Lockable rivetless biological atrial shunt device

Abstract

The present application relates to a kind of lockable rivetless biological atrial shunt device, belong to medical instrument technical field.The upper disc surface, waist, lower disc surface, shunt hole and locking structure are included;Upper disc surface and lower disc surface between the waist for connecting upper and lower disc surface are equipped with, shunt hole is equipped in waist, and the both ends of shunt hole are respectively opened in the disc surface of upper disc surface and lower disc surface, and through hole is formed between two end openings;Locking structure is equipped between the lower disc surface of waist outside and upper disc surface.The atrial shunt device provided by the present application is made of biodegradable material, adopts rivetless design, is provided with lockable form, and can be developed;The product of the present application can be locked, can be firmly fixed shunt in defect position, greatly improves its stability after implantation;It can be used for treating heart failure.

Description

TECHNICAL FIELD

[0001] The present application relates to a lockable rivet-free biological atrial shunt device, belonging to the technical field of medical instruments. BACKGROUND

[0002] Heart failure is the final result of various cardiovascular events and the cumulative effect of various heart abnormalities, ultimately leading to decreased cardiac pumping function. In heart failure patients, heart failure with preserved ejection fraction (HFpEF, LVEP) is a common type of heart failure, accounting for about 50% of heart failure cases, and is generally characterized by elevated left atrial pressure (LAP), which causes pulmonary hypertension (especially during exercise), leading to pulmonary congestion and dyspnea. In addition, heart failure with reduced ejection fraction (HFrEF) can also exhibit elevated LAP. Existing heart failure medications do not curb the progression of heart failure. Medical practice and computer simulation results have shown that puncturing a hole in the atrial septum can effectively reduce the high pressure in the left atrium of HFpEF and HFrEF patients, thereby reducing pulmonary artery pressure and pulmonary capillary wedge pressure (PCWP), reducing pulmonary complications, and alleviating dyspnea and fatigue in patients, thereby alleviating heart failure.

[0003] Existing related research has shown that heart failure can be treated by implanting an atrial shunt device. Most atrial shunt devices are made of metal, which can cause damage to the heart tissue, and once the metal implant device is implanted, it is permanent, and subsequent complications can occur, and the atrial septum passage can be blocked, thereby preventing other related interventional treatments. New biodegradable materials are implanted and metabolized by the human body after a period of time, eventually disappearing, avoiding various adverse effects that may be caused by permanent implantation of instruments. Biodegradable atrial shunt devices are a better method for treating heart failure as implantation devices. Biodegradable atrial shunt devices have slightly poorer mechanical properties than metal, and in addition, some heart failure patients have uneven atrial septal tissue, some require larger defects, or for various reasons, the stability of the implantation device is affected, and at this time, a more stable shunt device is needed to meet the needs of the patients. Therefore, there is an urgent need in the technical field for a more stable shunt device to meet the needs of patients. SUMMARY

[0004] The purpose of the present application is to solve the problem of how to overcome the defects in the prior art and provide a more stable atrial shunt device.

[0005] In order to solve the above problems, the technical scheme adopted by the present application is to provide a lockable rivet-free biological atrial shunt device, which comprises an upper disc surface, a waist part, a lower disc surface, a shunt hole and a locking structure; the waist part is arranged between the upper disc surface and the lower disc surface for connecting the upper disc surface and the lower disc surface; the shunt hole is arranged in the waist part; the shunt hole is open at both ends of the upper disc surface and the lower disc surface; and a through hole is formed between the two open ends; and the locking structure is arranged between the lower disc surface and the upper disc surface on the outer side of the waist part.

[0006] Preferably, the locking structure comprises a locking tube, a locking hole and a locking clamping head; the lower disc surface is provided with a hollow locking tube facing the upper disc surface; the end of the locking tube close to the upper disc surface is provided with a deformable locking clamping head; and the upper disc surface corresponding to the locking clamping head is provided with a locking hole for locking the locking clamping head.

