Coronary sinus constriction device and coronary sinus constriction system

Abstract

The invention provides a coronary sinus constriction device and a coronary sinus constriction system. The coronary sinus constriction device comprises a tubular body, the tubular body extends in the axial direction to form a lumen channel allowing blood to flow through, the tubular body comprises a supporting section and a reducing section which are sequentially connected, and the inner diameter of the supporting section is larger than that of the reducing section; the flow blocking piece is provided with a flow passing channel extending in the axial direction, the inner diameter of the first end of the flow blocking piece is smaller than that of the second end of the flow blocking piece, the inner diameter of the flow blocking piece is gradually reduced from the second end of the flow blocking piece to the first end of the flow blocking piece, and the second end of the flow blocking piece is connected with the end or the inner wall of the tubular body. The inner diameter of the first end of the flow blocking piece is smaller than that of the reducing section, and the flow blocking piece is made of biodegradable materials. The coronary sinus constriction device solves the problem that in the prior art, the immediate effect is poor after the coronary sinus constriction device is implanted.

Description

Technical Field

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

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

[0003] An estimated 10% of all patients with angina suffer from severe, persistent symptoms that cannot be controlled by conventional medical treatments. This severe and debilitating condition is known as refractory angina. The coronary sinus constriction device is considered a promising solution for the treatment of refractory angina. Its working principle is: through minimally invasive surgery to establish an interventional pathway, the coronary sinus constriction device is delivered through the pathway through the right atrium to the coronary sinus implantation site, narrowing the inner diameter of the coronary sinus, establishing a trans-sinus pressure gradient, increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing oxygen-rich blood flow to previously abnormal heart areas, thereby alleviating myocardial ischemia.

[0004] Since the coronary sinus constriction devices in the prior art are generally bare metal stent structures, they have limited effect on blood flow obstruction after implantation. It is necessary to wait for the device to be endothelialized before a significant trans-sinus pressure difference can be generated, which usually takes several weeks or even months. That is, the immediate effect of bare stent structure treatment is relatively poor. Of course, in order to solve the above problems, a layer of flow-blocking membrane can be coated on the surface of the stent to enhance the immediate effect of treatment. However, the existing flow-blocking membranes are all attached to the inner or outer surface of the coronary sinus constriction device, which usually has the following problems: (1) The coronary sinus constriction device is generally an hourglass-shaped special-shaped structure, which is difficult to coat with a film; (2) The flow-blocking membrane covering the surface of the metal stent will increase the outer diameter of the device after contraction, thereby increasing the difficulty of sheathing and pushing the device, and may reduce the compliance of the device, thereby further increasing the difficulty of pushing; (3) Compared with bare metal directly contacting vascular tissue, coating may cause a greater inflammatory response.

[0005] As can be seen from the above, the prior art has the problem of poor immediate effect after implantation of the coronary sinus constriction device. Summary of the invention

[0006] The main purpose 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 of the coronary sinus constriction device after implantation in the prior art.

[0007] In order to achieve the above-mentioned purpose, according to one aspect of the present invention, a coronary sinus narrowing device is provided, comprising: a tubular body, the tubular body extending axially to form a tubular cavity channel for blood to flow through, the tubular body comprising a supporting section and a reduced diameter section connected in sequence, the inner diameter of the supporting section being larger than the inner diameter of the reduced diameter section; a baffle, the baffle having a flow passage extending axially, the inner diameter of the first end of the baffle being smaller than the inner diameter of the second end of the baffle, and the inner diameter of the baffle gradually decreases from the second end of the baffle to the first end of the baffle, the second end of the baffle being connected to the end or inner wall of the tubular body, the inner diameter of the first end of the baffle being smaller than the inner diameter of the reduced diameter section, and the baffle being made of biodegradable material.

[0008] Furthermore, the supporting section comprises a first supporting section and a second supporting section, and the reduced diameter section is located between the first supporting section and the second supporting section.

