervention guide wire 200. In this way, it is possible to avoid forming protrusions or edges at the position where the third development mark 230 is provided on the outer peripheral surface of the intervention guide wire 200, which can avoid scratching the blood pump 100 and the inner wall of the blood vessel and the inner wall of the ventricle, and can also avoid the occurrence of hemolysis.

[0081] The third development mark 230 can be set as an annular structure. The annular third development mark 230 is conducive to the development device to determine the position of the third development mark 230. It can be understood that the third groove 203 is arranged in a circle on the intervention guide wire 200 along the circumferential direction of the intervention guide wire 200. Of course, in some other embodiments, a plurality of third development marks 230 can also be arranged at intervals along the circumferential direction of the intervention guide wire 200. Correspondingly, a plurality of third grooves 203 are also arranged along the circumferential direction of the intervention guide wire 200 and correspond to the third development marks 230 one by one.

[0082] The third developing mark 230 can be a metal coating or a sulfurized layer containing developing powder. A hydrophilic coating can be provided on the outer surface of the third developing mark 230, which can play a lubricating role, reduce the frictional force between the third developing mark 230 and the inner wall of the blood vessel and between the third developing mark 230 and the inner wall of the blood pump 100, and facilitate the pushing of the interventional guide wire 200 and the blood pump 100.

[0083] See Figure 2 , in some embodiments, the cannula assembly 110 includes a cannula 113, a proximal tube 112, and a distal tube 111; wherein, the proximal tube 112 is connected to the proximal end of the cannula 113, and the proximal tube 112 is provided with a proximal opening 102; the distal tube 111 is connected to the distal end of the cannula 113, and the distal tube 111 is provided with a distal opening 101, and the expected positioning portion 103 is located on the cannula 113. The cannula 113 is elastic and can deform conforming to the shape of the blood vessel. The proximal tube 112 and the distal tube 111 are rigid tubes, such as metal tubes. The proximal tube 112 and the distal tube 111 can respectively support both ends of the cannula 113.

[0084] Of course, in other embodiments, the proximal tube 112 and the distal tube 111 are not necessary, and both the proximal tube 112 and the distal tube 111 can be absent, that is, the cannula assembly 110 of the blood pump 100 includes the cannula 113, and a distal opening 101 is provided at the distal end of the cannula 113, and a proximal opening 102 is provided at the proximal end of the cannula 113. In addition, only one of the proximal tube 112 and the distal tube 111 can also be present.

[0085] See Figure 2 , optionally, the cannula 113 is preformed into a curved shape; the expected positioning portion 103 is located at the curved portion of the cannula 113, so that when the valve can be clamped at the expected positioning portion 103, it is clamped at the curved portion of the cannula 113, ensuring that the cannula 113 has sufficient length to extend into the target position.

[0086] See Figure 2 , in some embodiments, the blood pump 100 further includes an impeller, and the impeller (not shown in the drawings) is rotatably disposed within the cannula assembly. When the impeller rotates, it can drive blood to enter from one of the proximal opening 102 and the distal opening 101 and discharge from the other.

[0087] See Figure 2 , in some embodiments, the blood pump 100 further includes a drive motor 140, the drive motor 140 is fixedly connected to the proximal end of the cannula assembly 110, and the output shaft of the drive motor 140 is fixedly connected to the impeller, so that the drive motor 140 can drive the impeller to rotate. Of course, in other embodiments, the drive motor 140 can be arranged outside the body and connected to the impeller through a flexible shaft.

[0088] See Figure 2 , in some embodiments, the blood pump 100 further includes a catheter 130, and the catheter 130 is fixedly connected to the proximal end of the drive motor 140. The inner cavity of the catheter 600 can accommodate wires such as the flushing pipeline of the blood pump 10 and the wires of the sensor.

