Atrial septostomy device

Abstract

The present invention discloses an atrial septal fistula device, comprising a main body, the main body comprising a support ring and a skirt located on both sides of the support ring, the main body being cut from a metal tube; and a pressurized liquid bag, the pressurized liquid bag being used to expand the main body and flip the skirt around the support ring; in a first state, the pressurized liquid bag is in a contracted state, the main body is sleeved on the outer periphery of the pressurized liquid bag, and the main body is also in a contracted state, wherein the support ring and the skirt are attached to the peripheral wall of the pressurized liquid bag, and the main body is transported by the pressurized liquid bag; in a second state, the pressurized liquid bag expands, driving the main body sleeved on the outer periphery of the pressurized liquid bag to expand, wherein the support ring expands radially, and the skirt flip angle α is 30-120 degrees. The pressurized liquid bag of the present invention will also expand the open state of the atrial septum hole while expanding the main body, so that the hole open state is maintained for a longer time; the pressurized liquid bag expands the main body and is completely attached to the atrial septum to adapt to the atrial septum structure, so that the main body is more firmly fixed in the atrial septum position.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to an atrial septostomy device. Background Art

[0002] Heart failure (HF) is the culmination of various cardiovascular events and the cumulative effect of various cardiac abnormalities, ultimately leading to a decline in the heart's pumping function. The clinical manifestations of HF in cardiovascular patients indicate a poor prognosis. The more severe the HF, the higher the risk of death. HF is a complex clinical syndrome caused by abnormal changes in cardiac structure and function due to various factors, resulting in impairments in ventricular systolic ejection and / or diastolic filling function. Its primary manifestations are decreased exercise tolerance (dyspnea, fatigue) and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema).

[0003] According to statistics, 17% to 45% of heart failure patients die within one year of diagnosis, and the majority survive less than five years. Furthermore, the number of heart failure patients is rapidly increasing. For example, in the United States, the number of people with heart failure is projected to rise from 5.8 million in 2012 to 8.5 million by 2030. In my country, the incidence of heart failure is approximately 1.3%, with approximately 18 million people diagnosed with the condition, and around 500,000 new cases each year.

[0004] Heart failure with preserved ejection fraction (HFpEF; LVEF ≥ 50%) is a common type of heart failure, accounting for approximately 50% of heart failure cases. Epidemiological studies show that the incidence of HFpEF is increasing worldwide. Currently, treatment with inotropic, diuretic, and vasodilator medications can effectively slow the progression of this type of heart failure. However, to date, no medication or device has significantly reduced mortality or hospitalization risk in patients with HFpEF. Furthermore, HFpEF is associated with numerous complications, and its complex pathophysiology is poorly understood. HFpEF is commonly characterized by elevated left atrial pressure (especially during exercise), leading to pulmonary hypertension, pulmonary congestion, and dyspnea. Dyspnea is a major cause of frequent hospitalization in patients with HFpEF. Retrospective data show that, although pulmonary capillary wedge pressure (PCWP) is normal at rest, it increases significantly during exercise. This was associated with decreased 6-min walk distance and long-term survival. Therefore, PCWP at rest or during exercise may be a therapeutic target in patients with HFpEF.

[0005] Therefore, the purpose of the present invention is to provide an atrial septal fistula device that is implanted in the atrial septum of a HFpEF patient, creating a hole in the atrial septum to reduce left atrial pressure during exercise in HFpEF patients, thereby lowering pulmonary artery pressure and PCWP, reducing the occurrence of pulmonary congestion, and effectively alleviating symptoms such as dyspnea and fatigue in HFpEF patients. Summary of the Invention

[0006] The purpose of the present invention is to provide an atrial septal fistula device. The atrial septal fistula device of the present invention expands the main body through a pressurized liquid bag to fix the main body in the atrial septum position. The pressurized liquid bag of the present invention will expand the atrial septum position while expanding the main body to expand the hole opening state, so that the hole opening state can be maintained longer; the pressurized liquid bag can adapt well to the atrial septum structure, and then expand the main body to be completely attached to the atrial septum, so that the main body is more firmly fixed in the atrial septum position, and finally achieve the effect of moderately reducing left atrial blood pressure, reducing left atrial volume, alleviating chronic heart failure symptoms, improving left ventricular function and preventing left ventricular insufficiency.

