shunt

Abstract

The application discloses a shunt, comprising a tube body, comprising an outer skeleton and an inner skeleton connected, a first through hole is formed on the outer skeleton, the first through hole is arranged along the axial direction of the outer skeleton, the inner skeleton is located on the inner side of the first through hole, the outer wall of the inner skeleton is at least partially spaced from the inner wall of the first through hole, a second through hole is formed on the inner skeleton, and the second through hole is arranged along the axial direction of the inner skeleton. Thus, by spacing the outer wall of the inner skeleton from the inner wall of the first through hole, a certain spacing distance is formed between the outer wall of the inner skeleton and the inner wall of the first through hole, so that a certain deformation space is formed between the inner skeleton and the inner wall of the first through hole. After the left atrial pressure of the patient increases, the inner skeleton can expand towards the radial outside under the pressure of the blood flow, so that the area of the radial section of the second through hole increases, the blood flow passing amount per unit area is increased, and the long-term increased blood flow pressure in the left atrium can be adapted.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, specifically to a shunt. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Atrial septal shunts are primarily used to reduce left atrial pressure and divert blood flow from the left atrium to the right atrium to alleviate pulmonary congestion and dyspnea, without significantly increasing the burden on the right heart or reducing cardiac output, and without causing paradoxical embolism.

[0004] In existing atrial septal shunts, the basic dimensions of the shunt orifice remain fixed. For some patients with low initial shunt flow requirements, as they age or their condition worsens, the pressure in the left atrium increases, and the initially implanted low-flow atrial septal shunt cannot meet their needs. This requires re-puncturing the atrial septum to implant a new device, causing significant discomfort and inconvenience to the patient. Summary of the Invention

[0005] Therefore, it is necessary to provide a diverter including an outer frame and an inner frame connected to each other. The outer frame has a first through hole, which is arranged along the axial direction of the outer frame. The inner frame is located inside the first through hole. The outer wall of the inner frame is at least partially spaced from the inner wall of the first through hole. The inner frame has a second through hole, which is arranged along the axial direction of the inner frame.

[0006] Optionally, the inner skeleton and the outer skeleton are sealed together, and the inner skeleton is adapted to expand radially outward under pressure.

[0007] Optionally, the splitter also includes a connector, the two ends of which are connected to the outer frame and the inner frame respectively, and the connector is located between the outer frame and the inner frame.

[0008] Optionally, the connector includes a first section, a second section, and a third section. The first section is connected to the outer frame, and the third section is connected to the inner frame. The first section and the second section are set at a predetermined angle, and the second section and the third section are set at a predetermined angle.

[0009] Optionally, the connector is axially inclined relative to the inner frame. The connector includes a first connector and a second connector. The first connector and the second connector are radially opposite to each other on the outer frame, and the inclination directions of the first connector and the second connector are opposite.

[0010] Optionally, the diverter also includes a flow-blocking membrane, which is connected to the inner frame and the outer frame and is located between the inner frame and the outer frame, with the flow-blocking membrane and the connector spaced apart.

[0011] Optionally, the flow-blocking membrane is inclined relative to the inner skeleton, with the flow-blocking membrane inclined towards the center of the inner skeleton.

[0012] Optionally, the inner frame includes multiple corrugated rings and connecting rods. The multiple corrugated rings are spaced apart along the axial direction of the inner frame. The connecting rod connects two adjacent corrugated rings. Each corrugated ring includes a crest, a trough, and a wave rod connecting the crest and trough. The connecting rod connects to the midpoint of the wave rod. One end of the connector is connected to the connecting rod, and the other end of the connector is connected to the outer frame.

[0013] Optionally, the connecting rod includes a bent portion located between two adjacent corrugated rings, with the concave surface of the bent portion facing the crest or trough of the corrugated ring.

[0014] Optionally, the outer frame includes a first fixing frame and a second fixing frame, which are located at the two axial ends of the first through hole, respectively, and the ends of the first fixing frame and the second fixing frame are bent toward the side close to the center of the inner frame.

[0015] Compared with the prior art, the advantages of the shunt device described in this invention are:

[0016] This invention connects an inner frame and an outer frame. The inner frame has a second through-hole, allowing blood flow from the left atrium to enter the right atrium, thus achieving blood diversion within the left atrium. Furthermore, the outer wall of the inner frame is spaced apart from the inner wall of the first through-hole, creating a certain deformation space between them. When the pressure in the patient's left atrium increases, the inner frame can expand radially outward under the pressure of the blood flow, thereby increasing the radial cross-sectional area of ​​the second through-hole and increasing the blood flow per unit area. This allows it to accommodate the long-term increase in blood pressure within the left atrium. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of the splitter in Embodiment 1 of the present invention;

[0019] Figure 2 This is a schematic diagram of the deformation of the inner skeleton in Embodiment 1 of the present invention;

