Closure device, closure assembly and ventricular connection assembly

Abstract

This application provides a sealing device, a sealing assembly, and a ventricular connection assembly. The sealing device can seal the mounting hole of a ventricular connection member. The sealing device includes: a mating portion, which can be inserted into the mounting hole along a first direction and make sealing contact with the hole wall; the mating portion has a first end and a second end distributed along the first direction; and a connecting portion, which connects to the second end. The connecting portion can protrude outside the mounting hole when the mating portion mates with the mounting hole, so as to be able to connect with biological tissue. At least a portion of the surface roughness of the connecting portion is greater than the surface roughness of the mating portion. The technical solution provided by this application can achieve the dual functions of sealing and providing a place for biological tissue attachment and growth, and can further improve the sealing effect.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to an occlusion device, an occlusion assembly, and a ventricular connection assembly. Background Technology

[0002] Cardiovascular disease has become a leading cause of death worldwide, and heart transplantation is an effective treatment for critically ill heart patients. However, in reality, there are far more heart recipients than heart donors, leading to patients dying while waiting for a heart transplant. Blood pumps assist the heart in pumping blood and are commonly used devices in the adjunctive treatment of cardiovascular diseases.

[0003] When a blood pump, such as an implantable pump, is inserted into the human body, an opening needs to be made in the biological tissue, such as the heart, to allow part of the blood pump to pass through. To secure the blood pump to the biological tissue, a ventricular connector is typically added, with mounting holes on the connector corresponding to the opening in the heart. During surgery, the ventricular connector is first sutured to the heart, and then the blood pump is inserted through the mounting holes and the opening. Once the blood pump is in place, it is then secured to the ventricular connector. However, when the blood pump is removed, the opening in the biological tissue and the mounting hole on the ventricular connector are no longer blocked by the pump, causing blood to leak out. To address this, a sealing device is used to seal the mounting hole after the blood pump is removed. However, current sealing devices only serve a sealing function and have a limited functionality. Summary of the Invention

[0004] In view of the above problems, embodiments of this application are proposed to provide an occlusion device, an occlusion assembly, and a ventricular connection assembly capable of performing multiple functions.

[0005] This application provides a sealing device capable of sealing the mounting holes of ventricular connectors. The sealing device includes:

[0006] The mating portion is capable of being inserted into the mounting hole along a first direction and making sealing contact with the wall of the mounting hole; the mating portion has a first end and a second end distributed along the first direction; and,

[0007] A connecting portion, connected to the second end, the connecting portion being able to protrude outside the mounting hole when the insertion portion engages with the mounting hole, so as to be able to connect with biological tissue, and at least a portion of the surface roughness of the connecting portion being greater than the surface roughness of the insertion portion.

[0008] Optionally, the connecting portion includes a body portion and a biocompatible coating disposed on the body portion, the body portion being connected to the second end, and the surface roughness of the biocompatible coating being greater than the surface roughness of the mating portion.

[0009] Optionally, the body portion includes an end face and a peripheral face, the end face being opposite to the insertion portion, and the peripheral face connecting the insertion portion and the end face; the end face and the peripheral face are entirely covered by the biocompatible coating.

[0010] Optionally, the diameter of the body portion is smaller than the diameter of the mating portion, such that the orthographic projection of the biocompatible coating on the mating portion is located within the outer contour of the mating portion.

[0011] Optionally, the diameter of the connecting portion is smaller than the diameter of the mating portion.

[0012] Optionally, the thickness of the biocompatible coating is greater than or equal to 250 μm and less than or equal to 350 μm.

[0013] Optionally, the biocompatible coating is a titanium powder layer or a hydroxyapatite layer.

[0014] Optionally, the surface roughness of the connecting part is greater than or equal to 20 μm and less than or equal to 30 μm.

[0015] Optionally, the length of the connecting portion along the first direction is greater than or equal to 8 mm and less than or equal to 13 mm.

[0016] Optionally, the sealing device further includes a limiting part connected to the first end, the limiting part being able to abut against the edge of the mounting hole to prevent the sealing device from moving along the first direction.

[0017] Optionally, the surface of the limiting portion facing the mating portion is provided with a clearance notch, which extends outward through the side of the limiting portion in a direction perpendicular to the first direction.

[0018] Optionally, the limiting part has a slot on the side opposite to the insertion part, and the slot can be adapted to the insertion of the pushing structure.

[0019] Optionally, at least a portion of the slot has a non-circular radial cross-section.

[0020] This application also proposes a blocking component, including:

[0021] A sealing device, wherein the end of the sealing device away from the connecting portion is provided with a slot; and,

[0022] The push structure includes a mating part and a gripping part connected to each other. The mating part can be fitted into the slot, and the gripping part can protrude out of the slot. When the mating part is engaged with the mounting hole, the gripping part can protrude out of the mounting hole in the opposite direction to the first direction.

