A pressure regulating device for the atrium of the heart

Abstract

The application discloses a heart chamber pressure regulating device, which is a cylindrical structure and comprises, in the axial direction of the cylindrical structure, an atrial septum passage and an outflow tract arranged in sequence along the blood flow direction; the side of the atrial septum passage, which is opposite to the outflow tract, is provided with an inflow port; a one-way open valve is arranged in the outflow tract; and the cylindrical structure is provided with a first positioning part and a second positioning part which are respectively arranged on the two sides of the atrial septum. The heart chamber pressure regulating device can form a one-way open valve structure on the atrial septum, is stable in position when cooperating with the atrial septum, can be recycled when the release position is improper, and can be released again.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a pressure regulating device for heart chamber. BACKGROUND

[0002] Heart failure, in short, heart failure, is a disorder of the systolic and / or diastolic function of the heart, which cannot fully discharge the blood volume from the heart to the venous system, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system, and further causing a syndrome of heart circulation disorder.

[0003] Heart failure is a serious disease with high incidence and mortality. According to the site of heart failure, it can be divided into left heart failure, right heart failure and whole heart failure. According to the clinical manifestations of heart failure, it can also be divided into systolic heart failure and diastolic heart failure. Diastolic heart failure (DHF) accounts for about half of all heart failure patients. In China, there are more than 12 million heart failure patients, i.e. the incidence of heart failure is about 2-3%, among which there are about 6 million diastolic heart failure patients. Elderly people are mainly diastolic heart failure, and the number of elderly diastolic heart failure patients accounts for 66.99% of the total number of diastolic heart failure patients.

[0004] The main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, cardiomyopathy, etc. Cardiovascular disease causes left ventricular damage, leading to pathological remodeling of the left ventricle, and further causing heart function decline, which means that for every successful treatment of a myocardial infarction patient, there is a potential heart failure patient.

[0005] In the treatment of heart failure, the existing methods have defects, as follows:

[0006] a. Optimizing drug therapy cannot fundamentally eliminate the cause and still has the possibility of recurrence;

[0007] b. Cardiac resynchronization therapy (CRT) is ineffective for at least 20% of heart failure patients;

[0008] c. Left ventricular assist device (LVAD) surgery requires extracorporeal circulation, which not only has high trauma and high complication rate, but also is expensive and difficult to obtain, and domestic conditions do not have the conditions for surgery;

[0009] d. Heart transplantation can fundamentally solve the problem, but the source of donors is very limited, and the price is expensive.

[0010] One of the prior art solutions is to implant a shunt device between the left atrium and the right atrium, which has been clinically proven to be effective, but the existing shunt device still needs to be further improved in structure and performance. For example, Corvia Medical designed a full metal alloy stent for left atrial to right atrial shunt for diastolic heart failure. The alloy stent does not have a valve, and the internal blood flow channel is always open, but in non-ideal conditions, it is easy to cause excessive shunt, forming a right atrial to left atrial shunt, further worsening the ability of the left atrium to fill oxygenated blood, and there is a risk of causing abnormal embolism. The alloy stent does not have a covering film, which is easy to cause endothelialization and block the blood flow channel.

[0011] For another example, V-Wave designed a sandglass (kite) shaped shunt device. The sandglass shaped shunt device is easy to be displaced under the scouring of blood flow, change the installation angle, and form an artificial small angle with the atrial septum. Vortex and thrombus are easy to form in the angle space, and a high molecular ePTFE film is attached to the outer surface of the shunt device, which may cause thrombus and hemolysis and other complications. SUMMARY

[0012] The present application provides a heart atrium pressure regulating device, which reduces the occurrence of repeated embolism and complications by implanting a one-way open valve structure on the atrial septum.

[0013] A heart atrium pressure regulating device is a cylindrical structure, which includes an atrial septum passage and an outflow tract arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure. The side of the atrial septum passage facing away from the outflow tract has an inflow port. A one-way open valve is arranged in the outflow tract. The cylindrical structure is provided with a first positioning part and a second positioning part respectively abutting on both sides of the atrial septum.

[0014] The pressure regulating device is used to balance the pressure between the left atrium and the right atrium. When the pressure difference between the left atrium and the right atrium exceeds a threshold value, the valve gradually opens, and the blood flow in the left atrium enters the atrial septum passage through the inflow port, and then enters the right atrium through the outflow tract, thereby relieving the situation of excessive pressure in the left atrium. When the pressure difference between the left atrium and the right atrium does not reach the threshold value, the valve is closed, blocking the blood flow between the left atrium and the right atrium through the atrial septum passage.

[0015] Preferably, the diameter of the outflow tract is greater than the diameter of the atrial septum passage, and the junction part of the outflow tract and the atrial septum passage locally or entirely abuts on the atrial septum, which is used to ensure the blocking effect.

[0016] Preferably, an inflow tract is further arranged opposite to the inflow port of the atrial septum passage.

[0017] The inflow tract, the atrial septum passage and the outflow tract in the present application all refer to the channel structure of the entity, which is a section of the cylindrical structure.

[0018] The blood flow direction is from high pressure to low pressure, the inflow tract is located upstream of the blood flow, i.e. extends a certain length in the direction of high pressure, and the outflow tract is located downstream of the blood flow, i.e. extends a certain length in the direction of low pressure.

[0019] The heart room pressure regulating device of the present application can also not be provided with a valve, and then the outflow tract can be correspondingly shortened or even omitted, i.e. the heart room pressure regulating device of the present application is a cylindrical structure, and includes a room septum passage in the middle along the axial direction of the cylindrical structure, and the first positioning part and the second positioning part for abutting the corresponding side of the room septum are connected on both sides of the room septum passage.

[0020] The room septum is located between the left atrium and the right atrium, and the first positioning part and the second positioning part are located on both sides of the room septum respectively after the heart room pressure regulating device is released in the body, and abut the room septum from both sides to realize the position limitation of the pressure regulating device.

[0021] The first positioning part and the second positioning part form clamping on the room septum from both sides, and the inflow tract and the outflow tract both extend a certain length in the direction away from the room septum.

[0022] Preferably, the inflow tract, the room septum passage and the outflow tract are coaxially arranged, in order to reduce the opening size on the room septum as much as possible, the cross-sectional size of the room septum passage should be as small as possible, but also needs to meet the blood flow requirement, the cross section of the room septum passage is preferably circular, or elliptical or other shapes without obvious corners, when the cross section of the room septum passage is circular, the cross-sectional diameter is preferably 3-6 mm.

[0023] As a preferred, the first positioning part and the second positioning part are each independently a wire frame structure or a mesh structure.

[0024] The first positioning part and the second positioning part can adopt a wire frame structure or a mesh structure, the wire frame structure refers to that the first positioning part and the second positioning part have a skeleton structure that plays a supporting role, the skeleton structure is sparse, and when the first positioning part and the second positioning part clamp the room septum wall, the skeleton structure in contact with the room septum wall respectively applies a relatively concentrated force to different areas of the room septum.

[0025] The mesh structure refers to that the first positioning part and the second positioning part have obvious warp and weft characteristics, and when the first positioning part and the second positioning part clamp the room septum, the pressure applied to the room septum wall is as dispersed as possible, so that the pressure at each contact position is as small as possible, and then the local room septum wall is prevented from being damaged due to bearing excessive pressure.

[0026] The first positioning part, the second positioning part, and the pressure regulating device of the atrium can be independently processed by weaving or cutting. The three can adopt regular or irregular wire frame structures. When a wire frame structure is adopted, a skeleton can be arranged at a suitable position according to needs to improve the strength. The skeleton can have an increased cross-sectional area or at least higher strength relative to other parts.

[0027] The first positioning part, the second positioning part, and the pressure regulating device of the atrium can independently adopt a mesh structure. The mesh structure can be regular or irregular unit cells, preferably rhombic or approximately rhombic unit cells. At least the radial compression can be performed to facilitate recovery and release. The mesh structure has a clear warp and weft structure. The intersection of the warp and weft can be a fixed node, and more preferably a non-fixed node, that is, the warp and weft can be misaligned to provide compliance and deformation ability.

