Shunt

Abstract

Disclosed is a shunt (100), which comprises an outer framework (110) and an inner framework (120) connected to each other. A first through hole (111) is formed on the outer framework (110), and the first through hole (111) is arranged in an axial direction of the outer framework (110). The inner framework (120) is located on an inner side of the first through hole (111), and an outer wall of the inner framework (120) and an inner wall of the first through hole (111) are at least partially spaced apart. A second through hole (121) is formed on the inner framework (120), and the second through hole (121) is arranged in an axial direction of the inner framework (120). Therefore, by allowing the outer wall of the inner framework (120) and the inner wall of the first through hole (111) to be spaced apart, a certain spacing distance is formed between the outer wall of the inner framework (120) and the inner wall of the first through hole (111), so that a certain deformation space is present between the inner framework (120) and the inner wall of the first through hole (111). After the pressure of the left atrium of a patient is increased, the inner framework (120) can expand radially outward under the action of the pressure of the blood flow, so that the area of a radial section of the second through hole (121) is increased. This increases the blood flow throughput per unit area, allowing adaption to the long-term increased blood flow pressure in the left atrium.

Description

Shunt Technical Field

[0001] The present application relates to the technical field of interventional medical devices, and in particular to a shunt. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] An atrial septal shunt is mainly used to reduce the patient's left atrial pressure and divert blood flow from the left atrium to the right atrium to relieve pulmonary congestion and dyspnea. At the same time, it does not significantly increase the burden on the right heart, reduce cardiac output, or cause paradoxical embolism.

[0004] Existing atrial septal shunts have a fixed shunt orifice size. For some patients with initially low shunt flow requirements, left atrial pressure increases with aging or worsening of their condition. Initially implanted atrial septal shunts with low flow rates are no longer sufficient, necessitating re-puncture of the atrial septum for device re-implantation, causing significant discomfort and inconvenience. Summary of the Invention

[0005] Based on this, it is necessary to provide a diverter, comprising an outer skeleton and an inner skeleton connected to each other, a first through hole being provided on the outer skeleton, the first through hole being arranged along the axial direction of the outer skeleton, the inner skeleton being located on the inner side of the first through hole, the outer wall of the inner skeleton being at least partially spaced apart from the inner wall of the first through hole, a second through hole being provided on the inner skeleton, the second through hole being arranged along the axial direction of the inner skeleton.

[0006] Optionally, the inner frame is sealed to the outer frame, and the inner frame is adapted to expand radially outward of the inner frame under pressure.

[0007] Optionally, the diverter further includes a connecting member, both ends of which are connected to the outer frame and the inner frame respectively, and the connecting member is located between the outer frame and the inner frame.

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

[0009] Optionally, the connecting member is arranged to be tilted relative to the axial direction of the inner frame, and the connecting member includes a first connecting member and a second connecting member. The first connecting member and the second connecting member are arranged opposite to each other in the radial direction of the outer frame, and the tilt directions of the first connecting member and the second connecting member are opposite.

[0010] Optionally, the diverter further 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, and the flow-blocking membrane is spaced apart from the connecting piece.

[0011] Optionally, the flow-blocking membrane is arranged obliquely relative to the inner frame, and the flow-blocking membrane is arranged obliquely toward a center direction close to the inner frame.

[0012] Optionally, the inner skeleton includes a plurality of corrugated rings and a connecting rod, the plurality of corrugated rings are arranged at intervals along the axial direction of the inner skeleton, the connecting rod connects two adjacent corrugated rings, the corrugated rings include crests, troughs and corrugated rods connecting the crests and troughs, the connecting rods connect the midpoints of the corrugated rods, one end of the connecting member is connected to the connecting rod, and the other end of the connecting member is connected to the outer skeleton.

[0013] Optionally, the connecting rod includes a bending portion, the bending portion is located between two adjacent wave-shaped rings, and the concave surface of the bending portion is arranged toward the crest or trough of the wave-shaped ring.

