Coronary sinus constriction device and coronary sinus constriction system

Abstract

The present invention provides a coronary sinus constriction device and a coronary sinus constriction system. The coronary sinus constriction device includes: a tubular body that extends axially to form a lumen channel for blood to flow through. The tubular body includes a support section and a diameter-reducing section that are sequentially connected. The inner diameter of the support section is greater than the inner diameter of the diameter-reducing section; a flow-blocking member that has an axial through-flow channel. The inner diameter of the first end of the flow-blocking member is less than the inner diameter of the second end of the flow-blocking member, and the inner diameter of the flow-blocking member gradually decreases from the second end to the first end of the flow-blocking member. The second end of the flow-blocking member is connected to the end or inner wall of the tubular body. The inner diameter of the first end of the flow-blocking member is less than the inner diameter of the diameter-reducing section. The flow-blocking member is made of a biodegradable material. The present invention solves the problem of poor immediate effect after implantation of the coronary sinus constriction device in the prior art.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly, to a coronary sinus constriction device and a coronary sinus constriction system. Background Art

[0002] Angina pectoris is a clinical syndrome mainly manifested by paroxysmal chest pain or chest discomfort caused by insufficient blood supply to the coronary arteries, acute temporary ischemia and hypoxia of the myocardium. Angina pectoris is the pain felt on the body surface due to myocardial ischemia. It is characterized by paroxysmal and compressive pain in the front chest, which may be accompanied by other symptoms. The pain is mainly located in the posterior part of the sternum and can radiate to the precordial area and the left upper limb. The direct cause of angina pectoris is insufficient myocardial blood supply, which is usually a symptom of coronary artery disease.

[0003] Among all patients with angina pectoris, it is estimated that about 10% have severe, persistent symptoms that cannot be controlled by traditional medical therapies. This severe and debilitating condition is called refractory angina. The coronary sinus constriction device is considered a highly promising solution for treating refractory angina. Its principle of action is as follows: An interventional access is established through minimally invasive surgery. The coronary sinus constriction device is delivered through the right atrium to the implantation site of the coronary sinus through the access, constricts the inner diameter of the coronary sinus, establishes a trans-sinus pressure gradient, increases the back pressure, improves the ratio of epicardial and subendocardial blood perfusion, and increases the flow of oxygen-rich blood to the areas of the heart where the blood flow was abnormal before, thereby achieving the purpose of relieving myocardial ischemia.

[0004] Since the coronary sinus constriction devices in the prior art are generally of a bare metal stent structure, the obstruction effect on blood flow after implantation is limited. A significant trans-sinus pressure difference can only be generated after the device is endothelialized, which usually takes several weeks or even months, that is, the immediate effect of the bare stent structure treatment is relatively poor. Of course, to solve the above problems, a flow-blocking membrane can be coated on the surface of the stent to enhance the immediate effect of the treatment. However, the existing flow-blocking membranes are all attached to the inner surface or the outer surface of the coronary sinus constriction device, and the following problems usually exist: (1) The coronary sinus constriction device is generally of a special-shaped structure like a hourglass, and it is difficult to coat the special-shaped structure with a membrane; (2) Coating the flow-blocking membrane on the surface of the metal stent will increase the outer diameter of the device after contraction, thereby increasing the difficulty of sheath retraction and pushing of the device, and may reduce the compliance of the device, thereby further increasing the pushing difficulty; (3) Compared with the direct contact between the bare metal and the vascular tissue, coating the membrane may cause a greater inflammatory reaction.

[0005] As can be seen from the above, there is a problem that the immediate effect after implantation of the coronary sinus constriction device in the prior art is poor. Summary of the Invention

[0006] The main object of the present invention is to provide a coronary sinus constriction device and a coronary sinus constriction system to solve the problem of poor immediate effect after implantation of the coronary sinus constriction device in the prior art.

[0007] To achieve the above object, according to one aspect of the present invention, there is provided a coronary sinus constriction device, including: a tubular body that extends axially to form a lumen channel for blood to flow through, the tubular body includes a support section and a diameter-reducing section connected in sequence, and the inner diameter of the support section is greater than the inner diameter of the diameter-reducing section; a flow-blocking member that has a flow-through channel extending axially, the inner diameter of the first end of the flow-blocking member is smaller than the inner diameter of the second end of the flow-blocking member, and the inner diameter of the flow-blocking member gradually decreases from the second end to the first end of the flow-blocking member, the second end of the flow-blocking member is connected to the end or inner wall of the tubular body, the inner diameter of the first end of the flow-blocking member is smaller than the inner diameter of the diameter-reducing section, and the flow-blocking member is made of a biodegradable material.

