Fixed head, delivery system and inner tube mechanism thereof, catheter assembly, and medical device

Abstract

This invention provides a fixation head, a delivery system, its inner tube mechanism, a catheter assembly, and a medical device. The delivery system includes a delivery device and a filament. The delivery device includes the inner tube mechanism, which in turn includes the fixation head. The fixation head has a suture channel, and a portion of the suture channel's surface is formed as a smooth guide surface. The proximal end of the filament is connected to the delivery device, and the distal end of the filament passes through the suture channel. As the filament passes through the suture channel, the guide surface provides support to the filament and deflects its extension direction. The distal end of the filament is also used for detachable connection to a medical implant and the delivery device. Using the delivery device to load, deliver, and release the medical implant can improve the release stability of the medical implant and reduce surgical risks.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a fixation head, a delivery system and its inner tube mechanism, a catheter assembly, and a medical device. Background Technology

[0002] Medical implants, such as self-expanding stents and artificial valves, require specific structures during loading and deployment to connect with the corresponding structure of the delivery device through shape fitting or filaments, in order to maintain the position of the medical implant relative to the anatomical structure, improve the accuracy of the deployment position, and reduce damage to tissues.

[0003] In one method of connecting a medical implant to a delivery system using a thread, the implant is released by manipulating the thread after it has been delivered to the predetermined position. However, in this existing technology, significant friction exists between the thread and parts of the delivery system during thread manipulation, leading to substantial loss of control force, reduced stability during implant release, and increased surgical risks. Summary of the Invention

[0004] The purpose of this invention is to provide a fixation head, a delivery system and its inner tube mechanism, a catheter assembly, and a medical device, which aim to improve the stability of the wire-controlled release process and enhance surgical safety.

[0005] To achieve the above objectives, the present invention provides a fixing head having a threading channel formed thereon, a portion of the surface of the threading channel being formed as a smooth guide surface, the guide surface being used to support the thread as it passes through the threading channel and to deflect the extension direction of the thread.

[0006] Optionally, the guide surface includes a first sub-guide surface, a second sub-guide surface, and a third sub-guide surface that are smoothly connected sequentially from the proximal end to the distal end. The axes of the first sub-guide surface and the third sub-guide surface are both straight lines, the angle formed by the axis of the first sub-guide surface and the axis of the third sub-guide surface is 45° to 135°, and the axis of the second sub-guide surface is an arc.

[0007] Optionally, the threading channel includes a threading hole, the threading hole includes a first hole segment, and a portion of the hole wall of the first hole segment forms the first sub-guide surface.

[0008] Optionally, the threading hole further includes a second hole segment and a third hole segment; the proximal end of the second hole segment communicates with the distal end of the first hole segment, a portion of the hole wall of the second hole segment forms the second sub-guide surface, the proximal end of the third hole segment communicates with the distal end of the second hole segment, and a portion of the hole wall of the third hole segment forms the third sub-guide surface.

[0009] Optionally, the fixing head includes a proximal portion and a distal portion that are axially connected, wherein the cross-sectional area of ​​the proximal portion gradually increases from the proximal end to the distal end.

[0010] Optionally, the fixing head includes a fixing head body and a rotating member. The fixing head body has a threading groove extending through it along its axial direction. The rotating member is rotatably connected to the groove wall of the threading groove and forms the threading channel with at least a portion of the groove wall of the threading groove. The rotating member has a circumferential surface, and a portion of the circumferential surface constitutes the guide surface.

[0011] Optionally, the wire-threading groove extends radially along the fixing head body and opens at the edge of the fixing head body, and the circumferential surface of the rotating member at least partially forms the conductor surface on the side opposite to the opening.

[0012] Optionally, a positioning groove is formed on the circumferential surface of the rotating component, extending around the circumference of the rotating component, and part of the groove wall of the positioning groove constitutes the guide surface.

[0013] Optionally, the positioning groove is arc-shaped in the longitudinal section of the rotating component.

[0014] Optionally, the fixing head further includes a base, which is connected to the proximal end face of the fixing head body. The base has an inlet channel that communicates with the threading channel, and the cross-sectional area of ​​the base increases from the proximal end to the distal end.

[0015] Optionally, the fixing head is further provided with a mounting through hole so that the fixing head can be fitted onto the target tube body; the number of the wire-threading channels is at least one, and when the number of the wire-threading channels is multiple, the multiple wire-threading channels are arranged at intervals around the mounting through hole.

[0016] Optionally, the surface roughness Ra of the guide surface is less than or equal to 0.2.

[0017] To achieve the above objectives, the present invention also provides an inner tube mechanism for a conveying system, comprising an inner tube body and a fixing head as described in any of the preceding claims, the fixing head being disposed on the distal outer surface of the inner tube body.