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

[0010] Further, the spoiler comprises a first spoiler and a second spoiler, and an inner diameter of a first end of the first spoiler is greater than an inner diameter of a first end of the second spoiler.

[0011] Furthermore, the second end of the first flow spoiler and the second end of the second flow spoiler are both connected to an end of the second supporting section away from the diameter-reducing section, and the second flow spoiler is located inside the first flow spoiler.

[0012] Furthermore, the spoiler includes a first spoiler and a second spoiler, the second end of the first spoiler is connected to an end of the first support section away from the diameter reduction section, and the second end of the second spoiler is connected to an end of the second support section away from the diameter reduction section.

[0013] Further, the degradation rate of the second spoiler is greater than the degradation rate of the first spoiler.

[0014] Furthermore, the reduced diameter section is located downstream of the supporting section along the blood flow direction, and the second end of the flow blocking element is connected to the end of the supporting section.

[0015] Furthermore, the inner wall of the spoiler is provided with a collecting wire for collecting undegraded spoiler, one end of the collecting wire extends out of the spoiler and is connected to the tubular body, there are multiple collecting wires, and the multiple collecting wires are arranged at intervals along the circumference of the spoiler.

[0016] Furthermore, the collecting wire is made of a degradable material or a non-degradable material, and when the collecting wire is made of a degradable material, the degradation rate of the collecting wire is lower than the degradation rate of the flow-blocking element.

[0017] Furthermore, the tubular body is a porous structure woven from metal wires or cut from metal tubes.

[0018] Furthermore, the supporting section and the reduced diameter section are made of different materials.

[0019] Furthermore, the support section is a porous structure woven from metal wires 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 supporting 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 baffle is 1 mm to 3 mm.

[0021] Furthermore, the surface of the flow-blocking element is coated with an anti-endothelialization drug layer.

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

[0023] According to the technical solution of the present invention, the coronary sinus constriction device comprises a tubular body and a flow blocker, wherein the tubular body extends axially to form a tubular cavity channel for blood to flow through, the tubular body comprises a supporting section and a diameter-reducing section connected in sequence, the inner diameter of the supporting section is larger than the inner diameter of the diameter-reducing section, the flow blocker has a flow passage extending axially, the inner diameter of the first end of the flow blocker is smaller than the inner diameter of the second end of the flow blocker, and the inner diameter of the flow blocker gradually decreases from the second end of the flow blocker 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, and the flow blocker The inner diameter of the first end of the piece is smaller than the inner diameter of the reduced diameter section, and the flow blocker is made of biodegradable material. Thus, after the coronary sinus constriction device is implanted, due to the existence of the flow blocker and the inner diameter of the first end of the flow blocker being smaller than the inner diameter of the reduced diameter section, the flow blocker plays a major role in blocking flow in the early stage of implantation, and a large trans-sinus pressure difference is generated immediately after implantation, achieving the expected therapeutic effect, thereby effectively increasing the immediate effect of the coronary sinus constriction device after implantation, solving the problem of poor immediate effect of the coronary sinus constriction device after implantation in the prior art. Furthermore, when the flow blocker is degraded, the reduced diameter section becomes the main flow blocker, thereby achieving automatic adjustment of the trans-sinus pressure difference, and achieving a step-by-step change in the blood flow regulation effect of the coronary sinus constriction device, thereby making the treatment significantly effective at the beginning and gradually stable at the end, so that the coronary sinus constriction device can be effective for more patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary 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 A schematic structural diagram of a coronary sinus constriction device in Embodiment 1 of the present invention is shown;

[0026] Figure 2 A schematic structural diagram of a coronary sinus constriction device in a second embodiment of the present invention is shown;

[0027] Figure 3 A schematic structural diagram of a coronary sinus constriction device in a third embodiment of the present invention is shown;

[0028] Figure 4 A schematic structural diagram of a coronary sinus constriction device in a fourth embodiment of the present invention is shown;

[0029] Figure 5 A schematic structural diagram of a coronary sinus constriction device in a fifth embodiment of the present invention is shown;