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

[0015] Compared with the prior art, the beneficial effects of the diverter of the present invention are:

[0016] The present invention is connected by an inner skeleton and an outer skeleton, and a second through hole is opened on the inner skeleton, so that the blood flow in the left atrium can enter the right atrium through the second through hole, thereby realizing blood diversion in the left atrium; and then the outer wall of the inner skeleton and the inner wall of the first through hole are spaced apart, so that there is a certain spacing distance between the outer wall of the inner skeleton and the inner wall of the first through hole, so that there is a certain deformation space between the inner skeleton and the inner wall of the first through hole. After the patient's left atrial pressure increases, the inner skeleton can expand radially outward under the action of blood flow pressure, thereby increasing the area of ​​the radial cross-section of the second through hole, increasing the blood flow rate per unit area, and thus can adapt to the long-term increase in blood flow pressure in the left atrium. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in this application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0018] FIG1 is a schematic structural diagram of a flow divider in a first embodiment of the present invention;

[0019] FIG2 is a schematic diagram of the deformation of the inner skeleton in Example 1 of the present invention;

[0020] FIG3 is an exploded view of the connection between the flow-blocking membrane and the inner frame in Example 1 of the present invention;

[0021] FIG4 is a schematic structural diagram of an embodiment of a flow-blocking membrane in Example 1 of the present invention;

[0022] FIG5 is a schematic structural diagram of another embodiment of the flow-blocking membrane in Example 1 of the present invention;

[0023] FIG6 is a schematic diagram of the axial cross-sectional structure of the exoskeleton in Example 1 of the present invention;

[0024] FIG7 is a schematic structural diagram of a first fixing bracket in Embodiment 1 of the present invention;

[0025] FIG8 is a schematic structural diagram of a connecting member in a second embodiment of the present invention;

[0026] FIG9 is an enlarged schematic diagram of the structure at point A in FIG8 of the present invention;

[0027] FIG10 is a schematic structural diagram of an embodiment of an internal skeleton in Example 2 of the present invention;

[0028] FIG11 is a schematic diagram of the expanded structure of the inner skeleton in Example 2 of the present invention;

[0029] FIG12 is an enlarged schematic diagram of the structure at point B in FIG11 of the present invention. DETAILED DESCRIPTION

[0030] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope 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 those commonly understood by those skilled in the art of the present invention. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

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

[0033] Example 1

[0034] This embodiment provides a shunt 100, as shown in FIG1 and FIG2 , which is implanted in the atrial septum or ventricular septum to form a channel thereon, thereby connecting the left atrium with the right atrium, thereby diverting blood flow in the left atrium into the left ventricle. Alternatively, it connects the left ventricle with the right ventricle, thereby diverting blood flow in the left ventricle into the right ventricle.

[0035] The shunt 100 includes an exoskeleton 110 and an endoskeleton 120 connected to each other. The endoskeleton 120 and the exoskeleton 110 can be formed by braiding wire or by laser cutting a tubular member. The exoskeleton 110 and the endoskeleton 120 can be made of a shape memory material or medical stainless steel. The exoskeleton 110 and the endoskeleton 120 can be integrally connected or connected via a connector 140. Integrally connected means that the exoskeleton 110 and the endoskeleton 120 are integrally braided or integrally connected by laser cutting a tubular member.

[0036] The exoskeleton 110 is provided with a first through hole 111, which is arranged along the axial direction of the exoskeleton 110. The first through hole 111 passes through both axial ends of the exoskeleton 110 along the axial direction of the exoskeleton 110. The axis l1 of the first through hole 111 is aligned with the axis l1 of the exoskeleton 110.

[0037] The inner frame 120 is disposed within the first through hole 111. The inner frame 120 is located inside the first through hole 111 and is arranged axially along the first through hole 111. The axis of the inner frame 120 is aligned with 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. At least a portion of the outer wall of the inner frame 120 is spaced a certain distance from the inner wall of the first through hole 111.

[0038] The inner frame 120 is provided with a second through-hole 121, which is arranged along the axial direction of the inner frame 120. The second through-hole 121 extends axially through the inner frame 120 at both ends, with the axis of the second through-hole 121 being aligned with the axis of the first through-hole 111. The inner side of the second through-hole 121 forms a tubular lumen structure, with both ends of the second through-hole 121 open and the sidewalls of the second through-hole 121 sealed. When blood passes through the inner side of the second through-hole 121, it is difficult to penetrate the sidewalls of the second through-hole 121 and enter the space between the inner frame 120 and the outer frame 110.

[0039] As shown in FIG1 , the endoskeleton 120 is at least partially spaced apart from the exoskeleton 110. In one embodiment, both ends of the endoskeleton 120 are connected to the inner wall of the exoskeleton 110, and the sidewalls of the endoskeleton 120 protrude away from the sidewalls of the exoskeleton 110, so that the endoskeleton 120 is spaced apart from the exoskeleton 110. Specifically, the endoskeleton 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 wall of the exoskeleton 110. The main body 125 protrudes away from the exoskeleton 110. The concave surface of the main body 125 is disposed toward the exoskeleton 110, and the convex surface of the main body 125 is disposed toward the radial center of the endoskeleton 120. In another embodiment, the endoskeleton 120 and the exoskeleton 110 are connected via a connector 140, which is located between the endoskeleton 120 and the exoskeleton 110. One end of the connecting member 140 is connected to the main body 125 of the inner frame 120 , and the other end of the connecting member 140 is connected to the outer frame 110 to achieve the spacing between the inner frame 120 and the outer frame 110 .