[0008] Further, the support section includes a first support section and a second support section, and the diameter-reducing section is located between the first support section and the second support section.

[0009] Further, the second end of the flow-blocking member is connected to the end of the second support section away from the diameter-reducing section.

[0010] Further, the flow-blocking member includes a first flow-blocking member and a second flow-blocking member, and the inner diameter of the first end of the first flow-blocking member is greater than the inner diameter of the first end of the second flow-blocking member.

[0011] Further, the second ends of both the first flow-blocking member and the second flow-blocking member are connected to the end of the second support section away from the diameter-reducing section, and the second flow-blocking member is located inside the first flow-blocking member.

[0012] Further, the flow-blocking member includes a first flow-blocking member and a second flow-blocking member, the second end of the first flow-blocking member is connected to the end of the first support section away from the diameter-reducing section, and the second end of the second flow-blocking member is connected to the end of the second support section away from the diameter-reducing section.

[0013] Further, the degradation rate of the second flow-blocking member is greater than the degradation rate of the first flow-blocking member.

[0014] Further, the diameter-reducing section is located downstream of the support section in the blood flow direction, and the second end of the flow-blocking member is connected to the end of the support section.

[0015] Further, a collection wire for collecting the undegraded flow-blocking member is provided on the inner wall of the flow-blocking member, one end of the collection wire extends out of the flow-blocking member and is connected to the tubular body, there are a plurality of collection wires, and the plurality of collection wires are arranged at intervals along the circumferential direction of the flow-blocking member.

[0016] Further, the collection wire is made of a biodegradable material or a non-biodegradable material, and when the collection wire is made of a biodegradable material, the degradation rate of the collection wire is less than the degradation rate of the flow-blocking member.

[0017] Further, the tubular body is a porous structure woven from wire materials or cut from metal pipes.

[0018] Further, the support section and the reduced-diameter section are made of different materials.

[0019] Further, the support section is a porous structure woven from wire materials or cut from metal pipes, and the reduced-diameter section is made of non-degradable polymers or biological tissues.

[0020] Further, the inner diameter of the support section is 8 mm to 20 mm; and / or the inner diameter of the reduced-diameter section is 2 mm to 5 mm; and / or the inner diameter of the first end of the flow blocker is 1 mm to 3 mm.

[0021] Further, the surface of the flow blocker is coated with an anti-endothelialization drug layer.

[0022] According to another aspect of the present invention, there is provided a coronary sinus constriction system, including a delivery assembly and the above-mentioned coronary sinus constriction device, and the coronary sinus constriction device and the delivery assembly are detachably connected.

[0023] Applying the technical solution of the present invention, the coronary sinus constriction device includes a tubular body and a flow blocker. The tubular body extends axially to form a lumen channel for blood to flow through. The tubular body includes a support section and a reduced-diameter section connected in sequence. The inner diameter of the support section is larger than that of the reduced-diameter section. The flow blocker has an axially extending flow-through channel. The inner diameter of the first end of the flow blocker is smaller than that of the second end of the flow blocker, and the inner diameter of the flow blocker gradually decreases from the second end to the first end of the flow blocker. The second end of the flow blocker is connected to the end or inner wall of the tubular body. The inner diameter of the first end of the flow blocker is smaller than that of the reduced-diameter section. The flow blocker is made of a biodegradable material. Thus, when the coronary sinus constriction device is implanted, due to the presence of the flow blocker and the inner diameter of the first end of the flow blocker being smaller than that of the reduced-diameter section, the flow blocker plays a major flow-blocking role in the initial stage of implantation, and a large trans-sinus pressure difference is generated immediately upon implantation, achieving the expected therapeutic effect, thereby effectively increasing the immediate effect after the implantation of the coronary sinus constriction device and solving the problem of poor immediate effect after the implantation of the coronary sinus constriction device in the prior art. Further, when the flow blocker degrades, the reduced-diameter section becomes the main flow-blocking part, thereby realizing the automatic adjustment of the trans-sinus pressure difference and realizing the stepwise change of the blood flow regulation effect of the coronary sinus constriction device, so that the treatment changes from being significantly effective at the beginning to gradually stabilizing finally, so that the coronary sinus constriction device can be effective for more patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The specification drawings forming a part of this application are used to provide a further understanding of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0025] Figure 1 shows a schematic structural view of the coronary sinus constriction device in the first embodiment of the present invention;

