Atrial septal shunt device for treating heart failure

Abstract

The present invention discloses an atrial septal shunt device for treating heart failure. The device includes an outer tube, which is a hollow tube. A first stop block and a second stop block are provided at the distal end of the inner cavity of the outer tube, and a spring is provided between the first stop block and the second stop block; a cutter head delivery tube, which is placed in the hollow inner cavity of the outer tube and is also a hollow tube. A cutting cutter head is provided at the most distal end of the cutter head delivery pipe. A protruding portion is provided on the outer periphery of the cutter head delivery tube, and the protruding portion is located between the second stop block and the spring; a liquid sac catheter, which is placed in the hollow inner cavity of the cutter head delivery tube, and a liquid sac is provided on the liquid sac catheter; and an operating handle, and the proximal ends of the outer tube, the cutter head delivery tube and the liquid sac catheter are all fixedly connected to the operating handle. The device of the present invention presses against one side of the atrial septum through the expanded liquid sac and stent, and the cutting cutter head cuts in from the other side of the atrial septum to punch a hole at the atrial septum position, thereby effectively treating heart failure.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to an atrial septal shunt device for treating heart failure. Background Art

[0002] Heart failure is the final outcome of various cardiovascular events and the cumulative effect of various cardiac abnormalities, ultimately leading to a decline in the heart's pumping function. Once cardiovascular patients present with the clinical manifestations of heart failure, it indicates a poor prognosis. The more severe the heart failure, the higher the risk of death. Heart failure is a group of complex clinical syndromes caused by abnormal changes in the structure and function of the heart due to various reasons, resulting in impaired ventricular systolic ejection and / or diastolic filling function, mainly manifested by decreased exercise tolerance (dyspnea, fatigue) and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema).

[0003] Heart failure with preserved ejection fraction (HFpEF, LVEF value ≥ 50%) is a common type of heart failure, accounting for about 50% of heart failure cases. Epidemiology shows that the incidence of HFpEF is on the rise globally. Currently, for heart failure with reduced ejection fraction (HFrEF), drugs such as cardiotonic, diuretic, and vasodilator drugs can effectively slow down the progression of this type of heart failure. However, there has not yet been a drug or device that can significantly reduce the mortality or hospitalization risk of HFpEF patients. In addition, HFpEF is associated with many complications, and currently, we know very little about its complex pathophysiology. The common feature of HFpEF is an increase in left atrial pressure (especially during exercise), which causes pulmonary hypertension, leading to pulmonary congestion and dyspnea. Dyspnea is the main reason for frequent hospitalization of HFpEF patients. Retrospective data shows that although the pulmonary capillary wedge pressure (PCWP) is normal at rest, it rises significantly during exercise. This is related to the 6-minute walking distance and reduced long-term survival rate. Therefore, PCWP at rest or during exercise may be a treatment target for HFpEF patients.

[0004] Therefore, the object of the present invention is to provide an atrial septal shunt device for treating heart failure, so that a hole appears in the atrial septum position to reduce the left atrial pressure of HFpEF patients during exercise, thereby reducing the pulmonary artery pressure and PCWP, reducing the occurrence of pulmonary congestion, and effectively relieving symptoms such as dyspnea and fatigue of HFpEF patients. Summary of the Invention

[0005] The object of the present invention is to provide an atrial septal shunt device for treating heart failure. The atrial septal shunt device for treating heart failure of the present invention realizes the functions of moderately reducing the left atrial blood pressure, reducing the left atrial volume, alleviating the symptoms of chronic heart failure, improving the left heart function and preventing left heart insufficiency by abutting the dilated liquid sac against one side of the atrial septum and cutting into the other side of the atrial septum with a cutting head to create a hole at the position of the atrial septum.

[0006] The present invention provides an atrial septal shunt device for treating heart failure. The device includes an outer tube, which is a hollow tube. A first stop block and a second stop block are provided at the distal end of the inner cavity of the outer tube, and a spring is provided between the first stop block and the second stop block; a cutter head delivery tube, which is placed in the hollow inner cavity of the outer tube, and the cutter head delivery tube is also a hollow tube. A cutting cutter head is provided at the farthest end of the cutter head delivery pipe. A protruding portion is provided at a distance of 1-15 cm from the cutting cutter head on the outer periphery of the cutter head delivery tube, and the protruding portion is located between the second stop block and the spring; a liquid sac catheter, which is placed in the hollow inner cavity of the cutter head delivery tube, and a liquid sac is provided on the liquid sac catheter; and an operating handle. The proximal ends of the outer tube, the cutter head delivery tube and the liquid sac catheter are fixedly connected to the operating handle. The operating handle is used to control the forward and backward movement of the cutter head delivery tube, the forward and backward movement of the liquid sac catheter, and the inflation of the liquid sac.

[0007] In another preferred example, both the first stop block and the second stop block are configured as annular structures and are fixed to the inner wall of the outer tube.

[0008] In another preferred example, the cutting cutter head is an annular blade.

[0009] In another preferred example, the cutter head delivery tube includes a proximal delivery tube and a distal delivery tube. Among them, the outer diameter of the proximal delivery tube is smaller than the inner diameter of the outer tube, the outer diameter of the distal delivery tube is equal to the inner diameter of the proximal delivery tube, the proximal end of the proximal delivery tube is fixedly connected to the operating handle, the distal inner diameter of the proximal delivery tube is fixedly connected to the proximal outer diameter of the distal delivery tube, and the distal end of the distal delivery tube is fixedly connected to the cutting cutter head.

[0010] In another preferred example, the protruding portion is annularly arranged on the outer periphery of the distal delivery tube, and the spring is confined in the space surrounded by the first stop block, the protruding portion, the outer periphery of the distal delivery tube and the outer tube.

[0011] In another preferred example, the protruding portion is fixedly connected to the proximal end of the spring.

[0012] In another preferred example, a stent is sleeved on the outer periphery of the liquid sac and can expand along with the expansion of the liquid sac.

[0013] In another preferred example, the stent is a metal stent.

[0014] In another preferred example, the wall thickness of the stent is 0.05 - 0.4 mm; more preferably, 0.08 - 0.3 mm; most preferably, 0.1 - 0.2 mm.

[0015] In another preferred example, the material of the stent may be, but is not limited to, stainless steel, cobalt-chromium alloy, and nickel-titanium alloy.

[0016] In another preferred example, both ends of the stent are shrink-fixed on the liquid sac catheter.

[0017] In another preferred example, both ends of the stent do not need to be cut and are of solid structure.

[0018] In another preferred example, the distal end of the stent is shrink-fixed on the liquid sac catheter, and the proximal end is a free end and is not fixed on the supporting liquid sac catheter and is in an extended state.

