Positioning balloon and blood pump system

Abstract

This application relates to a positioning balloon and a blood pump system. The positioning balloon includes a balloon, a positioning tube, and a guide tube. The balloon can be implanted into the right ventricle and has an inflation cavity, allowing it to inflate. The balloon bends in an arc shape when inflated. The guide tube is connected to the balloon and at least partially passes through the inflation cavity of the balloon, allowing for the insertion of a pre-embedded guidewire. The positioning tube is located within the inflation cavity of the balloon and bends with the balloon during inflation. The positioning tube has a proximal opening and a distal opening exposed on the outside of the balloon, allowing the flexible main body of the pump to be inserted into the positioning tube. The blood inlet of the pump is located outside the proximal opening, and the blood outlet is located outside the distal opening. The positioning balloon of this application can position the blood pump in the right ventricle, allowing the distal end of the blood pump to extend directly towards the pulmonary artery after passing through the positioning balloon, avoiding the blood pump from impacting the internal tissues of the right ventricle and reducing the difficulty of blood pump implantation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a positioning balloon and blood pump system. Background Technology

[0002] There is a blood pump on the market that assists the right ventricle in pumping blood to the pulmonary artery. The typical implantation route for this blood pump is through the inferior or superior vena cava, passing sequentially through the right atrium, tricuspid valve, right ventricle, and pulmonary valve to reach the pulmonary artery. However, the right ventricle has a narrow interior and complex internal tissues. During the process of the blood pump passing from the right atrium through the tricuspid valve into the right ventricle, the distal end of the pump is prone to bumping against the internal tissues of the right ventricle. The distal end of the pump is also obstructed by the internal tissues of the right ventricle, making it difficult to deflect towards the top of the heart and penetrate into the pulmonary artery, thus making implantation of the blood pump quite challenging. Summary of the Invention

[0003] Based on this, this application provides a positioning balloon designed to position the blood pump in the right ventricle, so that the distal end of the blood pump can extend toward the pulmonary artery after passing through the positioning balloon, thereby reducing the occurrence of the blood pump hitting the internal tissue of the right ventricle and thus reducing the difficulty of blood pump implantation.

[0004] In some embodiments, the positioning balloon is suitable for installing a blood pump, the blood pump including a pump body having a blood inlet, a blood outlet, and a flexible main body located between the blood inlet and the blood outlet; the positioning balloon includes a balloon, a positioning tube, and a guide tube. The balloon can be installed into the right ventricle, the balloon has an inflation cavity allowing the balloon to inflate, and the balloon is arc-shaped when inflated; the guide tube is connected to the balloon, the guide tube at least partially passing through the inflation cavity of the balloon, the guide tube allowing for the insertion of a pre-embedded guidewire; the positioning tube is disposed within the inflation cavity of the balloon, the positioning tube is capable of bending in the same direction as the balloon when it inflates, the positioning tube has a proximal opening and a distal opening exposed on the outside of the balloon, so that the flexible main body of the pump body can pass through the positioning tube, and the blood inlet of the pump body is located outside the proximal opening, and the blood outlet of the pump body is located outside the distal opening.

[0005] In some embodiments, the positioning balloon further includes an inflation tube disposed on the outside of the balloon and connected to the balloon; the guide tube includes a first tube segment and a second tube segment connected to the first tube segment; the first tube segment passes through the inflation cavity, the second tube segment passes through the inner cavity of the inflation tube, an inflation channel is formed between the outer wall surface of the second tube segment and the inner wall surface of the inflation tube, one end of the inflation channel communicates with the inflation cavity, and the other end of the inflation channel can communicate with an external inflation device.

[0006] In some embodiments, the filling tube includes a filling section and a guide section connected to the filling section; the filling section is sleeved around the outside of the second tube section to form the filling flow channel spaced apart from the outer wall surface of the second tube section; an annular stepped surface is provided on the inner peripheral wall of the filling section adjacent to the guide section; the inner peripheral edge of the annular stepped surface is sealed to the end of the second tube section away from the first tube section, so that the inner cavity of the guide section communicates with the inner cavity of the second tube section for the pre-embedded guide wire to pass through.

[0007] In some embodiments, the positioning tubes are all inserted into the inflation cavity of the balloon along the central axis of the balloon; the guide tube has a first tube segment located in the inflation cavity, the first tube segment extends in the same direction as the positioning tube, and the first tube segment is located outside the positioning tube, and the outer wall surface of the first tube segment is connected and fixed or spaced apart from the outer wall surface of the positioning tube.

[0008] In some embodiments, the balloon includes a proximal wall, a distal wall, and a circumferential wall located between the proximal wall and the distal wall, the circumferential wall having an inner arc and an outer arc; wherein, the inner arc is the shortest arc of the circumferential wall extending between the proximal wall and the distal wall, the inner arc including a first inner arc segment connecting the proximal wall; the outer arc is the longest arc of the circumferential wall extending between the proximal wall and the distal wall, the outer arc including a first outer arc segment connecting the proximal wall, the curvature of the first outer arc segment being greater than the curvature of the first inner arc segment.

[0009] In some embodiments, the inner arc line further includes a second inner arc segment, the second inner arc segment connecting the first inner arc segment and the distal wall, the arc length of the second inner arc segment being less than the arc length of the first inner arc segment, and the curvature of the second inner arc segment being greater than the curvature of the first inner arc segment.

[0010] And / or, the outer arc further includes a second outer arc segment, the second outer arc segment connecting the first outer arc segment and the distal wall, the arc length of the second outer arc segment being less than the arc length of the first outer arc segment, and the curvature of the second outer arc segment being greater than the curvature of the first outer arc segment.

[0011] In some embodiments, the inner arc line further includes a second inner arc segment, the second inner arc segment connecting the first inner arc segment and the distal end wall; the outer arc line further includes a second outer arc segment, the second outer arc segment connecting the first outer arc segment and the distal end wall, and the curvature of the second inner arc segment is greater than the curvature of the second outer arc segment.

[0012] In one embodiment, the balloon includes a proximal wall, a distal wall, and a circumferential wall located between the proximal wall and the distal wall; one end of the positioning tube is connected to the proximal wall and has the proximal opening on the proximal wall; the other end of the positioning tube is connected to the distal wall and has the distal opening on the distal wall.

[0013] In some embodiments, the balloon, when inflated, has a first curvature that allows the shape of the balloon to conform to the anatomical shape of the blood pathway from the right atrium to the pulmonary artery, such that when the balloon is fitted into the blood pathway, the proximal end of the balloon is located in the right atrium, while the distal end of the balloon is located in the right ventricle or the pulmonary artery.

[0014] In some embodiments, the guide tube includes a first segment located within the balloon, wherein the first segment is capable of bending in the same direction as the balloon when it is inflated.

[0015] In some embodiments, the circumferential wall of the balloon includes an inner wall and an outer wall opposite to the inner wall, wherein the curvature of the inner wall is greater than the curvature of the outer wall when the balloon is inflated; wherein a shaping rib is provided on the inner surface of the inner wall, the shaping rib extending along the central axis of the balloon; and / or, the inner wall has a first thickness, the outer wall has a second thickness, and the first thickness is greater than the second thickness.

[0016] In some embodiments, the balloon has a first hardness, and the positioning tube has a second hardness, wherein the second hardness is less than the first hardness.

[0017] This application also provides a blood pump system, which includes a positioning balloon and a blood pump; the positioning balloon is a positioning balloon of any of the above examples. The blood pump includes a pump body having a blood inlet, a blood outlet, and a flexible main body located between the blood inlet and the blood outlet. The flexible main body of the pump body can be inserted into the positioning tube. The blood inlet of the pump body is located outside the proximal opening of the positioning tube, and the blood outlet of the pump body is located outside the distal opening of the positioning tube. When the balloon inflates, the flexible main body can bend together with the positioning tube along with the balloon.

[0018] In some embodiments, the portion of the positioning tube of the positioning balloon located between its proximal opening and distal opening has a first length, and the flexible body portion has a second length, the second length being greater than the first length of the positioning tube.

[0019] In some embodiments, the pump body is provided with a first imaging mark and a second imaging mark, both of which are located between the blood inlet and the blood outlet, with the first imaging mark adjacent to the blood inlet and the second imaging mark adjacent to the blood outlet; or, the pump body is provided with a first imaging mark, located between the blood inlet and the blood outlet and adjacent to the blood inlet, and the positioning tube is provided with a second imaging mark, located at or adjacent to the proximal opening; or, the pump body is provided with a first imaging mark, located between the blood inlet and the blood outlet and adjacent to the blood outlet, and the positioning tube is provided with a second imaging mark, located at or adjacent to the distal opening.

[0020] In some embodiments, the pump body includes an inlet pipe, an outlet pipe, and an elastic sleeve connecting the inlet pipe and the outlet pipe; wherein the inlet pipe has the blood inlet; the outlet pipe has the blood outlet; and the elastic sleeve forms the flexible main body.

