Blocking system

Abstract

The occluding system of the present invention comprises a conveyor and an occluder, wherein the occluder comprises a fixed disk at its distal end, the conveyor comprises a hollow sheath and a conveying member, the distal end of the conveying member is detachably connected to the occluder, and can move along the axial direction of the sheath when accommodated in the sheath, and the conveyor is provided with a first marking point and a second marking point spaced apart, and when the sheath and the conveying member move relative to each other so that the second marking point coincides with the first marking point, the occluder is in a semi-released state; when in the semi-released state, a part of the fixed disk is located outside the sheath, and the expansion diameter of the fixed disk is 35% to 65% of the diameter when it is fully expanded in the natural state. According to the occluding system of the present invention, the semi-release of the fixed disk of the occluder can be quickly realized, so that it can be fully expanded in the deeper part of the cavity later, and the accurate step-by-step release of the occluder can be realized, thereby improving the safety of the operation, shortening the operation time, and reducing the pain and other risks of the patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to a blocking system. Background Art

[0002] During the left atrial appendage occlusion surgery, due to the well-developed pectinate muscles and ravines inside the left atrial appendage, if the fixed disk of the left atrial appendage occluder is deployed from the sheath inside the left atrial appendage, it is easy to cause some support rods to be compressed by the pectinate muscles and unable to be fully deployed, affecting the anchoring effect of the left atrial appendage occluder, and further may cause the occluder to fall off. Therefore, during the implantation process of the left atrial appendage occluder with an everted fixed disk, after the sheath reaches the mouth of the left atrial appendage, it is necessary to partially release the fixed disk at the mouth of the left atrial appendage, and then further push it into the cavity of the left atrial appendage, and then fully release the fixed disk after reaching the appropriate position. This operation is conducive to the full deployment of the fixed disk in the cavity of the left atrial appendage, which is further conducive to the fixation of the occluder.

[0003] However, there is no definite conclusion yet on how much the fixation disc should be released at the left atrial appendage opening, and current surgeries often rely on the judgment of experienced professional doctors, which requires high professional skills and experience of doctors and is not conducive to widespread promotion. In addition, the uncertainty of human judgment has a greater impact during the operation, and the judgment process also takes a lot of time, which increases the time and difficulty of the operation.

[0004] In addition, due to the poor X-ray imaging ability of the material used for the fixed disk of the left atrial appendage occluder, the boundary of the fixed disk of the left atrial appendage occluder cannot be clearly observed during the operation when it is partially released, which brings inconvenience to the operation and increases the difficulty of the operation. Moreover, the step-by-step release of the occluder cannot be accurately controlled by human observation and manual judgment, which affects the safety of the operation. Summary of the invention

[0005] The purpose of the present invention is to at least solve the problem of how to accurately release the occluder in steps within the cavity so that it can be quickly in a semi-released state.

[0006] The present invention proposes an occlusion system, comprising a conveyor and an occluder, wherein the occluder comprises a fixed disk located at its distal end, the conveyor comprises a hollow sheath and a conveying member, the distal end of the conveying member is detachably connected to the occluder and can move along the axial direction of the sheath when accommodated in the sheath, and is characterized in that a first marking point and a second marking point spaced apart are provided on the conveyor, and when the sheath and the conveying member move relative to each other so that the second marking point coincides with the first marking point, the occluder is in a semi-released state; when in the semi-released state, a portion of the fixed disk is located outside the sheath, and the expanded diameter of the fixed disk is 35% to 65% of its diameter when it is fully expanded in a natural state.

[0007] According to the occluding system of the present invention, by setting the first marking point and the second marking point on the conveyor, when the occluder is connected to the conveyor and is accommodated in the sheath together, with the relative movement of the sheath and the conveyor, and when the second marking point coincides with the first marking point, a part of the fixed disk of the occluder is located outside the sheath, and the expansion diameter of the fixed disk is 35% to 65% of the diameter when it is fully expanded in the natural state, at this time, the occluder is in a semi-released state. In this semi-released state, the fixed disk of the occluder can release a part in advance before entering the deep cavity of the left atrial appendage, and can smoothly extend into the deeper position in the left atrial appendage cavity, and can also be fully expanded in the subsequent release process, to ensure the stability of the occluder fixation. In addition, the difficulty of the operation and the requirements for the professional level of the doctor are reduced, the safety of the operation is improved, the operation time is shortened, the pain and other risks of the patient are reduced, and it is also conducive to the general promotion of the left atrial appendage occlusion.

