Atrial shunt device and method of installing same

Abstract

The present application provides an atrial shunt device and a method for installing the same. The atrial shunt device is used to shunt blood from a left atrium to a right atrium through a stoma on an atrial septum of a patient, and the atrial shunt device comprises a shunt portion defining a shunt passage having a first opening and a second opening, the shunt passage being configured to communicate with the left atrium and the right atrium through the first opening and the second opening respectively, the first opening being configured to be closer to a head of the patient relative to the second opening, and / or the first opening being configured to be closer to an anterior portion of a body of the patient relative to the second opening. The atrial shunt device provided by the present application can effectively prevent or reduce blood and / or suspended matters in the blood from entering the left atrium from the right atrium, and the problem of passage blockage does not occur.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an atrial shunt device and its installation method. Background Technology

[0002] Heart failure, or HF for short, refers to a syndrome caused by impaired systolic and / or diastolic function of the heart, which fails to adequately pump venous blood back to the heart, leading to blood pooling in the venous system and insufficient blood perfusion in the arterial system.

[0003] Clinical studies have found that most heart failures begin as left ventricular failure. Increased left atrial pressure, even persistent high pressure, is a significant contributing factor to left ventricular failure. For heart failure patients with persistent left atrial pressure at rest, or significantly increased left atrial pressure during exercise while right atrial pressure remains relatively low, an atrial septum can be created and an atrial shunt device installed to divert blood from the left atrium to the right atrium, effectively reducing left atrial pressure and alleviating heart failure symptoms. Summary of the Invention

[0004] This application provides an atrial shunt device and its installation method.

[0005] In a first aspect, an atrial shunt device is provided. This atrial shunt device is used to shunt blood from the left atrium to the right atrium through a stoma on a patient's atrial septum. The atrial shunt device includes a shunt portion defining a shunt pathway having a first opening and a second opening, wherein the shunt pathway is configured to communicate with the left atrium and the right atrium through the first opening and the second opening, respectively, the first opening being configured to be close to the patient's head relative to the second opening, and / or the first opening being configured to be close to the anterior part of the patient's body relative to the second opening.

[0006] In conjunction with the first aspect, in some embodiments, the first opening is configured to be close to the front of the patient's head and body relative to the second opening.

[0007] In conjunction with the first aspect, in some embodiments, the first opening is configured to be close to the front of the patient's head and body relative to the stoma, and the second opening is configured to be close to the back of the patient's feet and body relative to the stoma.

[0008] In conjunction with the first aspect, in some embodiments, the first opening is configured such that its orthographic projection on the plane of the atrial septum lies in the first quadrant of an imaginary coordinate system, and the second opening is configured such that its orthographic projection on the plane of the atrial septum lies in the third quadrant of the coordinate system, wherein the coordinate system is a plane rectangular coordinate system with the plane of the atrial septum as the reference plane, the stoma as the origin, the intersection of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line passing through the origin and perpendicular to the x-axis on the reference plane as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

[0009] In conjunction with the first aspect, in some embodiments, the first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis.

[0010] In conjunction with the first aspect, in some embodiments, the first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis.

[0011] In conjunction with the first aspect, in some embodiments, the first opening is configured such that its orthographic projection on the plane of the interatrial septum at least partially coincides with the stoma, and the second opening is configured to be close to the patient's feet and the posterior part of the body relative to the stoma.

[0012] In conjunction with the first aspect, in some embodiments, the first opening is configured such that its orthographic projection on the plane of the atrial septum substantially coincides with the origin of an imaginary coordinate system, and the second opening is configured such that its orthographic projection on the plane of the atrial septum lies in the third quadrant of the coordinate system, wherein the coordinate system is a plane rectangular coordinate system with the plane of the atrial septum as the reference plane, the stoma as the origin, the intersection of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line passing through the origin and perpendicular to the x-axis on the reference plane as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

[0013] In conjunction with the first aspect, in some embodiments, the second opening is configured such that the line connecting its orthographic projection onto the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis.

[0014] In conjunction with the first aspect, in some embodiments, the second opening is configured such that the line connecting its orthographic projection onto the reference plane and the origin forms an angle of 45 degrees with the x-axis.

[0015] In conjunction with the first aspect, in some embodiments, the shunt is tubular, comprising a first part of the tube and a second part of the tube, the first part of the tube being configured to be placed in the left atrium and the second part of the tube being configured to be placed in the right atrium, wherein a first opening is provided on the end face or peripheral wall of the first part of the tube and a second opening is provided on the end face or peripheral wall of the second part of the tube.

[0016] In conjunction with the first aspect, in some embodiments, the shunt is tubular, comprising a first part of the tube and a second part of the tube, the first part of the tube being configured to be placed in the left atrium and the second part of the tube being configured to be placed in the right atrium, wherein a first opening and a second opening are respectively disposed on the first part of the tube and the second part of the tube, and the volume of the first part of the tube is smaller than the volume of the second part of the tube.

[0017] In conjunction with the first aspect, in some embodiments, the shunt is tubular, comprising a first part of the tube and a second part of the tube, the first part of the tube being configured to be placed in the left atrium and the second part of the tube being configured to be placed in the right atrium, wherein a first opening and a second opening are respectively disposed on the first part of the tube and the second part of the tube, and the first part of the tube is shorter than the second part of the tube.

[0018] In conjunction with the first aspect, in some embodiments, the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright or supine position, and the height difference between the first opening and the second opening in the direction of gravity is 1.5 cm to 2 cm.

[0019] In conjunction with the first aspect, in some embodiments, the inner diameter of the shunt path is 8 mm to 15 mm.

[0020] In conjunction with the first aspect, in some embodiments, the inner wall of the shunt passage has hydrophobic and / or anti-biodeformation properties.

[0021] In conjunction with the first aspect, in some embodiments, the atrial shunt device further includes a frame portion having a mesh structure, the frame portion including: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through the stoma, wherein the shunt portion is tubular, the shunt portion including: a first portion tube body with a first opening disposed on the first portion tube body and the first portion tube body configured to be surrounded by the first frame portion; and a second portion tube body with a second opening disposed on the second portion tube body and the second portion tube body configured to be surrounded by the second frame portion.

[0022] In conjunction with the first aspect, in some embodiments, the atrial shunt device further includes a frame portion comprising: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through an ostomy, wherein the shunt portion is tubular and includes: a first portion tube body having a first opening disposed on the first portion tube body, the first portion tube body being configured such that a portion is placed within the first frame portion and another portion extends outside the first frame portion, thereby exposing the first opening outside the first frame portion; and a second portion tube body having a second opening disposed on the second portion tube body, the second portion tube body being configured such that a portion is placed within the second frame portion and another portion extends outside the second frame portion, thereby exposing the second opening outside the second frame portion.

[0023] In conjunction with the first aspect, in some embodiments, the atrial shunt device further includes a frame portion comprising: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through an ostomy, wherein the shunt portion is tubular and includes: a first portion tube body configured to extend from the interior of the first frame portion to the surface of the first frame portion and form a first opening on the surface of the first frame portion; and a second portion tube body configured to extend from the interior of the second frame portion to the surface of the second frame portion and form a second opening on the surface of the second frame portion.

[0024] In conjunction with the first aspect, in some embodiments, the first frame portion is configured such that its orthographic projection on the plane of the interatrial septum covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane of the interatrial septum, and the second frame portion is configured such that its orthographic projection on the plane of the interatrial septum covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane of the interatrial septum.