[0040] The endoskeleton 120 has a certain degree of radial expandability. Radial expandability means that when subjected to radially outward pressure, the endoskeleton 120 can expand radially outward. That is, when subjected to radially outward pressure, the sidewalls of the endoskeleton 120 can move toward the inner wall of the first through-hole 111, thereby increasing the diameter of the endoskeleton 120 and the aperture of the second through-hole 121. The endoskeleton 120 can be made of an elastic material or include a radially expandable structure. The endoskeleton 120 includes a mesh structure formed by braiding wire or laser cutting a tubular member. In this embodiment, the mesh structure is formed by braiding wire made of a shape memory alloy, a shape memory polymer, or a filamentary material with a certain degree of elasticity. The material of the braided wire is not limited in this embodiment, as long as the endoskeleton 120 can expand radially outward when blood pressure increases within the second through-hole 121 or under the inflation pressure of the balloon. For example, in one embodiment, after the blood pressure in the second through hole 121 increases, the two intersecting braided wires slide relative to each other under the action of the blood pressure, thereby increasing the mesh area of ​​a single mesh in the mesh structure, thereby achieving radial expansion of the endoskeleton 120. It will be understood that in another embodiment, after the blood pressure in the second through hole 121 increases, the braided wires extend radially outward under the action of the blood pressure, thereby achieving radial expansion of the endoskeleton 120.

[0041] After the shunt 100 is implanted in the atrial septum, blood flows through the second through-hole 121 to the right atrium. As the patient's condition worsens or he ages, the blood pressure in the left atrium increases. Under the action of the blood pressure, the inner skeleton 120 expands radially outward, the aperture of the second through-hole 121 increases, and the through-hole area of ​​the second through-hole 121 increases. For example, in one embodiment, as shown in FIG2 , in the early stage of the implantation of the shunt 100, the blood pressure in the left atrium is relatively low. At this time, the inner skeleton 120 has a first form 122, the inner diameter of the inner skeleton 120 is relatively small, and the second through-hole 121 has an aperture d1. In the long term of the implantation of the shunt 100, the blood pressure in the left atrium is relatively high. At this time, the inner skeleton 120 has a second form 123, the inner skeleton 120 expands radially outward of the stent, the inner diameter of the inner skeleton 120 is relatively large, 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 is understood that in other embodiments, an expansion balloon may be inserted into the second through hole 121 to expand the inner skeleton 120 radially outward, thereby increasing the aperture of the second through hole 121 .

[0042] In this way, the inner skeleton 120 is connected to the outer skeleton 110, and a second through hole 121 is opened on the inner skeleton 120, so that the blood flow in the left atrium can enter the right atrium through the second through hole 121, thereby realizing blood diversion in the left atrium; and then the outer wall of the inner skeleton 120 and the inner wall of the first through hole 111 are spaced apart, so that there is a certain spacing distance between the outer wall of the inner skeleton 120 and the inner wall of the first through hole 111, so that there is a certain deformation space between the inner skeleton 120 and the inner wall of the first through hole 111. After the patient's left atrial pressure increases, the inner skeleton 120 can expand radially outward under the action of blood flow pressure, thereby increasing the area of ​​the radial cross-section of the second through hole 121, increasing the blood flow rate per unit area, and thus adapting to the increased blood flow pressure in the left atrium.

[0043] As shown in Figures 1 and 2, the diameters of the first end 124 and second end 126 of the endoskeleton 120 are larger than the diameter of the main body 125. The first end 124 and second end 126 of the endoskeleton 120 form a flared structure, and the diameter of the endoskeleton 120 decreases from the axial ends toward the axial center. Thus, by having the diameters of the first end 124 and second end 126 of the endoskeleton 120 larger than the diameter of the main body 125, the maximum blood pressure is concentrated in the main body 125 of the endoskeleton 120 when blood flows through the endoskeleton 120, making the main body 125 more susceptible to the pressure of the blood flow and expanding radially outward.