[0028] The shape of the first positioning part and the second positioning part can adopt at least one of a plane, a conical surface, and an arc surface. Taking the first positioning part as an example, the first positioning part can be a plane, a conical surface, an arc surface, a combination of a plane and a conical surface, a combination of a plane and an arc surface, a combination of a conical surface and an arc surface, and a combination of a plane, a conical surface, and an arc surface. The plane does not require a strict plane, and an approximate plane can also be adopted.

[0029] As a preference, the first positioning part and the second positioning part are in point contact or surface contact with the corresponding side of the atrial septum.

[0030] The point contact is not strictly a point, but has a small contact area, which is approximately a point. The area where the first positioning part and the second positioning part contact the atrial septum serves as a support point, and needs to be as small as possible to reduce damage to the atrial septum. Therefore, strict point contact and line contact are excluded, and other contact forms can be adopted, and are divided into point contact and surface contact according to the size of the contact area.

[0031] To achieve better positioning effect, preferably, the first positioning part and the second positioning part extend radially outward along the cylindrical structure. That is, the contact point of the first positioning part and the second positioning part with the atrial septum wall is as large as possible relative to the stoma area, and contacts the atrial septum in a larger size range to achieve better stability.

[0032] The one-way open valve can be implemented by two valves, three valves, or even more valves. Preferably, the pressure in the left atrium is P1, and the pressure in the right atrium is P2.

[0033] When P1-P2>2mmHg, the valve starts to open.

[0034] When P1-P2>15mmHg, the valve starts to fully open.

[0035] When P2-P1>1mmHg, the valve flap is closed.

[0036] As a further preference, when P1-P2>5mmHg, the valve flap starts to open.

[0037] That is, when the pressure difference between the left atrium and the right atrium is small, the automatic closing valve is closed and remains closed, and only when the pressure difference between the left atrium and the right atrium is large enough, the valve is opened to release pressure. The outflow tract includes a transition section and an outflow section arranged in sequence along the axial direction, wherein the transition section is connected to the interatrial septum passage. The outflow section can adopt a shape with no obvious sharp angle in cross section, such as a cylindrical or circular truncated cone shape. The cross-sectional area of the outflow section is larger than that of the interatrial septum passage. The transition section connects the interatrial septum passage and the outflow section, and the cross-sectional area gradually increases from the interatrial septum passage to the outflow section. The transition section can also function as a limiting part to a certain extent, i.e., acting on the interatrial septum to prevent displacement of the valve stent.

[0038] The first positioning part and the second positioning part can adopt various forms. For example, the first positioning part or the second positioning part includes a plurality of branched support rods extending radially outward along the cylindrical structure, and adjacent support rods intersect with each other through branching.

[0039] For another example, the first positioning part or the second positioning part includes a plurality of pairs of support rods extending radially outward along the cylindrical structure, and support rods belonging to the same pair intersect with each other.

[0040] Through the mutual separation and intersection of the support rods, the structure of the first positioning part and the second positioning part is formed, and there is no sharp edge in the outer periphery of each support rod.

[0041] As a preference, the inflow tract gradually decreases in diameter (radially gradually decreases) along the blood flow direction.

[0042] That is, the inflow tract forms a flared structure, which on the one hand prevents endothelial overgrowth and prevents the interatrial septum passage from being blocked, and on the other hand, when blood flows into the flared structure, the flow tract gradually narrows, and the blood generates greater impact force to push open the valve to release pressure.

[0043] As a preference, the inflow tract extends radially outward along the cylindrical structure from the inlet side of the interatrial septum passage, and the inflow tract also serves as the first positioning part. The axial dimension of the inflow tract is relatively short, and it is part of the first positioning part.

[0044] As a preference, the first positioning part is connected at the joint between the inflow tract and the interatrial septum passage or at the inlet side of the inflow tract.

[0045] The connection position of the first positioning part is preferably the joint between the inflow tract and the interatrial septum passage, and can also be connected at any position in the axial direction of the inflow tract, for example, at the inlet side of the inflow tract.

[0046] As a preference, the first positioning part is bent towards the atrial septal passage side until abutting against the atrial septum while extending radially outwards.

[0047] In order to reduce the damage to the atrial septum, preferably, the end of the first positioning part is bent towards the direction away from the outflow tract.

[0048] During the releasing process, the end of the first positioning part is bent towards the direction away from the atrial septum to reduce the direct puncture to the atrial septum.

[0049] The second positioning part is connected at least at one of the following positions:

[0050] at the outlet side of the outflow tract; or

[0051] at the axial middle part of the outflow tract; or

[0052] at the part of the outflow tract close to the atrial septal passage; or

[0053] at the joint part of the outflow tract and the atrial septal passage; or

[0054] at the atrial septal passage.

[0055] Preferably, the second positioning part is connected at the outlet side of the outflow tract.

[0056] A connecting structure matched with the delivery device can be provided at the outlet side of the outflow tract, for example, a connecting hole which can be selected in various shapes according to the need, for example, a round hole, a round corner square hole, etc.

[0057] As a preference, the second positioning part is bent towards the atrial septal passage side until abutting against the atrial septum from the connecting position of the outflow tract or the atrial septal passage.

[0058] As a preference, the second positioning part is bent towards the atrial septal passage side until abutting against the atrial septum from the outlet side of the outflow tract.

[0059] The second positioning part is turned by U-shaped bending at the outlet side of the outflow tract to realize the bending towards the atrial septal passage side.

[0060] In order to cooperate with the delivery instrument and realize the recovery of the pressure adjusting device, preferably, the edge of the outflow tract converges to at least two end parts distributed in the circumferential direction, and each end part is provided with a recovery connecting head.

[0061] If the release position of the pressure regulating device is not ideal, the end portion can be folded and retracted into the delivery instrument by pulling the retraction connector, and the rest of the pressure regulating device is re-compressed into the sheath under the tightening action of the delivery sheath for the next release.

[0062] As a preferred mode, a part of the edge of the outflow tract converges directly to the corresponding end portion, and another part converges to the corresponding end portion via an extension segment, which, in the compressed state, has an axial position further away from the inflow tract than the edge of the outflow tract.

[0063] Due to the provision of the extension segment, in the compressed state, the end portion converging via the extension segment is now longer in axial dimension than the directly converging end portion, and in order to meet the retraction requirement, the length of the traction cord can be adjusted to match the end portions at different axial positions, so that each end portion is retracted into the delivery instrument in the order of the axial position.

[0064] In the compressed state, the extension segment can also have a length substantially consistent with the edge of the outflow tract.

[0065] As a preferred mode, the edge of the outflow tract converges to the corresponding end portion via an extension segment, which, in the compressed state, extends axially from the edge of the outflow tract.

[0066] The extension segment can be composed of straight rods or V-shaped rods, i.e. straight rods and / or V-shaped rods are arranged uniformly or non-uniformly around the circumference of the outflow tract to form the extension segment.

[0067] As a preferred mode, in the released state, the extension segment extends from the edge of the outflow tract in a direction away from the inflow opening (which can also be understood as away from the inflow tract).

[0068] In this way, in the released state, the extension segment has an axial position further away from the inflow tract than the edge of the outflow tract.

[0069] As a preferred mode, in the released state, the extension segment has a first bend towards the inflow opening (which can also be understood as towards the inflow tract) and a second bend away from the inflow opening (which can also be understood as away from the inflow tract) from the edge of the outflow tract.

[0070] In this way, in the released state, the extension segment partially overlaps the outflow tract in the axial direction of the pressure regulating device.

[0071] As a preferred mode, in the released state, the extension segment constitutes the second positioning portion. The extension segment serves to converge the edge of the outflow tract to the end portion, and on the other hand, the extension segment can also serve as the second positioning portion. It is further preferred that when the extension segment constitutes the second positioning portion, the extension segment abuts against the atrial septum through the second bend.

[0072] As a preference, the second positioning part is turned up in a direction away from the inflow port (also understood as away from the inflow side) at a position abutting against the atrial septum, until the outlet side of the outflow tract.

[0073] The end of the second positioning part is provided with a recovery connector.

[0074] The second positioning part is turned by a U-shaped bend at a position abutting against the atrial septum, to achieve turning up in a direction away from the inflow tract.

[0075] When the release position is improper, the pressure regulating device can be retracted into the delivery device by pulling the recovery connector, and then released again.