[0018] To achieve the above objectives, the present invention also provides a conduit assembly for a delivery system, comprising an outer tube and an inner tube mechanism of the delivery system as described above, wherein the outer tube is fitted outside the inner tube mechanism and is configured to be capable of axial relative movement with the inner tube mechanism.

[0019] To achieve the above objectives, the present invention also provides a delivery system including a delivery device and a filament. The delivery device includes a handle and a catheter assembly of the delivery system as described above. The catheter assembly is used to load a medical implant. The handle is connected to the proximal end of the catheter assembly and is used to control the axial relative movement of the outer tube relative to the inner tube mechanism. The proximal end of the filament is connected to the delivery device, and the distal end of the filament is used to pass through the suture channel and is detachably connected to the medical implant and the delivery device.

[0020] To achieve the above objectives, the present invention also provides a medical device comprising a medical implant and a delivery system as described above, wherein the medical implant is loaded in the catheter assembly; the distal end of the filament passes through the suture channel and is detachably connected to the medical implant and the delivery device.

[0021] Optionally, the number of fixation heads is at least one, and the fixation heads are disposed on the proximal side and / or distal side of the medical implant;

[0022] When the medical implant is in a gripping state and the fixation head is located on the proximal side of the medical implant, the guide surface deflects the extension direction of the filament by 90° to 135°; or, when the medical implant is in a gripping state and the fixation head is located on the distal side of the medical implant, the guide surface deflects the extension direction of the filament by 45° to 90°.

[0023] Compared with the prior art, the fixation head, delivery system and its inner tube mechanism, catheter assembly and medical device of the present invention have the following advantages:

[0024] The aforementioned fixation head has a threading channel, at least a portion of which is formed as a smooth conductive surface. The guide surface supports the filament as it passes through the threading channel and deflects its extension direction. The fixation head is mounted on a delivery system including a delivery unit and a filament. The delivery unit includes a catheter assembly for loading a medical implant, and the catheter assembly includes an inner tube and the fixation head disposed thereon. The distal end of the filament passes through the threading channel on the fixation head and is detachably connected to the medical implant and the delivery unit. Due to the smooth guide surface, the distal end of the filament can smoothly deflect its direction as it passes through the threading channel. This reduces friction between the filament and the fixation head when the user manipulates the filament to release the medical implant, thereby reducing loss of control, improving the stability of the implant release process, and ultimately enhancing surgical safety.

[0025] Furthermore, the aforementioned medical device includes an implant and the delivery system, and the delivery system includes at least one fixing head disposed on the proximal and / or distal side of the medical implant. When the medical implant is in a gripped state and the fixing head is located on the proximal side of the medical implant, the guide surface deflects the extension direction of the filament by 90° to 135°; or, when the medical implant is in a gripped state and the fixing head is located on the distal side of the medical implant, the guide surface deflects the extension direction of the filament by 45° to 90°. This is done so that when the medical implant is radially compressed, it can be non-overlapping with the fixing head in the axial direction, reducing the flexibility of the medical device, improving the bending performance of the medical device, and facilitating the delivery system to deliver the medical implant to the predetermined position. Attached Figure Description

[0026] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0027] Figure 1 This is a schematic diagram of the overall structure of the conveying system provided by the present invention according to an embodiment;

[0028] Figure 2 This is a schematic diagram of the inner tube mechanism of the conveying system provided by the present invention according to an embodiment;

[0029] Figure 3 This is a schematic diagram of the structure of the fixed head of the conveying system provided by the present invention according to an embodiment;

[0030] Figure 4 This is a cross-sectional view (AA) of the fixed head of the conveying system provided by the present invention according to an embodiment;

[0031] Figure 5 This is a schematic diagram of the connection relationship between the filament and the medical implant when the delivery system provided by the present invention is loading a medical implant, according to an embodiment of the invention. In the diagram, the filament is connected to the medical implant in a radial manner.

[0032] Figure 6 This is a schematic diagram of the connection relationship between the filament and the medical implant when the delivery system provided by the present invention is loading a medical implant, according to an embodiment of the invention. In the diagram, the filament wraps around the medical implant in the circumferential direction.

[0033] Figure 7 This is a schematic diagram of the structure of the fixing head of the conveying system provided by the present invention according to another embodiment. The fixing head in the figure does not include the base.

[0034] Figure 8 This is a schematic diagram of the structure of the fixing head of the conveying system provided by the present invention according to another embodiment. The fixing head in the figure includes a base.

[0035] Figure 9 This is a schematic diagram of the structure of the fixed head of the conveying system provided by the present invention according to another embodiment. Figure 9 and Figure 8 The observation directions are different;

[0036] Figure 10 This is a schematic diagram showing the deflection of the extension direction of the wire in the conveying system provided by the present invention when it passes through the threading channel of the fixed head;

[0037] Figure 11 This is a partial structural schematic diagram of a medical device provided according to an embodiment of the present invention. The medical implant is in a gripping state, and the medical device includes a fixing head disposed on the distal side of the medical implant.

