Conveying system

Abstract

The invention relates to a conveying system. An outer tube is provided with a through sheath tube inner cavity, an inner tube is provided with a through catheter inner cavity, the inner tube is movably assembled in the sheath tube inner cavity, an inner core tube is provided with a through core tube inner cavity, the inner core tube is movably assembled in the catheter inner cavity, a deformation bag body is provided with a fillable inner cavity, and the inner core tube is arranged in the fillable inner cavity of the deformation bag body in a penetrating mode. One end of the deformation bag body is connected with the inner core tube, the other end of the deformation bag body is connected with the inner tube, a catheter inner cavity of the inner tube is communicated with the fillable inner cavity and used for filling and discharging filling materials, and the bending control driving part is connected with the inner tube and used for controlling the inner tube to actively bend. The conveying system adopts the inner tube to actively control bending, even if the outer tube carries out evacuation action, the overall bending degree of the conveying system is basically not changed, the valve prosthesis of which the position and the coaxiality are adjusted is not influenced, the valve prosthesis after alignment can be stably kept at a specified position, and the conveying accuracy of the valve prosthesis is ensured.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a delivery system. Background Art

[0002] Valve diseases have gradually become diseases that cannot be ignored threatening human health. Transcatheter valve replacement is a treatment method with less trauma, fewer complications, and lower risks. Currently, the artificial biological valves used in transcatheter aortic valve replacement mainly include two categories. The first category is the deformable capsule expansion type aortic valve, and the second category is the self-expanding aortic valve. Both solutions have their own advantages and disadvantages in actual clinical applications. The advantages of the self-expanding aortic valve are mainly reflected in the smaller impact on hemodynamics during the implantation process, and it has a certain degree of adjustability and retrievability during the release process. The deformable capsule expansion type aortic valve has a more stable supporting force and higher stability during the release process.

[0003] This treatment method generally requires delivering the valve prosthesis to the corresponding position through the femoral artery or femoral vein for release. It is required that the sizes of the valve prosthesis and the delivery system are smaller than the size of the blood vessel. The smaller the sizes of the valve prosthesis and the delivery system relative to the size of the blood vessel, the more beneficial it is for the valve prosthesis to be delivered in the body, and it can better reduce vascular complications. The valve prosthesis generally passes through the aortic arch during the delivery process, so it is required that the delivery system can actively control the bending to ensure that the valve prosthesis can be smoothly delivered to the designated position.

[0004] However, for the delivery systems currently applied to transcatheter aortic valve replacement, after delivering the valve prosthesis to the designated position and adjusting the position and coaxiality of the valve prosthesis during the operation, it is necessary to release the valve prosthesis. The conventional bending control method of the delivery system is to control the bending through the outer tube. However, the bending control method of the outer tube will cause the valve prosthesis with the adjusted position and coaxiality to move slightly. This slight movement will cause the valve prosthesis with the adjusted position and coaxiality to no longer be able to maintain the expected position and coaxiality. Therefore, it is necessary to re-align during the release of the valve prosthesis. Therefore, the bending control method of the outer tube not only affects the accuracy of the valve prosthesis delivery, but also affects the delivery efficiency of the valve prosthesis, increases the difficulty of delivery, and affects the safety of the operation, becoming a technical problem that needs to be urgently solved by those skilled in the art. Summary of the Invention

[0005] Based on this, it is necessary to provide a delivery system for the above-mentioned technical problems.

[0006] This application provides a delivery system, and the delivery system includes:

[0007] A catheter assembly, the catheter assembly includes an outer tube, an inner tube, and an inner core tube. The outer tube is sleeved outside the inner tube, and the inner tube is sleeved outside the inner core tube;

[0008] A deformable bladder having a fillable lumen, the inner core tube passing through the fillable lumen of the deformable bladder, the fillable lumen being for filling and discharging a filling substance;

[0009] A bending control driving member connected to the inner tube for controlling the bending of the inner tube.

[0010] In one embodiment, the hardness of the tube body of the inner tube gradually increases from the distal end to the proximal end; and / or,

[0011] the hardness of the tube body of the outer tube gradually increases from the distal end to the proximal end; and / or,

[0012] The inner tube includes an inner catheter layer, a middle catheter layer, and an outer catheter layer. The middle catheter layer is sleeved outside the inner catheter layer, and the outer catheter layer is sleeved outside the middle catheter layer; and / or,

[0013] The outer tube includes an inner sheath layer, a middle sheath layer, and an outer sheath layer. The middle sheath layer is sleeved outside the inner sheath layer, and the outer sheath layer is sleeved outside the middle sheath layer.

[0014] In one embodiment, the direction of the inner tube from the distal end to the proximal end includes a connected catheter distal section, a catheter middle section, and a catheter proximal section. Among them, the catheter distal section is provided with hollow holes, and the distribution density of the hollow holes in the catheter distal section gradually decreases from the distal end to the proximal end.