[0008] In addition, the blocking system according to the present invention may also have the following additional technical features:

[0009] In some embodiments of the present invention, at least one anchor barb is provided on the fixed plate, and a third marking point is also provided on the conveyor. When the sheath and the conveyor move relative to each other so that the second marking point coincides with the third marking point, the occluder is in a waiting-to-anchor state; when in the waiting-to-anchor state, the minimum angle between the anchor barb and the central axis of the occluder ranges from 70 degrees to 90 degrees.

[0010] In some embodiments of the present invention, the first marking point is disposed at the distal end of the sheath tube and has a developing property, and the second marking point is disposed at the distal end of the conveying member and has a developing property.

[0011] In some embodiments of the present invention, the third marking point is disposed at the distal end of the sheath tube and has visualization properties, and the third marking point is closer to the distal end of the sheath tube than the first marking point.

[0012] In some embodiments of the present invention, the distance between the first marking point and the distal end of the sheath is equal to the length of the occluder housed in the sheath when in a semi-released state.

[0013] In some embodiments of the present invention, the distance between the third marking point and the distal end of the sheath is equal to the length of the occluder housed in the sheath when in a waiting state for anchoring.

[0014] In some embodiments of the present invention, the conveyor further includes a hollow handle, the proximal end of the sheath is connected to the handle, the first marking point is located at the proximal end of the conveying member, and the second marking point is located on the handle or the proximal end of the sheath.

[0015] In some embodiments of the present invention, the third marking point is disposed at the proximal end of the conveying member, and the third marking point is closer to the proximal end of the conveying member than the first marking point.

[0016] In some embodiments of the present invention, the position of the first marking point on the conveying member is adjustable; or, the positions of the first marking point and the third marking point on the conveying member are both adjustable.

[0017] In some embodiments of the present invention, at least one anchoring thorn is disposed on the fixing plate, and at least one of the anchoring thorns has a developing property. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present invention. Moreover, the same reference numerals are used throughout the accompanying drawings to represent the same components. Among them:

[0019] Figure 1 is a schematic structural diagram of the occlusion system in the first embodiment when the occluder is in a fully deployed state;

[0020] Figure 2 for Figure 1 A schematic diagram of a portion of the structure of the occluding system when the middle occluder is in a semi-released state;

[0021] Figure 3 It is a structural schematic diagram of the occlusion system when the occluder is in a semi-released state in the second implementation mode;

[0022] Figure 4 for Figure 3 A schematic diagram of the structure of the occluding system when the middle occluder is in a state to be anchored;

[0023] Figure 5 It is a partial structural schematic diagram of another example of a conveying member in the second embodiment;

[0024] Figure 6 is a schematic structural diagram of the occluder in the third implementation mode when it is in a fully deployed state;

[0025] Figure 7 for Figure 6 Schematic diagram of the position structure of the middle anchor bar on the support rod;

[0026] Figure 8 This is a schematic structural diagram of another example of an occluder in the third implementation mode when it is partially unfolded;

[0027] Fig. 9 It is a schematic diagram of the position structure between the occlusion system and the left atrial appendage when the occluder is in a semi-released state in the present invention;

[0028] Fig.10 It is a schematic diagram of the position structure between the occlusion system and the left atrial appendage when the occluder is in a waiting state for anchoring in the present invention;

[0029] Fig.11 It is a schematic diagram of the position structure of the fixing plate between the occlusion system and the left atrial appendage after anchoring in the present invention;

[0030] Fig.12 It is a schematic diagram of the position structure between the occlusion system and the left atrial appendage when the occluder is in a fully released state in the present invention.

[0031] The symbols in the accompanying drawings are as follows:

[0032] 100: blocking system;

[0033] 10: conveyor, 11: sheath, 12: conveying member, 121: connecting end, 122: groove, 13: handle;

[0034] 20: occluder, 21: fixing plate, 211: support rod, 212: anchor bar, 22: sealing plate, 23: connecting piece, 24: first blocking film, 25: second blocking film;

[0035] 31: first marking point, 32: second marking point, 33: third marking point, 34: fourth marking point, 35: fifth marking point, 36: sixth marking point;

[0036] 200: Left atrial appendage. DETAILED DESCRIPTION

[0037] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0038] It should be understood that the terms used in the text are only for the purpose of describing specific example embodiments, and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used in the text may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0039] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0040] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0041] In order to more clearly describe the structure of the suturing device, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, the "proximal end" refers to the end close to the operator during the surgical operation, the "axial" refers to its length direction, and the "radial" refers to the direction perpendicular to the "axial" direction.