[0007] The present invention provides an atrial septal fistula device, which includes a main body, which includes a support ring and skirts located on both sides of the support ring, and the main body is cut from a metal tube; and a pressurized liquid bag, which is used to expand the main body and flip the skirt around the support ring; in a first state, the pressurized liquid bag is in a contracted state, and the main body is sleeved on the outer periphery of the pressurized liquid bag, and the main body is also in a contracted state, wherein the support ring and the skirt are attached to the peripheral wall of the pressurized liquid bag, and the main body is transported by the pressurized liquid bag; in a second state, the pressurized liquid bag expands, driving the main body sleeved on the outer periphery of the pressurized liquid bag to expand, wherein the support ring expands radially, and the skirt flipping angle α is 30-120 degrees; preferably, 30-90 degrees.

[0008] In another preferred embodiment, the support ring and the skirts on both sides are in a network structure.

[0009] In another preferred embodiment, the support ring includes a support body and optionally a plurality of limiting rings, the support body is a grid structure, and the limiting rings are annular and arranged perpendicular to the axial direction of the main body.

[0010] The support body expands in the radial direction, and optionally, in the axial direction. The limiting ring is used to limit the expansion of the support body in the radial direction so that the support body will not continue to increase due to the continuous change of the pressure of the pressurized liquid bag.

[0011] In another preferred embodiment, the grid structure unit of the support body may be, but is not limited to, a sinusoidal structure or a quadrilateral, hexagonal, or octagonal structure; preferably, a square, rectangle, rhombus, or spindle shape.

[0012] In another preferred embodiment, the number of the grid structure units of the support body is 6-120; preferably, 6-100.

[0013] In another preferred embodiment, one or more sides of the grid are curved to provide a greater deformation.

[0014] In another preferred embodiment, the number of the limiting rings is 1-10; preferably, 2-8; more preferably, 3-6.

[0015] In another preferred embodiment, the limiting ring is an annular structure formed by connecting a plurality of straight segments and a plurality of curved segments in series end to end.

[0016] In another preferred embodiment, the plurality of limiting rings are evenly spaced apart, with an interval of 0.5-2 mm; preferably, 0.7-1.5 mm.

[0017] In another preferred embodiment, the support body and the limiting ring are integral or integrally formed.

[0018] In another preferred example, the skirt includes a first skirt and a second skirt.

[0019] In another preferred embodiment, each of the skirt portions may be, but not limited to, a grid shape, a petal shape, etc.

[0020] In another preferred embodiment, each of the skirts includes a plurality of monomers, wherein the plurality of monomers are independent of each other and are evenly spaced around the circumference of the support body.

[0021] In another preferred embodiment, the number of the monomers is 3-16.

[0022] In the contracted state, each of the skirts is arranged along the axial direction of the main body, that is, the first skirt is arranged from the distal end of the support body to the distal end of the main body, and the second skirt is arranged from the proximal end of the support body to the proximal end of the main body;

[0023] It should be noted that the “distal end” refers to the end of the atrial septostomy device that is away from the operator when in use; and the “proximal end” refers to the end of the atrial septostomy device that is close to the operator when in use.

[0024] In the expanded state, the first skirt is turned outward around the distal end of the support body, and the second skirt is turned outward around the proximal end of the support body.

[0025] In another preferred embodiment, the main body and the skirt are integral or integrally formed.

[0026] In another preferred embodiment, the support body and the skirt are integral or integrally formed.

[0027] In another preferred embodiment, after the pressurized liquid bag is expanded, the diameters of the limiting rings in each row are equal.

[0028] In another preferred embodiment, after the pressurized liquid bag is expanded, the diameter of each row of the limiting rings increases by 1-1.5 times from the middle to both sides.

[0029] In another preferred embodiment, after the pressurized liquid bag is expanded, the diameter of each row of the limiting rings increases by 1-1.5 times from one side to the other.

[0030] In another preferred embodiment, after the pressurized liquid bag is expanded, the diameters of the limiting rings in each row are in different proportions.

[0031] In another preferred embodiment, the main body is manufactured by a laser cutting process.

[0032] In another preferred embodiment, the material of the main body is stainless steel, cobalt-chromium alloy, cobalt-nickel alloy, or one of platinum, gold, palladium, tantalum, or an alloy thereof.

[0033] In another preferred example, the pressurized liquid bag includes 1-3 pressurized liquid bag bodies, a pressurized liquid bag connecting tube, a pressurized liquid bag connector and a hollow tube, and 1-3 pressurized interfaces connected to the pressurized liquid bag fluid are respectively arranged at the distal end of the pressurized liquid bag connector, wherein the pressurized interfaces correspond one-to-one to the pressurized liquid bag bodies, and a guide wire interface is used to connect with the hollow tube.

[0034] In another preferred embodiment, the pressurized bladder is made of PU, TPU, PBAX or nylon.