[0020] Figure 3This is an exploded view of the connection between the flow-blocking membrane and the inner skeleton in Embodiment 1 of the present invention;

[0021] Figure 4 This is a schematic diagram of one embodiment of the flow-blocking membrane in Embodiment 1 of the present invention;

[0022] Figure 5 This is a schematic diagram of another embodiment of the flow-blocking membrane in Embodiment 1 of the present invention;

[0023] Figure 6 This is a schematic diagram of the axial cross-sectional structure of the outer skeleton in Embodiment 1 of the present invention;

[0024] Figure 7 This is a schematic diagram of the structure of the first fixing frame in Embodiment 1 of the present invention;

[0025] Figure 8 This is a schematic diagram of the connector structure in Embodiment 2 of the present invention;

[0026] Figure 9 For the present invention Figure 8 Enlarged schematic diagram of the structure at point A in the diagram;

[0027] Figure 10 This is a schematic diagram of one embodiment of the inner skeleton in Embodiment 2 of the present invention;

[0028] Figure 11 This is a schematic diagram of the unfolded structure of the inner skeleton in Embodiment 2 of the present invention;

[0029] Figure 12 For the present invention Figure 11 Enlarged schematic diagram of the structure at point B in the diagram. Detailed Implementation

[0030] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0032] In the field of interventional medical devices, "distal" is usually defined as the end furthest from the operator during surgery, while "proximal" is defined as the end closest to the operator during surgery.

[0033] Example 1

[0034] This embodiment provides a splitter 100, such as Figure 1 , Figure 2 As shown, this device is used to create a channel in the atrial or ventricular septum to connect the left and right atria, thereby diverting blood flow from the left atrium to the left ventricle. Alternatively, it can connect the left and right ventricles, thereby allowing blood flow from the left ventricle to flow back into the right ventricle.

[0035] The shunt 100 includes an outer frame 110 and an inner frame 120 connected to each other. The inner frame 120 and the outer frame 110 can be formed by braiding filaments or by laser cutting of tubular components. The outer frame 110 and the inner frame 120 can be made of shape memory material or medical-grade stainless steel. The outer frame 110 and the inner frame 120 can be integrally connected or connected via a connector 140. Integral connection means that the outer frame 110 and the inner frame 120 are integrally woven or integrally connected by laser cutting of tubular components.

[0036] The outer frame 110 has a first through hole 111, which is arranged along the axial direction of the outer frame 110. The first through hole 111 passes through both ends of the outer frame 110 along the axial direction. The axis l1 of the first through hole 111 is on the same straight line as the axis l1 of the outer frame 110.

[0037] An inner frame 120 is inserted into the first through hole 111, located inside the first through hole 111. The inner frame 120 is arranged along the axial direction of the first through hole 111, and the axis of the inner frame 120 is on the same straight line as the axis of the first through hole 111. The outer wall of the inner frame 120 is at least partially spaced from the inner wall of the first through hole 111. The outer wall of the inner frame 120 has a certain distance from the inner wall of the first through hole 111.

[0038] The inner frame 120 has a second through hole 121, which is arranged along the axial direction of the inner frame 120. The second through hole 121 extends through both ends of the inner frame 120 along the axial direction, and the axis of the second through hole 121 is on the same straight line as the axis of the first through hole 111. The inner side of the second through hole 121 forms a lumen structure. The two ends of the second through hole 121 are open, and the sidewall of the second through hole 121 is sealed. When blood passes through the inner side of the second through hole 121, it is difficult to pass through the sidewall of the second through hole 121 and enter the space between the inner frame 120 and the outer frame 110.

[0039] likeFigure 1 As shown, the inner frame 120 and the outer frame 110 are at least partially spaced apart. In one embodiment, both ends of the inner frame 120 are connected to the inner walls of the outer frame 110, and the sidewalls of the inner frame 120 protrude in a direction away from the sidewalls of the outer frame 110 to space the inner frame 120 from the outer frame 110. Specifically, the inner frame 120 includes a first end 124, a second end 126, and a main body 125, with the first end 124 and the second end 126 respectively connected to the inner walls of the outer frame 110. The main body 125 protrudes in a direction away from the outer frame 110. The concave surface of the main body 125 faces the outer frame 110, and the convex surface of the main body 125 faces the radial center of the inner frame 120. In another embodiment, the inner frame 120 and the outer frame 110 are connected by a connector 140, which is located between the inner frame 120 and the outer frame 110. One end of the connector 140 is connected to the main body 125 of the inner frame 120, and the other end of the connector 140 is connected to the outer frame 110 to achieve the inner frame 120 and the outer frame 110 being spaced apart.

