Volume reduction device for left ventricle

Abstract

The utility model relates to the technical field of medical instruments, in particular to a left ventricle volume reduction device which comprises a base, an isolation disc and a connecting component, the isolation disc comprises a plurality of memory supporting pieces and memory weaving wires, and the memory supporting pieces are sequentially arranged with the connecting component as the center and connected with the connecting component; a radial basic framework is formed; the basic framework and the base are sequentially arranged in a spaced mode from top to bottom in the first preset direction. The memory weaving wires are woven on the basic framework to form a tray top face and tray side faces, the free ends of the memory weaving wires on the tray side faces are connected with the base, and the free ends of the memory weaving wires on the tray top face are connected with the connecting components. It can be seen that the outer disc face formed by the memory woven wires is good in flexibility and not prone to damaging the inner wall of the ventricle, the memory supporting piece is high in strength and hardness and better in supporting effect, the basic skeleton has the memory characteristic and can be automatically opened, a balloon does not need to be used for expansion, and operation steps are simplified.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a left ventricular volume reduction device. Background Technology

[0002] Currently, the main structure of existing left ventricular volume reduction devices consists of a support base and a flexible profile support frame or a wire-woven frame, with a polymer membrane covering the frame. This device is delivered to the left ventricular implantation site via a minimally invasive catheter-based interventional procedure, through the femoral artery and ascending along the aorta, passing through the aortic valve. The support base contacts the inner wall of the apex of the heart, and the expanded support frame isolates the ventricle into a resting chamber and a dynamic chamber. However, the current flexible profile support frame has poor material flexibility, easily damaging the inner wall of the ventricle, while the wire-woven frame is too soft and provides poor support. Therefore, there is a need to develop a left ventricular volume reduction device that provides good support and does not damage the inner wall of the ventricle. Utility Model Content

[0003] The purpose of this application is to provide a left ventricular volume reduction device, which to some extent solves the technical problem in the prior art of needing to develop a left ventricular volume reduction device with good support effect and without causing damage to the inner wall of the ventricle.

[0004] This application provides a left ventricular volume reduction device, including: a base, an isolation plate, and a connecting member; wherein, the isolation plate includes memory support members and memory braided yarns, and there are multiple memory support members arranged sequentially around the connecting member, and each of them is connected to the connecting member to form a radial basic skeleton;

[0005] The basic frame and the base are arranged sequentially from top to bottom along a first preset direction; the memory braided yarn is woven on the basic frame to form the top surface and side surface of the disc, and the free end of the memory braided yarn on the side surface of the disc is connected to the base, and the free end of the memory braided yarn on the top surface of the disc is connected to the connecting member.

[0006] In the above technical solution, the end of the memory support member away from the connecting member is further provided with a first anchor, and the first anchor protrudes from the top surface and the side surface of the disk in a direction away from the connecting member.

[0007] In any of the above technical solutions, the top surface of the disc is circular, the first anchor extends along the radial direction of the top surface of the disc, or the extension direction of the first anchor forms an angle with the radial direction of the top surface of the disc, and the extension direction of the first anchor is opposite to the direction of the rotational tendency of the isolation disc during cardiac contraction.

[0008] In any of the above technical solutions, the first anchor spike is further described as an arc-shaped structure.

[0009] In any of the above technical solutions, the left ventricular volume reduction device further includes a first flow-blocking layer, and the first flow-blocking layer is disposed on the inner side of the top surface of the disk.

[0010] In any of the above technical solutions, the first flow-blocking layer is further provided with a flanged portion, and the flanged portion is disposed against the inner side of the disk side surface.

[0011] In any of the above technical solutions, the base is further provided with a second anchor protruding outward.

[0012] In any of the above technical solutions, the base further includes a connecting part and a plurality of hook parts; wherein, the plurality of hook parts are arranged sequentially with the connecting part as the center, and any two adjacent hook parts are connected near the tail end of the connecting part to form a flower shape;

[0013] Each of the hook portions includes a first curved portion, a flat support portion, and a second curved portion connected in sequence. The end of the first curved portion away from the flat support portion is connected to the connecting portion. The flat support portion is used to abut against and support the inner wall of the ventricle. The end of the second curved portion away from the flat support portion is curled towards the connecting portion.

