Medical device

Abstract

The present invention relates to a medical device, comprising a plugging device and a delivery device. The plugging device includes a main body, a proximal connecting member and a distal connecting member connected to both ends of the main body. Wherein, the proximal connecting member is provided with a perforation for the pushing tube of the delivery device to pass through. The distal end of the pushing tube is combined with the distal connecting member. The outer surface of the main body is coated with a first sealing agent. The pushing tube includes a liquid injection channel for passing a second liquid. The second liquid combines with the first sealing agent to generate an adhesion force to fix the plugging device to a predetermined area. In the medical device of the present invention, the first sealing agent on the outer surface of the main body of the plugging device combines with the second liquid injected from the liquid injection channel to generate an adhesion force, so as to firmly fix the plugging device at the implantation position. Subsequently, the plugging device is not easily detached from the implantation position, effectively solving the problem of poor plugging effect of the plugging device.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to medical devices. Background Art

[0002] Atrial fibrillation is the most common persistent arrhythmia clinically and has a risk of inducing ischemic stroke. Data shows that in patients with non-valvular atrial fibrillation, more than 90% of cardiogenic thrombi form in the left atrial appendage. In recent years, studies have shown that occluding the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation. Since the left atrial appendage occlusion for preventing thromboembolic events in atrial fibrillation was first applied clinically in 2001, its clinical application has developed rapidly at home and abroad and has become an important method for preventing thromboembolic events in patients with atrial fibrillation. At the same time, different types of occluding devices have emerged one after another, better meeting the clinical needs and improving the surgical efficacy and safety.

[0003] In the prior art, the occluders used for left atrial appendage occlusion can be basically divided into two categories. One category is the cage-shaped occluder represented by Watchman. Its characteristics are an integrally cut and formed self-expanding frame with anchoring hooks around it, and a porous permeable membrane covering the atrial surface. When in use, it is placed into the left atrial appendage cavity to play a occluding role. The other category is the double-disk occluder represented by LAmbre. Its characteristics are that it is composed of a positioning disk and a occluding disk connected. When in use, the positioning disk is embedded in the left atrial appendage to play a riveting effect and may also play a certain occluding role, and then mainly relies on the occluding disk attached to the left atrial appendage orifice to play a occluding role. Currently, the two types of occluders have a common feature, that is, they are mainly made of nitinol alloy and will accompany the patient for life once implanted into the human body.

[0004] However, such materials cannot be degraded, and long-term implantation will cause reactions such as inflammation and coagulation with human tissues, and even cause a certain degree of damage. In addition, there may be the following risks: (1) Nitinol alloy is a non-degradable metal material. Although its biocompatibility has been demonstrated, the long-term risks of permanent implantation still cannot be fully predicted and controlled; (2) There is a lack of long-term follow-up data on the safety of the occluder permanently remaining in the heart for the human body; (3) There is no clear scientific demonstration for complications such as nickel precipitation and allergy.

[0005] Although the prior art has designed the occluder, it mainly studies its materials and processing techniques, such as CN205849494U, CN207785224U, etc. Although certain structural designs are also proposed in the above patents, there are problems with poor occluding effects. Summary of the Invention

[0006] The present invention provides a medical device to solve the problem of poor occluding effect.

[0007] The present invention provides a medical device, comprising a occluder and a delivery device. The occluder includes a main body, a proximal connector and a distal connector connected to both ends of the main body. Wherein, the proximal connector is provided with a perforation for the push tube of the delivery device to pass through. The distal end of the push tube is combined with the distal connector. The outer surface of the main body is coated with a first sealant. The push tube includes an injection channel for passing a second liquid. The second liquid combines with the first sealant to generate an adhesive force to fix the occluder to a predetermined area.

[0008] In one embodiment, the main body, the proximal connector and the distal connector are all made of biodegradable materials.

[0009] In one embodiment, the first sealant includes pentaerythritol polyglycol ether tetra-succinimide glutarate and pentaerythritol polyglycol ether tetrathiol, and the second liquid includes sodium dihydrogen phosphate and sodium carbonate; or, the first sealant is bovine serum albumin or human serum albumin, and the second liquid is glutaraldehyde or polyethylene glycol or paraformaldehyde.

[0010] In one embodiment, the proximal connector includes a sealing flap that closes after the push tube is withdrawn from the occluder.

[0011] In one embodiment, the delivery device further includes a balloon sleeved on the outer wall of the push tube. The balloon includes at least one liquid dispersion hole and is communicated with the injection channel.