[0040] The inner skeleton 120 has a certain degree of radial expandability. Radial expandability means that when the inner skeleton 120 is subjected to pressure directed radially outward, it can expand radially outward. That is, when subjected to pressure directed radially outward, the sidewalls of the inner skeleton 120 can move towards the inner wall of the first through-hole 111, increasing the diameter of the inner skeleton 120 and the aperture of the second through-hole 121. The inner skeleton 120 can be made of an elastic material or include a radially expandable structure. The inner skeleton 120 includes a mesh structure, which is formed by braiding filaments or by laser cutting of tubular parts. In this embodiment, the mesh structure is formed by braiding filaments, which are made of shape memory alloys, shape memory polymers, or filamentous materials with a certain degree of elasticity. This embodiment does not limit the material of the braiding filaments, as long as the inner skeleton 120 can expand radially outward after the blood flow pressure in the second through-hole 121 increases or under the inflation pressure of the airbag. For example, in one embodiment, after the blood flow pressure within the second through-hole 121 increases, the two intersecting braided filaments slide against each other under the pressure of the blood flow, increasing the mesh area of ​​individual mesh openings within the mesh structure, thereby achieving radial expansion of the inner skeleton 120. It can be understood that, in another embodiment, after the blood flow pressure within the second through-hole 121 increases, the braided filaments extend radially outward under the pressure of the blood flow, thereby achieving radial expansion of the inner skeleton 120.

[0041] After the shunt 100 is implanted in the interatrial septum, blood flows through the second through-hole 121 into the right atrium. As the patient's condition worsens or they age, the blood pressure in the left atrium increases, and the endocardium 120 expands radially outward under this pressure, increasing the diameter and area of ​​the second through-hole 121. For example, in one embodiment, such as... Figure 2 As shown, in the initial stage of shunt 100 implantation, the blood flow pressure in the left atrium is relatively low. At this time, the inner framework 120 has a first shape 122, with a small inner diameter, and the second through-hole 121 has an aperture d1. In the later stage of shunt 100 implantation, the blood flow pressure in the left atrium is relatively high. At this time, the inner framework 120 has a second shape 123, with the inner framework 120 expanding radially outward towards the stent. The inner diameter of the inner framework 120 is larger, and the second through-hole 121 has an aperture d2. The aperture d1 of the first through-hole 111 is smaller than the aperture d2 of the second through-hole 121. It can be understood that in other embodiments, an expansion balloon can be inserted into the second through-hole 121 to expand the inner framework 120 radially outward, thereby increasing the aperture of the second through-hole 121.

[0042] In this way, the inner frame 120 is connected to the outer frame 110. The inner frame 120 has a second through hole 121, which allows blood flow in the left atrium to enter the right atrium, thus achieving blood diversion in the left atrium. Furthermore, the outer wall of the inner frame 120 is spaced apart from the inner wall of the first through hole 111, creating a certain distance between them. This provides a certain deformation space between the inner frame 120 and the inner wall of the first through hole 111. When the pressure in the patient's left atrium increases, the inner frame 120 can expand radially outward under the pressure of the blood flow, thereby increasing the radial cross-sectional area of ​​the second through hole 121 and increasing the blood flow per unit area, thus accommodating the increased blood pressure in the left atrium.

[0043] like Figure 1 , Figure 2 As shown, the diameters of the first end 124 and the second end 126 of the inner skeleton 120 are larger than the diameter of the main body 125. The first end 124 and the second end 126 of the inner skeleton 120 form a flared structure, and the diameter of the inner skeleton 120 decreases from both ends towards the axial center. Thus, because the diameters of the first end 124 and the second end 126 of the inner skeleton 120 are larger than the diameter of the main body 125, the maximum blood pressure is concentrated at the main body 125 of the inner skeleton 120 when blood flows through it, making the main body 125 more susceptible to the pressure of the blood flow and causing it to expand radially outward.

[0044] like Figures 3-4As shown, the inner frame 120 and the outer frame 110 are sealed together. The sealed connection means that after the inner frame 120 and the outer frame 110 are connected, a seal is formed between the inner frame 120 and the outer frame 110.

[0045] In one implementation, such as Figure 3 As shown, the diverter 100 also includes a flow-blocking membrane 130. The two ends of the inner frame 120 are respectively connected to the outer frame 110. The flow-blocking membrane 130 covers the side wall of the inner frame 120. The flow-blocking membrane 130 and the inner frame 120 enclose a cavity structure (i.e., the second through hole 121). The flow-blocking membrane 130 extends from the side wall of the inner frame 120 to the connection position between the inner frame 120 and the outer frame 110 to achieve a sealed connection between the inner frame 120 and the outer frame 110.

[0046] In another implementation, such as Figure 4 As shown, the inner frame 120 and the outer frame 110 are connected by a connector 140, which is located between the inner frame 120 and the outer frame 110. One end of the connector 140 is connected to the inner frame 120, and the other end is connected to the outer frame 110. There are multiple connectors 140, which are equidistantly spaced along the circumference of the inner frame 120.