[0035] In another preferred example, when the number of the pressurized bladder is one, the length of the pressurized bladder is 10-60 mm, and its shape after expansion can be cylindrical or dumbbell-shaped; when one pressurized bladder and the main body are used together, the main body is placed in the middle part of the pressurized bladder. After the main body is expanded, due to the limiting effect of the limiting ring, the pressurized bladder becomes dumbbell-shaped after the main body is expanded, and the two end parts of the pressurized bladder expand and fold over the skirt.

[0036] In another preferred embodiment, when the number of the pressurized balloon is one, the pressurized balloon is a compliant balloon.

[0037] In another preferred example, when the number of the pressurized bladders is two, the two pressurized bladders are arranged adjacent to each other along the axial direction, the length of each pressurized bladder is 5-30 mm, and its shape after expansion is cylindrical, spherical or ellipsoidal; when the two pressurized bladders and the main body are used in combination, the main body is placed in the middle part of the two pressurized bladders, and after the main body expands with the pressurized bladder, the support ring expands accordingly, and the skirts on both sides flip upward.

[0038] In another preferred embodiment, when the number of the pressurized balloons is two, the two pressurized balloons are compliant balloons.

[0039] In another preferred example, when the number of the pressurized bladders is 3, the 3 pressurized bladders are arranged adjacent to each other in the axial direction, the length of the distal pressurized bladder is 5-30mm, the length of the proximal pressurized bladder is 5-30mm, and the length of the middle pressurized bladder is 2-10mm, and the shape after expansion is cylindrical, spherical or ellipsoidal; when the 3 pressurized bladders and the main body are used in combination, the support ring of the main body is placed on the middle pressurized bladder, and the skirts on both sides of the support ring are placed on the pressurized bladders on both sides. After the main body expands with the pressurized bladder, the support ring expands accordingly, and the skirts on both sides are flipped upward.

[0040] In another preferred embodiment, when the number of the pressurized balloons is three, the distal pressurized balloon and the proximal pressurized balloon are compliant balloons, and the middle pressurized balloon is a non-compliant balloon.

[0041] In another preferred example, the outer diameter of the hollow tube is smaller than the inner diameter of the pressurized bladder connecting tube, the pressurized bladder connecting tube and the hollow tube are welded closed at the distal end, and a pressurized cavity is formed between the pressurized bladder and the hollow tube, and the pressurized bladder is pressurized and expanded through the pressurized cavity.

[0042] In another preferred embodiment, the interior of the hollow tube can be guided by a guide wire.

[0043] In another preferred embodiment, the guide wire has a gauge of 0.010" to 0.050".

[0044] In another preferred embodiment, after the pressurized liquid bag is expanded, the inner diameter of the support ring is 4-13 mm, and the axial length of the support ring is 1.5-6 mm.

[0045] In another preferred embodiment, after the pressurized liquid bag is expanded, the height h of the skirt portions on both sides is 2-8 mm, and the maximum distance s between the ends of the skirt portions on both sides is 3-12 mm.

[0046] In another preferred embodiment, the device includes a developing mark, and the developing mark is connected to the main body by inlaying or welding.

[0047] In another preferred embodiment, the number of the development marks is 3-30.

[0048] In another preferred embodiment, the support ring and / or the skirt is provided with a circular hole, and the development mark is arranged in the circular hole.

[0049] In another preferred embodiment, the material of the development mark is platinum, gold, palladium, tantalum or an alloy thereof.

[0050] In another preferred embodiment, the surface of the main body is coated with a drug that inhibits endothelialization, which may be but is not limited to paclitaxel or a rapamycin derivative.

[0051] In another preferred embodiment, the surface of the main body is coated with an anticoagulant drug, which may be but is not limited to heparin.

[0052] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features described in detail below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be listed here one by one. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] In order to more clearly illustrate the embodiments of the present invention 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 of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0054] Figure 1 is a front view of the main body of the atrial septostomy device in an embodiment of the present invention in an expanded state;

[0055] Figure 2 yes Figure 1 A side view of the body of the atrial septostomy device;

[0056] Figure 3 yes Figure 1 A perspective view of a main body of an atrial septostomy device;

[0057] Figure 4 yes Figure 1 A side view of the main body of the atrial septostomy device in a deflated state;

[0058] Figure 5 yes Figure 4 A perspective view of a main body of an atrial septostomy device;

[0059] Figure 6a FIG1 is a front view of a skirt portion of a main body of an atrial septostomy device according to an embodiment of the present invention, showing another grid structure;

[0060] Figure 6b This is a front view of a skirt portion of a main body of an atrial septostomy device according to an embodiment of the present invention, showing another grid structure;

[0061] Figure 6c yes Figure 6b The expanded view of the middle subject;

[0062] Figure 7 yes Figure 1 A side view of the main body of the atrial septostomy device in another expanded state;

[0063] Figure 8a A front view of an atrial septostomy device with a pressurized balloon according to an embodiment of the present invention;

[0064] Figure 8b yes Figure 8a A cross-sectional view of the pressurized bladder in FIG.