[0044] As shown in Figures 3 and 4, the inner frame 120 is sealedly connected to the outer frame 110. 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 embodiment, as shown in Figure 3, the diverter 100 also includes a flow-blocking membrane 130, and the two ends of the inner skeleton 120 are respectively connected to the outer skeleton 110. The flow-blocking membrane 130 covers the side wall of the inner skeleton 120. The flow-blocking membrane 130 and the inner skeleton 120 are combined to form a tubular cavity structure (i.e., the second through hole 121). The flow-blocking membrane 130 extends from the side wall of the inner skeleton 120 to the connection position between the inner skeleton 120 and the outer skeleton 110 to achieve a sealed connection between the inner skeleton 120 and the outer skeleton 110.

[0046] In another embodiment, as shown in FIG4 , the inner frame 120 and the outer frame 110 are connected via 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 of the connector 140 is connected to the outer frame 110. There are multiple connectors 140, which are evenly spaced along the circumference of the inner frame 120.

[0047] The flow-blocking film 130 includes a first flow-blocking film 131 and a second flow-blocking film 132. The first flow-blocking film 131 is coated on the side wall 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 films 132, which are respectively arranged at the axial ends of the inner skeleton 120. One end of the second flow-blocking film 132 is connected to the inner skeleton 120, and the other end of the second flow-blocking film 132 is connected to the outer skeleton 110. The first flow-blocking film 131 and the second flow-blocking film 132 are enclosed 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 passing through the dense mesh, blood flows in the mesh to form a thrombus, thereby forming a blockage on the side wall of the inner skeleton 120.

[0048] As shown in FIG5 , at least one axial end of the baffle film 130 is tilted relative to the inner frame 120 , and the axial end of the baffle film 130 is tilted toward the center of the inner frame 120 to form a guide surface.

[0049] It should be noted that both axial ends of the flow-blocking membrane 130 may be tilted toward the center of the inner frame 120, or only one axial end may be tilted toward the center of the inner frame 120. Specifically, the side of the flow-blocking membrane 130 close to the left atrium or left ventricle is tilted toward the center of the inner frame 120.

[0050] In one embodiment, the flow barrier 130 includes an axial first end close to the left atrium and an axial second end close to the right atrium, wherein the axial first end is tilted toward the center of the inner frame 120 and the axial second end is tilted toward the center of the inner frame 120.

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

[0052] As shown in FIG6 , the exoskeleton 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 the first fixing frame 112 is at least partially located radially outward from the support portion 114. The second fixing frame 113 extends radially outward from the support portion, and the second fixing frame 113 is at least partially located radially outward from the support portion 114. A first through hole 111 is defined in the support portion 114, and the first through hole 111 penetrates the support portion 114 along the axial direction at both axial ends. The first fixing frame 112 and the second fixing frame 113 are respectively located at the axial ends of the first through hole 111. The endoskeleton 120 is disposed within the first through hole 111. After the shunt 100 is implanted in the atrial septum, the first fixing frame 112 is in contact with the inner wall of the left ventricle, and the second fixing frame 113 is in contact with the inner wall of the right ventricle.

[0053] As shown in FIG6 , the first fixing frame 112 includes an anchor portion 1121, which is bent toward a side near the center of the inner frame 120. The anchor portion 1121 is bent toward a side near the center of the support portion 114. In an axial cross-section of the anchor portion 1121, the first anchor 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 segment is connected to the second bent segment 1121b. The first bent segment 1121a is bent toward the second fixing frame 113 (i.e., toward the perpendicular midline between 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 faces away from the second fixing frame 113, while the concave surface of the first bent segment 1121a faces toward the second fixing frame 113. Second bent section 1121b is bent toward second fixing frame 113 and away from support portion 114. The convex surface of second bent section 1121b is oriented toward second fixing frame 113, while the concave surface of second bent section 1121b is oriented away from second fixing frame 113. The curvature of second bent section 1121b is greater than that of first bent section 1121a. Thus, by bending the end of first fixing frame 112 or second fixing frame 113 away from support portion 114 toward the center of inner frame 120, first fixing frame 112 and second fixing frame 113 can clamp the atrial septum, thereby improving the stability of the connection between shunt 100 and the atrial septum.