[0025] In conjunction with the first aspect, in some embodiments, the first portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the second frame portion on the plane of the interatrial septum, and the second portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the first frame portion on the plane of the interatrial septum.

[0026] In conjunction with the first aspect, in some embodiments, the first frame portion is smaller than the second frame portion.

[0027] In conjunction with the first aspect, in some embodiments, the first frame portion and / or the second frame portion are dome-shaped.

[0028] Secondly, an atrial shunt device is provided. This atrial shunt device is used to divert blood from the left atrium to the right atrium through a stoma on the patient's atrial septum. The atrial shunt device includes a shunt portion defining a shunt pathway having a first opening and a second opening, wherein the shunt pathway is configured to communicate with the left atrium and the right atrium through the first opening and the second opening, respectively. The first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright position, and / or the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in a supine position.

[0029] Thirdly, an atrial shunt device is provided. The atrial shunt device includes a shunt portion defining a shunt path, the shunt path having a first opening and a second opening. The shunt portion is tubular and includes: a first tubular section with the first opening disposed on it; a second tubular section with the second opening disposed on it; and a third tubular section, one end connected to the first tubular section and the other end connected to the second tubular section, wherein the first tubular section is substantially parallel to the second tubular section and forms an angle with the third tubular section; the first tubular section and the second tubular section extend from the third tubular section in opposite directions.

[0030] Fourthly, an atrial shunt device is provided. The atrial shunt device includes a shunt portion defining a shunt path, the shunt path having a first opening and a second opening. The shunt portion is tubular and includes: a first portion of the tubular body with the first opening disposed on an end face of the first portion of the tubular body; and a second portion of the tubular body with the second opening disposed on the second portion of the tubular body, the second portion of the tubular body forming an angle with the first portion of the tubular body, and the first portion of the tubular body being shorter than the second portion of the tubular body.

[0031] The fifth aspect provides a method for installing an atrial shunt device. The method includes: providing an atrial shunt device for diverting blood from the left atrium to the right atrium through a stoma on the patient's atrial septum; the atrial shunt device includes a shunt portion defining a shunt pathway having a first opening and a second opening; and installing the atrial shunt device into the patient's atrium, wherein the shunt pathway is configured to communicate with the left and right atria through the first and second openings respectively, the first opening being configured to be close to the patient's head relative to the second opening, and / or the first opening being configured to be close to the anterior part of the patient's body relative to the second opening.

[0032] A sixth aspect provides a method for installing an atrial shunt device. The method includes: providing an atrial shunt device for diverting blood from the left atrium to the right atrium through a stoma on the patient's atrial septum; the atrial shunt device includes a shunt portion defining a shunt pathway having a first opening and a second opening; and installing the atrial shunt device into the patient's atrium, wherein the shunt pathway is configured to communicate with the left atrium and the right atrium through the first opening and the second opening, respectively; the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright and supine position, and / or the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in a supine position.

[0033] The atrial shunt device provided in this application can effectively prevent or reduce the flow of blood and / or suspended matter in the blood from the right atrium into the left atrium, and will not cause the problem of pathway blockage. Attached Figure Description

[0034] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0035] It should be understood that the same or similar reference numerals are used in the accompanying drawings to represent the same or similar components. It should also be understood that the drawings are schematic only, and the dimensions and scale of the components in the drawings are not necessarily precise.

[0036] Figure 1 This is a schematic diagram of an atrial shunt device configured in the atrium according to some embodiments of this application.

[0037] Figure 2 for Figure 1 Another view of the structure shows the atrial shunt device configured in the atrium.

[0038] Figure 3 for Figure 1 Another view of the structure shows the atrial shunt device configured in the atrium.

[0039] Figure 4 This is a schematic diagram of the structure of the flow divider provided in some embodiments of this application.

[0040] Figure 5 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0041] Figure 6This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0042] Figure 7 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0043] Figure 8 for Figure 7 Another view of the structure shows the atrial shunt device configured in the atrium.

[0044] Figure 9 for Figure 7 Another view of the structure shows the atrial shunt device configured in the atrium.

[0045] Figure 10 Schematic diagrams of the flow divider are provided for other embodiments of this application.

[0046] Figure 11 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0047] Figure 12 This is a schematic diagram of the structure of the framework according to some embodiments of this application.

[0048] Figure 13 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0049] Figure 14 This is a schematic diagram of the structure of the frame according to other embodiments of this application.

[0050] Figure 15 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0051] Figure 16 This is a schematic diagram of the structure of the frame according to other embodiments of this application.

[0052] Figure 17 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0053] Figure 18 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0054] Figure 19 This is a schematic diagram of an atrial shunt device configured in the atrium according to other embodiments of this application.

[0055] Figure 20This is a schematic flowchart illustrating the installation method of an atrial shunt device provided in some embodiments of this application. Detailed Implementation

[0056] Ideally, an atrial shunt should provide only one direction of blood flow, ensuring that blood can only flow from the left atrium to the right atrium and not from the right atrium to the left atrium. If blood flows from the right atrium to the left atrium, it can lead to health problems. For example, if a blood clot or other particles in venous blood are not filtered by pulmonary capillaries and instead pass directly through the opening of the interatrial septum into the left atrium, and then enter the systemic arterial circulation (including cerebral circulation), it can cause problems such as stroke, stroke-like events, or blockage of small arteries in organs.

[0057] To prevent blood from flowing from the right atrium to the left atrium, one approach is to install valves in the blood flow path of an atrial shunt. These valves function similarly to one-way valves, allowing blood to flow only from the left atrium to the right atrium. However, clinical studies have shown that with these atrial shunts, in most patients, after a period of use, the flow path of the atrial shunt will become blocked or partially blocked at the valves, leading to shunt failure or reduced effectiveness.

[0058] To address the aforementioned problems, this application proposes an atrial shunt device. The atrial shunt device of this application will be described below with reference to the accompanying drawings.

[0059] Figure 1 This is a schematic diagram of the structure of an atrial shunt device 1 configured in the atrium according to some embodiments of this application. Figure 2 and Figure 3 for Figure 1 A schematic diagram of the structure of the atrial shunt device configured in the atrium from other views. Figure 4 This is a schematic diagram of the structure of the diversion section 11 provided in some embodiments of this application. Figure 4 The shown splitter 11 can be applied to Figure 1 In the atrial shunt device 1 shown.

[0060] Figure 2 The view direction is the view direction from the left to the right of the patient when the patient is in an upright position. Figure 3 The view direction is the view from the patient's left side to the right side when the patient is in a supine position. Figure 2 and Figure 3 In the diagram, the solid line portion of the shunt 11 represents the portion placed in the patient's left atrium, and the dashed line portion represents the portion placed in the patient's right atrium.

[0061] Furthermore, it should be noted that in the accompanying drawings of the embodiments of this application, the area where RA is located is the patient's right atrium, the area where LA is located is the patient's left atrium, the area where RV is located is the patient's right ventricle, the area where LV is located is the patient's left ventricle, AS is used to represent the atrial septum, and H is used to represent the stoma on the atrial septum.

[0062] It should be understood that, in the embodiments of this application, for example, a stoma can refer to an opening made in the atrial septum between the left and right atria of a patient through a stoma procedure. An atrial shunt device can divert blood from the left atrium to the right atrium through the stoma in the patient's atrial septum.