[0007] Preferably, the locking structure is provided with a developing part.

[0008] Preferably, the developing part is provided with a medical developing coating or a developing material blended and processed with a standard visible solvent.

[0009] Preferably, the waist part is provided with an anticoagulant coating.

[0010] Preferably, the atrial shunt device is made of degradable materials, and the materials include degradable high molecular poly-p-dioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB, PVA, natural degradable high molecular silk fibroin, collagen fiber and / or chitosan.

[0011] Preferably, the atrial shunt device is woven by degradable wire materials.

[0012] The present application provides a delivery device for a lockable rivet-free biological atrial shunt device, which comprises a pull ring, a locking switch, a handle, an inner sheath, a connecting key, a mandrel and a functional head; the outer periphery of the mandrel is provided with an inner sheath; the end of the mandrel close to the operator is provided with a pull ring; the other end is provided with a connecting key for connecting with the functional head; a handle is arranged adjacent to the pull ring; the handle is provided with a locking switch for avoiding misoperation; and the functional head comprises a preloading head, a puncture needle head and a locking rod head.

[0013] Preferably, the preloading head comprises a hanging head for hanging the lockable rivet-free biological atrial shunt device; the puncture needle head is provided with a puncture needle for puncturing the locking point; and the locking rod head is provided with a locking rod for penetrating into the locking tube and guiding the locking clamping head to penetrate into the locking hole.

[0014] Compared with the prior art, the present application has the following beneficial effects:

[0015] 1. The present application provides a lockable rivet-free biological atrial shunt device, which can be used for treating heart failure.

[0016] 2. The atrial shunt device provided by the present application is biodegradable: the biocompatible material for biological implantation is a new way for treating cardiovascular diseases in recent years, which has good biocompatibility, can be metabolized by the human body, leaves no trace, and can reduce the adverse effects of heart failure patients after treatment. The biodegradable material selected in the present application meets the medical device standards, and the selected materials include: synthetic degradable high molecular polydioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB, PVA series, etc.; natural degradable high molecular silk fibroin, collagen fiber, chitosan, etc. The biodegradable atrial shunt is woven from these degradable materials, and one or more biodegradable materials are selected to make a locking device to lock and ensure that all structures are made of degradable materials.

[0017] 3. The present application is a rivet-free design: the atrial shunt of the present application adopts a rivet-free design, which has many advantages. The rivet head of the previous related interventional shunt or occluder will affect the endothelialization of the tissue, which is not conducive to the healing of the treatment site, delays the recovery process, and the patient's later burden is longer; and there is a possibility of inflammation, hyperplasia or even thrombosis at the rivet head site, which has certain long-term risks. In the rivet-free design, the product does not have a rivet, which is more conducive to the climbing of the human tissue endothelium, can quickly endothelialize at the treatment site, and after the endothelialization of the defect hole, a layer of membrane will be formed to cover the atrial shunt. The surface of the endothelial defect is no longer exposed to blood and tissue, which is more stable, and the tissue will no longer grow axially into the hole. This greatly shortens the patient's recovery time, reduces the patient's later burden, and reduces the long-term risk.

[0018] 4. The present application is a lockable form: the product of the present application can be locked, which can firmly fix the shunt at the defect position, greatly improving the stability after implantation. Avoid the risk of displacement, shedding and other risks caused by various reasons, and the safety is higher than that of the previous interventional products. In order to realize this function, more designs are made on the delivery device to support the locking function. The locking design is a hole plus buckle way, the hole is small and the buckle is large, but the buckle can be deformed, pass through the hole by becoming smaller, and restore the original shape after passing through the hole, forming a buckle locking state.