[0054] As shown in FIG7 , the first fixing frame 112 includes a plurality of anchoring portions 1121 arranged along the circumference of the support portion 114, with adjacent anchoring portions 1121 connected. The anchoring portions 1121 include a first anchor rod 1122 and a second anchor rod 1123. One end of the first anchor rod 1122 and the second anchor rod 1123 are connected. The end of the first anchor rod 1122 away from the second anchor rod 1123 is connected to the support portion 114, and the end of the second anchor rod 1123 away from the first anchor rod 1122 is connected to the support portion 114. The first anchor rod 1122 and the second anchor rod 1123 are arranged at a predetermined angle, and the connecting ends of the first anchor rod 1122 and the second anchor rod 1123 form an arc-shaped structure. The structure of the second fixing frame 113 corresponds to that of the first fixing frame 112. In this way, the outer skeleton 110 includes the first fixing frame 112, the second fixing frame 113 and the support part 114, and the inner skeleton 120 is inserted into the support part 114, so that the outer skeleton 110 forms a support on the outside of the inner skeleton 120, thereby allowing the deformation space of the inner skeleton 120. The first fixing frame 112 and the second fixing frame 113 are respectively connected to the two ends of the support part 114, so that the first fixing frame 112 and the second fixing frame 113 can clamp the atrial septum at the two ends of the support part 114, thereby increasing the anchoring force between the shunt 100 and the atrial septum, thereby increasing the connection stability of the shunt 100 and the atrial septum.

[0055] As shown in Figure 7, a threading hole 1124 is opened on the anchoring part 1121. The threading hole 1124 is located at the end of the anchoring part 1121 away from the supporting part 114. The threading hole 1124 is used to connect to the conveying line of the conveyor, so as to facilitate the collection of the diverter 100 into the sheath to realize the loading of the diverter 100.

[0056] Example 2

[0057] The difference between this embodiment and the first embodiment is that, as shown in Figures 8 and 9, the connecting member 140 is arranged to be inclined axially relative to the inner skeleton 120, and the connecting member 140 includes a first section 143, a second section 144 and a third section 145 that are connected to each other. The first section 143 is connected to the outer skeleton 110, and the third section 145 is connected to the inner skeleton 120. The first section 143 and the second section 144 are arranged at a predetermined angle, and the second section 144 and the third section 145 are arranged at a predetermined angle.

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

[0059] The first section 143 and the second section 144 are arranged at a predetermined angle. In one embodiment, as shown in FIG9 , the first section 143 is tilted relative to the second section 144, and a certain angle a1 is formed between the first section 143 and the second section 144. The angle of the angle a1 is between 90° and 180°. Specifically, the angle of the angle a1 can be 90°, 120°, 135° or 180°. In other embodiments, the first section 143 is tilted relative to the second section 144, and an arc structure is formed at the connection position of the first section 143 and the second section 144. The first section 143 is tangent to the arc structure, and the second section 144 is tangent to the arc structure. The angle between the first section 143 and the second section 144 is the angle between the tangent of the first section 143 and the arc structure and the tangent of the second section 144 and the arc structure.

[0060] The second section 144 and the third section 145 are arranged at a predetermined angle. In one embodiment, as shown in FIG9 , the third section 145 is arranged tilted relative to the second section 144, and a certain angle a2 is formed between the third section 145 and the second section 144. The angle of the angle a2 is between 90° and 180°. Specifically, the angle a1 can be 90°, 120°, 135° or 180°. In other embodiments, the third section 145 is arranged tilted relative to the second section 144, and an arc structure is formed at the connection position of the third section 145 and the second section 144. The third section 145 is tangent to the arc structure, and the second section 144 is tangent to the arc structure. The angle between the third section 145 and the second section 144 is the angle between the tangent line of the first section 143 and the arc structure and the tangent line of the second section 144 and the arc structure.

[0061] During the process of the inner skeleton 120 expanding and deforming radially outward toward the support portion 114, the side wall of the inner skeleton 120 is subjected to pressure toward the radial outward, and the side wall of the inner skeleton 120 pushes the connecting piece 140 to deform, and the end of the connecting piece 140 connected to the inner skeleton 120 is deformed toward the direction close to the outer skeleton 110.

[0062] In this way, by axially tilting the connecting member 140 relative to the inner skeleton 120, the first section 143 is connected to the outer skeleton 110, the third section 145 is connected to the inner skeleton 120, and the second section 144 is respectively connected to the first section 143 and the third section 145, the first section 143 and the second section 144 are set at a predetermined angle, and the third section 145 and the second section 144 are set at a predetermined angle, so that in the process of the inner skeleton 120 pushing the connecting member 140 to deform toward the outer skeleton 110, the connecting member 140 can deform toward the radial inside without generating axial displacement. Compared with the method in which the connecting member 140 is set as a straight rod, it can avoid the displacement of the connecting member 140 driving the inner skeleton 120 to move axially and extend out of the axial outside of the outer skeleton 110 to accelerate thrombosis, thereby facilitating the maintenance of the structural stability of the inner skeleton 120 after expansion, and preventing the inner skeleton 120 from returning to the state before expansion under the stress of the connecting member 140.