[0019] In another preferred example, the distal end of the stent is fixed on the supporting liquid sac, and the proximal end is fixed on the liquid sac rod.

[0020] In another preferred example, when the stent expands, the proximal end of the stent is in an inverted conical shape.

[0021] In the above situation, the proximal end of the stent can support the atrial septum when the liquid sac of the supporting liquid sac catheter is retracted, and provide a supporting force when the operator advances the cutting tool head for cutting.

[0022] In another preferred example, the distal end of the liquid sac catheter is a tip for penetrating the atrial septum.

[0023] In another preferred example, the distal delivery tube is a threaded cutting tube, and / or the cutting tool head is a threaded cutting tool head.

[0024] In another preferred example, the liquid sac is a non-compliant liquid sac or a semi-compliant liquid sac.

[0025] In another preferred example, the operation handle includes a tool head push button for pushing and retracting the cutting tool head.

[0026] In another preferred example, the operation handle includes a supporting liquid sac catheter rotation button. By rotating the supporting liquid sac catheter rotation button, the forward and backward movement of the supporting liquid sac catheter is controlled to finely adjust the position of the supporting liquid sac relative to the atrial septum.

[0027] In another preferred example, the operating handle includes a guiding balloon catheter operating button for controlling the rapid forward and backward movement of the guiding balloon catheter.

[0028] In another preferred example, the operating handle includes a balloon liquid inlet channel through which fluid is injected to expand the balloon. In another preferred example, the device includes an auxiliary fixing part for clamping and fixing the atrial septum together with the balloon.

[0029] In another preferred example, the auxiliary fixing part is annular, with its proximal end fixed to the first stop block and its distal end extending 1 - 10 mm outside the outer tube; preferably, 2 - 7 mm; more preferably, 3 - 5 mm.

[0030] In another preferred example, the auxiliary fixing part is located between the outer tube and the distal delivery tube and is disposed close to the distal delivery tube.

[0031] In another preferred example, the auxiliary fixing part is an annular multi - piece structure, which includes a plurality of single pieces that enclose a ring. The number of the single pieces is 2 - 30; preferably, 3 - 15; more preferably, 4 - 8.

[0032] In another preferred example, the proximal end of each single piece is fixed to the first stop block, and its distal end is serrated or needle - shaped.

[0033] In another preferred example, a plurality of through - holes are provided at the connection part of the cutting head and the distal delivery tube, and the through - holes correspond to the single pieces one by one, so that the single pieces can pass through the corresponding through - holes.

[0034] In another preferred example, the auxiliary fixing part is located between the outer tube and the distal delivery tube and is disposed close to the outer tube. The cutting head and the distal delivery tube are placed in the hollow inner cavity of the auxiliary fixing part.

[0035] In another preferred example, the distal end of the auxiliary fixing part is serrated or needle - shaped.

[0036] In another preferred example, a plurality of protruding teeth extend from the distal annular cross - section of the outer tube, and the protruding teeth are used to clamp and fix the atrial septum together with the balloon.

[0037] In another preferred example, the auxiliary fixing part includes an auxiliary fixing catheter and an auxiliary fixing head.

[0038] In another preferred example, the proximal end of the auxiliary fixing catheter is fixedly connected to the operating handle, and the distal end is fixedly connected to the auxiliary fixing head.

[0039] In another preferred example, the auxiliary fixing catheter is a thread cutting tube.

[0040] In another preferred example, an auxiliary fixing control button is provided on the operating handle, and the auxiliary fixing control button is used to control the advancement and retraction of the auxiliary fixing catheter.

[0041] In another preferred example, the auxiliary fixing catheter is located in the inner cavity of the cutter head delivery tube and can advance or retract in this inner cavity, and the balloon catheter is located in the inner cavity of the auxiliary fixing catheter. That is to say, the auxiliary fixing catheter is located between the cutter head delivery tube and the balloon catheter.

[0042] In another preferred example, the distal end of the auxiliary fixing head is serrated or corrugated, so as to be easily embedded in the atrial septum to clamp and fix the atrial septum relative to the balloon and / or stent on the other side of the atrial septum.

[0043] In another preferred example, the auxiliary fixing catheter is a thread cutting tube to have better flexibility and facilitate shuttling in blood vessels.

[0044] In another preferred example, on the one hand, the balloon on the balloon catheter serves as a guiding function when the device travels in blood vessels; on the other hand, when one end of the balloon abuts against the atrial septum, it serves as a supporting function for the atrial septum.

[0045] In another preferred example, the balloon catheter includes a guiding balloon catheter and a supporting balloon catheter. The guiding balloon catheter is delivered through the inner cavity of the cutter head delivery tube, and the supporting balloon catheter is delivered through the inner cavity of the guiding balloon catheter; the supporting balloon catheter is used to support the atrial septum when one end of its balloon abuts against the atrial septum.

[0046] In another preferred example, the length of the balloon of the guiding balloon catheter is 4 - 25 mm; preferably, 6 - 20 mm; more preferably, 8 - 16 mm.

[0047] In another preferred example, the outer diameter of the balloon of the guiding balloon catheter in the expanded state is 4 - 11 mm; preferably, 5 - 8 mm; more preferably, 6 mm.

[0048] In another preferred example, the working pressure of the balloon of the guiding balloon catheter is 2 - 30 atm; preferably, 4 - 10 atm; more preferably, 6 - 8 atm.

[0049] In another preferred example, the balloon of the guiding balloon catheter is a non-compliant balloon or a semi-compliant balloon.

[0050] In another preferred example, the balloon of the supporting balloon catheter is a non-compliant balloon or a semi-compliant balloon.

[0051] In another preferred example, the length of the balloon of the support balloon catheter is 3 - 30 mm; preferably, 4 - 20 mm; more preferably, 6 - 15 mm.

[0052] In another preferred example, the outer diameter of the balloon of the support balloon catheter in the expanded state is 2 - 8 mm; preferably, 3 - 6 mm; more preferably, 3.5 - 4.5 mm.

[0053] In another preferred example, the working pressure of the balloon of the support balloon catheter is 2 - 30 atm; preferably, 4 - 10 atm; more preferably, 6 - 8 atm.

[0054] In another preferred example, the cutting head is a threaded cutting head.

[0055] In another preferred example, small holes or grooves are formed on the outer periphery of the cutting head, and drugs such as paclitaxel are coated on its outer periphery. The drugs can be stored in the small holes or grooves. During the cutting process of the cutting head, the drugs are smeared on the side wall of the atrial septal hole to inhibit tissue regeneration at the incision.

[0056] In another preferred example, the cutting head is connected with an electrode, which can heat up the cutting head, so as to quickly coagulate the wound at the incision.