[0042] Implementation Method 1

[0043] Combination Figure 1 and Figure 2 As shown, the occlusion system 100 of this embodiment includes a conveyor 10 and an occluder 20. The conveyor 10 includes an internally hollow sheath 11, a conveying member 12 and an internally hollow handle 13. The proximal end of the sheath 11 is connected to the handle 13. The conveying member 12 is accommodated in the sheath 11 and the handle 13 and can move along the axial direction of the sheath 11. The distal end of the conveying member 12 can extend from the distal end of the sheath 11, and the proximal end of the conveying member 12 extends from the proximal end of the handle 13, so that the operator can hold the proximal end of the conveying member 12 for operation. The distal end of the conveying member 12 is connected to the occluder 20 in a detachable manner. The occluder 20 can move axially in the sheath 11 along with the conveying member 12. A first marking point 31 is provided on the sheath 11, and a second marking point 32 is provided at the distal end of the conveying member 12, such as the distal end of the conveying member 12 or a position close to its distal end. When the proximal end of the occluder 20 is connected to the distal end of the conveying member 12, the sheath 11 and the conveying member 12 move relative to each other, for example, the sheath 11 is kept stationary and the conveying member 12 is pushed toward the distal end, so that the second marking point 32 coincides with the first marking point 31, the occluder 20 is in a semi-released state, and part of the fixed disk 21 of the occluder 20 in the semi-released state is located outside the distal end of the sheath 11 and is in a semi-expanded shape, specifically, the expanded diameter of the fixed disk 21 is 35% to 65% of its diameter when it is fully expanded in a natural state.

[0044] The occluder 20 of this embodiment is mainly used for the occlusion of the left atrial appendage, so as to prevent non-valvular atrial fibrillation. The occluder 20 includes a fixing disk 21 located at its distal end and a sealing disk 22 located at its proximal end, wherein the sealing disk 22 is detachably connected to the distal end of the conveying member 12. The sealing disk 22 is used to block the opening of the left atrial appendage after being unfolded, and the fixing disk 21 is used to fix the occluder 20 in the cavity of the left atrial appendage. A plurality of anchor spikes 212 are provided on the fixing disk 21 at intervals along its circumferential direction. The conveying member 12 of this embodiment is a rod-shaped structure. By manipulating the proximal end of the conveying member 12 located outside the body, the axial movement of the conveying member 12 in the sheath 11 can be controlled, thereby pushing the occluder 20 to move toward the distal end or pulling the occluder 20 to move toward the proximal end, thereby realizing the delivery and release of the occluder 20. Specifically, when the occluder 20 is accommodated in the sheath 11, the proximal end of the sealing disc 22 is connected to the distal end of the conveying member 12, and the occluder 20 can be conveyed into the body with the help of the conveying member 12 and the sheath 11. When the occluder 20 gradually extends from the distal end of the sheath 11, the occluder 20 is gradually released until the sealing disc 22 also extends completely from the sheath 11 and self-expands into a predetermined shape, at which time the occluder 20 is initially released; when the conveying member 12 is disconnected from the sealing disc 22, the occluder 20 is completely released, thereby completing the occlusion of the left atrial appendage.

[0045] The distal end of the conveying member 12 of this embodiment is provided with a second marking point 32. When the occluder 20 is connected to the conveying member 12, the second marking point 32 is substantially located at the proximal end surface of the occluder 20. The outer surface of the sheath tube 11 is provided with a first marking point 31 and a third marking point 33 arranged at intervals, wherein the distance between the third marking point 33 and the distal end of the sheath tube 11 is smaller than the distance between the first marking point 31 and the distal end of the sheath tube 11, that is, the third marking point 33 is closer to the distal end of the sheath tube 11 than the first marking point 31. When the conveying member 12 moves in the axial direction toward the distal end of the sheath tube 11 in the sheath tube 11, the first marking point 31 and the third marking point 33 sequentially coincide with the second marking point 32 at the distal end of the conveying member 12. When the first marking point 31 coincides with the second marking point 32, the occluder 20 is in a semi-released state, and a portion of the fixing plate 21 of the occluder 20 in the semi-released state is located outside the distal end of the sheath tube 20. When the third marking point 33 coincides with the second marking point 32, the occluder 20 is in a state to be anchored, and the fixed disk 21 of the occluder 20 in the state to be anchored further extends outward from the distal end of the sheath 11 and further unfolds to the extent of its expansion in the semi-released state. By observing the relative position of the first marking point 31 or the third marking point 33 and the second marking point 32, the release and expansion degree of the occluder 20 can be accurately controlled, which is convenient for the operator to quickly and accurately control and operate the occluder 20 at the key release node. The overlap here refers to the second marking point 32 and the first marking point 31 being located on the same cross section, or the second marking point 32 and the third marking point 33 being located on the same cross section. The first marking point 31, the second marking point 32 and the third marking point 33 are all developable under the DSA device.