[0063] refer to Figures 1 to 4 The atrial shunt device 1 may include a shunt section 11. The shunt section 11 defines a shunt path 111. The shunt path 111 may be used to connect the left and right atria of a patient in order to shunt blood from the left atrium to the right atrium. The shunt path 111 may have a first opening 111a and a second opening 111b.

[0064] When the atrial shunt device is installed in a patient's atrium, the shunt pathway 111 can be configured to communicate with the left atrium and the right atrium via a first opening 111a and a second opening 111b, respectively. The first opening 111a can be configured to be close to the front of the patient's head and / or body relative to the second opening 111b.

[0065] If the first opening is closer to the patient's head than the second opening, then when the patient is in an upright position (or a position close to it, such as a sitting position with the upper body upright), the first opening 111a is higher than the second opening 111b in terms of gravity, so that blood and / or suspended matter (such as microthrombi) in the right atrium need to overcome gravity to reach the left atrium.

[0066] If the first opening is closer to the front of the patient's body than the second opening, then when the patient is in a supine position (or a position close to it), the first opening 111a is higher than the second opening 111b by gravity, so that blood and / or suspended matter (such as microthrombi) in the right atrium need to overcome gravity to reach the left atrium.

[0067] If the first opening is closer to both the patient's head and the front of the patient's body than the second opening, then when the patient is in an upright or supine position (or a position close to an upright or supine position), the first opening 111a is higher than the second opening 111b in terms of gravity, so that blood and / or suspended matter (such as microthrombi) in the right atrium need to overcome gravity to reach the left atrium.

[0068] Therefore, when the patient is in an upright or supine position (or a position similar to an upright or supine position), the atrial shunt device of this application embodiment can effectively prevent or reduce the flow of blood and / or suspended matter in the blood from the right atrium to the left atrium, and compared to installing valves, this method can avoid the problem of pathway blockage. Considering that people spend most of their time in an upright or supine position (or a position similar to an upright or supine position) in daily life, the atrial shunt device of this application embodiment can meet the needs of patients' daily activities.

[0069] In some embodiments, see again Figures 1 to 4 When the atrial shunt device 1 is installed in the patient's atrium, the first opening 111a can be configured to be close to the front of the patient's head and body relative to the stoma H, and the second opening 111b can be configured to be close to the patient's feet and the back of the body relative to the stoma H.

[0070] To describe this implementation more clearly and accurately, a hypothetical Cartesian coordinate system is constructed to provide another perspective. This coordinate system uses the plane containing the atrial septum (AS) as the reference plane, the location of the stoma (H) as the origin, the intersection of the horizontal plane passing through the stoma (H) and the plane containing the atrial septum (AS) when the patient is in an upright position as the x-axis, the direction from the back of the patient's body to the front as the positive direction of the x-axis, the straight line passing through the origin on the reference plane and perpendicular to the x-axis as the y-axis, and the direction from the patient's feet to the head as the positive direction of the y-axis.

[0071] It should be understood that the atrial septum of a patient is not an ideal plane; it has a certain thickness and is not absolutely flat. However, for the sake of describing the embodiments of this application as clearly as possible, the atrial septum can be considered to lie on a certain plane. For example, the plane on which the atrial septum lies can be the plane with the highest degree of overlap with the atrial septum. For example, the plane on which the atrial septum lies can also be a fitted plane (or an imaginary plane) where the sum of the distances (shortest distances) from all points of the atrial septum to the plane is minimized.

[0072] When the shunt device 1 is installed in the patient's atrium, the first opening 111a can be configured such that its orthographic projection on the plane of the atrial septum is located in the first quadrant of the coordinate system, and the second opening 111b can be configured such that its orthographic projection on the plane of the atrial septum is located in the third quadrant of the coordinate system.

[0073] like Figure 2 As shown, when the patient is in an upright position, the first opening 111a is higher than the second opening 111b in the direction of gravity (i.e., the direction indicated by the thick arrow in the figure). VD1 is used to represent the height difference between the first opening 111a and the second opening 111b in the direction of gravity at this time.

[0074] like Figure 3 As shown, when the patient is in a supine position, the first opening 111a is also higher than the second opening 111b in the direction of gravity (i.e., the direction indicated by the thick arrow in the figure). VD2 is used to represent the height difference between the first opening 111a and the second opening 111b in the direction of gravity at this time.

[0075] In this way, the first opening is positioned closer to the patient's head and front of the body than the second opening, thus effectively preventing or reducing the flow of blood and / or suspended matter in the blood from the right atrium to the left atrium when the patient is in an upright or supine position (or a position close to supine or upright).

[0076] In some embodiments, reference Figure 2 and Figure 3 When the shunt device 1 is installed in the patient's atrium, the first opening 111a can be configured such that the line connecting its orthographic projection on the plane of the atrial septum and the stoma H forms an angle α of 30 to 60 degrees with the x-axis, and the second opening 111b can be configured such that the line connecting its orthographic projection on the plane of the atrial septum and the stoma H forms an angle β of 30 to 60 degrees with the x-axis. More preferably, the angle α can be 45 degrees, and the angle β can also be 45 degrees.

[0077] In this way, the height differences VD1 and VD2 between the first and second openings are relatively close when the patient is in an upright or supine position (or a position close to supine or upright). This ensures that the shunt device can provide stable and sufficient resistance to prevent or reduce the flow of blood and / or suspended matter in the blood from the right atrium to the left atrium when the patient is in an upright or supine position (or a position close to supine or upright).

[0078] The embodiments of this application do not impose specific limitations on the height differences VD1 and VD2, and those skilled in the art can set them according to actual needs.

[0079] For example, in some embodiments, the height differences VD1 and VD2 can be set to 1.5 cm to 2 cm. This height difference will generate a pressure gradient of approximately equal to or greater than 2 mmHg, which is sufficient to prevent or reduce the flow of blood and / or suspended matter in the blood from the right atrium to the left atrium in most cases. In this way, the shunt device can be made compact while meeting usage requirements.

[0080] In some embodiments, refer again Figure 2 and Figure 3When the shunt device 1 is installed in the patient's atrium, the length TL of the line connecting the orthographic projections of the first opening 111a and the second opening 111b on the plane of the interatrial septum can be 0.5cm to 4cm, more preferably 2cm to 3cm. Setting TL to this length range, combined with the included angles α and β, allows the height differences VD1 and VD2 to be 1.5cm to 2cm.

[0081] In some embodiments, see again Figure 1 and Figure 4 The shunt 11 may be tubular and includes a first portion 11a and a second portion 11b. The first portion 11a may be configured to be placed in the left atrium of the patient, and the second portion 11b may be configured to be placed in the right atrium of the patient. A first opening 111a may be provided on the first portion 11a, and a second opening 111b may be provided on the second portion 11b.

[0082] The shunt 11 may also include a third section 11c. The third section 11c connects the first section 11a and the second section 11b. When the shunt device 1 is installed in the patient's atrium, the third section may be configured to pass through a stoma H in the interatrial septum.

[0083] The first part of the tube 11a and the second part of the tube 11b can be basically parallel, and form an angle (i.e., not parallel) with the third part of the tube 11c. In other words, the axis of the first part of the tube 11a and the axis of the second part of the tube 11b are basically parallel, and form an angle with the axis of the third part of the tube 11c.

