Coronary sinus constriction device and implantation system

Abstract

The utility model provides a coronary sinus constriction device and implantation system, the coronary sinus constriction device is hourglass-shaped, the coronary sinus constriction device comprises a first support section, a second support section and a central necking section, the central necking section is connected between the first support section and the second support section, the first supporting section is of a first net rack structure formed by cutting a first metal pipe, or the first supporting section is of a first net rack structure formed by weaving a first wire material; the second supporting section is of a second net rack structure formed by cutting a second metal pipe, or the second supporting section is of a second net rack structure formed by weaving a second wire material; the central necking section is of a third net rack structure formed by weaving third wires, and the third wires are made of shape memory alloy. The implantation system comprises the coronary sinus constriction device, the action effect of the supporting section of the coronary sinus constriction device and the action effect of the central necking section of the coronary sinus constriction device have small mutual influence, and the diameter reducing effect is stable.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a coronary sinus constriction device and an implantation system for implanting the aforementioned coronary sinus constriction device. Background Technology

[0002] Angina pectoris is a clinical syndrome characterized by paroxysmal chest pain or discomfort, caused by insufficient blood supply to the coronary arteries and acute, temporary ischemia and hypoxia of the myocardium. Angina pectoris is pain felt on the body surface as a reflection of ischemic heart disease; 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 may radiate to the precordial region 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] Of all patients with angina, it is estimated that about 10% suffer from severe, persistent symptoms that cannot be controlled by conventional medical treatments. This severe debilitating condition is known as refractory angina. Coronary sinus constriction devices are considered a promising solution for treating refractory angina. The mechanism of action is as follows: an interventional pathway is established through minimally invasive surgery, and the coronary sinus constriction device is delivered through the pathway to the coronary sinus implantation site via the right atrium. This narrows the diameter of the coronary sinus, establishes a transsinus pressure gradient, increases back pressure, improves the ratio of epicardial and subendocardial blood perfusion, and increases the flow of oxygen-rich blood to previously abnormal areas of the heart, thereby relieving myocardial ischemia.

[0004] Currently, there are two main types of coronary sinus constriction devices:

[0005] The first type is constructed using a medical-grade stainless steel cutting frame that is expanded with a balloon. Once the coronary sinus narrowing device is inserted into the target location, balloon expansion is used to press it tightly against the vessel wall, narrowing the coronary sinus diameter, thereby increasing back pressure and improving blood perfusion. However, this coronary sinus narrowing device has several drawbacks: the deployment process requires balloon expansion, making the procedure cumbersome; furthermore, while the central neck segment of the device is relatively stable, the dimensions of the two end support segments cannot be adjusted to adapt to changes in the lumen, and the effect of the device only occurs after endothelialization of the central neck segment.

[0006] The second type is made of medical-grade metal wire woven throughout. Although this coronary sinus narrowing device expands on the target blood vessel after being inserted into the target location to achieve a narrowing effect, the dimensional stability of the central narrowing segment is poor because the device is woven throughout, and the size of the central narrowing segment is affected by the size of the two supporting segments. In addition, the central narrowing segment requires a denser mesh structure to better affect blood flow, while the supporting segments require a sparser mesh structure to facilitate endothelialization. However, since the coronary sinus narrowing device is woven throughout, it is difficult to achieve both simultaneously, thus limiting the effectiveness of the device.

[0007] It is evident that the effects of the support segment and the central neck constriction segment in existing coronary sinus narrowing devices influence each other, and the diameter reduction effect is unstable. Summary of the Invention

[0008] To address the aforementioned problems, the main objective of this invention is to provide a coronary sinus narrowing device that minimizes the interaction between the supporting segment and the central constriction segment, and provides a stable diameter reduction effect.

[0009] Another objective of this invention is to provide an implantation system equipped with the aforementioned coronary sinus constriction device.

[0010] To achieve the main objective of this utility model, it provides a coronary sinus narrowing device in the shape of an hourglass. The coronary sinus narrowing device includes a first support segment, a second support segment, and a central constriction segment. The central constriction segment is connected between the first support segment and the second support segment. The first support segment is formed by cutting a first metal tube to form a first mesh structure, or by weaving a first wire to form a first mesh structure. The second support segment is formed by cutting a second metal tube to form a second mesh structure, or by weaving a second wire to form a second mesh structure. The central constriction segment is formed by weaving a third wire to form a third mesh structure. The third wire is made of shape memory alloy.

[0011] As can be seen from the above, because the coronary sinus constriction device has a segmented structural design, and the first support segment, the second support segment, and the central constriction segment can be made of different materials, the first support segment, the second support segment, and the central constriction segment can all be configured with different structures according to their respective functions. This greatly reduces the degree of mutual influence between the effect of the central constriction segment and the effects of the first support segment and the second support segment, enhances the diameter reduction effect of the coronary sinus constriction device, and ensures the stability of the diameter reduction effect.