[0012] In one embodiment, the number of the liquid dispersion holes is 100 to 300, and the diameter of the liquid dispersion holes is 5 μm to 30 μm.

[0013] In one embodiment, the balloon includes an inner layer and an outer layer. The liquid dispersion holes are located in the outer layer. The inner layer is communicated with the pressurization channel of the push tube, and the outer layer is communicated with the injection channel.

[0014] In one embodiment, the push tube includes an inner tube and an outer tube sleeved outside the inner tube. The inner tube is provided with a first hole communicating with the injection channel, and the outer tube is provided with a second hole communicating with the pressurization channel.

[0015] In one embodiment, the delivery device further includes a delivery sheath tube, and the occluder and the push tube are accommodated in the delivery sheath tube.

[0016] In one embodiment, the main body includes a stent rod and / or a filter membrane on the outer surface of the stent rod, and the first sealant is applied on the outer surface of the stent rod or the filter membrane.

[0017] In one embodiment, the sealing flap is made of a shape memory alloy material and includes a hollow tubular body and a plurality of flap leaves, and the flap leaves are conical when the sealing flap is closed.

[0018] In one embodiment, the distal connector includes a receiving cavity, and the distal end of the push tube is located in the receiving cavity.

[0019] In one embodiment, the outer layer of the balloon is made of a non-compliant material.

[0020] The medical device of the present invention includes a occluder and a delivery device. The occluder includes a main body, and the outer surface of the main body is coated with a first sealant. The first sealant combines with a second liquid injected by the push tube of the delivery device to generate an adhesive force. In this way, after the occluder is released to the implantation position, the first sealant and the second liquid are combined to generate an adhesive force, and the occluder is firmly fixed at the implantation position. Subsequently, the occluder is not easily detached from the implantation position, effectively solving the problem of poor occlusion effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] 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 following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figure 1 It is a schematic structural diagram of a medical device in an embodiment;

[0023] Figure 2 It is a schematic structural diagram of an occluder in a medical device in an embodiment;

[0024] Figure 3 It is a schematic structural diagram of the sealing flap of an occluder in an embodiment, wherein the sealing flap is in an open state;

[0025] Figure 4 It is a schematic structural diagram of the sealing flap of an occluder in an embodiment, wherein the sealing flap is in a closed state;

[0026] Figure 5 It is a schematic diagram of the state of an occluder in a medical device in an embodiment after being released in the left atrial appendage and before dilation;

[0027] Figure 6 It is a schematic diagram of the state of an occluder expanding with a balloon in a medical device in an embodiment;

[0028] Figure 7In a medical device according to an embodiment, the state diagram shows the occluder expanded to a predetermined size. At this time, the main body is in contact with the inner wall of the left atrial appendage;

[0029] Figure 8 In a medical device according to an embodiment, the state diagram shows that a second liquid is injected into the occluder to combine with the first sealant, thereby fixing the occluder to the inner wall of the left atrial appendage;

[0030] Figure 9 In a medical device according to an embodiment, the state diagram shows the occluder fixed to the left atrial appendage and the delivery device withdrawn. Detailed Embodiments

[0031] To make the above objects, features, and advantages of the present invention more apparent and understandable, the following describes the detailed embodiments of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein. Those skilled in the art can make similar improvements without departing from the spirit of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0032] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate the orientation or state relationship based on the orientation or state relationship shown in the drawings. These are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation of the present invention.

[0033] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, "a plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0034] In the present invention, unless otherwise clearly specified and defined, terms such as "installed", "connected", "linked", "fixed", etc. shall be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0035] It should be noted that the terms "distal end" and "proximal end" are commonly used terms in the field of medical devices. The "distal end" refers to the end far from the operator during the operation process, and the "proximal end" refers to the end close to the operator during the operation process. The axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device; the radial direction refers to the direction perpendicular to the above axial direction.

[0036] Refer to Figure 1 and Figure 2 As shown in, a medical device 100 provided by the present invention includes a plugging device 10 and a delivery device 20. Among them, the plugging device 10 is used to enter a position that needs to be plugged, such as a blood vessel or a left atrial appendage (hereinafter simply referred to as the "implantation position") under the delivery of the delivery device 20, and plug the blood flow.

[0037] The plugging device 10 includes a main body 11, a proximal connecting member 12 and a distal connecting member 13 connected to both ends of the main body 11.