[0019] 5. The product of the present application can be visualized: since the biodegradable material cannot be visualized (such as under DSA), the surface of the material can be treated, a medical visualization coating such as a metal polymer can be added, or a standard visualizable solvent (containing iodine compounds) can be blended and processed into a visualized material in the form of a wire, film, surface, rod, etc. The biodegradable atrial shunt can be visualized during the operation, the locking position is better positioned, the operation difficulty is greatly reduced, the doctor's operation is more convenient, and the convenience and safety factor are increased. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 Figure 1 is a schematic diagram of the delivery device structure of the present application.

[0021] Figure 2 Figure 2 is a schematic diagram of the preloading head structure of the delivery device.

[0022] Figure 3 Figure 3 is a schematic diagram of the puncture needle structure of the delivery device.

[0023] Figure 4 Figure 4 is a schematic diagram of the locking rod head structure of the delivery device.

[0024] Figure 5 Figure 5 is a schematic diagram of the structure of the present application.

[0025] Figure 6 Figure 6 is a schematic diagram of the structure of the present application.

[0026] Reference signs: 1. Pull ring; 2. Locking switch; 3. Handle; 4. Inner sheath; 5. Connection key; 6. Mandrel; 7. Preloading head; 8. Hanging head; 9. Connection head; 10. Puncture needle; 11. Locking rod; 12. Upper disc surface; 13. Waist; 14. Lower disc surface; 15. Shunt hole; 16. Locking tube; 17. Locking ball; 18. Locking hole; 19. Mushroom head; 20. Hanging foot. DETAILED DESCRIPTION

[0027] In order to make the present application more obvious and easy to understand, the preferred embodiments are described in detail below with the help of the drawings:

[0028] As Figures 1-6The application provides a lockable rivet-free biological atrial shunt device, which comprises an upper disc surface 12, a waist portion 13, a lower disc surface 14, a shunt hole 15 and a locking structure. The waist portion 13 is arranged between the upper disc surface 12 and the lower disc surface 14 and is used for connecting the upper disc surface 12 and the lower disc surface 14. The shunt hole 15 is arranged in the waist portion 13. The shunt hole 15 is open at the upper disc surface 12 and the lower disc surface 14, respectively, and a through hole is formed between the two openings. The locking structure is arranged between the lower disc surface 14 and the upper disc surface 12 outside the waist portion 13. The locking structure comprises a locking tube 16, a locking hole 18 and a locking clamping head (locking ball / mushroom head). The locking tube 16 is hollow and arranged on the lower disc surface 14 and faces the upper disc surface 12. The locking tube 16 is provided with a deformable locking clamping head at one end close to the upper disc surface 12. The upper disc surface 12 is provided with the locking hole 18 corresponding to the locking clamping head and used for locking the locking clamping head. The locking structure is provided with a developing part. The developing part is provided with a medical developing coating or a developing material blended and processed with a standard developing solvent. The waist portion 13 is provided with an anticoagulation coating. The atrial shunt device is made of degradable materials, and the materials include degradable high-molecular poly-p-dioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB, PVA, natural degradable high-molecular silk fibroin, collagen fiber and / or chitosan. The atrial shunt device is woven by degradable wire materials.

[0029] The application provides a delivery device for a lockable rivet-free biological atrial shunt device, which comprises a pull ring 1, a locking switch 2, a handle 3, an inner sheath 4, a connecting key 5, a mandrel 6 and a functional head. The inner sheath 4 is arranged on the outer periphery of the mandrel 6. The mandrel 6 is provided with the pull ring 1 at one end close to an operator. The other end is provided with the connecting key 5 used for connecting the functional head. The handle 3 is arranged adjacent to the pull ring 1. The handle 3 is provided with the locking switch 2 used for avoiding misoperation. The functional head comprises a preloading head 7, a puncture needle head and a locking rod head. The preloading head 7 comprises a hanging head 8 used for hanging the lockable rivet-free biological atrial shunt device. The puncture needle head is provided with a puncture needle 10 used for puncturing a locking point. The locking rod head is provided with a locking rod 11 used for penetrating into a locking tube and guiding the locking clamping head to penetrate into a locking hole.

