An interatrial shunt device

Abstract

The application relates to the technical field of medical devices, in particular to a heart atrial shunt device which comprises a lead-through part and first and second positioning bodies arranged on the two sides of the lead-through part respectively, and the lead-through part, the first positioning body and the second positioning body are integrally woven by a single braided wire. In the embodiment of the application, the heart atrial shunt device is integrally woven by the single braided wire without needing to process bulk wire heads, after installation, no redundant structure protrudes into the left and right atria, blood clots are not easy to form, the structure is simple, the size is smaller during contraction, and the damage to the access blood vessels during implantation is smaller.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an atrial shunt device. Background Technology

[0002] Heart failure (HF) is a syndrome caused by impaired systolic and / or diastolic function of the heart, resulting in insufficient venous return and venous congestion, inadequate arterial perfusion, and consequently, cardiac circulatory disorders. HF is a serious disease with high incidence and mortality. Based on the location of the heart failure, it can be classified as left ventricular failure, right ventricular failure, or biventricular failure. Based on clinical manifestations, it can also be divided into systolic heart failure and diastolic heart failure, with diastolic heart failure (DHF) accounting for approximately half of all HF cases. In China, there are over 12 million HF patients, representing an incidence rate of approximately 2-3%. Of these, about 6 million are diastolic heart failure patients. Diastolic heart failure is more common in the elderly, accounting for 66.99% of all diastolic heart failure cases.

[0003] The main causes of heart failure include hypertension, coronary heart disease, myocardial infarction, valvular heart disease, atrial fibrillation, and cardiomyopathy. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and consequently, decreased cardiac function. This means that for every patient successfully treated for myocardial infarction, there is a potential patient with heart failure.

[0004] In treating heart failure, existing methods all have limitations. For example, optimized drug therapy cannot fundamentally eliminate the cause and there is still a possibility of recurrence; cardiac resynchronization therapy (CRT) is ineffective in at least 20% of heart failure patients; left ventricular assist device (LVAD) surgery requires cardiopulmonary bypass, which is not only highly invasive with a high complication rate, but also expensive and difficult to obtain, and the conditions for performing the surgery are not available in China; heart transplantation can fundamentally solve the problem, but the source of donors is very limited and expensive.

[0005] Patent publication number CN113558820A discloses a shunt device consisting of two discs connected by a waist section as a shunt channel. The two discs have multiple independent petal-shaped structures that adhere to and anchor against the atrial wall. However, in this structure, the discs adhering to the atrial wall are composed of multiple independent petal structures, resulting in poor wall adhesion and anchoring effects, failing to ensure the shunt remains stably anchored at the atrial stoma site. Patent publication number CN110536657A discloses a shunt device for redistributing atrial blood volume. This shunt uses an hourglass-shaped shunt method, but its hourglass shape is prone to displacement under the scouring of blood flow, changing the installation angle and forming an artificial small angle with the atrial septum. This angle space easily generates eddies and thrombi. Furthermore, the attachment of a high-molecular-weight ePTFE membrane to the outer surface of the shunt device may lead to complications such as thrombosis and hemolysis.

[0006] Because a stoma needs to be created at the implantation site before the shunt device can be implanted, existing shunt devices are mostly made by cutting the covered structure or weaving multiple strands of fine filaments. Their structures are often quite complex, and after implantation, the structure often protrudes into the left and right atria, increasing the risk of subsequent thrombosis. Moreover, they still have a large cross-sectional area in the contracted state, so a large sheath diameter of the delivery device is often required. Such delivery devices are not suitable for cases with more tortuous access routes and more complex lesion structures. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a simplified atrial shunt device.

[0008] To achieve the above objectives, the present invention is implemented through the following technical solutions.

[0009] This application provides an atrial shunt device, including a first positioning body, a second positioning body located on both sides of the atrial septum, and a conductive portion penetrating the atrial septum;

[0010] The conductive part, the first positioning body, and the second positioning body are shaped by a single braided wire. The two ends of the braided wire are respectively attached to the atrial shunt device, and the two ends of the braided wire do not protrude outward from the atrial shunt device.

[0011] Further specifying, in the aforementioned atrial shunt device, the braided wire is made of one or more of the following materials: nickel-titanium alloy and platinum-iridium alloy.

[0012] Further specifying, in the above-mentioned atrial shunt device, the diameter of the braided filament is 0.08 to 0.3 mm.

[0013] Further specifying, in the above-mentioned atrial shunt device, the edge of the first positioning body extends beyond the edge of the conductive portion.

[0014] Further specifying, in the above-mentioned atrial shunt device, the first positioning body is disc-shaped.

[0015] Further specifying, in the aforementioned atrial shunt device, the edge of the first positioning body moves closer to the side of the conductive portion.