[0065] Figure 9 yes Figure 1 Schematic diagram of the cooperation between the main body of the atrial septostomy device in FIG. 8 and the pressurized fluid bag in FIG. 9 ;

[0066] Figure 10 yes Figure 1 A main body of the atrial septostomy device is in an expanded state, with its support ring expanding in a gradient manner;

[0067] Figure 11 yes Figure 10 A side view of the body of the atrial septostomy device;

[0068] Figure 12 yes Figure 11 A partial enlarged view of part I;

[0069] Figure 13 1 is a front view of an atrial septostomy device with two pressurized balloons according to an embodiment of the present invention;

[0070] Figure 14 1 is a front view of an atrial septostomy device with three pressurized balloons according to an embodiment of the present invention;

[0071] Figures 15a-15c yes Figure 14 A cross-sectional view of the middle section of the pressurized bladder connecting tube.

[0072] In the accompanying drawings, the following are marked:

[0073] 1-Support ring;

[0074] 2-skirt;

[0075] 3- support body;

[0076] 4-Limiting ring;

[0077] 5- pressurized capsule;

[0078] 6- pressurized bladder connecting tube;

[0079] 7- Pressurized fluid capsule connector;

[0080] 8-Hollow tube;

[0081] 9- pressurized interface;

[0082] 10- pressurized chamber;

[0083] 11-guidewire interface;

[0084] 12-development mark;

[0085] 13-monomer;

[0086] 14- Pressurized channel. DETAILED DESCRIPTION

[0087] After extensive and in-depth research and a large number of screenings, the inventors have developed an atrial septal fistula device for the first time. Compared with the prior art, the atrial septal fistula device of the present invention expands the main body through a pressurized liquid bag to fix the main body in the atrial septum position. The pressurized liquid bag of the present invention will expand the atrial septum position while expanding the main body to expand the open state of the hole, so that the hole open state can be maintained longer; the pressurized liquid bag can adapt well to the atrial septum structure, and then expand the main body to be completely attached to the atrial septum, so that the main body is more firmly fixed in the atrial septum position, and finally achieve the effect of moderately reducing left atrial blood pressure, reducing left atrial volume, alleviating chronic heart failure symptoms, improving left ventricular function and preventing left ventricular insufficiency. On this basis, the present invention was completed.

[0088] The invention provides an atrial septostomy device, which is an atrial septostomy device with a specific structure.

[0089] Typically, the atrial septal fistula device of the present invention consists of a main body and a pressurized fluid bag, and optionally a developing mark, wherein the main body is cut from a metal tube, and has a middle support ring and two side skirt structures, the middle support ring is provided with a limiting ring, the middle support ring surface and the two side skirts form a network structure, after the pressurized fluid bag is expanded, the diameter of the device main body becomes larger, and the two side skirts are folded outward at a certain angle to the central axis of the middle support ring, the developing marks are evenly distributed in the circular holes on both sides of the middle support ring, and in the end circular holes of the grid structure of the two side skirts, and the surface of the device main body can be coated with drugs that inhibit endothelialization or anticoagulation.

[0090] In another preferred embodiment, the limiting rings in the middle support ring of the main body can be distributed axially along the middle support ring in 2-6 rows, with a row spacing of 0.5-2 mm; preferably, 0.7-1.5 mm. After expansion by the pressurized liquid bag, the diameters of the limiting rings in each row can be equal, or they can increase by 1-1.5 times from the middle to both sides.

[0091] In another preferred embodiment, the main body is made by laser cutting process, and the material is stainless steel, cobalt-chromium alloy, cobalt-nickel alloy, or one of platinum, gold, palladium, tantalum or their alloys.

[0092] In another preferred embodiment, the structure of the pressurized liquid sac consists of 1-3 pressurized sac bodies and a hollow tube. The outer diameter of the hollow tube is smaller than the inner diameter of the pressurized sac body. The pressurized sac body and the hollow tube are welded closed at the distal end, and a pressurized cavity is formed between the pressurized sac body and the hollow tube. The interior of the hollow tube can be guided by a guide wire, and the compatible guide wire specifications are 0.010" to 0.050".

[0093] In another preferred embodiment, the middle support ring network unit of the main body has a sinusoidal structure or a quadrilateral, hexagonal, or octagonal structure, and the number is 6-120; preferably, 6-100, and the number of the skirt network units on both sides is 3-16.