[0014] In any of the above technical solutions, the second anchor is further formed at one end of the second curved portion near the flat support portion, and extends in a direction away from the connecting portion, and does not protrude from the second curved portion.

[0015] In any of the above technical solutions, the left ventricular volume reduction device further includes a second flow-blocking layer, and along the first preset direction, the second flow-blocking layer is disposed at the bottom of the base, and along the first preset direction, the projection of the second anchor on the base is located outside the projection of the second flow-blocking layer.

[0016] In any of the above technical solutions, the connecting member is a connecting nut, and the free end of the memory braided yarn on the top surface of the disc is gathered inside the connecting nut.

[0017] In any of the above technical solutions, the material of the memory support is a nickel-titanium alloy.

[0018] In any of the above technical solutions, the material of the memory braided yarn is a nickel-titanium alloy.

[0019] In any of the above technical solutions, the base is further made of nickel-titanium alloy.

[0020] In any of the above technical solutions, the memory support is further described as an arc-shaped structure.

[0021] Compared with the prior art, the beneficial effects of this application are as follows:

[0022] The isolation disc of the left ventricular volume reduction device provided in this application is composed of a memory skeleton and metal wires. The outer disc surface formed by the metal wires has good flexibility and is not easy to damage the inner wall of the ventricle. The memory skeleton has high strength and rigidity, providing better support. Moreover, it has the characteristic of having memory. When the device is released from the delivery sheath, multiple memory support members 21 form a radial basic skeleton centered on the connecting member 3. The basic skeleton will then open automatically, eliminating the need for balloon dilation, simplifying the surgical procedure, increasing the surgical speed, and reducing costs due to its simple structure.

[0023] In addition, the anchors on the isolation disc and base can penetrate the ventricular wall, providing a stabilizing effect.

[0024] In addition, the outer edge of the projection of the outer disc along the height direction of the memory skeleton is circular, and the projection of the anchor is set along the radius of the projection of the outer disc, or the extension direction of the projection of the anchor forms an angle with the radius direction of the projection of the outer disc, and the extension direction of the projection of the anchor is opposite to the direction of the rotational tendency of the isolation disc during cardiac contraction, so as to ensure that the first anchor will not detach from the inner wall of the ventricle during cardiac contraction.

[0025] In addition, making the anchor bar into an arc shape provides high elasticity, which can buffer the reaction force on the tip of the anchor bar and greatly improve fatigue strength.

[0026] In addition, the base adopts a flower-shaped structure, and the head of the hook part of the flower-shaped structure is curved towards the connecting part, which can effectively prevent the product from scratching the sheath. Moreover, the bottom of each hook part is a flat support part, which improves the support strength and enhances the stability of the product.

[0027] In addition, the base is provided with a flow-blocking layer, such as a polymer flow-blocking membrane. The flow-blocking layer enables the base to unfold smoothly, increases the support surface, and reduces the pressure on the bottom of the apex of the heart after implantation. Preferably, the flow-blocking layer can be sutured to the base, and the flow-blocking layer will not exceed the second anchor, so as not to affect the unfolding of the second anchor and its insertion into the myocardium. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the structure of the left ventricular volume reduction device provided in the embodiments of this application;

[0030] Figure 2 Another structural schematic diagram of the left ventricular volume reduction device provided in the embodiments of this application;

[0031] Figure 3 This is a schematic diagram of the structure of the isolation disk provided in an embodiment of this application;

[0032] Figure 4 for Figure 3 A magnified structural diagram at point A;

[0033] Figure 5 This is a schematic diagram of the structure of the base provided in an embodiment of this application.

[0034] Figure label:

[0035] 1-Base, 11-Connecting part, 12-Hook part, 121-First bending part, 122-Flat support part, 123-Second bending part, 1233-Second anchor, 2-Isolation plate, 21-Memory support, 211-First anchor, 22-Memory braided yarn, 3-Connecting component, 4-First flow barrier layer, 41-Flanged part, 5-Second flow barrier layer. Detailed Implementation

[0036] The technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of this application, but not all embodiments.