[0076] The U-shaped bend in the present application is not strictly U-shaped, and is intended to limit the smooth arc transition at the bend, and there is no sharp corner.

[0077] As a preference, the recovery connector is provided with a connecting hole. The connecting hole can be selected in various shapes as needed, for example, a round hole, a round-cornered square hole, etc., to be able to accurately match the delivery system.

[0078] In order to realize the recovery of the pressure regulating device, the recovery connector is preferably arranged along the circumference of the cylindrical structure. That is, during the recovery process, the extension direction of the recovery connector is parallel to the axial direction of the pressure regulating device, so that the pressure regulating device does not need to adjust the direction during the recovery into the delivery device, and can be directly axially retracted into the delivery device.

[0079] As a preference, the recovery connector is downstream of the outlet side of the outflow tract in the axial direction. During the recovery, the recovery connector enters the delivery device first, and the remaining parts are deformed to enter the sheath under the traction of the recovery connector and the extrusion of the sheath.

[0080] “Downstream” refers to the downstream of the blood flow pressure relief, and in fact corresponds to the direction of the recovery during use, i.e., closer to the delivery device for operation.

[0081] In order to realize the recovery, the outflow tract preferably has a unit grid structure, and at the outlet side of the outflow tract, all the unit grid vertices are connected to one of the recovery connectors through the second positioning part.

[0082] If there is an isolated unit grid vertex at the outlet side of the outflow tract that is not connected to the recovery connector, the isolated unit grid vertex is not easy to enter the sheath during the recovery process because of the lack of traction of the recovery connector. As a preference, a covering membrane is provided between the part corresponding to the atrial septum position in the atrial septum passage and the valve disc. The covering membrane part is used to form a closed passage to guide the blood flow from the atrial septum position to the valve disc.

[0083] In order to prevent endothelialization, preferably, the at least one of the inflow tract, the outflow tract and the interatrial septum is covered with a membrane.

[0084] The first positioning part can be not covered with a membrane, completely covered with a membrane or partially covered with a membrane, and the second positioning part can also be not covered with a membrane, completely covered with a membrane or partially covered with a membrane.

[0085] The membrane and the valve with a one-way opening can each independently adopt a biological valve or a polymer valve, the biological valve including a bovine pericardium, a porcine pericardium, a horse pericardium and the like, and the polymer valve including polytetrafluoroethylene, polyurethane, silicone rubber and the like.

[0086] Each of the inflow tract, the outflow tract and the interatrial septum can be completely covered with a membrane or partially covered with a membrane.

[0087] From the overall structure, the pressure regulating device has the diameter of the outflow tract greater than the diameter of the interatrial septum, and the first positioning part and the second positioning part have a tendency of expanding radially outward from the connection part with the cylindrical structure.

[0088] In the case of setting the inflow tract, the diameter of the outflow tract and the inflow tract is greater than the diameter of the interatrial septum, and the first positioning part and the second positioning part have a tendency of expanding radially outward from the connection part with the cylindrical structure.

[0089] Considering the positioning and recovery and combining the structural characteristics of the lesion site, as a preferred, the second positioning part has a first bending part towards the inflow port and a second bending part away from the inflow port from the connection part with the cylindrical structure.

[0090] The part between the first bending part and the second bending part is closer to the inflow port and expands radially, and the part after the second bending part is farther away from the inflow port and converges radially.

[0091] The pressure regulating device for the heart chamber provided by the application forms a one-way opening valve on the interatrial septum by being implanted on the interatrial septum of the left and right heart chambers, and the design of the first positioning part and the second positioning part makes the device more stable in position when cooperating with the interatrial septum, and can be recovered and released again when the release position is improper. BRIEF DESCRIPTION OF DRAWINGS

[0092] Figure 1 It is a front view of the pressure regulating device for the heart chamber of Example 1.

[0093] Figure 2 It is a schematic view of the valve opening of the pressure regulating device for the heart chamber of Example 1.

[0094] Figure 3This is a schematic diagram of the valve closure of the interatrial pressure regulating device in Example 1;

[0095] Figure 4 This is a front view of the interatrial pressure regulating device in Example 2;

[0096] Figure 5 This is a schematic diagram of the valve opening in the interatrial pressure regulating device of Example 2;

[0097] Figure 6 This is a schematic diagram of the valve closure in the interatrial pressure regulation device of Example 2;

[0098] Figure 7 This is a front view of the interatrial pressure regulating device in Example 3;

[0099] Figure 8 This is a schematic diagram of the valve opening in the interatrial pressure regulating device of Example 3;

[0100] Figure 9 This is a schematic diagram of the valve closure in the interatrial pressure regulation device of Example 3;

[0101] Figure 10 This is a front view of the interatrial pressure regulating device in Example 4;

[0102] Figure 11 This is a schematic diagram of the valve opening in the interatrial pressure regulating device of Example 4;

[0103] Figure 12 This is a schematic diagram of the valve closure of the interatrial pressure regulating device in Example 4;

[0104] Figure 13 This is a front view of the interatrial pressure regulating device in Example 5;

[0105] Figure 14 This is a schematic diagram of the valve opening in the interatrial pressure regulating device of Example 5;

[0106] Figure 15 This is a schematic diagram of the valve closure in the interatrial pressure regulation device of Example 5;

[0107] Figure 16 This is a three-dimensional structural schematic diagram of the interatrial pressure regulating device in Example 6;

[0108] Figure 17 This is a front view of the interatrial pressure regulating device in Example 6;

[0109] Figure 18 for Figure 17 A bottom view of the pressure regulating device in the central room;

[0110] Figure 19 forFigure 17 Fig. 4 is a plan view of the pressure regulating device of the atrium of heart. DETAILED DESCRIPTION

[0111] The pressure regulating device of the atrium of heart will be described in detail below with reference to the accompanying drawings.

[0112] Example 1

[0113] As shown in Fig. 1, a pressure regulating device 100 of the atrium of heart is in a cylindrical structure, which includes, in the axial direction of the cylindrical structure, an inflow tract 110, an atrial septum passage 130 and an outflow tract 140 arranged in sequence along the direction of blood flow, a one-way open valve is arranged in the outflow tract 140, and a first positioning part 120 and a second positioning part 150 are arranged on the inflow tract 110 and the outflow tract 140 respectively, which abut against the atrial septum wall on the corresponding side. Figure 1 Figure 2 As shown in Fig. 2, the inflow tract 110 is gradually tapered in the direction of blood flow to form a circular truncated cone shape, the diameter of the inlet end of the inflow tract 110 is 10 mm, and the diameter of the outlet end of the inflow tract 110 is 6 mm. The inflow tract 110 is composed of 12 support rods 111, each of which is distributed around the circumference of the inflow tract 110, and the adjacent two support rods 111 are in a mirror-symmetrical structure, and the adjacent two support rods as a group (i.e. support rod 111a and support rod 111b) intersect at intersection point 112 at the inlet end of the inflow tract 110. Figure 3 Between the two groups, the adjacent two support rods, for example, support rod 111a and support rod 111c, intersect at intersection point 113 at the outlet end of the inflow tract 110.

[0114] Figure 1 As shown in Fig. 3, the first positioning part 120 is connected at the joint between the inflow tract 110 and the atrial septum passage 130, and the first positioning part 120 extends radially outward in the cylindrical structure to form a circular truncated cone shape with an approximately flat top surface, the diameter of the top surface of the circular truncated cone is smaller than the diameter of the bottom surface, the diameter of the bottom surface of the circular truncated cone is 18 mm, and the outer edge of the top surface of the circular truncated cone is connected to the outlet end of the inflow tract. The bottom surface of the circular truncated cone is closer to the atrial septum than the top surface.

[0115] As shown in Fig. 4, the second positioning part 150 is connected at the joint between the atrial septum passage 130 and the outflow tract 140, and the second positioning part 150 extends radially outward in the cylindrical structure to form a circular truncated cone shape with an approximately flat top surface, the diameter of the top surface of the circular truncated cone is smaller than the diameter of the bottom surface, the diameter of the bottom surface of the circular truncated cone is 18 mm, and the outer edge of the top surface of the circular truncated cone is connected to the inlet end of the outflow tract. The bottom surface of the circular truncated cone is closer to the atrial septum than the top surface.