[0057] In another preferred example, the device includes a balloon sleeve rod, which is used to contract the expanded balloon and the stent, and can puncture the atrial septum to facilitate the delivery of the balloon to the other side of the atrial septum.

[0058] In another preferred example, the balloon sleeve rod is a hollow tube structure, and its head end is a sharp structure.

[0059] In another preferred example, the balloon sleeve rod is placed in the inner cavity of the auxiliary fixing part, and the balloon catheter is placed in the inner cavity of the balloon sleeve rod.

[0060] In another preferred example, the device includes an expansion stent, and the expansion stent is a self-expanding stent, and its material is nitinol.

[0061] In another preferred example, the expansion stent is sleeved on the balloon catheter near the proximal end of the stent.

[0062] In another preferred example, the expansion stent is configured as a part of the stent, that is, an extension of the proximal end of the stent.

[0063] In another preferred example, the expansion stent is a reticular structure tightly surrounding the balloon catheter in the compressed state, and is fixed at the distal end on the balloon stent and has an open proximal end in the natural state, presenting an inverted cone shape as a whole.

[0064] In another preferred example, the peripheral wall of the proximal opening end of the expansion stent is needle-shaped or other sharp structures.

[0065] In another preferred example, in the natural state, the axial length of the expansion stent is 2 - 10 mm, preferably 2.5 - 5 mm.

[0066] In another preferred example, in the natural state, the diameter at the maximum cross-sectional area of the expansion stent is 3 - 6 mm, preferably 4 - 5 mm.

[0067] In another preferred example, the device includes a folding stent and a push rod.

[0068] In another preferred example, the material of the folding stent can be, but is not limited to, stainless steel, cobalt-chromium alloy, nitinol alloy, etc.

[0069] In another preferred example, the distal end of the folding stent is fixed on the liquid sac catheter, and its proximal end is fixedly connected to the distal end of the push rod.

[0070] In another preferred example, the push rod is a hollow tube sleeved on the liquid sac catheter.

[0071] In another preferred example, the folding stent is compressed into a disc shape or stretched back into a hollow cylindrical shape surrounding the liquid sac catheter through the push rod.

[0072] In another preferred example, an operation button for manipulating the push rod is provided on the operation handle to control the forward and backward movement of the push rod.

[0073] In another preferred example, in the compressed state, the axial length of the folding stent is 2 - 10 mm, preferably 2.5 - 5 mm.

[0074] In another preferred example, in the compressed state, the diameter at the maximum cross-sectional area of the folding stent is 3 - 6 mm, preferably 4 - 5 mm.

[0075] It should be noted that the "distal end" refers to the end of the atrial septal shunt device for treating heart failure that is far from the medical operator during use; the "proximal end" refers to the end of the atrial septal shunt device for treating heart failure that is close to the medical operator during use.

[0076] The main advantages of the present invention include:

[0077] (a) Simple structure and convenient operation;

[0078] (b) There is no need for an implant to support the atrial septal hole, no foreign body remains in the body, reducing unpredictable risks;

[0079] (c) The thrust for cutting the atrial septum is buffered by a spring.

[0080] (d) The diameter of the atrial septum separation hole is larger, up to 6 - 10 mm, to avoid long-term blockage of the atrial septum.

[0081] (e) Clamping mechanisms are provided on both sides of the atrial septum, so that the cut tissue will not fall off into the right atrium, avoiding surgical risks.

[0082] It should be understood that within the scope of the present invention, the above technical features of the present invention and the technical features specifically described 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 elaborated one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0084] Figure 1 is a distal partial cross-sectional view of a device for treating heart failure by delivering an atrial septum shunt device to the atrial septum in an example of the present invention;

[0085] Figure 2 is Figure 1 a distal partial cross-sectional view of the liquid sac of the atrial septum shunt device for treating heart failure in being delivered to the other side of the atrial septum and the liquid sac being in a contracted state;

[0086] Figure 3 is Figure 2 the front view of

[0087] Figure 4 is Figure 2 a distal partial cross-sectional view of the device in which the liquid sac is not provided with a stent;

[0088] Figure 5 is Figure 2 the front view of the device in which the liquid sac is in an expanded state;

[0089] Figure 6 is Figure 5 a distal partial cross-sectional view of the expanded liquid sac of the device against one side of the atrial septum;

[0090] Figure 7 is Figure 6 a distal partial cross-sectional view of the cutting tool head being pushed to cut the atrial septum;

[0091] Figure 8 is Figure 7Partial distal cross-sectional view of the expanded liquid sac and the retracted cutting head in it;

[0092] Figure 9 Is a perspective view of the operating handle in an embodiment of the present invention;

[0093] Figure 10 Is a perspective view of the atrial septal shunt device for treating heart failure in an embodiment of the present invention supported by a fixing device;

[0094] Figure 11 Is a partial distal cross-sectional view of the cutting head of the atrial septal shunt device for treating heart failure being pushed to cut the atrial septum in another example of the present invention;

[0095] Figure 12 Is Figure 11 Partial distal cross-sectional view of the atrial septal shunt device for treating heart failure in it being retracted together with the cut atrial septal tissue;

[0096] Figure 13 Is a partial distal perspective view of the atrial septal shunt device for treating heart failure in another example of the present invention;

[0097] Figure 14 Is a partial distal cross-sectional view of the auxiliary fixing part of the atrial septal shunt device for treating heart failure in another example of the present invention;

[0098] Figure 15 Is a partial distal cross-sectional view of the liquid sac of the atrial septal shunt device for treating heart failure in an example of the present invention when used for guiding;

[0099] Figure 16 Is a partial distal cross-sectional view of the guiding liquid sac catheter and the supporting liquid sac catheter of the atrial septal shunt device for treating heart failure being transported together in an example of the present invention;

[0100] Figures 17 - 21 Is a partial distal cross-sectional view of the supporting liquid sac catheter of the atrial septal shunt device for treating heart failure with a stent having one end fixed and the other end freely extending during operation in an example of the present invention;

[0101] Figure 22 Is a partial distal front view of the stent of the atrial septal shunt device for treating heart failure having a needle-like structure at the proximal end in an example of the present invention; [[ID=4 ]]

[0102] Figure 23 Is a perspective view of the operating handle of the atrial septal shunt device for treating heart failure in another example of the present invention;

[0103] Figure 24 Is a perspective view of the operating handle of the atrial septal shunt device for treating heart failure in another example of the present invention;

[0104] Figure 25 It is a distal partial cross-sectional view of the liquid sac sleeve rod of the atrial septal shunt device for treating heart failure in an example of the present invention when it is in the initial state;

[0105] Figure 26 It is a distal partial cross-sectional view of the liquid sac sleeve rod of the atrial septal shunt device for treating heart failure in an example of the present invention when it is in the state of puncturing the atrial septum;

[0106] Figure 27 It is a distal partial front view of the atrial septal shunt device for treating heart failure with an expansion stent in an example of the present invention;

[0107] Figure 28 It is a distal partial cross-sectional view of the atrial septal shunt device for treating heart failure with a folding stent and a push rod in an example of the present invention;

[0108] Figure 29 It is Figure 28 The distal front view when the folding stent and the liquid sac in [[ ]] are delivered to the distal side of the atrial septum;

[0109] Figure 30 It is Figure 29 The distal front view when the folding stent in [[ ]] is compressed into a disc shape.

