Implant delivery tubing and implant delivery systems

Abstract

The present application relates to the technical field of medical devices, and is an implant delivery tube for loading and delivering implants, wherein the implant delivery tube comprises, from the proximal end to the distal end: an outer tube; and a sheath tube, which is arranged at the distal end of the outer tube, and the sheath tube is a telescopic structure, and its length becomes longer or shorter in the axial direction as the outer tube moves in the axial direction. The above-mentioned implant delivery tube, by arranging the sheath tube as a telescopic structure, enables the length of the sheath tube to be extended and retracted as the outer tube moves in the axial direction, so that the implant delivery tube can deliver the implant on a curved path and perform the retraction operation after release.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implant delivery tube and an implant delivery system. Background Art

[0002] Currently, in the field of medical devices, implant delivery tubes have certain requirements on hardness and length. However, implant delivery tubes with greater hardness and longer length are difficult to stably deliver and withdraw implants in curved paths.

[0003] For example, when using catheter intervention methods such as transcatheter mitral valve replacement (TMVR) to treat mitral regurgitation, the artificial valve is first compressed into a transmission catheter outside the body, and then the artificial valve is delivered to the mitral valve ring through a lumen such as an apical catheter, and the artificial valve is released and fixed at the mitral valve ring to replace the native valve. Among them, accurate and reliable positioning of the valve stent is the key to the success of TMVR surgery, but unfavorable factors such as the complex structure of the mitral valve, the irregular shape of the valve ring, the presence of multiple chordae in the ventricular cavity, and the high intracavitary pressure generated by ventricular contraction will seriously interfere with the implantation and positioning of the artificial valve, leading to a series of more serious complications.

[0004] At the same time, in order to bear the radial force of expansion when the stent is contracted, the sheath of the current artificial valve delivery device generally needs to have a high hardness, and the length of the sheath is also relatively long (generally 50mm to 70mm). This will cause the sheath to be difficult to deform due to its high hardness during the delivery of the artificial valve, especially in processes such as guidewire passing and artificial valve release, and thus require a large turning radius, and sometimes the above-mentioned turning radius is even larger than the spatial dimensions of the anatomical structure; at the same time, the current delivery device achieves the positioning of the artificial valve through internal control bending, and after positioning is achieved, the delivery track must be kept in a stationary state during the subsequent artificial valve release process to ensure the accuracy of the artificial valve release position.

[0005] That is, some existing artificial valve delivery devices have the following technical problems: due to the high hardness and long length of the sheath tube, and the high hardness of the inner tube in the controlled bending state, it is impossible to perform delivery and withdrawal operations on a curved path. At the same time, it will also cause the catheter to move when the artificial valve is released, which will drive the artificial valve being released, thereby reducing the accuracy of artificial valve implantation and positioning; in addition, if the delivery and withdrawal operations are forced to be performed on a curved path, it will not only further reduce the stability of the subsequent artificial valve release, but also damage the patient's lumen. Summary of the invention

[0006] Based on this, it is necessary to provide an implant delivery tube and an implant delivery system to address the above technical problems, which not only enables the implant delivery tube to adapt to the transmission and withdrawal of curved paths, but also enables accurate and reliable positioning of the implant to ensure the stability of implant release.

[0007] An implant delivery tube can be used to load and deliver an implant, and the implant delivery tube comprises, from the proximal end to the distal end:

[0008] Foreign control; and

[0009] The sheath tube is arranged at the distal end of the outer tube. The sheath tube is a telescopic structure, and its length becomes longer or shorter in the axial direction as the outer tube moves in the axial direction.

[0010] The above-mentioned implant delivery tube, by setting the sheath tube as a telescopic structure, allows the length of the sheath tube to be able to be extended and retracted as the outer tube moves in the axial direction, so that the implant delivery tube can deliver the implant on a curved path and perform the retraction operation after release; especially during the release of implants (such as aortic valve prosthesis, mitral valve prosthesis, tricuspid valve prosthesis, etc.), the length of the sheath tube section can gradually decrease as the outer tube retracts during the retraction process, that is, when the effect of releasing the valve prosthesis is also achieved, the space occupied by the sheath tube with a telescopic function in the embodiment of the present application is greatly reduced compared to the space occupied by the traditional sheath tube, thereby effectively avoiding the interference of the sheath tube with the inner tube during the retraction process, thereby improving the accuracy and reliability of the implant positioning and ensuring the stability of the implant release.

[0011] In an optional embodiment, the sheath tube includes at least two movably connected sheath tube segments, and adjacent sheath tube segments are sequentially sleeved to form a cylindrical telescopic structure.