[0021] The positioning balloon of this application can be implanted into the right ventricle of a patient for installation of a blood pump body. The balloon has an inflation chamber and is capable of inflating, and in the inflated state, the balloon is curved in an arc shape. The balloon is connected to a guide tube, which at least partially passes through the inflation chamber of the balloon. The guide tube allows a pre-embedded guidewire to pass through, so that the balloon can be fitted onto the pre-embedded guidewire, thereby allowing the balloon to be implanted into the human body along the pre-embedded guidewire. The inflation chamber of the balloon also contains a positioning tube with a proximal opening and a distal opening, through which the flexible body of the blood pump body passes. The blood inlet of the pump body is located outside the proximal opening of the positioning tube, and the blood outlet of the pump body is located outside the distal opening of the positioning tube, thereby ensuring that blood can enter the pump body from the blood inlet and exit from the blood outlet. Furthermore, the positioning tube bends with the balloon during inflation. When the flexible main body of the pump is inserted through the positioning tube, it bends into an arc shape along with the balloon, resulting in the pump being bent at the same angle as the balloon. Thus, when the pre-embedded guidewire adjusts the balloon's bending direction so that the distal end of the balloon faces the pulmonary valve at the top of the heart relative to the tricuspid valve, the distal end of the pump body also faces the pulmonary valve, rather than the right lateral wall of the right ventricle. As the pump continues to move, the distal end of the pump body extends from its distal opening towards the pulmonary valve and into the pulmonary artery, thus preventing the pump from impacting the right lateral wall of the right ventricle.

[0022] Understandably, because the positioning tube is placed within the balloon's inflation chamber, when the balloon inflates, the fluid within the inflation chamber separates the positioning tube from the internal tissues of the right ventricle, such as the chordae tendineae and papillary muscles. In other words, the positioning tube is enveloped by the fluid in the balloon's inflation chamber. Thus, if the pump body impacts the side wall of the positioning tube during its passage through the tube, the pushing force exerted by the pump on the tube will first be transmitted to the fluid in the inflation chamber. This fluid can buffer the pushing force, thereby reducing or preventing it from being directly transmitted to the chordae tendineae and papillary muscles within the right ventricle, thus avoiding damage to these tissues. In summary, using a positioning balloon to position the blood pump in the right ventricle can prevent the blood pump from impacting the chordae tendineae, papillary muscles, or right lateral wall of the right ventricle, and allows the distal end of the blood pump to extend towards the pulmonary valve, effectively reducing the difficulty of blood pump implantation. Attached Figure Description

[0023] Figure 1 A schematic diagram of a traditional blood pump implanted in the right ventricle of the heart.

[0024] Figure 2 This is a schematic diagram of the blood pump system of this application implanted in the right ventricle of the heart.

[0025] Figure 3 for Figure 2 Enlarged view of point A in the middle.

[0026] Figure 4 This is a schematic diagram of the assembly of the positioning device and the blood pump in one embodiment of the blood pump system of this application.

[0027] Figure 5 for Figure 4 A schematic diagram of the internal structure of the blood pump system.

[0028] Figure 6 for Figure 5 Enlarged view of a portion of the structure near the proximal end of the balloon, which is the mid-positioning device.

[0029] Figure 7 for Figure 5 Enlarged view of a portion of the structure near the distal end of the balloon of the positioning device.

[0030] Figure 8 for Figure 5 An enlarged view of the external structure of the positioning device.

[0031] Figure 9 This is a schematic diagram of another embodiment of the blood pump system of this application.

[0032] Figure 10 This is a schematic diagram of another embodiment of the blood pump system of this application.

[0033] Figure 11This is a schematic diagram of another embodiment of the blood pump system of this application.

[0034] Figure 12 This is a schematic diagram of another embodiment of the blood pump system of this application.

[0035] Figure 13 A schematic diagram of a pre-implanted guidewire in the human body.

[0036] Figure 14 A schematic diagram showing the placement of the positioning balloon onto the pre-embedded guide wire.

[0037] Figure 15 A schematic diagram of the placement of the positioning balloon into the right ventricle.

[0038] Figure 16 This is a schematic diagram showing the balloon inflating inside the right ventricle.

[0039] Figure 17 This is a schematic diagram showing the sequential implantation of the interventional guidewire and blood pump into the human body.

[0040] Figure 18 This is a schematic diagram of another embodiment of the blood pump system of this application.

[0041] Reference numerals: 100, balloon; 110, proximal wall; 120, distal wall; 130, circumferential wall; 131, medial wall; 132, lateral wall; 140, inner arc; 141, first inner arc segment; 142, second inner arc segment; 150, outer arc; 151, first outer arc segment; 152, second outer arc segment; 160, shaping rib; 101, filling cavity; 102, central axis; 200. 210. Filling tubing; 220. Guide section; 201. Filling flow channel; 202. Filling interface; 203. Annular stepped surface; 204. Second guide port; 300. Positioning tubing; 301. Proximal opening; 302. Distal opening; 400. Guide tubing; 410. First tubing segment; 420. Second tubing segment; 401. First guide port; 500. Blood pump; 510. Pump body; 511. 512. Proximal end; 513. Flexible main body; 520. Catheter; 501. Blood inlet; 502. Blood outlet; 503. First contrast marker; 504. Second contrast marker; 600. Pre-embedded guidewire; 700. Interventional guidewire; 10. Inferior vena cava; 11. Superior vena cava; 12. Right atrium; 13. Tricuspid valve; 14. Right ventricle; 14a. Chordus tendineae; 14b. Papillary muscle; 14c. Right lateral wall; 14d. Left inferior lateral wall; 15. Pulmonary valve; 16. Pulmonary artery; 17. Pulmonary vein; 18. Left atrium; 19. Left ventricle; 20. Aorta; 30. Positioning balloon; F. Blood; D1. First inner diameter; D2. Second inner diameter; D3. First outer diameter; D4. Third inner diameter; H1. First thickness; H2. Second thickness; L1. Connecting segment; L2. Bisector. Detailed Implementation

[0042] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0043] In the description of this application, if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing this application and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0044] Furthermore, where the terms "first" and "second" appear, these terms are 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 with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0045] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," 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 expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0046] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact through an intermediate medium. Furthermore, "above," "on top of," and "over" 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. Similarly, "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.

[0047] It should be noted that if 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 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 present. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0048] In this paper, the end of the medical device that is closer to the operator is defined as the proximal end, and the end that is farther from the operator is defined as the distal end.

[0049] Please see Figure 1 The human body's blood circulation includes systemic circulation and pulmonary circulation. Systemic circulation begins with blood being ejected from the left ventricle (19) through the aortic valve into the aorta (20). From there, it flows through the aorta to the capillaries throughout the body for substance exchange, transforming arterial blood into venous blood. This venous blood then returns to the right atrium (12) via the superior vena cava (11) and inferior vena cava (10). Next, blood from the right atrium (12) enters the right ventricle (14) through the tricuspid valve (13), and is then ejected from the right ventricle (14) through the pulmonary valve (15) into the pulmonary artery (16). From the pulmonary artery (16), it flows to the pulmonary capillaries for gas exchange, transforming venous blood into arterial blood. Finally, this arterial blood returns to the left atrium (18) through the pulmonary veins (17). Blood from the left atrium (18) then enters the left ventricle (19) through the mitral valve. This pulmonary circulation completes the process.

[0050] The blood pump 500 assists the heart in pumping blood to the pulmonary artery 16. The blood pump 500 generally includes a pump body 510 and a catheter 520 connected to the pump body 510. The pump body 510 has a blood inlet 501, a blood outlet 502, and a flexible main body 513 located between the blood inlet 501 and the blood outlet 502. The interior of the pump body 510 has a blood flow channel connecting the blood inlet 501 and the blood outlet 502. The blood pump 500 is implanted into the right ventricle 14 of the heart via the inferior vena cava 10 or superior vena cava 11, passing sequentially through the right atrium 12, tricuspid valve 13, right ventricle 14, and pulmonary valve 15 to reach the pulmonary artery 16. This ensures that the blood outlet 502 of the blood pump 500 is located within the pulmonary artery 16, while the blood inlet 501 of the blood pump 500 is located in any one of the inferior vena cava 10, superior vena cava 11, or right atrium 12. When the blood pump 500 is working, the blood pump 500 draws blood F from the blood inlet 501 into the pump body 510, drives the blood F through the blood flow channel inside the pump body 510, and finally discharges it from the blood outlet 502 into the pulmonary artery 16.

[0051] However, the internal space of the right ventricle 14 is narrow, and there are more chordae tendineae 14a and papillary muscles 14b growing on the inner wall of the tricuspid valve 13 adjacent to the right ventricle 14. The chordae tendineae 14a and papillary muscles 14b of the right ventricle 14 are much more complex than those of the left ventricle 19. Furthermore, the pump body 510 of the blood pump 500 is relatively long, making it difficult to deflect towards the pulmonary valve 15 at the top of the heart within the narrow right ventricle 14, thus hindering its entry into the pulmonary artery 16. Moreover, the pump body 510 typically includes an elastic sleeve, which is usually used to form the flexible body portion 513 of the pump body 510. This elastic sleeve has an elastic metal support, which allows the flexible body portion 513 of the pump body 510 to have good flexibility while still retaining a certain degree of rigidity. Therefore, during the process of the blood pump 500 entering the right ventricle 14 from the right atrium 12 via the tricuspid valve 13, the distal end 512 of the pump body 510 is very likely to bump into the chordae tendineae 14a and papillary muscles 14b of the right ventricle 14, which can easily damage the chordae tendineae 14a and papillary muscles 14b. The distal end 512 of the pump body 510 is blocked by the chordae tendineae 14a or papillary muscles 14b, making it difficult to deflect towards the top of the heart and enter the pulmonary artery 16. As a result, it is easy to bump into the right side wall 14c of the right ventricle 14, which makes the implantation of the blood pump 500 more difficult.