[0047] The flow-blocking membrane 130 includes a first flow-blocking membrane 131 and a second flow-blocking membrane 132. The first flow-blocking membrane 131 covers the sidewall of the inner skeleton 120 to form a second through-hole 121 on the inner side of the inner skeleton 120. There are two second flow-blocking membranes 132, which are respectively disposed at both ends of the axial direction of the inner skeleton 120. One end of the second flow-blocking membrane 132 is connected to the inner skeleton 120, and the other end of the second flow-blocking membrane 132 is connected to the outer skeleton 110. The first flow-blocking membrane 131 and the second flow-blocking membrane 132 enclose each other to achieve a sealed connection between the inner skeleton 120 and the outer skeleton 110. In another embodiment, the inner skeleton 120 forms a dense mesh structure to form a blockage. After blood flows through the dense mesh, it accumulates in the mesh openings to form a thrombus, thereby forming a blockage on the sidewall of the inner skeleton 120.

[0048] like Figure 5 As shown, the flow-blocking membrane 130 is inclined at least one axial end relative to the inner frame 120, and the axial end of the flow-blocking membrane 130 is inclined toward the center of the inner frame 120 to form a flow-guiding surface.

[0049] It should be noted that both ends of the flow-blocking membrane 130 can be inclined toward the center of the inner framework 120, or only one end of the flow-blocking membrane 130 can be inclined toward the center of the inner framework 120. Specifically, the side of the flow-blocking membrane 130 closest to the left atrium or left ventricle is inclined toward the center of the inner framework 120.

[0050] In one embodiment, the flow-blocking membrane 130 includes a first axial end near the left atrium and a second axial end near the right atrium, the first axial end being inclined toward the center of the inner framework 120. The second axial end is inclined toward the center of the inner framework 120.

[0051] In another embodiment, the flow-blocking membrane 130 includes a first flow-blocking membrane 131 disposed on the inner skeleton 120 and a second flow-blocking membrane 132 connecting the inner skeleton 120 and the outer skeleton 110. The second flow-blocking membrane 132 is inclined toward the radial center of the second through hole 121, and the second flow-blocking membrane 132 forms an inclined surface toward the center of the second through hole 121. Under the guidance of the second flow-blocking membrane 132, the blood flows toward the second through hole 121, thereby slowing down the accumulation rate of blood on the second flow-blocking membrane 132 and reducing the probability of thrombus formation on the second flow-blocking membrane 132.

[0052] like Figure 6 As shown, the outer frame 110 includes a first fixing frame 112, a second fixing frame 113, and a support portion 114. The first fixing frame 112 is connected to the proximal end of the support portion 114, and the second fixing frame 113 is connected to the distal end of the support portion 114. The first fixing frame 112 extends radially outward from the support portion 114, and is at least partially located radially outward from the support portion 114. The second fixing frame 113 extends radially outward from the support frame, and is at least partially located radially outward from the support portion 114. A first through hole 111 is formed on the support portion 114, and the first through hole 111 extends through both axial ends of the support portion 114. The first fixing frame 112 and the second fixing frame 113 are respectively located at both axial ends of the first through hole 111. The inner frame 120 passes through the first through hole 111. After the shunt 100 is implanted in the interatrial septum, the first fixation frame 112 is attached to the inner wall of the left ventricle, and the second fixation frame 113 is attached to the inner wall of the right ventricle.

[0053] like Figure 6As shown, the first fixing frame 112 includes an anchoring portion 1121, which is bent toward the side closer to the center of the inner frame 120. The anchoring portion 1121 is bent toward the side closer to the center of the support portion 114. In the axial section of the anchoring portion 1121, the first anchoring portion 1121 includes a first bent segment 1121a and a second bent segment 1121b. One end of the first bent segment 1121a is connected to the support portion 114, and the other end of the first bent portion is connected to the second bent segment 1121b. The first bent segment 1121a is bent toward the direction closer to the second fixing frame 113 (i.e., closer to the perpendicular bisector of the first fixing frame 112 and the second fixing frame 113) and away from the support portion 114. The convex surface of the first bent segment 1121a is oriented away from the second fixing frame 113, and the concave surface of the first bent segment 1121a is oriented toward the second fixing frame 113. The second bending segment 1121b bends towards the direction closer to the second fixing frame 113 and away from the support portion 114. The convex surface of the second bending segment 1121b faces the second fixing frame 113, and the concave surface faces away from the second fixing frame 113. The curvature of the second bending segment 1121b is greater than that of the first bending segment 1121a. Thus, by bending the end of the first fixing frame 112 or the second fixing frame 113 away from the support portion 114 towards the center of the inner frame 120, the first fixing frame 112 and the second fixing frame 113 can clamp the interseptum, thereby improving the connection stability between the shunt 100 and the interseptum.