[0038] The proximal connecting member 12 is provided with a perforation 12a for the pushing tube 21 of the delivery device 20 to pass through. The distal end of the pushing tube 21 is combined with the distal connecting member 13. In this way, the plugging device 10 can be moved to a suitable position of the left atrial appendage by using the pushing tube 21. After a stable connection between the plugging device 10 and the left atrial appendage is completed, by detaching the pushing tube 21 from the distal connecting member 13, the pushing tube 21 can be withdrawn from the body.

[0039] There are various possible ways of combination between the pushing tube 21 and the distal connecting member 13. For example, in some embodiments, the side of the distal connecting member 13 in contact with the distal end of the pushing tube 21 has a depression, and the distal end of the pushing tube 21 can be accommodated in the depression. In other embodiments, a detachable connection such as a threaded connection, clamping or buckling can also be adopted between the distal end of the pushing tube 21 and the distal connecting member 13.

[0040] The outer surface of the main body 11 is coated with a first sealing agent. The injection tube 21 includes an injection channel 21b for passing a second liquid. After the first sealing agent combines with the second liquid, an adhesive force is generated to firmly connect the occluder 10 to the wall surface of the implantation position (i.e., the predetermined area), thereby preventing the occluder 10 from falling off and effectively ensuring the occlusion effect of the occluder 10 at the predetermined area.

[0041] In some embodiments, the main body 11, the proximal connecting member 12, and the distal connecting member 13 are all made of biodegradable materials. Thus, after the occluder 10 is implanted into the body, it can be completely degraded and absorbed, thereby avoiding long-term complications and safety hazards caused by foreign body retention. Compared with metal occluders, since biocompatible and biodegradable materials are adopted, they can be absorbed by the organism, avoiding the occurrence of metal poisoning and complications.

[0042] It should be noted that the biodegradable material can be a biodegradable polymer material, such as polylactic acid, poly-p-dioxanone, polycaprolactone, polyglycolide, poly(lactic-co-glycolic acid), etc. The biodegradable material can also be a biodegradable metal material, such as magnesium alloy, zinc alloy, pure iron, etc. In other embodiments, the biodegradable material can also be obtained by coating a biodegradable polymer material on a biodegradable metal material. The types of biodegradable materials will not be elaborated one by one here.

[0043] In some embodiments, the main body 11 includes a stent rod (not shown in the figure) and / or a filter membrane (not shown in the figure) located on the outer surface of the stent rod, and the first sealing agent is applied on the outer surface of the stent rod or the filter membrane.

[0044] The main body 11 is woven from biodegradable filaments, or the main body 11 is cut from biodegradable tubing.

[0045] In the embodiments where the main body 11 includes a stent rod and a filter membrane located on the outer surface of the stent rod, there are various possibilities for the position of the filter membrane on the stent rod. For example, a filter membrane is provided on one side of the stent rod close to the proximal connecting member 12. Under the support of the main body 11, the filter membrane achieves a flow-blocking effect at the left atrial appendage. In some other embodiments, a filter membrane is provided on one side of the stent rod close to the distal connecting member 13, or filter membranes are provided on both sides of the stent rod close to the distal connecting member 13 and the proximal connecting member 12.

[0046] In some embodiments, the first sealant includes pentaerythritol polyethylene glycol ether tetra-succinimide glutarate and pentaerythritol polyethylene glycol ether tetrathiols, and the second liquid includes sodium dihydrogen phosphate and sodium carbonate. In other embodiments, the first sealant is bovine serum albumin or human serum albumin, and the second liquid is glutaraldehyde or polyethylene glycol or paraformaldehyde. The types of the first sealant and the second liquid are not limited herein, as long as the first sealant can generate an adhesive force after binding to the second liquid input from the liquid injection channel 21b, so as to realize the stable connection between the occluder 10 and the inner wall of the left atrial appendage.

[0047] For ease of understanding, the medical device 100 will be further described below by taking the implantation of the occluder 10 into the left atrial appendage as an example.

[0048] Combined with Figure 5 As shown, after the occluder 10 is moved into the left atrial appendage through the delivery device 20, it cannot self-expand to a predetermined shape due to the lack of shape memory performance of the degradable material. Based on this, the inventor improves the delivery device 20 and the occluder 10, so that after the occluder 10 is implanted into the body, the first sealant on the outer surface of the main body 11 can finally be bonded to the inner wall of the left atrial appendage through the manipulation of the delivery device 20, so that the occluder 10 can achieve a stable occlusion effect in the left atrial appendage, to make up for the poor occlusion effect caused by the insufficient mechanical properties of the degradable material.