[0038] Figure 12 yes Figure 11 A schematic diagram of the medical stent expanding in the medical device shown;

[0039] Figure 13 This is a partial structural schematic diagram of a medical device provided according to an embodiment of the invention. The medical implant is in a gripping state, and the medical device includes two fixing heads, which are respectively disposed on the proximal side and the distal side of the medical implant.

[0040] Figure 14 This is a partial structural schematic diagram of a medical device provided according to an embodiment of the present invention. The medical device is in a gripping state, and the medical device includes a fixing head, which is disposed inside a medical implant. The angle formed between the portion of the filament located between the fixing head and the medical implant and the axis of the delivery system is 90°.

[0041] Figure 15 This is a partial structural schematic diagram of the medical device provided by the present invention according to an embodiment. The medical device is in a gripping state, and the medical device includes a fixing head disposed inside the medical implant. The angle formed between the portion of the filament located between the fixing head and the medical implant and the axis of the delivery system is less than 90°.

[0042] [The annotations in the attached figures are explained below]:

[0043] 1-Delivery system, 100-Catheter assembly, 1000-Inner tube mechanism, 1100-Inner tube body, 1200-Fixing head, 1200a-Proximal segment, 1200b-Distal segment, 1210-Threading channel, 1201-Guide surface, 1201a-First sub-guide surface, 1201b-Second sub-guide surface, 1201c-Third sub-guide surface, 1211-First hole segment, 1212-Second hole segment, 1213-Third hole segment, 1220-Mounting through hole, 1230-Fixing head body, 1231-Threading groove, 1240-Rotating component, 1241-Positioning groove, 1250-Base, 1251-Introduction channel, 2000-Outer tube, 200-Handle, 20-Thread, 2-Medical implant. Detailed Implementation

[0044] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show components related to the present invention and are not drawn according to the actual number, shape, and size of components in the actual implementation. In the actual implementation, the type, quantity, and proportion of each component can be arbitrarily changed, and the component layout may also be more complex.

[0045] Furthermore, while each embodiment described below possesses one or more technical features, this does not imply that users of the present invention must simultaneously implement all technical features in any embodiment, or can only separately implement some or all technical features in different embodiments. In other words, provided it is feasible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility in implementing the present invention.

[0046] As used herein, the singular forms “a,” “an,” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or,” unless otherwise expressly indicated, and the terms “install,” “connect,” and “link” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can represent internal communication between two elements or an interaction between two elements. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0047] In this article, the terms “proximal” and “distal” refer to the relative orientation, position, and direction of the components or movements relative to each other from the perspective of the physician using the medical device. Although “proximal” and “distal” are not restrictive, “proximal” usually refers to the end of the medical device that is closer to the physician during normal operation, while “distal” usually refers to the end that first enters the patient’s body.

[0048] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar parts.

[0049] Figure 1 A schematic diagram of the overall structure of the conveying system 1 provided in an embodiment of the present invention is shown. Figure 2 This is a schematic diagram of the inner tube mechanism 1000 of the conveying system 1. Figure 3 This is a structural schematic diagram of the fixing head 1200 on the inner tube mechanism 1000. Figure 4 This is a cross-sectional view (AA) of the fixed head 1200.

[0050] Please refer to Figures 1 to 4 The conveying system includes a conveyor (not shown in the figure) and a wire 20 ( Figures 1 to 3 Not shown in the image, please refer to [link / reference]. Figure 6 and Figure 7(As indicated in the diagram), the proximal end of the thread 20 is connected to the delivery device. The delivery device includes a conduit assembly 100 and a handle 200. The conduit assembly 100 includes an inner tube mechanism 1000 and an outer tube 2000. The outer tube 2000 is fitted outside the inner tube mechanism 1000 and configured to allow axial relative movement between the outer and inner tube mechanisms 1000. The handle 200 is connected to the proximal end of the conduit assembly 100 and configured to control axial relative movement between the inner tube mechanism 1000 and the outer tube 2000. The inner tube mechanism 1000 specifically includes an inner tube body 1100 and at least one fixing head 1200. The fixing head 1200 is disposed on the distal outer surface of the inner tube body 1100. When there are two or more fixing heads 1200, the two or more fixing heads 1200 are axially spaced on the inner tube body 1100. The fixing head 1200 has a threading channel 1210 formed thereon. A portion of the surface of the threading channel 1210 is formed as a smooth guide surface 1201. The guide surface 1201 is used to provide support for the thread 20 when it passes through the threading channel 1210 and to deflect the extension direction of the thread 20. Here, "smooth" means that the guide surface 1201 has no sharp edges. That is, the guide surface 1201 is a continuous curved surface, or the guide surface 1201 includes multiple different surfaces, which can be planar or curved, and the multiple different surfaces are smoothly connected.