[0054] like Figure 7As shown, the first fixing frame 112 includes multiple anchoring parts 1121, which are arranged circumferentially along the support part 114. Adjacent anchoring parts 1121 are connected. Each anchoring part 1121 includes a first anchoring rod 1122 and a second anchoring rod 1123. One end of the first anchoring rod 1122 and the second anchoring rod 1123 are connected together. The end of the first anchoring rod 1122 away from the second anchoring rod 1123 is connected to the support part 114, and the end of the second anchoring rod 1123 away from the first anchoring rod 1122 is connected to the support part 114. The first anchoring rod 1122 and the second anchoring rod 1123 are arranged at a predetermined angle, and the connecting end of the first anchoring rod 1122 and the second anchoring rod 1123 forms an arc-shaped structure. The structure of the second fixing frame 113 corresponds to the structure of the first fixing frame 112. Thus, the outer frame 110 includes a first fixing frame 112, a second fixing frame 113, and a support portion 114, with the inner frame 120 passing through the support portion 114. This allows the outer frame 110 to provide support on the outside of the inner frame 120, thereby freeing up deformation space for the inner frame 120. The first fixing frame 112 and the second fixing frame 113 are respectively connected to both ends of the support portion 114, allowing the first fixing frame 112 and the second fixing frame 113 to clamp the interseptum at both ends of the support portion 114, increasing the anchoring force between the diverter 100 and the interseptum, thereby increasing the connection stability between the diverter 100 and the interseptum.

[0055] like Figure 7 As shown, the anchoring part 1121 is provided with a wire hole 1124. The wire hole 1124 is located at the end of the anchoring part 1121 away from the support part 114. The wire hole 1124 is used to connect the conveyor line of the conveyor, so as to facilitate the diverter 100 to be put into the sheath tube to realize the loading of the diverter 100.

[0056] Example 2

[0057] The difference between this embodiment and Embodiment 1 is that, as Figure 8 and Figure 9 As shown, the connector 140 is axially inclined relative to the inner frame 120. The connector 140 includes a first segment 143, a second segment 144, and a third segment 145 connected to each other. The first segment 143 is connected to the outer frame 110, and the third segment 145 is connected to the inner frame 120. The first segment 143 and the second segment 144 are set at a predetermined angle, and the second segment 144 and the third segment 145 are set at a predetermined angle.

[0058] The connector 140 has a certain degree of elasticity and can undergo elastic deformation when compressed. One end of the first segment 143 is connected to the outer frame 110, and the other end of the first segment 143 is connected to the second segment 144. The two ends of the second segment 144 are connected to the first segment 143 and the third segment 145 respectively. One end of the third segment 145 is connected to the second segment 144, and the other end of the third segment 145 is connected to the inner frame 120.

[0059] The first segment 143 and the second segment 144 are arranged at a predetermined angle. In one embodiment, such as... Figure 9 As shown, the first segment 143 is inclined relative to the second segment 144, and there is a certain angle α1 between the first segment 143 and the second segment 144. The angle α1 is between 90° and 180°, specifically, the angle α1 can be 90°, 120°, 135° or 180°. In other embodiments, the first segment 143 is inclined relative to the second segment 144, and an arc-shaped structure is formed at the connection position of the first segment 143 and the second segment 144. The first segment 143 is tangent to the arc-shaped structure, and the second segment 144 is tangent to the arc-shaped structure. The angle between the first segment 143 and the second segment 144 is the angle between the tangent of the first segment 143 to the arc-shaped structure and the tangent of the second segment 144 to the arc-shaped structure.

[0060] The second segment 144 and the third segment 145 are arranged at a predetermined angle. In one embodiment, such as... Figure 9 As shown, the third segment 145 is inclined relative to the second segment 144, and there is a certain angle α2 between the third segment 145 and the second segment 144. The angle α2 is between 90° and 180°. Specifically, the angle α1 can be 90°, 120°, 135° or 180°. In other embodiments, the third segment 145 is inclined relative to the second segment 144, and an arc-shaped structure is formed at the connection position of the third segment 145 and the second segment 144. The third segment 145 is tangent to the arc-shaped structure, and the second segment 144 is tangent to the arc-shaped structure. The angle between the third segment 145 and the second segment 144 is the angle between the tangent of the first segment 143 and the arc-shaped structure and the tangent of the second segment 144 and the arc-shaped structure.

[0061] During the process of the inner frame 120 expanding and deforming radially outward toward the support part 114, the side wall of the inner frame 120 is subjected to pressure in the radial direction outward. The side wall of the inner frame 120 pushes the connector 140 to deform, and the end of the connector 140 connected to the inner frame 120 deforms toward the direction closer to the outer frame 110.