[0012] A preferred embodiment is that the connection between the first support segment and the central constriction segment forms a first transition zone, which gradually narrows and smoothly transitions from the first support segment to the throat of the central constriction segment; the connection between the second support segment and the central constriction segment forms a second transition zone, which gradually narrows and smoothly transitions from the second support segment to the throat.

[0013] As can be seen from the above, making the first transition zone and the second transition zone transition smoothly can avoid excessive stimulation of the inner wall of the lumen by the first transition zone and the second transition zone, and avoid increasing damage to the inner wall.

[0014] A further proposed solution is that the first diameter of the first support section is greater than or equal to the second diameter of the second support section.

[0015] As can be seen from the above, this design enables the coronary sinus constriction device to effectively adapt to the shape of the coronary sinus and fix it in place, while ensuring the transsinus pressure gradient, thereby increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing the flow of oxygen-rich blood to previously abnormal cardiac regions.

[0016] A further option is that the first support segment has a first gentle section of equal diameter at the end away from the central constriction segment; and / or the second support segment has a second gentle section of equal diameter at the end away from the central constriction segment.

[0017] As can be seen from the above, the first gentle section allows the first support section to fit better against the inner wall of the lumen; similarly, the second gentle section allows the second support section to fit better against the inner wall of the lumen, thereby ensuring the diameter reduction effect and preventing the coronary sinus narrowing device from shifting after implantation.

[0018] Another preferred embodiment is that the first metal tube is made of shape memory alloy, the second metal tube is made of shape memory alloy, the first filament is made of shape memory alloy or medical bioabsorbable material, and the second filament is made of shape memory alloy or medical bioabsorbable material.

[0019] As can be seen from the above, by using shape memory alloys or medical bioabsorbable materials to make the first and second support segments, the coronary sinus narrowing device can be released without balloon dilation and can expand to the appropriate size at the appropriate position.

[0020] Another preferred embodiment is that the first support segment has a first connecting hole at the end near the central necked segment, and the first connecting hole is connected to the first end of the central necked segment; the second support segment has a second connecting hole at the end near the central necked segment, and the second connecting hole is connected to the second end of the central necked segment.

[0021] As can be seen from the above, the first connecting hole makes it easier to connect the first support section and the central necking section, and is less likely to damage the braided filaments of the central necking section; similarly, the second connecting hole makes it easier to connect the second support section and the central necking section, and is less likely to damage the braided filaments of the central necking section.

[0022] A further option is that the diameter of the first connecting hole is larger than the diameter of the third wire.

[0023] As can be seen from the above, after the coronary sinus narrowing device is implanted, the above design can prevent the first and / or second support segments from being compressed and narrowed due to the compression of the first and second support segments caused by the pressure in the lumen.

[0024] Another preferred embodiment is that the end of the first support section away from the central constriction section is provided with a connector.

[0025] As can be seen from the above, the connector is used to connect with the delivery assembly to enhance the stability of the delivery assembly for the delivery and retrieval of the coronary sinus constriction device.

[0026] A further option is that the number of connectors is two or more; and / or the connectors are T-shaped, with a horizontal segment and a vertical segment, the first end of the vertical segment being connected to the horizontal segment and located between the two ends of the horizontal segment, and the second end of the vertical segment being connected to the first support segment.

[0027] As can be seen from the above, the number of connectors can be designed according to the number of connecting parts that mate with them on the delivery assembly, so as to ensure that the delivery assembly can stably deliver and retrieve the coronary sinus constriction device.

[0028] Another preferred embodiment is that the inner and / or outer surfaces of the coronary sinus constriction device are provided with a flow-blocking membrane.

[0029] As can be seen from the above, the choke membrane can achieve an immediate diameter reduction effect, preventing blood from flowing out of the coronary sinus constrictor through the mesh of the coronary sinus constrictor.

[0030] A further option is that a first drug-carrying structure is provided on the first support section, and / or a second drug-carrying structure is provided on the second support section; and / or the first mesh edge of the first mesh structure is thicker than the third filament, the second mesh edge of the second mesh structure is thicker than the third filament, the first mesh opening of the first mesh structure is larger and sparser than the third mesh opening of the third mesh structure, and the second mesh opening of the second mesh structure is larger and sparser than the third mesh opening.

[0031] As can be seen from the above, setting a first drug-loading structure on the first support segment and a second drug-loading structure on the second support segment allows the drug-loading structure to accommodate the drug, which in turn helps to accelerate the endothelialization of the coronary sinus constriction device and reduce the risk of using the coronary sinus constriction device.

[0032] To achieve another objective of this invention, this invention provides an implantation system including a delivery assembly, which further includes the aforementioned coronary sinus constriction device, the coronary sinus constriction device being detachably connected to the delivery assembly.