[0015] In one embodiment, a bending control connecting member is provided on the inner tube, and the bending control driving member is connected to the inner tube through the bending control connecting member.

[0016] In one embodiment, the bending control connecting member is a ring-shaped connecting element provided at the distal end of the inner tube; and / or,

[0017] a connection slit or connection hole is provided on the bending control connecting member for connecting the bending control wire body; and / or,

[0018] a hollow window is provided on the bending control connecting member; and / or,

[0019] A plugging protrusion and a plugging groove that are inserted and matched with each other are respectively provided on the bending control driving member and the distal end of the inner tube, and the bending control driving member is assembled at the distal end of the inner tube through the plugging cooperation between the plugging protrusion and the plugging groove.

[0020] In one embodiment, the delivery system includes:

[0021] A first limiting element, which is arranged on the inner core tube;

[0022] A second limiting element, which is located at the distal end of the outer tube and has an elastic deformation function.

[0023] In one embodiment, the first limiting element includes a tubular member and a limiting end head with a central hole. The tubular member is connected to the limiting end head, and a plurality of first compressible holes are formed in the limiting end head. The plurality of first compressible holes are circumferentially distributed around the central hole.

[0024] In one embodiment, a plurality of second compressible holes are formed in the second limiting element, and at least one of the diameter and the wall thickness of the second limiting element gradually decreases along the direction from the distal end to the proximal end.

[0025] In one embodiment, a control handle is arranged at the proximal end of the inner tube, and the control handle is connected to the bending control driving member; and / or,

[0026] A guiding element is arranged at the distal end of the inner core tube. The guiding element is provided with a guiding channel communicating with the core tube inner cavity of the inner core tube. The core tube inner cavity and the guiding channel are used for threading a guiding wire.

[0027] In one embodiment, the deformation bladder has a bladder distal port and a bladder proximal port communicating with the inflatable inner cavity. The bladder distal port is hermetically connected to the distal end of the inner core tube, the bladder proximal port is hermetically connected to the distal end of the inner tube, and the catheter inner cavity of the inner tube is communicated with the inflatable inner cavity for filling and discharging a filling substance into the inflatable inner cavity, so that the deformation bladder has an expanded state and a contracted state.

[0028] In the above-mentioned delivery system, the inner tube is actively controlled to bend instead of the conventional outer tube actively controlled to bend. In contrast, even if the outer tube performs an evacuation action, the overall bending degree of the delivery system basically does not change, which will not affect the valve prosthesis whose position and coaxiality have been adjusted. This enables the valve prosthesis after alignment to be stably maintained at the designated position, ensuring the accuracy of valve prosthesis delivery, and the valve prosthesis can be directly released without adjusting the alignment and coaxiality. Description of the Drawings

[0029] Figure 1 It is a schematic structural diagram of a delivery system provided by an embodiment of the present application.

[0030] Figure 2 It is a schematic diagram of the contracted state of the deformation bladder in the delivery system provided by an embodiment of the present application.

[0031] Figure 3Schematic diagram of the expanded state of the deformable bladder in the delivery system provided by an embodiment of the present application.

[0032] Figure 4 Schematic diagram of the catheter middle layer structure of the inner tube provided by an embodiment of the present application.

[0033] Figure 5 As Figure 4 Schematic diagram of the unfolded catheter middle layer of the inner tube shown.

[0034] Figures 6 to 11 Schematic diagram of the unfolded structure of the bending control connector provided by several embodiments of the present application.

[0035] Figure 12 And Figure 13 Front view and side view of the first limiting element provided by an embodiment of the present application.

[0036] Figure 14 And Figure 15 Front view and side view of the second limiting element provided by an embodiment of the present application.

[0037] Figure 16 And Figure 17 Front view and side view of the second limiting element provided by another embodiment of the present application.

[0038] Figure 18 And Figure 19 Front view and side view of the second limiting element provided by yet another embodiment of the present application.

[0039] Reference numerals in the drawings:

[0040] 100, valve prosthesis;

[0041] 1000, outer tube; 2000, inner tube; 3000, inner core tube; 4000, deformable bladder; 5000, bending control connector; 6000, first limiting element; 7000, second limiting element; 8000, valve support element; 9000, guiding element;

[0042] 2100, distal catheter section; 2200, middle catheter section; 2300, proximal catheter section;

[0043] 2100a, first hollow hole; 2200a, second hollow hole; 2300a, third hollow hole;

[0044] 2100a1, first main hole section; 2100a2, first pair of side hole sections; 2200a1, second main hole section; 2200a2, second pair of side hole sections; 2300a1, third main hole section; 2300a2, third pair of side hole sections;

[0045] 4000a, inflatable lumen;

[0046] 5000a, connection seam; 5000b, connection hole; 5000c, hollow window; 5000d, insertion protrusion; 5000e, insertion groove;

[0047] 6000a, tubular member; 6000b, limiting end; 6000c, first compressible hole;

[0048] 7000a, second compressible hole; 7000b, inner wall compressible groove; 7000c, outer wall compressible groove. Detailed implementation manner

[0049] To make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manner of the present application in conjunction with the accompanying drawings. Many specific details are set forth in the following description 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 departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0050] In the description of the present application, it should be understood that if these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present application.