[0110] In each of the drawings, the various markings are as follows:

[0111] 1 - Outer tube;

[0112] 2 - Blade head delivery tube;

[0113] 3 - Liquid sac catheter;

[0114] 4 - Operating handle;

[0115] 5 - First stop ring;

[0116] 6 - Second stop ring;

[0117] 7 - Spring;

[0118] 8 - Cutting blade head;

[0119] 9 - Protrusion;

[0120] 10 - Liquid sac;

[0121] 11 - Atrial septum;

[0122] 12 - Metal stent;

[0123] 13 - Proximal delivery tube;

[0124] 14 - Distal delivery tube;

[0125] 15 - Blade Pushing Button

[0126] 16 - Liquid Sac Catheter Rotating Button

[0127] 17 - Liquid Sac Catheter Operating Button

[0128] 18 - Liquid Sac Liquid Inlet Channel

[0129] 19 - Fixing Device

[0130] 20 - Auxiliary Fixing Part

[0131] 21 - Monolithic Sheet

[0132] 22 - Auxiliary Fixing Catheter

[0133] 23 - Auxiliary Fixing Head

[0134] 24 - Guiding Liquid Sac Catheter

[0135] 25 - Supporting Liquid Sac Catheter

[0136] 26 - Needle - like Structure

[0137] 27 - Auxiliary Fixing Head Pushing Button

[0138] 28 - Guiding Liquid Sac Catheter Liquid Inlet Channel

[0139] 29 - Supporting Liquid Sac Catheter Liquid Inlet Channel

[0140] 30 - Supporting Liquid Sac Catheter Operating Button

[0141] 31 - Supporting Liquid Sac Catheter Rotating Button

[0142] 32 - Supporting Liquid Sac Rotating Button

[0143] 33 - Stop Button

[0144] 34 - Guiding Liquid Sac Button

[0145] 35 - Auxiliary Fixing Part Button

[0146] 36 - Cutter Button

[0147] 37 - Cutter Gear Adjustment

[0148] 38 - Supporting Liquid Sac Pressurizing Port

[0149] 39 - Guiding Liquid Sac Pressurizing Port

[0150] 40 - Liquid Sac Sleeve Rod

[0151] 41 - Expansion Bracket

[0152] 42 - Folding Bracket

[0153] 43 - Pusher rod. Detailed implementation manner

[0154] Through extensive and in - depth research and a large number of screenings, the inventor has developed for the first time an atrial septal shunt device for treating heart failure. Compared with the prior art, the atrial septal shunt device for treating heart failure of the present invention realizes the functions of moderately reducing the left atrial blood pressure, reducing the left atrial volume, alleviating the symptoms of chronic heart failure, improving the left heart function and preventing left heart dysfunction by abutting the dilated liquid sac against one side of the atrial septum and cutting the cutting head into the atrial septum from the other side to create a hole at the atrial septum position. On this basis, the present invention is completed.

[0155] The following further elaborates the present invention in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, the drawings are schematic diagrams, so the devices and equipment of the present invention are not limited by the dimensions or proportions of the schematic diagrams.

[0156] It should be noted that in the claims and the specification of this patent, relational terms such as first and second are only 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 term "comprising", "including" or any other variant thereof is intended to cover non - exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "including one" does not exclude the existence of another identical element in the process, method, article or device including the said element.

[0157] Embodiment 1

[0158] The atrial septal shunt device for treating heart failure in this embodiment is as Figures 1 - 9 shown. The device includes an outer tube 1, a cutter head delivery tube 2, a liquid sac catheter 3 and an operating handle 4.

[0159] The outer tube 1, as the outermost catheter, has a hollow tube structure. At the distal end of the inner cavity of the outer tube 1, a first stop ring 5 and a second stop ring 6 are provided, and the first stop ring 5 is arranged closer to the distal end relative to the second stop ring 6.

[0160] The cutter head delivery tube 2 is placed in the hollow inner cavity of the outer tube 1, and the cutter head delivery tube 2 is also a hollow tube. The cutter head delivery tube 2 includes a proximal delivery tube 13 and a distal delivery tube 14. Among them, the outer diameter of the proximal delivery tube 13 is smaller than the inner diameter of the outer tube 1, the outer diameter of the distal delivery tube 14 is equal to the inner diameter of the proximal delivery tube 13, the proximal end of the proximal delivery tube 13 is fixedly connected to the operating handle 4, the inner diameter of the distal end of the proximal delivery tube 13 is fixedly connected to the outer diameter of the proximal end of the distal delivery tube 14, and the distal end of the distal delivery tube 14 is fixedly connected to the cutting cutter head 8.

[0161] The cutting cutter head 8 is an annular blade. The annular blade in this embodiment has a hollow inner cavity. In another embodiment, the annular blade can also be an annular blade with a middle depression and a sharp periphery, and the middle depression is adapted to the, for example, elliptical end of the expanded balloon 10 to better fixedly engage the atrial septum 11. The cutting cutter head 8 is a threaded cutting cutter head.

[0162] A protruding portion 9 is provided at a distance of 1-15 cm from the outer periphery of the distal delivery tube 14 to the cutting cutter head 8. The protruding portion 9 is located between the second stop ring 6 and the spring 7, so that the spring 7 is confined in the annular space formed by the first stop ring 5, the protruding portion 9, the outer periphery of the distal delivery tube 14, and the outer tube 1.

[0163] The balloon catheter 3 is placed in the hollow inner cavity of the cutter head delivery tube 2, and a balloon 10 is provided on the balloon catheter 3. Preferably, a metal stent 12 is sleeved on the outer periphery of the balloon 10. By providing the metal stent 12, contact between the cutting cutter head 8 and the balloon 10 can be avoided, that is, the cutting cutter head 8 can be prevented from cutting and rupturing the balloon 10. The wall thickness of the metal stent 12 is 0.1-0.4 mm. Both ends of the metal stent 12 are shrink-fixed on the balloon catheter 3. Preferably, both ends of the metal stent 12 do not need to be cut and are solid structures, which reduces the processing amount while meeting the fixing requirements. Preferably, the distal end of the balloon catheter 3 is a tip for penetrating the atrial septum.