[0023] Optionally, at least a portion of the slot has a non-circular radial cross-section, and at least a portion of the mating portion has a correspondingly non-circular radial cross-section.

[0024] Optionally, the slot includes a first slot segment and a second slot segment distributed along the first direction, the first slot segment having an opening of the slot; the inner diameter of the first slot segment is larger than the inner diameter of the second slot segment, and a first stepped surface facing the opening is formed at the connection between the first slot segment and the second slot segment;

[0025] The mating part includes a first mating section and a second mating section connected to each other. The end of the first mating section away from the second mating section is connected to the gripping part. The first mating section is adapted to be inserted into the first groove section. The second mating section is adapted to be inserted into the second groove section. A second step surface is formed between the first mating section and the second mating section. The second step surface abuts against the first step surface.

[0026] The radial cross-sections of the first groove segment and the first mating segment are non-circular, while the radial cross-sections of the second groove segment and the second mating segment are circular.

[0027] Optionally, the grip portion is further provided with a connection hole, which allows for the detachable insertion of the handle.

[0028] This application also proposes a ventricular connection assembly, including:

[0029] Ventricular connector, having mounting holes; and,

[0030] A sealing device or sealing assembly, wherein the insertion part is capable of interference fit with the mounting hole.

[0031] The technical solution provided in this application embodiment uses a sealing device with a mating portion that seals the mounting hole on the ventricular connector, preventing blood from leaking out. Simultaneously, because biological tissue has the ability to grow, it gradually approaches the connecting portion. The relatively rough surface of the connecting portion of the sealing device provides significant friction, allowing biological tissue to attach and grow. Therefore, the connecting portion is essentially gradually covered by biological tissue, achieving a tight fit and preventing bleeding from openings in the biological tissue. Furthermore, the low surface roughness of the mating portion results in a smoother outer surface, improving the fitting accuracy with the mounting hole. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of the structure of a sealing device according to an embodiment of this application;

[0034] Figure 2 for Figure 1 A schematic diagram of the central sealing device from another angle;

[0035] Figure 3 for Figure 1 A plan view of the central sealing device;

[0036] Figure 4 for Figure 3 Cross-sectional view of the sealing device AA at point 2;

[0037] Figure 5 for Figure 3 A cross-sectional schematic diagram of the central sealing device AA, showing the biocompatible coating;

[0038] Figure 6 This is a schematic diagram of the ventricular connector in an embodiment of this application;

[0039] Figure 7 for Figure 1 The sealing device and Figure 6 A schematic diagram of the assembled ventricular connector.

[0040] Figure 8 for Figure 7 A schematic diagram of the assembly structure of the occlusion device and ventricular connector from another angle;

[0041] Figure 9 for Figure 7 A schematic diagram of the assembled central occlusion device and ventricular connector;

[0042] Figure 10 for Figure 9 Schematic diagram of the cross section at point BB;

[0043] Figure 11 This is a schematic diagram of the sealing component in an embodiment of this application;

[0044] Figure 12 for Figure 11 A schematic diagram of the propulsion structure in the middle;

[0045] Figure 13 for Figure 11 A schematic diagram of the mating structure of the occlusion component and surgical forceps;

[0046] Figure 14 for Figure 11 A cross-sectional diagram showing the occlusion component and surgical forceps in operation;

[0047] Figure 15 for Figure 14 Enlarged view of point C in the middle;

[0048] Figure 16 for Figure 13 A schematic diagram of the structure of surgical forceps.

[0049] Figure label:

[0050]

[0051] Detailed Implementation

[0052] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the embodiments of this application.

[0053] It should be noted that in the description of this application, if the terms "first" or "second" appear, they are only used for the convenience of describing different components or names, and should not be construed as indicating or implying a sequential relationship, relative importance, or implicitly specifying the number of technical features indicated. Therefore, a feature specified with "first" or "second" may explicitly or implicitly include at least one of those features. Furthermore, if the word "and / or" appears throughout the text, it means that it includes three parallel solutions; taking "A and / or B" as an example, it includes solution A, solution B, or a solution that simultaneously satisfies A and B.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0055] During blood pump implantation surgery, a ventricular connector 40 (such as...) is added to fix the blood pump relative to the biological tissue. Figure 6(As shown) to fix the blood pump. Taking the process of implanting the blood pump into the heart as an example, a surgical opening is made in the heart, and an installation hole 43 is made on the ventricular connector 40. The ventricular connector 40 is placed on the outside of the heart and fixed to the heart. At the same time, the installation hole 43 on the ventricular connector 40 is aligned with the surgical opening on the heart. Then, the blood inlet part of the blood pump is inserted into the ventricle or atrium through the installation hole 43 and the surgical opening, so that the blood in the ventricle or atrium flows to the artery through the blood pump, realizing the function of auxiliary blood pumping.

