Delivery and retrieval system for a heart occluder and method of delivery and retrieval thereof

Abstract

This application discloses a delivery and retrieval system and method for a cardiac occluder. The delivery device includes a delivery sheath and a delivery gripper. The delivery sheath establishes a delivery channel, and the delivery gripper is adapted to grasp the gripping portion of the cardiac occluder and move it to a target release position within the delivery channel. The retrieval device is used to retrieve the cardiac occluder when it moves to a non-target release position. The retrieval device includes a retrieval sheath and a retrieval gripper. The retrieval sheath establishes a retrieval channel, and the retrieval gripper is adapted to grasp the second disc portion of the cardiac occluder and retrieve the cardiac occluder along the retrieval channel. The delivery channel and the retrieval channel are spaced apart. Therefore, by setting a retrieval channel spaced apart from the delivery channel, the difficulty of moving the retrieval gripper to the expected position can be reduced. Furthermore, by using the retrieval gripper to grasp the second disc portion, the retrieval of the cardiac occluder can be achieved, thus reducing the difficulty of retrieval and improving the success rate.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a delivery and retrieval system and method for a cardiac occluder. Background Technology

[0002] Atrial septal defect (ASD) is a hole in the septum between two atria, accounting for about 7-10% of all congenital heart diseases. Depending on the location, it can be divided into: secundum ASD (80%): the defect is located in the middle of the atrial septum, hence also called central secundum ASD; primum ASD (10%): located near the mitral and tricuspid valve annulus, it may cause mitral valve cleft and insufficiency, and in a sense is equivalent to "partial endocardial septal defect"; sinus venosus ASD (10%): can be divided into superior vena cava (close to the superior vena cava entrance, often accompanied by right pulmonary vein drainage abnormalities) and inferior vena cava (located lower, connected to the inferior vena cava opening); patent foramen ovale (PFO): generally considered a type of ASD, it usually closes spontaneously within a few months after birth.

[0003] The foramen ovale is a physiological passage in the atrial septum during embryonic development. Around 5-7 months after birth, in most individuals, the secondary and primary septa of the atrial septum adhere and fuse to form a permanent atrial septum. If fusion fails, a patent foramen ovale (PFO) is formed. Because the shunt volume of the PFO is so small, it was long believed that PFO would not cause clinical consequences. In recent years, however, increasing research has found that patients with PFO have a significantly higher risk of stroke, migraine, peripheral artery embolism, and decompression sickness compared to the general population. This has drawn the attention of experts and scholars to the pathogenic effects of PFO, leading to clinical explorations using methods such as PFO closure to prevent recurrent stroke events and treat migraines and recumbent-orthostatic hypoxemia.

[0004] Ventricular septal defect (VSD) is a common congenital heart disease. The opening in the ventricular septum between the left and right ventricles is called a ventricular septal defect. VSDs primarily form during fetal development. In patients with VSDs, blood typically flows from the left ventricle into the right ventricle through the defect, increasing the blood volume in the right ventricle. The long-term presence of a VSD can cause pulmonary hypertension, congestive heart failure, palpitations, shortness of breath, fatigue, and recurrent lung infections.

[0005] Among related technologies, minimally invasive interventional treatments for cardiac defects such as atrial septal defects, patent foramen ovale, and ventricular septal defects are now highly mature. Compared to traditional surgery, minimally invasive interventional treatment is a modern, high-tech, minimally invasive procedure. Through femoral vein puncture, guided by medical imaging equipment, a guide wire is inserted along the femoral vein and inferior vena cava until it reaches the affected area. Finally, a cardiac occluder is pushed into the delivery sheath to the atrial or ventricular septal defect site for closure. The cardiac occluder is like an umbrella in everyday life; it is folded up when inserted and unfolded after being positioned at the defect site to close it, achieving the therapeutic goal. This minimally invasive interventional treatment has advantages such as no incision, minimal trauma, fewer complications, faster recovery, better efficacy, a wider range of indications, and relatively lower surgical costs.

[0006] The cardiac occluder has a shape memory function, exhibiting both contracted and open states. When contracted, the occluder is compressed into the sheath; when open, it occupies a larger volume. During delivery, once the occluder switches to the open state, it is difficult to retrieve via the original path, making retrieval challenging. Summary of the Invention

[0007] The present invention aims to at least solve one of the technical problems existing in the prior art. Therefore, one object of the present invention is to provide a delivery and retrieval system for a cardiac occluder, which can deliver the cardiac occluder through a delivery device and retrieve it through a retrieval device, with the delivery device and retrieval device having separate channels to reduce the difficulty of retrieval.

[0008] This application further proposes a delivery and recovery method for the aforementioned cardiac occluder delivery and recovery system.