[0049] Specifically, combined with Figure 1 and Figure 5 As shown, the delivery device 20 includes a delivery sheath (not shown in the figure), a push tube 21, and a balloon 22.

[0050] The delivery sheath has a delivery channel. The distal end of the push tube 21 is connected to the distal connector 13, and can push the occluder 10 out of the distal end of the delivery sheath along the delivery channel to release it at a suitable position in the left atrial appendage.

[0051] The balloon 22 is sleeved on the push tube 21. The push tube 21 can pressurize or depressurize the balloon 22, so that the balloon 22 is in a filled state or a contracted state, thereby using the balloon 22 to expand the occluder 10, so that the outer surface of the occluder 10 abuts against the inner wall of the left atrial appendage. At this time, the second liquid can be injected at the abutting position between the two, so that the second liquid combines with the first sealant to generate an adhesive force, and further makes the occluder 10 firmly connected to the left atrial appendage.

[0052] It should be noted that all components of the second liquid can be simultaneously injected into the joint between the outer surface of the occluder 10 and the inner wall of the left atrial appendage, or can be operated step by step, as long as the first sealant and the second liquid can finally combine to generate an adhesive force.

[0053] For example, in some embodiments, the second liquid is formed by mixing two solutions, namely a hydrochloric acid dilution solution and a mixture of sodium dihydrogen phosphate and sodium carbonate. Before implanting the occluder 10, the first sealant can be dissolved in the hydrochloric acid dilution solution and then applied to the outer surface of the main body 11. After drying, the occluder 10 is implanted into the appropriate position of the left atrial appendage. Then, the mixture of sodium dihydrogen phosphate and sodium carbonate is injected into the position where the main body 11 is applied, so that the mixture of sodium dihydrogen phosphate and sodium carbonate reacts with the hydrochloric acid dilution solution to create an environment suitable for the first sealant to generate adhesion force, that is, the combination of the second liquid and the first sealant is completed, thereby generating an adhesion force to stably bond and fix the occluder 10 to the inner wall of the left atrial appendage.

[0054] In some embodiments, referring to Figure 5 As shown, when the balloon 22 is in a contracted state, the balloon 22 can enter the space enclosed by the main body 11 through the perforation 12a along with the delivery tube 21. Understandably, the balloon 22 in the contracted state can also be withdrawn from the space enclosed by the main body 11 through the perforation 12a along with the delivery tube 21, that is, after the occluder 10 is fixed in the left atrial appendage, the delivery tube 21 and the balloon 22 can be withdrawn. When the balloon 22 is in a filled state, the balloon 22 drives the main body 11 to expand radially.

[0055] The delivery device 20 can move the occluder 10 to the appropriate position in the left atrial appendage for release. Combining Figure 6 and Figure 7 As shown, by regulating the state of the balloon 22 through the delivery tube 21, the balloon 22 can expand the main body 11 radially to be in contact with the inner wall of the left atrial appendage. Combining Figure 8 As shown, when an alkaline solvent is injected at the joint between the main body 11 and the inner wall of the left atrial appendage, the first sealant on the outer surface of the main body 11 is activated to generate an adhesive force, so as to stably connect the occluder 10 to the left atrial appendage firmly and not easily fall off, thereby enabling the occluder 10 to perform a good occlusion at the left atrial appendage.

[0056] It should be noted that the delivery tube 21 can not only pressurize the balloon 22 to make the balloon 22 expand, but also meet the pressure relief needs of the balloon 22. Specifically, when it is necessary to withdraw the balloon 22 and the delivery tube 21 proximally, the delivery tube 21 can be used to relieve the pressure of the balloon 22, so that the balloon 22 is in a contracted state, so that the balloon 22 can be withdrawn from the perforation 12a of the proximal connector 12 along with the delivery tube 21 from the occluder 10. As Figure 9 As shown, after the occluder 10 is firmly connected to the left atrial appendage, the delivery device 20 can be withdrawn from the left atrial appendage. At this time, the occluder 10 is always adhesively fixed in the left atrial appendage, achieving a stable occlusion effect.