[0056] After the blood pump is removed, the ventricular connector 40 remains on the biological tissue. However, with the blood pump no longer acting as a seal, the surgical opening and mounting hole 43 are directly exposed. To prevent blood from flowing out of the surgical opening and mounting hole 43, a sealing device is provided in this embodiment to seal the mounting hole 43.

[0057] like Figures 6 to 10 As shown in the embodiment of this application, the ventricular connector 40 includes a first surface 41 and a second surface 42 disposed opposite to each other. The second surface 42 is capable of adhering to biological tissue. The ventricular connector 40 also has a mounting hole 43 penetrating through the first surface 41 and the second surface 42. Please refer to the reference. Figure 1 The sealing device 101 is inserted into the mounting hole 43 from the first direction (i.e., the direction from the first surface 41 to the second surface 42) and makes sealing contact with the hole wall of the mounting hole 43, thereby sealing the mounting hole 43.

[0058] Please refer to the reference. Figures 2 to 5 Specifically, the sealing device 101 includes an insertion portion 11 and a connecting portion 12 distributed along a first direction. The insertion portion 11 is in sealing contact with the wall of the mounting hole 43. The insertion portion 11 has a first end 111 and a second end 112 distributed along the first direction. The connecting portion 12 connects to the second end 112. The connecting portion 12 can protrude outside the mounting hole 43 when the insertion portion 11 mates with the mounting hole 43, so as to be able to connect with biological tissue. Specifically, the connecting portion 12 can extend into an opening on the heart, and at least a portion of the surface roughness of the connecting portion 12 is greater than the surface roughness of the insertion portion 11.

[0059] In this embodiment, the insertion portion 11 of the occlusion device 101 serves a sealing function, sealing the mounting hole 43 on the ventricular connector 40 to prevent blood from flowing out of the mounting hole 43. Simultaneously, since biological tissue has the ability to grow on its own, it can gradually approach the connection portion 12. The surface of the connection portion 12 of the occlusion device 101 is relatively rough, thus providing greater friction, allowing biological tissue to attach and grow. Therefore, the connection portion 12 can be gradually covered by biological tissue and tightly fitted with it, preventing bleeding from openings in the biological tissue. Furthermore, because the surface roughness of the insertion portion 11 is low, its outer surface is relatively smooth, improving the fitting accuracy with the mounting hole 43.

[0060] In the above, the mating part 11 can be sealed by interference fit with the mounting hole 43. Of course, in other embodiments, a sealing ring such as a liquid silicone ring can also be used to seal the mating part 11 and the hole wall of the mounting hole 43.

[0061] In some embodiments, the connecting portion 12 includes a body portion 121 and a biocompatible coating 122 disposed on the body portion 121. The surface roughness of the biocompatible coating 122 is greater than the surface roughness of the mating portion 11. In this embodiment, the biocompatible coating 122 is a coating formed using a biocompatible material, exhibiting good biocompatibility, minimizing negative impacts on the human body, reducing the risk of rejection reactions, and improving medical efficacy and treatment quality. This biocompatible coating 122 does not cause excessive mechanical stimulation or abrasion and can integrate well with surrounding tissues, preventing bleeding at the junction of the connecting portion 12 and biological tissue.

[0062] Of course, in other embodiments, the mating part 11 and the connecting part 12 can be a single unit, for example, made entirely of titanium steel, and the surface roughness of the connecting part 12 is made greater than that of the mating part 11 through subsequent processing, without providing a biocompatible coating 122.

[0063] In some embodiments, the biocompatible coating 122 is a titanium powder layer, i.e., titanium powder is electroplated onto the outer surface of the body portion 121 to form the biocompatible coating 122. In other embodiments, the biocompatible coating 122 may also be a coating formed using hydroxyapatite. Furthermore, the biocompatible coating 122 may also be made of other biocompatible materials.

[0064] The main body 121 includes an end face 1211 and a peripheral face 1212. The end face 1211 is away from the insertion part 11, and the peripheral face 1212 connects the insertion part 11 and the end face 1211. The peripheral face 1212 forms a closed ring structure. The end face 1211 and the peripheral face 1212 are completely covered by a biocompatible coating 122. This is equivalent to the part of the sealing device 101 that protrudes outside the mounting hole 43 and can contact biological tissue being completely covered by the biocompatible coating 122. Therefore, the part of the sealing device 101 that can contact biological tissue has a large surface roughness, providing a larger attachment area for biological tissue. This allows biological tissue to better attach to the connection part 12 for growth, which is beneficial for the growth and closure of biological tissue.