[0084] The extension direction of the first part of the tube 11a (i.e., from the end of the first part of the tube 11a near the third part of the tube 11c to the end away from the third part of the tube 11c) is opposite to the extension direction of the second part of the tube 11b (i.e., from the end of the second part of the tube 11b near the third part of the tube 11c to the end away from the third part of the tube 11c). In other words, the first part of the tube 11a and the second part of the tube 11b can extend in opposite directions from the third part of the tube 11c. The flow divider 11 as a whole is constructed in a shape similar to the letter "Z".

[0085] During installation, the first part of the tube can be installed in the left atrium, with the first opening 111a positioned relative to the stoma H close to the front and head of the patient's body, and correspondingly, the second opening 111b positioned relative to the stoma H close to the back and feet of the patient's body.

[0086] In this way, when the patient is in an upright or supine position (or a position close to supine or upright), the first opening can be ensured to be higher than the second opening in the direction of gravity. At the same time, constructing the shunt in this way allows the first and second parts of the tube to be close to the patient's atrial septum, preventing the shunt from extending excessively into the middle part of the left and right atria, thereby reducing the disturbance of blood flow in the atria by the shunt, avoiding turbulence, and reducing thrombus formation.

[0087] In some embodiments, refer again Figures 1 to 4 The angle between the first part 11a and the third part 11c can be greater than 90 degrees, for example, it can be 135 degrees. Similarly, the angle between the second part 11b and the third part 11c can be greater than 90 degrees, for example, it can be 135 degrees. In other words, the angle between the axis of the first part 11a and the axis of the third part 11c is greater than 90 degrees, for example, it can be 135 degrees.

[0088] Setting the angle between the first and second sections of the tube and the third section to be greater than 90 degrees can make the flow path of the shunt section smoother and the changes in the flow path more gradual, thereby avoiding turbulence when the blood flows through the shunt section and reducing the formation of thrombi.

[0089] In some embodiments, the first opening 111 may be provided on the peripheral wall of the first part of the tube 11a, and the second opening 112 may be provided on the peripheral wall of the second part of the tube 11b.

[0090] Given the way blood flows in the atria, placing the opening on the peripheral wall of the shunt can prevent blood from directly flowing into the shunt, thereby reducing the possibility of eddies and the formation of thrombi.

[0091] In some embodiments, the first opening 111a may be located near the end of the first portion of the tube 11a, and the second opening 111b may be located near the end of the first portion of the tube 11b. This allows for a greater distance between the first opening and the second opening, resulting in a more compact structure for the flow divider.

[0092] Of course, the first opening and the second opening are not necessarily located on the peripheral wall of the tube. In other embodiments of this application, the first opening and the second opening may also be located on the end faces of the first part of the tube and the second part of the tube, respectively.

[0093] Figure 5 This is a schematic diagram of the structure of an atrial shunt device 2 configured in the atrium according to other embodiments of this application.

[0094] like Figure 5 As shown, the atrial shunt device 2 is largely the same as the atrial shunt device 1. For the sake of simplicity, the similarities will not be described again.

[0095] See Figure 5 In this embodiment, the first opening 211a and the second opening 211b of the diversion section 21 are respectively disposed on the end faces of the first part of the tube 21a and the second part of the tube 21b.

[0096] Given the way blood flows in the atria, placing the opening of the shunt on the end face allows blood to flow directly into the shunt, thereby increasing the flow velocity at the opening and preventing or reducing the adhesion of blood or floating substances in the blood to the opening, which can cause blockage and / or proliferation.

[0097] Figure 6 This is a schematic diagram of the structure of an atrial shunt device 3 configured in the atrium according to other embodiments of this application.

[0098] like Figure 6 As shown, the atrial shunt device 3 is largely the same as the atrial shunt device 1. For the sake of simplicity, the similarities will not be described again.

[0099] refer to Figure 6 The volume of the first part 31a of the flow divider 31 is smaller than the volume of the second part 31b. In other words, the first part 31a of the flow divider 31 is shorter than the second part 31b. That is, the axial length of the first part 31a is less than the axial length of the second part 31b.

[0100] Given the blood flow patterns in the left atrium, and the higher pressure there, the portion of the shunt placed in the left atrium is more prone to turbulence, thus increasing the risk of thrombosis. Simultaneously, a smaller implant volume in the left atrium results in less impact on left atrial blood flow, reducing the area requiring surface treatment and further minimizing the risk of thrombosis. Setting the first portion of the shunt (the part placed in the left atrium) smaller than the second portion (the part placed in the right atrium) further reduces the likelihood of thrombosis.

[0101] Figure 7 This is a schematic diagram of the structure of an atrial shunt device 4 configured in the atrium according to other embodiments of this application. Figure 8 and Figure 9 for Figure 7 A schematic diagram of the atrial shunt device 4 being configured in the atrium from other views. Figure 10 This is a schematic diagram of the structure of the diversion section 41 provided in some embodiments of this application. Figure 10 The shown splitter 41 can be applied to Figure 7 In the atrial shunt device shown.

[0102] Figure 8 The view direction is the view direction from the left to the right of the patient when the patient is in an upright position. Figure 9The view direction is the view from the patient's left side to the right side when the patient is in a supine position. Figure 8 and Figure 9 In the diagram, the dashed line represents the tubular portion of the shunt 41 placed in the patient's right atrium.

[0103] refer to Figures 7 to 10 The atrial shunt device 4 includes a shunt section 41. The shunt section 41 defines a shunt path 411. When the atrial shunt device 4 is installed in the atrium of a patient, the shunt path 411 can be configured to communicate with the patient's left atrium and right atrium through a first opening 411a and a second opening 411b, respectively.

[0104] When the atrial shunt device 4 is installed in the patient's atrium, the first opening 411a can be configured such that its orthographic projection on the plane of the interatrial septum coincides substantially with the stoma H, and the second opening 411b can be configured to be close to the patient's feet and the back of the body relative to the stoma H.

[0105] In other words, when the atrial shunt device 4 is installed in the patient's atrium, the first opening 411a can be configured such that its orthographic projection on the plane of the atrial septum substantially coincides with the origin of the imaginary coordinate system, and the second opening 411b can be configured such that its orthographic projection on the plane of the atrial septum lies in the third quadrant of the coordinate system. For a detailed description of the imaginary coordinate system, please refer to the foregoing embodiments; for brevity, it will not be repeated here.

[0106] In this way, the first opening is positioned closer to the patient's head and front of the body than the second opening, ensuring that the first opening is higher than the second opening in the direction of gravity when the patient is in an upright or supine position (or a position similar to an upright or supine position). Simultaneously, this method further reduces the portion of the shunt located in the left atrium, thereby reducing the surface area requiring endovascular lining and the risk of thrombus formation.

[0107] In some embodiments, refer again Figures 7 to 10 When the shunt device 4 is installed in the patient's atrium, the first opening 411a can be configured such that its orthographic projection on the plane of the interatrial septum substantially coincides with the stoma H, and the second opening 411b on the interatrial septum can be configured such that the line connecting its orthographic projection on the plane of the interatrial septum and the stoma H forms an angle β of 30 to 60 degrees with the x-axis. More preferably, the angle β can be 45 degrees.

[0108] This ensures that the height difference VD1 and VD2 between the first and second openings are essentially the same when the patient is in an upright or supine position, thus allowing the shunt to provide more stable resistance in different body positions.