[0063] As shown in FIG8 , the connecting member 140 includes a first connecting member 141 and a second connecting member 142 . The first connecting member 141 and the second connecting member 142 are arranged opposite to each other in the radial direction of the outer frame 110 , and the first connecting member 141 and the second connecting member 142 are inclined in opposite directions.

[0064] It should be noted that the opposite inclination directions of the first connection 141 and the second connection member 142 mean that, with the connection point between the first connection member 141 or the second connection member 142 and the outer skeleton 110 as the starting point and the connection point between the first connection member 141 or the second connection member 142 and the inner skeleton 120 as the end point, the direction in which the first connection member 141 extends from the starting point to the end point is opposite to the direction in which the second connection member 142 extends from the starting point to the end point.

[0065] Specifically, in one embodiment, the first connector 141 is located on one radial side of the axis of the endoskeleton 120, and the second connector 142 is located on the other radial side of the axis of the endoskeleton 120. The first connector 141 and the second connector 142 are arranged relative to each other with respect to the axis of the endoskeleton 120. The two ends of the first connector 141 are connected to the endoskeleton 120 and the exoskeleton 110, respectively. The end of the first connector 141 connected to the exoskeleton 110 is defined as the first connection point 1411, and the end of the first connector 141 connected to the endoskeleton 120 is defined as the second connection point 1412. Line l1 starts at the first connection point 1411 and ends at the second connection point 1412. Line l1 extends from the first connection point 1411 to the second connection point 1412. Line l1 is arranged to be inclined relative to the axial direction of the endoskeleton 120. Line l1 extends from a direction close to the right atrium to a direction close to the left atrium.

[0066] The second connector 142 is connected to the endoskeleton 120 and the exoskeleton 110 at both ends, with the end of the second connector 142 connected to the exoskeleton 110 being defined as a third connection point 1421, and the end of the second connector 142 connected to the endoskeleton 120 being defined as a fourth connection point 1422. A line L2 begins at the third connection point 1421 and ends at the fourth connection point 1422, extending from the third connection point 1421 to the fourth connection point 1422. Line L2 is tilted relative to the axial direction of the endoskeleton 120, tilting from closer to the left atrium toward closer to the right atrium.

[0067] Among them, the second connection point 1412 and the fourth connection point 1422 are respectively located on opposite sides of the perpendicular bisector of the axis of the inner skeleton 120, the second connection point 1412 is located on the proximal side of the fourth connection point 1422, and the fourth connection point 1422 is 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 and the line l2 connecting the third connection point 1421 and the fourth connection member 1422 extend in opposite directions from the starting point to the end point, that is, the inclination directions of the two are opposite, that is, the inclination directions of the first connection member 141 and the second connection member 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 close to the left atrium to the direction close to the right atrium, and the line l2 connecting the third connection point 1421 and the fourth connection member 1422 may extend from the direction close to the right atrium to the direction close to the left atrium, as long as the inclination directions of the two are opposite.

[0070] When the inner skeleton 120 is subjected to pressure toward the distal end, the resistance of the second connecting member 142 is greater than the resistance of the first connecting member 141, and the second connecting member 142 can provide resistance to deformation of the first connecting member 141 toward the distal end. When the inner skeleton 120 is subjected to pressure toward the proximal end, the resistance of the first connecting member 141 is greater than the resistance of the second connecting member 142, and the first connecting member 141 can provide resistance to deformation of the second connecting member 142 toward the proximal end.

[0071] After the shunt 100 is implanted in the atrial septum, when the first connector 141 and the second connector 142 are tilted in the same direction, due to the seal formed between the inner skeleton 120 and the outer skeleton 110, the inner skeleton 120 is easily washed by the blood flow and produces a certain axial displacement, thereby driving the connector 140 to extend in the axial direction and causing unnecessary expansion of the inner skeleton 120 (i.e., the expansion of the inner skeleton 120 is not caused by excessive left atrial pressure). Therefore, by setting the first connector 141 and the second connector 142 radially relative to each other and the first connector 141 and the second connector 142 in opposite directions, when the inner skeleton 120 is subjected to the blood flow flushing force in the axial direction, the first connector 141 and the second connector 142 can provide opposite resistance to each other's deformation, thereby preventing the connector 140 from extending in the axial direction and causing unnecessary expansion of the inner skeleton 120.