[0052] Please see Figure 2 and Figure 3In view of the above, this application provides a positioning balloon 30 for fixing the pump body 510 of a blood pump 500 to the right ventricle 14. The positioning balloon 30 can be installed in the right ventricle 14 for the blood pump 500 to be installed, making it less likely that the blood pump 500 installed on the positioning balloon 30 will collide with the chordae tendineae 14a or papillary muscles 14b of the right ventricle 14. Furthermore, the positioning balloon 30 can also constrain the blood pump 500 to extend towards the pulmonary valve 15 at a curved angle to prevent the distal end 512 of the blood pump 500 from collide with the right lateral wall 14c of the right ventricle 14. The structure of the positioning balloon 30 will be described below.

[0053] Please see Figures 3 to 5 In one embodiment of this application, the positioning balloon 30 includes a balloon 100, a positioning tube 300, and a guide tube 400. The balloon 100 can be installed into the right ventricle 14, and has an inflation chamber 101, allowing the balloon 100 to inflate and bend in an arc shape when inflated. The guide tube 400 is connected to the balloon 100, and at least partially passes through the inflation chamber 101 of the balloon 100. The guide tube 400 allows for the insertion of a pre-embedded guidewire 600. The positioning tube 300 is located in the inflation cavity 101 of the balloon 100. The positioning tube 300 can bend in the same direction as the balloon 100 when it inflates. The positioning tube 300 has a proximal opening 301 and a distal opening 302 exposed on the outside of the balloon 100, so that the flexible main body 513 of the pump body 510 can be inserted into the positioning tube 300. The blood inlet 501 of the pump body 510 is located outside the proximal opening 301 of the positioning tube 300, and the blood outlet 502 of the pump body 510 is located outside the distal opening 302 of the positioning tube 300.

[0054] Specifically, the inflation cavity 101 of the balloon 100 is connected to an extracorporeal inflator (not shown in the figure) to inject fluid into the inflation cavity 101 of the balloon 100, thereby allowing the balloon 100 to inflate. The fluid can be a liquid or a gas, and the liquid can be, but is not limited to, saline solution, contrast agents, etc. Initially, no fluid is injected into the inflation cavity 101 of the balloon 100, and the balloon 100 is in a hollow or deflated state, with a small and flexible volume. In the deflated state, the balloon 100 can be cylindrical, arc-shaped, or similar. After fluid is injected into the inflation cavity 101 of the balloon 100, the balloon 100 expands and inflates, causing it to bend in an arc shape, thus having a bending angle. It is understood that the arc shape can be a partial shape of a circle or an ellipse.

[0055] The positioning tube 300 is positioned within the inflation chamber 101 of the balloon 100, meaning it is surrounded by the inflation chamber 101. When fluid is injected into the inflation chamber 101 of the balloon 100, the positioning tube 300 is enveloped by the fluid within the chamber. This fluid buffers the pushing force exerted on the positioning tube 300 by the blood pump 500 as it passes through, preventing this force from being directly transmitted to the internal tissues of the right ventricle 14. The positioning tube 300 extends along the central axis 102 of the balloon 100 and may be collinear with or not collinear with the central axis 102. The positioning tube 300 is flexible, allowing it to bend in the same direction as the balloon 100 as it expands. Thus, when the flexible main body 513 of the blood pump 500, which passes through the positioning tube 300, is positioned by the positioning tube 300 to bend into an arc shape along with the balloon 100, thereby obtaining the same bending angle as the balloon 100. It can be understood that the positioning tube 300 can be a positioning channel within the balloon 100, or it can be an independent tube connected to the balloon 100. In other words, the positioning tube 300 can be integrally formed with the balloon 100, or it can be formed separately and then connected together. Similarly, the guide tube 400 can also be integrally formed with the balloon 100, or it can be formed separately and then connected together.

[0056] To facilitate understanding, the procedure for implanting the blood pump 500 and the positioning balloon 30 into the human body will be described in detail below, taking into account the structure of the blood pump 500. Specifically, the blood pump 500's pump body 510 has a proximal end 511 and a distal end 512, with a blood inlet 501 on the proximal end 511 and a blood outlet 502 on the distal end 512. The procedure for implanting the blood pump 500 into the human body using the positioning balloon 30 can be performed as follows:

[0057] Please see Figure 13 The first step involves pushing the pre-embedded guidewire 600 along the interventional path of the blood pump 500 to the pulmonary artery 16, so that the distal end 620 of the pre-embedded guidewire 600 reaches the pulmonary artery 16, while the proximal end 610 of the pre-embedded guidewire 600 remains outside the body. The interventional path can be from the inferior vena cava 10, sequentially through the right atrium 12, tricuspid valve 13, right ventricle 14, pulmonary valve 15, and pulmonary artery 16. Alternatively, the interventional path can also be from the superior vena cava 11, sequentially through the right atrium 12, tricuspid valve 13, right ventricle 14, pulmonary valve 15, and pulmonary artery 16.

[0058] Please see Figure 14 and Figure 15The second step involves passing the proximal end 610 of the pre-embedded guidewire 600 through the guide tube 400 of the balloon 100, so that the balloon 100 is fitted over the pre-embedded guidewire 600. The balloon 100 is then pushed along the pre-embedded guidewire 600 into the blood vessel until it reaches the right ventricle 14. In this step, because the balloon 100 is in a contracted state, its small diameter and flexibility, along with its short length, allow it to pass through narrow gaps in the chordae tendineae 14a or papillary muscles 14b of the right ventricle 14, minimizing the risk of injury. It is understood that after the balloon 100 is installed in the right ventricle 14, its proximal end is located in the right atrium 12, and its distal end can be located in the right ventricle 14 or the pulmonary artery 16. Figure 2 and Figure 3 and Figures 15 to 17 In the illustrated embodiment, the proximal end of balloon 100 is located in the right atrium 12, and the distal end of balloon 100 is located in the right ventricle 14. In these illustrated embodiments, the position of balloon 100 is adjusted by a pre-embedded guidewire 600, causing the distal end of balloon 100 to deflect relative to the tricuspid valve 13 towards the top of the heart and towards the pulmonary valve 15. In this case, the proximal end of balloon 100 can be clamped and fixed by the tricuspid valve 13, and the portion of balloon 100 located within the right ventricle 14 can abut against the lower left lateral wall 14d of the right ventricle 14 for support. Figure 18 In the illustrated embodiment, the proximal end of the balloon 100 is located in the right atrium 12, and the distal end of the balloon 100 passes through the right ventricle 14 and the pulmonary valve 15 in sequence and extends into the pulmonary artery 16. In this case, the proximal end of the balloon 100 is clamped and fixed by the tricuspid valve 13, and the distal end of the balloon 100 is clamped and fixed by the pulmonary valve 15.

[0059] Please see Figure 16The third step involves injecting fluid into the inflation chamber 101 of the balloon 100 using an external inflation device, causing the balloon 100 to gradually inflate. The inflated balloon 100 then bends in an arc shape, thus possessing a bending angle. Understandably, after the balloon 100 inflates, the fluid in the inflation chamber 101 separates the positioning tube 300 from the chordae tendineae 14a, papillary muscles 14b, and other tissues within the right ventricle 14. In other words, the positioning tube 300 is enveloped by the fluid in the inflation chamber 101 of the balloon 100. Compared to the flexible main body 513 of the pump body 510 of the blood pump 500, the fluid inside the balloon 100 better buffers the interaction forces between the balloon 100 and the internal tissues of the right ventricle 14, thus reducing the risk of compression and damage to the internal tissues of the right ventricle 14. Thus, when the pump body 510 of the blood pump 500 passes through the positioning tube 300, the pushing force applied by the pump body 510 to the positioning tube 300 will first be transmitted to the fluid in the filling cavity 101 around the positioning tube 300. The fluid can buffer the pushing force, thereby reducing or preventing the pushing force from being directly transmitted to the chordae tendineae 14a and papillary muscles 14b in the right ventricle 14, and preventing damage to the chordae tendineae 14a and papillary muscles 14b.

[0060] Please see Figure 17 In the fourth step, the interventional guidewire 700 is pushed along the interventional path of the blood pump 500 to the right atrium 12. When it encounters the balloon 100 of the positioning balloon 30, the distal end 720 of the interventional guidewire 700 enters the positioning tube 300 from the proximal opening 301 of the balloon 100 and exits from the distal opening 302 of the positioning tube 300, and finally extends into the pulmonary artery 16. The proximal end 710 of the interventional guidewire 700 is located outside the body.