[0051] In addition, if these terms "first" and "second" appear, these terms are only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0052] In this application, unless otherwise clearly specified and defined, if terms such as "installed", "connected", "joined", "fixed", etc. appear, these terms shall be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0053] In this application, unless otherwise clearly specified and defined, if there is a description such as a first feature being "on" or "under" a second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature can mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower horizontal height than the second feature.

[0054] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0055] Refer to Figures 1 to 3As shown in the figure, an embodiment of the present application provides a conveying system. The conveying system includes structures such as an outer tube 1000, an inner tube 2000, a core tube 3000, a deformable bladder 4000, and a bending control driving member. The outer tube 1000 has a through sheath lumen, the inner tube 2000 has a through catheter lumen, the inner tube 2000 is movably assembled in the sheath lumen, the core tube 3000 has a through core tube lumen, the core tube 3000 is movably assembled in the catheter lumen, the deformable bladder 4000 has a fillable lumen 4000a, the core tube 3000 passes through the fillable lumen 4000a of the deformable bladder 4000, one end of the deformable bladder 4000 is connected to the core tube 3000, the other end of the deformable bladder 4000 is connected to the inner tube 2000, the catheter lumen of the inner tube 2000 is communicated with the fillable lumen 4000a, and the communication between the two can be used to fill the fillable lumen 4000a with a filling substance or discharge the filling substance in the fillable lumen 4000a, so that the deformable bladder 4000 has an expanded state and a contracted state. The bending control driving member is connected to the inner tube 2000, and the bending control driving member is used to control the inner tube 2000 to actively bend.

[0056] A guiding wire can be passed through the core tube lumen of the core tube 3000, and the guiding wire can play a role in guiding the conveying path during the process of the conveying system entering the body. A guiding element 9000 can be arranged at the distal end of the core tube 3000. The guiding element 9000 can have a shape suitable for shuttling in the body, such as a cone. The guiding element 9000 is provided with a guiding channel communicated with the core tube lumen, and the guiding wire can pass through the core tube lumen and the guiding channel at the same time. A developing element can be arranged on the core tube 3000, and the developing element provides a developing function for marking and positioning. A control handle can be arranged at the proximal end of the inner tube 2000. The control handle can be used to be connected to the bending control driving member, and the operator can control the action of the bending control driving member through the control handle outside the body, so that the inner tube 2000 bends to a corresponding degree and angle, which is not limited here. The deformable bladder 4000 has a distal bladder port and a proximal bladder port communicated with the fillable lumen 4000a. The distal bladder port is hermetically connected to the distal end of the core tube 3000, and the proximal bladder port is hermetically connected to the distal end of the inner tube 2000. The catheter lumen of the inner tube 2000 is communicated with the fillable lumen 4000a for filling and discharging the filling substance, so that the deformable bladder 4000 has an expanded state and a contracted state.

[0057] In order to more clearly describe the structure of the conveying system, the term "distal end" is defined here to represent the end far from the operator during the surgical operation process, and the term "proximal end" represents the end close to the operator during the surgical operation process. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as those commonly understood by those skilled in the technical field to which the present application belongs. The terms used in the present application in the specification are only for the purpose of describing specific embodiments and are not intended to limit the present application.

[0058] As can be seen from the above, the conveying system provided in this application sets the function of actively controlling the bending on the inner tube 2000, and the inner tube 2000 also has the function of filling and discharging the filling substance. The valve prosthesis 100 can be directly pressed and held outside the deformable capsule 4000, or it can also be pressed and held outside the inner tube 2000, and then the valve prosthesis 100 is pushed onto the deformable capsule 4000 through the distal end of the outer tube 1000. During the conveying process of the valve prosthesis 100, the over-arching of the valve prosthesis 100 and the adjustment of the coaxiality with the valve annulus can be achieved based on the active bending control of the inner tube 2000. Therefore, when the valve prosthesis 100 reaches the designated position and is aligned, the operator can withdraw the outer tube 1000 proximally.

[0059] Since the conveying system of this application uses the inner tube 2000 to control the bending, even if the outer tube 1000 performs the withdrawal action, the overall bending degree of the conveying system will basically not change, and it will not affect the valve prosthesis 100 whose position and coaxiality have been adjusted. This enables the valve prosthesis 100 after alignment to be stably maintained at the designated position, ensuring the accuracy of the delivery of the valve prosthesis 100.