[0033] As can be seen from the above, the implantation system equipped with the aforementioned coronary sinus constriction device can enhance the diameter reduction effect of the coronary sinus constriction device and ensure the stability of the diameter reduction effect. Attached Figure Description

[0034] Figure 1 This is a structural schematic diagram from a first perspective of the first embodiment of the coronary sinus constriction device of this utility model.

[0035] Figure 2 This is a structural schematic diagram from a second perspective of the first embodiment of the coronary sinus constriction device of this utility model.

[0036] Figure 3 This is a schematic diagram of the second embodiment of the coronary sinus constriction device of this utility model.

[0037] Figure 4 This is a partial structural schematic diagram of the second embodiment of the coronary sinus narrowing device of this utility model.

[0038] Figure 5 This is a schematic diagram of the coronary sinus constriction device and the transmission steel cable in the second embodiment of the present invention.

[0039] Figure 6 This is a schematic diagram of the coronary sinus constriction device of the second embodiment of the present invention, showing the device being inserted into the delivery sheath.

[0040] Figure 7 This is a structural schematic diagram of the third embodiment of the coronary sinus constriction device of this utility model.

[0041] Figure 8 This is a schematic diagram of the fourth embodiment of the coronary sinus constriction device of this utility model.

[0042] The present invention will be further described below with reference to the accompanying drawings and embodiments. Detailed Implementation

[0043] First embodiment of coronary sinus constriction device

[0044] Reference Figure 1 and Figure 2 The coronary sinus narrowing device 100 is hourglass-shaped; wherein, the coronary sinus narrowing device 100 includes a first support segment 1, a second support segment 2 and a central constriction segment 3, the central constriction segment 3 connecting the first support segment 1 and the second support segment 2.

[0045] The first support segment 1 is bowl-shaped. In this embodiment, the first support segment 1 is formed by cutting a first metal tube to create a first mesh structure. The first metal tube is made of shape memory alloy, which includes, but is not limited to, nickel-titanium alloy, copper-based shape memory alloy, or other shape memory alloys with the same function and purpose. By using a shape memory-based first metal tube to form the first support segment 1, balloon dilation is not required during the release of the coronary sinus constriction device 100. The device can self-expand to a suitable size at an appropriate position, ensuring that the first support segment 1 is in close contact with the inner wall of the lumen, thereby stabilizing the coronary sinus constriction device 100 in the target position. Furthermore, since the first support segment 1 has the ability to self-adjust its size within a certain range, the risk of the coronary sinus constriction device 100 falling off or causing excessive damage to the target lumen is reduced. Moreover, the edges of each first mesh edge 10 of the first support segment 1 are rounded, making the outline of the first support segment 1 smooth and without sharp edges.

[0046] The second support segment 2 is bowl-shaped. In this embodiment, the second support segment 2 is formed by cutting a second metal tube to create a second mesh structure. The second metal tube is made of shape memory alloy, which includes, but is not limited to, nickel-titanium alloy, copper-based shape memory alloy, or other shape memory alloys with the same function and purpose. Similarly, by using a shape memory-based second metal tube to form the second support segment 2, balloon dilation is not required during the release of the coronary sinus constriction device 100, and the segment can self-expand to a suitable size at an appropriate position to ensure that the second support segment 2 is in close contact with the inner wall of the lumen, thereby stabilizing the coronary sinus constriction device 100 in the target position. In addition, since the second support segment 2 has the ability to self-adjust its size within a certain range, the risk of the coronary sinus constriction device 100 falling off or causing excessive damage to the target lumen is reduced. Furthermore, the edges of each second mesh edge 20 of the second support segment 2 are rounded, making the outline of the second support segment 2 smooth and without sharp edges.

[0047] In some embodiments, the end of the first support segment 1 furthest from the central constriction segment 3 has a first smooth section 12, the entire diameter of which is equal, so that after the coronary sinus constriction device 100 self-expands, the first support segment 1 can better conform to the inner wall of the lumen; and / or, the end of the second support segment 2 furthest from the central constriction segment 3 may have a second smooth section 22, the entire diameter of which is equal, so that after the coronary sinus constriction device 100 self-expands, the second support segment 2 can better conform to the inner wall of the lumen. This design can ensure the diameter reduction effect of the coronary sinus constriction device 100 and prevent the coronary sinus constriction device 100 from shifting after implantation. It is understood that the end of the first support segment 1 away from the central constriction segment 3 is a segment of a certain length, and this segment is located at the end of the first support segment 1 away from the central constriction segment 3; similarly, the end of the second support segment 2 away from the central constriction segment 3 is a segment of a certain length, and this segment is located at the end of the second support segment 2 away from the central constriction segment 3.