[0009] In a first aspect, this application proposes a delivery and retrieval system for a cardiac occluder, comprising: a delivery device and a retrieval device. The delivery device is used to deliver the cardiac occluder to a target release position, the target release position including a structure to be occluded with a through hole. The delivery device includes: a delivery sheath and a delivery gripper. The delivery sheath is used to establish a delivery channel, and the delivery gripper is adapted to grip the gripping portion of the cardiac occluder and move it within the delivery channel to the target release position. The retrieval device is used to retrieve the cardiac occluder when it moves to a non-target release position. The retrieval device includes: a retrieval sheath and a retrieval gripper. The retrieval sheath is used to establish a retrieval channel, and the retrieval gripper is adapted to grip the second disc portion of the cardiac occluder and retrieve the cardiac occluder along the retrieval channel. The conveying channel and the recycling channel are spaced apart.

[0010] According to the cardiac occluder delivery and retrieval system of the present application embodiment, by setting a retrieval channel spaced apart from the delivery channel, the difficulty of moving the retrieval gripper to the expected position to grasp the cardiac occluder can be reduced. Furthermore, by using the retrieval gripper to grasp the second disc, the cardiac occluder can be retrieved, which can also reduce the difficulty of retrieval and improve the success rate of retrieval.

[0011] According to some embodiments of this application, the delivery device further includes: a loading sheath having a loading channel adapted to accommodate the cardiac occluder, the loading sheath being selectively connected to the delivery sheath, and the delivery gripper being adapted to push the cardiac occluder from the loading channel to the delivery channel.

[0012] According to some embodiments of this application, the inner diameter of the delivery sheath is L1, the inner diameter of the recovery sheath is L2, and L2 > L1.

[0013] According to some embodiments of this application, the delivery sheath has a first inlet end and an outlet end, and the recovery sheath has a second inlet end and a recovery end, wherein at least the inner diameter of the second inlet end is larger than the inner diameter of the outlet end.

[0014] According to some embodiments of this application, the second inlet is configured as a flared opening.

[0015] Secondly, this application provides a conveying and recycling method for the aforementioned conveying and recycling system, comprising: The conveying device establishes the conveying channel, and the conveying gripper conveys the heart occluder to the target release position; Obtain the placement position of the cardiac occluder; If the placement position is the target release position, then release the conveying gripper; If the placement location is the non-target release location, the retrieval device establishes a retrieval channel and retrieves the cardiac occluder; wherein The cardiac occluder is constructed of a radiopaque material to allow for the location of the surgical cardiac occluder.

[0016] According to some embodiments of this application, the non-target location includes: a first location and a second location, wherein the first location is located on the left side of the structure to be blocked, and the second location is located on the right side of the structure to be blocked. The recovery device establishes a recovery channel and recovers the cardiac occluder, specifically including: If in the first position, the delivery gripper is released, and the retrieval gripper moves to the third position to grasp the second disc of the cardiac occluder; If in the second position, the retrieval gripper moves to the second position, grasps the cardiac occluder, and releases the delivery gripper; The third position is located below the target release position.

[0017] According to some embodiments of this application, the delivery and recovery method further includes: loading the cardiac occluder into the loading sheath before the delivery device establishes the delivery channel.

[0018] According to some embodiments of this application, the cardiac occluder includes: a first disc portion, a second disc portion, and an occlusion portion, wherein the first disc portion and the second disc portion are connected to the axial ends of the occlusion portion, and the loading sheath includes: a first end and a second end located at both ends of the loading channel, wherein loading the cardiac occluder into the loading sheath includes: The second disc, the sealing part, and the first disc are sequentially loaded into the loading channel from the first end.

[0019] According to some embodiments of this application, loading the cardiac occluder into the loading sheath further includes: The second disc extends out of the second end and moves back into the loading sheath so that the first disc and the second disc extend away from each other along the axial direction of the sealing portion to retract.

[0020] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0021] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a schematic diagram of a conveying and recycling system according to an embodiment of this application; Figure 2 This is a schematic diagram of a conveying gripper or a retrieval gripper according to an embodiment of this application; Figures 3-4 This is a schematic diagram of the recycling process of the recycling system according to an embodiment of this application; Figure 5 This is a schematic diagram illustrating the cooperation between the loading sheath and the cardiac occluder or the delivery sheath and the cardiac occluder according to embodiments of this application; Figure 6 This is a schematic diagram of a delivery sheath according to an embodiment of this application; Figure 7 This is a schematic diagram of a cardiac occluder; Figure 8 This is a flowchart of a conveying and recycling method according to an embodiment of the conveying and recycling system of this application.

[0022] Figure label: Conveying and recycling system 100, Conveying device 10, conveying sheath 11, conveying gripper 12, loading sheath 13. Recovery device 20, recovery sheath 21, recovery gripper 22. Heart occluder 200 First plate section 210, second plate section 220, blocking section 230, clamping section 240. Detailed Implementation

[0023] 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 described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0024] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used in the description of this application is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms "comprising" and "having," and any variations thereof, in the description, claims, and accompanying drawings of this application are intended to cover non-exclusive inclusion. The terms "first," "second," etc., in the description, claims, or accompanying drawings of this application are used to distinguish different objects, not to describe a specific order or hierarchy.