[0109] In some embodiments, refer again Figures 7 to 10 The height difference VD1 and VD2 can be set from 1.5cm to 2cm.

[0110] In some embodiments, refer again Figures 7 to 10 When the shunt device 4 is installed in the patient's atrium, the length TL of the line connecting the orthographic projections of the first opening 411 and the second opening 412 on the plane of the interatrial septum AS can be 0.5cm to 4cm, and more preferably, TL is 2cm to 3cm.

[0111] In some embodiments, refer again Figure 7 and Figure 10 The diversion section 41 may be tubular and includes a first part of the tube 41a and a second part of the tube 41b. The first part of the tube 41a and the second part of the tube 41b form an angle (i.e., they are not parallel), or in other words, the axis of the first part of the tube 41a forms an angle with the axis of the second part of the tube 41b.

[0112] When the shunt device 4 is installed in the patient's atrium, the second portion of the tube 41b can be configured to be placed in the right atrium, and the first portion of the tube 41a can be configured to pass through the stoma H of the interatrial septum and place its end in the left atrium.

[0113] The first opening 411a can be disposed on the end face of the first portion of the tube 41a, and the second opening 411b can be disposed on the peripheral wall of the second portion of the tube 41b. In other embodiments of this application, the second opening 411b can also be disposed on the end face of the second portion of the tube 41b. The first portion of the tube 41a can be shorter than the second portion of the tube 41b, so that after the first portion of the tube 41a passes through the interatrial septum AS, only a small portion of the structure is placed in the left atrium.

[0114] During installation, the first opening 411a can be placed in the left atrium, so that only a small part of the first tube body 41a is placed in the left atrium, so that the projection of the first opening 411a on the plane of the interatrial septum basically coincides with the stoma H, and the second tube body 41b is placed in the right atrium, so that the second opening 411b is close to the patient's feet and the back of the body relative to the stoma H.

[0115] This design ensures that when the patient is in an upright or supine position (or a position close to an upright or supine position), the first opening is higher than the second opening in the direction of gravity. Simultaneously, this configuration allows for a very small size of the tube portion of the shunt located in the left atrium, thereby significantly reducing turbulence in the left atrium and effectively decreasing thrombus formation.

[0116] In some embodiments, the inner diameter of the diversion section provided in this application is 4mm to 12mm, preferably 8mm to 12mm, and more preferably 10mm to 12mm.

[0117] The resistance encountered by blood flowing through the shunt is related to the inner diameter of the shunt. Setting the inner diameter of the shunt within the range mentioned above will result in a more suitable resistance.

[0118] In some embodiments, the inner wall of the diversion channel provided in this application may have hydrophobic and / or anti-biodeformation properties to prevent / reduce blood / floating matter adhering to the inner wall of the diversion tube. Alternatively, the inner wall of the diversion channel provided in this application may be a hydrophobic and / or anti-biodeformation surface.

[0119] In some embodiments, the diversion section provided in this application may include a supporting mesh frame and an inner liner tube. The supporting mesh frame is tubular, and the inner liner tube is placed within the supporting mesh frame.

[0120] For example, the support mesh can be made of a biocompatible metal mesh such as a nickel-titanium alloy with a smooth surface. The inner liner can be made of a hydrophobic and / or anti-growth / anti-tissue infiltration polymer material to prevent tissue proliferation from blocking the pathway.

[0121] Figure 11 This is a schematic diagram of the structure of an atrial shunt device 5 configured in the atrium according to other embodiments of this application. Figure 12 This is a schematic diagram of the structure of the frame portion 52 according to some embodiments of this application. Figure 12 The frame portion 52 shown can be applied to Figure 11 The atrial shunt device 5 shown.

[0122] refer to Figure 11 and Figure 12 In addition to the shunt portion 51, the atrial shunt device 5 may also include a frame portion 52. In some embodiments, the frame portion 52 may have a mesh structure. The frame portion 52 can be used to support (fix) the shunt portion 51. In some embodiments, the shunt portion 51 and the frame portion 52 can be two independent components. In some embodiments, the shunt portion 51 and the frame portion 52 can also be integrally formed.

[0123] The frame portion 52 may include a first frame portion 52a, a second frame portion 52b, and a connecting portion 52c. One end of the connecting portion 52c is connected to the first frame portion 52a, and the other end is connected to the second connecting portion 52b.

[0124] When the atrial shunt device 5 is installed in the patient's atrium, the first frame portion 52a can be configured to be placed in the patient's left atrium, the second frame portion 52b can be configured to be placed in the patient's right atrium, and the connecting portion 52c can be configured to pass through the stoma on the interatrial septum.

[0125] The shunt portion 51 may be tubular and include a first portion 51a and a second portion 51b. A first opening 511a and a second opening 511b of the shunt portion 51 may be respectively disposed on the first portion 51a and the second portion 51b. When the atrial shunt device 5 is installed in the atrium of a patient, the first portion 51a may be configured to be placed in the patient's left atrium and surrounded by a first frame portion 52a, and the second portion 51b may be configured to be placed in the patient's right atrium and surrounded by a second frame portion 52b.

[0126] By incorporating a mesh frame, the position and orientation of the shunt can be better secured. Furthermore, most existing atrial shunt devices utilize a mesh frame structure, and clinical studies have shown that this structure is less likely to cause adverse reactions. Therefore, placing the shunt within a mesh frame structure can reduce its impact on atrial physiological function and lower the likelihood of adverse reactions.

[0127] In some embodiments, refer again Figure 11 and Figure 12 The first frame portion 52a and the second frame portion 52b can be arranged symmetrically. When the atrial shunt device 5 is installed in the patient's atrium, the orthographic projection of the first frame portion 52a on the plane of the atrial septum covers the orthographic projection of the first portion tube 51a on the plane of the atrial septum and the orthographic projection of the second portion tube 51b on the plane of the atrial septum, and the orthographic projection of the second frame portion 52b on the plane of the atrial septum covers the orthographic projection of the first portion tube 51a on the plane of the atrial septum and the orthographic projection of the second portion tube 51b on the plane of the atrial septum.

[0128] This configuration allows for a more balanced distribution of the atrial shunt structure in the left and right atria, thereby making the position and orientation of the atrial shunt more stable.

[0129] Figure 13 This is a schematic diagram of the structure of an atrial shunt device 6 configured in the atrium according to other embodiments of this application. Figure 14 This is a schematic diagram of the structure of the frame portion 61 according to other embodiments of this application. Figure 14 The frame portion 61 shown can be applied to Figure 13 The atrial shunt device 6 shown.

[0130] refer to Figure 13 and Figure 14The atrial shunt device 6 is largely the same as the atrial device 5 in the above embodiments. For the sake of brevity, the similarities will not be described again.

[0131] In this embodiment, the first frame portion 62a and the second frame portion 62b of the frame portion 62 are arranged asymmetrically (or staggered). Thus, when the atrial shunt device 6 is installed in the patient's atrium, the orthographic projection of the second portion tube 61b of the shunt portion onto the plane of the atrial septum is at least partially outside the orthographic projection of the first frame portion 62a onto the plane of the atrial septum, and the orthographic projection of the first portion tube 61a onto the plane of the atrial septum is at least partially outside the orthographic projection of the second frame portion 62b onto the plane of the atrial septum. This arrangement allows for a smaller size of the first and second frame portions, resulting in a more compact overall structure of the atrial shunt device.