[0026] Figure 2 shows a schematic structural view of the coronary sinus constriction device in the second embodiment of the present invention;

[0027] Figure 3 shows a schematic structural view of the coronary sinus constriction device in the third embodiment of the present invention;

[0028] Figure 4 shows a schematic structural view of the coronary sinus constriction device in the fourth embodiment of the present invention;

[0029] Figure 5 shows a schematic structural view of the coronary sinus constriction device in the fifth embodiment of the present invention;

[0030] Figure 6 shows a schematic structural view of the flow blocking member in a specific embodiment of the present invention. Detailed implementation manners

[0031] It should be noted that, without conflict, the embodiments in this application and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the drawings and in combination with the embodiments.

[0032] It should be pointed out that unless otherwise specified, all technical and scientific terms used in this application have the same meanings as those commonly understood by those of ordinary skill in the technical field to which this application belongs.

[0033] In the present invention, unless otherwise stated, the orientation words such as "upper, lower, top, bottom" are usually in the directions shown in the drawings, or in the vertical, perpendicular or gravitational directions of the components themselves; similarly, for ease of understanding and description, "inner, outer" refer to the inner and outer of the contours of the components themselves, but the above orientation words are not used to limit the present invention.

[0034] Obviously, the above-described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present invention without creative efforts should fall within the protection scope of the present invention.

[0035] To solve the problem that the immediate effect after implantation of the coronary sinus constriction device in the prior art is poor, the present invention provides a coronary sinus constriction device and a coronary sinus constriction system. Among them, the following coronary sinus constriction device includes the following coronary sinus constriction device.

[0036] An embodiment of the present application provides a coronary sinus constriction device, which includes a tubular body and a flow blocking member. The tubular body extends axially to form a lumen channel for blood to flow through. The tubular body includes a support section and a diameter-reducing section connected in sequence. The inner diameter of the support section is greater than the inner diameter of the diameter-reducing section. The flow blocking member has a flow-through channel extending axially. The inner diameter of the first end of the flow blocking member is smaller than the inner diameter of the second end of the flow blocking member, and the inner diameter of the flow blocking member gradually decreases from the second end to the first end of the flow blocking member. The second end of the flow blocking member is connected to the end or inner wall of the tubular body. The inner diameter of the first end of the flow blocking member is smaller than the inner diameter of the diameter-reducing section. The flow blocking member is made of a biodegradable material.

[0037] When the coronary sinus constriction device of the present application is implanted, due to the presence of the flow blocking member and the inner diameter of the first end of the flow blocking member being smaller than the inner diameter of the diameter-reducing section, the flow blocking member plays a main flow blocking role in the initial stage of implantation, and a large cross-sinus pressure difference is generated immediately after implantation, achieving the expected therapeutic effect. Therefore, it can effectively increase the immediate effect after the implantation of the coronary sinus constriction device, and solves the problem of poor immediate effect after the implantation of the coronary sinus constriction device in the prior art. Further, when the flow blocking member degrades, the diameter-reducing section becomes the main flow blocking part, thereby realizing the automatic adjustment of the cross-sinus pressure difference, and realizing the stepwise change of the blood flow regulation effect of the coronary sinus constriction device, so that the treatment changes from significantly effective at the beginning to gradually stable finally, so that the coronary sinus constriction device can be effective for more patients.

[0038] In this embodiment, the flow blocking member is a trumpet-shaped structure formed by a sheet or a film. Specifically, the diameter of the second end of the flow blocking member is adapted to the caliber of the connection with the tubular body. That is to say, the flow blocking member is only connected to the tubular body through the end edge of the second end, and the first end extends axially without any restraint. Therefore, under the impact of blood flow, the flow blocking member will float in the blood without contacting the blood vessel wall. Therefore, it can greatly reduce the difficulty of covering the flow blocking member and will not cause an inflammatory reaction. Further, since the flow blocking member does not exert any restraint on the tubular body, it will not affect the compliance of the coronary sinus constriction device, that is, it will not affect the difficulty of sheath retraction and pushing of the coronary sinus constriction device.