[0060] In order to reflect the effect of the inner tube 2000 controlling the bending, this application also briefly describes the disadvantages of the conventional outer tube 1000 controlling the bending, so as to make a comparison with the effect of the inner tube 2000 controlling the bending in this application. After the valve prosthesis 100 is conveyed to the corresponding position, in order to enable the normal expansion of the deformable capsule 4000, the outer tube 1000 needs to be withdrawn proximally. If the bending control of the conveying system is achieved by the outer tube 1000, once the outer tube 1000 as the bending control main body changes (such as withdrawal), it will inevitably affect the overall bending degree of the conveying system. At this time, the position and coaxiality of the valve prosthesis 100 that has been aligned will also inevitably be affected, and it may be necessary to realign. It can be seen from this that after the bending control function is set on the inner tube 2000 in this application, even if the outer tube 1000 performs the withdrawal action, the valve prosthesis 100 can be directly released without adjusting the alignment and coaxiality, effectively improving the accuracy of the release.

[0061] In order to improve the bending control effect of the inner tube 2000, this application also adjusts the tube body hardness of the inner tube 2000. For example, in one of the embodiments, the tube body hardness of the inner tube 2000 can be set to gradually increase along the direction from the distal end to the proximal end. It should be noted that this gradual increase can be a non-segmented gradual increase along the entire axial direction of the inner tube 2000, or a gradual increase in multiple segments along the entire axial direction of the inner tube 2000. For example, refer to Figure 4 and Figure 5As shown, the inner tube 2000 includes, in the direction from the distal end to the proximal end, a connected catheter distal section 2100, a catheter intermediate section 2200, and a catheter proximal section 2300. The tube body hardness of the catheter distal section 2100 is defined to be less than that of the catheter intermediate section 2200, and the tube body hardness of the catheter intermediate section 2200 is less than that of the catheter proximal section 2300. Thus, by being axially divided into multiple sections, the multiple sections have different tube body hardnesses, and further, the tube body hardness of the inner tube 2000 gradually increases in the axial direction. The section with relatively softer tube body hardness can be used to provide better bending performance, and the section with relatively harder tube body hardness can be used to ensure axial support force and improve the anti-torsion and anti-bending capabilities. Those skilled in the art can also adopt different design methods to achieve the gradual change of the tube body hardness according to actual needs, which is not limited herein.

[0062] Correspondingly, the outer tube 1000 can also have its tube body hardness set to gradually increase along the direction from the distal end to the proximal end. Analogous to the design form of the inner tube 2000, the outer tube 1000 can also include, in the direction from the distal end to the proximal end, a sheath distal section, a sheath intermediate section, and a sheath proximal section. The tube body hardness of the sheath distal section is less than that of the sheath intermediate section, and the tube body hardness of the sheath intermediate section is less than that of the sheath proximal section. By being axially divided into multiple sections, the multiple sections have different tube body hardnesses, and further, the tube body hardness of the outer tube 1000 gradually increases in the axial direction. The section with relatively softer tube body hardness can be used to provide better bending performance, and the section with relatively harder tube body hardness can be used to ensure axial support force and improve the anti-torsion and anti-bending capabilities. Those skilled in the art can also adopt different design methods to achieve the gradual change of the tube body hardness according to actual needs, which is not limited herein.

[0063] Different sections of the inner tube 2000 and the outer tube 1000 can be adjusted in hardness through at least one of various design directions such as materials, structures, dimensions, etc. For example, in one embodiment, a plurality of first hollow holes 2100a are provided in the distal section 2100 of the catheter, a plurality of second hollow holes 2200a are provided in the middle section 2200 of the catheter, and a plurality of third hollow holes 2300a are provided in the proximal section 2300 of the catheter. The distribution density of the plurality of first hollow holes 2100a in the distal section 2100 of the catheter is the first distribution density, the distribution density of the plurality of second hollow holes 2200a in the middle section 2200 of the catheter is the second distribution density, and the distribution density of the plurality of third hollow holes 2300a in the proximal section 2300 of the catheter is the third distribution density. At this time, it is defined that the first distribution density is greater than the second distribution density. When the distribution density of the first hollow holes 2100a is relatively high, the distal section 2100 of the catheter is more likely to bend, so that the hardness of the tube body of the distal section 2100 of the catheter is less than the hardness of the tube body of the middle section 2200 of the catheter. Similarly, it can be defined that the second distribution density is greater than the third distribution density, so that the hardness of the tube body of the middle section 2200 of the catheter is less than the hardness of the tube body of the proximal section 2300 of the catheter.