[0132] Figure 15 This is a schematic diagram of the structure of an atrial shunt device 7 configured in the atrium according to other embodiments of this application. Figure 16 This is a schematic diagram of the structure of the frame portion 71 according to other embodiments of this application. Figure 16 The frame section 71 shown can be applied to Figure 15 The atrial shunt device 7 shown.

[0133] In this embodiment, the atrial shunt device 7 includes a shunt portion 71 and a frame portion 72. The frame portion 72 may include a first frame portion 72a, a second frame portion 72b, and a connecting portion 72c. Both the first frame portion 72a and the second frame portion 72b are dome-shaped. The first frame portion 72a can be installed in the patient's left atrium. The second frame portion 72b can be installed in the patient's right atrium. One end of the connecting portion 72c is connected to the first frame portion 72a, and the other end is connected to the second connecting portion 72b. The connecting portion 72c can be installed as a stoma passing through the atrial septum.

[0134] The shunt section 71 includes a first portion tube 71a and a second portion tube 71b. A first opening and a second opening of the shunt section 71 can be respectively disposed on the first portion tube 71a and the second portion tube 71b. When the atrial shunt device 7 is installed in the patient's atrium, the first portion tube 71a can be installed in the patient's left atrium, and is partially or entirely outside the space enclosed by the first frame portion 72a; the second portion tube 71b can be installed in the patient's right atrium, and is partially or entirely outside the space enclosed by the second frame portion 72b.

[0135] More specifically, when the atrial shunt device 7 is installed in the patient's atrium, the first portion of the tube 71a may be entirely or partially located outside the space enclosed by the first frame portion 72a, and the projection of the first portion of the tube 71a on the plane of the atrial septum may be entirely or partially covered by the orthographic projection of the second frame portion 72b on the plane of the atrial septum; the second portion of the tube 71b may be entirely or partially located outside the space enclosed by the second frame portion 72b, and the projection of the second portion of the tube 71b on the plane of the atrial septum may be entirely or partially covered by the orthographic projection of the first frame portion 72a on the plane of the atrial septum.

[0136] In this way, the structural distribution of the atrial shunt device in the atrium can be more balanced, thereby improving the stability of the atrial shunt device in the atrium.

[0137] Figure 17 This is a schematic diagram of an atrial shunt device 8 disposed in an atrium according to other embodiments of this application. The atrial shunt device 8 is substantially the same as the atrial device in the above embodiments. For the sake of brevity, the similarities will not be described again.

[0138] The first portion of the tube 81a of the diversion section 81 can be configured such that a portion is placed within the first frame section 82a and the other portion extends outside the first frame section 82a, so that the first opening 811a is exposed outside the first frame section 82a. Similarly, the second portion of the tube 81b can be configured such that a portion is placed within the second frame section 82b and the other portion extends outside the second frame section 82b, so that the second opening 811b is exposed outside the second frame section 82b.

[0139] In this way, blood in the atrium can flow directly into or out of the shunt pathway through the first and second openings without having to pass through the holes on the frame, thus avoiding the problem of blood being unable to flow through the shunt device due to blockage of the holes on the frame.

[0140] Figure 18 This is a schematic diagram of an atrial shunt device 9 disposed in an atrium according to other embodiments of this application. The atrial shunt device 9 is substantially the same as the atrial device in the above embodiments. For the sake of brevity, the similarities will not be described again.

[0141] In this embodiment, the first portion of the diversion section 91, tube 91a, can be configured to extend from the interior of the first frame section 92a to the surface of the first frame section 92a (or, the boundary of the first frame section 92a), and form the first opening 911a on the surface of the first frame section 92a. The second portion of the tube 91b can be configured to extend from the interior of the second frame section 92b to the surface of the second frame section 92b, and form the second opening 911b on the surface of the second frame section 92b.

[0142] In this way, blood in the atrium can flow directly into or out of the shunt pathway through the first and second openings without having to pass through the holes in the frame portion. This avoids the problem of blood being unable to flow through the shunt device due to blockage of the holes in the frame portion. Furthermore, this implementation method ensures that the shunt portion does not protrude beyond the frame portion, thereby reducing the impact on blood flow and lowering the possibility of thrombosis.

[0143] Figure 19 This is a schematic diagram of an atrial shunt device 10 configured in an atrium according to other embodiments of this application. The atrial shunt device 10 is substantially the same as the atrial device in the above embodiments. For the sake of brevity, the similarities will not be described again.

[0144] like Figure 19 As shown, the first frame portion 102a of the diversion device 10 can be smaller than the second frame portion 120b. In other words, the space occupied by the first frame portion 102a is smaller than the space occupied by the second frame portion 120b.

[0145] Given the flow pattern of blood in the left atrium, and the higher pressure there, the implant placed in the left atrium is more prone to turbulence, thus inducing thrombosis. Furthermore, the smaller the implant in the left atrium, the less impact it has on left atrial blood flow, and the smaller the area requiring epithelialization, which is more conducive to reducing the risk of thrombosis in the left atrium.

[0146] In some embodiments, see again Figure 19 The diversion section 101 of the diversion device 10 can be adopted Figure 7 The diversion section 41 in the illustrated embodiment can further reduce the size of the first frame section 102a.

[0147] In some embodiments, both the first frame portion and the second frame portion in the above embodiments may be dome-shaped. The surface of the dome-shaped frame portion is relatively flat, thereby reducing the impact on blood flow and lowering the possibility of thrombosis.

[0148] The above, combined with Figures 1 to 19 The atrial shunt device provided in the embodiments of this application has been illustrated with examples. The following is a description in conjunction with... Figure 20 The installation method embodiments of this application are illustrated with examples. The installation method provided in this application can be used to install the atrial shunt device provided in the above embodiments. The method embodiments and device embodiments correspond one-to-one; for the sake of brevity, repetitive descriptions are appropriately omitted.

[0149] Figure 20 This is a schematic flowchart illustrating the installation method of an atrial shunt device provided in some embodiments of this application.

[0150] refer to Figure 20 The installation method S100 for the atrial shunt device includes steps S110 and S120.

[0151] In step S110, an atrial shunt device is provided.

[0152] Here, an atrial shunt device is used to divert blood from the left atrium to the right atrium through a stoma on the patient's atrial septum. The atrial shunt device includes a shunt portion that defines a shunt pathway, the shunt pathway having a first opening and a second opening.

[0153] In step S120, the atrial shunt device is installed into the patient's atrium.

[0154] Here, the shunt pathway can be configured to communicate with the left and right atria via a first opening and a second opening, respectively. The first opening is configured to be closer to the patient's head relative to the second opening, and / or the first opening is configured to be closer to the anterior part of the patient's body relative to the second opening.

[0155] Alternatively, the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright position, and / or the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in a supine position.

[0156] The atrial shunt device provided in this application can effectively prevent blood from flowing from the right atrium into the left atrium without causing pathway blockage.

[0157] In some embodiments, the first opening is configured to be close to the front of the patient's head and body relative to the second opening.

[0158] In some embodiments, the first opening is configured to be close to the front of the patient's head and body relative to the stoma, and the second opening is configured to be close to the back of the patient's feet and body relative to the stoma.