[0061] Please also see Figure 17 Fifth step: Insert the pump body 510 of the blood pump 500 onto the interventional guidewire 700, and push the blood pump 500 along the interventional guidewire 700 into the blood vessel. When the blood pump 500 encounters the balloon 100, continue to push the blood pump 500 along the interventional guidewire 700 from the proximal opening 301 of the positioning tube 300 inside the balloon 100 into the positioning tube 300, until the distal end 512 of the blood pump 500 exits from the distal opening 302 of the positioning tube 300 and reaches the pulmonary artery 16, so that the blood outlet 502 on the distal end 512 is located in the pulmonary artery 16 (see...). Figure 2 and Figure 3The proximal end 511 of the blood pump 500 is located outside the proximal opening 301 of the positioning tube 300 (i.e., the proximal end 511 does not enter the positioning tube 300), ensuring that the blood inlet 501 on the proximal end 511 is exposed on the outside of the positioning balloon 30, so that blood from any of the inferior vena cava 10, superior vena cava 11, or right atrium 12 can enter the pump body 510 through the blood inlet 501. It is understood that the length of the pump body 510 can be reasonably configured as needed, so that the blood inlet 501 of the blood pump 500 exposed on the outside of the positioning balloon 30 can be positioned in any of the inferior vena cava 10, superior vena cava 11, or right atrium 12. When the blood pump 500 is working, blood F enters the blood flow channel of the pump body 510 from the blood inlet 501 of the blood pump 500, is accelerated in the blood flow channel of the pump body 510, and is finally discharged from the blood outlet 502 of the pump body 510 into the pulmonary artery 16, thereby assisting the right ventricle 14 in pumping blood.

[0062] In the fifth step described above, the proximal end 710 of the interventional guidewire 700 is inserted from the distal end 512 of the pump body 510 into the blood flow channel of the pump body 510, and then extends outward from the blood inlet 501 of the pump body 510, thereby allowing the pump body 510 to be inserted onto the interventional guidewire 700. Because the fluid in the inflation chamber 101 of the balloon 100 separates the chordae tendineae 14a and papillary muscles 14b in the positioning tube 300 and the right ventricle 14, if the flexible body 513 of the blood pump 500 bumps against the side wall of the positioning tube 300 during the process of pushing the blood pump 500 into the positioning tube 300, the pushing force exerted by the flexible body 513 on the side wall of the positioning tube 300 will be buffered by the fluid in the inflation chamber 101 around the positioning tube 300. Thus, the pushing force will not be directly applied to the chordae tendineae 14a or papillary muscles 14b outside the balloon 100, thereby avoiding impact damage to the chordae tendineae 14a and papillary muscles 14b. After the distal end 512 of the pump body 510 passes through the distal opening 302 of the positioning tube 300, the pump body 510 and the positioning tube 30 bend in the same direction as the balloon 100, so that the pump body 510 also has a bending angle of approximately the same as the balloon 100, so that the distal end 512 of the pump body 510 extends toward the pulmonary artery 16, rather than toward the right side wall 14c of the right ventricle 14; thereafter, when the blood pump 500 is continued to be pushed, the distal end 512 of the pump body 510 will pass directly through the pulmonary valve 15 and smoothly enter the pulmonary artery 16, thereby avoiding the blood pump 500 from hitting the right side wall 14c of the right ventricle 14 and reducing the difficulty of implanting the blood pump 500.

[0063] The above-described procedure for implanting the blood pump 500 into the human body via the positioning balloon 30 is merely an exemplary embodiment. In other embodiments, the second and fourth steps described above can be combined into one step. For example, the interventional guidewire 700 is passed through the positioning tube 300 of the balloon 100, so that the balloon 100 is fitted onto the interventional guidewire 700, thereby assembling the interventional guidewire 700 and the balloon 100 into a whole. The guide tube 400 of the balloon 100 carrying the interventional guidewire 700 is then passed over the proximal end 610 of the pre-embedded guidewire 600, so that the balloon 100 carrying the interventional guidewire 700 is fitted onto the pre-embedded guidewire 600. Then, the balloon 100 carrying the interventional guidewire 700 is pushed into the blood vessel of the human body along the pre-embedded guidewire 600 until the balloon 100 reaches the right ventricle 14, and the distal end 720 of the interventional guidewire 700 passes through the pulmonary valve 15 and reaches the pulmonary artery 16.

[0064] Therefore, the balloon 100 of the positioning balloon 30 of this application can be installed into the right ventricle 14 of the patient for installation of the pump body 510 of the blood pump 500; the balloon 100 has an inflation chamber 101 and can be inflated, and the balloon 100 is curved in an arc shape when inflated; the balloon 100 is connected to a guide tube 400, which at least partially passes through the inflation chamber 101 of the balloon 100, and the guide tube 400 allows the pre-embedded guide wire 600 to pass through, so that the balloon 100 can be fitted onto the pre-embedded guide wire 600, thereby allowing the balloon 100 to be implanted into the human body along the pre-embedded guide wire 600. The balloon 100 is further provided with a positioning tube 300 in its inflation cavity 101. The positioning tube 300 has a proximal opening 301 and a distal opening 302 exposed on the outside of the balloon 100, so that the flexible body part 513 of the pump body 510 of the blood pump 500 can pass through it. The blood inlet 501 of the pump body 510 is located outside the proximal opening 301 of the positioning tube 300, and the blood outlet 502 of the pump body 510 is located outside the distal opening 302 of the positioning tube 300. This ensures that blood can enter the pump body 510 from the blood inlet 501 and be discharged from the blood outlet 502. Furthermore, the positioning tube 300 can bend along with the balloon 100 when the balloon 100 is inflated. Thus, when the flexible main body 513 of the pump body 510 passes through the positioning tube 300, the flexible main body 513 of the pump body 510 will bend into an arc shape along with the positioning tube 300 along with the balloon 100, thereby bending the pump body 510 into the same bending angle as the balloon 100. Thus, when the position of the balloon 100 is adjusted using the pre-embedded guidewire 600 so that the distal end of the balloon 100 faces the pulmonary valve 15 at the top of the heart relative to the tricuspid valve 13, the distal end 512 of the pump body 510 of the blood pump will also face the pulmonary valve 15 accordingly, instead of facing the right side wall 14c of the right ventricle 14. Afterwards, the blood pump 500 is continued to be pushed, and the distal end 512 of the pump body 510 will extend from the distal opening 302 toward the pulmonary valve 15 and enter the pulmonary artery 16, thus avoiding the blood pump 500 from hitting the right side wall 14c of the right ventricle 14.

[0065] Understandably, since the positioning tube 300 is located inside the inflation chamber 101 of the balloon 100, when the balloon 100 inflates, the fluid in the inflation chamber 101 separates the positioning tube 300 from the chordae tendineae 14a, papillary muscles 14b, and other tissues of the right ventricle 14. That is, the positioning tube 300 is enveloped by the fluid in the inflation chamber 101 of the balloon 100. Thus, if the pump body 510 bumps against the side wall of the positioning tube 300 during the process of the pump body 510 passing through the positioning tube 300, the pushing force applied by the pump body 510 to the positioning tube 300 will first be transmitted to the fluid in the inflation chamber 101. The fluid can buffer the pushing force, thereby reducing or preventing the pushing force from being directly transmitted to the chordae tendineae 14a and papillary muscles 14b in the right ventricle 14, and preventing damage to the chordae tendineae 14a and papillary muscles 14b. In summary, using the positioning balloon 30 to position the blood pump 500 to the right ventricle 14 can prevent the blood pump 500 from bumping into the internal tissues of the right ventricle 14, such as the chordae tendineae 14a, papillary muscles 14b, or right lateral wall 14c, and allows the distal end 512 of the blood pump 500 to extend toward the pulmonary valve 15, effectively reducing the difficulty of implanting the blood pump 500.

[0066] Please see Figures 3 to 5 The balloon 100, in its inflated state, has a first curvature that allows its shape to conform to the anatomical shape of the blood flow pathway from the right atrium 12 to the pulmonary artery 16. When the balloon 100 is fitted into this blood flow pathway, the proximal end of the balloon 100 is located in the right atrium 12, while the distal end is located in the right ventricle 14 or the pulmonary artery 16. Specifically, the blood flow pathway refers to the path from the right atrium 12 through the tricuspid valve 13, right ventricle 14, and pulmonary valve 15 to the pulmonary artery 16. It should be noted that when the balloon 100 is a regular arc shape in its inflated state, the first curvature is the curvature of the arc containing the central axis 102 of the balloon 100; when the balloon 100 is an irregular arc shape in its inflated state, it is divided into multiple arc-shaped portions along the direction of the central axis 102 of the balloon 100, and the first curvature is the average of the sum of the curvatures of the central axes of these individual arc-shaped portions.

[0067] Please see Figures 5 to 7 In some embodiments, the balloon 100 is made of a flexible material, giving it flexibility. This flexible material can be, but is not limited to, polyurethane, polyethylene, or PET. The balloon 100 has a central axis 102. A positioning tube 300 extends through the inflation cavity 101 of the balloon 100 along the central axis 102.