[0116] As shown in Fig. 5, the valve 160 is arranged in the outflow tract 140, and the valve 160 is in a cylindrical structure, which includes, in the axial direction of the cylindrical structure, a valve body 161 and a valve leaflet 162 arranged in sequence along the direction of blood flow, the valve body 161 is arranged in the outflow tract 140, and the valve leaflet 162 is arranged in the valve body 161. Figure 2 As shown in Fig. 6, the valve body 161 is connected to the outflow tract 140, and the valve leaflet 162 is arranged in the valve body 161, and the valve leaflet 162 is in a cylindrical structure, which includes, in the axial direction of the cylindrical structure, a valve body 161 and a valve leaflet 162 arranged in sequence along the direction of blood flow, the valve body 161 is arranged in the outflow tract 140, and the valve leaflet 162 is arranged in the valve body 161.

[0117] ​​The first positioning part 120 is composed of six split support rods, which form 12 support rods 121 after splitting. Each support rod 121 is distributed around the axis of the first positioning part 120. Adjacent two support rods 121 are mirror-symmetric. Adjacent two support rods 121 intersect at intersection point 122 at the bottom surface. Adjacent two support rods 121 intersect at intersection point 123 at the top surface. The intersection point 123 is connected to the intersection point 113. The end 124 of the support rod 121 is curved away from the outflow tract. The curve of the end 124 is smooth arc-shaped to avoid piercing the atrial septum wall and to reduce damage to the atrial septum.

[0118] In this embodiment, the first positioning part can also be considered as a plurality of split support rods extending radially outward along the cylindrical structure. For example, the split part of one support rod is the intersection point 123. One split is the support rod 121a. The adjacent support rod also has a split structure. One split is the support rod 121b. The support rod 121a and the support rod 121b intersect at the intersection point 122.

[0119] As shown in Figure 1 , the atrial septal passage 130 is approximately a cylindrical passage. The diameter of the atrial septal passage 130 is 6 mm. The atrial septal passage 130 is composed of six support rods 131. The six support rods 131 are parallel to each other and uniformly distributed around the circumference of the cylindrical passage. One end of the six support rods is connected to the intersection point 113. The other end is connected to the inflow end of the outflow tract 140.

[0120] As shown in Figure 1 , the outflow tract 140 is composed of a transition section 141 and a cylindrical section 142. The transition section 141 is a circular truncated cone. The angle between the side surface of the circular truncated cone and the generatrix is 65°. The transition section 141 is composed of 12 support rods 143. Adjacent two support rods 143 are mirror-symmetric. Each support rod 143 is distributed around the axis of the transition section 141. Adjacent two support rods 143 intersect at intersection point 144 on the side close to the atrial septal passage 130. Adjacent two support rods 143 intersect at intersection point 145 on the side away from the atrial septal passage 130.

[0121] As shown in Figure 1 , the diameter of the cylindrical section 142 is 12 mm. The cylindrical section 142 is composed of 12 support rods 146. Adjacent two support rods 146 are mirror-symmetric. Each support rod 146 is distributed around the axis of the cylindrical section 142. Adjacent two support rods are a group, for example, the support rod 146a and the support rod 146b, which intersect at the intersection point 145 on the side close to the transition section 141.

[0122] In adjacent two groups, for example, the support rod 146a and the support rod 146c intersect at the intersection point 147 on the side away from the transition section 141.

[0123] As shown in Figure 1As shown, the second positioning part 150 includes three pairs of support rods extending radially outward along the cylindrical structure, i.e. a total of 6 cut support rods 151, each support rod 151 is distributed around the axis of the cylindrical structure, one end of each support rod 151 is connected to the intersection point 147 through a U-shaped circular arc, and the other end extends towards the atrial septal passage while radially extending outward along the cylindrical structure until it abuts the atrial septum.

[0124] The 6 support rods 151 are divided into three pairs, two support rods (support rod 151a and support rod 151b) belonging to the same pair are adjacent and intersect each other at the end close to the atrial septal passage, merging into an intersection point 152, the support rods 151 that are not in the same group are not connected, and each support rod 151 is flipped at the intersection point 152 to form a flipped segment 160 in a direction away from the inflow tract 110, the flipped segment 160 extends until the outlet side adjacent to the outflow tract 140, and the flipped segment 160 gradually approaches the axis of the cylindrical structure while extending in the axial direction.

[0125] The end of the flipped segment 160 is a recovery connector 162, the length of the recovery connector 162 is about 3-5 mm, and the edge of the recovery connector 162 is smooth without sharp corners. The recovery connector 162 is downstream of the outlet side adjacent to the outflow tract 140 in the axial direction, the recovery connector 162 is arranged along the circumference of the cylindrical structure, and a connection hole 163 is provided on the recovery connector 162, the connection hole 163 is a square round structure, and the connection hole 163 is used to cooperate with the delivery system.

[0126] The second positioning part 150 is generally in the shape of a circular truncated cone, the top surface of the circular truncated cone has a smaller diameter than the bottom surface, and the diameter of the bottom surface of the circular truncated cone is 22 mm.

[0127] In this embodiment, a layer of pig pericardium 170 is wrapped around the channel surfaces (inside the stent) of the inflow tract, the outflow tract and the atrial septal passage, and in the axial direction, the pig pericardium 170 extends from the inlet end of the inflow tract to the outlet end of the outflow tract, forming a cylindrical shape corresponding to the shape of the stent. Three pieces of pig pericardium valve 180 are sewn inside the channel of the outflow tract 140, the three pieces of pig pericardium valve serve as one-way opening valve, when the pressure difference between the left atrium and the right atrium is greater than 4 mmHg, the valve starts to open, forming a one-way shunt from the left atrium to the right atrium; when the pressure difference is greater than 18 mmHg, the valve is fully open, as shown in Figure 2 ; when the pressure difference between the right atrium and the left atrium is greater than 1 mmHg, the valve is fully closed, as shown in Figure 3 .

[0128] In this embodiment, the pressure regulating device of the atrium is an integral structure, which is cut on the cylindrical material and gets each part structure by heat setting. The first positioning part and the second positioning part are both frame line structures. Each support rod in the pressure regulating device of the atrium has a certain width, and the contact area is appropriately increased when contacting with the in-vivo tissue such as the atrial septum, so as to avoid the cutting effect caused by stress concentration through surface contact.

[0129] The intersection points are not strictly intersected at one point, but based on the extension of the support rod having a certain area, or the intersection is completed by short distance connection, for example, the intersection of the support rod 121 and the support rod 131 at the intersection point 113.

[0130] Each bending part of the pressure regulating device of the atrium is a smooth arc bending, and there is no sharp spike towards the outlet direction of the outflow tract. The atrial septum valve as a whole also does not have a sharp spike, and the edge of the isolated apex part is smoothly processed, for example, the edge of the intersection point 112 is smoothly processed.

[0131] Figure 1 、 Figure 2 、 Figure 3 All shown in FIGS. 1 to 3 are the state after setting, and in the delivery process, the pressure regulating device of the atrium is stretched with the recovery connector 162 and the inlet end of the inflow tract 110 as two ends until it is in a straightened state to be loaded in the delivery system.

[0132] If the delivery position is improper, the whole device can be put into the delivery system by pulling the recovery connector 162, and then released again.

[0133] Embodiment 2

[0134] As shown in FIGS. 1 to 3, Figure 4 、 Figure 5 、 Figure 6 A pressure regulating device of the atrium 100 is a cylindrical structure, which includes an inflow tract 110, an atrial septum passage 130 and an outflow tract 140 arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure, a one-way open valve is arranged in the outflow tract 140, and a first positioning part 120 and a second positioning part 150 are arranged on the inflow tract 110 and the outflow tract 140 respectively to abut against the atrial septum on the corresponding side.

[0135] As shown in FIGS. 1 to 3, Figure 4 The inflow tract 110 is gradually tapered along the blood flow direction to form a circular truncated cone shape, the diameter of the inlet end of the inflow tract 110 is 8 mm, and the diameter of the outlet end of the inflow tract 110 is 4 mm. The inflow tract 110 is composed of 8 support rods 111, each support rod 111 is distributed around the circumference of the inflow tract 110, the 8 support rods 111 are divided into four groups, two support rods 111 belonging to the same group are mirror-symmetric structures, and the two support rods 111 of different groups are not connected.