[0030] Figure 6 A schematic structural diagram of a flow-blocking member in a specific embodiment of the present invention is shown. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

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

[0033] In the present invention, unless otherwise specified, the directional words used, such as "up, down, top, bottom", usually refer to the directions shown in the drawings, or to the components themselves in the vertical, perpendicular or gravity directions; similarly, for ease of understanding and description, "inside and outside" refer to the inside and outside relative to the outline of each component itself, but the above-mentioned directional 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 the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0035] In order to solve the problem of poor immediate effect of coronary sinus constriction devices in the prior art after implantation, the present invention provides a coronary sinus constriction device and a coronary sinus constriction system. The coronary sinus constriction device includes the coronary sinus constriction device described below.

[0036] The embodiment of the present application provides a coronary sinus constriction device, including a tubular body and a flow blocker. The tubular body extends axially to form a tubular cavity channel for blood to flow through, and the tubular body includes a supporting section and a diameter-reducing section connected in sequence, and the inner diameter of the supporting section is larger than the inner diameter of the diameter-reducing section. The flow blocker has a flow passage extending axially, the inner diameter of the first end of the flow blocker is smaller than the inner diameter of the second end of the flow blocker, and the inner diameter of the flow blocker gradually decreases from the second end of the flow blocker 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 the inner diameter of the diameter-reducing section, and the flow blocker is made of a biodegradable material.

[0037] After the coronary sinus constriction device of the present application 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 the inner diameter of the diameter reduction section, the flow blocker plays a major role in blocking flow in the early stage of implantation, and a large trans-sinus pressure difference is generated immediately after implantation, achieving the expected therapeutic effect, thereby effectively increasing the immediate effect of the coronary sinus constriction device after implantation, solving the problem of poor immediate effect of the coronary sinus constriction device after implantation in the prior art. Furthermore, when the flow blocker is degraded, the diameter reduction section becomes the main flow blocker, thereby achieving automatic adjustment of the trans-sinus pressure difference, and achieving a step-by-step change in the blood flow regulation effect of the coronary sinus constriction device, thereby making the treatment significantly effective at the beginning and gradually stable at the end, so that the coronary sinus constriction device can be effective for more patients.

[0038] In this embodiment, the flow blocker is a trumpet-shaped structure surrounded by a sheet or film material. Specifically, the diameter of the second end of the flow blocker is adapted to the caliber of the connection of the tubular body, that is, the flow blocker is only connected to the tubular body through the end edge of the second end, and the first end extends axially without any constraints. Therefore, under the impact of blood flow, the flow blocker will float in the blood without contacting the blood vessel wall, thereby greatly reducing the difficulty of coating the flow blocker and will not cause an inflammatory reaction. Furthermore, since the flow blocker will not have any restraining effect 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 sheathing and pushing the coronary sinus constriction device.

[0039] Furthermore, in this embodiment, the second end of the spoiler is connected to the end of the support section. Specifically, the spoiler and the support section are connected by suturing, bonding or welding, preferably suturing.

[0040] In this embodiment, the flow blocker is made of polylactic acid PLA material, which is impermeable to blood. Therefore, under the obstruction of the flow blocker, blood will flow into the flow channel from the second end of the flow blocker and then flow out from the first end of the flow blocker. In other words, the inner diameter of the flow blocker gradually decreases along the flow direction of the blood, thereby having a throttling and regulating effect. Of course, the flow blocker can also be made of other biodegradable materials, which can be selected according to actual needs.

[0041] In this embodiment, there may be one or two supporting sections. Further, there may be one or two flow-blocking members, which can be selected according to actual needs.

[0042] In the present embodiment, the tubular body is a porous structure woven from metal wires or cut from metal tubes. The design of the porous structure allows the coronary sinus constriction device to contract and expand, and has good compliance, which facilitates the delivery of the coronary sinus constriction device. Specifically, the material of the tubular body is nickel-titanium alloy, that is, it is woven from nickel-titanium alloy wires or cut from nickel-titanium alloy tubes. Of course, the metal wire can also be other medical shape memory metal materials that are harmless to the human body and have excellent biocompatibility. Even after long-term implantation in the human body, it has good safety, which can achieve the purpose of treatment without causing inconvenience to the patient's daily life such as security checks and general medical examinations. Furthermore, 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 braided from nickel-titanium alloy wires or cut from nickel-titanium alloy tubes, 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 balloon expansion.

