Loading tool, auxiliary loading system and loading method

Abstract

The invention relates to a loading tool, an auxiliary loading system and a loading method. The loading tool is used for loading an implant into a delivery catheter of an auxiliary loading system. The loading tool comprises a mounting base; the first fixing seat is fixed on the mounting base and is used for fixing a guide pipe structure of the conveying guide pipe; the second fixing seat is movably arranged on the mounting base, and when the second fixing seat drives the sheathing canal of the conveying catheter to move towards the first fixing seat, the implant can be loaded in the sheathing canal; and the driving assembly is connected with the second fixing seat and drives the second fixing seat to move. The second fixing seat exerts acting force on the sheathing canal, then the sheathing canal exerts acting force on the implant, the implant is loaded into the sheathing canal, the inner core tube does not need to be pulled to load the implant, the tensile load borne by the inner core tube is reduced, in this way, the second fixing seat bears the acting force generated when the implant is loaded, and the inner core tube does not need to have high tensile strength; and the flexibility of the conveying catheter is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical surgical instruments, and in particular to a loading tool, an auxiliary loading system and a loading method. Background Art

[0002] Heart valve disease is one of the most common heart diseases in my country, mainly caused by rheumatic fever. In recent years, with the aging of the population, valve degeneration (including calcification and myxoid degeneration) and metabolic valve damage have also increased in my country. At present, minimally invasive interventional treatment methods (transcatheter heart valve replacement) have the advantages of no need for open chest, less trauma, and quick recovery of patients, and have attracted widespread attention from experts and scholars.

[0003] At present, due to the complex anatomical configurations of the mitral valve, tricuspid aortic valve, etc., the design of the delivery system has also become complex. How to load a larger stent into a sheath of limited size has become a difficulty. Because the surgical path of transfemoral mitral valve intervention is complex and requires large-angle bending control and multi-plane adjustment capabilities, the delivery system needs to have good flexibility to ensure that the valve stent can be delivered to the destination. However, since patients with mitral regurgitation generally have a larger valve annulus diameter, the radial size of the stent is also relatively large. Usually, the stent is loaded into the sheath by radially compressing the stent to a smaller size (for example, compressing a 40mm diameter stent to 10mm). The stent in the compressed state tends to rebound, generating a radial support force acting on the inner wall of the sheath.

[0004] The delivery system realizes the loading and release of the stent through the axial movement between the sheath and the stent, and there is sliding friction between the inner wall of the sheath and the outer surface of the stent. At this time, the larger radial support force leads to a larger friction resistance, which hinders the loading and release of the stent. At present, the stent is loaded by connecting the sheath with an inner core tube, and the sheath is moved from the distal end to the proximal end by pulling the inner core tube. At this time, the friction between the stent and the sheath will be transmitted to the inner core tube and the inner tube in the form of tension. The inner core tube needs a larger cross-sectional area to withstand a larger tensile load, and the inner tube needs to withstand a compressive load that is balanced with it. The larger cross-sectional area causes the bending stiffness of the inner core tube to become larger accordingly, and the delivery system requires a larger bending control force to bend the catheter, and the bending and twisting control of the delivery system become extremely difficult. That is, the current stent loading method requires the inner core tube to have a larger tensile strength, which greatly limits the flexibility of the delivery system and affects the convenience of operation of the delivery system. Summary of the invention

[0005] Based on this, it is necessary to provide a loading tool, an auxiliary loading system and a loading method to address the problem that the current delivery catheter loads the implant by pulling the inner core tube, which causes the inner core tube to be subjected to a large tensile strength and affects the flexibility of the delivery catheter. The system can assist in loading the implant into the delivery catheter, ensure that the inner core tube does not need to withstand tensile strength, and thereby ensure the flexibility of the delivery catheter.

[0006] A loading tool for loading an implant into a delivery catheter of an auxiliary loading system, the loading tool comprising:

[0007] Install the base;

[0008] A first fixing seat, fixed to the mounting base, for fixing the catheter structure of the delivery catheter;

[0009] a second fixing seat, movably disposed on the mounting base, and capable of loading an implant into the sheath tube when the second fixing seat drives the sheath tube of the delivery catheter to move toward the first fixing seat; and

[0010] A driving assembly is connected to the second fixing seat and drives the second fixing seat to move.

[0011] In one embodiment of the present application, the first fixing seat has an axially through-going mounting hole, in which the catheter structure is mounted and can be restrained, and the second fixing seat has a mounting position, which is matched with the distal outer edge of the sheath tube;

[0012] The central axis of the mounting hole coincides with the central axis of the mounting position.

[0013] In one embodiment of the present application, the cross-section of the mounting position is triangular.

[0014] In one embodiment of the present application, the first fixing seat includes a supporting seat body and a metal fixing head, the supporting seat body has a through hole for passing a screw rod, and the metal fixing head has a first groove and a second groove, and the first groove and the second groove constitute the mounting hole.

[0015] In one embodiment of the present application, the driving assembly includes a driving handle, a screw rod and a support member, wherein the support member is disposed on the mounting base, the screw rod is movably disposed on the first fixing seat, and its proximal end extends out of the first fixing seat and is connected to the driving handle, and its distal end is movably connected to the support member, and the second fixing seat is fixed to the screw rod and moves with the screw rod;

[0016] The driving handle drives the screw rod to drive the second fixing seat to move toward or away from the first fixing seat.

[0017] In one embodiment of the present application, the loading tool further comprises a guide assembly, and the guide assembly is capable of defining a moving path of the second fixing seat;

[0018] The guide assembly comprises a guide rail and a guide slider. The guide rail is arranged at the bottom of the second fixing seat. The guide slider is clamped and arranged on the guide rail and can slide relatively.