[0136] As shown in Figure 5 , the first positioning part 120 is connected at the joint of the inflow tract 110 and the atrial septal passage 130, and extends radially outward in a cylindrical shape to form a circular truncated cone shape with an approximately flat top surface. The diameter of the top surface of the circular truncated cone is smaller than that of the bottom surface, and the diameter of the bottom surface is 16 mm. The outer edge of the top surface of the circular truncated cone is connected to the outlet end of the inflow tract. The bottom surface of the circular truncated cone is closer to the atrial septum than the top surface.

[0137] The first positioning part 120 is composed of eight support rods 121, each of which is distributed around the axis of the first positioning part 120. Adjacent two support rods 121 are mirror-symmetrically arranged. Adjacent two support rods 121 intersect at an intersection point 122 at the bottom surface, and intersect at an intersection point 123 at the top surface. The intersection point 123 is connected to the intersection point 113. The end 124 of the support rod 121 is curved away from the outflow tract. The curved end 124 is a smooth arc shape to reduce damage to the atrial septum.

[0138] As shown in Figure 4 , the atrial septal passage 130 is approximately a cylindrical passage with a diameter of 4 mm. The atrial septal passage 130 is composed of four support rods 131, six of which are parallel to each other and uniformly distributed around the circumference of the cylindrical passage. One end of the four support rods is connected to the intersection point 113, and the other end is connected to the inflow end of the outflow tract 140.

[0139] As shown in Figure 4 , the outflow tract 140 is composed of a transition section 141 and a cylindrical section 142. The transition section 141 is in the shape of a circular truncated cone with an angle of 60° between the side surface and the generatrix. The transition section 141 is composed of eight support rods 143, each of which is distributed around the axis of the transition section 141. Adjacent two support rods 143 are mirror-symmetrically arranged. Adjacent two support rods 143 intersect at an intersection point 144 on the side close to the atrial septal passage 130, and intersect at an intersection point 145 on the side away from the atrial septal passage 130.

[0140] As shown in Figure 4 , the diameter of the cylindrical section 142 is 10 mm. The cylindrical section 142 is composed of eight support rods 146, each of which is distributed around the axis of the cylindrical section 142. Adjacent two support rods 146 are mirror-symmetrically arranged. Adjacent two support rods 146 form a nearly rhombic unit cell. Two support rods in the same unit cell intersect at the intersection point 144 on the side close to the atrial septal passage 130, and intersect at the intersection point 147 on the side away from the transition section 141. In adjacent unit cells, adjacent two support rods 146 intersect at the intersection point 145 on the side close to the transition section 141.

[0141] As shown in Figure 4As shown, the second positioning part 150 includes eight cut support rods 151. Each support rod 151 is distributed around the axis of the cylindrical structure. One end of each support rod 151 is connected to the intersection point 147 through a U-shaped arc, and the other end radiates outward along the radial direction of the cylindrical structure and extends toward the interatrial septum channel until it abuts against the interatrial septum.

[0142] The eight support rods 151 are divided into four groups. Two support rods 151 belonging to the same group are adjacent to each other and merge into an intersection point 152 at the end closer to the atrial septum channel. At the end away from the atrial septum channel, adjacent support rods not belonging to the same group merge into an intersection point 153. The intersection point 153 and the intersection point 147 are connected to form the two ends of a U-shaped arc.

[0143] Each support rod 151 is bent at the intersection 152 in a direction away from the inflow channel 110 to form a bent section 160. The bent section 160 extends 8mm along the axis of the second positioning part. As the bent section 160 extends axially, it gradually approaches the axis of the cylindrical structure.

[0144] The end of the upturned section 160 is a recycling connector 162, which is approximately 3 mm long and has smooth edges without sharp corners. The recycling connector 162 is located axially downstream of the outlet side of the outlet channel 140. It is arranged circumferentially along the cylindrical structure and has a connection hole 163, which is a square with rounded corners, used to mate with the conveying system.

[0145] The second positioning part 150 is roughly in the shape of a frustum, with the diameter of the top surface of the frustum being smaller than the diameter of the bottom surface. The diameter of the bottom surface of the frustum is 22mm.

[0146] In this embodiment, two porcine pericardial valves 180 are sewn inside the outflow duct 140. These two valves act as one-way valves. When the pressure difference between the left and right atria is greater than 2 mmHg, the valves begin to open, forming a one-way shunt from the left to the right atrium; when the pressure difference is greater than 15 mmHg, the valves are fully open. Figure 5 As shown; when the pressure difference between the right atrium and the left atrium is greater than 3 mmHg, the valve is completely closed, as... Figure 6 As shown.

[0147] like Figure 5 , Figure 6 As shown, a layer of porcine pericardium 170 is wrapped around the surface of the inflow tract, the interatrial septum, and part of the outflow tract (inside the stent). The porcine pericardium 170 extends axially from the inlet end of the inflow tract to 1-2 mm beyond the valve suture line.

[0148] In this embodiment, the interatrial pressure regulating device is a single, integral structure, formed by cutting a cylindrical material and heat-setting each component. Both the first and second positioning parts are frame structures. Each support rod in the interatrial pressure regulating device has a certain width, and when in contact with internal tissues such as the interatrial septum, the contact area is appropriately increased to avoid stress concentration and cutting effects through surface contact.

[0149] The intersections are not strictly at a single point, but are based on the extension of the support rod over a certain area, or are completed by short-distance connection, such as at intersection 113, where support rod 121 and support rod 131 intersect.

[0150] All bends in the pressure regulating device of the atrium are smooth arc-shaped bends, and there are no sharp points pointing towards the outflow tract. The atrial septal valve is also generally free of sharp points, with rounded edges at isolated apex locations, such as the edge of intersection 112.

[0151] Figure 4 , Figure 5 , Figure 6 The images shown are of the final shape. During the transport process, the pressure regulating device of the atrium is stretched at both ends, namely the recovery connector 162 and the inlet end of the inflow channel 110, until it is in a straight state and is mounted on the transport system.

[0152] If the conveying position is incorrect, the entire device can be pulled into the conveying system by pulling the recovery connector 162 and then released again.

[0153] Example 3

[0154] like Figure 7 , Figure 8 , Figure 9 As shown, a pressure regulating device 100 for the atrium has a cylindrical structure. The cylindrical structure includes an inflow channel 110, an interatrial septum channel 130, and an outflow channel 140 arranged sequentially along the blood flow direction. A one-way valve is provided in the outflow channel 140. A first positioning part 120 and a second positioning part 150 are respectively provided on the inflow channel 110 and the outflow channel 140, which abut against the interatrial septum on the corresponding side.

[0155] like Figure 7As shown, the inflow channel 110 gradually narrows along the blood flow direction to form a frustum shape. The inlet diameter of the inflow channel 110 is 8 mm, and the outlet diameter is 5 mm. The inflow channel 110 is composed of 12 support rods 111, which are distributed around the circumference of the inflow channel 110. Adjacent support rods 111 are mirror-symmetrical and form a group. The two support rods 111 in the same group intersect at the inlet end of the inflow channel 110 at intersection point 112, and the two adjacent support rods 111 in different groups intersect at the outlet end of the inflow channel 110 at intersection point 113.

[0156] like Figure 8 As shown, the first positioning part 120 is connected to the inlet end of the inflow channel 110. The first positioning part 120 extends radially outward along the cylindrical shape to form a frustum. The height of the frustum is approximately equal to the axial length of the inflow channel. The diameter of the top surface of the frustum is larger than the diameter of the bottom surface. The diameter H of the top surface of the frustum is 24 mm. The outer edge of the top surface of the frustum is connected to the outlet end of the inflow channel. The bottom surface of the frustum is closer to the interatrial septum than the top surface.

[0157] like Figure 7 As shown, the first positioning part 120 is composed of 6 S-shaped support rods 121. Each support rod 121 is distributed around the axis of the first positioning part 120. One end of each support rod 121 starts from the intersection point 112. The other end of the support rod 121 extends radially outward and bends towards the atrial septum channel until it abuts against the atrial septum. The end 124 of the support rod 121 is curved away from the outflow channel. The curvature of the end 124 is a smooth arc to reduce damage to the atrial septum.