[0039] Further, in this embodiment, the second end of the flow blocking member is connected to the end of the support section. Specifically, the connection method between the flow blocking member and the support section includes suture, bonding or welding, etc., and suture is preferred.

[0040] In this embodiment, the flow blocking member is made of polylactic acid (PLA) material, which is impermeable to blood. Therefore, under the blockage of the flow blocking member, blood will flow into the flow-through channel from the second end of the flow blocking member and then flow out from the first end of the flow blocking member. That is to say, the inner diameter of the flow blocking member gradually decreases along the blood flow direction, so it has a throttling and regulating effect. Of course, the flow blocking member can also be made of other biodegradable materials, which can be selected according to actual needs.

[0041] In this embodiment, the support section can be one or two. Further, the flow blocker can also be one or two, which can be selected according to actual needs.

[0042] In this embodiment, the tubular body is a porous structure woven from metal wire or cut from a metal tube. The design of the porous structure enables the coronary sinus constriction device to contract and expand, and has good compliance, facilitating the delivery of the coronary sinus constriction device. Specifically, the material of the tubular body is nitinol, that is, woven from nitinol wire or cut from nitinol tubing. Of course, the metal wire can also be other biocompatible medical shape memory metal materials harmless to the human body, with excellent biocompatibility, and has good safety even after long-term implantation in the human body, achieving the treatment purpose without causing inconvenience to the patient's daily life such as passing through security checks and general medical examinations. Further, when the tubular body is cut from a metal tube, the metal material can also be stainless steel, which can be selected according to actual needs.

[0043] It should be noted that if the tubular body is woven from nitinol wire or cut from nitinol tubing, the coronary sinus constriction device will automatically expand after being delivered to the target position. If it is cut from a stainless steel tube, the coronary sinus constriction device needs to be expanded by a balloon.

[0044] In an alternative embodiment, the support section and the diameter-reducing section are made of different materials. Among them, the support section is a porous structure woven from metal wire or cut from a metal tube, and the specific setting method is the same as the overall tubular body described above, which will not be elaborated here. The diameter-reducing section is made of a non-degradable polymer or biological tissue. Specifically, the polymer is made of PTFE, EPTFE or PET, and the biological tissue can be bovine or porcine tissue. Of course, if you want the coronary sinus constriction device to function permanently, the diameter-reducing section needs to be made of non-degradable materials.

[0045] Further, in this embodiment, the support section and the diameter-reducing section can be connected by suture or bonding or welding.

[0046] In this embodiment, the inner diameter of the support section is 8 mm to 20 mm. The inner diameter of the diameter-reducing section is 2 mm to 5 mm. The inner diameter of the first end of the flow blocker is 1 mm to 3 mm.

[0047] In this embodiment, the surface of the flow blocker is coated with an anti-endothelialization drug layer. Through the above setting, the possibility of endothelialization on the flow blocker can be reduced, and the formation of thrombus can be reduced. Specifically, the anti-endothelialization drug layer can be an anticoagulant drug such as heparin or phosphorylcholine, etc., which can be selected according to actual needs.

[0048] The following specifically elaborates on different setting methods of the tubular body and the flow blocking member through specific embodiments.

[0049] Embodiment 1

[0050] As Figure 1 shown, this embodiment provides a coronary sinus constriction device 10, including a tubular body 100 and a flow blocking member 104. The tubular body 100 extends axially to form a lumen channel 1000 for blood to flow through. There are two support segments in this embodiment, namely the first support segment 101 and the second support segment 103. The diameter-reducing segment 102 is located between the first support segment 101 and the second support segment 103, that is, the first support segment 101, the diameter-reducing segment 102, and the second support segment 103 are connected in sequence.

[0051] Furthermore, if the blood vessel is conical, the inner diameter of the first support segment 101 is different from that of the second support segment 103. Specifically, in this embodiment, as Figure 1 shown, the inner diameter of the first support segment 101 is greater than that of the second support segment 103 to better adapt to the shape of the blood vessel. When the blood vessel is cylindrical, the inner diameter of the first support segment 101 can be the same as that of the second support segment 103, depending on the specific situation.