[0051] The delivery system 1 is used to load a medical implant 2 ( Figures 1 to 3 Not shown in the image, please refer to [link / reference]. Figure 5 and Figure 6 (as indicated in the diagram), and is used to deliver and release the medical implant 2 to a predetermined location within the patient's body. The medical implant 2 includes, but is not limited to, medical stents, artificial valves, etc.

[0052] When loading the medical implant 2, firstly, the distal end of the inner tube mechanism 1000 extends out of the outer tube 2000. Then, the medical implant 2 is fitted onto the distal outer surface of the inner tube body 1100. The fixing head 1200 can be located inside the medical implant 2, or on the proximal and / or distal side of the medical implant 2. The medical implant 2 is also provided with a connector (not shown in the figure), which may be, for example, a connecting coil or a connecting hole. Next, the filament 20 is extended along the axial direction of the delivery device, and the distal end of the filament 20 is passed sequentially through the threading channel 1210 and the connector on the medical implant 2 in its expanded state, and then connected to the delivery device to secure the medical implant 2 to the inner tube mechanism 1000. Next, the thread 20 is tightened and the medical implant 2 is radially compressed so that the medical implant 2 is in a gripped state. At this time, the thread 20 is against at least a portion of the guide surface 1201, and the extension direction of the thread 20 is deflected. The deflection angle of the thread 20 can be 45°~135°. Here, "the deflection angle of the thread 20 is 45°~135°" refers to the angle α formed by the extension direction of the thread 20 at the exit of the threading channel 1210 and the axis of the conveyor (e.g., ...). Figures 11 to 15 The angle (as indicated) is 45°~135°, that is, the angle α formed by the portion of the thread 20 located between the fixing head 1200 and the medical implant 2 and the axis of the delivery device is 45°~135°. Finally, the user controls the outer tube 2000 and the inner tube mechanism 1000 to move axially relative to each other through the handle 200, so that the outer tube 2000 wraps around the medical implant 2.

[0053] When releasing the medical implant 2, the user controls the inner tube mechanism 1000 and the outer tube 2000 to move axially relative to each other via the handle 200, so that the distal end of the inner tube mechanism 1000 and the medical implant 2 thereon extend out of the outer tube 2000. The user then applies a control force to the suture 20 to loosen it, causing the medical implant 2 to expand radially along the inner tube mechanism 1000 until it is in contact with a predetermined position. Finally, depending on the connection method between the distal end of the suture 20 and the delivery device, the user performs an operation to allow the distal end of the suture 20 to pass through a connector (e.g., a connecting coil) on the medical implant 2, thus releasing the medical implant 2. It is understood that during the radial expansion of the medical implant 2, if the medical implant 2 is not accurately positioned, the user can apply a control force to the filament 20 to re-tighten the filament 20 and re-compress the medical implant 2. Then, the user can control the outer tube 2000 to move relative to the inner tube mechanism 1000 from proximal to distal end and re-wrap the medical implant 2 (this process can be called the retrieval process). Afterward, the user can adjust the position of the medical implant 2 and release it again. It should be noted that the embodiment of the present invention does not limit the connection method between the distal end of the filament 20 and the delivery device, as long as the distal end of the filament 20 can be made to pass through the connector on the medical implant 2 through appropriate operation. The specific connection method can refer to the prior art.

[0054] Here, the specific movement method by which the user controls the outer tube 2000 and the inner tube mechanism 1000 to move axially relative to each other via the handle 200 is related to the specific structure of the conduit assembly 100 and its connection method with the handle 200.

[0055] In detail, in some implementations, the handle 200 is provided with an outer tube control mechanism and / or an inner tube control mechanism, and the outer tube 2000 is a tube with a relatively long length. When assembling the conduit assembly 100 with the handle 200, the proximal end of the outer tube 2000 is connected to the outer tube control mechanism, and the proximal end of the inner tube body 1100 of the inner tube mechanism 1000 is connected to the inner tube control mechanism (e.g., Figure 1(As shown). Thus, when loading the medical implant 2, the inner tube mechanism 1000 can be kept stationary, and the outer tube can be moved from proximal to distal end by the outer tube control mechanism on the handle 200; or the outer tube can be kept stationary, and the inner tube mechanism 1000 can be moved from distal to proximal end by the inner tube control mechanism. When releasing the medical implant 2, the inner tube mechanism 1000 can be kept stationary, and the outer tube 2000 can be moved from distal to proximal end; or the outer tube can be kept stationary, and the inner tube mechanism 1000 can be moved from proximal to distal end.