[0037] The components of the embodiments of this application described and shown in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following detailed description of the embodiments of this application provided in the drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application.

[0038] Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0039] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0040] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0041] The following reference Figures 1 to 5 This application describes a left ventricular volume reduction device according to some embodiments.

[0042] See Figures 1 to 4 As shown, an embodiment of this application provides a left ventricular volume reduction device, including: a base 1, an isolation plate 2, and a connecting member 3; wherein, the isolation plate 2 includes memory support members 21 and memory braided filaments 22, the number of memory support members 21 is multiple, and they are arranged sequentially with the connecting member 3 as the center, and are all connected to the connecting member 3 to form a radial basic skeleton;

[0043] The basic frame and the base 1 are arranged sequentially from top to bottom along a first preset direction; memory braided wires 22 are woven on the basic frame to form the top surface and side surface of the disc, and the free ends of the memory braided wires 22 on the side surface of the disc are connected to the base 1, and the free ends of the memory braided wires 22 on the top surface of the disc are connected to the connecting member 3.

[0044] As can be seen from the structure described above, the isolation disc 2 of the left ventricular volume reduction device provided in this application is composed of a memory support 21 and a memory braided wire 22. The outer disc surface formed by the memory braided wire 22 has good flexibility and is not easy to damage the inner wall of the ventricle. The memory support 21 has high strength and hardness, and better support effect. Moreover, the memory support 21 has memory characteristics. When the device is released from the delivery sheath, multiple memory support 21 form a radial basic skeleton with the connecting member 3 as the center. The basic skeleton will open automatically without the need for balloon expansion, simplifying the surgical steps, improving the surgical speed, and reducing costs due to its simple structure.

[0045] In this embodiment, preferably, as follows: Figures 1 to 4 As shown, a first anchor 211 is formed at the end of the memory support member 21 away from the connecting member 3, and the first anchor 211 protrudes from the top surface and the side surface of the disk in a direction away from the connecting member 3.

[0046] As can be seen from the structure described above, the anchors on the isolation disc 2 can penetrate the ventricular wall, i.e., the myocardium, and play a stabilizing role.

[0047] In this embodiment, preferably, as follows: Figures 1 to 3 As shown, the top surface of the disk is circular, and the first anchor 211 extends along the radial direction of the top surface of the disk.

[0048] As can be seen from the structure described above, the first anchor 211 extends along the radial direction of the top surface of the disc, ensuring that the first anchor 211 will not detach from the inner wall of the ventricle during cardiac contraction.

[0049] It should be noted that, not only as described above, the extension direction of the first anchor 211 can also be angled with the radial direction of the top surface of the disk, and the extension direction of the first anchor 211 can be opposite to the direction of the rotational tendency of the isolation disk 2 during cardiac contraction, which can also ensure that the first anchor 211 will not detach from the inner wall of the ventricle during cardiac contraction.

[0050] In this embodiment, preferably, as follows: Figure 1 and Figure 2 As shown, the left ventricular volume reduction device also includes a first flow-blocking layer 4, which is disposed on the inner side of the top surface of the disk.

[0051] As can be seen from the structure described above, the first flow-blocking layer 4 plays a role in grouping the flow, isolating ineffective cardiac chambers, and thus achieving the effect of ventricular volume reduction.

[0052] Furthermore, preferably, the first flow-blocking layer 4 has a flanged portion 41, and the flanged portion 41 is disposed against the inner side of the disk side. It can be seen that the first flow-blocking layer 4 and the flanged portion 41 together form a cap-shaped structure, which can block the entire top surface of the disk and play a good role in flow control. Of course, it is not limited to this, and the flanged portion 41 may not be provided, depending on the actual needs.

[0053] Furthermore, preferably, the first flow-blocking layer 4 is a polymer flow-blocking membrane, but of course, it is not limited to this.