[0016] Further specifying, in the above-mentioned atrial shunt device, the edge of the second positioning body protrudes beyond the edge of the conductive portion.

[0017] Further specifying, in the aforementioned atrial shunt device, the second positioning body is disc-shaped.

[0018] Further specifying, in the aforementioned atrial shunt device, the second positioning body has a double-layer structure.

[0019] Further specifying, in the above-mentioned atrial shunt device, the middle portion of the second positioning body is recessed towards the side closer to the conducting portion.

[0020] Further specifying, the aforementioned atrial shunt device further includes:

[0021] A diaphragm covers the surfaces of the first positioning body and the second positioning body.

[0022] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0023] 1. The conductive section, first positioning body, and second positioning body are constructed using a single braided filament, with both ends of the braided filament abutting against the atrial shunt device. No additional structure is needed to treat the ends of the braided filament, simplifying the overall structure of the shunt device. Furthermore, due to the small diameter of the braided filament, its cross-sectional area when contracted to its minimum diameter is small, allowing for a smaller sheath when loaded into the transmission unit that mates with the atrial shunt device.

[0024] 2. Because the atrial shunt device can shrink to a smaller sheath, the outer diameter of the transmission unit is reduced. During the actual operation, the smaller outer diameter of the transmission unit reduces the damage to the access vessel as it enters the atrium through the puncture point along the access path. Furthermore, the smaller outer diameter of the transmission unit provides better flexibility, improving its adaptability to tortuous vessels. It also offers better passage performance for vessels with complex lesions compared to a larger outer diameter transmission unit.

[0025] 3. The diverging edge of the first positioning body moves closer to the side of the second positioning body. The second positioning body has a double-layer structure and the middle part of the guide section is concave on one side, so that after the atrial shunt device is implanted, the first positioning body and the second positioning body can achieve better wall adhesion and anchoring effect under their own elasticity.

[0026] 4. Since the first and second positioning bodies are made of a single braided filament, after installation, there are no extra structures protruding into the left and right atria, which allows the first and second positioning bodies to quickly become endothelialized and makes it less likely for thrombi to form.

[0027] 5. Since the first positioning body, the second positioning body, and the conductive part are made of a single braided filament, there are no excess braided filaments protruding from their contact surfaces with the heart structure, which can avoid causing trauma points to the atrium during frequent atrial contractions.

[0028] 6. The surfaces of the first and second positioning bodies are covered with diaphragms, which can isolate blood flow and provide better adhesion for the first and second positioning bodies. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the specific structure of the interatrial shunt device according to an embodiment of this application;

[0030] Figure 2 This is a schematic diagram of the front view of the interatrial shunt device according to an embodiment of this application;

[0031] Figure 3 This is a side view of the interatrial shunt device according to an embodiment of this application;

[0032] Figure 4 This is a side sectional view of the interatrial shunt device according to an embodiment of this application;

[0033] Figure 5 This is a side sectional view of the interatrial shunt device according to an embodiment of this application;

[0034] Figure 6 This is a side sectional view of the interatrial shunt device according to an embodiment of this application;

[0035] Figure 7 This is a side sectional view of the interatrial shunt device according to an embodiment of this application;

[0036] Figure 8 This is a schematic diagram of the front view of the interatrial shunt device according to an embodiment of this application;

[0037] Figure 9 This is a schematic diagram of the installation structure of the interatrial shunt device according to an embodiment of this application.

[0038] Figure Labels

[0039] Braided yarn-100, conductive part-110, flow cavity-111, first positioning body-121, second positioning body-122, diverging end-1221, gathering end-1222, cross hole-123, cross node-124, flow port-125, diaphragm-200. Detailed Implementation

[0040] The technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application are within the scope of protection of this application.

[0041] The terms "first," "second," etc., used in the specification and claims of this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such use of data can be interchanged where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class and the number of objects is not limited; for example, a first object can be one or more. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0042] The server provided in this application will be described in detail below with reference to the accompanying drawings, through specific embodiments and application scenarios.

[0043] Example 1:

[0044] like Figures 1-4 As shown, this application provides an atrial shunt device, including a conducting part 110 and a first positioning body 121 and a second positioning body 122 respectively disposed on both sides of the conducting part 110. The conducting part 110, the first positioning body 121, and the second positioning body 122 are integrally woven from a single braided filament 100. The two ends of the braided filament 100 abut against the atrial shunt device and the two ends do not protrude outward from the atrial shunt device. The braided filament 100 can be made of plastic expandable or self-expanding materials such as nickel-titanium alloy and platinum-iridium alloy, and its filament diameter is between 0.12 and 0.2 mm.