[0056] In some implementations, the outer tube is shorter, perhaps only slightly longer than the medical implant. Here, the catheter assembly further includes a top tube, a guide connector, and a push tube. The top tube is fitted over the inner tube assembly and positioned proximally to the outer tube, with its distal end abutting against the proximal end of the outer tube. The guide connector is connected to the distal end of the outer tube and located distally to the inner tube body. The push tube is at least partially disposed within the lumen of the inner tube body, with its distal end connected to the guide connector. The push tube is also configured to be axially movable relative to the inner tube body, thereby causing the outer tube to axially move relative to the inner tube assembly (not shown in the figure). The handle is equipped with a push control mechanism. When the catheter assembly is assembled with the handle, the proximal ends of the inner tube and the top tube are both connected to the handle, and the inner tube and the top tube remain relatively stationary. The proximal end of the push tube is connected to the push control mechanism, which controls the axial movement of the push tube along the inner tube. After the medical implant is loaded and compressed, the push tube is controlled to move from distal to proximal, thereby moving the outer tube from distal to proximal until the outer tube encloses the medical implant and the proximal end of the outer tube abuts against the distal end of the top tube. When releasing the medical implant, the push tube is controlled to move from proximal to distal, thereby moving the outer tube from proximal to distal.

[0057] Furthermore, in this embodiment of the invention, when the filament 20 is tightened to radially compress the medical implant 2, the guide surface 1201 provides support to the filament 20 and smoothly deflects the extension direction of the distal end of the filament 20. This reduces the frictional force between the filament 20 and the fixation head 1200 when the filament 20 is loosened to release the medical implant 2 or when it is re-tightened during retrieval, thereby reducing the loss of control force and making the release or retrieval process of the medical implant 2 more stable, improving the safety of the surgery. Optionally, in a cross-section parallel to the axial direction of the fixation head 1200, at least a portion of the contour line of the guide surface 1021 is curved.

[0058] It should be noted that the connection form between the filament 20 and the medical implant 2 is not limited in the embodiments of the present invention, and can be referred to the prior art. For example, in an optional implementation, the medical implant 2 includes a plurality of the connectors, which are arranged at circumferential intervals along the medical implant 2. The delivery system 1 includes multiple strands of the filament 20, and the number of strands of the filament 20 can correspond to the number of the connectors. The distal end of each strand of the filament 20 passes through a suture channel 1210, first passes through a connector on the medical implant 2, and then is detachably connected to the delivery device. When the plurality of suture channels 1210 on the fixing head 1200 are arranged around the mounting through hole 1220, the multiple strands of the filament 20 are arranged radially in the axial projection of the medical device (e.g., Figure 5 (As shown). In another alternative implementation, the medical implant 2 still includes multiple connectors, and the multiple connecting coils are arranged circumferentially spaced along the medical implant 2. The delivery system 1 includes a single thread 20, the distal end of which, after passing through one of the threading channels 1210, sequentially passes through all the connectors on the medical implant 2 and finally connects to the delivery device, thus the thread 20 substantially surrounds the medical implant 2 circumferentially (e.g., Figure 6 (As shown).

[0059] Next, this article will provide a detailed description of the optional structures of the fixed head 1200.

[0060] In one embodiment of the present invention, such as Figure 3 and Figure 4As shown, the guide surface 1201 includes a first sub-guide surface 1201a, a second sub-guide surface 1201b, and a third sub-guide surface 1201c, which are smoothly connected sequentially from the proximal end to the distal end. The axes of the first sub-guide surface 1201a and the third sub-guide surface 1201c are both straight lines, and the angle formed between them is 45° to 135°. The axis of the second sub-guide surface 1201b is an arc, so that at least a portion of the contour line of the second sub-guide surface 1201b is curved in a cross-section parallel to the axial direction of the fixing head 1200. Thus, when the distal end of the thread 20 passes through the threading channel 1210, under the support of the guide surface 1201, the extension direction of the thread 20 at the exit of the threading channel 1210 (i.e., at the end of the third sub-guide surface 1201c away from the second sub-guide surface 1201b) can be deflected at least within the range of 45° to 135° relative to the extension direction of the thread 20 at the entrance of the threading channel 1210.

[0061] Optionally, a mounting through hole 1220 is also formed on the fixing head 1200, and the fixing head 1200 is mounted on the inner tube body 1100 through the mounting through hole 1220. The wire passage 1210 includes a wire hole (not shown in the figure), the wire hole includes a first hole segment 1211, the axis of the first hole segment 1211 is parallel to the axis of the mounting through hole 1220, and a portion of the hole wall of the first hole segment 1211 can form the first sub-guide surface 1201a. In this embodiment, the hole wall of the first hole segment 1211 on the side away from the mounting through hole 1220 forms the first sub-guide surface 1201a.

[0062] Furthermore, the threading hole may further include a second hole segment 1212 and a third hole segment 1213. The proximal end of the second hole segment 1212 is connected to the distal end of the first hole segment 1211, and a portion of the hole wall of the second hole segment 1212 forms the second sub-guide surface 1201b. The proximal end of the third hole segment 1213 is connected to the distal end of the second hole segment 1212, and a portion of the hole wall of the third hole segment 1213 forms the third sub-guide surface 1201c.