[0046] Among them, when the occluder 20 is in a semi-released state, the expansion diameter of the fixed disk 21 is 35% to 65% of the diameter when fully expanded in the natural state, preferably 50%, so that it can better extend into the deep part of the left atrial appendage cavity and ensure that the subsequent fixed disk 21 can be fully expanded. The semi-release here does not mean releasing half of the fixed disk 21 in a strict sense, but refers to releasing half of the fixed disk 21 in general. When the occluder 20 is in a state to be anchored after being expanded, the minimum angle a between the anchor 212 and the central axis of the occluder 20 ranges from 70 degrees to 90 degrees. After the occluder 20 is expanded in this state, the operator can select a suitable position for the next step of anchoring, and when the occluder 20 is further released and expanded so that the anchor 212 penetrates the body tissue, the minimum angle a ranges from 30 degrees to 60 degrees. In addition, after the fixing plate 21 is fully deployed in the natural state, the minimum angle a between the anchor 212 and the central axis of the occluder 20 is also in the range of 30 to 60 degrees. Further releasing the occluder 20 in the waiting anchoring state can ensure that the anchor 212 is better inserted into a more ideal target position, and the anchoring force of the anchor 212 is stronger, which can improve the fixing strength of the occluder 20 after being connected to the left atrial appendage.

[0047] To facilitate observation, the marking points in this embodiment are all annular developing parts, so that the specific position of each marking point can be easily determined from any angle. The material of the marking point can be gold, platinum, platinum-iridium alloy or other materials with strong developing properties. The axial width of the annular developing part ranges from 1 to 10 mm, preferably 2 to 6 mm. A sixth marking point 36 is also provided at the distal end of the sheath 11. The sixth marking point 36 is used to locate the distal end of the sheath 11 under the DSA (digital subtraction angiography) device during surgery, so as to facilitate the determination of the position of the distal end of the sheath 11.

[0048] Under the display of the DSA device, when the conveying member 12 is connected to the sealing disk 22, the position of the second marking point 32 on the conveying member 12 can be regarded as the position of the proximal end of the sealing disk 22. For a certain specification of the occluder 20, the total length of the occluder 20 as a whole when compressed in the sheath 11 can be measured by using a transparent loader with the same specifications as the sheath 11 to be used during surgery to fully compress and load the occluder 20. Similarly, the occluder 20 is partially compressed by means of the loader to put it in a semi-released state, and the length m of the occluder 20 contained in the loader when it is in the semi-released state is measured, thereby setting a semi-release marking point and a first marking point 31 at a position where the distance from the distal end of the sheath 11 is m. In the semi-released state, the length m of the occluder 20 contained in the loader is the same as the length when it is contained in the sheath 11 of the same specifications as the loader. When the occluder 20 is released to a semi-released state by means of the sheath 11 , the second marking point 32 at the distal end of the conveying member 12 coincides with the first marking point 31 on the sheath 11 .

[0049] Similarly, the occluder 20 is partially compressed by the above-mentioned loader to put it in a state to be anchored, and the length n of the occluder 20 accommodated in the loader when it is in the state to be anchored is measured, thereby setting a mark point to be anchored, that is, a third mark point 33, at a position where the distance between the sheath 11 and its distal end is n. In the state to be anchored, the length n of the occluder 20 accommodated in the loader is the same as the length of the occluder 20 accommodated in the sheath 11 of the same specification as the loader. When the occluder 20 is released to the state to be anchored with the help of the sheath 11, the second mark point 32 at the distal end of the conveying member 12 coincides with the third mark point 33 on the sheath 11. Among them, m>n, that is, the distance between the first mark point 31 and the distal end face of the sheath 11 is greater than the distance between the third mark point 33 and the distal end face of the sheath 11. For the occluder 20 of fixed specifications, the length m and the length n can be measured at the factory, and the first marking point 31 and the third marking point 33 matching them can be preset, or a matching comparison table can be provided for selection, without the need for measurement during surgery.