[0052] It can be understood that the first support segment 101 is the downstream support segment and the second support segment 103 is the upstream support segment. Since the diameter of the coronary sinus is not uniform along the length direction and is usually a conical structure that gradually tapers from the sinus ostium to the upstream end, in order to make the forces on the coronary sinus constriction device consistent after implantation, the inner diameters of the first support segment 101 and the second support segment 103 can be designed differently, that is, the inner diameter of the second support segment 103 is smaller than that of the first support segment 101. Specifically, in this embodiment, the inner diameter of the second support segment 103 is 3 mm to 5 mm smaller than that of the first support segment 101.

[0053] In this embodiment, the second end of the flow blocking member 104 is connected to the end of the second support segment 103 away from the diameter-reducing segment 102. That is to say, the flow blocking member 104 is located within the second support segment 103. Specifically, the inner diameter of the second end of the flow blocking member 104 is the same as the inner diameter of the end of the second support segment 103 away from the diameter-reducing segment 102.

[0054] As Figure 1 shown, the flow blocking member 104 has a flow-through channel 1041 extending axially, and has a first end 1042 and a second end 1043. The inner diameter of the first end 1042 is smaller than that of the second end 1043 and smaller than the inner diameter of the diameter-reducing segment 102. The diameter of the second end 1043 is the same as the inner diameter of the second support segment 103 and is fixed to the upstream end of the second support segment 103.

[0055] Embodiment 2

[0056] As Figure 2 shown, in this embodiment, a coronary sinus constriction device 20 is provided, which includes a tubular body 200 and a flow blocking member 204. There are two support segments in this embodiment, namely a first support segment 201 and a second support segment 203. The diameter-reducing segment 202 is located between the first support segment 201 and the second support segment 203, that is, the first support segment 201, the diameter-reducing segment 202 and the second support segment 203 are connected in sequence. Further, there are also two flow blocking members, namely a first flow blocking member 204 and a second flow blocking member 205. The first flow blocking member 204 has a first end 2041 and a second end 2042, and the second flow blocking member 205 has a first end 2051 and a second end 2052. Among them, the inner diameter of the first end 2041 of the first flow blocking member 204 is greater than the inner diameter of the first end 2051 of the second flow blocking member 205. The second end 2042 of the first flow blocking member 204 and the second end 2052 of the second flow blocking member 205 are both connected to one end of the second support segment 203 away from the diameter-reducing segment 202, and the second flow blocking member 205 is located inside the first flow blocking member 204. That is to say, the first flow blocking member 204 and the second flow blocking member 205 are arranged in an inner and outer nested manner, and both are located inside the second support segment 203.

[0057] Specifically, in this embodiment, the inner diameter of the first end 2051 of the second flow blocking member 205 is 1 mm, the inner diameter of the first end 2041 of the first flow blocking member 204 is 2 mm, and the inner diameter of the diameter-reducing segment 202 is 3 mm.

[0058] In this embodiment, the inner diameters of the second end 2042 of the first flow blocking member 204 and the second end 2052 of the second flow blocking member 205 are the same as the inner diameter of one end of the second support segment 203 away from the diameter-reducing segment 202.

[0059] In this embodiment, the degradation rate of the second flow blocking member 205 is greater than the degradation rate of the first flow blocking member 204.

[0060] In this embodiment, at the beginning of implantation, since the second flow blocker 205 is located at the most upstream and has the smallest inner diameter, the second flow blocker 205 plays a major role and has a relatively strong regulatory effect on blood flow. After the second flow blocker 205 degrades, the first flow blocker 204 begins to play a major role. Since the inner diameter of the first end 2041 of the first flow blocker 204 is larger than that of the first end 2051 of the second flow blocker 205, the intensity of the regulatory effect of the coronary sinus constriction device on blood flow becomes slower. As the implantation time extends, both the first flow blocker 204 and the second flow blocker 205 are completely degraded, and finally the diameter-reducing section 202 takes effect. At this time, the regulatory effect of the coronary sinus constriction device on blood flow reaches a stable state and is maintained for a long time, thus realizing a stepped change in the regulatory effect of the coronary sinus constriction device on blood flow. In addition, it should be noted that the intensity of the regulatory effect of the coronary sinus constriction device on blood flow gradually becomes slower, indicating that the therapeutic effect will change from significantly effective to gradually stable.