[0064] The first hollow holes 2100a, the second hollow holes 2200a, and the third hollow holes 2300a can be designed in various shapes, dimensions, etc., as long as the hardness of the tube bodies of the distal section 2100, the middle section 2200, and the proximal section 2300 of the catheter meet the design requirements, and no limitations are made here. For example Figure 4 and Figure 5 As shown, in one embodiment, the first hollow holes 2100a can be designed as linear hollow holes that surround the circumference of the distal section 2100 of the catheter, the second hollow holes 2200a are linear hollow holes that surround the circumference of the middle section 2200 of the catheter, and the third hollow holes 2300a are linear hollow holes that surround the circumference of the proximal section 2300 of the catheter. The linear hollow holes can surround the inner tube 2000 in the circumferential direction, so that the linear hollow holes can form a bendable compression space in the circumferential direction of the inner tube 2000, facilitating the bending of the inner tube 2000. For example, a plurality of first hollow holes 2100a can be parallel to each other and perpendicular to the axis of the distal section 2100 of the catheter, a plurality of second hollow holes 2200a can be parallel to each other and perpendicular to the axis of the middle section 2200 of the catheter, and a plurality of third hollow holes 2300a can be parallel to each other and perpendicular to the axis of the proximal section 2300 of the catheter. This design structure can better adapt to the bending of the inner tube 2000 perpendicular to its axis.

[0065] The first hollow hole 2100a, the second hollow hole 2200a, and the third hollow hole 2300a can also be designed in a special way to make the inner tube 2000 more likely to bend in a certain direction. This design can also be achieved based on design directions such as material, shape, and size. For example, in one embodiment, the first hollow hole 2100a may include a first main hole section 2100a1 and a first pair of side hole sections 2100a2. The length of the first main hole section 2100a1 is greater than that of the first pair of side hole sections 2100a2. The longer first main hole section 2100a1 will make it easier for the inner tube 2000 to bend compared to the shorter first pair of side hole sections 2100a2. Therefore, it can be set that all the first main hole sections 2100a1 of the first hollow holes 2100a are located on one side of the distal section 2100 of the catheter, and all the first pair of side hole sections 2100a2 of the first hollow holes 2100a are located on the other side of the distal section 2100 of the catheter relative to the first main hole section 2100a1, so that the inner tube 2000 is more likely to bend towards the side where the first main hole section 2100a1 is arranged in the distal section 2100 of the catheter, thereby actively setting the bending direction of the distal section 2100 of the catheter.

[0066] Similar to the design of the first hollow hole 2100a, the second hollow hole 2200a may also include a second main hole section 2200a1 and a second pair of side hole sections 2200a2. The length of the second main hole section 2200a1 is greater than that of the second pair of side hole sections 2200a2. All the second main hole sections 2200a1 of the second hollow holes 2200a are located on one side of the middle section 2200 of the catheter, and all the second pair of side hole sections 2200a2 of the second hollow holes 2200a are located on the other side of the middle section 2200 of the catheter relative to the second main hole section 2200a1, making the inner tube 2000 more likely to bend towards the side where the second main hole section 2200a1 is arranged in the middle section 2200 of the catheter. The third hollow hole 2300a includes a third main hole section 2300a1 and a third pair of side hole sections 2300a2. The length of the third main hole section 2300a1 is greater than that of the third pair of side hole sections 2300a2. All the third main hole sections 2300a1 of the third hollow holes 2300a are located on one side of the proximal section 2300 of the catheter, and all the third pair of side hole sections 2300a2 of the third hollow holes 2300a are located on the other side of the proximal section 2300 of the catheter relative to the third main hole section 2300a1, making the inner tube 2000 more likely to bend towards the side where the third main hole section 2300a1 is arranged in the proximal section 2300 of the catheter.

[0067] In addition, the inner tube 2000 and the outer tube 1000 are constructed by interlocking and fixing more than one layer of tube structure, and the hardness and other properties of the inner tube 2000 and the outer tube 1000 are adjusted by limiting the materials of different layers. For example, the inner tube 2000 may include a catheter inner layer, a catheter middle layer and a catheter outer layer, the catheter middle layer is sleeved on the outside of the catheter inner layer, and the catheter outer layer is sleeved on the outside of the catheter middle layer. The material of the catheter inner layer is polytetrafluoroethylene, the material of the catheter outer layer is a polymer material, and the catheter middle layer is a hypotube or a braided tube. The hypotube and the braided tube can be used alone to construct the catheter middle layer, or they can be combined with each other and used in different sections of the catheter middle layer to construct the catheter middle layer, which is not limited here. For example, the distal section 2100 of the catheter in the catheter middle layer can adopt a hypotube, which has a soft hardness, a simple structure, good active bending control performance, and good bending control recovery. The remaining sections can be made of metal braided tubes, which are relatively harder and can be used to ensure axial support and improve anti-torsion and anti-bending capabilities.