[0050] In this embodiment, by setting the second marking point 32 at the distal end of the conveying member 12, when the occluder 20 is connected to the conveying member 12, the second marking point 32 is set close to the proximal end of the occluder 20, so that the position of the occluder 20 can be determined by the position of the second marking point 32 in the same observation window under the DSA device, thereby reducing the measurement error caused by the large distance between the two. In other examples of this embodiment, the second marking point 32 can also be set at other positions of the conveying member 12, and the positions of the first marking point 31 and the third marking point 33 are adjusted accordingly according to the distance between the proximal end of the occluder 20 and the second marking point 32.

[0051] According to the occlusion system 100 of the present invention, a first marking point 31 is provided on the sheath 11, and a second marking point 32 is provided at the distal end of the conveying member 12, and both the first marking point 31 and the second marking point 32 are developable. When the occluder 20 is connected to the conveying member 12 and housed in the sheath 11 together, the conveying member 12 is pushed toward the distal end of the sheath 11, and the conveying member 12 drives the occluder 20 to move toward the distal end. When the second marking point 32 coincides with the first marking point 31, the occluder 20 is in a semi-released state, and a portion of the fixing plate 21 of the occluder 20 in the semi-released state is located outside the distal end of the sheath 11, so that the position of the first marking point 31 and the relative position of the second marking point 32 can be observed by using an in vitro digital subtraction angiography (DSA) device, thereby quickly controlling the occluder 20 to be released and deployed to a semi-released degree in the body. On the other hand, since the fixing plate 21 can extend to a deeper position in the left atrial appendage cavity to a greater extent when the occluder 20 is in a semi-released state, and does not affect its full deployment, it is a key node in releasing the occluder 20 more perfectly to a suitable position in the left atrial appendage. However, currently, the occluder 20 can only be controlled to be deployed to a semi-released state when entering the left atrial appendage cavity through a large amount of experience and accurate judgment of the operator through repeated operations and practices. With the help of the conveyor 10 provided by the present invention, the operation and judgment of the operator in the operation are simplified, so that the operation process is more dependent on objective reference objects rather than subjective judgment, and the requirements for the professional level of the operator are reduced, so that the left atrial appendage occlusion operation becomes simpler and easier for most operators to quickly get started.

[0052] Implementation Method 2

[0053] Combination Figure 3 and Figure 4As shown, the structures and matching modes of the conveyor 10 and the occluder 20 in this embodiment are basically the same as those in the first embodiment, and the same parts are not repeated here. The difference is that the first marking point 31 and the third marking point 33 in this embodiment are both arranged at the proximal end of the conveyor 12, and the second marking point 32 is arranged at the proximal end face of the handle 13. The distance between the third marking point 33 and the proximal end of the conveyor 12 is smaller than the distance between the first marking point 31 and the proximal end of the conveyor 12, that is, the third marking point 33 is closer to the proximal end of the conveyor 12 than the first marking point 31. When the conveyor 12 moves toward the distal end of the sheath 11 in the axial direction, the first marking point 31 and the third marking point 33 coincide with the second marking point 32 on the handle 13 in sequence. When the first marking point 31 coincides with the second marking point 32, the occluder 20 is in a semi-released state, and a part of the fixing plate 21 of the occluder 20 in the semi-released state is located outside the distal end of the sheath 11. When the third marking point 33 coincides with the second marking point 32, the occluder 20 is in a waiting state for anchoring, and the fixing plate 21 of the occluder 20 in the waiting state further extends outward from the distal end of the sheath tube 11 and further expands at the expansion degree of the semi-released state. By observing the relative positions of the first marking point 31, the third marking point 33 and the second marking point 32 under the DSA device, the release and expansion degree of the occluder 20 can be accurately controlled, so that the operator can quickly and accurately control and operate the occluder 20 at the key release node.

[0054] In this embodiment, by setting the first marking point 31 and the third marking point 33 at the proximal end of the conveying member 12, and by cooperating with the second marking point 32 on the proximal end surface of the handle 13, the operator can directly observe the position of each developing member outside the body and operate to control its relative position, which is convenient for the operator to quickly and accurately perform the semi-release operation or the operation to be anchored on the occluder 20, so that the occluder 20 is released and deployed to the desired deployment degree and release state. The reference marking points for controlling the rapid release of the occluder 20 to the semi-release state or the state to be anchored, that is, the first marking point 31, the second marking point 32 and the third marking point 33 are set outside the body, which is not only convenient for the operator to observe quickly and without error, but also easier to achieve during processing and manufacturing.