[0012] In an optional embodiment, the at least two movably connected sheath segments include a distal sheath segment and a proximal sheath segment, and the inner diameter of the distal sheath segment is greater than the inner diameter of the proximal sheath segment.

[0013] In an optional embodiment, the proximal end of the distal sheath segment is fixedly connected to the distal end of the outer tube, the outer tube drives the distal sheath segment to move, and the distal sheath segment drives the remaining sheath segments to move, so as to realize telescopic movement of the sheath in the axial direction.

[0014] In an optional embodiment, when the sheath is in a fully expanded state, the length of the sheath is less than or equal to the sum of the lengths of all sheath segments; and

[0015] When the sheath is in a fully contracted state, the length of the sheath is greater than or equal to the length of the longest of all sheath segments;

[0016] Among them, when the sheath is in a fully contracted state, for the case where the lengths of all the sheath segments are equal, the length of the longest of all the sheath segments can be equal to the length of any sheath segment, and for the case where different sheath segments have different lengths, the number of sheath segments with the longest length is at least one, that is, for the case where the lengths of different sheath segments are different, there is only one sheath segment with the longest length, and when only some of the sheath segments have different lengths, the number of sheath segments with the longest length may be one, two or more than two. For example, for five sheath segments A, B, C, E, and D, if L A =L B =L C =L D =L E , then the length of the sheath segment with the longest length L = L A =L B =L C =L D =L E ; If L A >L B >L C >L D >L E , then L=L A ; If L A >L B =L C >L D >L E , then L=L A ; If L A =L B >L C >L D >L E , then L=L A =L B ; If L A =L B =L C >L D >L E , then L=L A =L B =L C Among them, L A , L B , L C , L D , L E The lengths of the sheath segments A, B, C, D, and E correspond to each other.

[0017] In another optional embodiment, the length of the sheath segment located outermost when the sheath is in a fully contracted state can be set to be the longest, for example, the length of the distal sheath segment can be set to be the longest, so that the outer shape of the sheath is smoother when it is in a fully contracted state, and it also facilitates the connection between the sheath and other tube components, further facilitating operations such as delivery and withdrawal of the entire implant delivery tube.

[0018] In an optional embodiment, the at least two movably connected sheath sections further include a limiting component disposed at the proximal end of the proximal sheath section.

[0019] In an optional embodiment, a hardness reinforcement member is further disposed in the distal sheath segment to enhance the hardness of the distal sheath segment.

[0020] In an optional embodiment, among the at least two movably connected sheath tube segments, two adjacent sheath tube segments are slidably connected.

[0021] In an optional embodiment, one of the two adjacent sheath tube segments is provided with a guide rail extending in the axial direction, and the other of the two adjacent sheath tube segments is provided with a sliding block corresponding to the guide rail.

[0022] In an optional embodiment, in the at least two movably connected sheath tube segments, two adjacent sheath tube segments are connected by static friction.

[0023] In an optional embodiment, the sheath tube is made of metal.

[0024] In an optional embodiment, the metal is a shape memory alloy.

[0025] An implant delivery system can be used to load and deliver an implant, and the implant delivery system comprises, from the proximal end to the distal end:

[0026] A control handle, comprising a body and a control component, wherein the control component is arranged on the body; and

[0027] A catheter, comprising a first tube and an implant delivery tube as described in any one of the above, wherein the implant delivery tube is sleeved on the outside of the first tube;

[0028] Wherein, the body of the control handle is connected to the first tube, and the control component of the control handle is connected to the outer tube of the implant delivery tube, for controlling the movement of the implant delivery tube relative to the first tube.

[0029] In the above-mentioned implant delivery system, during the process of releasing implants such as aortic valve prosthesis, mitral valve prosthesis, tricuspid valve prosthesis, etc., the sheath can gradually become shorter in length during the withdrawal process. While achieving the same effect of releasing the implant, the space occupied by the sheath in the embodiment of the present application is greatly reduced compared to the space occupied by the traditional sheath, thereby effectively avoiding interference of the sheath with the inner tube during the withdrawal process, improving the accuracy and reliability of implant positioning, and ensuring the stability of implant release.

[0030] In an optional embodiment, when the implant delivery tube moves toward the distal end of the first tube, the length of the sheath becomes longer; when the implant delivery tube moves away from the proximal end of the first tube, the length of the sheath becomes shorter; when the implant delivery tube and the first tube remain relatively stationary in the axial direction, the length of the sheath remains unchanged.