[0063] Furthermore, the surface roughness Ra of the guide surface 1201 should be as small as possible to further reduce the frictional force generated between the filament 20 and the guide surface 1201 during the release or retrieval of the medical implant 2. Preferably, the surface roughness Ra of the guide surface 1201 can be less than or equal to 0.2. In some implementations, the surface roughness Ra of the guide surface 1201 can be reduced by the selection of materials, for example, by using relatively smooth materials such as polytetrafluoroethylene, ceramics, or glass to manufacture the fixation head 1200, or the fixation head 120 includes a substrate and a lubricating coating, wherein a channel for the filament 20 to pass through is formed on the substrate, and the lubricating coating is disposed on a portion of the surface of the channel to form the guide surface 1201. In other implementations, the fixing head 1200 can be a metal structural component, and the surface roughness Ra of the guide surface 1201 can be reduced by grinding, polishing or other treatments on the surface of the wire channel 1210. Here, the material of the fixing head 1200 includes, but is not limited to, any one of titanium carbonitride, titanium nitride, stainless steel, and nickel titanium.

[0064] Optionally, the number of the threading channels 1210 can be set according to actual needs, and can be one, two, three, or more. For example... Figures 2 to 4 As shown, when there are two or more threading channels 1210, it is preferable that two or more threading channels 1210 are arranged at intervals around the mounting through hole 1220 to reduce the radial dimension of the fixing head 1200, thereby reducing the radial dimension of the conveying system 1. Optionally, the outlets of a plurality of threading channels 1210 are located on the same circumference, or at least some of the outlets of the threading channels 1210 are located on different circumferences.

[0065] Furthermore, in this embodiment, as Figures 2 to 4 As shown, the fixing head 1200 has a streamlined shape and includes an axially connected proximal segment 1200a and a distal segment 1200b. The cross-sectional area of ​​the proximal segment 1200a gradually increases from the proximal end to the distal end. This design improves the flexibility of the delivery system 1, facilitating its passage through tortuous blood vessels while minimizing interference with the vessels and reducing damage.

[0066] In addition, in this embodiment, the fixing head 1200 can be an integral component or an assembled component, as long as the fixing head 1200 can form the wire passage 1210 and the mounting through hole 1220.

[0067] Please refer to this again. Figure 7In another embodiment of the present invention, the fixing head 1200 includes at least a fixing head body 1230 and a rotating member 1240. A first insertion hole is formed at the center of the fixing head body 1230, serving as at least a portion of the mounting through hole 1220. A wire-passing groove 1231 is also formed on the fixing head body 1230, extending axially through the fixing head body 1230. Optionally, the wire-passing groove 1231 extends radially along the fixing head body 1230 and opens at the edge of the fixing head body 1230. The wire-passing groove 1231 is a U-shaped groove or a fan-shaped groove. The rotating member 1240 is rotatably connected to the groove wall of the wire-passing groove 1231 and, together with at least a portion of the groove wall of the wire-passing groove 1231, forms the wire-passing channel 1210. The rotating member 1240 has a circumferential surface, a portion of which constitutes the guide surface 1201. Typically, at least a portion of the circumferential surface facing away from the opening constitutes the guide surface 1201, that is, at least a portion of the circumferential surface facing the mounting through hole 1220 constitutes the guide surface 1201. When the distal end of the wire 20 passes through the threading channel 1210 and abuts against the rotating member 1240, the extension direction of the distal end of the wire 20 can be deflected (e.g., Figure 10 (As shown). In other words, in this embodiment, a portion of the surface of the rotating member 1240 is used as a support for the wire 20 when it deflects in direction, so that the friction between the wire 20 and the fixed head 1200 is rolling friction, thereby reducing the loss of control force.