[0068] Optionally, the balloon 100 includes a proximal wall 110, a distal wall 120, and a circumferential wall 130 located between the proximal wall 110 and the distal wall 120. The proximal wall 110 and the distal wall 120 are located at opposite ends in the direction of the central axis 102 of the balloon 100. One end of the positioning tube 300 is connected to the proximal wall 110, and a proximal opening 301 is formed in the proximal wall 110; the other end of the positioning tube 300 is connected to the distal wall 120, and a distal opening 302 is formed in the distal wall 120. The orientation of the distal wall 120 of the balloon 100 toward the pulmonary valve 15 can be adjusted by pre-embedded guidewire 600 so that the distal opening 302 on the distal wall 120 also faces the pulmonary valve 15. When the distal end 512 of the pump body 510 extends from the distal opening 302 to the outside of the balloon 100, the distal end 512 of the pump body 510 can directly face the pulmonary valve 15, ensuring that the balloon 100 can stably fix the pump body 510 in a shape extending toward the pulmonary valve 15.

[0069] Please see Figures 5 to 7 The distal end of the guide tube 400 is connected to the distal wall 120, and a first guide port 401 is provided on the distal wall 120. The proximal end of the guide tube 400 can be connected to the proximal wall 110, or it can pass through the proximal wall 110 to extend to the outside of the balloon 100. The pre-embedded guidewire 600 can be inserted into the guide tube 400 through the first guide port 401 on the distal end of the guide tube 400 and exit from the proximal end of the guide tube 400.

[0070] Specifically, the proximal end of the guide tube 400 penetrates the proximal wall 110 to extend to the outside of the balloon 100. That is, a portion of the guide tube 400 is housed in the inflation cavity 101 of the balloon 100, while the other portion of the guide tube 400 is located on the outside of the balloon 100; the entire positioning tube 300 is located within the inflation cavity 101 of the balloon 100. This design, on the one hand, distinguishes the guide tube 400 from the positioning tube 300, making it less likely for the operator to accidentally insert the pre-embedded guidewire 600 into the positioning tube 300 during use; on the other hand, it extends the length of the guide tube 400, allowing for a longer length of insertion and engagement between the guide tube 400 and the pre-embedded guidewire 600.

[0071] Please continue reading. Figures 5 to 7 In some embodiments, the positioning balloon 30 further includes an inflation tube 200, which is disposed on the outside of the balloon 100. One end of the inflation tube 200 is connected to the balloon 100 and communicates with the inflation cavity 101 of the balloon 100; the other end of the inflation tube 200 can communicate with an external inflation device. Specifically, the end of the inflation tube 200 away from the balloon 100 is provided with an inflation port 202, which is used to connect to the external inflation device, so that the external inflation device can inflate fluid into the inflation cavity 101 of the balloon 100 through the inflation tube 200, thereby causing the balloon 100 to inflate.

[0072] Considering that if the inflation tube 200 and the guide tube 400 are connected side-by-side to the outside of the balloon 100, the external wiring of the positioning balloon 30 will be numerous and prone to tangling, making it difficult to manage. Therefore, in this embodiment, the guide tube 400 includes a first tube segment 410 and a second tube segment 420 connected to the first tube segment 410; the first tube segment 410 passes through the filling cavity 101, and the second tube segment 420 passes through the inner cavity of the inflation tube 200. An inflation channel 201 is formed between the outer wall of the second tube segment 420 and the inner wall of the inflation tube 200, with one end of the inflation channel 201 communicating with the filling cavity 101 and the other end communicating with an external inflation device.

[0073] Specifically, the first segment 410 and the second segment 420 of the guide tube 400 are integrally formed; and the outer diameter of the second segment 420 is smaller than the inner diameter of the filling tube 200, so that an filling channel 201 is formed between the outer wall surface of the second segment 420 and the inner wall surface of the filling tube 200. After the extracorporeal infusion device injects fluid into the filling tube 200, the fluid will flow along the filling channel 201 into the inflation cavity 101 of the balloon 100. The second segment 420 belongs to the portion of the guide tube 400 located outside the balloon 100. Since the second segment 420 passes through the inner cavity of the filling tube 200, that is, the portion of the guide tube 400 located outside the balloon 100 is housed inside the filling tube 200. Therefore, from the outside of the positioning balloon 30, there is only one wire harness, the inflation tube 200, which reduces the number of exposed wire harnesses. The guide tube 400 and the inflation tube 200 are less likely to move and get tangled together, making it easier to manage the wire harness of the positioning balloon 30.

[0074] Please see Figure 5 , Figure 7 and Figure 8 Furthermore, the filling tube 200 includes a filling section 210 and a guide section 220 connected to the filling section 210; the filling section 210 is wrapped around the outside of the second tube section 420 to form a filling flow channel 201 with the outer wall surface of the second tube section 420 at intervals; an annular step surface 203 is protruding on the inner wall surface of one end of the filling section 210 adjacent to the guide section 220; the inner periphery of the annular step surface 203 is sealed and connected to the end of the second tube section 420 away from the first tube section 410, so that the inner cavity of the guide section 220 is connected to the inner cavity of the second tube section 420 for the pre-embedded guide wire 600 to pass through.

[0075] Specifically, the filling section 210 and the guide section 220 of the filling tube 200 are integrally formed. The filling port 202 of the filling tube 200 is provided on the filling section 210. The filling section 210 has a first inner diameter D1, the guide section 220 has a second inner diameter D2, and the second section 420 of the guide tube 400 has a first outer diameter D3. The first inner diameter D1 of the filling section 210 is larger than the first outer diameter D3 of the second section 420, i.e., D1 > D3, so that the inner wall surface of the filling section 210 and the outer wall surface of the second section 420 form a filling flow channel 201 at intervals. Furthermore, the second inner diameter D2 of the guide section 220 is smaller than the first inner diameter D1 of the filling section 210, i.e., D2 < D1, so that an annular stepped surface 203 is formed at the connection between the guide section 220 and the filling section 210, and the end of the second section 420 away from the first section 410 is sealed to this annular stepped surface 203. This design serves two purposes: firstly, it seals the proximal end of the filling channel 201, preventing leakage; secondly, the guide section 220 of the filling tube 200 is integrated and connected to the second section 420 of the guide tube 400. The proximal end of the filling tube 200 has only one second guide port 204 for the pre-embedded guide wire 600 to pass through. The pre-embedded guide wire 600 can enter the guide tube 400 from the first guide port 401, then enter the guide section 220 of the filling tube 200 from the second section 420 of the guide tube 400, and finally extend from the second guide port 204 of the guide section 220. The second guide port 204 and the filling interface 202 are far apart and do not interfere with each other.

[0076] Please see Figure 8 Optionally, the second tube segment 420 has a third inner diameter D4, which is equal to the second inner diameter D2 of the guide segment 220, i.e., D4 = D2. This allows the inner wall surface of the second tube segment 420 to smoothly connect with the wall surface of the guide segment 220 to form a cylindrical surface, thus avoiding the formation of a transition step between the inner wall surface of the second tube segment 420 and the wall surface of the guide segment 220. When the balloon 100 is inserted onto the pre-embedded guide wire 600, the proximal end of the pre-embedded guide wire 600 can smoothly enter the guide segment 220 of the filling tube 200 from the guide tube 400.

[0077] Please see Figures 5 to 7 In one embodiment, the first segment 410 of the guide tube 400 is located within the inflation cavity 101. The first segment 410 extends in the same direction as the positioning tube 300 and is located outside the positioning tube 300. The outer wall surface of the first segment 410 is connected and fixed to the outer wall surface of the positioning tube 300. This allows the guide tube 400 and the positioning tube 300 to support each other, reducing their swaying within the inflation cavity 101 of the balloon 100. Of course, in other embodiments, the outer wall surface of the first segment 410 and the outer wall surface of the positioning tube 300 can also be spaced apart, making it easier for the positioning tube 300 to bend together when the balloon 100 inflates.

[0078] Optionally, when the balloon 100 is inflated, the first segment 410 of the guide tube 400 can bend in the same direction as the balloon 100 when it is inflated, so as to support the balloon 100 through the pre-embedded guide wire 600 in the guide tube 400, so that the balloon 100 can better maintain its arc-shaped bending shape.

[0079] Please see Figure 5 In some embodiments, the circumferential wall 130 of the balloon 100 includes an inner wall 131 and an outer wall 132 opposite to the inner wall 131. The inner wall 131 is closer to the inner side of the balloon 100 than the outer wall 132. Specifically, the proximal wall 110 of the balloon 100 has a first endpoint P1, and the distal wall 120 has a second endpoint P2. The shortest connecting line between the first endpoint P1 and the second endpoint P2 is a connecting line segment L1. The straight line perpendicularly bisects the connecting line segment L1 is a bisector L2, which intersects the connecting line segment L1 to form an intersection point P3. The region of the balloon 100 near the intersection point P3 is the inner side of the balloon 100 in its inflated state, and the region of the balloon 100 opposite to the intersection point P3 is the outer side of the balloon 100 in its inflated state. Therefore, it can be understood that the inner wall 131 is closer to the intersection point P3 than the outer wall 132. When the balloon 100 is inflated, the lateral wall 132 is also curved, making the shape of the lateral wall 132 similar to or the same as that of the left inferior lateral wall 14d. When the balloon 100 is installed in the right ventricle 14, the balloon 100 can be adjusted by the pre-embedded guidewire 600 so that the inner wall 131 of the balloon 100 faces the top of the heart, while the lateral wall 132 of the balloon 100 faces the bottom of the heart, that is, the left inferior lateral wall 14d of the right ventricle 14. The lateral wall 132 can be adjacent to the left inferior lateral wall 14d or abut against the left inferior lateral wall 14d to use the left inferior lateral wall 14d to support the balloon 100.