[0055] In this implementation, the first marking point 31, the second marking point 32 and the third marking point 33 are not developable, and corresponding marking points can be set on the conveying member 12 or the handle 13 by laser marking, printing, lamination, etc. In other implementations, the first marking point 31, the second marking point 32 and the third marking point 33 may also be developable.

[0056] The second marking point 32 may also be set at the proximal end of the sheath tube 11 or at other positions of the handle 13. When the second marking point 32 is set at other positions on the handle 13 except the proximal end surface, the handle 13 may be set to be transparent to facilitate observation of the positions of the first marking point 31 and the third marking point 33 in the handle 13. Similarly, when the second marking point 32 is set at the proximal end of the sheath tube 11, the proximal end of the sheath tube 11 may also be set to be transparent to facilitate observation.

[0057] When manufacturing the conveyor 10, the steps for calibrating the positions of the first marking point 31 and the third marking point 33 on the conveyor 12 are as follows: mark the second marking point 32 on the handle 13; connect the occluder 20 to the distal end of the conveyor 12 in vitro and accommodate them in the sheath 11 together, push the conveyor 12 toward the distal end of the sheath 11, so that the occluder 20 extends from the distal end of the sheath 11 and releases a part until it is in a semi-released state. At this time, a semi-released marking point, i.e., the first marking point 31, is set at a corresponding position on the same cross section as the second marking point 32 on the conveyor 12. Further push the conveyor 12 toward the distal end of the sheath 11 so that the occluder 20 is further released and is in a waiting anchoring state. At this time, a waiting anchoring marking point, i.e., the third marking point 33, is set at a corresponding position on the same cross section as the second marking point 32 on the conveyor 12. The spacing between the first marking point 31 and the third marking point 33 is mn. For occluders 20 of different specifications and sizes, the above method can be used to set the first marking point 31 and the third marking point 33 at corresponding appropriate positions.

[0058] For example Figure 5As shown, in another implementation, the proximal end of the conveying member 12 is provided with a plurality of grooves 122 spaced apart in the axial direction, and the first marking point 31 and the third marking point 33 are annular structures that can match the grooves 122, and the annular structures are provided with convex points that match the grooves 122, so that the first marking point 31 and the third marking point 33 are clamped in the grooves 122 of the conveying member 12, and the first marking point 31 or the third marking point 33 is prevented from shifting during the conveying process. Further, the conveying member 12 has a certain elasticity, so as to better fix the first marking point 31 and the third marking point 33 in the grooves 122, and the axial positions of the first marking point 31 and the third marking point 33 on the conveying member 12 can be adjusted by axial movement. Thus, according to the parameters such as the axial compression length m in the semi-release state and the axial compression length n in the anchoring state of the occluder 20 of different specifications that have been measured before leaving the factory, the corresponding first marking point 31 and the third marking point 33 can be set in the adjustable area of ​​the conveying member 12 provided with the grooves 122. When the occluder 20 needs to be replaced, it is only necessary to adjust the positions of the first marking point 31 and the third marking point 33 on the conveying member 12 so that they correspond to the specifications of the replaced occluder 20. The circumferential length of the adjustable area on the conveying member 12 ranges from 50 to 200 mm, the spacing of the grooves 122 ranges from 1 to 5 mm, and the size of the protrusion is much smaller than the axial width of the annular structure. The surface of the protrusion is smoothly transitioned, for example, it is a raised arc. The farthest end of the conveying member 12 is also provided with a connecting end 121, and the outer surface of the connecting end 121 is provided with a continuous external thread structure, so that it can be plugged into the proximal end of the sealing disk 22 through threaded cooperation to achieve the connection between the conveying member 12 and the occluder 20.

[0059] Further, the groove 122 can be a continuously arranged thread groove, and the first marking point 31 and the third marking point 33 can both cooperate with the thread groove in a rotating manner, so that the first marking point 31 can be rotated to achieve its movement in the axial direction, thereby adjusting its position on the conveying member 12, and the third marking point 33 can be rotated to achieve its movement in the axial direction, thereby adjusting its position on the conveying member 12, so that the first marking point 31 and the third marking point 33 can be matched to the occluder 20 of the corresponding specification. Specifically, the inner surface of the first marking point 31 and the third marking point 33 that cooperates with the groove 122 is provided with an internal thread, and the internal thread cooperates with the spiral groove 122, so as to realize the rotation of the first marking point 31 and the third marking point 33. The internal threads on the first marking point 31 and the third marking point 33 protrude from the inner surface thereof, and can be embedded in the groove 122 of the conveying member 12, so as to limit its axial movement when not rotating.