[0048] In some embodiments, the first diameter D1 of the first support segment 1 is greater than or equal to the second diameter D2 of the second support segment 2, that is, the first diameter D1 of the first support segment 1 at the farthest end from the central constriction segment 3 is greater than or equal to the second diameter D2 of the second support segment 2 at the farthest end from the central constriction segment 3; it can be understood that the diameter of the first smooth segment 12 is greater than or equal to the diameter of the second smooth segment 22. This design allows the two ends of the coronary sinus constriction device 100 to better match different parts of the coronary sinus, ensuring that the first support segment 1 and the second support segment 2 can be accurately placed and closely fitted to the coronary sinus, reducing the risk of displacement or unnecessary compression of surrounding tissues; in addition, it also ensures the transsinus pressure gradient, which increases back pressure, effectively improves the ratio of epicardial and subendocardial blood perfusion, and increases the flow of oxygen-rich blood to previously abnormal cardiac regions.

[0049] In some embodiments, a first drug-loading structure is provided on the first support segment 1, and when the first support segment 1 is formed by cutting a first metal tube, the arrangement of the first drug-loading structure can be simpler and more convenient. The first drug-loading structure is used to contain and store the drug, which helps to accelerate the endothelialization of the coronary sinus constriction device 100, better realize the flow regulation function, and reduce the risk of using the coronary sinus constriction device 100. The first drug-loading structure can be located at the intersection of each of the first grid edges 10, in which case the first drug-loading structure can be a cylindrical groove; of course, the first drug-loading structure can also be located on the first grid edge 10, in which case the first drug-loading structure can be a strip groove. Preferably, the first drug-loading structure is located at the end of the first support segment 1 away from the central constriction segment 3. And / or, a second drug-loading structure is provided on the second support segment 2, and when the second support segment 2 is formed by cutting a second metal tube, the arrangement of the second drug-loading structure can be simpler and more convenient. The second drug-carrying structure is used to contain and store the drug, thereby accelerating the endothelialization of the coronary sinus constrictor 100, better realizing the flow regulation function, and reducing the risk of using the coronary sinus constrictor 100. Similarly, the second drug-carrying structure can be located at the intersection of each of the second grid edges 20, in which case the second drug-carrying structure can be a cylindrical groove; of course, the second drug-carrying structure can also be located on the second grid edge 20, in which case the second drug-carrying structure can be a strip groove. Preferably, the second drug-carrying structure is located at the end of the second support section 2 away from the central constriction section 3.

[0050] The central constriction segment 3 is woven from a third filament 30 to form a third mesh structure. The third filament 30 is made of a shape memory alloy, including but not limited to nickel-titanium alloys, copper-based shape memory alloys, or other shape memory alloys with the same function and purpose. Because the central constriction segment 3 is woven from the third filament 30 made of shape memory alloy, it can self-expand to a suitable size at the appropriate position during the release of the coronary sinus constriction device 100. In addition, compared with the cutting structure, the central constriction segment 3 woven from the third filament 30 is more flexible.

[0051] The first mesh opening 14 of the first mesh structure (i.e., the first support segment 1) is larger and less dense than the third mesh opening 34 of the third mesh structure (i.e., the central constriction segment 3), and the second mesh opening 24 of the second mesh structure (i.e., the second support segment 2) is larger and less dense than the third mesh opening 34. Because both the first support segment 1 and the second support segment 2 have larger mesh openings and fewer meshes, they effectively reduce vascular wall hyperplasia and thrombus formation during endothelialization, and also shorten the endothelialization time of the coronary sinus constriction device 100. The central constriction area, being more flexible and having smaller and denser mesh openings, can increase the regulatory effect of the coronary sinus constriction device 100 in the early stages of implantation, better influencing blood flow, achieving throttling regulation, increasing back pressure, improving the perfusion ratio of epicardial and subendocardial blood flow, and compared with a purely cut mesh structure, it is more conducive to endothelial cell adhesion, shortening the endothelialization time of the coronary sinus constriction device 100 and enhancing the effect of the coronary sinus constriction device 100. Furthermore, the first grid edge 10 of the first grid structure is thicker than the third wire 30, and the second grid edge 20 of the second grid structure is thicker than the third wire 30, to ensure support stability and make it fit more closely to the inner wall of the tube.

[0052] The first transition zone A is formed at the connection between the first supporting segment 1 and the central constricted segment 3. The first transition zone A gradually narrows and smoothly transitions from the first supporting segment 1 towards the throat 33 of the central constricted segment 3. The smooth transition between the first supporting segment 1 and the central constricted segment 3 via the first transition zone A can prevent excessive stimulation of the inner wall of the lumen at the connection between the first supporting segment 1 and the central constricted segment 3, thus avoiding increased damage to the inner wall. The second transition zone B is formed at the connection between the second supporting segment 2 and the central constricted segment 3. The second transition zone B gradually narrows and smoothly transitions from the second supporting segment 2 towards the throat 33. Similarly, the smooth transition between the second supporting segment 2 and the central constricted segment 3 via the second transition zone B can prevent excessive stimulation of the inner wall of the lumen at the connection between the second supporting segment 2 and the central constricted segment 3, thus avoiding increased damage to the inner wall.