[0061] Embodiment Three

[0062] As Figure 3 shown, this embodiment provides a coronary sinus constriction device 30, which includes a tubular body 300 and flow blockers 304. There are two support sections in this embodiment, namely the first support section 301 and the second support section 303. Further, there are also two flow blockers, namely the first flow blocker 304 and the second flow blocker 305. The first flow blocker 304 has a first end 3041 and a second end 3042, and the second flow blocker 305 has a first end 3051 and a second end 3052. Among them, the inner diameter of the first end 2041 of the first flow blocker 204 is larger than that of the first end 2051 of the second flow blocker 205. The second end 3042 of the first flow blocker 304 is connected to one end of the first support section 301 away from the diameter-reducing section 302, and the second end 3052 of the second flow blocker 305 is connected to one end of the second support section 303 away from the diameter-reducing section 302. That is to say, the first flow blocker 304 is located outside the tubular body 300, and the second flow blocker 305 is located inside the second support section 303.

[0063] It can be understood that the first flow blocker 304 and the second flow blocker 305 in this embodiment are respectively located at both ends of the tubular body 300. Through the above settings, the diameter of the coronary sinus constriction device after contraction can be effectively reduced, thus facilitating sheath withdrawal and pushing.

[0064] In this embodiment, the diameter of the second end 3042 of the first flow blocker 304 is the same as the diameter of one end of the first support section 301 away from the diameter-reducing section 302. Correspondingly, the diameter of the second end 3052 of the second flow blocker 305 is the same as the inner diameter of one end of the second support section 303 away from the diameter-reducing section 302.

[0065] Embodiment Four

[0066] AsFigure 4 As shown, this embodiment provides a coronary sinus constriction device 40, including a tubular body 400 and a flow blocking member 403. In this embodiment, there is one support section, namely the support section 401, and the diameter reduction section 402 is located downstream of the support section 401 along the blood flow direction. Further, there is also one flow blocking member, namely the flow blocking member 403. The flow blocking member 403 has a first end 4031 and a second end 4032, and the second end 4032 of the flow blocking member 403 is connected to one end of the support section 401 away from the diameter reduction section 402. That is to say, the flow blocking member 403 is located within the support section 401.

[0067] In this embodiment, the inner diameter of the second end 4032 of the flow blocking member 403 is the same as the inner diameter of one end of the support section 401 away from the diameter reduction section 402.

[0068] In this embodiment, by reducing the number of support sections, the amount of exogenous metal material can be effectively reduced, thereby reducing the release of toxic substances in the material, such as nickel ions.

[0069] In an alternative embodiment, two flow blocking members can be provided. The setting manner of the two flow blocking members is the same as that in Embodiments 2 and 3, which will not be elaborated here.

[0070] Embodiment 5

[0071] As Figure 5 As shown, this embodiment provides a coronary sinus constriction device 50, including a tubular body 500 and a flow blocking member 503. In this embodiment, there is one support section, namely the support section 501, and the diameter reduction section 502 is located downstream of the support section 501 along the blood flow direction. Further, there is also one flow blocking member, namely the flow blocking member 503. The flow blocking member 503 has a first end 5031 and a second end 5032, and the second end 5032 of the flow blocking member 503 is connected to one end of the support section 401 close to the diameter reduction section 502. That is to say, the flow blocking member 503 is located within the diameter reduction section 502.

[0072] In this embodiment, the inner diameter of the second end 5032 of the flow blocking member 503 is the same as the inner diameter of one end of the support section 501 close to the diameter reduction section 502.

[0073] As is well known, free foreign substances in blood vessels or the heart will increase the possibility of thrombus formation. The harm of thrombus formation in arterial blood is relatively large. Although the coronary sinus constriction device in this embodiment is in a venous blood environment and the harm is relatively low, in order to reduce the possibility of pulmonary artery embolism caused by the undegraded completely blocked wall floating in the blood, corresponding collection measures are adopted.

[0074] As Figure 6As shown, a collecting wire 601 for collecting the undegraded flow restrictor 60 is disposed on the inner wall of the flow restrictor 60. One end of the collecting wire 601 extends out of the flow restrictor 60 and is connected to the tubular body. Specifically, the first end of the collecting wire 601 is located inside the flow restrictor 60, and the second end 602 of the collecting wire 601 extends out of the flow restrictor 60 and is connected to the tubular body. Through the above arrangement, when the flow restrictor 60 degrades unevenly, the undegraded part will adhere to the collecting wire 601 and will not detach from the coronary sinus constriction device and float in the blood, thereby reducing the possibility of thrombus formation.