[0060] Implementation Method 3

[0061] Combination Figure 6 and Figure 7 As shown, the structure and matching mode of the conveyor 10 and the occluder 20 in this embodiment are basically the same as those in the first embodiment or the second embodiment, and the same parts are not repeated here. The first marking point 31, the second marking point 32 and the third marking point 33 can be any of the settings in the first embodiment and the second embodiment. Further, the occluding system 100 of this embodiment also includes a fourth marking point 34, and a plurality of fourth marking points 34 are respectively arranged on the anchor barb 212 of the fixed disk 21 or are a part of the anchor barb 212, so that the anchor barb 212 has a developability that can be developed under the DSA device. All the anchor barbs are distributed at intervals on the same cross section of the fixed disk 21, and therefore, all the fourth marking points 34 are also distributed at intervals on the same cross section of the fixed disk 21. By setting the fourth marking point 34 on the anchor barb 212 of the occluder 20 or setting it as a part of the anchor barb 212, the release state and position of the occluder 20 can be intuitively observed under the DSA device, which is conducive to ensuring the effectiveness of the release operation of the occluder 20 and the safety of the operation. Among them, the occluder 20 is a conventional occluder structure, including a fixed disk 21 and a sealing disk 22. The fixed disk 21 and the sealing disk 22 are connected by a connecting piece 23. A first flow-blocking membrane 24 is provided inside the sealing disk 22, and a second flow-blocking membrane 25 connected in series with each support rod 211 is provided on the fixed disk 21, thereby performing multi-layer sealing on the position after the occluder 20 is released.

[0062] Specifically, the anchor thorn 212 can be made of a metal material with a developing property, so that the anchor thorn 212 itself has a developing property, which is convenient for intuitive observation. Alternatively, the fourth marking point 34 with a developing property is set on the anchor thorn 212 by embedding. The material of the fourth marking point 34 can be gold, platinum, platinum-iridium alloy or other materials with good developing properties. Figure 7 In addition to the embedded riveting method shown to fix the fourth marking point 34, it can also be fixed by fixing with a developing ring, winding with a developing wire, etc. The setting of the fourth marking point 34 can assist in judging the release effect of the occluder 20 in the anchoring state.

[0063] Furthermore, if Figure 8 As shown, the occlusion system 100 of this embodiment further includes a fifth marking point 35, and a plurality of fifth marking points 35 are respectively arranged on a plurality of support rods 211 of the fixed disk 21. Specifically, the fifth marking point 35 can be arranged at a position where the support rod 211 has the maximum bending strength after being folded toward the proximal end, so that the fifth marking point 35 can be used to assist in judging the release effect of the occluder 20 in the semi-released state. All the fifth marking points 35 are distributed at intervals on the same cross-section of the fixed disk 21. In other examples of this embodiment, only the fifth mark 35 can be set without setting the fourth marking point 34. In addition, one or more developable marking points can be set at other positions of the fixed disk 21.

[0064] The occlusion system 100 of the present invention can not only be used for the delivery and release process of the occluder 20, but also can be applied to the delivery and release process of other devices.

[0065] When the occlusion system 100 according to any embodiment of the present invention is used to occlude the left atrial appendage 200, the following steps are included:

[0066] The distal end of the conveying member 12 is connected to the proximal end of the occluder 20, and they are housed together in the sheath tube 11, and the distal end of the occluder 20 is flush with the distal end of the sheath tube 11;

[0067] Pushing the sheath tube 11 toward the left atrial appendage 200;

[0068] When the distal end of the sheath tube 11 approaches the opening position of the left atrial appendage 200, the conveying member 12 is pushed and the distal end of the fixing plate 21 is pushed out from the distal end of the sheath tube 11. When the first marking point 31 coincides with the second marking point 32, the occluder 20 is in a semi-released state. Fig. 9 As shown;