[0025] In this application, the reference to "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment that is mutually exclusive with other embodiments.

[0026] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "attachment" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0027] In this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, in this application, the character " / " generally indicates that the preceding and following related objects have an "or" relationship.

[0028] In the embodiments of this application, the same reference numerals denote the same components, and for the sake of brevity, detailed descriptions of the same components are omitted in different embodiments. It should be understood that the thickness, length, width, and other dimensions of various components in the embodiments of this application shown in the accompanying drawings, as well as the overall thickness, length, width, and other dimensions of the integrated device, are merely illustrative and should not constitute any limitation on this application.

[0029] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0030] In the description of this invention, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or it may include the first and second features not being in direct contact but being in contact through another feature between them.

[0031] In the description of this invention, the terms "above," "over," and "on top" for the first feature and the second feature include the first feature being directly above or diagonally above the second feature, or simply indicating that the first feature is at a higher horizontal level than the second feature.

[0032] In this application, "multiple" means two or more (including two).

[0033] First, the specific structure of each component involved in this application will be described in detail.

[0034] The Cardiac Occluder 200 is an interventional medical device used to treat congenital heart disease. It is primarily used to close abnormal pathways between the heart and major blood vessels, such as atrial septal defects, ventricular septal defects, and patent ductus arteriosus, thereby improving cardiac hemodynamic abnormalities. The Cardiac Occluder 200 is typically made of biocompatible materials such as nickel-titanium alloys and ceramics, and possesses shape memory properties.

[0035] like Figure 1 As shown, the delivery and retrieval system 100 of this application embodiment includes a delivery device 10 and a retrieval device 20. The delivery device 10 is used to deliver the cardiac occluder 200 to the target release position, while the retrieval device 20 is used to retrieve the cardiac occluder 200 when it moves to a non-target release position.

[0036] In some embodiments of this application, the target release location of the cardiac occluder 200 may be a specific region in a model containing defects or openings such as atrial septal defect, ventricular septal defect, or patent foramen ovale, which is stored outside the body and is the structure to be occluded.

[0037] In some other embodiments of this application, the target release location of the cardiac occluder 200 refers to a specific area on the heart, such as atrial septal defect, ventricular septal defect, or patent foramen ovale, which is the structure to be occluded.

[0038] like Figure 7 As shown, the cardiac occluder 200 includes a first disc portion 210, a second disc portion 220, an occlusion portion 230, and a clamping portion 240 arranged opposite to each other in the unfolded state. The two ends of the occlusion portion 230 are connected to the first disc portion 210 and the second disc portion 220, respectively. After unfolding, the second disc portion 220 and the first disc portion 210 can be located on both sides of the defect hole (i.e. the structure to be occluded), and the occlusion portion 230 can seal the defect hole.

[0039] like Figures 1-6 As shown, the delivery device 10 includes a delivery sheath 11 and a delivery gripper 12. The delivery sheath 11 can form a delivery channel, that is, the delivery sheath 11 is used to form a channel for delivering the cardiac occluder 200 to the target release position. The delivery gripper 12 can grasp the clamping part 240 of the cardiac occluder 200, and by pushing the delivery gripper 12, the cardiac occluder 200 is moved to the target release position.

[0040] Correspondingly, the retrieval device 20 includes a retrieval sheath 21 and a retrieval gripper 22. The retrieval sheath 21 can form a retrieval channel, that is, the retrieval sheath 21 is used to form a channel for retrieving the cardiac occluder 200. The retrieval gripper 22 can grasp the second disc portion 220 of the cardiac occluder 200. After grasping, the cardiac occluder 200 is retrieved through the retrieval sheath 21.

[0041] It should be noted that during the process of placing the cardiac occluder 200 to the target release position, situations may arise such as the cardiac occluder 200 becoming misfit or being placed in a position other than the target release position. In such cases, the cardiac occluder 200 needs to be retrieved. However, at this time, the cardiac occluder 200 changes from a contracted state to an open state, and the inner diameter of the delivery channel is limited. Furthermore, the delivery gripper 12 may need to grip the cardiac occluder 200 to prevent it from shifting, making it difficult to retrieve the cardiac occluder 200 through the delivery channel. Based on this, this application further includes a retrieval device 20. The retrieval device 20 can establish a retrieval channel separated from the delivery channel, and can cooperate with the delivery gripper 12 through the retrieval gripper 22 to position the cardiac occluder 200. The delivery gripper 12 then moves to the expected position, thereby retrieving the cardiac occluder 200.