[0068] In one embodiment, the material and structure can also be combined to adjust the hardness and other characteristics of the inner tube 2000 and the outer tube 1000. For example, when the distal section 2100 of the catheter in the middle layer of the catheter adopts a hypotube, and the middle section 2200 and the proximal section 2300 of the catheter in the middle layer of the catheter adopt a braided tube made of metal, a hollow hole can also be opened on the hypotube of the distal section 2100 of the catheter, referring to Figure 4 and Figure 5 Regarding the opening of the hollow holes, if the distal section 2100 of the catheter is constructed by a hypotube, the distribution density of the hollow holes opened by the hypotube can be divided into multiple sections in the axial direction, so that the multiple sections have different distribution densities, thereby forming different tube body hardnesses in the multiple sections, or it can be undivided into sections, and the distribution density of the hollow holes is gradually reduced in the distal and proximal directions, so that the tube body hardness can be gradually increased in the distal to proximal directions. Those skilled in the art can set the actual construction method of the tube body hardness according to actual needs, which is not limited to multiple methods such as material and structure and a combination of multiple methods, and is not limited here.

[0069] When the inner tube 2000 is formed by the inner layer of the catheter, the middle layer of the catheter and the outer layer of the catheter, the design of the first hollow hole 2100a, the second hollow hole 2200a and the third hollow hole 2300a can also be constructed only in the middle layer of the catheter, and then the special design of the middle layer of the catheter makes it easier for the inner tube 2000 to bend in a certain direction. In addition, those skilled in the art can also construct the relevant design of the first hollow hole 2100a, the second hollow hole 2200a and the third hollow hole 2300a on at least one of the inner layer of the catheter, the middle layer of the catheter and the outer layer of the catheter according to actual needs, which is not limited here.

[0070] Similar to the design of the inner tube 2000, the outer tube 1000 may also include a sheath inner layer, a sheath middle layer and a sheath outer layer. The sheath middle layer is sleeved on the outside of the sheath inner layer, and the sheath outer layer is sleeved on the outside of the sheath middle layer. The material of the sheath inner layer is polytetrafluoroethylene, and the material of the sheath outer layer is a polymer material. The sheath middle layer may be a hypotube or a braided tube. The hypotube and the braided tube may be used alone to construct the sheath middle layer, or may be combined with each other and used in different sections of the sheath middle layer to construct the sheath middle layer, which is not limited here.

[0071] The inner tube 2000 can be controlled by various methods. For example, the control bending driving member is a control bending wire, and one end of the control bending wire is connected to the inner tube 2000. According to the actual control bending requirements, the control bending driving member can be connected to the distal end of the inner tube 2000 or some positions close to the distal end. The control bending driving member can be directly connected to the inner tube 2000 or indirectly assembled with the inner tube 2000 using a control bending connector 5000. For example, the control bending connector 5000 is set at the distal end of the inner tube 2000 and some positions close to the distal end, and the control bending driving member is connected to the inner tube 2000 through the control bending connector 5000.

[0072] The bending control connector 5000 can be constructed into various structures, sizes, etc. according to the assembly requirements of the bending control drive component. For example, in one embodiment, the bending control connector 5000 can be a ring-shaped connecting element, such as Figures 6 to 8 The diagram shows a planar development of various replacement connection elements. The annular connection element can be of a size matching the diameter of the inner tube 2000 and coaxially assembled at the distal end of the inner tube 2000. When the bending control drive element adopts a bending control wire, the bending control wire can be connected to the bending control drive element by bonding, welding, tying, etc. For example, a connection seam 5000a or a connection hole 5000b can be provided on the bending control connector 5000 according to the connection requirements, and the bending control wire can be connected to the bending control connector 5000 after passing through the connection seam 5000a or the connection hole 5000b. A hollow window 5000c may be provided on the bending control connector 5000. The hollow window 5000c is suitable for the inner tube 2000 having a multi-layer structure of a catheter inner layer, a catheter middle layer and a catheter outer layer. For example, when a hollow window 5000c is provided on the bending control connector 5000, it is convenient for the material of the catheter outer layer to penetrate into the catheter middle layer through the hollow window 5000c, thereby making the connection between the catheter outer layer and the catheter middle layer more stable.

[0073] The bending control driving member can be assembled at the distal end of the inner tube 2000 in various ways such as bonding, clamping, welding, etc. For example, the bending control driving member is provided with a plugging protrusion 5000d, and the distal end of the inner tube 2000 is provided with a plugging groove 5000e. Or, the bending control driving member is provided with a plugging groove 5000e, and the distal end of the inner tube 2000 is provided with a plugging protrusion 5000d, so that the bending control driving member is assembled at the distal end of the inner tube 2000 through the plugging fit between the plugging protrusion 5000d and the plugging groove 5000e. The plugging protrusion 5000d and the plugging groove 5000e can be referred to Figure 5 and Figures 6 to 11 As shown, the shapes and sizes of the plugging protrusion 5000d and the plugging groove 5000e can be set according to requirements and are not limited herein.