[0164] The proximal ends of the outer tube 1, the cutter head delivery tube 2, and the balloon catheter 3 are all fixedly connected to the operating handle 4. The operating handle 4 includes a cutter head push button 15 for pushing and retracting the cutting cutter head 8; a balloon catheter rotation button 16. By rotating the balloon catheter rotation button 16, the balloon catheter 3 can be controlled to slowly advance and retreat to finely adjust the position of the balloon relative to the atrial septum; a balloon catheter operation button 17 for quickly advancing and retracting the balloon catheter; and a balloon liquid inlet channel 18. Through the balloon liquid inlet channel 18, a fluid (such as normal saline, contrast agent, etc.) for expanding the balloon 10 is injected, and then the expansion of the balloon 10 is realized.

[0165] During use, the operation steps of the atrial septal shunt device for treating heart failure in this embodiment are as follows:

[0166] (1) Deliver the distal end of the device of this embodiment to the position on the atrial septum 11 of the heart where a hole is to be punched;

[0167] (2) By pressing the balloon catheter operation button 17 on the operation handle 4, quickly push the balloon catheter 3 until the balloon 10 is pushed to the other side of the atrial septum 11;

[0168] (3) Inject fluid through the balloon fluid inlet channel 18 on the operation handle 4 to expand the balloon 10, along with expanding the metal stent 12 sleeved on the outer periphery of the balloon 10;

[0169] (4) Retract the balloon catheter 3 by turning the balloon catheter rotation button 16 on the operation handle 4, so that the expanded balloon 10 abuts against the other side of the atrial septum 11;

[0170] (5) By pressing the cutter head push button 15 on the operation handle 4, push the cutting cutter head 8 distally until a hole is successfully punched in the atrial septum 11. Among them, the other side of the atrial septum 11 is blocked by the expanded balloon 10, and one side is pierced and cut by the cutting cutter head 8. During this process, due to the buffering and blocking effect of the spring 7, medical staff need to apply a relatively large force to push the cutting cutter head 8 forward to avoid damaging the atrial septum 11 due to excessive force applied at one time;

[0171] (6) By operating the cutter head push button 15 and the balloon catheter rotation button 16 on the operation handle 4, retract the cutter head delivery tube 2 and the balloon catheter 3 into the outer tube 1, and the cut atrial septum piece is also retracted together;

[0172] (7) Withdraw the atrial septal shunt device for treating heart failure of this embodiment to the outside of the body, and the operation of punching a hole in the atrial septum 11 is completed.

[0173] In another preferred example, the atrial septal shunt device for treating heart failure of this embodiment can be fixed to the operating table through the fixing device 19, as Figure 10 shown.

[0174] Embodiment 2

[0175] The atrial septal shunt device for treating heart failure of this embodiment is substantially the same as that of Embodiment 1. The difference is that the atrial septal shunt device of this embodiment is provided with an auxiliary fixing part 20, which is used to clamp and fix the atrial septum together with the balloon 10. When in use, the expanded balloon 10 abuts against one side of the cardiac atrial septum, and the auxiliary fixing part 20 abuts against the other side of the cardiac atrial septum, and its position corresponds to the position of the balloon 10. The wall surface of the cardiac atrial septum to be perforated is fixed through the clamping action of the two, so as to facilitate the punching operation of the cutting cutter head 8.

[0176] The auxiliary fixing part 20 of this embodiment is located between the outer tube 1 and the distal delivery tube 14, and is disposed close to the distal delivery tube 14. The auxiliary fixing part 20 is annular, with its proximal end fixed to the first stop ring 5, and its distal end extending 1 - 10 mm out of the outer tube 1; preferably, 2 - 7 mm; more preferably, 3 - 5 mm. The auxiliary fixing part 20 is an annular multi-piece structure, that is, the auxiliary fixing part 20 includes a plurality of single pieces 21, and the plurality of single pieces 21 enclose an annular shape. The number of single pieces 21 is 2 - 30; preferably, 3 - 15; more preferably, 4 - 8. The proximal end of each single piece 21 is fixed to the first stop ring 5, and its distal end is serrated or needle-shaped. A plurality of through holes are provided at the connection part between the cutting head 8 and the distal delivery tube 14, and the through holes correspond to the single pieces 21 one by one. The single pieces 21 can pass through the corresponding through holes. This configuration enables that even though the auxiliary fixing part 20 is added relative to Embodiment 1, the added auxiliary fixing part 20 does not affect the advancement and retraction of the cutting head 8.

[0177] In another preferred example, the distal end of the cutter head delivery tube (for example, the distal delivery tube 14) is a threaded cutting tube.

[0178] Embodiment 3

[0179] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 2. The difference is that the atrial septal shunt device in this embodiment is provided with an auxiliary fixing part 20 which is an independent structure. As Figure 14 shown, it is located in the inner cavity of the cutter head delivery tube 2 and advances or retracts in this inner cavity. The auxiliary fixing part 20 of this embodiment includes an auxiliary fixing catheter 22 and an auxiliary fixing head 23, and the balloon catheter 3 is located in the inner cavity of the auxiliary fixing catheter 22, that is, the auxiliary fixing catheter 22 is located between the cutter head delivery tube 2 and the balloon catheter 3. Among them, the auxiliary fixing catheter 22 is located in the inner cavities of the proximal delivery tube 13 and the distal delivery tube 14, and the auxiliary fixing head 23 is located in the cavity of the annular cutting head 8. The proximal end of the auxiliary fixing catheter 22 is fixedly connected to the operating handle 4, and the distal end is fixedly connected to the auxiliary fixing head 23. Among them, the auxiliary fixing catheter 22 and the auxiliary fixing head 23 are in a threaded cutting configuration. In another preferred example, an auxiliary fixing control button (for example, Figure 23 the auxiliary fixing head push button 27 shown) is provided on the operating handle 4, and the auxiliary fixing control button is used to control the advancement and retraction of the auxiliary fixing part 20. The distal end of the auxiliary fixing head 23 is serrated or corrugated, so as to be easily embedded into the atrial septum wall to clamp and fix the atrial septum 11 relative to the balloon 10 and / or the metal stent 12 on the other side of the atrial septum wall.

[0180] Embodiment 4

[0181] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 3. The difference is that on the one hand, when the device travels through the blood vessel, the balloon 10 on the balloon catheter 3 plays a guiding role, as Figure 15 shown; on the other hand, when one end of the balloon 10 abuts against the atrial septum 11, it plays a role in supporting the atrial septum, as described above.