[0042] It should be noted that although minimally invasive interventional procedures treat heart defects such as atrial septal defects, patent foramen ovale, and ventricular septal defects through the cardiac occluder 200, the structure of the delivery device 10 and the retrieval device 20 of the delivery and retrieval system 100 in this application, as well as the delivery and retrieval methods of the delivery and retrieval system 100, such as delivery operation, retrieval operation, loading operation of the cardiac occluder 200, and the cooperative relationship between the delivery device 10 and the retrieval device 20, are all specific descriptions of the medical device itself and its delivery and retrieval methods. The core purpose is to enable the retrieval of the cardiac occluder 200 through the retrieval device 20. This is a specific structural improvement made to address the difficulty of retrieving the cardiac occluder 200 using the existing delivery device 10. The delivery and retrieval system 100 of this application can reduce the difficulty of retrieving the cardiac occluder 200.

[0043] Combination Figure 1 As shown, Figure 1 A schematic diagram is shown of the delivery gripper 12 pushing the heart occluder 200 in the delivery channel. A schematic diagram is also shown of the retrieval gripper 22 grabbing the second disc 220 and retrieving the heart occluder 200. The gripping form of the retrieval gripper 22 is schematic and may deviate slightly during the actual gripping process.

[0044] like Figure 2 As shown, Figure 2 The structure of the delivery gripper 12 or the retrieval gripper 22 in the embodiments of this application is shown. The delivery and retrieval system 100 of this application includes at least the delivery gripper 12 and the retrieval gripper 22. It can also be further configured with an auxiliary gripper based on the need to load the cardiac occluder 200, or any gripper can be reused as an auxiliary gripper. The gripper can be a screw-type gripper or a scissor-type gripper. This application does not make any specific limitation.

[0045] like Figure 3 As shown, Figure 3 This diagram illustrates the process of the retrieval gripper 22 grasping the cardiac occluder 200. Specifically, it shows the process of the cardiac occluder 200 being grasped by the retrieval gripper 22 after the delivery gripper 12 is released, when the cardiac occluder 200 is in the first position.

[0046] like Figure 4 As shown, Figure 4 This is another schematic diagram illustrating the process of the retrieval gripper 22 grasping the cardiac occluder 200. Specifically, it is a schematic diagram in which the retrieval gripper 22 further grasps the second disc 220 when the cardiac occluder 200 is in the second position and the delivery gripper 12 is still gripping the clamping part 240 to position the cardiac occluder 200.

[0047] certainly, Figure 4 The scissor-type gripper can also be an auxiliary gripper, and the sheath can be a loading sheath 13. Figure 4 The corresponding diagram is a schematic diagram of the auxiliary gripper and the delivery gripper 12 working together to assemble the cardiac occluder 200 to the loading sheath 13.

[0048] Figure 5 This is a schematic diagram of the cardiac occluder 200 inside the loading sheath 13 or delivery sheath 11.

[0049] Figure 6 This is a schematic diagram of the delivery sheath 11 according to an embodiment of this application. Figure 7 This is a schematic diagram of the cardiac occluder 200 according to an embodiment of this application. Figure 8 This is a flowchart illustrating the recycling method used in this application.

[0050] The following is for reference. Figures 1-8 A delivery and retrieval system 100 and a delivery and retrieval method for a cardiac occluder 200 according to an embodiment of the present invention are described.

[0051] like Figure 1 As shown, this application proposes a delivery and retrieval system 100 for a cardiac occluder 200, comprising: a delivery device 10 and a retrieval device 20. The delivery device 10 is used to deliver the cardiac occluder 200 to a target release position of the cardiac occluder 200, the target release position including a structure to be occluded with a through hole. The delivery device 10 includes: a delivery sheath 11 and a delivery gripper 12. The delivery sheath 11 is used to establish a delivery channel, and the delivery gripper 12 is adapted to grip the gripping portion 240 of the cardiac occluder 200 and move it to the target release position within the delivery channel. The retrieval device 20 is used to retrieve the cardiac occluder 200 when it moves to a non-target release position. The retrieval device 20 includes: a retrieval sheath 21 and a retrieval gripper 22. The retrieval sheath 21 is used to establish a retrieval channel, and the retrieval gripper 22 is adapted to grip the second disc portion 220 of the cardiac occluder 200 and retrieve the cardiac occluder 200 along the retrieval channel.

[0052] Specifically, the delivery device 10 can be used to deliver the cardiac occluder 200 to the target release position. If the cardiac occluder 200 fails to be delivered to the target position, a retrieval channel can be established through the retrieval sheath 21. The retrieval gripper 22 grabs the cardiac occluder 200 through the retrieval channel and removes the cardiac occluder 200 from the retrieval channel.

[0053] It should be noted that the diameter of the delivery channel is limited, making it difficult to accommodate multiple grippers simultaneously. Also, when the cardiac occluder 200 is in the deployed state, it is difficult for the cardiac occluder 200 to enter the delivery channel with a smaller diameter. When the cardiac occluder 200 is in the retracted state, the first disc 210 retracts to one end of the clamping part 240 and extends away from the occlusion part 230, pulling the clamping part 240 located in the center of the first disc 210. It is difficult to pull the first disc 210 in the reverse direction to retract, making it difficult to pull the cardiac occluder 200 back into the delivery channel by the reverse movement of the delivery gripper 12 when it is in the deployed state.