[0031] In an optional embodiment, the first pipe member includes a conical head, an inner core tube, a fixed head and a controllable inner tube connected in sequence; the inner tube is connected to the body of the control handle;

[0032] Wherein, the sheath tube in a fully expanded state is at least sleeved on the inner core tube and the fixing head, and the outer tube is at least sleeved on a portion of the inner tube.

[0033] In an optional embodiment, the fixing head is provided with a groove for fixing the implant.

[0034] In an optional embodiment, the catheter further comprises:

[0035] a second tube, sleeved on the proximal end of the implant delivery tube and radially spaced apart from the implant delivery tube;

[0036] Wherein, the second pipe is fixedly connected to the body of the control handle. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 is a schematic structural diagram of an artificial valve delivery device in an embodiment;

[0038] Figure 2 yes Figure 1 A partial structural schematic diagram of the first pipe member shown in ;

[0039] Figure 3a yes Figure 1 A cross-sectional schematic diagram of the implant delivery tube fitting and the fixing head of the first tube fitting shown in FIG.

[0040] Figure 3b is a schematic cross-sectional view of a delivery device loaded with an artificial valve;

[0041] Figures 4a to 4c It is a schematic diagram of the structure using different connection methods between sheath segments;

[0042] Figure 5 is a schematic diagram of the structure of the sheath tube composed of three sheath tube segments when it is in a fully expanded state;

[0043] Figure 6 yes Figure 5 Schematic diagram of the sheath being retracted;

[0044] Figure 7 yes Figure 5 A schematic diagram of the structure of the sheath tube when it is in a fully contracted state;

[0045] Figure 8 yes Figure 7 A schematic diagram of the sheath being deployed is shown;

[0046] Fig. 9 is a schematic diagram of the structure of a control handle in an embodiment;

[0047] Fig.10 The figure is a schematic diagram of the structure when a valve prosthesis is loaded in one embodiment. DETAILED DESCRIPTION

[0048] In order to make the purpose, technical solution and advantages of the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0049] The present application is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of describing the embodiments of the present application in detail and should not be used as limitations of the present application. As used in this specification and the appended claims, the singular forms "one", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. The terms "proximal end" and "distal end" refer to the two opposite ends of the same object, and the "proximal end" generally refers to the end close to the operator, while the "distal end" refers to the end away from the operator.

[0050] In an optional embodiment, an implant delivery tube can be used to load and deliver implants such as aortic valve prostheses, mitral valve prostheses, tricuspid valve prostheses, etc. The implant delivery tube may include an outer tube and a sheath tube distributed in sequence from the proximal end to the distal end, and the sheath tube may be arranged at the distal end of the outer tube; wherein the sheath tube may be a telescopic structure, and when the outer tube moves along its own axial direction, the sheath tube extends or shortens along its own axial direction as the outer tube moves, that is, the length of the sheath tube becomes longer or shorter as the outer tube moves along the axial direction. Therefore, in the process of loading or delivering the above-mentioned implants, the length of the sheath tube can be extended or retracted according to demand, so as to facilitate the implant delivery tube to deliver the implant and withdraw it after release in special circumstances such as curved paths.

[0051] In an optional embodiment, in the above-mentioned implant delivery tube, the sheath may include at least two movably connected sheath segments, and adjacent sheath segments may be sequentially sleeved and connected by means such as static friction, sliding, etc., thereby forming a retractable structure such as a cylinder.

[0052] In an optional embodiment, in the above-mentioned implant delivery tube, the sheath segments constituting the sheath may include a distal sheath segment and a proximal sheath segment, and the inner diameter of the distal sheath segment is greater than or equal to the outer diameter of the proximal sheath segment, so as to form a cylindrical telescopic structure that gradually tapers from the distal end to the proximal end; at the same time, the proximal end of the above-mentioned distal sheath segment can be fixedly connected to the distal end of the above-mentioned outer tube, so that when the outer tube moves axially, the distal sheath segment is driven to move, and then the other sheath segments are driven to move, thereby realizing the telescopic movement of the sheath.

[0053] In an optional embodiment, an implant delivery system can be used to load and deliver implants such as aortic valve prosthesis, mitral valve prosthesis, tricuspid valve prosthesis, etc., and the implant delivery system may include a control handle and a catheter distributed in sequence in the direction extending from the proximal end to the distal end; the above-mentioned control handle may include a body and a control component disposed on the body, and the above-mentioned catheter may include a first tube and an implant delivery tube described in any embodiment of the present application, and the implant delivery tube is sleeved on the outside of the above-mentioned first tube. The above-mentioned body is connected to the first tube, and the control component is connected to the outer tube, so that the control handle controls the above-mentioned implant delivery tube to move relative to the above-mentioned first tube, thereby enabling the sheath in the implant delivery tube to be retracted and retracted according to demand, thereby facilitating the loading and delivery of the above-mentioned implant through special paths such as curved paths.