[0044] In an optional embodiment, the support segment and the reduced diameter segment are made of different materials. Among them, the support segment is a porous structure woven from metal wires or cut from metal pipes. The specific setting method is the same as the overall structure of the above-mentioned tubular body, which will not be repeated here. The reduced diameter segment is made of non-degradable polymers or biological tissues. Specifically, the polymer is PTFE, EPTFE or PET, and the biological tissue can be bovine or pig tissue. Of course, if the coronary sinus constriction device is to function permanently, the reduced diameter segment needs to be made of non-degradable materials.

[0045] Furthermore, in this embodiment, the supporting section and the reduced diameter section may be connected by suturing, bonding or welding.

[0046] In this embodiment, the inner diameter of the supporting section is 8 mm to 20 mm, the inner diameter of the diameter-reducing section is 2 mm to 5 mm, and the inner diameter of the first end of the flow-blocking element 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 arrangement, 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 such as heparin or phosphorylcholine, etc., which can be selected according to actual needs.

[0048] The different configurations of the tubular body and the flow-blocking element are described in detail below through specific embodiments.

[0049] Embodiment 1

[0050] like Figure 1 As shown, this embodiment provides a coronary sinus constriction device 10, comprising 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. In this embodiment, there are two support segments, namely a first support segment 101 and a second support segment 103. The reduced diameter segment 102 is located between the first support segment 101 and the second support segment 103, that is, the first support segment 101, the reduced diameter segment 102 and the second support segment 103 are connected in sequence.

[0051] Furthermore, if the blood vessel is tapered, the inner diameter of the first supporting segment 101 is different from the inner diameter of the second supporting segment 103. Specifically, in this embodiment, Figure 1 As shown, the inner diameter of the first support segment 101 is larger than the inner diameter 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 the inner diameter 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 non-uniform along the length direction, and is generally a tapered structure that tapers gradually from the sinus opening to the upstream end, in order to ensure that the coronary sinus constriction device is subjected to consistent force after implantation, the inner diameters of the first support segment 101 and the second support segment 103 can be designed differentially, that is, the inner diameter of the second support segment 103 is smaller than the inner diameter 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 the inner diameter of the first support segment 101.

[0053] In this embodiment, the second end of the spoiler 104 is connected to the end of the second support section 103 away from the diameter reduction section 102. In other words, the spoiler 104 is located in the second support section 103. Specifically, the inner diameter of the second end of the spoiler 104 is the same as the inner diameter of the end of the second support section 103 away from the diameter reduction section 102.

[0054] like Figure 1 As shown, the flow blocker 104 has a flow passage 1041 extending in the axial direction, and has a first end 1042 and a second end 1043, the inner diameter of the first end 1042 is smaller than the inner diameter of the second end 1043, and smaller than the inner diameter of the reduced diameter section 102. The diameter of the second end 1043 is the same as the inner diameter of the second support section 103 and is fixed to the upstream end of the second support section 103.

[0055] Embodiment 2

[0056] like Figure 2 As shown, this embodiment provides a coronary sinus constriction device 20, including a tubular body 200 and a flow blocker 204. There are two support sections in this embodiment, namely, a first support section 201 and a second support section 203, and the diameter reduction section 202 is located between the first support section 201 and the second support section 203, that is, the first support section 201, the diameter reduction section 202 and the second support section 203 are connected in sequence. Further, there are also two flow blocks, namely, a first flow blocker 204 and a second flow blocker 205. The first flow blocker 204 has a first end 2041 and a second end 2042, and the second flow blocker 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 blocker 204 is greater than the inner diameter of the first end 2051 of the second flow blocker 205. The second end 2042 of the first spoiler 204 and the second end 2052 of the second spoiler 205 are both connected to one end of the second support section 203 away from the diameter-reducing section 202, and the second spoiler 205 is located inside the first spoiler 204. In other words, the first spoiler 204 and the second spoiler 205 are arranged in an inner-outer nested manner, and are both located inside the second support section 203.