[0080] Optionally, when the balloon 100 is inflated, the curvature of the inner wall 131 is greater than that of the outer wall 132. This configuration allows the fluid within the inflation cavity 101 of the balloon 100 to tend to push the outer wall 132 outwards (i.e., away from the intersection point P3), making the outer wall 132 more easily expandable than the inner wall 131, thereby allowing the balloon 100 to stably maintain its inwardly curved state. Furthermore, the outer wall 132 of the balloon 100 is also more likely to abut against the lower left side wall 14d, enabling the lower left side wall 14d to support the balloon 100.

[0081] It should be noted that if the inner wall 131 is an arc extending along the direction of the central axis 102, then the curvature of the inner wall 131 is the curvature of the arc in which the inner wall 131 is located. If the inner wall 131 is an irregular arc extending along the direction of the central axis 102, then the inner wall 131 can be divided into multiple connected arc segments along the direction of the central axis 102, and the curvature of the inner wall 131 is the average of the sum of the curvatures of the multiple arc segments. Similarly, if the outer wall 132 is an arc extending along the direction of the central axis 102, then the curvature of the outer wall 132 is the curvature of the arc in which the outer wall 132 is located. If the outer wall 132 is an irregular arc extending along the direction of the central axis 102, then the outer wall 132 can be divided into multiple connected arc segments along the direction of the central axis 102, and the curvature of the outer wall 132 is the average of the sum of the curvatures of the multiple arc segments.

[0082] Please see Figure 5 and Figure 11 In one embodiment, to achieve a curvature of the inner wall 131 greater than that of the outer wall 132, the inner wall 132 may optionally have a first thickness H1 and the outer wall 132 have a second thickness H2, wherein the first thickness H1 is greater than the second thickness H2, i.e., H1 > H2. This also makes the hardness of the inner wall 131 greater than that of the outer wall 132, so that when fluid is injected into the inflation cavity 101 of the balloon 100, the outer wall 132 of the balloon 100 expands outward (i.e., away from the intersection point P3) more easily under the pressure of the fluid than the inner wall 131, thereby forcing the two ends of the inner wall 131 to bend inward, and thus the balloon 100 expands into an arc-shaped bend.

[0083] Please see Figure 9 Of course, in other embodiments, shaping ribs 160 may be provided on the inner surface of the inner wall 131, extending along the central axis 102 of the balloon 100. The shaping ribs 160 can enhance the rigidity of the inner wall 131, so that when fluid is injected into the inflation cavity 101 of the balloon 100, the outer wall 132 of the balloon 100 expands outward (i.e., away from the intersection point P3) more easily under the pressure of the fluid than the inner wall 131, thereby forcing the two ends of the inner wall 131 to bend inward, and thus the balloon 100 expands into an arc-shaped bend. The number of shaping ribs 160 can be one or more, where "more" means two or more. When there are multiple shaping ribs 160, all of them extend along the length direction of the balloon 100, and are spaced apart along the length direction of the balloon 100.

[0084] Please see Figure 5In some embodiments, when the balloon 100 is inflated, the circumferential wall 130 of the balloon 100 has an inner arc 140 and an outer arc 150. The inner arc 140 is the shortest arc on the circumferential wall 130 extending between the proximal wall 110 and the distal wall 120, and the outer arc 150 is the longest arc on the circumferential wall 130 extending between the proximal wall 110 and the distal wall 120. Specifically, both the inner arc 140 and the outer arc 150 are arcs extending along the central axis 102 of the balloon 100. The inner arc 140 is the arc located on the inner wall 131 and closest to the intersection point P3 along the bisector L2; the outer arc 150 is the arc located on the outer wall 132 and farthest from the intersection point P3 along the bisector L2. In this embodiment, both the inner wall 131 and the outer wall 132 are irregular arc-shaped walls extending along the direction of the central axis 102. Therefore, the inner arc 140 and the outer arc 150 are also irregular arcs (i.e., non-circular arcs). The inner arc 140 includes a first inner arc segment 141 connecting the proximal wall 110; the outer arc 150 includes a first outer arc segment 151 connecting the proximal wall 110, and the curvature of the first outer arc segment 151 is greater than the curvature of the first inner arc segment 141.

[0085] Specifically, such as Figure 2 and Figure 3As shown, the right ventricle 14 has a region B1 adjacent to the tricuspid valve 13 and near the top of the heart, and a region B2 adjacent to region B1 and near the bottom of the heart. Region B1 is relatively narrow, and the blood flow path from the right atrium 12 through the tricuspid valve 13 to region B1 extends downwards; region B2 provides space for the inflation of the balloon 100. The portion of the medial wall 131 with a first inner arc segment 141 is defined as the first proximal portion, and the portion of the lateral wall 132 with a first outer arc segment 151 is defined as the second proximal portion. When the balloon 100 is implanted into the right ventricle 14, the first proximal portion of the medial wall 131 is closer to region B1; while the second proximal portion of the lateral wall 132 is closer to region B2. Therefore, by setting the curvature of the first outer arc segment 151 to be greater than that of the first inner arc segment 141, on the one hand, the second proximal portion of the outer wall 132 can expand in region B2, allowing more fluid to fill the side of the balloon 100 adjacent to the outer wall 132. This fluid can better buffer the pushing force exerted on the positioning tube 300 when the blood pump 500 is implanted between the positioning tube 300 of the balloon 100 and the papillary muscle 14b of region B2, thereby preventing the pushing force from being directly applied to the papillary muscle 14b. On the other hand, the second proximal portion of the outer wall 132 can be made closer to the shape of the lower left side wall 14d located below region B2, so that the outer wall 132 can abut against the lower left side wall 14d to support the balloon 100. It should be noted that the figure does not show the state of the outer wall 132 abutting against the lower left side wall 14d.

[0086] It is understandable that when the balloon 100 is in a contracted state, it can be a regular cylinder. In this case, the initial state of the inner arc 140 and the outer arc 150 of the balloon 100 are straight segments on opposite sides of the balloon 100. The inner arc 140 and the outer arc 150 are formed by the curvature of the straight segments on the inner and outer sides of the balloon 100 after the balloon 100 inflates and bends into an arc. Alternatively, when the balloon 100 is in a contracted state, it can also be an irregular cylinder. In this case, the initial state of the inner arc 140 is a straight segment on one side of the balloon 100 without curvature, and the initial state of the outer arc 150 is an arc segment on the other side of the balloon 100 with a small initial curvature. The straight segments of the balloon 100 bend to form the inner arc 140 after the balloon inflates and bends into an arc, and the arc segments further bend to form the outer arc 150. Of course, in other embodiments, when the balloon 100 is in a contracted state, the balloon 100 can also be bent into an arc shape with an initial curvature. In this case, the initial state of the inner arc 140 and the outer arc 150 of the balloon 100 are the arc segments on opposite sides of the balloon 100, and they have a small initial curvature. After the balloon 100 is inflated, the arc segments on opposite sides of the balloon 100 are further bent, so that the curvature of the inner arc 140 and the outer arc 150 are both greater than the initial curvature.

[0087] Please continue reading. Figure 5 In some embodiments, the inner arc 140 further includes a second inner arc segment 142, which connects the first inner arc segment 141 and the distal wall 120. The arc length of the second inner arc segment 142 is less than the arc length of the first inner arc segment 141, and the curvature of the second inner arc segment 142 is greater than the curvature of the first inner arc segment 141. Specifically, as... Figure 2 and Figure 3 As shown, the right ventricle 14 also has a region B3 located between region B1 and the pulmonary valve 15. Region B3 is less affected by the chordae tendineae 14a or papillary muscles 14b, and is characterized by a narrow lateral dimension and a long longitudinal dimension. Therefore, by setting the arc length of the second inner arc segment 142 to be less than the arc length of the first inner arc segment 141, the distal end of the balloon 100 can be prevented from hitting the right side wall 14c of the right ventricle 14. By setting the curvature of the second inner arc segment 142 to be greater than the curvature of the first inner arc segment 141, the distal end of the balloon 100 can bend upward along the longitudinal direction of the heart in region B3 and turn towards the pulmonary valve 15.

[0088] Similarly, the outer arc 150 also includes a second outer arc segment 152, which connects the first outer arc segment 151 and the distal wall 120. The arc length of the second outer arc segment 152 is less than the arc length of the first outer arc segment 151, and the curvature of the second outer arc segment 152 is greater than the curvature of the first outer arc segment 151. The shorter arc length of the second outer arc segment 152 prevents the distal end of the balloon 100 from abutting against the right lateral wall 14c of the right ventricle 14. The greater curvature of the second outer arc segment 152 allows the distal end of the balloon 100 to bend upwards along the longitudinal direction of the heart in region B3 towards the pulmonary valve 15.