[0054] In an optional embodiment, the above-mentioned implant delivery system may also include a second tube, and the second tube can be sleeved on the proximal end of the above-mentioned implant delivery tube, and the second tube is fixedly connected to the main body of the above-mentioned control handle; wherein the above-mentioned second tube is spaced apart from the implant delivery tube in the radial direction (that is, they are non-contacting with each other in the radial direction).

[0055] The following takes an artificial valve as an implant as an example, and describes in detail the implant delivery tube and the implant delivery system in the present application in conjunction with the accompanying drawings:

[0056] Figure 1 FIG. 1 is a schematic diagram of the structure of an artificial valve delivery device in one embodiment. Figure 1 As shown, an artificial valve delivery device can be used to carry valve prostheses to load, deliver, release, and recover artificial heart valves (such as mitral valve artificial valves). The device may include a catheter 1 and a control handle 2 connected to the proximal end of the catheter 1; the catheter 1 may include a first tube 11, an implant delivery tube 12, and a second tube 13, which are sequentially sleeved, that is, the second tube 13 may be sleeved on the outside of the implant delivery tube 12, and the implant delivery tube 12 may be sleeved on the outside of the first tube 11. For the convenience of illustration, Figure 1 The implant delivery tube 12 does not completely cover the first tube 11 , but after actual assembly, the implant delivery tube 12 will cover all parts except the tapered part at the head end of the first tube 11 .

[0057] In an optional embodiment, if Figure 1 As shown, the first tube 11 and the second tube 13 can be connected to the control handle 2 and restricted from relative movement with the control handle 2 in the axial direction, so as to realize the bending control operation of the first tube 11 and the second tube 13, and restrict the first tube 11 and the second tube 13 from moving axially relative to the control handle 2, thereby improving the stability of the above-mentioned bending control operation. For example, the first tube 11 can be fixedly connected to the fixing member in the control handle 2, so as to effectively restrict the freedom of the first tube 11 in various directions relative to the control handle 2, and better fix the valve prosthesis. Of course, in other embodiments, the first tube 11 can also be set to rotate relative to the control handle as needed, as long as it does not move relative to the control handle in the axial direction, and the present invention does not limit this.

[0058] In an optional embodiment, if Figure 1As shown, the implant delivery tube 12 can be movably connected to the control handle 2, such as by fixing the implant delivery tube 12 to the movable part on the control handle 2 to achieve the above-mentioned movable connection, so as to drive the implant delivery tube 12 to extend or reciprocate in the axial direction through the control handle 2, so as to achieve the operations of loading, conveying, releasing and recovering the valve prosthesis. Preferably, the above-mentioned control handle 2 can also improve the stability of the reciprocating motion of the implant delivery tube 12 by limiting the movement of the implant delivery tube 12 in the circumferential direction (i.e., it cannot rotate).

[0059] In an optional embodiment, the implant delivery tube 12 may include a sheath for compressing and gripping the valve prosthesis, and the sheath includes at least two movably connected sheath segments, that is, a plurality of sheath segments movably connected to each other are used to replace the traditional one-piece sheath structure, so that during the release of the valve prosthesis, the sheath segments are compressed and nested, so that the length of the sheath gradually decreases during the withdrawal process, thereby reducing the space occupied by the sheath, so that the implant delivery tube 12 can adapt to the three-dimensional curved path in space, facilitate the delivery, release and withdrawal of the valve prosthesis, and then ensure the coaxiality of the valve prosthesis with the valve ring when released and the stability of the release process, thereby achieving high-quality valve replacement operation.

[0060] In the artificial valve delivery device in the above-mentioned embodiment, during the process of releasing the valve prosthesis, the length of the sheath segment will become shorter during the withdrawal process. When the effect of releasing the valve prosthesis is also achieved, the space occupied by the sheath segment is greatly reduced compared to the space occupied by the traditional sheath. This can effectively avoid the interference of the sheath with the inner tube during the withdrawal process, improve the accuracy and reliability of the valve stent positioning, and ensure the stability of the artificial valve release.

[0061] In an optional embodiment, when the implant delivery tube 12 moves toward the distal end of the first tube 11, the length of the sheath becomes longer to facilitate the compression and gripping of the valve prosthesis and the loading operation of the valve prosthesis; when the implant delivery tube 12 moves away from the distal end of the first tube 11 (i.e., withdraws), the length of the sheath becomes shorter to facilitate the release of the valve prosthesis. When the implant delivery tube 12 and the first tube 11 remain relatively stationary in the axial direction, the length of the sheath remains unchanged, so that when the valve prosthesis is delivered, the valve prosthesis maintained in a compressed state has a higher stability.