[0045] The conduit 110 has a through-hole for blood flow 111. The cross-section of the through-hole 111 is circular or nearly circular. The first positioning body 121 and the second positioning body 122 are disc-shaped. The first positioning body 121 is located on the first side of the conduit 110 and is radiating. It gradually shifts towards the side closer to the second positioning body 122 along the radiating path. In other words, the edge of the first positioning body 121 is closer to the second positioning body 122 than the center. The second positioning body 122 is disposed on the second side of the conduction part 110, that is, the end of the conduction part 110 away from the first positioning body 121. The second positioning body 122 has a folded double-layer structure, which is formed by the conduction part 110 diverging from the end away from the first positioning body 121 and then folding and closing along the side away from the conduction part 110. Its diverging end 1221 is located on the second side of the conduction part 110, and its closing end 1222 is offset towards the side close to the conduction part 110 and forms a flow opening 125 corresponding to the cross-sectional boundary position of the flow cavity 111. The diameter of the flow opening 125 is the same as the diameter of the flow cavity 111 to ensure normal blood flow in the flow cavity 111.

[0046] like Figure 9 As shown, after the atrial shunt device is implanted at the atrial septum stoma site, the divergent edge of the first positioning body 121 initially moves closer to the conduction portion 110 and deforms due to the contact with the atrial septum after implantation. Under the action of this deformation elastic force, the anchoring force between the first positioning body 121 and the atrial septum is enhanced. In other words, because the edge of the first positioning body 121 moves closer to the second positioning body, the clamping force on the atrial septum is improved. The conduction portion 110 penetrates the atrial septum stoma, and the flow cavity 111 can meet the blood flow requirements.

[0047] The first positioning body 121 and the second positioning body 122 are mesh structures. The weaving method is that a single braided filament 100 meanders and forms multiple cross nodes 124. The cross node 124 is the intersection point formed by two braided filaments 100 that are bent from a single braided filament 100. The braided filaments 100 that constitute the cross node 124 form multiple quadrilateral cross holes 123. The two braided filaments 100 that constitute a single cross node 124 can be connected to each other or separated at the position of the cross node 124. When the atrial shunt device is in the contracted state, the cross hole 123 is in the closed state. After the atrial shunt device is implanted, the cross hole 123 is in the open state.

[0048] The conductive part 110 is composed of a ring array of multiple parallel braided filaments 100 formed by bending a single braided filament 100. There are gaps between the multiple parallel braided filaments 100, which allows the conductive part 110 to have a certain degree of stretching and contraction in the radial direction.

[0049] The intersection nodes 124 at the edges of the first positioning body 121 and the second positioning body 122, as well as the braided wire 100, are all passivated to reduce the trauma to the atrium during and after implantation.

[0050] In this embodiment, since the conductive part 110, the first positioning body 121, and the second positioning body 122 are woven from a single braided filament 100, the atrial shunt device has only two ends of braided filament 100. The two ends of the braided filament 100 abut against the atrial shunt device respectively. Therefore, after the atrial shunt device is woven, no other parts or structures are needed to process the loose ends, avoiding excess structures protruding into the left and right atria and reducing the risk of thrombosis.

[0051] Example 2:

[0052] like Figure 5 As shown, in this embodiment, the length of the guide portion 110 is extended, that is, guide portions 110 of different lengths are woven to meet the needs of room partitions of different thicknesses, thereby adapting to different room partition widths, making the anchoring force of the first positioning body 121 and the second positioning body 122 more suitable, thereby achieving a better diversion effect.

[0053] Of course, materials with greater elasticity or extensibility can also be used to fabricate the conductive part 110, so that it can adapt to room partitions of different thicknesses through its own deformation.

[0054] Example 3:

[0055] like Figure 6 As shown, in this embodiment, the second positioning body 122 has a folded double-layer structure. It is formed by the diverging end of the conductive part 110 away from the first positioning body 121 and then folding it close to the first side of the conductive part 110. Its diverging end 1221 is located on the side of the conductive part 110 away from the first positioning body 121, and its folding end 1222 is offset towards the side close to the first positioning body 121 and surrounds the outer surface of the conductive part 110. At this time, blood flows directly through the flow cavity 111. This double-layer structure of the second positioning body 122 can avoid the formation of a small angle between it and the interatrial septum after implantation, thereby avoiding the formation of eddies and thrombi in the angle space.

[0056] Example 4:

[0057] like Figure 7As shown, in this embodiment, the first positioning body 121 and the second positioning body 122 are symmetrically arranged, that is, the second positioning body 122 is a single-layer disk structure. At this time, the second positioning body 122 is located on the side of the conducting part 110 away from the first positioning body 121 and is in a divergent shape. It gradually shifts towards the side closer to the first positioning body 121 along the divergent path. The second positioning body 122 under this structure can further reduce its cross-sectional area when it contracts, so that it can be contracted into a smaller sheath when loaded into the transmission unit that cooperates with the interatrial shunt device.