[0094] In another preferred embodiment, the middle support ring network unit of the main body has a limiting ring so that the inner diameter of the middle support ring can be limited to a certain size after being expanded by the pressurized liquid bag and will not continue to increase due to continuous changes in the pressure of the pressurized liquid bag.

[0095] In another preferred embodiment, after the main body is expanded by the pressurized liquid bag, the inner diameter of the middle support ring is 4-13 mm, and the width of the support ring is 1.5-6 mm.

[0096] In another preferred embodiment, after the main body is expanded by the pressurized liquid bag, the height of the skirts on both sides is 2-8 mm, and the maximum distance between the ends of the skirts on both sides is 3-12 mm.

[0097] In another preferred embodiment, the developing marking material of the main body is platinum, gold, palladium, tantalum or an alloy thereof.

[0098] In another preferred embodiment, the number of the developing marks on the main body is 3-30, which are connected to the device main body by inlaying or welding.

[0099] In another preferred embodiment, the surface of the main body may be coated with endothelialization inhibiting drugs or anticoagulant drugs.

[0100] The main advantages of the present invention include:

[0101] (a) The atrial septal hole is further expanded by applying a pressure balloon to extend the opening of the hole, thereby maintaining the hole's opening longer and ensuring the stability of the artificial atrial septal fistula without the risk of secondary closure;

[0102] (b) The pressurized sac can adapt well to the atrial septal structure, and the dilated body is completely attached to the atrial septum;

[0103] (c) adjusting the main body to an optimal position and expansion state by means of a pressurized liquid bag;

[0104] (d) Easy to operate.

[0105] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are intended to illustrate the present invention only and are not intended to limit the scope of the present invention. In addition, the accompanying drawings are schematic diagrams, and therefore the devices and apparatuses of the present invention are not limited by the dimensions or proportions of the schematic diagrams.

[0106] It should be noted that in the claims and description of this patent, relational terms such as first and second, etc. are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "including a" does not exclude the presence of other identical elements in the process, method, article or device that includes the element.

[0107] Example 1

[0108] The atrial septal fistula device of this embodiment is as follows Figure 1-12 As shown, it consists of a main body and a pressurized liquid bag.

[0109] The main body is manufactured from a metal tube using a laser cutting process and includes a support ring 1 and skirts 2 located on either side of the support ring 1. The support ring 1 includes a support body 3 and multiple retaining rings 4. The main body is made of stainless steel, cobalt-chromium alloy, cobalt-nickel alloy, or one of platinum, gold, palladium, tantalum, or their alloys.

[0110] The support body 3 is a grid structure, and its grid structure units can be, but are not limited to, a sinusoidal structure or a quadrilateral, hexagonal, or octagonal structure; preferably, a square, rectangle, rhombus, or spindle shape. In another preferred embodiment, one or more sides of the grid are curved, for example, wavy, to provide a larger deformation amount. Based on this grid structure, the support body 3 can expand in the radial direction or even in the axial direction. The number of grid structure units of the support body 3 is 6-120; preferably, 6-100, and this number can be adjusted according to actual needs.

[0111] The limiting ring 4 is annular and arranged perpendicular to the axial direction of the main body. It is used to limit the radial expansion of the support body 3 so that it does not continue to increase due to the continuous changes in the pressure of the pressurized liquid sac. The limiting ring 4 is an annular structure composed of multiple straight segments and multiple curved segments connected in series end to end. The multiple limiting rings 4 are evenly spaced, with an interval of 0.5-2mm; preferably, 0.7-1.5mm. The number of limiting rings 4 in this embodiment is three, and this number can be adjusted according to actual needs.

[0112] In this embodiment, each skirt 2 is shaped like a flower. Each skirt 2 comprises six independent petal-shaped units 13, evenly spaced around the circumference of the support body 3. The support ring 1 and skirt 2 are integral or integrally formed. In the contracted state, each skirt 2 converges axially along the body. In the expanded state, the two skirts 2 rotate radially outward around the ends of the support ring 1.

[0113] The monomers 13 of a single skirt 2 can have the same structure or different structures. The skirts 2 on both sides can have the same structure or different structures. For example, the structure of the monomers 13 of one side of the skirt 2 is as follows: Figure 1 As shown, the structure of the monomer 13 of the other side skirt 2 is as follows Figure 6a As shown. The structure of the monomer 13 of the skirt 2 can also be as follows Figures 6b-6c There is no special limitation on the shape of the mesh structure of the skirt 2, as long as it can be easily turned over and can fix the main body to the atrial septum hole.