[0054] This application further separates the delivery channel and the retrieval channel. Through the retrieval channel, the retrieval gripper 22 is introduced to grasp the cardiac occluder 200. During the process of the retrieval gripper 22 grasping the cardiac occluder 200, the delivery gripper 12 can selectively cooperate with the retrieval gripper 22, or the cardiac occluder 200 can be retrieved by the retrieval gripper 22 alone. When the retrieval gripper 22 grasps the second disc 220 of the cardiac occluder 200, the second disc 220 is also retracted and stored away from the end of the occlusion part 230 during the process of switching from the open state to the contracted state. The edge of the second disc 220 is directly grasped for retrieval. The second disc 220 is first pulled into the retrieval sheath 21, which can reduce the difficulty of grasping and make it easier for the cardiac occluder 200 to enter the retrieval channel.

[0055] According to the embodiment of this application, the delivery and retrieval system 100 of the cardiac occluder 200 can reduce the difficulty of moving the retrieval gripper 22 to the expected position to grasp the cardiac occluder 200 by setting a retrieval channel spaced apart from the delivery channel. Furthermore, by using the retrieval gripper 22 to grasp the second disc 220, the cardiac occluder 200 can be retrieved, which can also reduce the difficulty of retrieval and improve the success rate of retrieval.

[0056] It should be noted that the retrieval gripper 22 is suitable for gripping the second disc 220 to retrieve the cardiac occluder 200, and it can also grip other areas of the cardiac occluder 200 to achieve retrieval. This application does not make specific limitations.

[0057] Combination Figure 5 and Figure 6As shown, according to some embodiments of this application, the delivery device 10 further includes: a loading sheath 13 having a loading channel adapted to accommodate the cardiac occluder 200, the loading sheath 13 being optionally connected to the delivery sheath 11, and the delivery gripper 12 adapted to push the cardiac occluder 200 from the loading channel to the delivery channel.

[0058] It should be pointed out that, as Figure 5 As shown, in the contracted state, the first disc portion 210 and the second disc portion 220 extend away from each other along the axial direction of the occlusion portion 230 to contract. In the open state, the first disc portion 210 and the second disc portion 220 extend radially along the occlusion portion 230 to form a disc shape, and the first disc portion 210 and the second disc portion 220 are arranged in parallel.

[0059] Specifically, the loading channel can accommodate the cardiac occluder 200. Within the loading channel, the first disc portion 210 and the second disc portion 220 extend away from each other to be housed within the delivery channel. This allows the second disc portion 220 to move toward the occlusion portion 230 to switch to an open state as it extends out of the delivery channel, and the first disc portion 210 to move toward the occlusion portion 230 to switch to an open state as it extends out of the delivery channel. This improves the clamping effect of the first disc portion 210 and the second disc portion 220 on both sides of the occlusion portion 230, thereby enhancing the reliability and stability of the cardiac occluder 200 at the target release position.

[0060] In this way, by setting up the loading sheath 13 and connecting it with the delivery sheath 11, the difficulty of the cardiac occluder 200 entering the delivery sheath 11 can be reduced.

[0061] The loading sheath 13 is used to transport the cardiac occluder 200 to the delivery sheath 11, so that the delivery sheath 11 can guide the cardiac occluder 200 to the target release position where the structure to be blocked is located. The cardiac occluder 200 deforms to reduce its volume so as to fit into the loading sheath 13 for easy transport. After the cardiac occluder 200 is delivered from the delivery sheath 11, the cardiac occluder 200 can automatically return to its original shape to block the structure to be blocked.

[0062] The release process of the cardiac occluder 200 is briefly described below. First, the delivery sheath 11 is extended to the target release position. Then, the cardiac occluder 200 is pushed along the delivery sheath 11. The second disc 220 is released from the delivery sheath 11 on one side of the structure to be sealed. After release, the second disc 220 automatically returns to its original state and abuts against one side of the structure to be sealed. Then, the sealing part 230 is released from the delivery sheath 11 and is positioned at the gap in the structure to be sealed, sealing the defect. Finally, the first disc 210 is released from the delivery sheath 11 on the other side of the structure to be sealed. After release, the first disc 210 automatically returns to its original state and abuts against the other side of the structure to be sealed. The first disc 210 and the second disc 220 together clamp the two sides of the structure to be sealed to achieve the sealing of the structure.

[0063] like Figure 1 As shown, according to some embodiments of this application, the inner diameter of the delivery sheath 11 is L1, the inner diameter of the recovery sheath 21 is L2, and L2 > L1.

[0064] In other words, by making the inner diameter of the retrieval channel larger than that of the delivery channel, the heart occluder 200 is easier to retrieve through the retrieval sheath 21, which can further reduce the difficulty of retrieving the heart occluder and improve the success rate of retrieval.