[0068] In some implementations, the fixing head body 1230 may have a smaller axial dimension, such as... Figure 8 and Figure 9 As shown, the fixing head 1200 may further include a base 1250, which is connected to the proximal end face of the fixing head body 1230. The base 1250 also has a second insertion hole corresponding to the first insertion hole, which, together with the first insertion hole, constitutes the mounting through hole 1220. Furthermore, the base 1250 may also have an inlet channel 1251 communicating with the threading channel. The distal end of the thread 20 passes through the inlet channel 1251 and then through the threading channel 1210. The inlet channel 1251 may be located on the base 1250 at a position corresponding to the threading channel 1210, and may be a hole (e.g.,...). Figure 8 and Figure 9(As shown), for example, circular holes, square holes, etc. It should be noted that the embodiment of the present invention does not have a particular limitation on the setting position of the inlet channel, as long as it allows the distal end of the thread 20 to pass through and enter the threading channel 1210. In addition, it is preferable that the cross-sectional area of ​​the base 1250 gradually increases from the proximal end to the distal end to improve the bending performance of the conveying system 1. It can be understood that the base 1250 and the fixing head body 1230 can be integrally formed, or they can be separately formed and then connected as one. Alternatively, the fixing head body 1230 can have a large axial dimension. In this case, it is preferable that the cross-section of the fixing head body 1230 gradually increases from the proximal end to the distal end. Further, in this embodiment, the rotating member 1240 can be a rotating shaft, which is mounted on the groove wall of the threading groove 1231 by bearings. Alternatively, an mounting shaft (not shown in the figure) is formed on the two opposite walls of the threading groove 1231, and the rotating member 1240 is a fixed pulley, which is rotatably mounted on the mounting shaft. The rotating member 1240 is preferably a metal structural component, and its material includes, but is not limited to, titanium carbonitride, titanium nitride, stainless steel, and nickel-titanium. Preferably, a positioning groove 1241 is provided on the circumferential surface of the rotating member 1240, the positioning groove 1241 extending circumferentially around the rotating member 1240, and a portion of the groove wall of the positioning groove 1241 (i.e., the portion of the positioning groove 1241 facing the mounting through hole) constitutes the guide surface 1201. When the wire 20 passes through the threading channel 1210, it is confined in the positioning groove 1241, preventing the wire 20 from having a large range of movement in the axial direction of the rotating member 1240, which could adversely affect the release or retrieval of the medical implant 2. More preferably, the positioning groove 1241 is arc-shaped in the longitudinal section of the rotating member 1240. The delivery system 1 provided in this embodiment of the invention optimizes the structure of the fixing head 1200 to reduce the friction of the thread 20 when passing through the threading channel 1210 on the fixing head 1200. This reduces the loss of control force when releasing or retrieving the medical implant 2, thereby improving the stable release or retrieval of the medical implant 2 and reducing damage to human tissue during release or retrieval. Furthermore, the delivery system 1 effectively overcomes the axial displacement of the medical implant 2 during release or retrieval, improving the positioning accuracy of the medical implant 2.

[0069] Furthermore, this embodiment of the invention also provides a fixing head, which is the aforementioned fixing head 1200.

[0070] Furthermore, this embodiment of the invention also provides an inner tube mechanism for a conveying system, wherein the inner tube mechanism is the aforementioned inner tube mechanism 1000.

[0071] Furthermore, embodiments of the present invention also provide a conduit assembly for a delivery system, the conduit assembly being the aforementioned conduit assembly 100.

[0072] Furthermore, embodiments of the present invention also provide a medical device, the medical device comprising the aforementioned delivery system 1 and the aforementioned medical implant 2.

[0073] This invention does not impose any particular limitations on the number or placement of the fixing heads 1200 included in the delivery device, as long as the distal end of the wire 20 can be turned under the action of the guide surface 1201 and connected to the medical implant 2. For example, the fixing head 1200 can be one (e.g., Figure 11 , Figure 12 , Figure 14 and Figure 15 As shown), two (as shown) Figure 13 As shown), and more (not shown in the figure), the fixation head 1200 can be disposed on the proximal side and / or distal side of the medical implant 2 (e.g., Figure 11 , Figure 12 and Figure 13 As shown), the fixing head can also be located on the inner side of the medical implant 2 (e.g. Figure 14 and Figure 15 (As shown).

[0074] In a preferred embodiment, such as Figure 11 , Figure 12 and Figure 13 As shown, the delivery device includes at least one of the fixing heads 1200, and in the axial direction of the delivery system 1, the distance between any of the fixing heads 1200 and the medical implant 2 is greater than or equal to zero (e.g., ...). Figure 11 and Figure 13As shown in the diagram, when the medical implant 2 is in a gripping state, the guide surface 1201 of the fixation head 1200 deflects the extension direction of the filament 20 by a predetermined angle. Specifically, when the fixation head 1200 is positioned on the proximal side of the medical implant 2, and the distance between the distal end of the fixation head 1200 and the proximal end of the medical implant 2 is greater than or equal to 0, the guide surface 1201 deflects the extension direction of the filament 20 by 90°~135° (i.e., the angle α formed by the portion of the filament 20 located between the fixation head 1200 and the medical implant 2 and the axis of the delivery device is 90°~135°). And / or, the fixation head 1200 is disposed on the distal side of the medical implant 2, and the distance between the proximal end of the fixation head 1200 and the distal end of the medical implant is greater than or equal to 0. Simultaneously, the guide surface 1201 deflects the extension direction of the filament by 45°~90° (i.e., the angle α formed by the portion of the filament 20 located between the fixation head 1200 and the medical implant 2 and the axis of the delivery device is 45°~90°). The purpose of this arrangement is that when the medical implant 2 is compressed, the medical implant 2 and the fixation head 1200 do not overlap axially and do not contact each other, which improves the flexibility of the entire medical device, allowing it to better adapt to tortuous blood vessels. Preferably, the medical implant 2 is coaxially arranged with the inner tube body 1100.