[0089] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0090] The above-described embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A blood pump system, characterized in that: The blood pump system comprises: An interventional guidewire, wherein the interventional guidewire is provided with a first development mark and a second development mark, wherein the first development mark and the second development mark are arranged to be spaced apart along the length direction of the interventional guidewire and can be located at both sides of the valve respectively after the interventional guidewire is pushed to the target position; and A blood pump, comprising a cannula assembly, wherein the cannula assembly is provided with a proximal opening, a distal opening and an expected positioning portion located between the distal opening and the proximal opening, wherein the expected positioning portion is provided with a positioning development mark; the blood pump can be pushed into the body along the interventional guide wire, and the positioning development mark can reach between the first development mark and the second development mark.

2. The blood pump system according to claim 1, characterized in that: The blood pump further comprises a flexible support member disposed at the distal end of the cannula assembly, wherein the distal end of the flexible support member has a first vertex having the largest vertical distance to the positioning imaging mark, and the vertical distance between the first vertex and the proximal edge of the positioning imaging mark is a first distance H1; The distal end of the interventional guide wire has a second vertex with the largest vertical distance to the first development mark, and the vertical distance between the second vertex and the distal edge of the first development mark is a second distance H2; The second development mark is farther away from the second vertex than the first development mark, and a vertical distance between a proximal edge of the second development mark and the second vertex is a third distance H3; Among them, H3>H1>H2.

3. The blood pump system according to claim 1, characterized in that: The positioning development mark has a first axial length L1, the first development mark has a second axial length L2, and the second development mark has a third axial length L3; wherein L1>L2; and / or L1>L3.

4. The blood pump system according to claim 1, characterized in that: The first development mark and the second development mark are separated by a fourth axial length L4, and the fourth axial length L4 is 15mm~30mm; and / or the interventional guide wire is also provided with a plurality of third development marks, and the third development mark is farther away from the distal end of the interventional guide wire than the first development mark, and the second development mark is located between the third development mark and the first development mark.

5. The blood pump system according to claim 1, characterized in that: The cannula assembly includes a cannula, which is pre-formed into a curved shape; the expected positioning portion is located at the curve of the cannula.

6. The blood pump system according to any one of claims 1 to 5, characterized in that: The blood pump system also has at least one of the following features: The outer circumference of the interventional guide wire is provided with a first groove, the first development mark is arranged in the first groove, and the outer circumference of the first development mark is flush with the outer circumference of the interventional guide wire; A second groove is provided on the outer circumference of the interventional guide wire, and the second development mark is arranged in the second groove. The outer circumference of the second development mark is flush with the outer circumference of the interventional guide wire.

7. The blood pump system according to any one of claims 1 to 5, characterized in that: The blood pump system also has at least one of the following features: At least one of the positioning development mark, the first development mark and the second development mark is configured as a ring structure; The outer surface of at least one of the positioning development mark, the first development mark and the second development mark is provided with a hydrophilic coating; The positioning development mark is arranged on the outer peripheral surface of the cannula assembly; The first development mark and the second development mark are arranged on the outer peripheral surface of the interventional guide wire.

8. The blood pump system according to any one of claims 1 to 5, characterized in that: The cannula assembly comprises a cannula, the proximal end of the cannula is provided with the distal opening, and the distal end of the cannula is provided with the proximal opening; Alternatively, the cannula assembly comprises a proximal tube, a distal tube and a cannula connecting the proximal tube and the distal tube, the proximal tube is provided with the distal opening, the distal tube is provided with the proximal opening, and the expected positioning portion is located on the cannula.

9. The blood pump system according to any one of claims 1 to 5, characterized in that: The blood pump is one of a left ventricular assist device and a right ventricular assist device; the blood pump includes an impeller and a drive motor, the impeller is rotatably disposed in the cannula assembly, the drive motor is connected to the proximal end of the cannula assembly, and the output shaft of the drive motor is fixedly connected to the impeller so as to drive the impeller to rotate.

10. An interventional guidewire capable of guiding a blood pump into the body, characterized in that: The interventional guidewire is provided with a first development mark and a second development mark, and the first development mark and the second development mark are arranged to be spaced apart along the length direction of the interventional guidewire, and can be located on both sides of the valve respectively after the interventional guidewire is pushed to the target position, so that the blood pump can push the positioning development mark on the blood pump along the interventional guidewire to between the first development mark and the second development mark.

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