[0062] Of course, the inventive concept of the present invention is to utilize the relative movement of the implant delivery tube relative to the first tube to synchronously change the length of the sheath tube, so that the sheath tube can release the artificial valve within a limited cardiac anatomical structure, and during the release process, the sheath tube will not interfere with the inner tube that maintains a certain curvature, thereby improving the accuracy and reliability of the artificial valve positioning and the operability and safety of the release. Therefore, in other embodiments, the length of the sheath tube can also be changed by other means, and the present invention does not limit this.

[0063] In an optional embodiment, the sheath tube segments included in the above-mentioned sheath tube can be connected in sequence to form a cylindrical telescopic structure (see Figures 4a to 8 The structure shown in the figure is convenient for loading, conveying, releasing, withdrawing and recovering the valve prosthesis. At the same time, when the sheath is in a fully expanded state, the inner diameter of the sheath section away from the control handle is larger than the inner diameter of the sheath section close to the control handle, that is, the inner diameter of the multiple sheath sections of the movable sleeve increases as the distance between them and the control handle increases, so that the nesting of the sheath sections can be achieved, further facilitating the loading and releasing of the valve prosthesis.

[0064] In an optional embodiment, the implant delivery tube may further include an outer tube, the sheath includes a distal sheath segment and a proximal sheath segment, and the control handle is fixedly connected to the proximal end of the distal sheath segment through the distal end of the outer tube, so as to drive the distal sheath segment to drive the proximal sheath segment and the remaining sheath segments to move in sequence, so that the sheath performs telescopic movement in the axial direction. The distal sheath segment is the sheath segment farthest from the control handle when the sheath is in a fully expanded state; the proximal sheath segment is the sheath segment closest to the control handle when the sheath is in a fully expanded state, and the remaining sheath segments refer to the sheath segments sleeved between the proximal sheath segment and the distal sheath segment.

[0065] In other embodiments, the outer tube can be integrally formed with the distal sheath segment. In order to increase the hardness of the distal sheath, the distal sheath segment can be provided with a hardness reinforcement member, such as a plurality of reinforcing ribs, or by providing metal mesh layers with different densities on the outer tube and the distal sheath segment, so that the hardness of the distal sheath segment is higher than that of the outer tube.

[0066] Figure 2 yes Figure 1 The partial structural diagram of the first pipe member is shown in FIG. Figures 1-2As shown, in one embodiment, the first tube 11 may include a conical head 111, an inner core tube 112, a fixed head 113 and a controllable inner tube 115 connected in sequence, and a step 114 may be provided between the inner core tube 112 and the fixed head 113; wherein, the distal end (i.e., the free end) of the conical head 111 is streamlined in shape, so that it encounters less resistance during transmission in the lumen and has better traceability; at the same time, the proximal end of the conical head 111 may be located in the inner cavity of the sheath in a fully expanded state, and the stepped design of the conical head 111 may prevent the formation of a flare between the front end face of the sheath (i.e., the end face of the distal end away from the control handle) and the conical head 111 (see FIG. 3 ).

[0067] Figure 3a yes Figure 1 A cross-sectional schematic diagram of the implant delivery tube fitting and the fixing head of the first tube fitting shown in FIG. Figure 3b is a cross-sectional schematic diagram of a delivery device loaded with an artificial valve; in order to more clearly show the positional relationship between the deployed sheath tube segment and the outer tube, Figure 3a The structure of the inner core tube of the first pipe member located at the front end of the fixed head is not shown. Figure 2 , 3a As shown in Fig. 3b, the inner core tube 112 can be used to load the valve prosthesis 3, that is, the valve prosthesis 3 is sleeved on the inner core tube 112, and one end of the valve prosthesis 3 in the contracted state is fixed on the fixing head 113, and the other end face is against the rear end face of the conical head 111 (that is, the end face of the proximal end adjacent to the control handle), so as to facilitate the delivery of the valve prosthesis 3. The fixing head 113 can be provided with a plurality of grooves to facilitate the fixing of the valve stent of the valve prosthesis, and in order to better support the valve stent and prevent kinking during loading and recovery operations, a step 114 can be provided at the distal end of the fixing head 113 (that is, the end away from the control handle).