[0019] An auxiliary loading system, comprising a delivery catheter and a loading tool as described in any of the above technical features, wherein the loading tool cooperates with the delivery catheter to load an implant into the delivery catheter;

[0020] The delivery catheter comprises a catheter structure, an inner core tube, a sheath tube and a fixed head. The catheter structure comprises an inner tube, a middle tube and an outer tube which are sheathed in layers, and the inner core tube is movably arranged in the inner tube. The fixed head is arranged at the distal end of the inner tube. The distal end of the inner core tube passes through the fixed head and the sheath tube and is connected to the distal end of the sheath tube.

[0021] The delivery catheter is installed on the loading tool, the fixing head fixes the hanging ear of the implant, and the loading tool drives the sheath to move toward the proximal end of the delivery catheter to load the implant into the sheath.

[0022] In one embodiment of the present application, the inner core tube has a curved section, and the curved section is made of laser-cut nickel-titanium capillary, or the curved section is an elastic tube with the same outer diameter as the inner core tube.

[0023] In one embodiment of the present application, the laser-cut pattern of the curved segment is a plurality of slots spaced apart in the axial direction, the slots extend in the circumferential direction, and adjacent slots are at least partially staggered in the circumferential direction;

[0024] Alternatively, the laser-cut pattern of the curved section is spiral;

[0025] Alternatively, the laser-cut pattern of the curved section is a double-rib spiral groove, and the double-rib spiral groove is arranged in sections.

[0026] In one embodiment of the present application, the delivery catheter further comprises a fixing seat, which is arranged at the distal end of the inner tube and is used to fix the proximal end of the fixing head, and the fixing seat can limit the axial and circumferential degrees of freedom of the fixing head.

[0027] In one embodiment of the present application, the fixing seat includes a first clamping seat, a second clamping seat and a fastener, one side of the first clamping seat can be rotatably set on the second clamping seat, the fastener fastens the first clamping seat and the second clamping seat, and the first clamping seat and the second clamping seat clamp the proximal end of the fixing head.

[0028] In one embodiment of the present application, the inner tube includes an inner layer, a middle layer and an outer layer which are stacked one on top of the other. The inner layer and the outer layer are made of polymer materials, the middle layer is a woven structure layer, and the inner tube also includes reinforcing ribs which are arranged between the inner layer and the middle layer along the axial direction and connect the proximal end and the distal end of the inner layer.

[0029] In one embodiment of the present application, the inner tube further comprises a welding ring, which is disposed at the distal end of the inner layer and connected to the proximal end of the fixing head, and the welding ring is also connected to the distal end of the reinforcing rib.

[0030] A loading method, using a loading tool as described in any of the above technical features to load an implant into a sheath of a delivery catheter;

[0031] Pushing the sheath tube toward the distal end and allowing the fixing head to be exposed from the sheath tube;

[0032] Installing the implant's hanging ear on the fixing head;

[0033] Loading the catheter structure of the delivery catheter onto the first fixing seat of the loading tool, and abutting the distal end of the sheath against the second fixing seat;

[0034] The second fixing seat is driven to drive the sheath to move toward the proximal end until the implant is loaded.

[0035] After adopting the above technical solution, this application has at least the following technical effects:

[0036] The loading tool, auxiliary loading system and loading method of the present application, in which the first fixing seat and the second fixing seat are arranged on the mounting base, and the first fixing seat is located at the proximal side and fixed, and the second fixing seat is located at the distal side and can be movably arranged, and the driving component is connected to the second fixing seat to drive the second fixing seat to move toward the proximal end or the distal end. After the sheath is extended to the distal end to expose the fixing head, the ear of the implant is installed on the fixing head, and then the delivery catheter is installed on the loading tool, the first fixing seat clamps and fixes the catheter structure of the delivery catheter, and the second fixing seat abuts the distal end of the sheath. When the driving component drives the second fixing seat to move toward the proximal end, the sheath will load the implant into the sheath through the fixing head to achieve the loading of the implant.

[0037] When the loading tool loads the implant, the second fixing seat applies a force to the sheath tube, and then the sheath tube applies a force to the implant, so that the implant is loaded into the sheath tube, and there is no need to pull the inner core tube to load the implant, thereby reducing the tensile load borne by the inner core tube. In this way, the inner core tube does not need to have a strong tensile strength to withstand the force when the implant is loaded, so that the inner core tube can have good bending performance, so as to increase the flexibility of the delivery catheter and facilitate the delivery of the implant by the delivery catheter. The loading tool can assist in the loading of the implant, is simple and convenient to operate, and can also reduce the design requirements for the inner core tube during the loading process. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a schematic diagram of the cooperation between a loading tool and a delivery catheter according to an embodiment of the present application.

[0039] Figure 2 for Figure 1 A schematic diagram of the delivery catheter is shown in a loaded state.

[0040] Figure 3 for Figure 2 Schematic diagram of the delivery catheter shown in a released state.

[0041] Figure 4 for Figure 1 A schematic diagram of the cooperation between the sheath tube and the second fixing seat is shown.

[0042] Figure 5 for Figure 2 A schematic diagram of an embodiment of an inner core tube in a delivery catheter is shown.

[0043] Figure 6 for Figure 2 A schematic diagram of another embodiment of an inner core tube in a delivery catheter is shown.

[0044] Figure 7 for Figure 1 A schematic structural diagram of the distal end of the catheter structure in the delivery catheter is shown.

[0045] Figure 8 for Figure 1 Schematic diagram of the structure of the inner tube in the delivery catheter shown.

[0046] Fig. 9 for Figure 1 A partial schematic diagram of the distal end of the inner tube in the delivery catheter is shown.