[0065] Of course, in other embodiments, the biocompatible coating 122 may be provided only on the end face 1211, or only on the peripheral face 1212, or the biocompatible coating 122 may be provided on the entire end face 1211 and the area of ​​the peripheral face 1212 near the end face 1211, or the biocompatible coating 122 may be provided in a local area of ​​the end face 1211 and a local area of ​​the peripheral face 1212.

[0066] In some embodiments, the diameter D1 of the body portion 121 is smaller than the diameter D2 of the mating portion 11, so that the orthographic projection of the biocompatible coating 122 on the mating portion 11 lies within the outer contour of the mating portion 11. When the diameter D1 of the body portion 121 is smaller than the diameter D2 of the mating portion 11, it is equivalent to the sealing device 101 forming an annular space S at the position corresponding to the body portion 121. This space S can be filled by the biocompatible coating 122 without causing the biocompatible coating 122 to laterally protrude from the periphery of the mating portion 11, thus avoiding the situation where the diameter D3 of the entire body portion 121 and the biocompatible coating 122 combined is larger than the diameter D2 of the mating portion 11. Since the mating portion 11 needs to be in sealed contact with the wall of the mounting hole 43, it means that the inner diameter of the mounting hole 43 matches the diameter D2 of the mating portion 11, and the two cannot differ too much. If the connecting portion 12 has a large diameter D3, which is larger than the diameter D2 at the insertion portion 11, the connecting portion 12 will have difficulty passing through the mounting hole 43 with a smaller inner diameter. Alternatively, the connecting portion 12 may be easily damaged by compression during the process of passing through the mounting hole 43, or the ventricular connector 40 with the mounting hole 43 may be deformed, resulting in subsequent unfavorable sealing and matching with the insertion portion 11. Therefore, in this embodiment, by setting the diameter D1 of the body portion 121 to be smaller than the diameter D2 of the insertion portion 11, the orthographic projection of the biocompatible coating 122 on the insertion portion 11 is located within the outer contour of the insertion portion 11, thus avoiding an excessively large diameter D3 for the connecting portion 12.

[0067] Furthermore, the diameter D3 of the connecting part 12 is smaller than the diameter D2 of the mating part 11. Since the mating part 11 mates with the mounting hole 43, it means that the diameter D3 of the connecting part 12 will be slightly smaller than the diameter of the mounting hole 43. Therefore, it can be ensured that the connecting part 12 can pass smoothly through the mounting hole 43 without causing mutual wear.

[0068] In some embodiments, the diameter D3 is the same at all locations of the connecting portion 12. For example, in some specific embodiments, the connecting portion 12 is cylindrical, and the radial cross-sectional shape and size are the same at all locations of the connecting portion 12. In some specific embodiments, the connecting portion 12 has a cuboid structure, and the size of the square cross-section of the connecting portion 12 along the first direction is converted into a circular cross-section to obtain the diameter.

[0069] In some embodiments, the diameter D2 is the same at all points of the mating portion 11. For example, the mating portion 11 may be cylindrical, cuboid, or cubic. Optionally, both the mating portion 11 and the connecting portion 12 are cylindrical and coaxially arranged. Furthermore, the length of the mating portion 11 is less than the length of the connecting portion 12. Specifically, the length of the mating portion 11 generally matches the depth of the mounting hole 43, and the two are essentially the same. The connecting portion 12 is relatively long to allow it to be inserted deeper into the biological tissue, thus better sealing the openings in the biological tissue.

[0070] In some embodiments, the length L of the connecting portion 12 along the first direction is greater than or equal to 8 mm and less than or equal to 15 mm. Optionally, the length L of the connecting portion 12 along the first direction is greater than or equal to 8 mm and less than or equal to 13 mm. Typically, the thickness of heart tissue is between 8 mm and 13 mm. Therefore, setting the length of the connecting portion 12 between 8 mm and 13 mm ensures that the connecting portion 12 can be inserted substantially close to the interior of the ventricle, and that the connecting portion 12 does not protrude into the interior of the ventricle or only protrudes a small portion into the interior of the ventricle, thus reducing the space occupied by the ventricle. Specifically, the length L of the connecting portion 12 along the first direction can be 8 mm, 9 mm, 10.5 mm, 13 mm, etc.