[0058] Example 5:

[0059] like Figure 8 As shown, in this embodiment, during the weaving process of the braided yarn 100 to the first positioning body 121 and the second positioning body 122, the inner diameter of the cross hole 123 is increased and the number of cross nodes 124 is reduced. The surfaces of the first positioning body 121 and the second positioning body 122 are covered with a diaphragm 200.

[0060] The diaphragm 200 has a double-layer structure at the cross hole 123 position of the first positioning body 121 and the second positioning body 122. The double-layer diaphragm 200 at the cross hole 123 position is bonded together by means of heat fusion or adhesive bonding. At this time, the first positioning body 121 and the second positioning body 122 are completely wrapped by the diaphragm 200, thus having an integral structure. The first positioning body 121 and the second positioning body 122 use their woven structure to provide support, and the membrane can play the role and purpose of isolating blood flow.

[0061] The diaphragm 200 covers the first positioning body 121 and the second positioning body 122 at a boundary that is not greater than the actual size boundary of the first positioning body 121 and the second positioning body 122, meaning that the diaphragm 200 will not affect the blood flow in the flow cavity 111.

[0062] In this embodiment, due to the above-mentioned structure, the overall structure of the first positioning body 121 and the second positioning body 122 is stronger, thereby further simplifying the overall structure of the atrial shunt device by increasing the inner diameter of the cross hole 123 and reducing the number of cross nodes 124, so that it has stronger extensibility and contraction and better wall adhesion effect.

[0063] Example 6:

[0064] This application provides an assembly for an implantable shunt device, including an atrial shunt device and a transmission unit that accommodates the atrial shunt device in a compressed state and transmits the atrial shunt device to the stoma location in the middle of the atrial septum.

[0065] In this embodiment, during the specific surgical procedure, the transmission unit delivers the atrial shunt device in its contracted state through the puncture point and along the access path into the atrium. Since the atrial shunt device is woven from a single braided filament 100 with a very small diameter, the cross-sectional area of ​​the atrial shunt device is small when contracted to its minimum diameter. Therefore, the transmission unit for transmitting the atrial shunt device is smaller, more flexible, and more adaptable to tortuous blood vessels, resulting in less damage to the access blood vessels during the implantation of the atrial shunt device.

[0066] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. Furthermore, it should be noted that the scope of the methods and apparatuses in the embodiments of this application is not limited to performing functions in the order shown or discussed, but may also include performing functions substantially simultaneously or in the reverse order, depending on the functions involved. For example, the described methods may be performed in a different order than described, and various steps may be added, omitted, or combined. Additionally, features described with reference to certain examples may be combined in other examples.

[0067] The embodiments of this application have been described above with reference to the accompanying drawings. However, this application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of this application.

Claims

1. An atrial shunt device, characterized in that, It includes a first positioning body, a second positioning body located on both sides of the interatrial septum, and a guiding part that penetrates the interatrial septum; The conductive part, the first positioning body, and the second positioning body are shaped by a single braided wire. The two ends of the braided wire are respectively attached to the atrial shunt device and the two ends of the braided wire do not protrude outward from the atrial shunt device. The internal passage of the guide section is provided with a flow cavity for blood flow. The second positioning body has a folded double-layer structure. It is made by diverging from the end of the guide section away from the first positioning body and then folding and closing along the side away from the guide section. Its diverging end is located on the second side of the guide section, and its closing end is offset towards the side close to the guide section and forms a flow opening corresponding to the cross-sectional boundary position of the flow cavity. The edge of the first positioning body moves closer to the side of the conductive part; The middle part of the second positioning body is recessed towards the side closer to the conductive part.

2. The atrial shunt device according to claim 1, characterized in that, The braided yarn is made of one or more materials, such as nickel-titanium alloy and platinum-iridium alloy.

3. The atrial shunt device according to claim 1, characterized in that, The diameter of the braided yarn is 0.08~0.3mm.

4. The atrial shunt device according to claim 1, characterized in that, The edge of the first positioning body protrudes beyond the edge of the conductive portion.

5. An atrial shunt device according to claim 4, characterized in that, The first positioning body is disc-shaped.

6. The atrial shunt device according to claim 1, characterized in that, The edge of the second positioning body protrudes beyond the edge of the conductive portion.

7. An atrial shunt device according to claim 6, characterized in that, The second positioning body is disc-shaped.

8. An atrial shunt device according to claim 1, characterized in that, Also includes: A diaphragm covers the surfaces of the first positioning body and the second positioning body.

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