[0047] Among them: 100, loading tool; 110, mounting base; 120, first fixed seat; 121, mounting hole 130, second fixed seat; 131, mounting position; 140, driving assembly; 141, driving handle; 142, screw rod; 143, support member; 150, guide assembly; 151, guide rail; 152, guide slider; 200, conveying catheter; 210, catheter structure; 211, inner tube; 2111, inner layer; 2112, middle layer; 2113, outer layer; 2114, reinforcing rib; 2115, welding ring; 220, inner core tube; 221, bending section; 230, sheath tube; 240, fixing head; 250, fixing seat; 251, first clamping seat; 252, second clamping seat. DETAILED DESCRIPTION

[0048] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0049] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0050] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0051] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0052] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0053] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0054] See also Figures 1 to 3 The present application provides a loading tool 100. The loading tool 100 is used to load an implant into a delivery catheter 200 of an auxiliary loading system. Figure 1 This is a schematic diagram of the cooperation between the loading tool 100 and the delivery catheter 200 according to an embodiment of the present application. Figure 2 for Figure 1 The schematic diagram of the delivery catheter 200 shown is in a loaded state, Figure 3 for Figure 2 The schematic diagram of the delivery catheter 200 shown in the released state. It can be understood that the implant here is a valve stent, and the loading tool 100 can load the valve stent into the delivery catheter 200, and deliver the valve stent to the target area through the delivery catheter 200 and release it to achieve the purpose of treatment. Of course, in other embodiments of the present application, the implant can also be other components that need to be delivered to the patient's body. In this application, only the implant as a valve stent is used as an example for description.

[0055] It is understandable that, when the implant is currently loaded into the delivery catheter, the sheath is usually moved from the distal end to the proximal end by pulling the inner core tube to achieve the loading of the stent. However, this stent loading method requires the inner core tube to have a large tensile strength, which greatly limits the flexibility of the delivery system and affects the convenience of the delivery system operation. To this end, the present application provides a novel loading tool 100, which does not need to pull the inner core tube 220 to load the implant when loading the implant, thereby reducing the tensile load borne by the inner core tube 220, so that the inner core tube 220 does not need to have a strong tensile strength, so that the inner core tube 220 can have a good bending performance, so as to increase the flexibility of the delivery catheter 200, and facilitate the delivery of the implant by the delivery catheter 200.

[0056] In order to better describe the process of loading the implant into the delivery catheter 200 by the loading tool 100, the structure of the delivery catheter 200 is first introduced. The delivery catheter 200 includes a catheter structure 210, an inner core tube 220, a sheath tube 230 and a fixed head 240. The catheter structure 210 includes an inner tube 211, a middle tube and an outer tube that are sleeved layer by layer, that is, the inner tube 211 is arranged on the inner side of the middle tube, and the middle tube is arranged on the outer side of the outer tube. The inner core tube 220 is movably arranged in the inner tube 211, and the distal end of the inner core tube 220 can extend out of the distal end of the inner tube 211, that is, the inner tube 211 sleeves part of the inner core tube 220. The proximal end of the fixed head 240 is connected to the distal end of the inner core tube 220, and the distal end of the inner core tube 220 passes through the fixed head 240 and the sheath tube 230, and is connected to the sheath tube 230. When the inner core tube 220 moves, it can drive the sheath tube 230 to move synchronously. When the inner core tube 220 drives the sheath tube 230 to move toward the distal end, the sheath tube 230 can release the implant.

[0057] It can be understood that the delivery catheter 200 has a proximal end and a distal end that are relatively arranged along its axial direction. The proximal end of the delivery catheter 200 refers to the end of the delivery catheter 200 that is close to the operator, and the distal end of the delivery catheter 200 refers to the end of the delivery catheter 200 that is away from the operator. It should be noted that the concepts of the proximal end and the distal end here are also applicable to the loading tool 100 and the various components of the delivery catheter 200, and will not be repeated in the following text. Moreover, the axial direction in this application is the length direction of the delivery catheter 200, which refers to the direction of the delivery catheter 200 from the proximal end to the distal end.

[0058] The fixing head 240 has a lug connected to the implant, and the implant can be installed on the lug. The sheath tube 230 can move relative to the inner tube 211 through the inner core tube 220. In this way, the sheath tube 230 can wrap or expose the fixing head 240, thereby realizing the loading and release of the implant, that is, the delivery catheter 200 has a loading state and a release state. Figure 2 When the delivery catheter 200 is in a loaded state, the sheath 230 wraps around the fixing head 240; see Figure 3 When the delivery catheter 200 is in the released state, the fixing head 240 is exposed from the sheath tube 230. Specifically, when the implant is loaded, the inner core tube 220 stretches the sheath tube 230 toward the distal end to expose the fixing head 240. Figure 3 As shown, the lug of the implant is mounted on the fixing head 240. Subsequently, the inner core tube 220 controls the sheath tube 230 to move toward the proximal end, and the sheath tube 230 applies a force to the fixing head 240 and the implant to load the implant into the sheath tube 230, as shown in FIG. Figure 2 After the delivery catheter 200 reaches the target area, the inner core tube 220 drives the sheath tube 230 to move toward the distal end, so that the implant and the fixing head 240 move out of the sheath tube 230, thereby releasing the implant.

[0059] The loading tool 100 of the present application can push the sheath tube 230 to move toward the proximal end to achieve the loading of the implant. The specific structure of the loading tool 100 of one embodiment is introduced below.

[0060] See also Figures 1 to 3 In one embodiment, the loading tool 100 includes a mounting base 110, a first fixing base 120, a second fixing base 130, and a driving assembly 140. The first fixing base 120 is fixed to the mounting base 110, and is used to fix the catheter structure 210 of the delivery catheter 200. The second fixing base 130 is movably arranged on the mounting base 110 and is located at the distal end side of the first fixing base 120. When the second fixing base 130 drives the sheath tube 230 of the delivery catheter 300 to move toward the first fixing base 120, the implant can be loaded into the sheath tube 230. The driving assembly 140 is connected to the second fixing base 130, and drives the second fixing base 130 to move.