[0057] In some embodiments, the push tube 21 is a single-lumen catheter, that is, the push tube 21 has only one lumen, and this lumen is in communication with the balloon 22. At this time, the lumen of the push tube 21 can meet the need to inject the medium into the balloon 22 and also meet the need to release the medium in the balloon 22. That is to say, when the push tube 21 is a single-lumen catheter, the lumen of the push tube 21 forms a channel for the medium to enter and exit the balloon 22.

[0058] In other embodiments, the push tube 21 is a double-lumen catheter, that is, the push tube 21 has two lumens. By using the communication of these two lumens with the balloon 22, one lumen is used to inject the medium into the balloon 22 to cause the balloon 22 assembly to expand, and the other lumen is used to release the medium in the balloon 22, so that the balloon 22 returns to the contracted state.

[0059] In addition, in other embodiments, when the push tube 21 has two lumens, both lumens can be used to supply the medium to the balloon 22 and release the medium in the balloon 22 when the balloon 22 needs to be depressurized. In this way, the expansion or contraction efficiency of the balloon 22 is relatively fast, and the operation time can be shortened.

[0060] It should be noted that in some embodiments, the push tube 21 can not only meet the need to pressurize or depressurize the balloon 22, but also meet the need for the delivery of the second liquid. That is to say, after using the push tube 21 to inject the medium into the balloon 22 so that the balloon 22 presses the outer surface of the main body 11 against the inner wall of the left atrial appendage, the push tube 21 can also be used to inject the second liquid into the place where the main body 11 is in contact with the inner wall of the left atrial appendage, so that the second liquid and the first sealant combine to generate an adhesive force to stably fix the occluder 10 to the left atrial appendage.

[0061] Combined with Figure 1 As shown, in some embodiments, the push tube 21 has a pressurization channel 21a that is not in communication with the liquid injection channel 21b. The pressurization channel 21a is used to pressurize or depressurize the balloon 22. The balloon 22 includes an inner layer 221 and an outer layer 222. The outer layer 222 is sleeved outside the inner layer 221. The inner layer 221 forms a filling cavity 2211, and the filling cavity 2211 is in communication with the pressurization channel 21a. A liquid injection cavity 2221 is formed between the outer layer 222 and the inner layer 221, and the liquid injection cavity 2221 is in communication with the liquid injection channel 21b. The outer layer 222 is provided with liquid dispersion holes 222a.

[0062] Combined with Figure 6 As shown, when the pressurization channel 21a pressurizes the filling cavity 2211, the inner layer 221 gradually expands so that the balloon 22 is in a filled state. Combined with Figure 8As shown, the outer layer 222 expands with the inner layer 221 and positions the liquid dispersion holes 222a opposite to the position of the main body 11 coated with the first sealant. When the second liquid is injected into the liquid injection cavity 2221 through the liquid injection channel 21b, the second liquid in the liquid injection cavity 2221 can flow out through the liquid dispersion holes 222a. In this way, the second liquid combines with the first sealant to generate an adhesive force.

[0063] In some embodiments, the number of the liquid dispersion holes 222a is 100 to 300, and the diameter of the liquid dispersion holes 222a is 5 μm to 30 μm. In this way, there are enough and small enough liquid dispersion holes 222a to facilitate the uniform release of the second liquid to the position where the outer surface of the main body 11 is in contact with the inner wall of the left atrial appendage, enabling the first sealant to combine with the second liquid to generate an adhesive force, thereby firmly connecting the occluder 10 to the inner wall of the left atrial appendage, reducing the possibility of the occluder 10 falling off from the left atrial appendage, and maintaining a good occlusion effect.

[0064] The outer layer 222 of the balloon 22 is made of a non-compliant material, so its expansion is also restricted by the structure of the non-compliant material, avoiding excessive expansion. In this way, when the outer layer 222 expands to contact the inner wall of the left atrial appendage, the process of injecting the second liquid will not cause the outer layer 222 to continue to expand, so that the second liquid can enter the position where the outer surface of the main body 11 is in contact with the inner wall of the left atrial appendage through the liquid dispersion holes 222a, improving the reaction efficiency of the second liquid and the first sealant, and realizing the stable connection between the occluder 10 and the inner wall of the left atrial appendage.

[0065] Refer again to Figure 1 As shown, the push tube 21 is a double-lumen tube with an inner and outer nesting structure. Specifically, the push tube 21 includes an inner tube 211 and an outer tube 212 sleeved outside the inner tube 211. The outer wall of the inner tube 211 and the inner wall of the outer tube 212 enclose a pressurization channel 21a. At this time, the pressurization channel 21a is an annular channel, that is, the cross-section of the pressurization channel 21a is annular.