[0075] Furthermore, those skilled in the art will understand that when the medical implant 2 is released and expands radially, the angle α formed by the portion of the filament 20 located between the fixation head 1200 and the medical implant 2 and the axis of the inner tube 1100 will change accordingly. For example, when the fixation head 1200 is located on the proximal side of the medical implant 2, the angle α decreases after the medical implant 2 is released; when the fixation head 1200 is located on the distal side of the medical implant 2, the angle α increases after the medical implant 2 is released.

[0076] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A conveying system, characterized in that, The device includes a delivery system and a filament. The delivery system includes a handle and a catheter assembly. The catheter assembly includes an outer tube and an inner tube mechanism. The inner tube mechanism includes an inner tube body and a fixing head. The fixing head is disposed on the distal outer surface of the inner tube body. A filament channel is formed on the fixing head. A portion of the surface of the filament channel is formed as a smooth guide surface. The guide surface is used to support the filament as it passes through the filament channel and to deflect the extension direction of the filament. The fixing head includes an axially connected proximal portion and a distal portion. The cross-sectional area of ​​the proximal portion gradually increases from the proximal end to the distal end. The outer tube is fitted outside the inner tube mechanism. The catheter assembly is used to load a medical implant. The handle is connected to the proximal end of the catheter assembly and is used to control the axial relative movement of the outer tube with respect to the inner tube mechanism. The proximal end of the filament is connected to the delivery system, and the distal end of the filament passes through the filament channel and is detachably connected to the medical implant and the delivery system.

2. The conveying system according to claim 1, characterized in that, The guide surface includes a first sub-guide surface, a second sub-guide surface, and a third sub-guide surface that are smoothly connected sequentially from the proximal end to the distal end. The axes of the first sub-guide surface and the third sub-guide surface are both straight lines, and the angle formed by the axis of the first sub-guide surface and the axis of the third sub-guide surface is 45° to 135°. The axis of the second sub-guide surface is an arc.

3. The conveying system according to claim 2, characterized in that, The threading channel includes a threading hole, and the threading hole includes a first hole segment, with a portion of the hole wall of the first hole segment forming the first sub-guide surface.

4. The conveying system according to claim 3, characterized in that, The threading hole further includes a second hole segment and a third hole segment; the proximal end of the second hole segment is connected to the distal end of the first hole segment, and a portion of the hole wall of the second hole segment forms the second sub-guide surface; the proximal end of the third hole segment is connected to the distal end of the second hole segment, and a portion of the hole wall of the third hole segment forms the third sub-guide surface.

5. The conveying system according to claim 1, characterized in that, The fixing head includes a fixing head body and a rotating member. A wire-passing groove is formed on the fixing head body and extends through it along its axial direction. The rotating member is rotatably connected to the groove wall of the wire-passing groove and forms the wire-passing channel with at least a portion of the groove wall of the wire-passing groove. The rotating member has a circumferential surface, and a portion of the circumferential surface constitutes the guide surface.

6. The conveying system according to claim 5, characterized in that, The threading groove extends radially along the fixed head body and opens at the edge of the fixed head body, and at least a portion of the circumferential surface of the rotating member opposite to the opening forms the guide surface.

7. The conveying system according to claim 5, characterized in that, A positioning groove is formed on the circumferential surface of the rotating component, extending in a circle around the circumference of the rotating component, and part of the groove wall constitutes the guide surface.

8. The conveying system according to claim 7, characterized in that, On the longitudinal section of the rotating component, the positioning groove is arc-shaped.

9. The conveying system according to claim 5, characterized in that, The fixing head also includes a base, which is connected to the proximal end face of the fixing head body and forms the proximal part. The base is provided with an inlet channel that communicates with the threading channel.

10. The conveying system according to any one of claims 1-9, characterized in that, The fixing head is also provided with a mounting through hole so that the fixing head can be fitted onto the target tube body; the number of the wire-threading channels is at least one, and when the number of the wire-threading channels is multiple, the multiple wire-threading channels are arranged at intervals around the mounting through hole.

11. The conveying system according to any one of claims 1-9, characterized in that, The surface roughness Ra of the guide surface is less than or equal to 0.

2.

12. A medical device, characterized in that, The device includes a medical implant and a delivery system as described in any one of claims 1-11, wherein the medical implant is loaded in the catheter assembly; the distal end of the filament passes through the suture channel and deflects the direction of extension of the filament, and the distal end of the filament is also detachably connected to the medical implant and the delivery device.

13. The medical device according to claim 12, characterized in that, The number of fixation heads is at least one, and the fixation heads are disposed on the proximal side and / or distal side of the medical implant; When the medical implant is in a gripping state and the fixation head is located on the proximal side of the medical implant, the guide surface deflects the extension direction of the filament by 90° to 135°; or, when the medical implant is in a gripping state and the fixation head is located on the distal side of the medical implant, the guide surface deflects the extension direction of the filament by 45° to 90°.

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