[0074] The delivery system may further include structures such as a first limiting element 6000, a second limiting element 7000, and a valve support element 8000. Among them, the first limiting element 6000 can be arranged on the inner core tube 3000. When the valve prosthesis 100 is assembled outside the deformable capsule 4000 in the contracted state, the function of the first limiting element 6000 is to limit the distal assembly position of the valve prosthesis 100. Similarly, the second limiting element 7000 can be arranged on the outer tube 1000. For example, the second limiting element 7000 is located at the distal end of the outer tube 1000, and the function of the second limiting element 7000 is to limit the proximal assembly position of the valve prosthesis 100. The valve support element 8000 is arranged on the inner core tube 3000, and the function of the valve support element 8000 is to support the valve prosthesis 100.

[0075] The first limiting element 6000 needs to be located in the distal direction of the valve support element 8000. When the valve prosthesis 100 is assembled outside the deformable capsule 4000 in the contracted state and is supported by the valve support element 8000, the first limiting element 6000 can be exactly located at the distal end of the valve prosthesis 100 to limit the distal assembly position of the valve prosthesis 100. Among them, a certain gap or direct connection can be formed between the first limiting element 6000 and the valve support element 8000 according to the assembly requirements of the valve prosthesis 100, which is not limited herein.

[0076] The valve support element 8000 can adopt a tubular support element, and the tubular support element is sleeved on the inner core tube 3000. The first limiting element 6000 and the second limiting element 7000 can be designed to have an elastic deformation function according to the use requirements. The elastic deformation function can form a certain buffer when the valve prosthesis 100 contacts the first limiting element 6000 or the second limiting element 7000, avoiding hard contact. The elastic deformation function can be constructed according to design directions such as materials and structures.

[0077] For example Figure 12 and Figure 13Among them, the first limiting element 6000 includes a tubular member 6000a and a limiting end 6000b with a central hole. The limiting end 6000b can adopt various shapes such as columnar and spherical. Moreover, as Figure 13 shown, the limiting end 6000b can have a certain length in the axial direction. Those skilled in the art can set the length of the limiting end 6000b according to requirements, so that the limiting end 6000b can provide better stability. The tubular member 6000a is connected to the limiting head, and both the tubular member 6000a and the limiting end 6000b are sleeved on the inner core tube 3000 at the same time. A plurality of first compressible holes 6000c are formed in the limiting end 6000b, and the plurality of first compressible holes 6000c are circumferentially distributed around the central hole. The limiting end 6000b is made of a deformable material, so that the first compressible holes 6000c can be compressed and deformed when the limiting end 6000b is stressed, and the first compressible holes 6000c can return to their original state after the external force is withdrawn. Furthermore, the elastic deformation function of the first limiting element 6000 is realized through the deformation of the first compressible holes 6000c, which facilitates the wing separation and curling of the deformable bladder 4000. The first limiting element 6000 is easy to assemble, has good compressibility, does not affect the folding of the deformable bladder 4000, has a good limiting effect on the valve prosthesis 100, and can effectively prevent the valve prosthesis 100 after being compressed and held from moving distally during the delivery process.

[0078] The second limiting element 7000 is similar to the first limiting element 6000. For example, Figures 14 to 17 among them, a part or all of the structures in the second limiting element 7000 can adopt a cylindrical body. The diameter or wall thickness of the second limiting element 7000 can gradually decrease along the direction from the distal end to the proximal end. Moreover, as Figure 15 shown, the second limiting element 7000 can have a certain length in the axial direction. Those skilled in the art can set the length of the second limiting element 7000 according to requirements, so that the second limiting element 7000 can provide better stability. A plurality of second compressible holes 7000a are formed in the second limiting element 7000, and the plurality of second compressible holes 7000a are circumferentially surrounded on the second limiting element 7000. The second limiting element 7000 is made of a deformable material, so that the second compressible holes 7000a can be compressed and deformed when the second limiting element 7000 is stressed, and the second compressible holes 7000a can return to their original state after the external force is withdrawn. Furthermore, the elastic deformation function of the second limiting element 7000 is realized through the deformation of the second compressible holes 7000a, which facilitates the wing separation and curling of the deformable bladder 4000. Among them, the second compressible holes 7000a can adopt various structures. For example, Figure 14 and Figure 15 the circular holes shown, and the aperture of the circular holes can also gradually decrease along the direction from the distal end to the proximal end. Or, the second compressible holes 7000a can also adopt, for example, as Figure 15 andFigure 17 The diamond-shaped holes shown. In addition, those skilled in the art can also select hole shapes of other shapes according to actual needs, which are not limited herein.