[0068] In an optional embodiment, if Figure 2 , 3aAs shown in Figure 3b, the inner tube 115 can be a controllable bending tube such as a polymer tube or a hollow metal reinforcement tube, and at least one metal wire is buried in the controllable bending tube. In order to improve the accuracy of the bending control, multiple metal wires are generally buried, that is, the bending angle, position and direction of the inner tube 115 are controlled by pulling different metal wires. Among them, when the inner tube 15 is a metal tube, it can be a metal reinforcement layer with a spiral braiding structure or a cross-braiding structure woven by a weaving process, or a metal reinforcement layer with a cut groove structure formed by a cutting process. At the same time, the inner tube 115 can also be a solid or hollow multi-module connecting tube formed by multiple sections connected in series. Because the inner tube 115 can realize active bending control, it makes it easier to pass through the spatial position of the atrial septum, and then quickly reach the native valve ring of the mitral valve for valve replacement.

[0069] In an optional embodiment, if Figures 1-2 As shown in FIGS. 3a to 3b, the implant delivery tube 12 may include a sheath tube 121 located at the distal end of the delivery device and an outer tube 122 located at the proximal end of the delivery device; the sheath tube 121 may be used to press and hold the valve stent 3 when the valve prosthesis is loaded; the second tube 13 includes a stabilizing tube, which is sleeved on the outside of the outer tube 122 and radially spaced from the outer tube, so that it will not interfere with the movement of the outer tube 122, and can prevent the operator of the delivery device from contacting the outer tube 122 in motion. The outer tube 122 is fixedly connected to the sheath tube 121, and is used to drive the sheath tube 121 to perform telescopic movement in the axial direction, thereby realizing operations such as loading, releasing and recovering the valve prosthesis.

[0070] like Figure 3a-3b As shown, in an optional embodiment, the sheath 121 includes a first sheath segment 121a (i.e., the distal sheath segment) and a second sheath segment 121b (i.e., the proximal sheath segment), and when the sheath 121 is in a fully expanded state (such as from loading to release), the inner diameter of the first sheath segment 121a at the distal end is larger than the inner diameter of the second sheath segment 121b at the proximal end, and when other sheath segments are also arranged between the first sheath segment 121a and the second sheath segment 121b, the first sheath segment 121a at the distal end is the sheath segment with the largest inner diameter among all the sheath segments, and the second sheath segment 121b at the proximal end is the sheath segment with the smallest inner diameter among all the sheath segments, that is, the smaller the distance from the control handle, the smaller the inner diameter of the sheath segment. Among them, the first sheath segment 121a and the second sheath segment 121b are movably connected to each other in a socket-like manner, thereby forming a cylindrical telescopic structure, and the distal end of the outer tube 122 is fixedly connected to the proximal end of the first sheath segment 121a, so as to drive each sheath segment to move in the axial direction in turn, thereby realizing the telescopic movement of the sheath; at the same time, in order to improve the stability of valve replacement, the material of the sheath 121 can be metal such as shape memory alloy.

[0071] In an optional embodiment, if Figure 3a-3b As shown, a limiting component 123 is provided at one end of the second sheath tube segment 121b (i.e., the proximal sheath tube segment) close to the fixing head 113 to achieve unidirectional limiting of the second sheath tube segment 121b on the fixing head 113, thereby effectively preventing the second sheath tube segment 121b from falling off from the fixing head 113 when the second sheath tube segment 121b moves relatively to the distal end for telescopic movement. Figure 3a As shown, the limiting component 123 can be integrally formed with the second sheath tube segment 121b and have an L-shaped cross section. In other embodiments, the above-mentioned fixing head 113 can also be provided with a limiting component 123 separately or simultaneously, that is, as long as the provided limiting component 123 can prevent the proximal sheath tube segment from falling off from the fixing head 113.

[0072] Figures 4a to 4c Figure 1 is a schematic diagram of the structure of different connection methods between sheath segments. Figures 4a to 4c As shown, in an optional embodiment, adjacent sheath sections may be connected by snap-fit ​​connections (such as Figure 4a and Figure 4b As shown), static friction connection (as Figure 4c The sheath segments are connected by means of connection such as a sliding connection as shown in the figure, and different sheath segments in the same sheath can adopt the same and / or different connection methods according to actual needs to enhance the flexibility of sheath segment manufacturing, assembly and use.