[0071] In some embodiments, the thickness T of the biocompatible coating 122 is greater than or equal to 200 μm and less than or equal to 400 μm. Optionally, the thickness T of the biocompatible coating 122 is greater than or equal to 250 μm and less than or equal to 350 μm. Specifically, the thickness T of the biocompatible coating 122 can be 250 μm, 280 μm, 300 μm, 320 μm, etc. If the thickness T of the biocompatible coating 122 is too small, it is difficult to fully cover the outer surface of the connecting portion 12 to form a uniform coating, and the roughness is difficult to meet the requirements. When the thickness of the biocompatible coating 122 is too large, it is easy to bulge laterally on the periphery of the insertion portion 11, resulting in an excessively large diameter D3 of the connecting portion 12. In addition, in order to avoid an excessively large diameter D3 after the biocompatible coating 122 and the body portion 121 are superimposed, the diameter D1 of the body portion 121 is reduced. However, this can easily lead to insufficient strength of the body portion 121 and breakage, which is detrimental to safety. Therefore, in this embodiment, limiting the thickness T of the biocompatible coating 122 to a suitable range can avoid the aforementioned problems. Furthermore, the thickness T of the biocompatible coating 122 is designed for the fit between the insertion portion 11 and the mounting hole 43, as well as the dimensions of the insertion portion 11 and the body portion 121.

[0072] In some embodiments, the surface roughness of the connecting portion 12 is greater than or equal to 18 μm and less than or equal to 35 μm. Optionally, the surface roughness of the connecting portion 12 is greater than or equal to 20 μm and less than or equal to 30 μm. Specifically, the surface roughness of the connecting portion 12 can be 20 μm, 22 μm, 25 μm, 33 μm, etc. If the surface roughness of the connecting portion 12 is too large, it is easy to scratch and damage biological tissue; while if the surface roughness of the connecting portion 12 is too small, close to a smooth surface, it is not conducive to the growth and adhesion of biological tissue. Therefore, in this embodiment, the surface roughness of the connecting portion 12 is set between 18 μm and 35 μm, which can avoid the above phenomenon and is also beneficial to processing.

[0073] Furthermore, the occlusion device 101 also includes a limiting portion 20, which is connected to the occlusion device 101. The limiting portion 20 is located outside the mounting hole 43 and can abut against the edge of the mounting hole 43 to prevent the occlusion device 101 from moving in the first direction. In some specific embodiments, the limiting portion 20 can abut against the first surface 41 of the ventricular connector 40.

[0074] In this embodiment, by adding a sealing device 101, after the blood pump is removed, the sealing device 101 can be used to seal the mounting hole 43 on the ventricular connector 40, preventing blood from flowing out of the mounting hole 43. Simultaneously, the limiting part 20 of the sealing device 101 abuts against the edge of the mounting hole 43 of the ventricular connector 40, preventing the sealing device 101 from being excessively inserted into the mounting hole 43 and soft biological tissue in the first direction. It also avoids the sealing device 101 colliding with biological tissue due to excessive insertion, thereby improving the safety of using the sealing device 101. Furthermore, the setting of the limiting part 20, by abutting against the edge of the mounting hole 43 of the ventricular connector 40, also avoids the problem of the sealing device 101 not being fully inserted into the mounting hole 43, resulting in a poor sealing effect.

[0075] Please refer to the reference. Figure 4 and Figure 16 Furthermore, the surface of the limiting part 20 facing the blocking device 101 is provided with a clearance notch 21, which extends outward through the side surface 22 of the limiting part 20 in a direction perpendicular to the first direction. When the blocking device 101 is inserted into the mounting hole 43 of the ventricular connector 40, the clearance notch 21 is provided facing the first surface 41 of the ventricular connector 40.

[0076] When the occlusion device 101 deviates from the mounting hole 43 or for other reasons, and needs to be removed, a considerable amount of force is required to successfully remove it because the occlusion device 101 fits tightly with the mounting hole 43. However, the ventricular connector 40 with the mounting hole 43 is directly sewn onto the biological tissue, which is soft. Therefore, when the occlusion device 101 is pulled outward (in the opposite direction of the first direction), the ventricular connector 40 and the biological tissue will be pulled along with it, potentially causing severe tearing of the biological tissue. Therefore, in this embodiment of the application, by providing a clearance notch 21 on the occlusion device 101, a surgical forceps 50 can be used during surgery. The clamping part 51 of the surgical forceps 50 extends into the clearance notch 21 and abuts against the first surface 41 of the ventricular connector 40, and keeps the surgical forceps 50 basically in a fixed position. At this time, when the occlusion device 101 is pulled outward, even if the occlusion device 101 applies an outward force to the ventricular connector 40, the ventricular connector 40 can be restricted from moving outward due to the fixation of the surgical forceps 50 and its abutment against the first surface 41, thereby preventing the biological tissue from being pulled outward excessively.

[0077] In the above description, the clearance notch 21 can form a closed loop around the limiting part 20; or, the clearance notch 21 can form a non-closed loop around the limiting part 20, thus forming a superior or inferior arc shape; or, multiple clearance notches 21 can be provided, such as two, and symmetrically distributed on the left and right. The shape of the clearance notch 21 can be specifically designed according to the clamping part 51 of the surgical forceps 50.