[0065] like Figure 1 As shown, according to some embodiments of this application, the delivery sheath 11 has a first inlet end and an outlet end, and the recovery sheath 21 has a second inlet end and a recovery end, wherein at least the inner diameter of the second inlet end is larger than the inner diameter of the outlet end.

[0066] Specifically, see Figure 1 As shown, Figure 1 The top end of the left-hand delivery sheath 11 is the output end, and the bottom end is the first inlet end. The first inlet end can be used to dock with the loading sheath 13. The cardiac occluder 200 can be removed from the output end and switched to the open state to seal the structure to be sealed. Figure 1 The bottom end of the right-side retrieval sheath 21 is the retrieval end, and the top end is the second entry end. The second entry end is used for the entry of the cardiac occluder 200, and the retrieval end is used for the retrieval of the cardiac occluder 200 after it is removed.

[0067] Furthermore, the inner diameter of the second inlet end is made larger than the inner diameter of the outlet end, so that the heart occluder 200 that unfolds through the outlet end can be retrieved by the retrieval end with a larger inner diameter, which can effectively reduce the difficulty of retrieving the heart occluder 200.

[0068] like Figure 3 and Figure 4 As shown, according to some embodiments of this application, the second entry end is constructed as a horn-shaped opening.

[0069] In this way, by constructing a retrieval end with a funnel-shaped opening for retrieving the cardiac occluder 200, the opening size of the funnel gradually decreases. During the retrieval process of the cardiac occluder 200, it is possible to guide the cardiac occluder 200, thereby further reducing the difficulty of retrieving the cardiac occluder 200.

[0070] It should be pointed out that, in combination Figure 2 and Figure 3 As shown, both the recovery gripper 22 and the conveying gripper 12 can be constructed as scissor grippers, or as screw grippers, or of course as grippers of other structural forms.

[0071] See Figure 3 and Figure 4 As shown, during the process of the retrieval gripper 22 grasping the heart occluder 200, the delivery gripper 12 can either release the heart occluder 200 and retrieve the gripper 22 for grasping, or the delivery gripper 12 can position the heart occluder 200 and retrieve the gripper 22 for grasping. The two methods can be rationally selected based on the current position of the heart occluder 200.

[0072] See Figure 8 As shown, this application provides a conveying and recycling method for a conveying and recycling system 100, comprising: The conveying device 10 establishes a conveying channel, and the conveying gripper 12 conveys the heart occluder 200 to the target release position; Obtain the placement location of the cardiac occluder 200; If the placement position is the target release position, then release the conveyor gripper 12; If the placement location is not the target release location, the retrieval device 20 establishes a retrieval channel and retrieves the cardiac occluder 200.

[0073] Specifically, the cardiac occluder 200 is constructed of a radiopaque material to obtain the position of the cardiac occluder 200. Based on the position of the cardiac occluder 200, the delivery device 10 and the retrieval device 20 can be controlled. When the placement position of the cardiac occluder 200 is the target release position, the delivery gripper 12 can be released, that is, the clamping part 240 can be released, so that the cardiac occluder 200 located at the target release position can perform its function.

[0074] Furthermore, if the placement location is not the target release location, the retrieval device 20 is operated to retrieve the heart occluder 200, thereby reducing the difficulty of retrieving the heart occluder 200.

[0075] According to the delivery and retrieval method of the delivery and retrieval system 100 in the embodiments of this application, the delivery device 10 or the retrieval device 20 can be selectively operated based on the placement position of the cardiac occluder 200, which can reduce the difficulty of placing and retrieving the cardiac occluder 200.

[0076] It should be noted that the cardiac occluder 200 is used to seal the structure to be sealed. The structure to be sealed is a through-hole structure. The delivery gripper 12 needs to release the second disc 220 from one side of the structure to be sealed and the first disc 210 from the other side of the structure to be sealed. Therefore, there are two situations in which the cardiac occluder 200 is in the non-target release position. One is that the first disc 210 and the second disc 220 are both released on one side of the structure to be sealed (i.e., the first position), and the other is that the first disc 210 and the second disc 220 are both released on the other side of the structure to be sealed (i.e., the second position). In these two situations, the retrieval device 20 needs to retrieve the structure from both sides of the structure to be sealed. Therefore, the operation of the retrieval device 20 and the delivery device 10 are different.

[0077] Specifically, combined Figure 8 As shown, the non-target locations include: a first location and a second location. The first location is located on the left side of the structure to be blocked, and the second location is located on the right side of the structure to be blocked. The recovery device 20 establishes a recovery channel and recovers the cardiac occluder 200, specifically including: If in the first position, release the delivery gripper 12, retract the gripper 22 and move it to the third position to grab the heart occluder 200; If in the second position, the retractable gripper 22 moves to the second position, grips the second disc 220 of the cardiac occluder 200, and releases the delivery gripper 12; The third position is located below the target release position.