[0073] In another optional embodiment, when the adjacent first sheath tube segment 121a and the second sheath tube segment 121b are connected by a snap-fit ​​method, the sheath tube segments are connected in a guided movable manner by providing a protrusion 1222 and a track 1211 matching the protrusion 1222, and the protrusion 1222 can be provided on the inner wall of the second sheath tube segment 121b, and the track 1211 can be provided on the inner wall of the first sheath tube segment 121a (such as Figure 4a As shown), the track 1211 may be arranged on the inner wall of the second sheath tube section 121b along the axial direction, and the protrusion 1222 may be arranged on the inner wall of the first sheath tube section 121a (as shown). Figure 4b As shown). The protrusion 1222 may be in a circular, semicircular, rectangular or polygonal shape, the track 1211 may be in a rectangular, elliptical or circular track shape, and the number of tracks 1211 is at least one (such as one, two, three or more tracks), that is, the track 1211 and the protrusion 1222 match each other to play a guiding and limiting role. When the track 1211 is in an elliptical or circular track shape, the distal sheath tube segment needs to rotate with the outer tube. In this case, the implant delivery tube as a whole can not only move axially relative to the handle, but also can rotate circumferentially.

[0074] When static friction is used to connect adjacent sheath segments, the pressure exerted on the sheath by the self-expanding stent when the valve prosthesis is loaded can be used to increase the static friction between adjacent sheath segments, thereby ensuring the overall stability of the sheath in the expanded state and facilitating the transmission and release of the valve prosthesis.

[0075] In other embodiments, the above-mentioned retractable sheath structure can be realized by overlapping sleeves with a certain taper according to actual needs.

[0076] In another alternative embodiment, the sheath in the implant delivery tube may include a double-layer, triple-layer, or multi-layer collapsible nested structure. Figure 5 This is a schematic diagram of the structure of the sheath tube, which is composed of three sheath tube segments, when it is in a fully expanded state. Figure 6 yes Figure 5 Schematic diagram of the sheath being retracted. Figure 7 yes Figure 5 The schematic diagram of the structure of the sheath tube when it is in a fully contracted state is shown in FIG. Figures 5 to 7 As shown, the sheath tube 121 may include a distal sheath tube segment 121c, an intermediate sheath tube segment 121d and a proximal sheath tube segment 121e which are sequentially connected, and in order to increase the stability of the connection between the outer tube and the sheath tube, the distal sheath tube segment 121c and the outer tube connected thereto may be an integral structure. Figure 5 Once the delivery device reaches the target position and needs to be released or loaded, the distal sheath section 121c can be driven by the outer tube to move along the Figure 6 The intermediate sheath tube section 121d and the proximal sheath tube section 121e are moved in the direction of the arrow shown in the figure to drive the intermediate sheath tube section 121d and the proximal sheath tube section 121e to move in sequence along the Figure 6 Move in the direction of the arrow until a Figure 7 The structure shown in the figure is nested in sequence and is in a fully contracted state to complete the release of the valve prosthesis or facilitate the loading of the valve prosthesis, that is, at this time, the intermediate sheath segment 121d is sleeved on the outside of the proximal sheath segment 121e, and the distal sheath segment 121c is sleeved on the outside of the intermediate sheath segment 121d, and at this time the overall length of the sheath 121 is equal to the length L of the distal sheath segment 121c, that is, the length of the sheath 121 in a fully contracted state is equal to the length of the distal sheath segment 121a. In the process of contraction of the above-mentioned sheath 121, the distal sheath segment 121c, which is located at the farthest end and has the largest inner diameter, contracts first and is nested on the outside of the intermediate sheath segment 121d along the built-in track direction. After being completely nested between the distal sheath segment 121c and the intermediate sheath segment 121d, the intermediate sheath segment 121d is driven to continue along the track by means of the binding force between the buckle and the track or the static friction between the distal sheath segment 121c and the intermediate sheath segment 121d. Figure 6Continue to shrink in the direction of the arrow shown in the figure, and so on, until the Figure 7 . The sheath 121 is shown in a fully retracted state. Figure 8 yes Figure 7 Schematic diagram of the sheath being deployed. Figures 7-8 As shown, when the sheath tube 121 is deployed, the outer tube is used to drive the distal sheath tube section 121c with the largest inner diameter to be deployed first, and then the distal sheath tube section 121c is deployed along the built-in track. Figure 8 In the direction indicated by the dotted arrow in the figure, the sheath tube section 121c is moved from the position B1 to the distal position B2, and after the sheath tube section 121c is fully deployed between the distal end and the intermediate sheath tube section 121d, the intermediate sheath tube section 121d is driven to continue along the track by the combination force between the buckle and the track, or the friction force between the distal end and the intermediate sheath tube section 121c. Figure 8 Continue to expand in the direction of the arrow shown in the figure, and so on, until the Figure 5 The structure is shown in the fully expanded state.

[0077] In other optional embodiments, in order to facilitate the production and assembly of the telescopic sheath and to enable the sheath to shrink to the maximum extent, the length of the sheath 121 in the fully contracted state will be slightly larger than the longest length of the distal sheath segment 121c, the middle sheath segment 121d and the proximal sheath segment 121e. This slightly larger length comes from the portion between adjacent sheath segments that cannot be completely overlapped due to connection requirements.