[0159] In some embodiments, the first opening is configured such that its orthographic projection on the plane of the atrial septum lies in the first quadrant of an imaginary coordinate system, and the second opening is configured such that its orthographic projection on the plane of the atrial septum lies in the third quadrant of the coordinate system, wherein the coordinate system is a plane rectangular coordinate system with the plane of the atrial septum as the reference plane, the stoma as the origin, the intersection of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line passing through the origin and perpendicular to the x-axis on the reference plane as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

[0160] In some embodiments, the first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin makes an angle of 30 to 60 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin makes an angle of 30 to 60 degrees with the x-axis.

[0161] In some embodiments, the first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis.

[0162] In some embodiments, the first opening is configured such that its orthographic projection on the plane of the interatrial septum at least partially coincides with the stoma, and the second opening is configured to be close to the patient's feet and the posterior part of the body relative to the stoma.

[0163] In some embodiments, the first opening is configured such that its orthographic projection on the plane of the atrial septum substantially coincides with the origin of an imaginary coordinate system, and the second opening is configured such that its orthographic projection on the plane of the atrial septum lies in the third quadrant of the coordinate system, wherein the coordinate system is a plane rectangular coordinate system with the plane of the atrial septum as the reference plane, the stoma as the origin, the intersection of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line passing through the origin and perpendicular to the x-axis on the reference plane as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

[0164] In some embodiments, the second opening is configured such that the line connecting its orthographic projection onto the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis.

[0165] In some embodiments, the second opening is configured such that the line connecting its orthographic projection onto the reference plane and the origin forms an angle of 45 degrees with the x-axis.

[0166] In some embodiments, the shunt is tubular, comprising a first portion of the tube and a second portion of the tube, wherein the first portion of the tube is configured to be placed in the left atrium and the second portion of the tube is configured to be placed in the right atrium, wherein a first opening is provided on the end face or peripheral wall of the first portion of the tube and a second opening is provided on the end face or peripheral wall of the second portion of the tube.

[0167] In some embodiments, the shunt is tubular, comprising a first portion of the tube and a second portion of the tube. The first portion of the tube is configured to be placed in the left atrium, and the second portion of the tube is configured to be placed in the right atrium. A first opening and a second opening are respectively provided on the first portion of the tube and the second portion of the tube. The volume of the first portion of the tube is smaller than the volume of the second portion of the tube.

[0168] In some embodiments, the shunt is tubular, comprising a first portion of the tube and a second portion of the tube, the first portion of the tube being configured to be placed in the left atrium and the second portion of the tube being configured to be placed in the right atrium, wherein a first opening and a second opening are respectively provided on the first portion of the tube and the second portion of the tube, and the first portion of the tube is shorter than the second portion of the tube.

[0169] In some embodiments, the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright or supine position, and the height difference between the first opening and the second opening in the direction of gravity is 1.5 cm to 2 cm.

[0170] In some embodiments, the inner diameter of the branch flow path is 8 mm to 15 mm.

[0171] In some embodiments, the inner wall of the branch flow path has hydrophobic and / or anti-biodeformation properties.

[0172] In some embodiments, the atrial shunt device further includes a frame portion having a mesh structure, the frame portion including: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through the stoma, wherein the shunt portion is tubular, the shunt portion including: a first portion tube body, a first opening disposed on the first portion tube body, the first portion tube body being configured to be surrounded by the first frame portion; and a second portion tube body, a second opening disposed on the second portion tube body, the second portion tube body being configured to be surrounded by the second frame portion.

[0173] In some embodiments, the atrial shunt device further includes a frame portion comprising: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through an ostomy, wherein the shunt portion is tubular and includes: a first portion tube body having a first opening disposed on the first portion tube body, the first portion tube body being configured such that a portion is placed within the first frame portion and another portion extends outside the first frame portion, thereby exposing the first opening outside the first frame portion; and a second portion tube body having a second opening disposed on the second portion tube body, the second portion tube body being configured such that a portion is placed within the second frame portion and another portion extends outside the second frame portion, thereby exposing the second opening outside the second frame portion.

[0174] In some embodiments, the atrial shunt device further includes a frame portion comprising: a first frame portion configured to be placed in the left atrium; a second frame portion configured to be placed in the right atrium; and a connecting portion connecting the first frame portion and the second frame portion and configured to pass through an ostomy, wherein the shunt portion is tubular and includes: a first portion tube body configured to extend from the interior of the first frame portion to the surface of the first frame portion and form a first opening on the surface of the first frame portion; and a second portion tube body configured to extend from the interior of the second frame portion to the surface of the second frame portion and form a second opening on the surface of the second frame portion.

[0175] In some embodiments, the first frame portion is configured such that its orthographic projection on the plane where the interatrial septum is located covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane where the interatrial septum is located, and the second frame portion is configured such that its orthographic projection on the plane where the interatrial septum is located covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane where the interatrial septum is located.

[0176] In some embodiments, the first portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the second frame portion on the plane of the interatrial septum, and the second portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the first frame portion on the plane of the interatrial septum.

[0177] In some embodiments, the first frame portion is smaller than the second frame portion.

[0178] It should be understood that the term "comprising" and its variations as used in this application are open-ended, meaning "including but not limited to". The term "according to" means "at least in part according to". The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment".

[0179] It should be understood that although terms such as "first" or "second" may be used in this application to describe various elements (such as a first part of the conduit, a second part of the conduit), these elements are not limited by these terms, which are only used to distinguish one element from another.

[0180] It should be understood that the term "comprising" and its variations as used in this application are open-ended, meaning "including but not limited to". The term "according to" means "at least in part according to". The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment".

[0181] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. An atrial shunt device for diverting blood from the left atrium to the right atrium through a stoma on the patient's atrial septum, characterized in that, The atrial shunt device includes a shunt section defining a shunt pathway, the shunt pathway having a first opening and a second opening, wherein... The shunt pathway is configured to communicate with the left atrium and the right atrium through the first opening and the second opening, respectively. The first opening is configured to be closer to the patient's head relative to the second opening, and the first opening is configured to be closer to the front of the patient's body relative to the second opening. The first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright position, and also higher than the second opening in the direction of gravity when the patient is in a supine position.

2. The atrial shunt device according to claim 1, characterized in that, The first opening is configured to be close to the front of the patient's head and body relative to the stoma, and the second opening is configured to be close to the back of the patient's feet and body relative to the stoma.

3. The atrial shunt device according to claim 1, characterized in that, The first opening is configured such that its orthographic projection on the plane containing the interatrial septum lies in the first quadrant of an imaginary coordinate system, and the second opening is configured such that its orthographic projection on the plane containing the interatrial septum lies in the third quadrant of the coordinate system, wherein... The coordinate system is a plane rectangular coordinate system. The coordinate system takes the plane where the atrial septum is located as the reference plane, the stoma as the origin, the intersection line of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line on the reference plane passing through the origin and perpendicular to the x-axis as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

4. The atrial shunt device according to claim 3, characterized in that, The first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis.

5. The atrial shunt device according to claim 4, characterized in that, The first opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis, and the second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis.

6. The atrial shunt device according to claim 1, characterized in that, The first opening is configured such that its orthographic projection on the plane of the interatrial septum at least partially coincides with the stoma, and the second opening is configured relative to the stoma to be close to the patient's feet and the back of the body.