[0053] In some embodiments, the central necked section 3 is hourglass-shaped and has a third transition arc 31, a fourth transition arc 32, and a throat 33. The throat 33 connects the third transition arc 31 and the fourth transition arc 32, and the third transition arc 31, the fourth transition arc 32, and the throat 33 are woven together throughout. The first support section 1 has a first transition arc 11 at one end near the central necked section 3. The first transition arc 11 and the third transition arc 31 are smoothly joined, so that the first transition area A formed by the first transition arc 11 and the third transition arc 31 has a rounded corner shape that gradually narrows from the first support section 1 to the throat 33, thereby achieving a smooth transition at the connection between the first support section 1 and the central necked section 3. The second support segment 2 has a second transition arc 21 at one end near the central necking segment 3. The second transition arc 21 and the fourth transition arc 32 are smoothly connected, so that the second transition area B formed by the second transition arc 21 and the fourth transition arc 32 is a rounded corner that gradually narrows from the second support segment 2 to the throat 33, thereby achieving a smooth transition at the connection between the second support segment 2 and the central necking segment 3.

[0054] In some embodiments, the first support segment 1 is provided with a first connecting hole 13 at its end near the central constricted segment 3. The first connecting hole 13 is connected to the first end of the central constricted segment 3, that is, the first transition arc portion 11 is provided with the first connecting hole 13, and the third transition arc portion 31 is connected to the first connecting hole 13. Preferably, the diameter of the first connecting hole 13 is larger than the diameter of the third wire 30, so that after the coronary sinus narrowing device 100 is implanted, it can effectively prevent the first support segment 1 from being compressed due to the pressure in the lumen, thereby preventing hyperplasia caused by the central constricted segment 3 being too narrow and preventing danger. The first connecting hole 13 can be a circular ring, a triangle with rounded apex, or other feasible structures. In this embodiment, the first connecting hole 13 can be a circular ring. Furthermore, the connection methods between the first connecting hole 13 (or the first transition arc 11) and the third transition arc 31 include, but are not limited to, welding, bonding, riveting (including direct riveting or riveting using a connecting sleeve), and integral weaving [referring to weaving the third filament 30 onto the first connecting hole 13 (or the first transition arc 11) when weaving the central necking section 3]. Similarly, the second supporting section 2 has a second connecting hole 23 at its end near the central necking section 3. The second connecting hole 23 is connected to the second end of the central necking section 3, that is, the second transition arc 21 has a second connecting hole 23, and the fourth transition arc 32 is connected to the second connecting hole 23. Preferably, the diameter of the second connecting hole 23 is larger than the diameter of the third wire 30, so that after the coronary sinus narrowing device 100 is implanted, it can effectively prevent the second supporting segment 2 from being compressed due to the pressure in the lumen, thereby preventing the central necking segment 3 from being compressed and narrowed, and thus preventing hyperplasia caused by the central necking segment 3 being too narrow, thus preventing danger. The second connecting hole 23 can be a circular ring, a triangle with rounded apex, or other feasible structures. In this embodiment, the second connecting hole 23 can be a circular ring. In addition, the connection method between the second connecting hole 23 (or the second transition arc 21) and the fourth transition arc 32 includes, but is not limited to, welding, bonding, riveting (including direct riveting or riveting using a connecting sleeve), integral weaving [referring to weaving the third wire 30 onto the second connecting hole 23 (or the second transition arc 21) when weaving the central necking segment 3], etc.

[0055] Furthermore, a flow-blocking membrane can be provided on the inner and / or outer surface of the coronary sinus constriction device 100. It is understood that if the first support segment 1 has a first drug-loaded structure and the second support segment 2 has a second drug-loaded structure, the flow-blocking membrane does not cover the medication within the first and second drug-loaded structures, allowing the medication to exert its normal effect. By providing the flow-blocking membrane, the coronary sinus constriction device 100 can achieve an immediate diameter reduction effect after implantation, preventing blood from flowing out of the coronary sinus constriction device 100 through its mesh. The flow-blocking membrane can be made of polytetrafluoroethylene (PTFE), polyurethane (PU), vinyl alcohol (PVA), collagen, or other membranes with similar functions.

[0056] In summary, the design of the coronary sinus constriction device 100 achieves the following beneficial effects:

[0057] First, since the coronary sinus constriction device 100 has a segmented structure design, and the first support segment 1, the second support segment 2, and the central constriction segment 3 can be made of different materials, the first support segment 1, the second support segment 2, and the central constriction segment 3 can all be configured with different structures according to their respective functions. This greatly reduces the degree of mutual influence between the effect of the central constriction segment 3 and the effects of the first support segment 1 and the second support segment 2, enhances the diameter reduction effect of the coronary sinus constriction device 100, and ensures the stability of the diameter reduction effect.