[0072] As shown in FIG8 , the baffle film 130 is spaced apart from the connector 140. Two second baffle films 130 are disposed at the axial ends of the inner frame 120, one end of each second baffle film 130 being connected to the inner frame 120, and the other end of each second baffle film 130 being connected to the outer frame 110. The second baffle films 130 form a seal between the inner frame 120 and the outer frame 110. The second baffle films 130 are spaced apart from the connector 140, with a certain spacing therebetween. Therefore, by spacing the second flow-blocking membrane 130 and the connecting member 140, there is a spacing distance between the second flow-blocking membrane 130 and the connecting member 140, thereby eliminating the path for the tissue to climb from the second flow-blocking membrane 130 to the connecting member 140, preventing the tissue from passing through the flow-blocking membrane 130 and climbing onto the connecting member 140 to fill the gap between the inner skeleton 120 and the outer skeleton 110, thereby avoiding the tissue filling the gap between the inner skeleton 120 and the outer skeleton 110 and affecting the expansion of the inner skeleton 120 toward the radial outward direction, thereby ensuring that the inner skeleton 120 has long-term expansion adaptability after implantation.

[0073] As shown in Figures 10 and 11, the inner skeleton 120 includes a plurality of wavy rings 127 and a connecting rod 128. The plurality of wavy rings 127 are arranged at intervals along the axial direction of the inner skeleton 120. The connecting rod 128 connects two adjacent wavy rings 127. The wavy rings 127 include crests, troughs, and wave rods connecting the crests and troughs. The connecting rod 128 connects the midpoints of the wave rods. One end of the connecting member 140 is connected to the connecting rod 128, and the other end of the connecting member 140 is connected to the outer skeleton 110.

[0074] The corrugated ring 127 includes multiple corrugated rods, which are connected at their ends to form the corrugated ring 127. The connection points of two adjacent corrugated rods form wave crests and troughs. Multiple corrugated rings 127 are spaced apart along the axial direction of the inner skeleton 120. A coating is provided on the sidewalls of all corrugated rings 127 to form a tubular structure of the inner skeleton 120. Two adjacent corrugated rings 127 include a first corrugated ring 1271 and a second corrugated ring 1272. The first corrugated ring 1271 and the second corrugated ring 1272 are spaced apart. A connecting rod 128 is located between the first corrugated ring 1271 and the second corrugated ring 1272. One end of the connecting rod 128 is connected to the first corrugated ring 1271, and the other end of the connecting rod 128 is connected to the second corrugated ring 1272.

[0075] The first wave-shaped ring 1271 includes a first wave crest 1271a, a first wave trough 1271b, and a first wave rod 1271c. The first wave rod 1271c connects the first wave crest 1271a and the first wave trough 1271b. The second wave-shaped ring 1272 includes a second wave crest 1272a, a second wave trough 1272b, and a second wave rod 1272c. The second wave rod 1272c connects the second wave crest 1272a and the second wave trough 1272b. The first wave crest 1271a and the second wave crest 1272a are arranged in correspondence with each other, and the first wave crest 1271a and the second wave crest 1272a are 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 arranged in correspondence with each other, and the first wave trough 1271b and the second wave trough 1272b are 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 arranged in correspondence with each other. Connecting rod 128 connects the midpoints of first wave rod 1271c and second wave rod 1272c. Connecting member 140 is connected to connecting rod 128 at one end, and to exoskeleton 110 at the other end. Connecting rod 128 defines a connection hole, into which one end of connecting member 140 is inserted, securing the connection between connecting member 140 and connecting rod 128.

[0076] In this way, during the radial expansion of the inner skeleton 120, the middle position of the first wave rod 1271c and the second wave rod 1272c remains unchanged, so that the connecting rod 128 will not be affected by the deformation of the first and second wave rings 1272. One end of the connecting member 140 is connected to the outer skeleton 110, and the other end of the connecting member 140 is connected to the connecting rod 128, so that the connecting member 140 is only subjected to the radial compression of the inner skeleton 120, and will not be subjected to the axial stretching of the inner skeleton 120, thereby avoiding the axial mutual interference between the first connecting member 141140 and the second connecting member 142140 during the expansion of the inner skeleton 120.

[0077] As shown in FIG. 12 , the connecting rod 128 includes a bending portion 1281 . The bending portion 1281 is located between two adjacent wave-shaped rings 127 , and the concave surface of the bending portion 1281 is arranged toward the crest or trough of the wave-shaped ring 127 .