[0061] The mounting base 110 is a bearing platform of the loading tool 100, and the various components of the loading tool 100 are carried by the mounting base 110. In this way, the loading tool 100 forms a whole through the mounting base 110, which is convenient for the transportation of the loading tool 100, and at the same time, it is convenient for the operator to use the loading tool 100. The structural form of the mounting base 110 is not limited in principle, as long as the installation of the various components of the loading tool 100 can be achieved. Optionally, the mounting base 110 is set in a flat plate shape. Of course, in other embodiments of the present application, the mounting base 110 can also be set in a block shape or other shapes. Optionally, the mounting base 110 is set on an operating trolley or other operating platform. Of course, in other embodiments of the present application, the mounting base 110 can also be an integrated structure with the operating trolley or other operating platform.

[0062] The first fixing seat 120 is fixedly arranged on one side of the mounting base 110, and the second fixing seat 130 is movably arranged on the other side of the mounting base 110 relative to the first fixing seat 120, and the second fixing seat 130 can be close to or away from the first fixing seat 120 along the mounting base 110. The first fixing seat 120 is fixedly mounted on the catheter structure 210 of the delivery catheter 200. It can be understood that the inner tube 211, the middle tube and the outer tube are fixedly arranged. The first fixing seat 120 can clamp and fix the outer tube or the middle tube to achieve the fixation of the delivery catheter 200. The second fixing seat 130 can abut the sheath tube 230 to achieve the limiting of the sheath tube 230, and the second fixing seat 130 can drive the sheath tube 230 to move toward the proximal end so that the sheath tube 230 can be loaded with an implant.

[0063] The driving assembly 140 is connected to the second fixing seat 130. The driving assembly 140 can output linear motion when it moves, and the second fixing seat 130 is driven to move by the driving assembly 140, so that the second fixing seat 130 is close to or away from the first fixing seat 120. Optionally, the driving assembly 140 is fixedly arranged on the first fixing seat 120, and the output end of the driving assembly 140 is connected to the second fixing seat 130. Of course, in other embodiments of the present application, the driving assembly 140 can be fixedly arranged on the mounting base, and its output end is connected to the second fixing seat 130.

[0064] When the loading tool 100 of the present application is used to load the implant into the delivery catheter 200, the sheath 230 is first pulled out to the distal end through the inner core tube 220 so that the fixed head 240 is exposed from the sheath 230. At this time, the delivery catheter 200 is in a released state. The hanging ear of the implant is installed on the fixed head 240, the catheter structure 210 is fixed to the first fixed seat 120, and the position of the second fixed seat 130 is adjusted so that the second fixed seat 130 abuts the distal end of the sheath 230. The operator operates the drive assembly 140 to drive the second fixed seat 130 to move toward the proximal end, and then the second fixed seat 130 can push the sheath 230 to squeeze the fixed head 240 and the implant, completing the loading operation of the implant. Subsequently, the delivery catheter 200 can be implanted. The release process of the implant has been mentioned above and will not be repeated here.

[0065] The loading tool 100 of the above embodiment applies a force to the sheath tube 230 through the second fixing seat 130, and then the sheath tube 230 applies a force to the implant, so that the implant is loaded into the sheath tube 230, and there is no need to pull the inner core tube 220 to load the implant, thereby reducing the tensile load borne by the inner core tube 220. In this way, the inner core tube 220 does not need to have a strong tensile strength to withstand the force when the implant is loaded, so that the inner core tube 220 can have good bending performance, so as to increase the flexibility of the delivery catheter 200 and facilitate the delivery of the implant by the delivery catheter 200. The loading tool 100 can assist in the loading of the implant, is simple and convenient to operate, and can also reduce the design requirements for the inner core tube 220 during the loading process.

[0066] See also Figure 1 and Figure 4 In one embodiment, the first fixing seat 120 has an axially through-going mounting hole 121, in which the catheter structure 210 is installed and can be restricted, and the second fixing seat 130 has a mounting position 131, which fits with the distal outer edge of the sheath tube 230. Figure 4 for Figure 1 The schematic diagram shown is a combination of the sheath tube 230 and the second fixing seat 130.

[0067] The catheter structure 210 is arranged in the mounting hole 121. By fixing the catheter structure 210 in the mounting hole 121, the axial and circumferential limitation of the catheter structure 210 is achieved, which is convenient for loading the implant. The mounting position 131 extends in the axial direction and is arranged toward the proximal direction. In this way, after the catheter structure 210 is arranged in the mounting hole 121, the sheath tube 230 can be extended into the mounting position 131, and the sheath tube 230 is limited by the mounting position 131, and the sheath tube 230 is driven to move toward the proximal end. Optionally, the mounting position 131 is a hole or a groove.

[0068] like Figure 1 As shown, in one embodiment, the central axis of the mounting hole 121 coincides with the central axis of the mounting position 131. In other words, the mounting hole 121 and the mounting position 131 are coaxially arranged. When the sheath 230 is installed in the mounting position 131 and the catheter structure 210 is installed in the mounting hole 121, the coaxiality between the sheath 230 and the fixing head 240 can be ensured. In this way, during the loading process, there will be no force offset, which will cause uneven circumferential force on the implant and uneven loading of the implant, so that the implant is evenly loaded into the sheath 230, ensuring the performance of the implant.