[0058] Second, the first support segment 1 and the second support segment 2 can fit closely to the inner wall of the lumen, thereby stabilizing the coronary sinus narrowing device 100 in the target position. Moreover, the first support segment 1 and the second support segment 2 can adjust their size autonomously within a certain range, reducing the risk of the coronary sinus narrowing device 100 falling off or causing excessive damage to the target lumen.

[0059] Third, the first drug-loading structure on the first support segment 1 and the second drug-loading structure on the second support segment 2 facilitate rapid endothelialization of the coronary sinus narrowing device 100.

[0060] Fourth, the central constricted segment 3 is woven from filaments with shape memory capabilities, which is softer than the cut structure and has a higher mesh density, enabling it to better influence blood flow, achieve throttling regulation, increase back pressure, and improve the ratio of epicardial and subendocardial blood perfusion.

[0061] Fifth, the coronary sinus narrowing device 100 has good shape adaptability and does not require balloon dilation after implantation, simplifying the procedure.

[0062] Sixth, the first support segment 1 and the central constriction segment 3 are smoothly transitioned through the first transition zone A, and the second support segment 2 and the central constriction segment 3 are smoothly transitioned through the second transition zone B, which effectively avoids excessive stimulation of the inner wall of the lumen by the coronary sinus constriction device 100, thereby avoiding increased damage to the inner wall.

[0063] Seventh, the first connecting hole 13 is provided in the first support section 1 to connect with the central necking section 3, and the second connecting hole 23 is provided in the second support section 2 to connect with the central necking section 3, which makes the connection between the central necking section 3 and the first support section 1 and the second support section 2 more convenient, and will not cause damage to the third wire 30 of the central necking section 3.

[0064] Eighth, the coronary sinus constriction device 100 was not completely or partially disengaged from the delivery sheath 1012 (see reference). Figure 8 When the coronary sinus constriction device 100 is compressed and retracted into the delivery sheath 1012 relatively stably, it has strong recyclability.

[0065] Second embodiment of coronary sinus constriction device

[0066] Reference Figure 3 and Figure 4 The difference between this embodiment and the first embodiment of the coronary sinus constriction device is that, in this embodiment:

[0067] A connector 15 is provided at the end of the first support segment 1 furthest from the central constriction segment 3. If the connector 15 is located at the farthest end of the first support segment 1 furthest from the central constriction segment 3, the connector 15 is used to connect with the delivery assembly 101 to enhance the stability of the delivery and retrieval of the coronary sinus constriction device 100 by the delivery assembly 101. The connector 15 and the first support segment 1 can be an integral structure or a separate connection. When the connector 15 and the first support segment 1 are a separate connection, the connection method between the connector 15 and the first support segment 1 is not limited to welding, bonding, etc.

[0068] In addition, the number of connectors 15 is preferably two or more. The number of connectors 15 can be designed according to the number of connecting parts 10111 that cooperate with them on the delivery assembly 101, so as to ensure that the delivery assembly 101 can stably deliver and retrieve the coronary sinus constriction device 100.

[0069] In some embodiments, the connector 15 is T-shaped. Specifically, the connector 15 has an integrally formed horizontal segment 151 and a vertical segment 152. The first end of the vertical segment 152 is connected to the horizontal segment 151 and located between the two ends of the horizontal segment 151, and the second end of the vertical segment 152 is connected to the first support segment 1. Through the structural design of the connector 15, the reliability of the fit between the connector 15 and the connecting portion 10111 on the conveying assembly 101 and the ease of assembly and disassembly can be improved.

[0070] Combination Figure 5 and Figure 6 When implanting the coronary sinus constriction device 100, firstly, the connectors 15 of the coronary sinus constriction device 100 are embedded into the corresponding grooves on the delivery cable 1011 of the delivery assembly 101 (the grooves are the connecting parts 10111; when the connectors 15 are T-shaped, the grooves are also T-shaped similar to the connectors 15); then, the delivery cable 1011 is withdrawn (at this time, the delivery cable 1011 is inserted into the delivery sheath 1012), so that the connectors 15 enter the delivery sheath 1012; then, the delivery cable 1011 is withdrawn again, and under the traction of the delivery cable 1011, the coronary sinus constriction device 100 is placed in the delivery sheath 1012 (e.g., Figure 6 (As shown).