[0182] Specifically, when the device travels through the blood vessel, the distal end of the balloon 10 extends outside the outer tube 1, and its proximal end remains inside the outer tube 1. The balloon 10 is expanded so that the outer diameter of the balloon 10 is approximately equal to the diameter of the outer tube 1. When the distal end of the device advances to the position of the heart atrial septum, the guiding role of the balloon 10 ends. The balloon 10 is contracted, and the contracted balloon 10 passes through the heart atrial septum 11 to reach the other side of the heart atrial septum 11. Then the balloon 10 is expanded, and the balloon 10 is retracted until its proximal end abuts against the heart atrial septum 11, and together with the auxiliary fixing head 23 on the other side, it clamps and fixes the heart atrial septum, facilitating the cutter head 8 to punch holes in the atrial septum 11.

[0183] Embodiment 5

[0184] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 4. The difference is that the number of balloon catheters 3 in this embodiment is two, namely the guiding balloon catheter 24 and the supporting balloon catheter 25. Among them, the guiding balloon catheter 24 is used to guide the device to travel through the blood vessel; the supporting balloon catheter 25 is used to support the atrial septum when one end of its balloon abuts against the atrial septum 11.

[0185] The balloon of the guiding balloon catheter 24 in this embodiment has a length of 16 mm, an outer diameter of 6 mm in the expanded state, and a working pressure of 6 atm. The balloon of the guiding balloon catheter 24 is a non-compliant balloon.

[0186] The balloon of the supporting balloon catheter 25 in this embodiment has a length of 12 mm, an outer diameter of 4 mm in the expanded state, and a working pressure of 6 atm. The balloon of the supporting balloon catheter 25 is also a non-compliant balloon.

[0187] During use, the guiding balloon catheter 24 and the supporting balloon catheter 25 can be transported together, as Figure 16As shown, when the two are transported together, the guiding balloon catheter 24 is transported through the inner cavity of the cutter head delivery tube 2, and the supporting balloon catheter 25 is transported through the inner cavity of the guiding balloon catheter 24, that is, the supporting balloon catheter 25 is placed inside the inner cavity of the guiding balloon catheter 24 and is transported together in the inner cavity of the cutter head delivery tube 2; they can also be transported separately. When transported separately, first place the guiding balloon catheter 24 in the cutter head delivery tube 2 and transport the distal end of the device to the atrial septum 11 of the heart, then completely withdraw the guiding balloon catheter 24 from the device, and then transport the supporting balloon catheter 25 through the cutter head delivery tube 2 to the other side of the atrial septum 11 for supporting effect.

[0188] Preferably, a metal stent 12 is disposed around the outer sides of the balloon of the guiding balloon catheter 24 and the balloon of the supporting balloon catheter 25.

[0189] Embodiment 6

[0190] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 5. The difference is that the distal end of the metal stent 12 in this embodiment is shrink-fixed on the supporting balloon catheter 25, and the proximal end is a free end and is not fixed on the supporting balloon catheter 25 and is in an extended state. Preferably, the proximal end of the metal stent 12 also has a needle-like structure 26 or other sharp structures, such as Figure 22 as shown.

[0191] The diameter of the hole drilled in the atrial septum 11 through the above operation is not less than 6 mm; preferably, not less than 10 mm, which is larger than the holes drilled by conventional devices. Larger holes are less likely to close in the long term.

[0192] The above operation is through such as Figure 23It is achieved by the operation handle shown below. The operation handle of this embodiment is provided with an auxiliary fixing head push button 27, a cutter head push button 15, a guiding balloon catheter liquid inlet channel 28, a supporting balloon catheter liquid inlet channel 29, a supporting balloon catheter operation button 30, and a supporting balloon catheter rotation button 31. Among them, the auxiliary fixing head push button 27 is used to control the advancement and retraction of the auxiliary fixing head 23; the cutter head push button 15 is used to control the advancement and retraction of the cutting cutter head 8; the guiding balloon catheter liquid inlet channel 28 is used to inject / extract fluids (such as normal saline, contrast agents, etc.) to expand / contract the liquid balloon of the guiding balloon catheter 24, and this guiding balloon catheter liquid inlet channel 28 can also be used as a push button to control the advancement and retreat of the guiding balloon catheter 24; the supporting balloon catheter liquid inlet channel 29 is used to inject / extract fluids (such as normal saline, contrast agents, etc.) to expand / contract the liquid balloon of the supporting balloon catheter 25, and this supporting balloon catheter liquid inlet channel 29 can also be used as a rotation button to control the (rapid) advancement and retreat (coarse adjustment) of the supporting balloon catheter 25; the supporting balloon catheter rotation button 31 is used to control the slow advancement and retreat of the supporting balloon catheter 25 and finely adjust the position of its liquid balloon relative to the atrial septum; the supporting balloon catheter operation button 30 is used to brake the supporting balloon catheter 25, that is, to fix the position of its liquid balloon relative to the atrial septum 11 (after adjusting the position of its liquid balloon relative to the atrial septum 11).

[0193] In another preferred example, the above operation can also be achieved by an operation handle as follows Figure 24 shown. The operation handle 4 of this embodiment is provided with a supporting balloon rotation button 32, a stop button 33, a guiding balloon button 34, a serrated push knife button 35, a cutter button 36, a cutter gear adjustment 37, a supporting balloon pressure port 38, and a guiding balloon pressure port 39. Among them, the supporting balloon rotation button 32 can move the supporting balloon catheter 25 quickly or slowly; the stop button 33 is used to brake the supporting balloon catheter 25, that is, to fix the position of its liquid balloon relative to the atrial septum 11 (after adjusting the position of its liquid balloon relative to the atrial septum 11); the guiding balloon button 34 is used to separately control the advancement and retreat of the guiding balloon catheter 24; the serrated push knife button 35 is used to separately control the advancement and retraction of the auxiliary fixing head 23; the cutter button 36 is used to control the advancement and retreat of the cutting cutter head 8; the cutter gear adjustment 37 is used to control the advancement distance of the cutting cutter head 8. In this embodiment, the cutter gear adjustment has three gears. Among them, the advancement distance of the cutting cutter head 8 at the first gear is 5 mm, the advancement distance of the cutting cutter head 8 at the second gear is 8 mm, and the advancement distance of the cutting cutter head 8 at the third gear is 10 mm; the supporting balloon pressure port 38 is used to expand / contract the liquid balloon of the supporting balloon catheter 25; the guiding balloon pressure port 39 is used to expand / contract the liquid balloon of the guiding balloon catheter 24.

[0194] Embodiment 7

[0195] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 4. The difference is that the shunt device in this embodiment further includes a liquid sac sleeve rod 40, as Figures 25 - 26 shown. The liquid sac sleeve rod 40 is a hollow tube structure, and its head end is a sharp structure. The liquid sac sleeve rod 40 is placed in the inner cavity of the auxiliary fixing part 20, and the liquid sac catheter 3 is placed in the inner cavity of the liquid sac sleeve rod 40.