[0062] In this way, by setting the connector 140 axially inclined relative to the inner skeleton 120, the first segment 143 is connected to the outer skeleton 110, the third segment 145 is connected to the inner skeleton 120, and the second segment 144 connects the first segment 143 and the third segment 145 respectively. The first segment 143 and the second segment 144 are set at a predetermined angle, and the third segment 145 and the second segment 144 are set at a predetermined angle. During the process of the inner skeleton 120 pushing the connector 140 to deform in the direction of the outer skeleton 110, the connector 140 can deform radially inward without axial displacement. Compared with the connector 140 being set as a straight rod, it can avoid the displacement of the connector 140 causing the inner skeleton 120 to move axially and extend outward from the outer skeleton 110, thus accelerating thrombus formation. This makes it easier to maintain the structural stability of the inner skeleton 120 after expansion and prevents the inner skeleton 120 from returning to its pre-expansion state under the stress of the connector 140.

[0063] like Figure 8 As shown, the connector 140 includes a first connector 141 and a second connector 142. The first connector 141 and the second connector 142 are arranged opposite to each other in the radial direction of the outer frame 110, and the inclination directions of the first connector 141 and the second connector 142 are opposite.

[0064] It should be noted that the opposite tilting directions of the first connector 141 and the second connector 142 mean that, taking the connection point between the first connector 141 or the second connector 142 and the outer frame 110 as the starting point and the connection point between the first connector 141 or the second connector 142 and the inner frame 120 as the ending point, the direction in which the first connector 141 extends from the starting point to the ending point is opposite to the direction in which the second connector 142 extends from the starting point to the ending point.

[0065] Specifically, in one embodiment, the first connector 141 is located on one radial side of the axis of the inner frame 120, and the second connector 142 is located on the other radial side of the axis of the inner frame 120. The first connector 141 and the second connector 142 are arranged opposite to each other with respect to the axis of the inner frame 120. Both ends of the first connector 141 are connected to the inner frame 120 and the outer frame 110, respectively. The end of the first connector 141 connected to the outer frame 110 is defined as the first connection point 1411, and the end of the first connector 141 connected to the inner frame 120 is defined as the second connection point 1412. A line l1 starts at the first connection point 1411 and ends at the second connection point 1412. The line l1 extends from the first connection point 1411 to the second connection point 1412. The line l1 is inclined relative to the axial direction of the inner frame 120. The line l1 extends from near the right atrium to near the left atrium.

[0066] The two ends of the second connector 142 are connected to the inner frame 120 and the outer frame 110, respectively. The end of the second connector 142 connected to the outer frame 110 is defined as the third connection point 1421, and the end of the second connector 142 connected to the inner frame 120 is defined as the fourth connection point 1422. Line l2 extends from the third connection point 1421 to the fourth connection point 1422. Line l2 is inclined relative to the axial direction of the inner frame 120. Line l2 is inclined from the direction closer to the left atrium to the direction closer to the right atrium.

[0067] The second connection point 1412 and the fourth connection point 1422 are located on opposite sides of the vertical line of the axis of the inner skeleton 120, with the second connection point 1412 located on the proximal side of the fourth connection point 1422 and the fourth connection point 1422 located on the distal side of the second connection point 1412.

[0068] Therefore, the line l1 connecting the first connection point 1411 and the second connection point 1412 extends in the opposite direction from the starting point to the ending point as the line l2 connecting the third connection point 1421 and the fourth connector 1422. That is, their inclination directions are opposite, and the inclination directions of the first connector 141 and the second connector 142 are opposite.

[0069] It is understood that in other embodiments, the line l1 connecting the first connection point 1411 and the second connection point 1412 may extend from the direction closer to the left atrium to the direction closer to the right atrium. The line l2 connecting the third connection point 1421 and the fourth connector 1422 may extend from the direction closer to the right atrium to the direction closer to the left atrium. As long as the inclination directions of the two are opposite, it is acceptable.

[0070] During the process of the inner frame 120 being subjected to pressure toward the distal end of the axial direction, the resistance of the second connector 142 is greater than that of the first connector 141, and the second connector 142 can provide resistance to the deformation of the first connector 141 toward the distal end. During the process of the inner frame 120 being subjected to pressure toward the proximal end of the axial direction, the resistance of the first connector 141 is greater than that of the second connector 142, and the first connector 141 can provide resistance to the deformation of the second connector 142 toward the proximal end.

[0071] After the shunt 100 is implanted in the atrial septum, with the first connector 141 and the second connector 142 tilted in the same direction, a seal is formed between the inner skeleton 120 and the outer skeleton 110. This makes the inner skeleton 120 susceptible to axial displacement due to blood flow, which in turn causes the connector 140 to extend axially, resulting in unnecessary expansion of the inner skeleton 120 (i.e., expansion of the inner skeleton 120 not caused by excessive left atrial pressure). Therefore, by radially opposing the first connector 141 and the second connector 142, and by setting their tilt directions in opposite directions, when the inner skeleton 120 is subjected to axial blood flow scouring force, the first connector 141 and the second connector 142 can provide opposite resistance to each other's deformation, preventing the connector 140 from extending axially and causing unnecessary expansion of the inner skeleton 120.