[0075] In this embodiment, there are a plurality of collecting wires 601, and the plurality of collecting wires 601 are arranged at intervals along the circumferential direction of the flow restrictor 60. Through the above arrangement, the undegraded part of the flow restrictor 60 can adhere to the collecting wire 601 as much as possible, reducing the occurrence of thrombus.

[0076] In this embodiment, the collecting wire 601 is made of a degradable material or a non-degradable material. Specifically, when the collecting wire 601 is made of a non-degradable material, when the flow restrictor 60 is completely degraded, the collecting wire 601 will float freely in the blood. However, since one end of it is fixed to the tubular body, it will not detach from the coronary sinus constriction device and float in the blood, nor will it have any impact on blood flow. When the collecting wire 601 is made of a degradable material, the degradation rate of the collecting wire 601 needs to be less than that of the flow restrictor 60. When the flow restrictor 60 is degraded, the collecting wire 601 begins to degrade. Since the collecting wire 601 is very thin, even if a part of it detaches from the coronary sinus constriction device and floats in the blood in the later stage of degradation, the possibility of thrombus formation is very low.

[0077] The present application also provides a coronary sinus constriction system, which includes a delivery assembly and the above-mentioned coronary sinus constriction device, and the coronary sinus constriction device and the delivery assembly are detachably connected.

[0078] Specifically, the delivery assembly includes a delivery steel cable and a delivery sheath. A connector is provided on the delivery steel cable, and the connector is detachably connected to the hanging tubular body. The coronary sinus constriction device is accommodated in the delivery sheath.

[0079] The usage process of the coronary sinus constriction system in this embodiment is as follows:

[0080] First, the coronary sinus constriction device is placed within the delivery sheath by connecting the delivery cable to the connecting member. In the stored state, the coronary sinus constriction device is completely accommodated within the delivery sheath and is squeezed into an elongated shape, thereby minimizing the size of the delivery sheath as much as possible and reducing vascular injury caused by establishing the delivery path. Then, the coronary sinus constriction device is moved to the target position. When switching from the stored state to the released state, the delivery sheath is gradually retracted so that one end of the coronary sinus constriction device extends out of the delivery sheath and gradually returns to the tubular body under the action of the metal memory property or the expansion of the balloon. After the coronary sinus constriction device returns to its original state, the connection between the delivery cable and the connecting member is released, causing the coronary sinus constriction device to separate from the delivery assembly and be supported and fixed at the target position. Subsequently, the delivery assembly is withdrawn from the patient's body to complete the entire release process.

[0081] Furthermore, before the coronary sinus constriction device is completely detached from the delivery sheath, if the position of the device is not ideal or there are other situations, the delivery cable can be retracted backward or the delivery sheath can be pushed forward to recover and re-release the coronary sinus constriction device.

[0082] From the above description, it can be seen that the above embodiments of the present invention achieve the following technical effects: By setting the coronary sinus constriction device to include a tubular body and a flow-blocking member, the tubular body extends axially to form a lumen channel for blood flow. The tubular body includes a support section and a diameter-reducing section connected in sequence. The inner diameter of the support section is larger than that of the diameter-reducing section. The flow-blocking member has an axially extending flow-through channel. The inner diameter of the first end of the flow-blocking member is smaller than that of the second end of the flow-blocking member, and the inner diameter of the flow-blocking member gradually decreases from the second end to the first end of the flow-blocking member. The second end of the flow-blocking member is connected to the end or inner wall of the tubular body. The inner diameter of the first end of the flow-blocking member is smaller than that of the diameter-reducing section. The flow-blocking member is made of a biodegradable material. Thus, when the coronary sinus constriction device is implanted, due to the presence of the flow-blocking member and the inner diameter of the first end of the flow-blocking member being smaller than that of the diameter-reducing section, the flow-blocking member plays a major flow-blocking role in the initial stage of implantation, and a large trans-sinus pressure difference is generated immediately upon implantation, achieving the expected therapeutic effect. Thereby, it can effectively increase the immediate effect after the implantation of the coronary sinus constriction device. Further, when the flow-blocking member degrades, the diameter-reducing section becomes the main flow-blocking part, thereby realizing the automatic adjustment of the trans-sinus pressure difference and achieving a stepwise change in the blood flow regulation effect of the coronary sinus constriction device, so that the treatment changes from being significantly effective at the beginning to gradually stabilizing at the end, enabling the coronary sinus constriction device to be effective for more patients.