[0196] During the process of delivering the head end (i.e., the distal end) of the atrial septal shunt device to the atrial septum 11, the distal end of the liquid sac 10 extends out of the outer tube 1, and its proximal end remains inside the outer tube 1. The liquid sac 10 is expanded so that the outer diameter of the liquid sac 10 is approximately equal to the diameter of the outer tube 1. During the above process, the metal stent 12 covering the outer periphery of the liquid sac 10 expands along with the expansion of the liquid sac 10. When the distal end of the device advances to the position of the cardiac atrial septum, the guiding function of the liquid sac 10 ends, the liquid sac catheter 3 is retracted, and the liquid sac sleeve rod 40 is pushed distally, so that the metal stent 12 and the liquid sac 10 are retracted into the liquid sac sleeve rod 40 together. Then, the liquid sac sleeve rod 40 is pushed forward so that the sharp structure at the distal end of the liquid sac sleeve rod 40 penetrates the atrial septum 11. The liquid sac catheter 3 is delivered to the other side of the atrial septum 11 through the liquid sac sleeve rod 40, the liquid sac sleeve rod 40 is withdrawn, the liquid sac 10 and the metal stent 12 covering it are inflated again, and the liquid sac 10 is retracted to abut against the distal side of the atrial septum 11, and together with the auxiliary fixing head 23 on the other side, it clamps and fixes the cardiac atrial septal wall, facilitating the punching of the atrial septum 11 by the cutting head 8.

[0197] Correspondingly, an operation button for operating the liquid sac sleeve rod 40 is provided on the operation handle 4 to control the advancement and retraction of the liquid sac sleeve rod 40.

[0198] Embodiment 8

[0199] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 7. The difference is that the shunt device in this embodiment further includes an expansion stent 41, and the expansion stent 41 is sleeved on the liquid sac catheter 3 near the proximal end of the metal stent 12, as [[ID=!5]] Figure 27 shown. The expansion stent 41 is a self-expanding stent, and its material is nitinol. The expansion stent 41 is a reticular structure tightly surrounding the liquid sac catheter 3 in the compressed state. In the state without external force (i.e., in the natural state), its distal end is fixed on the liquid sac catheter 3, and the proximal end expands radially outward and is in an open shape. So that the overall shape of the expansion stent 41 presents an inverted cone shape in the natural state. In another preferred example, the expansion stent 41 can be constructed as a part of the metal stent 12, that is, an extension of the proximal end of the metal stent 12. The peripheral wall of the proximal open end of the expansion stent 41 is needle-shaped or other sharp structures. In the natural state, the axial length of the expansion stent 41 is 2 - 10 mm, preferably 2.5 - 5 mm; the diameter at the maximum cross-sectional area is 3 - 6 mm, preferably 4 - 5 mm.

[0200] During use, the pusher balloon sleeve rod 40 penetrates through the atrial septum 11, and the balloon catheter 3 is pushed through the inner cavity of the pusher balloon sleeve rod 40 to the distal side of the atrial septum 11. Then, the pusher balloon sleeve rod 40 is retracted to the proximal side of the atrial septum 11, and the balloon 10 and the expansion stent 41 are exposed in the heart. At this time, the expansion stent 41 is released from the restraint of the pusher balloon sleeve rod 40 and returns to its expanded structure in the natural state, that is, it automatically deforms into an inverted conical shape, and then the balloon 10 is pressurized and inflated. After that, the balloon catheter 3 is withdrawn so that the proximal end (open end) of the expansion stent 41 abuts against the distal wall of the atrial septum 11.

[0201] It should be noted that the above structure of the expansion stent 41 can also be applied to the atrial septal shunt device with a double balloon for treating heart failure as described in Embodiment 5. Specifically, the expansion stent 41 is arranged on the support balloon catheter 25, wherein the pusher balloon sleeve rod 40 is sleeved in the inner cavity of the guiding balloon catheter 24, and the support balloon catheter 25 is located in the inner cavity of the pusher balloon sleeve rod 40.

[0202] Embodiment 9

[0203] The atrial septal shunt device for treating heart failure in this embodiment is substantially the same as that in Embodiment 8. The difference is that the shunt device in this embodiment uses a folding stent 42 to replace the expansion stent 41 in Embodiment 8, as Figures 28 - 30 shown. The material of the folding stent 42 in this embodiment can be, but is not limited to, stainless steel, cobalt-chromium alloy, nitinol alloy, etc. The folding stent 42 is compressed into a disc shape or stretched back to its original shape (i.e., a hollow cylindrical shape surrounding the balloon catheter 3) by a push rod 43. The distal end of the folding stent 42 is fixed on the balloon catheter 3, and its proximal end is fixedly connected to the distal end of the push rod 43. Among them, the push rod 43 is a hollow tube sleeved on the balloon catheter 3. Correspondingly, an operation button for manipulating the push rod 43 is provided on the operation handle 4 to control the forward and backward movement of the push rod 43, so as to push the folding stent 42 distally to be compressed into a disc shape and stretch it proximally back into a cylindrical shape. In the compressed state, the axial length of the folding stent 42 is 2 - 10 mm, preferably 2.5 - 5 mm; the diameter at the maximum cross-sectional area is 3 - 6 mm, preferably 4 - 5 mm.

[0204] It should be noted that in this embodiment, the pusher balloon sleeve rod 40 is an optional structure.

[0205] In use, the folding stent 42 and the balloon 10 are delivered together to the distal side of the atrial septum 11. The balloon 10 is inflated, and the stent attached to the balloon 10 is expanded accordingly. Then, the push rod 43 is advanced distally by operating the operation knob on the operation handle 4. The distal end of the folding stent 42 remains stationary, and the proximal end is advanced by the push rod 43. As a result, the folding stent 42 is compressed into a disc shape. Alternatively, by operating the operation knob on the operation handle 4 to control the push rod 43 to remain stationary and retracting the balloon catheter 3 backward, the folding stent 42 can also be compressed into a disc shape. Subsequently, the balloon catheter 3 is retracted, and the folding stent 42 is pressed against the atrial septum 11 and the balloon 10 to facilitate the cutting by the cutting head 8.

[0206] All documents mentioned in the present invention are cited herein by reference as if each individual document was specifically and individually cited by reference. In addition, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.