[0114] The pressurized liquid sac is used to expand the main body. The number of pressurized sac bodies of the pressurized liquid sac is 1, and the length of the pressurized sac body is 10-60mm. Its shape after expansion can be cylindrical or dumbbell-shaped. When in use, the main body is placed in the middle part of the pressurized liquid sac body. After the pressurized liquid sac expands the main body, due to the limiting effect of the limiting ring 4, the pressurized liquid sac becomes dumbbell-shaped after the main body is expanded, and the two ends of the pressurized liquid sac are partially expanded and the skirt 2 is folded over. The pressurized liquid sac is made of polymer materials, such as PU, TPU, PEBAX or nylon. The pressurized liquid sac includes a pressurized sac body 5, a pressurized sac body connecting tube 6, a pressurized liquid sac connector 7 and a hollow tube 8. The pressurized sac body 5 is arranged at the distal end of the pressurized sac body connecting tube 6, the pressurized liquid sac connector 7 is arranged at the proximal end of the pressurized sac body connecting tube 6, and the hollow tube 8 is located inside the pressurized sac body connecting tube 6.

[0115] The outer diameter of the hollow tube 8 is smaller than the inner diameter of the pressurized bladder connecting tube 6. The pressurized bladder connecting tube 6 and the hollow tube 8 are welded closed at the distal end, forming a pressurization chamber 10 between the pressurized bladder 5 and the hollow tube 8. The pressurized bladder 5 is pressurized and expanded through the pressurization chamber 10. A pressurization interface 9 and a guidewire interface 11 are provided at the proximal end of the pressurized liquid bladder connector 7, wherein the pressurization interface 9 is connected to the pressurization chamber 10. Preferably, the pressurization interface 9 is connected to the pressurization chamber 10 through the connecting channel between the pressurized bladder connecting tube 6 and the hollow tube 8, while the guidewire interface 11 is connected to the hollow tube 8. The interior of the hollow tube 8 can be guided by a guidewire. The specification of the guidewire is 0.010" to 0.050".

[0116] During the transportation process, the pressurized liquid bag is in a contracted state, and the main body is sleeved on the periphery of the pressurized liquid bag, and the main body is also in a contracted state, such as Figure 4-5 As shown, the support ring 1 and the skirt 2 are attached to the peripheral wall of the pressurized liquid bag, and the main body is transported through the pressurized liquid bag.

[0117] During expansion, the pressurized liquid bag expands, driving the main body sleeved on the outer periphery of the pressurized liquid bag to expand, wherein the support ring 1 expands radially, and the skirt 2 flips at an angle α of 30-120 degrees, preferably 30-90 degrees. After the pressurized liquid bag expands, the diameters of the limiting rings 4 in each row can be equal, such as Figure 1-3 As shown, it can also be different to better adapt to the atrial septum hole structure. For example, each row of limit rings 4 presents a certain gradient change. For example, Figure 10-12As shown, the diameter increases by 1-1.5 times from the middle to the sides, that is, the diameter of the limiting ring in the middle position after expansion is 1 unit, the diameter of the limiting rings on both sides of the middle limiting ring is 1.1 units, and the interval between adjacent limiting rings is 0.1 unit; it is also possible that the diameter of each row of limiting rings 4 increases by 1-1.5 times from one side to the other. Alternatively, the diameter of each row of limiting rings 4 does not change in a gradient, but changes irregularly. For example, there are 5 limiting rings, the diameter of the first limiting ring after expansion is 1 unit, the diameter of the second limiting ring after expansion is 1.1 units, the diameter of the third limiting ring after expansion is 1.4 units, the diameter of the fourth limiting ring after expansion is 1.2 units, and the diameter of the fifth limiting ring after expansion is 1 unit. In short, each row of limiting rings 4 can be expanded into diameters with different proportions by the pressurized bag 5 to adapt to the specific structure of the atrial septal fistula.

[0118] The skirt 2 can be turned over at a smaller angle, such as 50 degrees. Figure 7 As shown, it is also possible to flip at a larger angle, such as 75 degrees, as shown in Figure 2 As shown, the skirts 2 on both sides can be flipped at the same angle or at different angles. Multiple units 13 on the same side of the skirt 2 can be flipped at the same angle or at different angles. The flipping of the skirt 2 is determined by the structure of the atrial septum, and the hydraulic balloon is used to apply pressure to the corresponding flip angle to adapt to the specific structure of the atrial septum.

[0119] After expansion by the pressurized liquid sac, the inner diameter of the support ring 1 is 4-13 mm, and the axial length of the support ring 1 is 1.5-6 mm.