[0071] When the coronary sinus constriction device 100 is moved to the target position via the delivery assembly 101, the delivery sheath 1012 switches from the retracted state to the released state. This is achieved by retracting the delivery sheath 1012 in conjunction with the delivery cable 1011, causing the second support section 2 of the coronary sinus constriction device 100 to extend out of the sheath and self-expand under the influence of its memory properties. As the delivery sheath 1012 gradually retracts, the coronary sinus constriction device 100 gradually self-expands back to its original state. When the connector 15 of the coronary sinus constriction device 100 is completely removed from the delivery sheath 1012, the connector 15 automatically disengages from the groove of the delivery cable 1011. At this time, the connector 15 automatically reverts to its original shape during the recovery process of the coronary sinus constriction device 100. The coronary sinus constriction device 100 is then completely released to detach from the delivery assembly 101 and is fixed at the target position. Subsequently, the delivery assembly 101 is withdrawn from the patient, completing the entire release process.

[0072] It should be noted that when the connector 15 is not completely detached from the delivery sheath 1012, if the position of the coronary sinus constriction device 100 is not ideal or there are other situations, the delivery sheath 1012 can be pushed forward or the delivery steel cable 1011 can be pulled back to retract and adjust the coronary sinus constriction device 100, so that the coronary sinus constriction device 100 can be retrievable.

[0073] Except for the differences mentioned above, the other structural designs of the coronary sinus constriction device 100 in this embodiment are the same as those in the first embodiment of the coronary sinus constriction device 100.

[0074] Third embodiment of coronary sinus constriction device

[0075] Reference Figure 7 The difference between this embodiment and the above embodiments is that, in this embodiment:

[0076] The first support section 1 is no longer formed by cutting the first metal tube to form the first mesh structure, but by weaving the first wire to form the first mesh structure; wherein, the first wire is made of shape memory alloy, which includes, but is not limited to, nickel-titanium alloy, copper-based shape memory alloy or other shape memory alloys with the same function and purpose. In addition, the first wire is thicker than the third wire.

[0077] The second support section 2 is no longer formed by cutting the second metal tube to form the second mesh structure, but by weaving the second wire to form the second mesh structure; wherein, the second wire is made of shape memory alloy, including but not limited to nickel-titanium alloy, copper-based shape memory alloy, or other shape memory alloys with the same function and purpose. In addition, the second wire is thicker than the third wire.

[0078] Similarly, in this embodiment, the first support segment 1, the second support segment 2, and the central constriction segment 3 are segmented. The central constriction segment 3 and the first support segment 1 and the second support segment 2 are made of medical shape memory metal wires with different diameters. The first support segment 1 and the second support segment 2 use thicker braided wires with larger mesh openings and lower density. Therefore, compared with a coronary sinus constriction device that is entirely braided, this coronary sinus constriction device 100 has fewer intersections with the inner wall of the lumen, so it is less likely to cause greater stimulation to the inner wall of the lumen, reducing the risk of excessive proliferation and thrombosis, and shortening the endothelialization time. This meets the requirements of the support segment to have greater support without causing excessive vascular damage or excessive proliferation inside the lumen.

[0079] Similarly, segmented weaving allows for a more flexible central neck segment 3 with a smaller and denser mesh, effectively increasing blood flow restriction and enhancing the regulatory effect of the coronary sinus constrictor 100 in the early stages of implantation. Simultaneously, compared to a purely diced stent structure, it facilitates endothelial cell adhesion, shortens the endothelialization time of the coronary sinus constrictor 100, and enhances its overall effect. Furthermore, the multi-filament segmented weaving significantly reduces the influence between the supporting segment's effect and the central neck segment, increasing the overall effect of the coronary sinus constrictor 100 and enhancing its stability.

[0080] Apart from the differences mentioned above, the other structural designs of the coronary sinus constriction device 100 in this embodiment are the same as those in other embodiments.

[0081] Fourth embodiment of coronary sinus constriction device

[0082] Reference Figure 8 The difference between this embodiment and the first or second embodiment of the coronary sinus constriction device is that, in this embodiment:

[0083] The first support section 1 is no longer formed by cutting the first metal tube to form the first mesh structure, but by weaving the first filament to form the first mesh structure; wherein, the first filament is made of medical bio-absorbable material. In addition, the first filament is thicker than the third filament.

[0084] The second support section 2 is no longer formed by cutting the second metal tube to form the second mesh structure, but by weaving the second filament to form the second mesh structure; wherein, the second filament is made of medical bioabsorbable material. In addition, the second filament is thicker than the third filament.

[0085] The first support segment 1 and the second support segment 2 are made of bioabsorbable materials. In the initial stage of coronary sinus narrowing device 100 implantation, they directly contact the inner wall of the lumen, stabilizing the device in the target position. As the implantation time increases, the first support segment 1 and the second support segment 2 gradually degrade. During the endothelialization process of the coronary sinus narrowing device 100, they do not continuously cause excessive stimulation to the vascular inner wall, thereby inhibiting excessive proliferation within the blood vessel, preventing the final lumen diameter from being too small, and reducing the risks associated with using the coronary sinus narrowing device 100.