[0072] like Figure 8 As shown, the flow-blocking membrane 130 and the connector 140 are spaced apart. Two second flow-blocking membranes 130 are respectively disposed at both ends of the inner frame 120. One end of the second flow-blocking membrane 130 is connected to the inner frame 120, and the other end of the second flow-blocking membrane 130 is connected to the outer frame 110. The second flow-blocking membrane 130 forms a seal between the inner frame 120 and the outer frame 110. The second flow-blocking membrane 130 and the connector 140 are spaced apart, with a certain distance between them. Therefore, by spaced apart from the second flow-blocking membrane 130 and the connector 140, a gap is created between the second flow-blocking membrane 130 and the connector 140, thereby eliminating the path for tissue to crawl from the second flow-blocking membrane 130 to the connector 140. This prevents tissue from crawling through the flow-blocking membrane 130 onto the connector 140 and filling the gap between the inner skeleton 120 and the outer skeleton 110. Consequently, tissue filling the gap between the inner skeleton 120 and the outer skeleton 110 avoids affecting the expansion of the inner skeleton 120 in the radially outward direction, ensuring the long-term expansion adaptability of the inner skeleton 120 after implantation.

[0073] like Figure 10 , Figure 11 As shown, the inner frame 120 includes multiple wave-shaped rings 127 and connecting rods 128. The multiple wave-shaped rings 127 are spaced apart along the axial direction of the inner frame 120. The connecting rods 128 connect two adjacent wave-shaped rings 127. Each wave-shaped ring 127 includes a crest, a trough, and a wave rod connecting the crest and the trough. The connecting rods 128 connect to the midpoint of the wave rods. One end of the connector 140 is connected to the connecting rod 128, and the other end of the connector 140 is connected to the outer frame 110.

[0074] The wave-shaped ring 127 includes multiple wave rods, which are connected end to end to form the wave-shaped ring 127. The connection point of two adjacent wave rods forms a wave crest and a wave trough. Multiple wave-shaped rings 127 are spaced apart along the axial direction of the inner frame 120. A film is applied to the sidewalls of all wave-shaped rings 127 to form a tubular structure within the inner frame 120. Two adjacent wave-shaped rings 127 include a first wave-shaped ring 1271 and a second wave-shaped ring 1272, which are spaced apart. A connecting rod 128 is located between the first wave-shaped ring 1271 and the second wave-shaped ring 1272. One end of the connecting rod 128 is connected to the first wave-shaped ring 1271, and the other end is connected to the second wave-shaped ring 1272.

[0075] The first wave-shaped annular structure 1271 includes a first wave crest 1271a, a first wave trough 1271b, and a first wave rod 1271c, with the first wave rod 1271c connecting the first wave crest 1271a and the first wave trough 1271b. The second wave-shaped annular structure 1272 includes a second wave crest 1272a, a second wave trough 1272b, and a second wave rod 1272c, with the second wave rod 1272c connecting the second wave crest 1272a and the second wave trough 1272b. The first wave crest 1271a and the second wave crest 1272a are correspondingly arranged and located on the same straight line in the axial direction of the inner frame 120. The first wave trough 1271b and the second wave trough 1272b are correspondingly arranged and located on the same straight line in the axial direction of the inner frame 120. The first wave rod 1271c and the second wave rod 1272c are correspondingly arranged. Connecting rod 128 connects the midpoint of the first wave rod 1271c and the second wave rod 1272c. One end of connecting piece 140 is connected to connecting rod 128, and the other end of connecting piece 140 is connected to outer frame 110. Connecting rod 128 has a connecting hole, and one end of connecting piece 140 is inserted into the connecting hole, thus fixing connecting piece 140 to connecting rod 128.

[0076] In this way, during the radial expansion of the inner frame 120, the middle position of the first wave rod 1271c and the second wave rod 1272c remains unchanged, so that the connecting rod 128 is not affected by the deformation of the first wave ring and the second wave ring 1272. It is connected to the outer frame 110 through one end of the connecting member 140 and the connecting rod 128 through the other end of the connecting member 140. This allows the connecting member 140 to be only subjected to the radial compression of the inner frame 120, and not to the axial tension of the inner frame 120. This avoids the first connecting member 141 and the second connecting member 142 from interfering with each other axially during the expansion of the inner frame 120.

[0077] like Figure 12As shown, the connecting rod 128 includes a bent portion 1281, which is located between two adjacent wave-shaped rings 127, and the concave surface of the bent portion 1281 is arranged facing the crest or trough of the wave-shaped ring 127.

[0078] The bend 1281 is located between the first wave-shaped ring 1271 and the second wave-shaped ring 1272. The bend 1281 includes a first bend 1282 and a second bend 1283 1281 connected to each other. The wave-shaped ring 127 includes crests and troughs. The concave surface of the first bend 1282 faces the trough of the first wave-shaped ring 1271, and the convex surface of the second bend 1283 1281 faces the crest of the second wave-shaped ring 1272.