[0079] In another embodiment, the elastic deformation function of the second limiting element 7000 can also be constructed by means of grooving. For example Figure 18 and Figure 19 As shown, a plurality of inner wall compressible grooves 7000b are formed on the inner wall of the second limiting element 7000, and a plurality of outer wall compressible grooves 7000c are formed on the outer wall of the second limiting element 7000. The plurality of inner wall compressible grooves 7000b and the plurality of outer wall compressible grooves 7000c are circumferentially surrounded on the second limiting element 7000. The second limiting element 7000 is made of a deformable material, so that after the second limiting element 7000 is stressed, both the outer wall compressible groove 7000c and the inner wall compressible groove 7000b on the second limiting element 7000 can be compressed and deformed, and the second compressible hole 7000a can return to its original state after the external force is withdrawn. Furthermore, the elastic deformation function of the second limiting element 7000 is realized through the deformation of the outer wall compressible groove 7000c and the inner wall compressible groove 7000b. Among them, an interlaced distribution form can also be formed between the inner wall compressible groove 7000b and the outer wall compressible groove 7000c.

[0080] The structure of the second limiting element 7000 is simple, convenient for assembly, has good compressibility, does not affect the overall contour of the conveying system, has good limiting property for the valve prosthesis 100, and can effectively prevent the valve prosthesis 100 after being crimped from moving proximally during the conveying process.

[0081] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0082] The above-described embodiments merely represent several implementation manners of the present application. Their descriptions are relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A conveying system, characterized in that, The conveying system includes: A catheter assembly, the catheter assembly includes an outer tube, an inner tube, and a core tube. The outer tube is sleeved outside the inner tube, and the inner tube is sleeved outside the core tube; A deformable bladder, the deformable bladder has an inflatable inner cavity, the core tube passes through the inflatable inner cavity of the deformable bladder, and the inflatable inner cavity is used for filling and discharging filling substances; A bending control driving member, the bending control driving member is connected to the inner tube and is used for controlling the bending of the inner tube.

2. The conveying system according to claim 1, wherein The hardness of the tube body of the inner tube gradually increases in the direction from the distal end to the proximal end; and / or, The hardness of the tube body of the outer tube gradually increases in the direction from the distal end to the proximal end; and / or, The inner tube includes an inner catheter layer, a middle catheter layer, and an outer catheter layer. The middle catheter layer is sleeved outside the inner catheter layer, and the outer catheter layer is sleeved outside the middle catheter layer; and / or, The outer tube includes an inner sheath layer, a middle sheath layer, and an outer sheath layer. The middle sheath layer is sleeved outside the inner sheath layer, and the outer sheath layer is sleeved outside the middle sheath layer.

3. The conveying system according to claim 2, wherein The direction of the inner tube from the distal end to the proximal end includes a connected catheter distal section, a catheter middle section, and a catheter proximal section. Among them, the catheter distal section is provided with hollow holes, and the distribution density of the hollow holes in the catheter distal section gradually decreases in the direction from the distal end to the proximal end.

4. The conveying system according to claim 1, wherein A bending control connecting member is arranged on the inner tube, and the bending control driving member is connected to the inner tube through the bending control connecting member.

5. The conveying system according to claim 4, characterized in that The bending control connecting member is a ring-shaped connecting element, and the ring-shaped connecting element is arranged at the distal end of the inner tube; and / or, A connecting slit or a connecting hole is formed in the bending control connecting member, and the connecting slit or the connecting hole is used for connecting the bending control wire body; and / or, A hollow window is formed in the bending control connecting member; and / or, The bending control driving member and the distal end of the inner tube are respectively provided with a plugging protrusion and a plugging groove that are plugged and matched with each other, and the bending control driving member is assembled at the distal end of the inner tube through the plugging cooperation between the plugging protrusion and the plugging groove.

6. The conveying system according to claim 1, wherein The conveying system includes: A first limiting element, the first limiting element is arranged on the core tube; A second limiting element, the second limiting element is located at the distal end of the outer tube, and the second limiting element has an elastic deformation function.

7. The conveying system according to claim 6, characterized in that, The first limiting element includes a tubular member and a limiting end head with a central hole. The tubular member is connected to the limiting end head, and a plurality of first compressible holes are formed in the limiting end head, and the plurality of first compressible holes are circumferentially distributed around the central hole.

8. The conveying system according to claim 6, characterized in that, A plurality of second compressible holes are formed in the second limiting element, and at least one of the diameter and the wall thickness of the second limiting element gradually decreases in the direction from the distal end to the proximal end.

9. The conveying system according to claim 1, wherein A control handle is arranged at the proximal end of the inner tube, and the control handle is connected to the bending control driving member; and / or, A guiding element is arranged at the distal end of the core tube, and the guiding element is provided with a guiding channel communicating with the core tube inner cavity of the core tube. The core tube inner cavity and the guiding channel are used for threading a guiding wire.

10. The conveying system according to claim 1, wherein, The deformable bladder has a distal bladder port and a proximal bladder port that communicate with the inflatable lumen. The distal bladder port is sealingly connected to the distal end of the inner core tube, and the proximal bladder port is sealingly connected to the distal end of the inner tube. The catheter lumen of the inner tube communicates with the inflatable lumen for filling and discharging a filling substance into the inflatable lumen, so that the deformable bladder has an expanded state and a contracted state.

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