[0030] Embodiment

[0031] The shunt device is provided with a locking design. The locking design is a hole plus buckle mode. The hole is smaller and the buckle is larger. However, the buckle can be deformed. The buckle passes through the hole by being deformed and restores the original shape after passing through the hole, so as to form a buckle locking state. The locking process needs a delivery device and a special functional head to realize.

[0032] 1. A delivery device for a lockable rivet-free biological atrial shunt device:

[0033] The device is used for delivering an atrial shunt into a human body, and mainly comprises a pull ring 1, a locking switch 2, a handle 3, an inner sheath 4, a connecting key 5 and a mandrel 6. The pull ring 1 can be used to push and pull the mandrel 6 to move forward and backward, and the locking switch 2 can be used to lock to avoid misoperation. The handle 3 is used to hold the delivery device and perform operation. The inner sheath 4 is used for interventional delivery, the connecting key 5 is used to connect a functional head, and the mandrel 6 is connected with the pull ring 1 and can remotely control the functional head. The device needs to be combined with other interventional devices such as an outer sheath to perform surgery, and the inner sheath 4 can be loaded into the outer sheath.

[0034] 1.1 Preloading head 7:

[0035] The rivet-free design has many benefits for patients, such as reducing thrombosis and promoting endothelialization, but it is difficult to clamp the shunt. Therefore, the preloading head 7 is designed to clamp and pre-load the rivet-free shunt.

[0036] The preloading head 7 is used to pre-load the shunt, and mainly comprises the preloading head 7 and a hanging head 8. The preloading head 7 has four hanging heads 8 evenly distributed at 90 degrees around the circumference, which are used to hold the atrial shunt, and the preloading is performed by holding the corresponding mesh or hanging foot 20. The device can pre-load the atrial shunt into a preloading tube. In use, the preloading head 7 can be connected with the connecting key 5.

[0037] 1.2 Puncture needle

[0038] The puncture needle 10 is used to puncture the locking point, and mainly comprises a connecting head 9 and the puncture needle 10. In use, the puncture needle 10 reaches the designated imaging site to perform puncture.

[0039] 1.3 Locking rod head

[0040] The locking rod 11 is used to push the locking position to assist the locking of the shunt locking position, and mainly comprises a connecting head 9 and the locking rod 11.

[0041] 2. Lockable rivet-free biological atrial shunt

[0042] All components of the lockable rivet-free biological atrial shunt are made of biodegradable materials, and are made by weaving, shaping and melting. The locking position is shaped by corresponding molds. The biodegradable material is added with a medical imaging coating, such as a metal polymer or a visible solvent (containing an iodine compound) blended and processed into various shapes of imaging materials such as wires, films, surfaces and rods, to make the product visible. The locking position is provided with a key imaging point.

[0043] 2.1 Spherical locking shunt

[0044] The application is a spherical locking shunt, which has two disc surfaces, upper and lower, and is woven from degradable wire. It includes an upper disc surface 12, a waist 13, a lower disc surface 14, a shunt hole 15, a locking tube 16, a locking ball 17, and a locking hole 18.

[0045] The upper and lower disc surfaces of the device are the same size and are woven. In order to better play the role of shunting, an anticoagulant coating is applied to the waist 13 to prevent closure and prolong the service life. The other disc surface parts are not coated with an anticoagulant coating, which can make the disc surface achieve endothelialization and tissue integration faster. The design is rivet-free, which is more conducive to tissue adhesion after implantation and is less likely to have thrombosis. The locking position is provided with a visible point.

[0046] The locking tube 16 and the locking ball 17 (the ball is a buckle in this embodiment) in the device are elastic, and the locking ball 17 is hollow and communicates with the locking tube 16 (hollow), the locking hole 18 has a diameter smaller than that of the locking ball 17, the locking ball 17 deforms into a strip shape when passing through the hole, and then restores to a spherical shape through the locking hole 18, meeting the locking requirements.