[0078] Please refer to the reference. Figure 3 , Figure 4 and Figures 11 to 16 Furthermore, the limiting part 20 has a slot 23 on the side opposite to the sealing device 101, and the slot 23 is for the push structure 30 to fit into. Here, fitting into means that the part of the push structure 30 located in the slot 23 is substantially the same shape as the slot 23, and the part of the push structure 30 located in the slot 23 can basically fill the slot 23, for example, the two are in a small clearance fit, an interference fit, or a transition fit.

[0079] Furthermore, at least a portion of the radial cross-section of the slot 23 is non-circular. Since the push structure 30 is adapted to fit into the slot 23, the shape of the part of the push structure 30 that mates with the slot 23 is also at least partially non-circular, such as square or elliptical. This non-circular fit prevents the push structure 30 from rotating relative to the slot 23. During the process of pressing the occlusion device 101 into the mounting hole 43, the occlusion device 101 is subjected to a large clamping force from the ventricular connector 40, making it difficult to push and prone to jamming. At this time, the push structure 30 can be rotated to rotate the occlusion device 101, so that the occlusion device 101 is equivalent to being rotated and pushed through the mounting hole 43. Therefore, the occlusion device 101 can be more smoothly assembled into the mounting hole 43, and the compression on the biological tissue is reduced.

[0080] Please refer to the reference. Figures 11 to 14This application also proposes an occlusion assembly 100, which further includes a pushing structure 30. The pushing structure 30 is adapted to be inserted into the slot 23, and the pushing structure 30 also partially protrudes from the slot 23. Specifically, the pushing structure 30 includes a connected mating part 31 and a gripping part 32. The mating part 31 is adapted to be inserted into the slot 23 of the occlusion device 101; the gripping part 32 can protrude from the slot 23, and when the mating part 11 is engaged with the mounting hole 43, the gripping part 32 can protrude from the mounting hole 43 in the opposite direction to the first direction. Since the occlusion device 101 needs to be placed on biological tissue, such as possibly hidden in the thoracic cavity, the size of the occlusion device 101 should be set as small as possible to reduce the impact on the patient. However, a smaller occlusion device 101 is inconvenient to operate when pushed into the ventricular connector 40. Therefore, the setting of the pushing structure 30 is equivalent to extending the size of the occlusion device 101, which makes it easier for doctors to hold and improves the convenience of operation. When the pushing structure 30 is pushed in the first direction, i.e., the side where the biological tissue is located, the pushing structure 30 drives the sealing device 101 to move and insert into the mounting hole 43. After the sealing device 101 is inserted into the mounting hole 43, since the gripping part 32 of the pushing structure 30 protrudes outside the mounting hole 43 in the opposite direction of the first direction, i.e., the gripping part 32 and the connecting part 12 are respectively located on two opposite sides of the mounting hole 43, the pushing structure 30 can be pulled out from the sealing device 101 from the outside. The pushing structure 30 separates from the sealing device 101, and the sealing device 101 remains in the biological tissue to seal the surgical opening.

[0081] In this embodiment, the pushing structure 30 can be generally cylindrical, prismatic, square columnar, or other shapes. The shape of the slot 23 is adapted to the pushing structure 30, and the shape of the slot 23 can be circular, prismatic, or square, etc. The adaptation of the slot 23 to the pushing structure 30 means that the radial cross-section of the slot 23 is generally the same as the radial cross-section of the pushing structure 30. The pushing structure 30 can substantially fill the slot 23, achieving a relatively tight fit, thereby allowing the pushing structure 30 to push the sealing device 101 towards the heart, and also to drive the sealing device 101 to rotate.

[0082] In some embodiments, the slot 23 includes a first slot segment 231 and a second slot segment 232 distributed along a first direction. The first slot segment 231 has an opening for the slot 23. The inner diameter of the first slot segment 231 is larger than the inner diameter of the second slot segment 232, and a first stepped surface 233 facing the opening is formed at the connection between the first slot segment 231 and the second slot segment 232. In this embodiment, when a non-circular structure is used, the inner diameter of the first slot segment 231 being larger than the inner diameter of the second slot segment 232 means that the radial cross-sectional area of ​​the first slot segment 231 is larger than the radial cross-sectional area of ​​the second slot segment 232.

[0083] The mating part 31 includes a first mating section 311 and a second mating section 312 connected to each other. The end of the first mating section 311 away from the second mating section 312 is connected to the gripping part 32. The first mating section 311 is adapted to be inserted into the first groove section 231 of the slot 23, and the second mating section 312 is adapted to be inserted into the second groove section 232 of the slot 23. Further, a second stepped surface 33 is formed between the first mating section 311 and the second mating section 312, and the second stepped surface 33 abuts against the first stepped surface 233 of the slot 23.