[0158] like Figure 7 As shown, the atrial septum channel 130 is approximately cylindrical, with a diameter of 5 mm. The atrial septum channel 130 is composed of 6 support rods 131, which are parallel to each other and evenly distributed around the circumference of the cylindrical channel. One end of each support rod is connected to the intersection 113, and the other end is connected to the inflow end of the outflow channel 140.

[0159] like Figure 7 As shown, the outflow channel 140 is composed of a transition section 141 and a cylindrical section 142. The transition section 141 is frustum-shaped, with the side of the frustum forming an angle of 65° with the generatrix. The transition section 141 is composed of 12 support rods 143, with adjacent support rods 143 being mirror-symmetrical. Each support rod 143 is distributed around the axis of the transition section 141. Adjacent support rods 143 intersect with support rod 131 at intersection point 144 on the side adjacent to the interatrial septum channel 130, and adjacent support rods 143 intersect at intersection point 145 on the side away from the interatrial septum channel 130.

[0160] like Figure 7As shown, the diameter of the cylindrical segment 142 is 8 mm, the cylindrical segment 142 is composed of 6 support rods 146, each of which is distributed around the axis of the cylindrical segment 142, the 6 support rods 146 are divided into three groups, two support rods 146 in the same group are adjacent and mirror-symmetric, the support rods in the same group form an inverted V-shaped structure, specifically, the two support rods 146 in the same group intersect at the intersection point 147 on the side away from the transition segment 141, and the other ends are respectively connected to different intersection points 145.

[0161] The intersection point 147 extends in the axial direction away from the outflow tract, and a connecting hole 148 is arranged on the extension segment formed thereby, which is used to connect with the delivery system.

[0162] As shown, Figure 7 The second positioning part 150 includes 6 cut support rods 151, each of which is distributed around the axis of the cylindrical structure, one end of each support rod 151 is connected to the intersection point 145 through a U-shaped arc, and the other end extends towards the atrial septal passage while radiating outward in the radial direction of the cylindrical structure until it abuts against the atrial septum.

[0163] The 6 support rods 151 are divided into three groups, two support rods 151 in the same group are adjacent, and merge into an intersection point 152 at the position adjacent to the atrial septum. Each support rod 151 is flipped at the intersection point 152 to form a flipped segment 160 in the direction away from the inflow tract 110, the flipped segment 160 extends 8 mm in the axial direction, and the flipped segment 160 gradually approaches the axis of the cylindrical structure while extending in the axial direction.

[0164] The end of the flipped segment 160 is a connecting head 161, the length of the connecting head 161 is about 4 mm, and the edge of the connecting head 161 is smooth without sharp corners. The connecting head 161 is located downstream of the outlet side of the outflow tract 140 in the axial direction, and is arranged along the circumference of the cylindrical structure. A connecting hole 163 is arranged on the connecting head 161, which is a square and rounded structure, and is used to cooperate with the delivery system.

[0165] The second positioning part 150 is approximately in the shape of a circular truncated cone, the top surface of the circular truncated cone has a smaller diameter than the bottom surface, and the diameter of the bottom surface of the circular truncated cone is 22 mm.

[0166] In this embodiment, a layer of pig pericardium 170 is coated on the channel surface (inside the stent) of the inflow tract, outflow tract and atrial septal passage, and in the axial direction, the pig pericardium 170 starts from the inlet end of the inflow tract and extends outwards by 0-1 mm of the suture line of the valve. Three pieces of pig pericardium valve 180 are sewn inside the channel of the outflow tract 140, which serve as one-way open valve, and when the pressure difference between the left atrium and the right atrium is greater than 5 mmHg, the valve starts to open, forming a one-way shunt from the left atrium to the right atrium; when it is greater than 20 mmHg, the valve is fully open, as shown in Figure 8as shown; when the right atrium is greater than the left atrium pressure difference is greater than 2 mmHg, the valve is completely closed, as shown Figure 9

[0167] In this embodiment, the pressure regulating device of the atrium is an integral structure, which is cut on the cylindrical material and obtains the structure of each part by heat setting. The first positioning part and the second positioning part are both frame line structures. Each support rod in the pressure regulating device of the atrium has a certain width, and when it contacts the in-vivo tissue such as the atrial septum, the contact area is appropriately increased to avoid the cutting effect caused by stress concentration through surface contact.

[0168] Each bending part of the pressure regulating device of the atrium is a smooth arc bending, and there is no sharp spike towards the outlet direction of the outflow tract. The atrial septal port valve as a whole also does not have a sharp spike, and the edge of the isolated apex part is smoothly processed, for example, the edge of the intersection 112 is smoothly processed.

[0169] Figure 7 、 Figure 8 、 Figure 9 As shown in the above, the state after setting, each support rod of the pressure regulating device of the atrium is stretched to be in an extended state during the delivery process, to be carried in the delivery system, and the connection hole 148 and the connection hole 163 are connected with the delivery system.

[0170] Embodiment 4

[0171] As shown in the above, the state after setting, each support rod of the pressure regulating device of the atrium is stretched to be in an extended state during the delivery process, to be carried in the delivery system, and the connection hole 148 and the connection hole 163 are connected with the delivery system. Figure 10 As shown in the above, the state after setting, each support rod of the pressure regulating device of the atrium is stretched to be in an extended state during the delivery process, to be carried in the delivery system, and the connection hole 148 and the connection hole 163 are connected with the delivery system.

[0172] As shown in the above, the state after setting, each support rod of the pressure regulating device of the atrium is stretched to be in an extended state during the delivery process, to be carried in the delivery system, and the connection hole 148 and the connection hole 163 are connected with the delivery system. Figure 10 As shown in the above, the state after setting, each support rod of the pressure regulating device of the atrium is stretched to be in an extended state during the delivery process, to be carried in the delivery system, and the connection hole 148 and the connection hole 163 are connected with the delivery system.

[0173] ​The first positioning part 120 is composed of 12 support rods 121, each of which is distributed around the axis of the first positioning part 120, and adjacent two support rods 121 are mirror-symmetrically structured, and adjacent two support rods 121 form a group, and the two support rods 121 of the same group intersect at the intersection point 122 at the bottom surface, and adjacent two support rods 121 of different groups intersect at the intersection point 123 at the top surface. The end 124 of the support rod 121 is turned up in the direction away from the outflow tract, and the turning up of the end 124 is a smooth arc shape to reduce the damage to the interatrial septum.

[0174] As shown in Figure 10 , the interatrial septum passage 130 is approximately a cylindrical passage, the diameter of the interatrial septum passage 130 is 6mm, the interatrial septum passage 130 is composed of 6 support rods 131, the 6 support rods 131 are parallel to each other and uniformly distributed around the circumference of the cylindrical passage, one end of the 6 support rods is connected to the intersection point 123, and the other end is connected to the inflow end of the outflow tract 140.

[0175] As shown in Figure 10 , the outflow tract 140 is composed of a transition section 141 and a cylindrical section 142. The transition section 141 is in the shape of a circular truncated cone, and the angle between the side surface of the circular truncated cone and the generatrix is 75°. The transition section 141 is composed of 12 support rods 143, and adjacent two support rods 143 are mirror-symmetrically structured, each support rod 143 is distributed around the axis of the transition section 141, and adjacent two support rods 143 intersect at the intersection point 144 on the side close to the interatrial septum passage 130, and adjacent two support rods 143 intersect at the intersection point 145 on the side away from the interatrial septum passage 130.

[0176] As shown in Figure 10 , the diameter of the cylindrical section 142 is 12mm, and the cylindrical section 142 is composed of 12 support rods 146, and adjacent two support rods 146 are mirror-symmetrically structured, each support rod 146 is distributed around the axis of the cylindrical section 142, and adjacent two support rods 146 intersect at the intersection point 145 on the side close to the transition section 141, and adjacent two support rods 146 intersect at the intersection point 147 on the side away from the transition section 141.