[0047] In use, the atrial shunt is first loaded with the preloading head 7, and then implanted into the defect position to release the upper disc surface 12 of the atrial shunt, at this time the lower disc surface 14 and the locking tube 16 are in a folded state, then the pull ring 1 is pushed forward by holding the handle 3, and the lower disc surface 14 is slowly released, and the shunt is completely released (at this time the locking tube 16 is in a folded state), and the delivery device is withdrawn; the preloading head 7 is removed from the connecting key 5, the puncture needle 10 is installed, and is delivered to the defect position through the outer sheath tube, and two holes are punctured on both sides of the defect along the locking tube 16 and the visible point, and then the delivery device is withdrawn; the puncture needle 10 is removed, the locking rod 11 is installed, and is delivered to the defect position through the outer sheath tube, and the locking rod 11 is inserted into the locking tube 16 to drive the locking tube 16 and the locking ball 17 to pass through the defect, at this time under the extrusion of the tissue, the locking ball 17 has deformed into a strip shape and can pass through the locking hole 18 of the upper disc surface 12 of the shunt, and then restores to a spherical shape, and the other side is locked by repeating the above steps. Thus, the locking step is completed.

[0048] The application can firmly fix the shunt in the defect position, greatly improving the stability.

[0049] 2.2 Mushroom-shaped locking shunt

[0050] The application is a mushroom-shaped locking shunt, which has two disc surfaces, upper and lower, and is woven from degradable wire. It includes an upper disc surface 12, a waist 13, a lower disc surface 14, a shunt hole 15, a locking tube 16, a locking hole 18, a mushroom head 19, and a hanging foot 20.

[0051] In order to make the product better play the role of shunt, in its waist 13 is coated with an anti-coagulation coating can prevent closure, extend the service life, and other disc body disc surface part is not added anti-coagulation coating, can make the disc surface can faster realize endothelialization and tissue integration. The design is rivet-free design, more conducive to tissue climbing after implantation, not easy to have thrombus. And there is a locking position, the locking position is provided with a developing point.

[0052] The locking tube 16 and the mushroom head 19 (the mushroom head is a buckle in the embodiment) are both elastic, and the mushroom head 19 is connected with the locking tube 16 (hollow), the locking hole 18 is smaller in diameter than the diameter of the mushroom head 19, the mushroom head 19 is deformed into a strip shape (its shape is like a tight umbrella) when passing through the hole, and then restores the mushroom shape after passing through the hole 18, so that the locking requirement is achieved.

[0053] In use, the atrial shunt is first loaded with the preloading head 7, and then implanted into the defect position, and the upper disc surface 12 of the atrial shunt is released, at this time, the lower disc surface 14 and the locking tube 16 are in a folded state, then the pull ring 1 is pushed forward by holding the handle 3, and the lower disc surface 14 is slowly released, and the shunt is completely released (at this time, the locking tube 16 is in a folded state), and the delivery device is withdrawn; the preloading head 7 is removed from the connecting key 5, the puncture needle 10 is installed, and is delivered to the defect position through the outer sheath, and two holes are punctured on both sides of the defect along the locking tube 16 and the developing point, and then the delivery device is withdrawn; the puncture needle 10 is removed, the locking rod 11 is installed, and is delivered to the defect position through the outer sheath, and the locking rod 11 is inserted into the locking tube 16, so that the locking tube 16 and the mushroom head 19 pass through the defect, at this time, under the extrusion of the tissue, the mushroom head 19 has been deformed into a strip shape (its shape is like a tight umbrella), passes through the locking hole 18 of the upper disc surface 12 of the shunt, and then restores to the mushroom shape, and the other side is locked by repeating the step. Thus, the locking step is completed.

[0054] The atrial shunt can be firmly fixed in the defect position, and the stability is greatly improved.