Claims

1. An atrial septal shunt device for treating heart failure, characterized in that, The device includes an outer tube, which is a hollow tube. At the distal end of the inner cavity of the outer tube, a first stop block and a second stop block are provided, and a spring is provided between the first stop block and the second stop block; a cutter head delivery tube, which is placed in the hollow inner cavity of the outer tube, and the cutter head delivery tube is also a hollow tube. At the most distal end of the cutter head delivery pipe, a cutting cutter head is provided. At a distance of 1-15 cm from the cutting cutter head on the outer periphery of the cutter head delivery tube, a protrusion is provided. The protrusion is located between the second stop block and the spring. The cutter head delivery tube includes a proximal delivery tube and a distal delivery tube. The proximal end of the proximal delivery tube is fixedly connected to an operating handle, and the distal end of the distal delivery tube is fixedly connected to the cutting cutter head; a liquid sac catheter, which is placed in the hollow inner cavity of the cutter head delivery tube, and a liquid sac is provided on the liquid sac catheter; and an operating handle. The proximal ends of the outer tube, the cutter head delivery tube and the liquid sac catheter are all fixedly connected to the operating handle. The operating handle is used to control the forward and backward movement of the cutter head delivery tube, the forward and backward movement of the liquid sac catheter, and the inflation of the liquid sac; an auxiliary fixing part, the distal end of which is tooth-shaped or needle-shaped. The auxiliary fixing part is used to clamp and fix the atrial septum together with the liquid sac. The auxiliary fixing part is located between the outer tube and the distal delivery tube and is arranged close to the outer tube. The cutting cutter head and the distal delivery tube are placed in the hollow inner cavity of the auxiliary fixing part. The auxiliary fixing part is annular, and its proximal end is fixed on the first stop block.

2. The device according to claim 1, characterized in that, Wherein, the outer diameter of the proximal delivery tube is smaller than the inner diameter of the outer tube, the outer diameter of the distal delivery tube is equal to the inner diameter of the proximal delivery tube, and the distal end of the proximal delivery tube is fixedly connected to the proximal end of the distal delivery tube.

3. The device according to claim 1, characterized in that The most distal end of the liquid sac catheter is a tip for penetrating the atrial septum.

4. The device according to claim 1, characterized in that, The liquid sac on the liquid sac catheter, on the one hand, plays a guiding role when the device travels in the blood vessel; on the other hand, when one end of the liquid sac abuts against the atrial septum, it plays a role in supporting the atrial septal wall.

5. The device according to claim 1, characterized in that, The liquid sac catheter includes a guiding liquid sac catheter and a supporting liquid sac catheter. The guiding liquid sac catheter is transported through the inner cavity of the cutter head delivery tube; the supporting liquid sac catheter is used to support the atrial septal wall when one end of its liquid sac abuts against the atrial septum.

6. The device according to claim 1, characterized in that, The protrusion is annularly arranged on the outer periphery of the cutter head delivery tube, and the spring is limited in the space surrounded by the first stop block, the protrusion, the outer periphery of the cutter head delivery tube and the outer tube.

7. The device according to claim 6, characterized in that, The protrusion is fixedly connected to the proximal end of the spring.

8. The device according to claim 5, characterized in that, A stent is sleeved on the outer periphery of the liquid sac.

9. The device according to claim 8, wherein The distal end of the stent is shrink-fixed on the liquid sac catheter, and the proximal end is a free end and is not fixed on the supporting liquid sac catheter and is in an extended state.

10. The device according to claim 1, characterized in that, The auxiliary fixing part includes an auxiliary fixing catheter and an auxiliary fixing head. The proximal end of the auxiliary fixing catheter is fixedly connected to the operating handle, and the distal end is fixedly connected to the auxiliary fixing head. The distal end of the auxiliary fixing head is tooth-shaped or corrugated.

11. The device according to claim 1, characterized in that, The distal end of the auxiliary fixing part extends 1-10 mm out of the outer tube.

12. The device according to claim 1, characterized in that, The auxiliary fixing part is a ring-shaped multi-piece structure, the auxiliary fixing part includes a plurality of single pieces, the plurality of single pieces enclose a ring shape, and the number of the single pieces is 2-30.

13. The device according to claim 12, characterized in that, The proximal end of each single piece is fixed on the first stop block, and its distal end is serrated or needle-shaped.

14. The device according to claim 12, characterized in that, A plurality of through holes are provided at the connection part of the cutting head and the distal conveying pipe, and the through holes correspond to the single pieces one by one, so that the single pieces pass through the corresponding through holes.

15. The device according to claim 1, characterized in that, The cutter head conveying pipe is a threaded cutting pipe.

16. The device according to claim 1, characterized in that, The cutting head is a threaded cutting head.

17. The device according to claim 1, characterized in that, Small holes or small grooves are formed on the outer periphery of the cutting head, and paclitaxel is coated on the outer periphery thereof. The paclitaxel is stored in the small holes or small grooves. During the cutting process of the cutting head, the paclitaxel is smeared on the side wall of the atrial septal hole to inhibit tissue regeneration at the incision.

18. The device according to claim 1, characterized in that, The cutting head is connected with an electrode for heating the cutting head, so as to quickly coagulate the wound at the incision.

19. The device according to claim 1, characterized in that, The device includes a liquid sac sleeve rod for shrinking the expanded liquid sac and the stent and puncturing the atrial septum to facilitate the delivery of the liquid sac to the other side of the atrial septum.

20. The device according to claim 19, wherein, The liquid sac sleeve rod is of a hollow tube structure, and its head end is a sharp structure.

21. The device according to claim 19, characterized in that, The liquid sac sleeve rod is placed in the inner cavity of the auxiliary fixing part, and the liquid sac catheter is placed in the inner cavity of the liquid sac sleeve rod.

22. The device according to claim 1, characterized in that, The device includes an expandable stent, the expandable stent is a self-expanding stent, and its material is nitinol.

23. The device according to claim 22, characterized in that, The proximal end of the expandable stent near the stent is sleeved on the liquid sac catheter.

24. The device according to claim 22, characterized in that, The expandable stent is a net-like structure tightly surrounding the liquid sac catheter in the compressed state, and is fixed at the distal end on the liquid sac stent and has an open proximal end in the natural state, presenting an inverted cone shape as a whole.

25. The device according to claim 24, wherein, The peripheral wall of the proximal open end of the expandable stent is needle-shaped.

26. The device according to claim 1, wherein The device includes a folded stent and a push rod.

27. The device according to claim 26, wherein The distal end of the folded stent is fixed on the liquid sac catheter, and its proximal end is fixedly connected with the distal end of the push rod.

28. The device according to claim 26, characterized in that, The push rod is a hollow tube sleeved on the liquid sac catheter.

29. The device according to claim 26, characterized in that, The folded stent is compressed into a disc shape or stretched back into a hollow cylindrical shape surrounding the liquid sac catheter through the push rod.

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