[0177] As shown in Figure 10 , the second positioning part 150 includes 6 cut support rods 151, each of which is distributed around the axis of the cylindrical structure, one end of each support rod 151 is connected through a U-shaped circular arc intersection point 147, and the other end extends towards the interatrial septum passage while radiating outward along the radial direction of the cylindrical structure until it abuts against the interatrial septum.

[0178] The six support rods 151 are divided into three groups. The two support rods 151 in the same group are adjacent and merge at the end near the interatrial septum passage to form an intersection point 152. The support rods 151 in different groups are not connected. At the intersection point 152, each support rod 151 is turned up in the direction away from the inflow channel 110 to form a turned-up section 160. The turned-up section 160 extends to the outlet side of the adjacent outflow channel 140. As the turned-up section 160 extends axially, it gradually approaches the axis of the cylindrical structure.

[0179] The end of the upturned section 160 is a recovery connector 162, which is approximately 3-5 mm long and has smooth edges without sharp corners. The recovery connector 162 is located axially downstream of the outlet side of the outlet channel 140. It is arranged circumferentially along the cylindrical structure and has a connection hole 163, which is a square with rounded corners, used to mate with the conveying system.

[0180] The second positioning part 150 is roughly in the shape of a frustum, with the diameter of the top surface of the frustum being smaller than the diameter of the bottom surface. The diameter of the bottom surface of the frustum is 22mm.

[0181] In this embodiment, a layer of porcine pericardium 170 is wrapped around the surface of the inflow tract, outflow tract, and interatrial septum (inside the stent). Axially, the porcine pericardium 170 extends from the inlet end of the inflow tract to the outlet end of the outflow tract, forming a cylindrical shape corresponding to the stent shape. Three porcine pericardial valves 180 are sewn inside the outflow tract 140. These three valves act as one-way valves. When the pressure difference between the left and right atria is greater than 5 mmHg, the valves begin to open, forming a one-way shunt from the left atrium to the right atrium; when the pressure difference is greater than 15 mmHg, the valves are fully open. Figure 11 As shown; when the pressure difference between the right atrium and the left atrium is greater than 1 mmHg, the valve is completely closed, as... Figure 12 As shown.

[0182] In this embodiment, the interatrial pressure regulating device is a single, integral structure, formed by cutting and heat-setting a cylindrical material. Both the first and second positioning parts are frame-line structures. Each support rod in the interatrial pressure regulating device has a certain width, and when in contact with tissues such as the interatrial septum, the contact area is appropriately increased to avoid stress concentration and cutting effects through surface contact. The intersection points are not strictly at a single point, but rather represent an extension of the support rod over a certain area.

[0183] All bends in the pressure regulating device of the atrium are smooth arc-shaped bends, and there are no sharp points pointing towards the outflow tract. The atrial septal valve is also free of sharp points, and the edges of isolated apical parts are rounded, for example, the end edge of the support rod 121 is rounded.

[0184] Figure 10 、 Figure 11 、 Figure 12 The state shown in the middle is after the shaping, and in the delivery process, the atrial pressure regulating device is stretched with the recovery connector 162 and the inflow port end as two ends until it is in a straightened state to be loaded in the delivery system.

[0185] If the delivery position is improper, the device can be entirely received in the delivery system by pulling the recovery connector 162, and then released again.

[0186] Example 5

[0187] As shown in Figure 13 、 Figure 14 、 Figure 15 The atrial pressure regulating device of the present embodiment is a cylindrical structure, which includes, in the axial direction of the cylindrical structure, the inflow 110, the atrial septum passage 130, and the outflow 140 arranged in sequence along the blood flow direction, and a one-way open valve is arranged in the outflow 140. The cylindrical structure is respectively provided with a first positioning part 120 and a second positioning part 150 abutting against the atrial septum wall on the corresponding side.

[0188] The first positioning part 120 is connected to the junction of the inflow 110 and the atrial septum passage 130 in the cylindrical structure. The second positioning part 150 is connected to the junction of the outflow 140 and the atrial septum passage 130 in the cylindrical structure.

[0189] A layer of porcine pericardium 170 is coated on the passage surface (the inside of the stent) of the inflow, the outflow, and the atrial septum passage. In the axial direction, the porcine pericardium 170 extends from the inlet end of the inflow to the outlet end of the outflow, forming a cylinder corresponding to the shape of the stent. Three pieces of porcine pericardium valve 180 are sewn inside the passage of the outflow 140. The three pieces of porcine pericardium valve serve as a one-way open valve. When the pressure difference between the left atrium and the right atrium is greater than 2 mmHg, the valve starts to open, forming a one-way shunt from the left atrium to the right atrium. When the pressure difference is greater than 20 mmHg, the valve is fully open, as shown in Figure 14 When the pressure difference between the right atrium and the left atrium is greater than 2 mmHg, the valve is fully closed, as shown in Figure 15 .

[0190] Compared with Example 1, on the one hand, the connection position of the second positioning part 150 is closer to the atrial septum passage 130, and on the other hand, the second positioning part 150 no longer has the intersection structure of the support rods, but only has six radially outwardly distributed support rods 151. The support rods 151 extend substantially radially outwardly, and have recovery connectors at the ends of the support rods, which are bent away from the inflow at the end positions.

[0191] Example 6

[0192] AsFigure 16 , Figure 17 , Figure 18 , Figure 19 As shown, the interatrial pressure regulating device in this embodiment has a cylindrical structure. The cylindrical structure includes an interatrial septum channel 200 in the middle along its axial direction. A first positioning part 210 is provided on the side of the interatrial septum channel 200 facing the left atrium, and a second positioning part 220 is provided on the side of the interatrial septum channel 200 facing the right atrium (in the context of use). This embodiment does not use a valve; therefore, compared to other embodiments, both sides of the interatrial septum channel 200 directly connect to the positioning parts. Although no valve is used, a layer of porcine pericardium can be used to cover the interatrial septum channel area as needed.

[0193] The pressure regulating device is made of tubing cut into shape. After being released inside the body, it forms a frame structure that can keep the interatrial septum passage unobstructed. Alternatively, it can be made using a braiding method, or a combination of partial braiding and partial tubing cutting. Different parts can be welded or fixed together with connectors.

[0194] Both the first positioning part 210 and the second positioning part 220 are integral with the atrial septum channel 200. The atrial septum channel 200 has a wave-like structure in the circumferential direction. Locally, it is formed by multiple V-shaped units arranged and connected in sequence. When the density changes, it can also be formed by multiple X-shaped units arranged and connected in sequence, or even a more complex grid structure. Overall, it is required to facilitate radial compression and maintain the necessary strength.

[0195] The interatrial compartment channel 200 has multiple structural endpoints, such as grid endpoints or intersections, on the first positioning part 210 side and the second positioning part 220 side, respectively.

[0196] Endpoints 203 and 204 are visible on one side of the first positioning part 210. The first positioning part 210 includes two branches that radiate radially outward from each structural endpoint on the corresponding side of the interseptal channel 200. Each branch intersects and connects with an adjacent branch from the adjacent structural endpoint.

[0197] For example:

[0198] Endpoint 203 radiates outward in a radial direction with two branches, one of which is branch 211;

[0199] Endpoint 204 radiates outward in a radial direction with two branches, one of which is branch 212;

[0200] Branches 211 and 212 intersect and connect at endpoint 213.

[0201] The first positioning part 210 is a plurality of support rod structures radiating outward in the radial direction, and the first positioning part 210 is generally inclined and bent slightly toward the atrial septal passage 200 while radiating outward, and is slightly inclined and bent away from the atrial septal passage 200 near the outermost end in the radial direction of the first positioning part 210.

[0202] The first positioning part 210 has a short axial length, and of course, the first positioning part 210 can also adopt a more complex winding manner. The preferred manner is only schematically shown in the drawings.

[0203] Similarly, taking one of the V-shaped units of the atrial septal passage 200 as an example, including the support rod 201 and the support rod 202, the support rod 201 and the support rod 202 meet at the end point 205 on the side of the second positioning part 220, and another end point 206 and an end point 207 adjacent to the end point 205 can be seen in the drawings.

[0204] The second positioning part 220 includes two branches radiating outward in the radial direction from each structural end point on the corresponding side of the atrial septal passage 200, each branch meets the adjacent branch from the adjacent structural end point to form a support rod, and all the support rods have a plurality of pairs in the circumferential direction, the support rods belonging to the same pair meet each other, and a recycling connector is arranged at the meeting position.