[0055] Unlike the spherical atrial shunt, the design is smooth in shape instead of a grid, and the shape is more flexible to manufacture, and the waist 13 of the shunt is less likely to leak than the grid woven shunt waist 13, so the defect is less likely to close.

[0056] The device can be selected according to clinical conditions and doctor's needs.

[0057] The present application provides a lockable rivet-free biological atrial shunt device, which has a locking design, the locking design is a hole plus buckle mode, the hole is smaller and the buckle is larger, but the buckle can be deformed, passes through the hole by being smaller, restores the original shape after passing through the hole, and forms a buckle locking state. The locking process needs a delivery device and a special function head to realize.

[0058] The application provides a lockable rivet-free biodegradable atrial shunt which can be developed, and because the biodegradable material cannot be developed (for example, cannot be developed under DSA), the surface of the material can be treated, a medical developing coating such as a metal polymer is added, or a developing material in the form of a wire, a film, a surface, a rod or the like is processed by blending with a developing solvent (containing an iodine compound) meeting the standard, so that the biodegradable atrial shunt can be visible during the operation, the locking position is better positioned, and the difficulty of the operation is greatly reduced.

[0059] The application provides a delivery device of the lockable rivet-free biodegradable atrial shunt, which comprises a pull ring 1, a locking switch 2, a handle 3, an inner sheath 4, a connecting key 5 and a mandrel 6; the pull ring 1 can be used to push and pull to control the mandrel 6 to advance and retreat; the locking switch 2 is used for protection and can be used to lock to avoid misoperation; the handle 3 is used for holding the delivery device and operation; the inner sheath 4 is used for interventional delivery; the connecting key 5 is used for connecting a functional head; and the mandrel 6 is connected with the pull ring 1 and can remotely control the functional head.

[0060] The application provides the lockable rivet-free biodegradable atrial shunt device, which is made of degradable materials, and the optional materials include: synthetic degradable high molecular poly-p-dioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB, PVA series and the like; natural degradable high molecular silk fibroin, collagen fiber and chitosan.

[0061] The application provides the lockable rivet-free biodegradable atrial shunt device, which is designed without rivets, and the product without the rivet head is more conducive to the climbing of the human body tissue endothelium, can be rapidly endothelialized at the treatment site, and after endothelialization of the defect hole, a membrane is formed to cover the atrial shunt, the defect surface after endothelialization is no longer exposed to blood and tissue, is more stable, and the tissue cannot grow axially into the hole. The recovery time of the patient is greatly shortened, the postoperative burden of the patient is reduced, and the long-term risk is reduced.

[0062] The application provides the lockable rivet-free biodegradable atrial shunt device, which is designed without rivets, and the product without the rivet head is more conducive to the climbing of the human body tissue endothelium, can be rapidly endothelialized at the treatment site, and after endothelialization of the defect hole, a membrane is formed to cover the atrial shunt, the defect surface after endothelialization is no longer exposed to blood and tissue, is more stable, and the tissue cannot grow axially into the hole. The recovery time of the patient is greatly shortened, the postoperative burden of the patient is reduced, and the long-term risk is reduced.

[0063] The application provides a lockable rivet-free biological atrial shunt device, which is a spherical lockable shunt device, has two disc surfaces of the same size, and is woven by degradable wire material. The device comprises an upper disc surface, a waist part, a lower disc surface, a shunt hole, a locking tube, a locking ball, and a locking hole. The waist part is coated with an anticoagulant coating to prevent closure and prolong service life, and the other disc surface parts are not coated with the anticoagulant coating, so that the disc surface can be more quickly endothelialized and integrated with tissues. The design is a rivet-free design, is more conducive to tissue adhesion after implantation, is not prone to thrombosis, and is provided with a developing point at the locking position.

[0064] The application provides a lockable rivet-free biological atrial shunt device, which is a mushroom-shaped lockable shunt device, has two disc surfaces, and comprises an upper disc surface, a waist part, a lower disc surface, a shunt hole, a locking tube, a mushroom head, a locking hole, and a hanging foot. The device is made of a degradable material. The waist part of the device is coated with an anticoagulant coating, and the mushroom head is elastic and is expanded after passing through the locking hole to play a locking role.