[0089] Furthermore, the curvature of the second inner arc segment 142 can be set to be greater than the curvature of the second outer arc segment 152. This setting ensures that after the balloon 100 is inflated, the distal end of its inner wall 131 is more curved than the distal end of its outer wall 132, thus ensuring that the distal end of the balloon 100 can stably maintain its shape extending toward the pulmonary valve 15 and preventing the outer wall 132 from compressing the right side wall 14c of the right ventricle 14.

[0090] Please see Figure 4 and Figure 5 In some embodiments, the positioning tube 300 is flexible, allowing it to bend into an arc shape along with the balloon 100 when the balloon 100 inflates. Optionally, the balloon 100 has a first hardness, and the positioning tube 300 has a second hardness, which is less than the first hardness. This makes the positioning tube 300 more flexible than the balloon 100. Thus, when the balloon 100 inflates and bends, the positioning tube 300 is more easily compressed by both ends of the balloon 100 and bent into an arc shape, with the bending angle of the positioning tube 300 being closer to that of the balloon 100. This allows the pump body 510, which passes through the positioning tube 300, to also have the same bending angle as the balloon 100, thereby ensuring that the distal end 512 of the pump body 510 is more accurately oriented towards the pulmonary artery 16. Of course, in other embodiments, the second hardness can also be equal to the first hardness.

[0091] Optionally, the balloon 100 and the positioning tube 300 can be made of different materials and integrally formed through secondary molding. For example, the thickness of the circumferential wall 130 of the balloon 100 and the wall thickness of the positioning tube 300 are the same, while the balloon 100 is made of a first material and the positioning tube 300 is made of a second material. The second material is different from the first material, and the hardness of the second material is less than that of the first material, which can make the second hardness of the positioning tube 300 less than the first hardness of the balloon 100. In other embodiments, the balloon 100 and the positioning tube 300 can also be made of the same material, but the wall thickness of the positioning tube 300 is less than the thickness of the circumferential wall 130 of the balloon 100, which can also make the second hardness of the positioning tube 300 less than the first hardness of the balloon 100.

[0092] Please see Figure 4 and Figure 5 This application also provides a blood pump system, which includes a blood pump 500 and a positioning balloon 30. The specific structure of the positioning balloon 30 is described in any of the above embodiments. The blood pump 500 includes a pump body 510, which has a blood inlet 501, a blood outlet 502, and a flexible main body 513 located between the blood inlet 501 and the blood outlet 502. The flexible main body 513 of the pump body 510 can pass through the positioning tube 300 of the positioning balloon 30. The blood inlet 501 of the pump body 510 is located outside the proximal opening 301 of the positioning tube 300, and the blood outlet 502 of the pump body 510 is located outside the distal opening 302 of the positioning tube 300. Since the blood pump system of this application adopts all the technical solutions of all the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments, and will not be repeated here.

[0093] Specifically, the pump body 510 has a proximal end 511 and a distal end 512, with the proximal end 511 having a blood inlet 501 and the distal end 512 having a blood outlet 502. Optionally, the portion of the positioning tube 300 located between the proximal opening 301 and the distal opening 302 has a first length; the flexible main body 513 of the pump body 510 has a second length, which is greater than the first length of the positioning tube 300. Since the second length of the flexible main body 513 of the pump body 510 is greater than the first length of the positioning tube 300, when the flexible main body 513 of the pump body 510 is inserted into the positioning tube 300, the proximal end 511 of the pump body 510 is located outside the proximal opening 301 of the positioning tube 300, that is, the proximal end 511 is not contained inside the positioning tube 300, so that the blood inlet 501 on the proximal end 511 is located outside the positioning tube 300; the distal end 512 of the pump body 510 is located outside the distal opening 302 of the positioning tube 300, that is, the distal end 512 is not contained inside the positioning tube 300, so that the blood outlet 502 on the distal end 512 is located outside the positioning tube 300.

[0094] Understandably, different patients have different heart shapes or sizes, requiring varying second lengths for the pump body 510. For example, younger patients have smaller hearts, requiring shorter second lengths for the pump body 510; older patients have larger hearts, requiring longer second lengths for the pump body 510. Furthermore, the depth to which the blood inlet 501 of the blood pump 500 can be implanted varies depending on the patient's physical condition. For instance, in some cases, the blood inlet 501 of the blood pump 500 needs to be pushed into the patient's right atrium, requiring a shorter second length for the pump body 510; while in other cases, the blood inlet 501 needs to be pushed into the patient's inferior vena cava 10 or superior vena cava 11, requiring a longer second length for the pump body 510. Therefore, in practical applications, the second length of the pump body 510 can be configured according to the patient's actual needs; and the first length of the positioning tube 300 can be designed accordingly based on the second length of the pump body 510. In addition, the diameter of the balloon 100 in its inflated state can be reasonably configured by combining the diameter of the pump body 510 of the blood pump 500 and the size of the right ventricle 14 of the patient in actual use, without making specific limitations here.

[0095] Furthermore, the inner diameter of the positioning tube 300 can be equal to the outer diameter of the pump body 510 of the blood pump 500, so that the dimensions of the positioning tube 300 and the pump body 510 are matched, and the stability of the positioning tube 300 in fixing the pump body 510 is better. However, the inner diameter of the positioning tube 300 can also be slightly larger than the outer diameter of the pump body 510 of the blood pump 500, so that there is a small gap between the inner wall surface of the positioning tube 300 and the outer wall surface of the pump body 510, so that the pump body 510 can be pushed through the inside of the positioning tube 300, avoiding the contact between the outer wall surface of the pump body 510 and the inner wall surface of the positioning tube 300, which would generate large friction and affect the pushing of the pump body 510.

[0096] In some embodiments, the blood pump 500 further includes a conduit 520 connected to the pump body 510, the distal end of the conduit 520 being connected to the proximal end 511 of the pump body 510, and the conduit 520 being able to accommodate cables and flushing lines of the blood pump 500.

[0097] In some embodiments, the pump body 510 includes an inlet pipe, an outlet pipe, and an elastic sleeve connecting the inlet pipe and the outlet pipe; wherein the inlet pipe has a blood inlet 501 and forms a proximal end 511 of the pump body 510; the outlet pipe has a blood outlet 502 and forms a distal end 512 of the pump body; and the elastic sleeve forms a flexible main body portion 513. Of course, the inlet pipe and the outlet pipe are not mandatory. For example, in other embodiments, the blood inlet 501 may be located at the proximal end of the elastic sleeve, and the blood outlet 502 may be located at the distal end of the elastic sleeve, with the portion of the elastic sleeve located between the blood inlet 501 and the blood outlet 502 forming the flexible main body portion 513.

[0098] Please see Figure 4 and Figure 6 In some embodiments, the blood pump 500 further includes an impeller (not shown) rotatably disposed inside the pump body 510. When the impeller rotates, it drives blood to enter from the blood inlet 501 of the pump body 510 and exit from the blood outlet 502. The blood pump 500 also includes a motor 530, which may be an internal motor. The distal end of the motor 530 is connected to the proximal end 511 of the pump body 510, and the proximal end of the motor 530 is connected to a conduit 520. The motor shaft of the motor 530 extends into the pump body 510 and is connected to the impeller to drive its rotation. Alternatively, in other embodiments, the motor 530 may be an external motor connected to the impeller via a flexible shaft passing through the conduit 520.

[0099] Please see Figure 10 In some embodiments, the pump body 510 is provided with a first imaging mark 503 and a second imaging mark 504. Both the second imaging mark 503 and the first imaging mark 504 are located between the blood inlet 501 and the blood outlet 502. The first imaging mark 503 is adjacent to the blood inlet 501, and the second imaging mark 504 is adjacent to the blood outlet 502. Specifically, the first imaging mark 503 is disposed at the proximal end of the elastic sleeve, adjacent to the blood inlet 501; the second imaging mark 504 is disposed at the distal end of the elastic sleeve, adjacent to the blood outlet 502.

[0100] During the installation of the blood pump 500 into the positioning tube 300 of the balloon 100, the position of the first contrast marker 503 and the second contrast marker 504 can be observed to determine whether the pump body 510 of the blood pump 500 is inserted into the target position of the positioning tube 300. That is, whether the blood inlet 501 of the pump body 510 is located outside the proximal opening 301 of the positioning tube 300, and whether the blood outlet 502 of the pump body 510 extends from the distal opening 302 of the positioning tube 300 to the outside of the positioning tube 300 (i.e., the outside of the balloon 100). When either the first contrast marker 503 or the second contrast marker 504 is observed to be inside the positioning tube 300, it indicates that the blood inlet 501 or the blood outlet 502 is located or adjacent to the positioning tube 300, and there is a risk that it may be blocked by the tube wall of the positioning tube 300. In this case, it is necessary to move the blood pump 500 to adjust its position in the positioning tube 300.