[0066] In some other embodiments, the pressurization channel 21a may not be an annular channel. For example, the pressurization channel 21a and the liquid injection channel 21b are arranged side by side in the radial direction of the push tube 21 and extend along the axial direction of the push tube 21. In this way, the push tube 21 can still provide a non-communicating pressurization channel 21a and liquid injection channel 21b.

[0067] In the embodiment where the push tube 21 includes an inner tube 211 and an outer tube 212 with an inner and outer nesting structure, the inner wall of the inner tube 211 encloses a liquid injection channel 21b. The inner tube 211 is provided with a first hole 213a, and the first hole 213a connects the liquid injection channel 21b with the liquid injection cavity 2221, so as to output the second liquid from the first hole 213 through the liquid injection channel 21b to the liquid injection channel 21b of the balloon 22.

[0068] Refer toFigure 1 As shown, in some embodiments, a tip 213 is connected to the distal end of the inner tube 211. The tip 213 can be integrally formed with the inner tube 211 or separately provided from the inner tube 211 and connected by connection means such as threading or welding.

[0069] In this embodiment, the distal end of the inner tube 211 is connected to the distal connector 13 through the tip 213. The tip 213 is connected to the distal end of the outer tube 212 and blocks the pressurization channel 21a. The first hole 213a can be formed on the tip 213.

[0070] Adopting this structural arrangement is beneficial to the processing and manufacturing of the push tube 21. Only by using the tip 213 as a carrier and installing the inner tube 211 and the outer tube 212 on the tip 213, the inner tube 211 and the outer tube 212 are sleeved with each other to form the corresponding liquid injection channel 21b and pressurization channel 21a.

[0071] There are multiple first holes 213a, and the multiple first holes 213a are evenly arranged around the circumference of the push tube 21. Thus, the second liquid in the liquid injection cavity 2221 can flow out evenly through the multiple first holes 213a to the position where the main body 11 contacts the inner wall of the left atrial appendage, so that the second liquid can quickly combine with the first sealant to generate an adhesive force, improve the bonding efficiency between the occluder 10 and the inner wall of the left atrial appendage, reduce the surgical operation time, and improve the surgical safety.

[0072] The outer tube 212 is provided with a second hole 212a, and the second hole 212a communicates the pressurization channel 21a with the inflation cavity 2211 surrounded by the inner layer 221 of the balloon 22.

[0073] There are multiple second holes 212a, and the multiple second holes 212a are evenly arranged along the circumference of the outer tube 212. Thus, when the pressurization channel 21a pressurizes the inner layer 221 of the balloon 22, the inner layer 221 of the balloon 22 has a consistent inflation effect in the circumferential direction around the push tube 21, that is, the balloon 22 inflates evenly in the circumferential direction, so as to drive the occluder 10 to expand evenly in the radial direction, so that the occluder 10 can be quickly adjusted to completely fit the inner wall of the left atrial appendage. Specifically, if one side of the balloon 22 inflates too fast and the other side inflates too slow, it is difficult for the balloon 22 to stably drive the occluder 10 to expand synchronously in each radial direction, resulting in a situation where one side of the occluder 10 is overly close to the inner wall of the left atrial appendage while the other side is not in contact. In this case, it takes a long time to wait for the balloon to gradually stabilize before the occluder 10 can be expanded to make the circumference of the main body 11 completely fit the inner wall of the left atrial appendage. In this embodiment, by evenly pressurizing the inner layer 221 of the balloon 22, the balloon 22 can drive the occluder 10 to expand synchronously in each radial direction and quickly fit the inner wall of the left atrial appendage, so as to solve the operation time and improve the surgical efficiency.

[0074] It should be noted that the balloon 22 can also be a single-layer sac structure, that is, the balloon 22 is only provided with an inner layer 221 or only provided with an outer layer 222. Correspondingly, the balloon 22 retains the liquid-dispersing holes that connect the inside and the outer wall of the balloon 22. That is to say, the balloon 22 includes at least one liquid-dispersing hole, and the structure of the liquid-dispersing hole can refer to the liquid-dispersing hole 222a provided on the outer layer 222, which will not be elaborated here. In this embodiment, the balloon 22 is sleeved on the outer wall of the push tube 21 so that the balloon 22 is communicated with the liquid injection channel 21b of the push tube 21. As long as the second liquid input into the balloon 22 from the liquid injection channel 21b of the push tube 21 can flow out from the liquid-dispersing hole, so that the second liquid combines with the first sealant to generate an adhesive force, and the occluder 10 can be fixed to the predetermined area.