[0057] Specifically, in this embodiment, the inner diameter of the first end 2051 of the second spoiler 205 is 1 mm, the inner diameter of the first end 2041 of the first spoiler 204 is 2 mm, and the inner diameter of the reduced diameter section 202 is 3 mm.

[0058] In this embodiment, the inner diameter of the second end 2042 of the first spoiler 204 and the inner diameter of the second end 2052 of the second spoiler 205 are both the same as the inner diameter of the end of the second supporting section 203 away from the diameter-reducing section 202 .

[0059] In this embodiment, the degradation rate of the second spoiler 205 is greater than the degradation rate of the first spoiler 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 regulating effect on blood flow. After the second flow blocker 205 is degraded, the first flow blocker 204 opens and plays a major role. Since the inner diameter of the first end 2041 of the first flow blocker 204 is larger than the inner diameter of the first end 2051 of the second flow blocker 205, the intensity of the regulating effect of the coronary sinus constriction device on blood flow slows down. As the implantation time increases, the first flow blocker 204 and the second flow blocker 205 are both degraded, and finally the diameter reduction section 202 plays a role. At this time, the regulating effect of the coronary sinus constriction device on blood flow reaches a stable state and is maintained for a long time, thereby realizing a step-by-step change in the regulating effect of the coronary sinus constriction device on blood flow. In addition, it should be noted that the intensity of the regulating effect of the coronary sinus constriction device on blood flow gradually slows down, indicating that the treatment effect will change from being significantly effective to gradually stable.

[0061] Embodiment 3

[0062] like Figure 3 As shown, this embodiment provides a coronary sinus narrowing device 30, including a tubular body 300 and a flow blocker 304. There are two support sections in this embodiment, namely a first support section 301 and a second support section 303. Further, there are also two flow blocks, namely a first flow blocker 304 and a 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 greater than the inner diameter of the first end 2051 of the second flow blocker 205. The second end 3042 of the first flow blocker 304 is connected to an end of the first support section 301 away from the diameter reduction section 302, and the second end 3052 of the second flow blocker 305 is connected to an end of the second support section 303 away from the diameter reduction section 302. That is, the first flow blocking member 304 is located outside the tubular body 300 , and the second flow blocking member 305 is located inside the second supporting section 303 .

[0063] It is understandable that the first flow blocker 304 and the second flow blocker 305 in this embodiment are respectively located at two ends of the tubular body 300. Through the above arrangement, the diameter of the coronary sinus constriction device after contraction can be effectively reduced, thereby facilitating the sheathing 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 the end of the first support section 301 away from the diameter reduction section 302. Correspondingly, the diameter of the second end 3052 of the second flow blocker 305 is the same as the inner diameter of the end of the second support section 303 away from the diameter reduction section 302.

[0065] Embodiment 4

[0066] like Figure 4 As shown, this embodiment provides a coronary sinus constriction device 40, including a tubular body 400 and a flow blocker 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 blocker, namely, the flow blocker 403. The flow blocker 403 has a first end 4031 and a second end 4032, and the second end 4032 of the flow blocker 403 is connected to an end of the support section 401 away from the diameter reduction section 402. In other words, the flow blocker 403 is located in the support section 401.

[0067] In this embodiment, the inner diameter of the second end 4032 of the blocking member 403 is the same as the inner diameter of the end of the supporting section 401 away from the diameter-reducing section 402 .

[0068] This embodiment can effectively reduce the amount of exogenous metal materials by reducing the number of support segments, thereby reducing the release of toxic substances in the material, such as nickel ions.