[0101] Please see Figure 11 In some embodiments, unlike the previous embodiment, the pump body 510 is provided with a first imaging mark 503, which is located between and adjacent to the blood inlet 501 and the blood outlet 502. The positioning tube 300 is provided with a second imaging mark 504, which is located at or adjacent to the proximal opening 301. During the installation of the blood pump 500 into the positioning tube 300 of the balloon 100, when it is observed that the first imaging mark 503 is located distal to the second imaging mark 504, it indicates that the proximal end 511 of the pump body 510 has at least partially extended into the positioning tube 300. The blood inlet 501 is located at or adjacent to the positioning tube 300, and there is a risk that it may be blocked by the tube wall of the positioning tube 300. In this case, it is necessary to move the blood pump 500 along the direction from the distal opening 302 to the proximal opening 301 of the positioning tube 300 so that the blood inlet 501 of the blood pump 500 moves outward from the proximal opening 301 of the positioning tube 300.

[0102] Please see Figure 12In another embodiment, the difference from the previous embodiment is that the distal end 512 of the pump body 510 is provided with a first imaging mark 503, which is located between the blood inlet 501 and the blood outlet 502 and adjacent to the blood outlet 502. The positioning tube 300 is provided with a second imaging mark 504, which is located at or adjacent to the distal opening 302. During the installation of the blood pump 500 into the positioning tube 300 of the balloon 100, when it is observed that the first imaging mark 503 is located proximal to the second imaging mark 504, it indicates that part of the distal end 512 of the pump body 510 is still in the positioning tube 300, the blood outlet 502 is located or adjacent to the positioning tube 300, and the blood outlet 502 has not reached the pulmonary artery 16. At this time, it is necessary to continue pushing the blood pump 500 in the direction from the proximal opening 301 to the distal opening 302 of the positioning tube 300 so that the blood outlet 502 of the blood pump 500 extends from the distal opening 302 of the positioning tube 300 toward the pulmonary artery 16.

[0103] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification. The embodiments described above only illustrate several implementation methods of this application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. For those skilled in the art, several modifications and improvements can be made without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A positioning balloon adapted for mounting a blood pump, the blood pump comprising a pump body having a blood inlet, a blood outlet and a flexible body portion between the blood inlet and the blood outlet; characterized in that, The positioning balloon comprises: a balloon capable of being mounted to the right ventricle, the balloon having an inflation cavity, so that the balloon can be inflated, and the balloon is curved in an arc shape in the inflated state; a guide tube connected with the balloon, the guide tube being at least partially arranged in the inflation cavity of the balloon, and the guide tube being capable of being arranged with a pre-embedded guide wire; a positioning tube arranged in the inflation cavity of the balloon, the positioning tube being capable of being curved in the same direction as the balloon when the balloon is inflated, the positioning tube being provided with a proximal opening and a distal opening exposed outside the balloon, so that a flexible main body of the pump body can be arranged in the positioning tube, and a blood inlet of the pump body is located outside the proximal opening, and a blood outlet of the pump body is located outside the distal opening.

2. The positioning balloon of claim 1, wherein, The positioning balloon further comprises an inflation tube arranged outside the balloon and connected with the balloon; the guide tube comprises a first tube segment and a second tube segment connected with the first tube segment; the first tube segment is arranged in the inflation cavity, and the second tube segment is arranged in the inner cavity of the inflation tube; an inflation flow channel is formed between the outer wall surface of the second tube segment and the inner wall surface of the inflation tube, one end of the inflation flow channel is communicated with the inflation cavity, and the other end of the inflation flow channel is capable of being communicated with an extracorporeal inflation device.

3. The positioning balloon of claim 2, wherein, The inflation tube comprises an inflation segment and a guide segment connected with the inflation segment; the inflation segment is sleeved outside the second tube segment to form the inflation flow channel with the outer wall surface of the second tube segment; the inner peripheral wall of the end of the inflation segment adjacent to the guide segment is provided with an annular step surface; the inner peripheral edge of the annular step surface is sealingly connected with the end of the second tube segment away from the first tube segment, so that the inner cavity of the guide segment is communicated with the inner cavity of the second tube segment to allow the pre-embedded guide wire to pass through.

4. The positioning balloon of any one of claims 1 to 3, wherein, The positioning tube is arranged in the inflation cavity of the balloon along the central axis direction of the balloon; the guide tube has a first tube segment arranged in the inflation cavity, the first tube segment extends in the same direction as the positioning tube, and the first tube segment is located outside the positioning tube; the outer wall surface of the first tube segment is connected and fixed with the outer wall surface of the positioning tube or is spaced apart from the outer wall surface of the positioning tube.

5. The positioning balloon of any one of claims 1 to 3, wherein, The balloon comprises a proximal end wall, a distal end wall, and a circumferential wall between the proximal end wall and the distal end wall, the circumferential wall having an inner arc line and an outer arc line; the inner arc line is the arc line of the circumferential wall extending between the proximal end wall and the distal end wall and having the shortest arc length, and the inner arc line comprises a first inner arc segment connected with the proximal end wall; the outer arc line is the arc line of the circumferential wall extending between the proximal end wall and the distal end wall and having the longest arc length, and the outer arc line comprises a first outer arc segment connected with the proximal end wall, and the curvature of the first outer arc segment is greater than the curvature of the first inner arc segment.

6. The positioning balloon of claim 5, wherein, The inner arc line further comprises a second inner arc segment connected with the first inner arc segment and the distal end wall, the arc length of the second inner arc segment is less than the arc length of the first inner arc segment, and the curvature of the second inner arc segment is greater than the curvature of the first inner arc segment; And / or, the outer arc line further comprises a second outer arc segment, the second outer arc segment connecting the first outer arc segment and the distal end wall, the second outer arc segment having an arc length smaller than that of the first outer arc segment, and the second outer arc segment having a curvature greater than that of the first outer arc segment.

7. The positioning balloon of claim 5, wherein, The inner arc line further comprises a second inner arc segment, the second inner arc segment connecting the first inner arc segment and the distal end wall; and the outer arc line further comprises a second outer arc segment, the second outer arc segment connecting the first outer arc segment and the distal end wall, the second inner arc segment having a curvature greater than that of the second outer arc segment.

8. The positioning balloon of any one of claims 1 to 3, wherein, The balloon comprises a proximal end wall, a distal end wall, and a circumferential wall between the proximal end wall and the distal end wall; One end of the positioning tube is connected to the proximal end wall and the proximal end opening is formed in the proximal end wall; the other end of the positioning tube is connected to the distal end wall and the distal end opening is formed in the distal end wall.

9. The positioning balloon of any one of claims 1 to 3, wherein, The balloon has a first curvature in the inflated state, the first curvature enabling the shape of the balloon to conform to the anatomical shape of a blood passageway between a right atrium and a pulmonary artery, such that when the balloon is fitted in the blood passageway, a proximal end of the balloon is located in the right atrium and a distal end of the balloon is located in the right ventricle or the pulmonary artery.

10. The positioning balloon of any one of claims 1 to 3, wherein, The guide tube comprises a first tube segment located in the balloon, the first tube segment being capable of bending in the same direction as the balloon when the balloon is inflated.

11. The positioning balloon of any one of claims 1 to 3, wherein, The circumferential wall of the balloon comprises an inner side wall and an outer side wall opposite to the inner side wall, the inner side wall having a curvature greater than that of the outer side wall in the inflated state of the balloon; wherein a molding rib is arranged on an inner surface of the inner side wall, the molding rib extending along the direction of the central axis of the balloon; and / or the inner side wall has a first thickness and the outer side wall has a second thickness, the first thickness being greater than the second thickness.

12. The positioning balloon of any one of claims 1 to 3, wherein, The balloon has a first hardness and the positioning tube has a second hardness, the second hardness being smaller than the first hardness.

13. A blood pump system, characterized by The blood pump system comprises: The positioning balloon according to any one of claims 1 to 12; and The blood pump system comprises:

14. The blood pump system of claim 13, wherein, The positioning balloon according to any one of claims 1 to 12; and 15. The blood pump system of claim 13, wherein, The blood pump system comprises: The pump body is provided with a first imaging marker and a second imaging marker, both of which are located between the blood inlet and the blood outlet, the first imaging marker being adjacent to the blood inlet and the second imaging marker being adjacent to the blood outlet; Alternatively, the pump body is provided with a first visualization marker, the first visualization marker being located between the blood inlet and the blood outlet and adjacent to the blood inlet, and the positioning tube is provided with a second visualization marker, the second visualization marker being located at or adjacent to the proximal opening; Alternatively, the pump body is provided with a first visualization marker, the first visualization marker being located between the blood inlet and the blood outlet and adjacent to the blood outlet, and the positioning tube is provided with a second visualization marker, the second visualization marker being located at or adjacent to the distal opening.

16. The blood pump system of claim 13, wherein, The pump body comprises an inlet tube, an outlet tube, and an elastic sleeve connecting the inlet tube and the outlet tube; wherein the inlet tube is provided with the blood inlet; the outlet tube is provided with the blood outlet; and the elastic sleeve forms the flexible main body part.

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