[0120] like Figure 2 As shown, after expansion by the pressurized bladder, the height h of the skirt portions 2 on both sides is 2-8 mm, and the maximum distance s between the ends of the skirt portions 2 on both sides is 3-12 mm. The device of this embodiment also has a developing mark 12, which is positioned within a circular hole provided in the support ring 1 and the skirt portion 2. The developing mark 12 is made of platinum, gold, palladium, tantalum, or an alloy thereof.

[0121] The surface of the main body is coated with a drug that inhibits endothelialization or an anticoagulant drug.

[0122] Example 2

[0123] The atrial septal fistula device in this embodiment is similar to that in embodiment 1, except that the number of pressurized sacs 5 in the device in this embodiment is two. Figure 13As shown, two pressurized bladders are positioned adjacent to each other along the axial direction. Each bladder is 5-30 mm long and, after expansion, is cylindrical, spherical, or ellipsoidal. Correspondingly, two pressurized interfaces 9 are provided at the distal end of the pressurized fluid bladder connector 7. These interfaces 9 are fluidically connected to the two pressurized bladders 5 via two pressurized channels, thereby controlling the expansion and contraction of the bladders 5. During use, the main body is placed between the two bladders. As the bladders expand, the support ring expands with the main body, causing the skirts on both sides to flip upward.

[0124] Example 3

[0125] The atrial septal fistula device in this embodiment is similar to that in embodiment 1, except that the number of pressurized bladders in the device in this embodiment is 3. Figure 14 As shown, the three pressurized sacs are arranged adjacent to each other in the axial direction. The length of the distal pressurized sac is 5-30mm, the length of the proximal pressurized sac is 5-30mm, and the length of the middle pressurized sac is 2-10mm. The shapes after expansion are cylindrical, spherical or ellipsoidal. Correspondingly, three pressurized interfaces 9 are respectively arranged at the distal end of the pressurized liquid sac joint 7. The three pressurized interfaces 9 are respectively connected to the three pressurized sacs 5 through three pressurized channel fluids, thereby controlling the expansion and contraction of the pressurized sacs 5. When the three pressurized sacs are used in conjunction with the main body, the support ring of the main body is placed on the middle pressurized sac, and the skirts on both sides of the support ring are placed on the pressurized sacs on both sides. After the main body expands with the pressurized sac, the support ring expands accordingly, and the skirts on both sides flip upward. The three pressurized channels 14 are arranged as shown in FIG. Figures 15a-15c As shown. Among them, Figure 15a As shown in the figure, the hollow tube 8 is arranged at the center of the pressurized bladder connecting tube 6, and the three pressurized channels 14 are concentric with the hollow tube 8 and are arranged around the hollow tube 8 in layers. Figure 15b , the hollow tube 8 is arranged at the center of the pressurized bladder connecting tube 6 , and the three pressurized channels 14 are evenly distributed in the ring-shaped portion surrounded by the hollow tube 8 and the pressurized bladder connecting tube 6 . Figure 15c , the hollow tube 8 is arranged on one side of the pressurized bladder connecting tube 6 (ie, eccentrically arranged), and the three pressurized channels 14 are arranged on the other side of the pressurized bladder connecting tube 6 .

[0126] All documents mentioned in this application are incorporated herein by reference, just as if each document were incorporated herein by reference individually. It should also be understood that after reading the above teachings of the present invention, those skilled in the art may make various changes or modifications to the present invention, and that such equivalents also fall within the scope of the claims appended hereto.

Claims

1. An atrial septal fistula device, characterized in that: The device is used to be implanted in the patient's atrial septum, and comprises A main body, the main body including a support ring and skirts located on both sides of the support ring, the main body being cut from a metal tube, the support ring including a support body and a plurality of limiting rings, the main body, the support body, the limiting rings, and the skirt being integrated, the material of the main body being one of the following materials: stainless steel, cobalt-chromium alloy, cobalt-nickel alloy, platinum, gold, palladium, tantalum, platinum alloy, gold alloy, palladium alloy, tantalum alloy; as well as a pressurized liquid bladder, the pressurized liquid bladder being used to expand the main body and flip the skirt around the support ring; In the first state, the pressurized liquid bladder is in a contracted state, the main body is sleeved on the outer periphery of the pressurized liquid bladder, and the main body is also in a contracted state, wherein the support ring and the skirt are attached to the peripheral wall of the pressurized liquid bladder, and the main body is transported by the pressurized liquid bladder; In the second state, the pressurized liquid bag expands, driving the main body arranged on the outer periphery of the pressurized liquid bag to expand, wherein the support ring expands radially, and the skirt flip angle α is 30-120 degrees. The limit ring is used to limit the expansion of the support body in the radial direction and will not continue to increase due to the continuous change of the pressure of the pressurized liquid bag.