[0069] See also Figure 4In one embodiment, the cross section of the mounting position 131 is triangular. That is, the mounting position 131 is roughly conical. In other words, the shape of the mounting position 131 is adapted to the shape of the distal end of the sheath tube 230. In this way, after the sheath tube 230 is installed in the mounting position 131, the outer wall of the distal end of the sheath tube 230 can fit the inner wall of the mounting position 131, and while the sheath tube 230 is positioned, the second fixing seat 130 can push the sheath tube 230 to move toward the proximal end to achieve the loading of the implant.

[0070] See also Figure 1 In one embodiment, the first fixed seat 120 includes a support seat body and a metal fixing head. The support seat body has a through hole for passing the screw rod 142. The metal fixing head has a first groove and a second groove. The metal fixing head is installed on the support seat body. The first groove and the second groove constitute a mounting hole 121.

[0071] The support seat body is fixed to the mounting base 110, and the metal fixing head is detachably arranged on the top of the support seat body through a fixing piece. In addition, the top of the support seat body has a first groove, and the top of the metal fixing head has a second groove. After the metal fixing head is fixed to the support seat body, the first groove and the second groove are matched to form a mounting hole 121. After the conduit structure 210 is installed in the mounting hole 121, the cooperation between the metal fixing head and the support seat body can clamp the conduit structure 210 to limit the axial and circumferential displacement of the conduit structure 210 and prevent the conduit structure 210 from moving.

[0072] Optionally, one end of the metal fixing head is rotatably connected to the support seat body through a rotating member, and the other end of the metal fixing head is detachably mounted to the support seat body through a fixing member such as a screw. In this way, when the catheter structure 210 needs to be installed, the fixing member is removed, and after the catheter structure 210 is installed in the installation hole 121, the fixing member is tightened. At this time, the cooperation between the metal fixing head and the support seat body can reliably clamp the catheter structure 210. Of course, in other embodiments of the present application, the metal fixing head can also be removed from the support seat body as a whole, and its two ends are fixed to the support seat body through fixing members, or other structural forms that can achieve the fixing of the catheter structure 210 are adopted.

[0073] In one embodiment, the driving assembly 140 includes a driving handle 141, a screw rod 142, and a support member 143. The support member 143 is disposed on the mounting base 110 and is located at the distal end of the second fixed seat 130. The screw rod 142 is movably disposed on the first fixed seat 120, and its proximal end extends out of the first fixed seat 120 and is connected to the driving handle 141, and its distal end is movably connected to the support member 143. The second fixed seat 130 is fixed to the screw rod 142 and moves with the screw rod 142. The driving handle 141 drives the screw rod 142 to drive the second fixed seat 130 to move in a direction close to or away from the first fixed seat 120.

[0074] The driving assembly 140 outputs a linear motion through the screw rod 142, so that the second fixed seat 130 can move on the mounting base 110. The support member 143 is arranged on the distal side of the mounting base 110, that is, located on the side of the second fixed seat 130 away from the first fixed seat 120, and the second fixed seat 130 is movably arranged between the support member 143 and the first fixed seat 120. The proximal end of the screw rod 142 is rotatably supported on the first fixed seat 120, and the distal end of the screw rod 142 passes through the second fixed seat 130 and is rotatably supported on the support member 143. When the screw rod 142 rotates, the screw rod 142 can drive the second fixed seat 130 to move, so that the second fixed seat 130 moves linearly along the screw rod 142.

[0075] Moreover, the proximal end of the screw rod 142 is exposed from the first fixing seat 120, so that the proximal end of the screw rod 142 can be installed with the driving handle 141. The operator operates the driving handle 141 to drive the screw rod 142 to rotate, so as to adjust the position of the second fixing seat 130, so that the second fixing seat 130 can drive the sheath 230 to load the implant into the sheath 230. Optionally, the support member 143 is a support plate. Of course, in other embodiments of the present application, the support member 143 is designed in the form of a block or a seat body, as long as the rotatable support of the distal end of the screw rod 142 can be achieved.

[0076] See also Figure 1 In one embodiment, the loading tool 100 further includes a guide assembly 150, which guides and connects the second fixing seat 130 and the mounting base 110, and can define the moving path of the second fixing seat 130. The guide assembly 150 is arranged at the bottom of the mounting base 110 and the second fixing seat 130 along the axial direction of the delivery catheter 200. In this way, when the screw rod 142 drives the second fixing seat 130 to move, the guide assembly 150 can guide the movement of the second fixing seat 130, reduce the shaking of the second fixing seat 130, and ensure the coaxiality of the sheath tube 230 and the fixing head 240.

[0077] See also Figure 1 In one embodiment, the guide assembly 150 includes a guide rail 151 and a guide slider 152. The guide rail 151 is disposed at the bottom of the second fixed seat 130, and the guide slider 152 is disposed at the bottom of the second fixed seat 130 in a clamping manner and can slide relatively. That is, the guide slider 152 can be slidably disposed on the guide rail 151. When the screw rod 142 drives the second fixed seat 130 to move, the second fixed seat 130 moves along the guide rail 151 with the help of the guide slider 152 to limit the movement trajectory of the second fixed seat 130, so as to ensure that the second fixed seat 130 moves axially relative to the first fixed seat along the central axis.

[0078] The loading tool 100 of the present application can assist in loading implants. During loading, the sheath tube 230 is first pushed out to the distal end relative to the fixing head 240 and the inner tube 211 through the inner core tube 220, so that the fixing head 240 exposes the sheath tube 230; the ear of the implant is installed on the fixing head 240. Subsequently, the delivery catheter 200 is fixed to the loading tool 100, the catheter structure 210 is placed in the mounting hole 121 of the first fixing seat 120, and the catheter structure 210 is clamped by the metal fixing head so that the catheter structure 210 is reliably fixed, and the position of the second fixing seat 130 is adjusted by the driving assembly 140 so that the distal end of the sheath tube 230 is installed in the mounting position 131 of the second fixing seat 130. In this way, the delivery catheter 200 is locked in the loading tool 100. Subsequently, the operator operates the driving handle 141, which drives the screw 142 to rotate, and the screw 142 drives the second fixing seat 130 to axially displace. When the second fixing seat 130 moves, it drives the sheath 230 to move synchronously to squeeze the fixing head 240 and the implant to achieve implant loading.