[0079] During the compression loading process of the inner frame 120, the corrugated ring 127 is squeezed by the sheath, which reduces the included angle between two adjacent wave rods on the corrugated ring 127. The distance between the crest and trough of the corrugated ring 127 on the axis of the inner frame 120 increases, and the circumference of the corrugated ring 127 decreases. The trough of the first corrugated ring 1271 can be accommodated in the first bend 1282, and the crest of the second corrugated ring 1272 can be accommodated in the second bend 12831281. During the expansion of the inner frame 120, the first wave-shaped ring 1271 and the second wave-shaped ring 1272 expand under the pressure directed radially outward. The angle between two adjacent wave rods on the wave-shaped ring 127 increases, the distance between the crest and trough of the wave-shaped ring 127 in the axial direction of the inner frame 120 decreases, the circumference of the wave-shaped ring 127 increases, the trough of the first wave-shaped ring 1271 moves away from the first bend 1282, and the crest of the first wave-shaped ring 1271 moves away from the second bend 1283.

[0080] Thus, by including a bent portion 1281 in the connecting rod 128, the bent portion 1281 is located between two adjacent corrugated rings 127. The concave surface of the bent portion 1281 is set towards the crests and troughs of the corrugated rings 127, so that the bent portion 1281 can avoid the relative movement of the crests and troughs, thereby preventing the setting of the connecting rod 128 from increasing the loading stress of the inner frame 120.

[0081] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A shunt, characterized in that, The device includes an outer frame and an inner frame connected to each other. The outer frame has a first through hole arranged along the axial direction of the outer frame. The inner frame is located inside the first through hole, and the outer wall of the inner frame is at least partially spaced from the inner wall of the first through hole. The inner frame has a second through hole arranged along the axial direction of the inner frame. The inner frame is sealed to the outer frame, and the inner frame is adapted to expand radially outward under pressure. The inner frame includes a first end, a second end, and a main body. The first end and the second end are respectively connected to the inner wall of the outer frame. The main body protrudes in a direction away from the outer frame. The diverter also includes a connector. One end of the connector is connected to the main body of the inner frame, and the other end of the connector is connected to the outer frame. The connector is located between the outer frame and the inner frame. The connector is inclined relative to the axial direction of the inner frame. The connector includes a first connector and a second connector. The first connector and the second connector are arranged opposite to each other in the radial direction of the outer frame. The connection point between the first connector or the second connector and the outer frame is taken as the starting point, and the connection point between the first connector or the second connector and the inner frame is taken as the ending point. The direction in which the first connector extends from the starting point to the ending point is opposite to the direction in which the second connector extends from the starting point to the ending point.

2. The shunt according to claim 1, characterized in that, The connector includes a first segment, a second segment, and a third segment connected in sequence. The first segment is connected to the outer frame, and the third segment is connected to the inner frame. The first segment and the second segment are set at a predetermined angle, and the second segment and the third segment are set at a predetermined angle.

3. The shunt according to claim 1, characterized in that, The flow divider further includes a flow-blocking membrane, the two ends of which are connected to the axial ends of the inner skeleton; or the two ends of the flow-blocking membrane are connected to the inner wall of the first through hole, the inner skeleton is located inside the flow-blocking membrane, and the flow-blocking membrane and the outer skeleton enclose a sealed cavity structure.

4. The shunt according to claim 3, characterized in that, The flow-blocking membrane is inclined at least at one axial end relative to the inner skeleton, and the axial end of the flow-blocking membrane is inclined toward the center of the inner skeleton to form a flow-guiding surface.

5. The shunt according to claim 3, characterized in that, The flow-blocking membrane includes a first flow-blocking membrane and a second flow-blocking membrane. The first flow-blocking membrane covers the sidewall of the inner skeleton, and the two ends of the second flow-blocking membrane are respectively connected to the first flow-blocking membrane and the outer skeleton. The second flow-blocking membrane is located between the inner skeleton and the outer skeleton.

6. The shunt according to claim 1, characterized in that, The inner frame includes multiple wave-shaped rings and connecting rods. The multiple wave-shaped rings are spaced apart along the axial direction of the inner frame. The connecting rod connects two adjacent wave-shaped rings. Each wave-shaped ring includes a crest, a trough, and a wave rod connecting the crest and the trough. The connecting rod connects to the midpoint of the wave rod. One end of the connector is connected to the connecting rod, and the other end of the connector is connected to the outer frame.

7. The shunt according to claim 6, characterized in that, The connecting rod includes a bent portion located between two adjacent wave-shaped rings, with the concave surface of the bent portion facing the crest or trough of the wave-shaped ring.

8. The shunt according to claim 1, characterized in that, The outer frame includes a first fixing frame and a second fixing frame, which are located at the two ends of the first through hole respectively. The ends of the first fixing frame and the second fixing frame away from the inner frame are both bent toward the side close to the vertical line of the axis of the inner frame.

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