2. The device according to claim 1, wherein The main body is made of a metal tube through a laser cutting process, and includes the support ring and the skirts located on both sides of the support ring. The support ring includes the support body and a plurality of limiting rings.

3. The device according to claim 1, wherein The support body is a grid structure, and the limiting ring is annular and arranged perpendicular to the axial direction of the main body.

4. The device according to claim 3, characterized in that One or more sides of the grid of the support body are curved.

5. The device according to claim 3, wherein The limiting ring is an annular structure formed by connecting a plurality of straight sections and a plurality of curved sections in series end to end.

6. The device according to claim 3, wherein The plurality of limiting rings are evenly spaced apart, with a spacing of 0.5-2 mm.

7. The device according to claim 1, wherein The skirt includes a first skirt and a second skirt.

8. The device according to claim 7, wherein The shape of each skirt portion includes a grid shape or a petal shape.

9. The device according to claim 1, wherein Each of the skirts includes a plurality of monomers, wherein the plurality of monomers are independent of each other and are evenly spaced around the circumference of the support body.

10. The device according to claim 7, wherein In the contracted state, each skirt is arranged along the axial direction of the main body; in the expanded state, the first skirt is turned outward around the distal end of the support body, and the second skirt is turned outward around the proximal end of the support body.

11. The device according to claim 3, wherein After the pressurized liquid bag is expanded, the diameters of the limiting rings in each row are equal.

12. The device according to claim 3, wherein After the pressurized liquid bag is expanded, the diameter of each row of the limiting rings increases by 1-1.5 times from the middle to both sides.

13. The device according to claim 3, wherein After the pressurized liquid bag is expanded, the diameter of each row of the limiting rings increases by 1-1.5 times from one side to the other.

14. The device according to claim 3, wherein After the pressurized liquid bag is expanded, the diameters of the limiting rings in each row are in different proportions.

15. The device according to claim 1, wherein The main body is manufactured by a laser cutting process.

16. The device according to claim 1, wherein The pressurized liquid bag includes 1-3 pressurized liquid bag bodies, a pressurized liquid bag connecting tube, a pressurized liquid bag joint and a hollow tube. 1-3 pressurized interfaces connected to the pressurized liquid bag fluid are respectively arranged at the distal end of the pressurized liquid bag joint, wherein the pressurized interfaces correspond one-to-one to the pressurized liquid bag bodies, and a guide wire interface is used to connect with the hollow tube.

17. The device according to claim 16, wherein The pressurized bladder is made of PU, TPU, PBAX or nylon.

18. The device according to claim 16, wherein When the number of the pressurized bladder is one, the length of the pressurized bladder is 10-60 mm, and the main body is placed in the middle of the pressurized bladder; In the case where there are two pressurized bladders, the two pressurized bladders are adjacently arranged along the axial direction, the length of each pressurized bladder is 5-30 mm, and the main body is placed between the two pressurized bladders; When there are three pressurized sacs, the three pressurized sacs are arranged adjacent to each other in the axial direction, the length of the distal pressurized sac is 5-30 mm, the length of the proximal pressurized sac is 5-30 mm, the length of the middle pressurized sac is 2-10 mm, the support ring of the main body is placed on the middle pressurized sac, and the skirts on both sides of the support ring are placed on the pressurized sacs on both sides.

19. The device according to claim 18, wherein When the number of the pressurized balloon is one, the pressurized balloon is a compliant balloon.

20. The device according to claim 18, wherein When the number of the pressurized balloons is two, the two pressurized balloons are compliant balloons.

21. The device according to claim 18, wherein When the number of the pressurized balloons is three, the distal pressurized balloon and the proximal pressurized balloon are compliant balloons, and the middle pressurized balloon is a non-compliant balloon.

22. The device according to claim 16, wherein The outer diameter of the hollow tube is smaller than the inner diameter of the pressurized sac connecting tube. The pressurized sac connecting tube and the hollow tube are welded closed at the distal end, and a pressurization cavity is formed between the pressurized sac and the hollow tube. The pressurized sac is pressurized and expanded through the pressurization cavity.

23. The device according to claim 16, wherein The interior of the hollow tube can be guided by a guide wire.

24. The device according to claim 1, wherein The device includes a visual marker connected to the main body by inlaying or welding.

25. The device according to claim 24, characterized in that The support ring and / or the skirt is provided with a circular hole, and the development mark is arranged in the circular hole.

26. The device according to claim 1, wherein The surface of the main body is coated with drugs that inhibit endothelialization, including paclitaxel or rapamycin derivatives.

27. The device according to claim 1, wherein The surface of the main body is coated with anticoagulant drugs, including heparin.

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