[0079] The loading tool 100 of the present application can realize the force transfer when the implant is loaded, and transfer the larger loading force from the inner core tube 220 to the second fixed seat 130, which is beneficial to the structural design of the delivery catheter 200. There is no need to pull the inner core tube 220 to load the implant, thereby reducing the tensile load borne by the inner core tube 220. In this way, the force when the implant is loaded is borne by the second fixed seat 130, and the inner core tube 220 does not need to have a strong tensile strength, so that the inner core tube 220 can have better bending performance. The inner core tube 220 can be designed into a low-rigidity structure to increase the flexibility of the delivery catheter 200 and facilitate the delivery of the implant by the delivery catheter 200.

[0080] See also Figure 1 The present application also provides an auxiliary loading system, including a delivery catheter 200 and a loading tool 100 as in any of the above embodiments, the loading tool 100 cooperates with the delivery catheter 200 to load the implant into the delivery catheter 200. The delivery catheter 200 includes a catheter structure 210, an inner core tube 220, a sheath tube 230 and a fixing head 240, the catheter structure 210 includes an inner tube 211, a middle tube and an outer tube which are arranged in layers, and the inner core tube 220 is movably arranged in the inner tube 211, the fixing head 240 is arranged at the distal end of the inner tube 211, the distal end of the inner core tube 220 passes through the fixing head 240 and the sheath tube 230 and is connected to the distal end of the sheath tube 230. The delivery catheter 200 is installed on the loading tool 100, the fixing head 240 fixes the ear of the implant, and the loading tool 100 drives the sheath tube 230 to move toward the proximal end of the delivery catheter 200 to load the implant into the sheath tube 230.

[0081] After the auxiliary loading system of the present application adopts the loading tool 100 of the above-mentioned embodiment, the loading tool 100 can load the implant into the delivery catheter 200. In this way, the force when loading the implant can be transferred from the inner core tube 220 to the loading tool 100. The inner core tube 220 does not need to bear the tensile load and can be designed into a low-rigidity structure, thereby improving the overall flexibility of the delivery catheter 200, so as to facilitate the delivery catheter 200 to deliver the implant to the target area.

[0082] See also Figure 3 , Figure 5 and Figure 6 In one embodiment, the inner core tube 220 has a curved section 221. That is, the inner core tube 220 includes a curved section 221 and a straight tube section, and the curved section 221 is connected to the straight tube section. The curved section 221 can ensure that the inner core tube 220 has good bending performance, so that the inner core tube 220 can be more easily bent in the blood vessel, which is convenient for delivering the implant to the target area. The bending control of the delivery catheter 200 is achieved by the curved section 221, and the cooperation between the straight tube section and the curved section 221 makes the delivery catheter 200 have good pushing performance, and no failure such as buckling occurs during the release process.

[0083] In one embodiment of the present application, the bending section 221 is made of laser-cut nickel-titanium capillary. That is, the nickel-titanium capillary is laser-cut, and the portion with the laser-cut pattern is the bending section 221. After being laser-cut, it can have good bendability and good pushability, and no failure such as buckling occurs during the release process.

[0084] In another embodiment of the present application, the curved section 221 is an elastic tube with the same outer diameter as the inner core tube 220. Optionally, the elastic tube is a spring tube. In other words, the curved section 221 can be a compact spring with the same inner and outer diameter as the inner core tube 220, and the compact spring is connected to the nickel-titanium tube by welding or the like. The compact spring can also make the delivery catheter 200 have good bendability, and also have good pushability. Of course, in other embodiments of the present application, the elastic tube can also be other structural parts with good bendability and good pushability.

[0085] In one embodiment, the laser cutting pattern of the curved section 221 is a plurality of slots spaced apart in the axial direction, the slots extend in the circumferential direction, and adjacent slots are at least partially staggered in the circumferential direction. In other words, the slots have a certain central angle in the circumferential direction, and the plurality of slots are not connected in the axial direction and are staggered. In this way, when the delivery conduit 200 is bent, it can be bent in any direction through the slots, thereby ensuring the bending performance of the delivery conduit 200.

[0086] like Figure 5 As shown, in one embodiment, the laser-cut pattern of the curved segment 221 is spiral. Figure 5 for Figure 2 A schematic diagram of an embodiment of an inner core tube 220 in a delivery catheter 200 is shown. Figure 5 A spiral pattern is cut on the nickel-titanium tube to form a curved section 221 to ensure the bending performance of the inner core tube 220 .

[0087] like Figure 6 As shown, in one embodiment, the laser-cut pattern of the curved section 221 is a double-rib spiral groove, and the double-rib spiral groove is arranged in sections. Figure 6 for Figure 2 A schematic diagram of another embodiment of the inner core tube 220 in the delivery catheter 200 is shown. Figure 6 A double-helix spiral groove is provided on the spiral tube, and the spiral groove is provided in sections, so as to ensure the structural strength of the bending section 221 and the bending performance at the same time.