[0075] Correspondingly, in this embodiment, the push tube 21 can be a single-chamber tube, that is, only has an inner tube 211. Correspondingly, through the first hole 213a on the inner tube 211, it can meet the requirement of outputting the second liquid in the inner tube 211 to the balloon 22 sleeved on the outer wall of the push tube 21. Then the second liquid flows out from the liquid-dispersing hole of the balloon 22 to the position where the outer surface of the main body 11 is in contact with the inner wall of the left atrial appendage. Under the action of the adhesive force generated by the combination of the second liquid and the first sealant, the occluder 10 is firmly connected to the inner wall of the left atrial appendage.

[0076] Refer to again Figure 1 and Figure 2 As shown, a sealing flap 14 is connected to the proximal side of the proximal connector 12, and the sealing flap 14 can move relative to the proximal connector 12 to a closed state and an open state. In the closed state, the sealing flap 14 blocks the perforation 12a. Exactly speaking, after the push tube 21 is withdrawn from the occluder 10, the sealing flap 14 closes to block the perforation 12a. Correspondingly, after the push tube 21 penetrates into the occluder 10 through the perforation 12a, the sealing flap 14 is in an open state.

[0077] Since the sealing flap 14 can move relative to the proximal connector 12 to a closed state and an open state, the perforation 12a on the proximal connector 12 can be selectively blocked. In this way, in the open state, since the sealing flap 14 releases the block of the perforation 12a, at this time, the push tube 21 sleeved with the balloon 22 can pass through the perforation 12a and enter the space enclosed by the main body 11, so that when the balloon 22 expands, it can drive the main body 11 to expand, and then ensure that the main body 11 can fit to the inner wall of the left atrial appendage. In this way, the firm connection between the occluder 10 and the left atrial appendage can be achieved by using the adhesive force generated after the activation of the first sealant, so as to reduce the risk that the occluder 10 is easily detached from the left atrial appendage due to insufficient supporting force, and effectively improve the stable occlusion effect of the occluder 10 at the left atrial appendage.

[0078] Accordingly, after the occluder 10 is firmly connected to the left atrial appendage, when the balloon 22 needs to be withdrawn, with the sealing flap 14 in the open state, the balloon 22 can be smoothly withdrawn along with the delivery catheter 21. After the balloon 22 is withdrawn, the perforation 12a can be blocked by the sealing flap 14 to ensure the overall sealing performance of the occluder 10, so as to maintain a good occlusion effect in the left atrial appendage.

[0079] Combined with Figure 3 and Figure 4 As shown, the sealing flap 14 includes a hollow tubular body 14a and a plurality of valve leaves 14b. The valve leaves 14b are conical when the sealing flap 14 is closed. Combined with Figure 2 As shown, by using the conical structure presented by the plurality of valve leaves 14b when the sealing flap 14 is closed to cover the proximal end of the proximal connector 12, the purpose of blocking the perforation 12a on the proximal connector 12 can be achieved.

[0080] In some embodiments, the hollow tubular body 14a can be sleeved on the proximal connector 12, or can be connected to the proximal connector 12 by means of welding, threaded connection or glue bonding, etc., to fixedly connect the sealing flap 14 to the proximal connector 12. For the structure of the sealing flap 14 and its connection with the proximal connector 12, there can also be other situations, which are not limited herein.

[0081] The number of the valve leaves 14b of the sealing flap 14 can be configured as needed. For example, the number of the valve leaves 14b of the sealing flap 14 can be 2 or more than 2.

[0082] In some embodiments, combined with Figure 3 and Figure 4 As shown, the number of the valve leaves 14b of the sealing flap 14 is 3. In this way, the 3 valve leaves 14b can block or release the blockage of the perforation 12a through the opening and closing form.

[0083] In other embodiments, the valve leaves 14b of the sealing flap 14 are rotatably connected to the hollow tubular body 14a and are connected to the proximal connector 12 through the hollow tubular body 14a. After the occluder 10 is implanted into the left atrial appendage, the impact force of the blood flow is used to force the sealing flap 14 to rotate relative to the proximal connector 12 to the closed state.