[0086] Implantation System Examples

[0087] refer to Figure 5 and Figure 6 The implantation system includes a delivery component 101 and a coronary sinus constriction device, wherein the coronary sinus constriction device is the coronary sinus constriction device 100 described in any one of the first to fourth embodiments of the coronary sinus constriction device.

[0088] The delivery assembly 101 includes a delivery cable 1011 and a delivery sheath 1012. The coronary sinus constriction device 100 can be detachably connected to the connection portion 10111 of the delivery cable 1011 via a connector 15 thereon. Of course, when the coronary sinus constriction device 100 is not provided with a connector 15, the connection portion 10111 of the coronary sinus constriction device 100 and the delivery cable 1011 can be connected by other existing known connection methods, so no examples will be given here.

[0089] The coronary sinus constriction device 100 can be delivered to the target location via the delivery assembly 101 for release; wherein, the coronary sinus constriction device 100 can be received into the delivery sheath 1012 via the delivery cable 1011 or pushed out of the delivery sheath 1012 by the delivery cable 1011.

[0090] The implanted system enhances the diameter reduction effect of the coronary sinus constriction device 100 by setting up the coronary sinus constriction device 100, and ensures the stability of the diameter reduction effect.

[0091] Finally, it should be emphasized that the above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. For those skilled in the art, the present utility model can have various changes and modifications. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A coronary sinus constriction device, hourglass-shaped, comprising a first support segment, a second support segment, and a central constriction segment, wherein the central constriction segment is connected between the first support segment and the second support segment, characterized in that: The first support section is formed by cutting a first metal tube to form a first mesh structure, or the first support section is formed by weaving a first wire to form the first mesh structure; The second support section is formed by cutting a second metal tube to form a second space frame structure, or the second support section is formed by weaving a second wire to form the second space frame structure; The central necked section is woven from a third filament to form a third mesh structure, and the third filament is made of shape memory alloy.

2. The coronary sinus constriction device according to claim 1, characterized in that: The connection between the first support section and the central constriction section forms a first transition zone, which gradually narrows and smoothly transitions from the first support section to the throat of the central constriction section. The connection between the second support section and the central constriction section forms a second transition zone, which gradually narrows and smoothly transitions from the second support section to the throat.

3. The coronary sinus constriction device according to claim 2, characterized in that: The first diameter of the first support section is greater than or equal to the second diameter of the second support section.

4. The coronary sinus constriction device according to claim 3, characterized in that: The first support segment has a first gentle section of equal diameter at its end away from the central constriction segment; and / or The second support section has a second gentle section of equal diameter at its end away from the central constriction section.

5. The coronary sinus constriction device according to claim 1, characterized in that: The first metal tube is made of shape memory alloy, and the second metal tube is made of shape memory alloy; The first filament is made of shape memory alloy or medical bioabsorbable material, and the second filament is made of shape memory alloy or medical bioabsorbable material.

6. The coronary sinus constriction device according to claim 1, characterized in that: The first support section has a first connecting hole at its end near the central necked section, and the first connecting hole is connected to the first end of the central necked section. The second support section has a second connecting hole at its end near the central necked section, and the second connecting hole is connected to the second end of the central necked section.

7. The coronary sinus constriction device according to claim 6, characterized in that: The diameter of the first connecting hole is larger than the diameter of the third wire. The diameter of the first connecting hole is larger than the diameter of the third wire.

8. The coronary sinus constriction device according to claim 1, characterized in that: The end of the first support section away from the central constricted section is provided with a connector.

9. The coronary sinus constriction device according to claim 8, characterized in that: The number of the connectors is two or more; and / or The connector is T-shaped and has a horizontal segment and a vertical segment. The first end of the vertical segment is connected to the horizontal segment and is located between the two ends of the horizontal segment. The second end of the vertical segment is connected to the first support segment.

10. The coronary sinus constriction device according to claim 1, characterized in that: The inner and / or outer surfaces of the coronary sinus constriction device are provided with a flow-blocking membrane.

11. The coronary sinus constriction device according to any one of claims 1 to 10, characterized in that: The first support segment is provided with a first drug-loading structure, and / or The second support section is provided with a second drug-carrying structure; and / or The first mesh edge of the first space frame structure is thicker than the third wire, the second mesh edge of the second space frame structure is thicker than the third wire, the first mesh opening of the first space frame structure is larger and sparser than the third mesh opening of the third space frame structure, and the second mesh opening of the second space frame structure is larger and sparser than the third mesh opening.

12. An implantation system, including a delivery component, characterized in that, It also includes the coronary sinus constriction device as described in any one of claims 1 to 11, wherein the coronary sinus constriction device is detachably connected to the delivery assembly.

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