[0088] See also Figure 1 and Figure 7 In one embodiment, the delivery catheter 200 further includes a mounting seat 250 , which is disposed at the distal end of the inner tube 211 and is used to fix the proximal end of the fixing head 240 . The mounting seat 250 can limit the axial and circumferential degrees of freedom of the fixing head 240 . Figure 7 for Figure 1 The schematic diagram of the structure of the distal end of the catheter structure 210 in the delivery catheter 200 is shown. The mounting seat 250 is located at the distal end of the inner tube 211, and the catheter structure 210 is connected to the proximal end of the fixing head 240 through the mounting seat 250 to achieve reliable fixation of the fixing head 240 to limit the axial and circumferential displacement of the fixing head 240, so that the fixing head 240 can reliably fix the implant.

[0089] See also Figure 7 In one embodiment, the mounting seat 250 includes a first clamping seat 251, a second clamping seat 252 and a fastener. One side of the first clamping seat 251 can be rotatably set on the second clamping seat 252. The fastener fastens the first clamping seat 251 and the second clamping seat 252. The first clamping seat 251 and the second clamping seat 252 clamp the proximal end of the fixing head 240.

[0090] The second clamping seat 252 is fixedly arranged at the distal end of the inner tube 211, and the first clamping seat 251 is detachably mounted on the second clamping seat 252. After the first clamping seat 251 is mounted on the second clamping seat 252, the first clamping seat 251 and the second clamping seat 252 can clamp the proximal end of the fixed head 240 to fix the fixed head 240, so as to limit the axial and circumferential displacement of the fixed head 240 and prevent the fixed head 240 from moving.

[0091] Optionally, the first clamping seat 251 has a third partial hole, and the second clamping seat 252 has a fourth partial hole. After the first clamping seat 251 is installed on the second clamping seat 252, the third partial hole and the fourth partial hole are matched to form a clamping hole, and the diameter of the clamping hole is smaller than the diameter of the proximal end of the fixing head 240. In this way, the fixing head 240 is reliably fixed.

[0092] See also Figure 8 and Fig. 9 In one embodiment, the inner tube 211 includes an inner layer 2111, an intermediate layer 2112 and an outer layer 2113 which are stacked one on top of the other. The inner layer 2111 and the outer layer 2113 are made of polymer materials. The intermediate layer 2112 is a woven structure layer. The inner tube 211 also includes a reinforcing rib 2114 which is arranged between the inner layer 2111 and the intermediate layer 2112 along the axial direction and connects the proximal end and the distal end of the inner layer 2111. Figure 8 for Figure 1 The schematic diagram of the structure of the inner tube 211 in the delivery catheter 200 is shown in FIG. Fig. 9 for Figure 1 A partial schematic diagram of the distal end of the inner tube 211 in the delivery catheter 200 is shown.

[0093] The middle layer 2112 is fixedly arranged on the outside of the inner layer 2111, and the outer layer 2113 is fixedly arranged on the outside of the middle layer 2112, so that the inner tube 211 forms an integral tubular structure. Moreover, the inner layer 2111 and the outer layer 2113 are made of polymer materials, and after the middle layer 2112 is a woven structure layer, it can ensure that the inner tube 211 has good bending performance and structural strength. At the same time, the reinforcing rib 2114 is arranged between the inner layer 2111 and the middle layer 2112, and connects the distal end and the proximal end of the inner layer 2111, so that the reinforcing rib 2114 can strengthen the inner tube 211, so that the release force of the implant acts on the distal end of the inner tube 211 and then is transmitted to the reinforcing rib 2114, and the inner tube 211 will not be axially deformed due to the large release force.

[0094] Optionally, the reinforcing ribs 2114 are made of a stainless steel rope woven from multiple strands. In this way, the reinforcing ribs 2114 can have good bending performance and structural strength, so that the inner tube 211 as a whole has good tensile performance and bending performance. Optionally, the reinforcing ribs 2114 are woven together with the middle layer 2112 and are finally radially compressed by the middle layer 2112.

[0095] In one embodiment, the inner tube 211 further includes a welding ring 2115, which is disposed at the distal end of the inner layer 2111 and connected to the proximal end of the fixing head 240, and the welding ring 2115 is also connected to the distal end of the reinforcing rib 2114. The welding ring 2115 is disposed at the distal end of the inner tube 211, and the welding ring 2115 is connected to the distal end of the reinforcing rib 2114. The cooperation between the reinforcing rib 2114 and the welding ring 2115 improves the tensile strength of the inner tube 211, so that the delivery catheter 200 will not be axially deformed due to a large release force. Optionally, the reinforcing rib 2114 and the welding ring 2115 are connected by welding, and the welding method can be laser welding or silver-tin welding.

[0096] The present application also provides a loading method, using the loading tool 100 of any of the above embodiments to load an implant into the sheath 230 of the delivery catheter 200;

[0097] Push the sheath tube 230 toward the distal end, and allow the fixing head 240 to be exposed out of the sheath tube 230;

[0098] Installing the implant's lugs on the fixing head 240;

[0099] Load the catheter structure 210 of the delivery catheter 200 onto the first fixing seat 120 of the loading tool 100, and abut the distal end of the sheath tube 230 against the second fixing seat 130;

[0100] The second fixing seat 130 is driven to drive the sheath tube 230 to move toward the proximal end until the implant is loaded.

[0101] When the implant is loaded into the delivery catheter 200 by using the loading tool 100, the sheath tube 230 is first pushed out to the distal end relative to the fixing head 240 and the inner tube 211 through the inner core tube 220, so that the fixing head 240 is exposed from the sheath tube 230; the implant hook is installed on the fixing head 240. Subsequently, the delivery catheter 200 is fixed to the loading tool 100, the catheter structure 210 is placed in the mounting hole 121 of the first fixing seat 120, and the catheter structure 210 is clamped by the metal fixing head so that the catheter structure 210 is reliably fixed, and the position of the second fixing seat 130 is adjusted by the driving assembly 140 so that the distal end of the sheath tube 230 is installed in the mounting position 131 of the second fixing seat 130. In this way, the delivery catheter 200 is locked in the loading tool 100. Subsequently, the operator operates the driving handle 141, and the driving handle 141 drives the screw 142 to rotate. The screw 142 can drive the second fixing seat 130 to move toward the proximal end. When the second fixing seat 130 moves, it can drive the sheath 230 to move synchronously to squeeze the fixing head 240 and the implant to achieve the loading of the implant.