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

[0079] During the compression loading process of the inner skeleton 120, the waveform ring 127 is squeezed by the sheath, so that the angle between the two adjacent wave rods on the waveform ring 127 is reduced, the distance between the peak and the trough of the waveform ring 127 on the axis of the inner skeleton 120 is increased, the circumference of the waveform ring 127 is reduced, the trough of the first waveform ring 1271 can be accommodated in the first bending portion 1282, and the peak of the second waveform ring 1272 can be accommodated in the second bending portion 12831281. During the expansion of the inner skeleton 120, the first waveform ring 1271 and the second waveform ring 1272 expand due to the pressure toward the radial outside, the angle between the two adjacent wave rods on the waveform ring 127 increases, the distance between the crest and trough of the waveform ring 127 in the axial direction of the inner skeleton 120 decreases, the circumference of the waveform ring 127 increases, the trough of the first waveform ring 1271 moves in the direction away from the first bending portion 1282, and the crest of the first waveform ring 1271 moves in the direction away from the second bending portion 12831281.

[0080] In this way, the connecting rod 128 includes a bending portion 1281, and the bending portion 1281 is located between two adjacent corrugated rings 127. The concave surface of the bending portion 1281 is set toward the crests and troughs of the corrugated rings 127, so that the bending portion 1281 can avoid the relative movement of the crests and troughs, thereby avoiding the setting of the connecting rod 128 from increasing the loading stress of the inner skeleton 120.

[0081] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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 above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A flow divider, characterized in that: It includes an outer frame and an inner frame connected to each other, the outer frame is provided with a first through hole, the first through hole is arranged along the axial direction of the outer frame, the inner frame is located on the inner side of the first through hole, the outer wall of the inner frame is at least partially spaced apart from the inner wall of the first through hole, and the inner frame is provided with a second through hole, the second through hole is arranged along the axial direction of the inner frame.

2. The flow divider according to claim 1, characterized in that: The inner frame is sealed to the outer frame, and the inner frame is suitable for expanding toward the radial outer side of the inner frame under the action of pressure.

3. The flow divider according to claim 1, characterized in that: The diverter also includes a connecting member, two ends of which are respectively connected to the outer frame and the inner frame, and the connecting member is located between the outer frame and the inner frame.

4. The flow divider according to claim 3, characterized in that: The connecting member includes a first section, a second section and a third section connected in sequence, the first section is connected to the outer frame, the third section is connected to the inner frame, the first section and the second section are arranged at a predetermined angle, and the second section and the third section are arranged at a predetermined angle.

5. The flow divider according to claim 3, characterized in that: The connecting member is arranged to be tilted relative to the axial direction of the inner frame, and the connecting member includes a first connecting member and a second connecting member. The first connecting member and the second connecting member are arranged opposite to each other in the radial direction of the outer frame, and the tilt directions of the first connecting member and the second connecting member are opposite.

6. The flow divider according to claim 1, characterized in that: The diverter also includes a baffle membrane, the two ends of which are connected to the two axial ends of the inner skeleton; or the two ends of the baffle membrane are connected to the inner wall of the first through hole, the inner skeleton is located on the inner side of the baffle membrane, and the baffle membrane and the outer skeleton are enclosed to form a sealed cavity structure.

7. The flow divider according to claim 6, characterized in that: At least one axial end of the baffle film is tilted relative to the inner frame, and one axial end of the baffle film is tilted toward the center direction of the inner frame to form a guide surface.

8. The flow divider according to claim 6, characterized in that: The baffle film includes a first baffle film and a second baffle film, the first baffle film is coated on the side wall of the inner frame, the two ends of the second baffle film are respectively connected to the first baffle film and the outer frame, and the second baffle film is located between the inner frame and the outer frame.

9. The flow divider according to claim 3, characterized in that: The inner skeleton includes a plurality of wavy rings and a connecting rod, wherein the plurality of wavy rings are arranged at intervals along the axial direction of the inner skeleton, and the connecting rod connects two adjacent wavy rings, and the wavy rings include wave crests, wave troughs, and wave rods connecting the wave crests and the wave troughs, and the connecting rod connects the midpoints of the wave rods, one end of the connecting member is connected to the connecting rod, and the other end of the connecting member is connected to the outer skeleton.

10. The flow divider according to claim 9, characterized in that: The connecting rod comprises a bending portion, wherein the bending portion is located between two adjacent wave-shaped rings, and the concave surface of the bending portion is arranged toward the wave crest or the wave trough of the wave-shaped ring.

11. The flow divider according to claim 1, characterized in that: The outer frame includes a first fixing frame and a second fixing frame, the first fixing frame and the second fixing frame are respectively located at two axial ends of the first through hole, and one end of the first fixing frame and the second fixing frame away from the inner frame are bent toward a side close to the mid-perpendicular line of the axis of the inner frame.

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