[0069] Continue to push the sheath tube 11 toward the inside of the left atrial appendage 200, so that the sheath tube 11 is located at a suitable position in the cavity of the left atrial appendage 200 to wait for the next anchoring operation, and then further push the conveying member 12 to make the fixing plate 21 further extend outward from the distal end of the sheath tube 11. When the third marking point 33 coincides with the second marking point 32, the occluder 20 is in a waiting anchoring state. Fig.10 As shown;

[0070] Continue to push the conveying member 12 toward the distal end and make the fixing plate 21 completely extend from the distal end of the sheath tube 11. At this time, the fixing plate 21 is in a completely released state, and the anchor barb 212 on the fixing plate 21 pierces the inner wall of the cavity of the left atrial appendage 200. Fig.11 As shown;

[0071] Continue to push the conveying member 12 toward the distal end and make the sealing disk 22 completely extend from the distal end of the sheath tube 11. At this time, the sealing disk 22 is in a completely released state, and the sealing disk 22 fits with the opening of the left atrial appendage 200, thereby blocking the opening of the left atrial appendage 200. Fig.12 As shown;

[0072] Finally, after confirming that the occlusion is tight, the connection between the delivery member 12 and the proximal end of the occluder 20 is released, and the delivery member 12 and the sheath 11 are withdrawn outside the body, and the completely released occluder 20 is retained in the left atrial appendage 200, thereby completing the surgical operation process.

[0073] During this process, by directly observing the relative positions of the first marker 31, the third marker 33 and the second marker 32 under the DSA device or in vitro and performing corresponding operation controls, the occluder 20 can be quickly placed in a semi-released state or a waiting-to-anchor state, thereby accurately releasing the occluder 20 in steps within the cavity of the left atrial appendage 200, allowing the occluder 20 to extend into a deeper position within the cavity and to be fully deployed within the cavity, while saving operation time and reducing the difficulty of the operation.

[0074] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A blocking system, comprising a conveyor and an occluder, wherein the occluder is used for blocking the left atrial appendage, the occluder comprises a fixing plate at the distal end thereof, the conveyor comprises a hollow sheath tube and a conveying member, the distal end of the conveying member is detachably connected to the occluder and can move along the axial direction of the sheath tube when accommodated in the sheath tube, characterized in that: The conveyor is provided with a first marking point and a second marking point which are respectively arranged on the sheath and the conveying member. When the sheath and the conveying member move relative to each other so that the second marking point coincides with the first marking point, the occluder is in a semi-released state; in the semi-released state, a part of the fixed disk is located outside the sheath, and the expanded diameter of the fixed disk is 35% to 65% of its diameter when it is fully expanded in a natural state.

2. The blocking system according to claim 1, characterized in that: At least one anchor barb is provided on the fixing plate, and a third marking point is also provided on the conveyor. When the sheath tube and the conveyor member move relative to each other so that the second marking point coincides with the third marking point, the occluder is in a waiting-to-anchor state; when in the waiting-to-anchor state, the minimum angle between the anchor barb and the central axis of the occluder ranges from 70 degrees to 90 degrees.

3. The blocking system according to claim 1 or 2, characterized in that: The first marking point is disposed at the distal end of the sheath tube and has a developing property, and the second marking point is disposed at the distal end of the conveying member and has a developing property.

4. The blocking system according to claim 2, characterized in that: The third marking point is disposed at the distal end of the sheath tube and has a developing property, and the third marking point is closer to the distal end of the sheath tube than the first marking point.

5. The blocking system according to claim 3, characterized in that: The distance between the first marking point and the distal end of the sheath is equal to the length of the occluder contained in the sheath when in a semi-released state.

6. The blocking system according to claim 4, characterized in that: The distance between the third marking point and the distal end of the sheath is equal to the length of the occluder accommodated in the sheath when in the waiting anchoring state.

7. The blocking system according to claim 1, characterized in that: The conveyor also includes a hollow handle, the proximal end of the sheath is connected to the handle, the first marking point is arranged at the proximal end of the conveying member, and the second marking point is arranged on the handle or the proximal end of the sheath.

8. The blocking system according to claim 7, characterized in that: The conveyor is also provided with a third marking point, which is arranged at the proximal end of the conveying member, and the third marking point is closer to the proximal end of the conveying member than the first marking point.

9. The blocking system according to claim 8, characterized in that: The position of the first marking point on the conveying member is adjustable; or, the positions of the first marking point and the third marking point on the conveying member are both adjustable.

10. The blocking system according to claim 1, characterized in that: At least one anchor thorn is arranged on the fixed disk, and at least one of the anchor thorns has developing property.

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