[0102] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0103] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A loading tool, characterized in that: Used to load an implant into a delivery catheter of an auxiliary loading system, the loading tool comprising: Install the base; A first fixing seat, fixed to the mounting base, for fixing the catheter structure of the delivery catheter; a second fixing seat, movably disposed on the mounting base, and capable of loading an implant into the sheath tube when the second fixing seat drives the sheath tube of the delivery catheter to move toward the first fixing seat; and A driving assembly is connected to the second fixing seat and drives the second fixing seat to move.

2. The loading tool according to claim 1, characterized in that: The first fixing seat has an axially through-going mounting hole, in which the catheter structure is mounted and can be restrained, and the second fixing seat has a mounting position, which is matched with the distal outer edge of the sheath tube; The central axis of the mounting hole coincides with the central axis of the mounting position.

3. The loading tool according to claim 2, characterized in that: The cross section of the installation position is triangular.

4. The loading tool according to claim 2, characterized in that: The first fixing seat includes a supporting seat body and a metal fixing head, the supporting seat body has a through hole for passing a screw rod, and the metal fixing head has a first groove and a second groove, and the first groove and the second groove constitute the mounting hole.

5. The loading tool according to any one of claims 1 to 4, characterized in that: The driving assembly includes a driving handle, a screw rod and a support member, wherein the support member is arranged on the mounting base, the screw rod is movably arranged on the first fixing seat, and its proximal end extends out of the first fixing seat and is connected to the driving handle, and its distal end is movably connected to the support member, and the second fixing seat is fixed to the screw rod and moves with the screw rod; The driving handle drives the screw rod to drive the second fixing seat to move toward or away from the first fixing seat.

6. The loading tool according to any one of claims 1 to 4, characterized in that: The loading tool further comprises a guide assembly, wherein the guide assembly is capable of defining a movement path of the second fixing seat; The guide assembly comprises a guide rail and a guide slider. The guide rail is arranged at the bottom of the second fixing seat. The guide slider is clamped and arranged on the guide rail and can slide relatively.

7. An auxiliary loading system, characterized in that: A delivery catheter and a loading tool as claimed in any one of claims 1 to 6, wherein the loading tool cooperates with the delivery catheter to load an implant into the delivery catheter; The delivery catheter comprises a catheter structure, an inner core tube, a sheath tube and a fixed head. The catheter structure comprises an inner tube, a middle tube and an outer tube which are sheathed in layers, and the inner core tube is movably arranged in the inner tube. The fixed head is arranged at the distal end of the inner tube. The distal end of the inner core tube passes through the fixed head and the sheath tube and is connected to the distal end of the sheath tube. The delivery catheter is installed on the loading tool, the fixing head fixes the hanging ear of the implant, and the loading tool drives the sheath to move toward the proximal end of the delivery catheter to load the implant into the sheath.

8. The auxiliary loading system according to claim 7, characterized in that: The inner core tube has a curved section, and the curved section is made of a laser-cut nickel-titanium capillary tube, or the curved section is an elastic tube with the same outer diameter as the inner core tube.

9. The auxiliary loading system according to claim 8, characterized in that: The laser cutting pattern of the curved section is a plurality of slots spaced apart in the axial direction, the slots extend in the circumferential direction, and adjacent slots are at least partially staggered in the circumferential direction; Alternatively, the laser-cut pattern of the curved section is spiral; Alternatively, the laser-cut pattern of the curved section is a double-rib spiral groove, and the double-rib spiral groove is arranged in sections.

10. The auxiliary loading system according to any one of claims 7 to 9, characterized in that: The delivery catheter further comprises a fixing seat, which is arranged at the distal end of the inner tube and is used for fixing the proximal end of the fixing head. The fixing seat can limit the axial and circumferential degrees of freedom of the fixing head.

11. The auxiliary loading system according to claim 10, characterized in that: The fixing seat includes a first clamping seat, a second clamping seat and a fastener. One side of the first clamping seat can be rotatably set on the second clamping seat. The fastener fastens the first clamping seat and the second clamping seat. The first clamping seat and the second clamping seat clamp the proximal end of the fixing head.

12. The auxiliary loading system according to any one of claims 7 to 9, characterized in that: The inner tube includes an inner layer, a middle layer and an outer layer which are stacked one on top of the other. The inner layer and the outer layer are made of polymer materials. The middle layer is a woven structure layer. The inner tube also includes reinforcing ribs which are arranged between the inner layer and the middle layer along the axial direction and connect the proximal end and the distal end of the inner layer.

13. The auxiliary loading system according to claim 12, characterized in that: The inner tube further comprises a welding ring, which is arranged at the distal end of the inner layer and connected to the proximal end of the fixing head, and the welding ring is also connected to the distal end of the reinforcing rib.

14. A loading method, characterized in that: Using the loading tool as described in any one of claims 1 to 6 to load the implant into the sheath of the delivery catheter; Pushing the sheath tube toward the distal end and allowing the fixing head to be exposed from the sheath tube; Installing the implant's hanging ear on the fixing head; Loading the catheter structure of the delivery catheter onto the first fixing seat of the loading tool, and abutting the distal end of the sheath against the second fixing seat; The second fixing seat is driven to drive the sheath to move toward the proximal end until the implant is loaded.

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