[0054] Furthermore, preferably, the first flow barrier layer 4 can be sewn onto the top surface and the side surface of the disk, so that the first flow layer 4 will not fall off or shift.

[0055] In this embodiment, preferably, as follows: Figure 2 and Figure 5As shown, the base 1 has a second anchor spike 1233 extending outward.

[0056] As can be seen from the structure described above, the anchors on the isolation disc 2 and the base 1 can penetrate the ventricular wall and play a stabilizing role.

[0057] It should be noted that: the anchor spikes are not limited to the aforementioned arrangement of setting anchor spikes on both the isolation plate 2 and the base 1; they can also be set on the isolation plate 2 or the base 1 alone, depending on the actual needs of the design.

[0058] In this embodiment, preferably, as follows: Figure 2 and Figure 5 As shown, the base 1 includes a connecting part 11 and a plurality of hook parts 12; wherein, the plurality of hook parts 12 are arranged sequentially with the connecting part 11 as the center, and the tail ends of any two adjacent hook parts 12 near the connecting part 11 are connected to form a flower shape.

[0059] Each hook portion 12 includes a first curved portion 121, a flat support portion 122, and a second curved portion 123 connected in sequence. The end of the first curved portion 121 away from the flat support portion 122 is connected to the connecting portion 11. The flat support portion 122 is used to abut against and support the inner wall of the ventricle. The end of the second curved portion 123 away from the flat support portion 122 is curled toward the connecting portion 11.

[0060] As can be seen from the structure described above, the base 1 adopts a flower-shaped structure, and the head end of the hook part 12, which is the petal of the flower-shaped structure, is curved towards the connecting part 11, which can effectively prevent the product from scratching the sheath. Moreover, the bottom of each hook part 12 is a flat support part 122, which improves the support strength and enhances the stability of the product.

[0061] In this embodiment, preferably, as follows: Figure 5 As shown, the second anchor 1233 is formed at one end of the second curved portion 123 near the flat support portion 122 and extends in a direction away from the connecting portion 11, and does not protrude from the second curved portion 123.

[0062] As can be seen from the structure described above, the second anchor 1233 is formed at one end of the second curved portion 123 near the flat support portion 122, and does not protrude from the second curved portion 123, thus avoiding scraping against the sheath. When delivered to the correct position, the second anchor extends away from the connecting portion 11 and can be sequentially inserted into the myocardium. Of course, the position of the second anchor 1233 is not limited to the above and can be selected according to actual needs.

[0063] In this embodiment, preferably, as follows: Figure 5As shown, the left ventricular volume reduction device also includes a second flow-blocking layer 5, and along the first preset direction, the second flow-blocking layer 5 is disposed at the bottom of the base 1, and along the first preset direction, the projection of the second anchor 1233 on the base 1 is located outside the projection of the second flow-blocking layer 5.

[0064] As can be seen from the structure described above, a second flow-blocking layer 5, such as a polymer flow-blocking membrane, is provided on the base 1. The second flow-blocking layer 5 enables the base 1 to unfold smoothly, increases the support surface, reduces the pressure on the bottom of the apex of the heart during implantation, and also plays a role in flow blocking. Preferably, the second flow-blocking layer 5 can be sutured to the base 1, and the second flow-blocking layer 5 will not exceed the second anchor 1233, and will not affect the unfolding of the second anchor 1233 and its insertion into the myocardium.

[0065] Furthermore, preferably, the second flow-blocking layer 5 is in the shape of a ring or a disk.

[0066] In this embodiment, preferably, as follows: Figure 3 As shown, the connecting component 3 is a connecting nut, and the free end of the memory braided wire 22 on the top surface of the disc is gathered inside the connecting nut.

[0067] As can be seen from the structure described above, the inner ring of the connecting nut is provided with an internal thread for connecting and separating from the delivery steel cable, and at the same time it can help to retrieve the implant and reposition the implant.

[0068] In this embodiment, preferably, the memory support 21, the base 1, and the memory braided wire 22 are all made of nickel-titanium alloy.