[0065] The above description is only a preferred embodiment of the application, and is not intended to limit the application in any form or in essence. It should be noted that those skilled in the art can make some improvements and supplements without departing from the application, and these improvements and supplements should be considered as the protection scope of the application. For those skilled in the art, some minor changes, modifications and equivalent changes made by using the disclosed technical content without departing from the spirit and scope of the application are equivalent embodiments of the application; meanwhile, any equivalent changes, modifications and evolution of the above-mentioned embodiments according to the essential technology of the application are still within the scope of the technical solutions of the application.

Claims

1. A lockable rivetless bioatrial shunt device; characterized by: The upper disc surface, the waist, the lower disc surface, the shunt hole and the locking structure are included; the waist for connecting the upper and lower disc surfaces is arranged between the upper disc surface and the lower disc surface, the shunt hole is arranged in the waist, the two ends of the shunt hole are respectively opened on the disc surfaces of the upper disc surface and the lower disc surface, and a through hole is formed between the two end openings; the locking structure is arranged between the lower disc surface and the upper disc surface on the outer side of the waist; The locking structure includes the locking tube, the locking hole and the locking clamping head; the hollow locking tube is arranged on the lower disc surface and faces the upper disc surface, the deformable locking clamping head is arranged at the end of the locking tube close to the upper disc surface; the locking hole for locking the locking clamping head is arranged on the upper disc surface corresponding to the locking clamping head; The locking clamping head is a locking ball or a mushroom head; When the locking clamping head is a locking ball, the locking tube and the locking ball are both elastic, the locking ball is hollow and communicates with the locking tube, the diameter of the locking hole is smaller than that of the locking ball, the locking ball is deformed into a strip shape when passing through the locking hole, and then restores to a spherical shape through the locking hole, so that the locking requirement is met; When the locking clamping head is a mushroom head, the locking tube and the mushroom head are both elastic, the mushroom head is connected with the locking tube, the diameter of the locking hole is smaller than that of the mushroom head, the mushroom head is deformed into a strip shape like a tightened umbrella when passing through the locking hole, and then restores to a mushroom shape through the locking hole, so that the locking requirement is met.

2. A lockable rivetless bioatrial shunt device as claimed in claim 1; characterized in that: The locking structure is provided with a developing part.

3. The lockable rivetless bioatrial shunt device of claim 2, wherein: The developing part is provided with a medical developing coating, or a developing material blended and processed with a standard visible solvent.

4. The lockable rivetless bioatrial shunt device of claim 1, wherein: The waist is provided with an anticoagulation coating.

5. The lockable rivetless bioatrial shunt device of claim 1, wherein: The atrial shunt device is made of degradable material.

6. The lockable rivetless bioatrial shunt device of claim 5, wherein: The atrial shunt device is woven by degradable wire material.

7. A lockable rivetless bioatrial shunt delivery device according to any one of claims 1 to 6, wherein: The device includes a pull ring, a locking switch, a handle, an inner sheath, a connecting key, a mandrel and a functional head; the inner sheath is arranged on the outer periphery of the mandrel, the pull ring is arranged at the end of the mandrel close to the operator; the other end is provided with a connecting key for connecting with the functional head; the handle is arranged adjacent to the pull ring, and the handle is provided with a locking switch for avoiding misoperation; the functional head includes a preloading head, a puncture needle and a locking rod head.

8. The delivery device of a lockable rivetless bio-atrial shunt device as claimed in claim 7, wherein: The preloading head includes a hanging head for hanging a lockable rivet-free biological atrial shunt device; the puncture needle is provided with a puncture needle for puncturing a locking point; the locking rod head is provided with a locking rod for penetrating into the locking tube and guiding the locking clamping head to penetrate into the locking hole.

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