[0205] In order to facilitate the arrangement of the recycling connector, the second positioning part 220 converges gradually from each structural end point on the corresponding side of the atrial septal passage 200, until converging into 2-8 end points, and a recycling connector is arranged at each end point, and in the embodiment, there are 4 end points.

[0206] The branches meet to form support rods, and the support rods belonging to the same pair meet each other again, which can be regarded as a two-level converging structure, and the convergence refers to the convergence and reduction of the number of grids, and has no necessary connection with the appearance, and more levels of converging structures can be used under the complex grid structure.

[0207] For example:

[0208] The end point 205 radiates two branches outward in the radial direction, which are branch 221 and branch 222;

[0209] The end point 206 radiates two branches outward in the radial direction, which are branch 223 and branch 224;

[0210] The end point 207 radiates two branches outward in the radial direction, which are branch 225 and branch 226;

[0211] The branch 222 and the branch 223 meet to form a support rod 227;

[0212] The branch 224 and the branch 225 meet to form a support rod 228;

[0213] The support rods 227 and 228 are a pair and meet at the end point 229, and the end point 229 is provided with a connecting hole 230 as a recycling connector.

[0214] The recycling connector has a length of about 3-5 mm, and a smooth edge without sharp corners. All the recycling connectors are arranged along the circumference of the cylindrical structure. The connecting hole 230 is a round hole, an oval hole or a square round corner structure, which is beneficial for cooperation with the conveying system.

[0215] The second positioning part 220 extends towards the atrial septal passage 200 while radiating outward along the radial direction of the cylindrical structure, and then extends towards the direction away from the atrial septal passage 200 until the outlet side adjacent to the atrial septal passage 200.

[0216] Each branch of the second positioning part 220 extends to the position abutting against the atrial septum, and then converges correspondingly and is flipped in the form of a support rod. The flipped part can form a circular or elliptical extension path.

[0217] The end of the second positioning part 220 is each recycling connector, and the pointing direction of each recycling connector is away from the atrial septal passage 200 for recycling. The pointing direction of each recycling connector is substantially parallel or has a small angle, for example, less than 45 degrees, preferably less than 30 degrees, to the axis away from the atrial septal passage 200. When there is an angle, each recycling connector can be gathered towards the axis of the atrial septal passage 200 or diverged away from the axis of the atrial septal passage 200.

Claims

1. An interatrial pressure regulation device, characterized in that, The cylindrical structure comprises a atrial septum passage and an outflow tract arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure, the atrial septum passage has an inlet on the side opposite to the outflow tract, the outflow tract comprises a transition section and an outflow section arranged in sequence along the axial direction, the outflow section and the atrial septum passage are connected through the transition section, the cross-sectional area of the outflow section is larger than that of the atrial septum passage, the cross-sectional area gradually increases from the atrial septum passage to the outflow section, a one-way open valve is arranged in the outflow tract, and the cylindrical structure is provided with a first positioning part and a second positioning part arranged on the two sides of the atrial septum respectively. The first positioning part and the second positioning part are each independently a wire frame structure or a mesh structure, and the first positioning part and the second positioning part each extend radially outward along the cylindrical structure. The second positioning part is connected to the outlet side of the outflow tract and is bent from the outlet side of the outflow tract to the side of the atrial septum passage until a position abutting against the atrial septum, the second positioning part is turned to the direction away from the inlet of the atrial septum passage through a U-shaped bending at the position abutting against the atrial septum until the outlet side of the outflow tract, the second positioning part and the outflow tract are an integral structure, which is cut from the cylindrical material and obtained through heat setting, and the end of the second positioning part is provided with a recycling connector. The outflow tract has a unit grid structure, and all the vertices of the unit grids are connected to one of the recycling connectors through the second positioning part at the outlet side of the outflow tract.

2. The heart chamber pressure regulating device of claim 1, wherein, The first positioning part and the second positioning part are in point contact or surface contact with the atrial septum on the corresponding side.

3. The heart chamber pressure regulation device of claim 1, wherein, The first positioning part or the second positioning part comprises a plurality of branched support rods extending radially outward along the cylindrical structure, and adjacent support rods intersect with each other through branching.

4. The heart chamber pressure regulation device of claim 1, wherein, The first positioning part or the second positioning part comprises a plurality of pairs of support rods extending radially outward along the cylindrical structure, and the support rods belonging to the same pair intersect with each other.

5. The heart chamber pressure regulation device of claim 1, wherein, The diameter of the outflow tract is larger than that of the atrial septum passage, and the connection part between the outflow tract and the atrial septum passage is locally or entirely abutted against the atrial septum.

6. The heart chamber pressure regulation device of claim 1, wherein, An inflow tract is further arranged opposite to the inlet of the atrial septum passage.

7. The heart chamber pressure regulation device of claim 6, wherein, The inflow tract gradually decreases in diameter along the blood flow direction.

8. The heart chamber pressure regulation device of claim 6, wherein, The inflow tract extends radially outward along the cylindrical structure from the inlet side of the atrial septum passage, and the inflow tract serves as the first positioning part.

9. The interatrial pressure regulation device of claim 6, wherein, The first positioning part is connected to the connection part between the inflow tract and the atrial septum passage or the inlet side of the inflow tract.

10. The heart chamber pressure regulation device of claim 1, wherein, The first positioning part is bent to the side of the atrial septum passage while extending radially outward until abutting against the atrial septum.

11. The heart chamber pressure regulation device of claim 1, wherein, The end of the first positioning part is turned to the direction away from the outflow tract.

12. The device for regulating the pressure in the atrial chambers according to any one of claims 1 to 11, characterized in that A membrane is arranged between the position corresponding to the atrial septum in the atrial septum passage and the valve.

13. The heart chamber pressure regulation device of claim 12, wherein, The recycling connector is provided with a connecting hole.

14. The heart chamber pressure regulation device of claim 12, wherein, The recycling connector is arranged along the circumferential direction of the cylindrical structure.

15. The heart chamber pressure regulation device of claim 12, wherein, The recycling connector is downstream of the outlet side of the outflow tract in the axial direction.

16. The heart chamber pressure regulation device of claim 1, wherein, The edges of the outflow tract converge into at least two end portions distributed at intervals in the circumferential direction, and each end portion is provided with a recycling connector.

17. The heart chamber pressure regulation device of claim 16, wherein, A portion of the edge of the outflow tract converges directly to the respective end portion, and another portion converges to the respective end portion via an extension section which, in the compressed state, has an axial position further away from the inflow tract than the edge of the outflow tract.

18. The heart chamber pressure regulation device of claim 16, wherein, The edge of the outflow tract converges to the respective end portion via an extension section which, in the compressed state, extends axially from the edge of the outflow tract.

19. The heart chamber pressure regulation device of claim 17 or 18, wherein, In the released state, the extension section extends from the edge of the outflow tract in a direction away from the inflow port.

20. The heart chamber pressure regulation device of claim 17 or 18, wherein, In the released state, the extension section has, from the edge of the outflow tract, a first bend towards the inflow port and a second bend away from the inflow port.

21. The heart chamber pressure regulation device of claim 20, wherein, In the released state, the extension section constitutes the second positioning portion.

22. The heart chamber pressure regulation device of claim 20, wherein, The extension section abuts against the atrial septum via the second bend.

23. The heart chamber pressure regulation device of claim 1, wherein, The diameter of the outflow tract is greater than the diameter of the atrial septal passage, and both the first and second positioning portions have a tendency to expand radially from the point of connection with the tubular structure.

24. The heart chamber pressure regulation device of claim 6, wherein, The diameter of the outflow tract and the inflow tract are both greater than the diameter of the atrial septal passage, and both the first and second positioning portions have a tendency to expand radially from the point of connection with the tubular structure.

25. The heart chamber pressure regulation device of claim 23 or 24, wherein, The second positioning portion has, from the point of connection with the tubular structure, a first bend towards the inflow port and a second bend away from the inflow port. The portion between the first bend and the second bend expands radially the closer it is to the inflow port, and the portion after the second bend converges radially the further it is from the inflow port.

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