[0069] As can be seen from the structure described above, nickel-titanium alloy is a shape memory alloy, which has the property of automatically recovering its original shape at a specific temperature. This gives it good plasticity, so nickel-titanium alloy is selected for the shape memory skeleton.

[0070] Furthermore, preferably, the base 1 is cut from a nickel-titanium alloy tube and then heat-set. Of course, the forming method is not limited to this.

[0071] It should be noted that the materials of the memory support 21, the base 1 and the memory braided wire 22 are not limited to nickel-titanium alloy, and other memory materials can also be selected, depending on the actual needs of the design.

[0072] In this embodiment, preferably, as follows: Figure 3 As shown, the memory support 21 has an arc-shaped structure. When multiple memory support 21 are arranged sequentially around the connecting member 3 and spaced apart in the circumference of the connecting member 3, the support effect is better. Preferably, all memory support 21 are bent towards the same side. Of course, it is not limited to this. The memory support 21 can also be other shapes, such as straight lines, etc., depending on the actual needs of the design.

[0073] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A left ventricular volume reduction device, characterized in that, include: The base, the isolation plate, and the connecting components; wherein the isolation plate includes memory support members and memory braided yarns, and there are multiple memory support members arranged sequentially around the connecting components, and each of them is connected to the connecting components to form a radial basic skeleton; The basic frame and the base are arranged sequentially from top to bottom along a first preset direction; the memory braided yarn is woven on the basic frame to form the top surface and side surface of the disc, and the free end of the memory braided yarn on the side surface of the disc is connected to the base, and the free end of the memory braided yarn on the top surface of the disc is connected to the connecting member.

2. The left ventricular volume reduction device according to claim 1, characterized in that, The memory support member has a first anchor bar at the end away from the connecting member, and the first anchor bar protrudes from the top surface and the side surface of the disk in a direction away from the connecting member.

3. The left ventricular volume reduction device according to claim 2, characterized in that, The top surface of the disc is circular, and the first anchor extends along the radial direction of the top surface of the disc, or the extension direction of the first anchor forms an angle with the radial direction of the top surface of the disc, and the extension direction of the first anchor is opposite to the direction of the rotational tendency of the isolation disc during cardiac contraction.

4. The left ventricular volume reduction device according to claim 1, characterized in that, The left ventricular volume reduction device further includes a first flow-blocking layer, which is disposed on the inner side of the top surface of the disk.

5. The left ventricular volume reduction device according to claim 4, characterized in that, The first flow-blocking layer has a flanged portion, and the flanged portion is disposed against the inner side of the disk side.

6. The left ventricular volume reduction device according to claim 1, characterized in that, The base is formed with a second anchor bar extending outward.

7. The left ventricular volume reduction device according to claim 6, characterized in that, The base includes a connecting part and a plurality of hook parts; wherein, the plurality of hook parts are arranged sequentially with the connecting part as the center, and any two adjacent hook parts are connected near the tail end of the connecting part to form a flower shape; Each of the hook portions includes a first curved portion, a flat support portion, and a second curved portion connected in sequence. The end of the first curved portion away from the flat support portion is connected to the connecting portion. The flat support portion is used to abut against and support the inner wall of the ventricle. The end of the second curved portion away from the flat support portion is curled towards the connecting portion.

8. The left ventricular volume reduction device according to claim 7, characterized in that, The second anchor is formed at one end of the second bend near the flat support portion and extends in a direction away from the connection portion, and does not protrude from the second bend.

9. The left ventricular volume reduction device according to claim 1, characterized in that, The left ventricular volume reduction device further includes a second flow-blocking layer, which is disposed at the bottom of the base along the first preset direction, and the projection of the second anchor on the base is located outside the projection of the second flow-blocking layer along the first preset direction; and / or The connecting component is a connecting nut, and the free ends of the memory braided yarns on the top surface of the disc are gathered inside the connecting nut.

10. The left ventricular volume reduction device according to any one of claims 1 to 9, characterized in that, The memory support component is made of nickel-titanium alloy; and / or The memory braided yarn is made of nickel-titanium alloy; and / or The base is made of nickel-titanium alloy; and / or The memory support component has an arc-shaped structure.

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