[0078] Specifically, when the cardiac occluder 200 is in the first position, the retrieval device 20 can be controlled to move to the third position, and the delivery gripper 12 is released. The cardiac occluder 200 can move to the third position on its own (under the influence of the medium flow and gravity within the structure to be sealed). The retrieval gripper 22 then grabs any one of the first disc portion 210, the second disc portion 220, or the clamping portion 240 of the cardiac occluder 200 in the third position, thereby realizing the retrieval of the cardiac occluder 200. When the cardiac occluder 200 is in the second position, the retrieval device 20 can be controlled to move to the third position, while the delivery gripper 12 remains in the gripping state of the clamping portion 240. After the retrieval device 20 grabs the second disc portion 220, the delivery gripper 12 is released to realize the retrieval of the cardiac occluder 200 and prevent the cardiac occluder 100 from shifting in the second position, thereby improving the safety of the retrieval process.

[0079] It should be noted that in the first position, retrieval can be completed independently by the retrieval gripper 22. However, in the second position, the delivery gripper 12 positions the heart occluder 200, and the retrieval gripper 22 then grasps the heart occluder 200. This avoids the problem of the heart occluder 200 shifting in the second position, thus reducing the difficulty of grasping.

[0080] Understandably, during the delivery of the cardiac occluder 200 by the delivery device 10, it is necessary to ensure that the first disc 210 and the second disc 220 are in a contracted state (i.e., in a straight line) that extends away from each other along the axial direction of the occlusion portion 230. This makes the operation of changing the cardiac occluder 200 from an open state to a contracted state and inserting it into the delivery sheath 11 more complicated, often requiring multiple people to assist in the operation, thus reducing the efficiency of the operation.

[0081] Based on this, this application further defines the loading process of the delivery device 10 before the delivery of the cardiac occluder 200 based on the structure of the delivery device 10 in the embodiments of this application.

[0082] Specifically, the delivery and recovery method also includes loading the cardiac occluder 200 onto the loading sheath 13 before the delivery channel is established in the delivery device 10.

[0083] In other words, before the delivery device 10 delivers the cardiac occluder 200, the delivery and recovery method of this application is required to load the cardiac occluder 200 into the loading sheath 13, and further through the docking of the loading sheath 13 and the delivery sheath 11, in conjunction with the pushing of the delivery gripper 12, the cardiac occluder 200, which is contracted according to the expected contraction state, is first pushed into the delivery sheath 11, and then further pushed to the target release position where the structure to be blocked is located through the delivery sheath 11.

[0084] Combination Figure 5 As shown, according to some embodiments of this application, the loading sheath 13 includes: a first end and a second end located at both ends of the loading channel; loading the cardiac occluder 200 into the loading sheath 13 includes: The second plate section 220, the sealing section 230, and the first plate section 210 are sequentially loaded into the loading channel from the first end; The second disc 220 extends out the second end and moves again into the loading sheath 13 so that the first disc 210 and the second disc 220 extend away from each other along the axial direction of the sealing portion 230 to retract.

[0085] The specific process of loading the cardiac occluder 200 into the loading sheath 13 is as follows: First, the conveyor gripper 12 grasps the clamping part 240 and compresses the second disc part 220. The compression of the second disc part 220 can be done manually by the operator, or by using existing parts such as tweezers or clamps, or the second disc part 220 can be compressed using the first end. It is understood that the operator compresses the second disc part 220 manually, with tools, or using the first end. After that, the operator moves the compressed second disc part 220 into the loading channel. Specifically, the operator can move the second disc part 220 into the loading channel by pushing the conveyor gripper 12 to push the clamping part 240, or it can be further achieved by directly grasping the second disc part 220 using an auxiliary gripper that extends from the second end. This application does not make any specific limitations.

[0086] It should be noted that when the operator continues to push the conveying gripper 12 or pull the auxiliary gripper, the first disc 210 can contact and compress the loading sheath 13 during the movement. Compared with manual compression by the operator, compression by the loading sheath 13 can make the compression effect of the first disc 210 better, so that the first disc 210 can unfold better in the future, thereby improving the stability of the release of the first disc 210.

[0087] Furthermore, if an auxiliary gripper is used, it can be removed, and the operator can push the delivery gripper 12 to move the cardiac occluder 200 until the second disc 220 is fully extended from the second end. The second disc 220 then returns to its open state based on its own elastic force. After the second disc 220 is unfolded, the operator can pull the delivery gripper 12 to move the second disc 220 toward the loading channel. During the movement, the second disc 220 can contact and compress the loading sheath 13. Compared with the aforementioned auxiliary compression and manual compression by the operator, compression by the loading sheath 13 can achieve a better compression effect for the second disc 220 and ensure that the contracted state of the second disc 220 after compression is the expected contracted state, which facilitates the unfolding of the second disc 220 after passing through the structure to be occluded.

[0088] Finally, the second end is connected to the first entry end of the delivery sheath 11. After the connection is completed, the heart occluder 200 is pushed into the delivery sheath 11 by the delivery gripper 12, and the loading sheath 13 is removed.