[0084] In other embodiments, the sealing flap 14 is made of an elastic material, more specifically, the sealing flap 14 is made of a shape memory alloy material, such as a nickel-titanium alloy material or a cobalt-chromium alloy material. The sealing flap 14 made of a shape memory alloy material has a shape memory function, so that it can automatically return to its original shape when not subjected to external force. In this embodiment, when the sealing flap 14 is not subjected to external force, its leaflets 14b have a tendency to move toward a closed state relative to the proximal connector 12, so that when it is necessary to pass the push tube 21 through the perforation 12a, it is sufficient to push aside the leaflets 14b of the sealing flap 14 to release the blockage of the perforation 12a. After the push tube 21 is withdrawn from the occluder 10, the leaflets 14b of the sealing flap 14 can re-block the perforation 12a to ensure the overall sealing performance of the occluder 10.

[0085] The sealing flap 14 can be integrally formed with the proximal connector 12, so that the connection structure between the two can be omitted, which is conducive to the miniaturization of the occluder 10. The integrally formed structure has good stability and the sealing flap 14 is not likely to fall off from the proximal connector 12 and cause surgical risks.

[0086] In some embodiments, the sealing flap 14 and the proximal connector 12 are cut from a tube. This processing technology is simple and efficient, and the sealing flap 14 and the proximal connector 12 have good stability and are not prone to falling off.

[0087] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0088] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A medical device, characterized in that, It includes a occluder and a delivery device. The occluder includes a main body, a proximal connector and a distal connector connected to both ends of the main body. Among them, the proximal connector is provided with a perforation for the push tube of the delivery device to pass through. The distal end of the push tube is combined with the distal connector. The outer surface of the main body is coated with a first sealant. The push tube includes an injection channel for passing a second liquid. The second liquid combines with the first sealant to generate an adhesive force to fix the occluder to a predetermined area. The delivery device further includes a balloon sleeved on the outer wall of the push tube. The balloon includes at least one liquid-dispersing hole and is communicated with the injection channel. The delivery device further includes a delivery sheath. The occluder and the push tube are accommodated in the delivery sheath.

2. The medical device according to claim 1, wherein, The main body, the proximal connector and the distal connector are all made of biodegradable materials.

3. The medical device according to claim 1, wherein The first sealant includes pentaerythritol polyethylene glycol ether tetra-succinimide glutaric acid and pentaerythritol polyethylene glycol ether tetra-thiol. The second liquid includes sodium dihydrogen phosphate and sodium carbonate; or, the first sealant is bovine serum albumin or human serum albumin, and the second liquid is glutaraldehyde or polyethylene glycol or paraformaldehyde.

4. The medical device according to claim 1, wherein The proximal connector includes a sealing flap that closes after the push tube is withdrawn from the occluder.

5. The medical device according to claim 1, characterized in that, The distal end of the push tube is threadedly connected, clamped or snap-connected to the distal connector.

6. The medical device according to claim 1, wherein The number of the liquid-dispersing holes is 100 to 300, and the diameter of the liquid-dispersing holes is 5μm to 30μm.

7. The medical device according to claim 1, wherein, The balloon includes an inner layer and an outer layer. The liquid-dispersing holes are located in the outer layer. The inner layer is communicated with the pressurization channel of the push tube, and the outer layer is communicated with the injection channel.

8. The medical device according to claim 1, characterized in that, The push tube includes an inner tube and an outer tube sleeved outside the inner tube. The inner wall of the inner tube encloses to form the injection channel. The inner tube is provided with a first hole that communicates with the injection channel. A pressurization channel is formed between the outer wall of the inner tube and the inner wall of the outer tube. The outer tube is provided with a second hole that communicates with the pressurization channel.

9. The medical device according to claim 1, characterized in that, One side of the distal connector in contact with the distal end of the push tube has a depression, and the distal end of the push tube can be accommodated in the depression.

10. The medical device according to claim 1, wherein The main body includes a stent rod and / or a filter membrane on the outer surface of the stent rod. The first sealant is applied on the outer surface of the stent rod or the filter membrane.

11. The medical device according to claim 4, wherein, The sealing flap is made of a shape memory alloy material and includes a hollow tubular body and a plurality of valve leaves. The valve leaves are conical when the sealing flap is closed.

12. The medical device according to claim 1, wherein, The distal connector includes a receiving cavity, and the distal end of the push tube is located in the receiving cavity.

13. The medical device according to claim 5, wherein, The outer layer of the balloon is made of non-compliant material.

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