[0084] The arrangement of the first step surface 233 and the second step surface 33 allows the force exerted by the pushing structure 30 on the blocking device 101 to be partially dispersed from the bottom wall of the slot 23 to the first step surface 233. Since the inner diameter of the first step surface 233 is larger than the inner diameter of the second slot segment 232, the force will be dispersed from the center of the slot 23 to the surrounding area, squeezing the blocking device 101 in the direction close to the surrounding area. This makes the force on the blocking device 101 more uniform, and the limiting part 20 of the blocking device 101 can better abut against the ventricular connector 40.

[0085] In this embodiment, at least a portion of the slot 23 has a non-circular radial cross-section, and at least a portion of the push structure 30 also has a correspondingly non-circular radial cross-section. For example, the entire slot 23 is non-circular, and all of the push structure 30 located within the slot 23 is set to be non-circular. As another example, in the following embodiment, the second slot segment 232 has a circular radial cross-section, and the first slot segment 231 has a non-circular radial cross-section.

[0086] In one embodiment, the radial cross-section of the second groove segment 232 is circular, while the radial cross-section of the first groove segment 231 is non-circular. Correspondingly, the radial cross-section of the second mating segment 312 is circular, while the radial cross-section of the first mating segment 311 is non-circular. Here, the radial cross-section refers to the cross-section taken through a plane perpendicular to the first direction.

[0087] In some embodiments, the shape and size of the radial cross section of the first mating segment 311 correspond to the shape and size of the radial cross section of the grip portion 32. Therefore, the radial cross section of the grip portion 32 is also non-circular, which can prevent the hand from slipping when the hand holds the grip portion 32.

[0088] In other embodiments, the radial cross-section of the first mating section 311 is different from the radial cross-section of the gripping part 32, but this application embodiment does not limit it.

[0089] Because a portion of the slot 23 is a non-circular hole, and a portion of the push structure 30 is a non-circular post that matches the non-circular hole, rotation of the push structure 30 relative to the slot 23 can be prevented. During the process of pressing the occlusion device 101 into the mounting hole 43, the occlusion device 101 is subjected to a large clamping force from the ventricular connector 40, making it difficult to push and prone to jamming. At this time, the push structure 30 can be rotated to drive the occlusion device 101 to rotate, so that the occlusion device 101 is equivalent to being rotated and pushed through the mounting hole 43. Therefore, the occlusion device 101 can be more smoothly assembled into the mounting hole 43, and the compression on biological tissue can be reduced.

[0090] Alternatively, a pin can be provided on the side of the limiting part 20 away from the sealing device 101, and a slot 23 can be provided on the pushing structure 30, with the pin and slot 23 engaging.

[0091] Furthermore, the grip portion 32 has a connecting hole 34 for mounting a handle for easy operation. The handle and grip portion 32 are detachably connected, for example, by direct insertion, snap-fit, or screw connection. The handle can be L-shaped, straight, etc.

[0092] A post can be connected inside the connection hole 34 of the push structure 30, similar to forming a handle, so that the user can apply force to push and rotate the push structure 30, which can prevent slippage.

[0093] For ease of understanding, one specific structure of the ventricular connector 40 is described below, but it is not limited thereto. In some embodiments, the ventricular connector 40 includes a suture ring 44 and a locking ring 45, with a mounting hole 43 penetrating the suture ring 44 and the locking ring 45. The suture ring 44 is used for suturing onto biological tissue, and the locking ring 45 connects to the suture ring 44 to adjust the size of the mounting hole 43. The side of the locking ring 45 facing away from the suture ring 44 is a first surface 41, and the side of the suture ring 44 facing away from the locking ring 45 is a second surface 42.

[0094] Since the ventricular connector 40 is directly sutured onto the biological tissue, and the biological tissue is soft, when the occlusion device 101 is pushed inward to squeeze through the ventricular connector 40, it will directly squeeze the biological tissue, causing the occlusion device 101 to be unable to bear force or to have a poor force-bearing effect, making it difficult to pass through the ventricular connector 40. At the same time, excessive squeezing of the biological tissue can also easily lead to bleeding. Therefore, referring to Figures 1-4, during surgery, a surgical forceps 50 can be used. The clamping part 51 of the surgical forceps 50 extends into the operating groove 46 between the suture ring 44 and the locking ring 45, and pulls the surgical forceps 50 outward, thereby fixing the locking ring 45 in a basically fixed position. Then, the sealing device 101 is pushed into the mounting hole 43. At this time, even if the locking ring 45 is squeezed axially by the sealing device 101, it will be basically fixed in a fixed position under the action of the surgical forceps 50. Therefore, on the one hand, the sealing device 101 is better subjected to force, making it easier for the sealing device 101 to pass through the locking ring 45, and on the other hand, it avoids the sealing device 101 from excessively squeezing biological tissue.