[0083] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should also be understood that when the terms "comprise" and / or "include" are used in this specification, they specify the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0084] It should be noted that the terms "first", "second", etc. in the specification, claims and above-mentioned drawings of the present application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein.

[0085] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A coronary sinus constriction device, characterized in that, Comprising: A tubular body which extends axially to form a lumen channel for blood to flow through. The tubular body includes a support section and a reduced-diameter section connected in sequence. The inner diameter of the support section is greater than that of the reduced-diameter section. A flow-blocking member which has a flow-through channel extending axially. The inner diameter of the first end of the flow-blocking member is smaller than that of the second end of the flow-blocking member, and the inner diameter of the flow-blocking member gradually decreases from the second end to the first end of the flow-blocking member. The second end of the flow-blocking member is connected to the end or inner wall of the tubular body. The inner diameter of the first end of the flow-blocking member is smaller than that of the reduced-diameter section. The flow-blocking member is made of a biodegradable material. After the flow-blocking member degrades, the reduced-diameter section takes over the flow-blocking function of the flow-blocking member.

2. The coronary sinus constriction device according to claim 1, wherein, The support section includes a first support section and a second support section, and the reduced-diameter section is located between the first support section and the second support section.

3. The coronary sinus constriction device according to claim 2, characterized in that, The second end of the flow-blocking member is connected to the end of the second support section away from the reduced-diameter section.

4. The coronary sinus constriction device according to claim 2, characterized in that, The flow-blocking member includes a first flow-blocking member and a second flow-blocking member, and the inner diameter of the first end of the first flow-blocking member is greater than that of the first end of the second flow-blocking member.

5. The coronary sinus constriction device according to claim 4, characterized in that, The second ends of the first flow-blocking member and the second flow-blocking member are both connected to the end of the second support section away from the reduced-diameter section, and the second flow-blocking member is located inside the first flow-blocking member.

6. The coronary sinus constriction device according to claim 4, characterized in that, The flow-blocking member includes a first flow-blocking member and a second flow-blocking member. The second end of the first flow-blocking member is connected to the end of the first support section away from the reduced-diameter section, and the second end of the second flow-blocking member is connected to the end of the second support section away from the reduced-diameter section.

7. The coronary sinus constriction device according to claim 4, characterized in that, The degradation rate of the second flow-blocking member is greater than that of the first flow-blocking member.

8. The coronary sinus constriction device according to claim 1, characterized in that, The reduced-diameter section is located downstream of the support section in the blood flow direction, and the second end of the flow-blocking member is connected to the end of the support section.

9. The coronary sinus constriction device according to claim 1, characterized in that, The inner wall of the flow-blocking member is provided with collection filaments for collecting the undegraded flow-blocking member. One end of each collection filament extends out of the flow-blocking member and is connected to the tubular body. There are multiple collection filaments, and the multiple collection filaments are arranged at intervals along the circumferential direction of the flow-blocking member.

10. The coronary sinus constriction device according to claim 9, characterized in that, The collection filaments are made of a biodegradable material or a non-biodegradable material. When the collection filaments are made of the biodegradable material, the degradation rate of the collection filaments is less than that of the flow-blocking member.

11. The coronary sinus constriction device according to any one of claims 1 to 10, characterized in that, The tubular body is a porous structure woven from metal wire or cut from a metal pipe.

12. The coronary sinus constriction device according to any one of claims 1 to 10, characterized in that, The support section and the reduced-diameter section are made of different materials.

13. The coronary sinus constriction device according to claim 12, wherein, The support section is a porous structure woven from metal wire or cut from a metal pipe, and the reduced-diameter section is made of a non-biodegradable polymer or biological tissue.

14. The coronary sinus constriction device according to any one of claims 1 to 10, wherein The inner diameter of the support section is 8 mm to 20 mm; and / or The inner diameter of the reduced-diameter section is 2 mm to 5 mm; and / or The inner diameter of the first end of the flow-blocking member is 1 mm to 3 mm.

15. The coronary sinus constriction device according to any one of claims 1 to 10, characterized in that, The surface of the flow-blocking member is coated with an anti-endothelialization drug layer.

16. A coronary sinus constriction system, characterized in that, Comprising a delivery assembly and a coronary sinus constriction device according to any one of claims 1 to 15, the coronary sinus constriction device and the delivery assembly being detachably connected.

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