[0069] In an optional embodiment, two flow-blocking members may be provided. The arrangement of the two flow-blocking members is the same as that of the second and third embodiments, and will not be described in detail here.

[0070] Embodiment 5

[0071] like Figure 5 As shown, this embodiment provides a coronary sinus constriction device 50, including a tubular body 500 and a flow blocker 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 blocker, namely, the flow blocker 503. The flow blocker 503 has a first end 5031 and a second end 5032, and the second end 5032 of the flow blocker 503 is connected to an end of the support section 401 close to the diameter reduction section 502. In other words, the flow blocker 503 is located in 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 the end of the supporting section 501 close to the diameter-reducing section 502 .

[0073] As is known to all, free foreign bodies in blood vessels or heart blood will increase the possibility of thrombosis, and thrombosis in arterial blood is more harmful. Although the coronary sinus constriction device in this embodiment is in a venous blood environment and has a lower risk, in order to reduce the possibility of pulmonary embolism caused by incompletely degraded obstruction walls floating in the blood, corresponding collection measures are adopted.

[0074] like Figure 6As shown, the inner wall of the flow blocker 60 is provided with a collecting wire 601 for collecting the undegraded flow blocker 60, and one end of the collecting wire 601 extends out of the flow blocker 60 and is connected to the tubular body. Specifically, the first end of the collecting wire 601 is located in the flow blocker 60, and the second end 602 of the collecting wire 601 extends out of the flow blocker 60 and is connected to the tubular body. Through the above arrangement, when the flow blocker 60 is unevenly degraded, the undegraded part will adhere to the collecting wire 601 and will not be separated from the coronary sinus constriction device and free in the blood, thereby reducing the possibility of thrombosis.

[0075] In this embodiment, there are multiple collecting filaments 601, and the multiple collecting filaments 601 are arranged at intervals along the circumference of the flow blocking member 60. Through the above arrangement, the undegraded part of the flow blocking member 60 can be attached to the collecting filaments 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 a non-degradable material, when the flow blocker 60 is completely degraded, the collecting wire 601 will float freely in the blood, but because one end of it is fixed to the tubular body, it will not be separated from the coronary sinus constriction device and be free in the blood, nor will it have any effect on the blood flow. When the collecting wire 601 is a degradable material, the degradation rate of the collecting wire 601 needs to be less than the degradation rate of the flow blocker 60. When the flow blocker 60 is completely degraded, the collecting wire 601 begins to degrade. Since the collecting wire 601 is very thin, even if it is partially separated from the coronary sinus constriction device and free in the blood in the later stage of degradation, the possibility of thrombosis is also very low.

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

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

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

[0080] First, the coronary sinus constriction device is placed in the delivery sheath by connecting the delivery cable to the connector. In the stored state, the coronary sinus constriction device is completely contained in the delivery sheath and is squeezed into a long strip, thereby reducing the size of the delivery sheath as much as possible and reducing the vascular damage caused by establishing the delivery pathway. 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 withdrawn so that one end of the coronary sinus constriction device extends out of the delivery sheath and gradually returns to a tubular body under the action of the metal memory property or the expansion of the balloon. When the coronary sinus constriction device returns to its original state, the connection between the delivery cable and the connector is released, so that the coronary sinus constriction device is separated from the delivery component and supported and fixed at the target position, and then the delivery component is withdrawn from the patient's body to complete the entire release process.

[0081] Furthermore, before the coronary sinus constriction device is completely separated from the delivery sheath, if the device position is not ideal or there are other situations, the delivery cable can be withdrawn backwards or the delivery sheath can be pushed forward to retrieve and release the coronary sinus constriction device.