7. The atrial shunt device according to claim 1, characterized in that, The first opening is configured such that its orthographic projection onto the plane containing the interatrial septum substantially coincides with the origin of an imaginary coordinate system, and the second opening is configured such that its orthographic projection onto the plane containing the interatrial septum lies in the third quadrant of the coordinate system. The coordinate system is a plane rectangular coordinate system. The coordinate system takes the plane where the atrial septum is located as the reference plane, the stoma as the origin, the intersection line of the horizontal plane passing through the origin and the reference plane when the patient is in an upright position as the x-axis, the direction from the back to the front of the patient's body as the positive direction of the x-axis, the straight line on the reference plane passing through the origin and perpendicular to the x-axis as the y-axis, and the direction from the feet to the head of the patient's body as the positive direction of the y-axis.

8. The atrial shunt device according to claim 7, characterized in that, The second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 30 to 60 degrees with the x-axis.

9. The atrial shunt device according to claim 8, characterized in that, The second opening is configured such that the line connecting its orthographic projection on the reference plane and the origin forms an angle of 45 degrees with the x-axis.

10. The atrial shunt device according to claim 1, characterized in that, The diversion section is tubular, and includes a first part of the tube and a second part of the tube. The first part of the tube is configured to be placed in the left atrium, and the second part of the tube is configured to be placed in the right atrium. The first opening is provided on the end face or peripheral wall of the first part of the tube, and the second opening is provided on the end face or peripheral wall of the second part of the tube.

11. The atrial shunt device according to claim 1, characterized in that, The diversion section is tubular, comprising a first part of the tube and a second part of the tube. The first part of the tube is configured to be placed in the left atrium, and the second part of the tube is configured to be placed in the right atrium. The first opening and the second opening are respectively provided on the first part of the tube and the second part of the tube. The volume of the first part of the tube is smaller than the volume of the second part of the tube.

12. The atrial shunt device according to claim 1, characterized in that, The diversion section is tubular, comprising a first part of the tube and a second part of the tube. The first part of the tube is configured to be placed in the left atrium, and the second part of the tube is configured to be placed in the right atrium. The first opening and the second opening are respectively provided on the first part of the tube and the second part of the tube, and the first part of the tube is shorter than the second part of the tube.

13. The atrial shunt device according to claim 1, characterized in that, The height difference between the first opening and the second opening in the direction of gravity is 1.5cm to 2cm.

14. The atrial shunt device according to any one of claims 1 to 13, characterized in that, The inner diameter of the branch flow path is 8mm to 15mm.

15. The atrial shunt device according to any one of claims 1 to 13, characterized in that, The inner wall of the branch flow path has hydrophobic and / or anti-biodeformation properties.

16. The atrial shunt device according to claim 1, characterized in that, The atrial shunt device further includes a frame section, the frame section having a mesh structure, the frame section comprising: The first frame portion is configured to be placed in the left atrium; The second frame portion is configured to be placed in the right atrium; and A connecting portion, connecting the first frame portion and the second frame portion, and configured to pass through the stoma, wherein the diversion portion is tubular and includes: A first portion of the tube, the first opening being disposed on the first portion of the tube, the first portion of the tube being configured to be surrounded by the first frame portion; and The second part of the tube has the second opening disposed on it, and the second part of the tube is configured to be surrounded by the second frame portion.

17. The atrial shunt device according to claim 1, characterized in that, The atrial shunt device further includes a frame portion, the frame portion comprising: The first frame portion is configured to be placed in the left atrium; The second frame portion is configured to be placed in the right atrium; and A connecting portion, connecting the first frame portion and the second frame portion, and configured to pass through the stoma, wherein the diversion portion is tubular and includes: A first portion of the tube, wherein the first opening is disposed on the first portion of the tube, the first portion of the tube being configured such that a portion is placed within the first frame portion and another portion extends outside the first frame portion, such that the first opening is exposed outside the frame portion; and The second part of the tube has the second opening disposed on it. The second part of the tube is configured such that a portion is placed inside the second frame portion and another portion extends outside the second frame portion, so that the second opening is exposed outside the frame portion.

18. The atrial shunt device according to claim 1, characterized in that, The atrial shunt device further includes a frame portion, the frame portion comprising: The first frame portion is configured to be placed in the left atrium; The second frame portion is configured to be placed in the right atrium; and A connecting portion, connecting the first frame portion and the second frame portion, and configured to pass through the stoma, wherein the diversion portion is tubular and includes: A first portion of the tube, configured to extend from the interior of the first frame portion to a surface of the first frame portion, and forming the first opening on the surface of the first frame portion; and The second part of the tube is configured to extend from the interior of the second frame portion to the surface of the second frame portion, and to form the second opening on the surface of the second frame portion.

19. The atrial shunt device according to any one of claims 16 to 18, characterized in that, The first frame portion is configured such that its orthographic projection on the plane where the interatrial septum is located covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane where the interatrial septum is located, and the second frame portion is configured such that its orthographic projection on the plane where the interatrial septum is located covers the orthographic projections of the first portion of the tube and the second portion of the tube on the plane where the interatrial septum is located.

20. The atrial shunt device according to any one of claims 16 to 18, characterized in that, The first portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the second frame portion on the plane of the interatrial septum, and the second portion of the tube is configured such that its orthographic projection on the plane of the interatrial septum is at least partially outside the orthographic projection of the first frame portion on the plane of the interatrial septum.

21. The atrial shunt device according to any one of claims 16 to 18, characterized in that, The first frame portion is smaller than the second frame portion.

22. The atrial shunt device according to any one of claims 16 to 18, characterized in that, The first frame portion and / or the second frame portion are dome-shaped.

23. An atrial shunt device for diverting blood from the left atrium to the right atrium through a stoma on the patient's atrial septum, characterized in that, The atrial shunt device includes a shunt section defining a shunt pathway, the shunt pathway having a first opening and a second opening, wherein... The shunt pathway is configured to communicate with the left atrium and the right atrium through the first opening and the second opening, respectively. The first opening is configured to be higher than the second opening in the direction of gravity when the patient is in an upright position, and the first opening is configured to be higher than the second opening in the direction of gravity when the patient is in a supine position.

24. An atrial shunt device, characterized in that, Includes a diversion section defining a diversion path having a first opening and a second opening, the first opening being configured to be higher in the direction of gravity than the second opening when the patient is in an upright position, and also higher in the direction of gravity than the second opening when the patient is in a supine position. The diversion section is tubular, and the diversion section includes: The first part of the tube body, the first opening is provided on the first part of the tube body; The second part of the tube, the second opening being disposed on the second part of the tube; and The third part of the tube is connected at one end to the first part of the tube and at the other end to the second part of the tube. The first part of the tube is substantially parallel to the second part of the tube and forms an angle with the third part of the tube. The first part of the tube and the second part of the tube extend from the third part of the tube in opposite directions.

25. An atrial shunt device, characterized in that, Includes a diversion section defining a diversion path having a first opening and a second opening, the first opening being configured to be higher in the direction of gravity than the second opening when the patient is in an upright position, and also higher in the direction of gravity than the second opening when the patient is in a supine position. The diversion section is tubular, and the diversion section includes: The first part of the tube body, wherein the first opening is provided on the end face of the first part of the tube body; as well as The second part of the tube has the second opening located on it. The second part of the tube forms an angle with the first part of the tube, and the first part of the tube is shorter than the second part of the tube.

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