[0089] It should be noted that the first end, the first inlet end, and the second inlet end can all be constructed as a flared structure. Constructing the first end as a flared structure can reduce the difficulty of loading the cardiac occluder 200. Constructing the first inlet end as a flared structure can reduce the difficulty of docking between the loading sheath 13 and the delivery sheath 11. Constructing the second inlet end as a flared structure can reduce the difficulty of retrieving the cardiac occluder 200.

[0090] In summary, the delivery and recovery method of the delivery and recovery system 100 according to the embodiments of this application specifically includes a loading method of loading the cardiac occluder 200 into the loading sheath 13, a delivery method of the delivery device 10 delivering the cardiac occluder 200, and a recovery method of the recovery device 20 recovering the cardiac occluder 200.

[0091] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0092] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A delivery and retrieval system for a cardiac occluder, characterized in that, include: A delivery device (10) is used to deliver the cardiac occluder to the target release position of the cardiac occluder, the target release position including a structure to be occluded with a through hole, the delivery device (10) including: a delivery sheath (11) and a delivery gripper (12), the delivery sheath (11) being used to establish a delivery channel, the delivery gripper (12) being adapted to clamp the clamping part (240) of the cardiac occluder and move within the delivery channel to the target release position; A retrieval device (20) is used to retrieve the cardiac occluder when it moves to a non-target release position. The retrieval device (20) includes a retrieval sheath (21) and a retrieval gripper (22). The retrieval sheath (21) is used to establish a retrieval channel, and the retrieval gripper (22) is adapted to grasp the second disc portion (220) of the cardiac occluder and retrieve the cardiac occluder along the retrieval channel. The conveying channel and the recycling channel are spaced apart.

2. The delivery and retrieval system for the cardiac occluder according to claim 1, characterized in that, The delivery device (10) further includes: a loading sheath (13) having a loading channel adapted to accommodate the cardiac occluder, the loading sheath (13) being optionally connected to the delivery sheath (11), and the delivery gripper (12) adapted to push the cardiac occluder from the loading channel to the delivery channel.

3. The delivery and retrieval system for the cardiac occluder according to claim 1 or 2, characterized in that, The inner diameter of the delivery sheath (11) is L1, and the inner diameter of the recovery sheath (21) is L2, and L2 > L1.

4. The delivery and retrieval system for the cardiac occluder according to claim 1 or 2, characterized in that, The delivery sheath (11) has a first inlet end and an outlet end, and the recovery sheath (21) has a second inlet end and a recovery end, wherein at least the inner diameter of the second inlet end is greater than the inner diameter of the outlet end.

5. The delivery and retrieval system for the cardiac occluder according to claim 4, characterized in that, The second inlet is constructed as a flared opening.

6. A delivery and retrieval method for the delivery and retrieval system of the cardiac occluder, the delivery and retrieval method being applicable to the delivery and retrieval system according to any one of claims 1-5, characterized in that, include: The delivery device (10) establishes the delivery channel, and the delivery gripper (12) delivers the heart occluder to the target release position; Obtain the placement position of the cardiac occluder; If the placement position is the target release position, then release the conveying gripper (12). If the placement location is the non-target release location, the retrieval device (20) establishes a retrieval channel and retrieves the cardiac occluder; wherein The cardiac occluder is constructed of a radiopaque material to allow for the location of the surgical cardiac occluder.

7. The conveying and recycling method of the conveying and recycling system according to claim 6, characterized in that, The non-target locations include: a first location and a second location, wherein the first location is located on the left side of the structure to be blocked, and the second location is located on the right side of the structure to be blocked. The recovery device (20) establishes a recovery channel and recovers the cardiac occluder, specifically including: If in the first position, the delivery gripper (12) is released, and the retrieval gripper (22) moves to the third position to grasp the second disc (220) of the cardiac occluder. If in the second position, the retrieval gripper (22) moves to the second position, grips the cardiac occluder, and releases the delivery gripper (12). The third position is located below the target release position.

8. The conveying and recycling method of the conveying and recycling system according to claim 6, characterized in that, The delivery and recovery method further includes loading the cardiac occluder into the loading sheath (13) before the delivery device (10) establishes the delivery channel.

9. The conveying and recycling method of the conveying and recycling system according to claim 8, characterized in that, The cardiac occluder includes a first disc portion (210), a second disc portion (220), and an occlusion portion (230). The first disc portion (210) and the second disc portion (220) are connected to the axial ends of the occlusion portion (230). The loading sheath (13) includes a first end and a second end located at both ends of the loading channel. Loading the cardiac occluder into the loading sheath (13) includes: The second disc (220), the sealing part (230), and the first disc (210) are sequentially loaded into the loading channel from the first end.

10. The conveying and recycling method of the conveying and recycling system according to claim 9, characterized in that, The loading of the cardiac occluder into the loading sheath (13) also includes: The second disc (220) extends out of the second end and moves back into the loading sheath (13) so that the first disc (210) and the second disc (220) extend away from each other along the axial direction of the sealing portion (230) to retract.

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