[0082] From the above description, it can be seen that the above-mentioned embodiments of the present invention achieve the following technical effects: by setting the coronary sinus narrowing device including a tubular body and a flow blocker, the tubular body extends axially to form a tubular cavity channel for blood to flow through, the tubular body includes a supporting section and a reduced diameter section connected in sequence, the inner diameter of the supporting section is larger than the inner diameter of the reduced diameter section, the flow blocker has a flow passage extending axially, the inner diameter of the first end of the flow blocker is smaller than the inner diameter of the second end of the flow blocker, and the inner diameter of the flow blocker gradually decreases from the second end of the flow blocker 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 the inner diameter of the reduced diameter section, and the flow blocker is made of biodegradable material In this way, after the coronary sinus constriction device is implanted, due to the existence of the flow blocker and the inner diameter of the first end of the flow blocker is smaller than the inner diameter of the reduced diameter section, the flow blocker plays a major flow blocking role in the early stage of implantation, and a large trans-sinus pressure difference is generated immediately after implantation, thereby achieving the expected therapeutic effect, thereby effectively increasing the immediate effect of the coronary sinus constriction device after implantation. Furthermore, when the flow blocker is degraded, the reduced diameter section becomes the main flow blocker, thereby achieving automatic adjustment of the trans-sinus pressure difference and a step-by-step change in the blood flow regulating effect of the coronary sinus constriction device, thereby making the treatment significantly effective at the beginning and gradually stable at the end, so that the coronary sinus constriction device can 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 be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates 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 and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way can be interchanged where appropriate, 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 description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A coronary sinus constriction device, characterized in that: include: A tubular body, the tubular body extending axially to form a tubular cavity channel for blood to flow through, the tubular body comprising a supporting section and a reduced diameter section connected in sequence, the inner diameter of the supporting section being larger than the inner diameter of the reduced diameter section; A flow blocker, wherein the flow blocker has a flow passage extending in an axial direction, the inner diameter of the first end of the flow blocker is smaller than the inner diameter of the second end of the flow blocker, and the inner diameter of the flow blocker gradually decreases from the second end of the flow blocker 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 the inner diameter of the reduced diameter section, and the flow blocker is made of a biodegradable material.

2. The coronary sinus constriction device according to claim 1, characterized in that: The supporting section comprises a first supporting section and a second supporting section, and the reduced diameter section is located between the first supporting section and the second supporting 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 an end of the second supporting section away from the diameter-reducing section.

4. The coronary sinus constriction device according to claim 2, characterized in that: The spoiler includes a first spoiler and a second spoiler, wherein an inner diameter of a first end of the first spoiler is greater than an inner diameter of a first end of the second spoiler.

5. The coronary sinus constriction device according to claim 4, characterized in that: The second end of the first flow spoiler and the second end of the second flow spoiler are both connected to an end of the second supporting section away from the reduced diameter section, and the second flow spoiler is located inside the first flow spoiler.

6. The coronary sinus constriction device according to claim 4, characterized in that: The baffle comprises a first baffle and a second baffle, wherein the second end of the first baffle is connected to an end of the first support section away from the diameter-reducing section, and the second end of the second baffle is connected to an end of the second support section away from the diameter-reducing 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 the degradation rate 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 supporting section along the blood flow direction, and the second end of the flow blocking member is connected to the end of the supporting 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 a collecting wire for collecting the undegraded flow-blocking member, one end of the collecting wire extends out of the flow-blocking member and is connected to the tubular body, and the collecting wires are multiple and are arranged at intervals along the circumference of the flow-blocking member.

10. The coronary sinus constriction device according to claim 9, characterized in that: The collecting wire is made of a degradable material or a non-degradable material, and when the collecting wire is made of the degradable material, the degradation rate of the collecting wire is lower than the degradation rate of the blocking element.

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 wires or cut from metal tubes.

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

13. The coronary sinus constriction device according to claim 12, characterized in that: The support section is a porous structure woven from metal wires or cut from metal pipes, and the reduced diameter section is made of non-degradable polymers or biological tissues.

14. The coronary sinus constriction device according to any one of claims 1 to 10, characterized in that: 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 baffle 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 element is coated with an anti-endothelialization drug layer.

16. A coronary sinus constriction system, characterized in that: The invention comprises a delivery component and the coronary sinus constriction device according to any one of claims 1 to 15, wherein the coronary sinus constriction device and the delivery component are detachably connected.

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