[0095] This application also proposes a ventricular connection assembly, including a ventricular connector 40 and a closure assembly 100. The structures of the ventricular connector 40 and the closure assembly 100 are described in the above embodiments and will not be repeated here.

[0096] This application also proposes a ventricular connection assembly, including a ventricular connector 40 and a blocking device 101. The structures of the ventricular connector 40 and the blocking device 101 are described in the above embodiments and will not be repeated here.

[0097] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although the embodiments of this application have been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A closure device capable of closing a mounting hole of a ventricular connection member, characterized by, The sealing device includes: The mating portion is capable of being inserted into the mounting hole along a first direction and making sealing contact with the wall of the mounting hole; the mating portion has a first end and a second end distributed along the first direction; and, A connecting portion, connected to the second end, the connecting portion being able to protrude outside the mounting hole when the insertion portion mates with the mounting hole, so as to be able to connect with biological tissue, the connecting portion being configured to allow biological tissue attachment, and at least a portion of the surface roughness of the connecting portion being greater than the surface roughness of the insertion portion.

2. The occlusion device of claim 1, wherein, The connecting portion includes a body portion and a biocompatible coating disposed on the body portion. The body portion is connected to the second end, and the surface roughness of the biocompatible coating is greater than the surface roughness of the mating portion.

3. The occlusion device of claim 2, wherein, The body portion includes an end face and a peripheral face, the end face being opposite to the insertion portion, and the peripheral face connecting the insertion portion and the end face; the end face and the peripheral face are entirely covered by the biocompatible coating.

4. The occlusion device of claim 2, wherein, The diameter of the body portion is smaller than the diameter of the insertion portion, such that the orthographic projection of the biocompatible coating on the insertion portion is located within the outer contour of the insertion portion.

5. The occlusion device of claim 4, wherein, The diameter of the connecting part is smaller than the diameter of the mating part.

6. The occlusive device of claim 2, wherein, The thickness of the biocompatible coating is greater than or equal to 250 μm and less than or equal to 350 μm.

7. The occlusive device of claim 2, wherein, The biocompatible coating is a titanium powder layer or a hydroxyapatite layer.

8. The occlusion device of any one of claims 1 to 7, wherein, The surface roughness of the connecting part is greater than or equal to 20 μm and less than or equal to 30 μm.

9. The occlusive device of claim 1, wherein, The length of the connecting portion along the first direction is greater than or equal to 8 mm and less than or equal to 13 mm.

10. The occlusive device of claim 1, wherein, The sealing device further includes a limiting part, which is connected to the first end and can abut against the edge of the mounting hole to prevent the sealing device from moving in the first direction.

11. The occlusion device of claim 10, wherein, The surface of the limiting part facing the mating part is provided with a clearance notch, which extends outward through the side of the limiting part in a direction perpendicular to the first direction.

12. The occlusive device of claim 10, wherein, The limiting part has a slot on the side opposite to the insertion part, and the slot can be adapted to the insertion of the pushing structure.

13. The occlusion device of claim 12, wherein, At least a portion of the slot has a non-circular radial cross-section.

14. A closure assembly comprising: include: The sealing device as described in any one of claims 1 to 11, wherein the end of the sealing device away from the connecting portion is provided with a slot; and, The push structure includes a mating part and a gripping part connected to each other. The mating part can be fitted into the slot, and the gripping part can protrude out of the slot. When the mating part is engaged with the mounting hole, the gripping part can protrude out of the mounting hole in the opposite direction to the first direction.

15. The occlusion assembly of claim 14, wherein, At least a portion of the slot has a non-circular radial cross-section, and at least a portion of the mating portion has a correspondingly non-circular radial cross-section.

16. The occlusion assembly of claim 15, wherein, The slot includes a first slot segment and a second slot segment distributed along the first direction, the first slot segment having an opening of the slot; the inner diameter of the first slot segment is larger than the inner diameter of the second slot segment, and a first stepped surface facing the opening is formed at the connection between the first slot segment and the second slot segment; The mating part includes a first mating section and a second mating section connected to each other. The end of the first mating section away from the second mating section is connected to the gripping part. The first mating section is adapted to be inserted into the first groove section. The second mating section is adapted to be inserted into the second groove section. A second step surface is formed between the first mating section and the second mating section. The second step surface abuts against the first step surface. The radial cross-sections of the first groove segment and the first mating segment are non-circular, while the radial cross-sections of the second groove segment and the second mating segment are circular.

17. The occlusion assembly of claim 14, wherein, The grip portion is also provided with a connection hole, which allows for the detachable insertion of the handle.

18. A ventricular connection assembly comprising: include: Ventricular connector, having mounting holes; and, In any one of the sealing devices as claimed in claims 1 to 13 or in any one of the sealing assemblies as claimed in claims 14 to 17, the insertion portion is capable of interference fit with the mounting hole.

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