[0078] Fig. 9 is a schematic diagram of the structure of a control handle applicable to any of the above embodiments. Figures 1-2 As shown in Figures 3a to 3b and 9, in an optional embodiment, the control handle may be a manual handle, an electric handle or a manual and electric hybrid handle. The control handle may specifically include a main body 51 and a control component 52 disposed on the main body 51. The main body 51 may be fixedly connected to the first tube 11 and the second tube 13, respectively. For example, the main body 51 may be connected to the inner tube in the first tube 11 to perform bending control operations on the first tube 11 and the second tube 13. The control component 52 may be connected to the implant delivery tube 12 to control the movement of the implant delivery tube 12 relative to the first tube 11. For example, the control component 52 may be connected to the outer tube in the implant delivery tube 12 to drive the sheath tube to perform telescopic movement by driving the outer tube, thereby realizing operations such as loading and releasing the valve prosthesis.

[0079] In another optional embodiment, Figures 1-2, 3a-3b and 9, the second tube 13 located between the control handle 2 and the implant delivery tube 12 can be made of the same material as the inner tube 115; for example, the second tube 13 can be a tube with controllable bending, such as a reinforced polymer tube or a metal tube, or a metal multi-module connecting tube or a polymer tube with a reinforcing ring, so as to achieve controlled bending in front of the right atrium and the atrial septum, thereby achieving precise positioning. At the same time, the second tube 13 can also prevent the operator from contacting the implant delivery tube 12 during operations such as loading, implanting, releasing and recovering the valve prosthesis, thereby ensuring that the movement of the implant delivery tube 12 is not affected.

[0080] The delivery device in the above-mentioned embodiment can effectively solve the problem of interference between the sheath and the curved inner tube of the interventional valve (valve prosthesis) by setting the sheath to multiple sheath segments, thereby achieving precise positioning of the interventional valve in the body and improving operational accuracy while ensuring the coaxiality requirements required for releasing the access valve, thereby effectively improving the release quality of the interventional valve.

[0081] The following is combined with the attached Figures 1-2 , 3a-3b and 9-10, the working process of the artificial valve delivery device is described in detail:

[0082] First, the control component 52 on the control handle 2 can be driven by electric drive or manual drive to drive the movable component to move forward and backward, thereby making the implant delivery tube 12 move forward and backward relative to the first tube 11 and the second tube 13, that is, unfolding the sheath 121 or causing the sheath 121 to perform movements such as contraction, so as to achieve operations such as loading and subsequent release of the valve prosthesis 3; wherein the valve prosthesis 3 may include a valve support 32 and an artificial valve 33 disposed on the valve support 32, and a hanging ear 31 is disposed on the end of the valve support 32 away from the artificial valve 33 (as shown in Figures 3 and Fig.10 shown).

[0083] Specifically, when loading the artificial valve 33, the implant delivery tube 12 can be moved toward the control handle 2 by the control handle 2 until the front end of the sheath tube 121 is located on the side of the fixed head 113 close to the control handle 2, forming a Figure 7 The structure shown in the figure makes the groove 116 for fixing the valve prosthesis 3 on the fixing head 113 in the first tube 11 exposed. Then, the ears 31 on the valve support 32 of the valve prosthesis 3 are clamped in the above-mentioned groove 116 one by one (see Fig.10 ), and after stabilizing the valve stent 32 with the aid of auxiliary tools, the outer tube 122 is driven forward, thereby driving the distal sheath segment 121c, the intermediate sheath segment 121d and the proximal sheath segment 121e to fully expand to form Figure 5The structure shown is such that the sheath 121 completely wraps around the valve prosthesis 3, and the front end face of the valve prosthesis 3 presses against the end face of the conical head 111, forming the structure shown in FIG. 3, thereby completing the loading step of the valve prosthesis 3; wherein the length of the sheath 121 when fully expanded is equal to the total length of the combination of each sheath segment.

[0084] In other optional embodiments, in order to facilitate the production and assembly of a telescopic sheath while taking into account the stability of the sheath when fully expanded, the length of the sheath 121 in the fully expanded state will be slightly smaller than the sum of the lengths of each sheath segment. This slightly smaller length comes from the overlap between adjacent sheath segments in the fully expanded state due to the need for connection.

[0085] Secondly, the delivery device loaded with the valve prosthesis 3 is controlled to extend into the puncture port along the guide wire (i.e., the metal wire 21) and enter the human body, and can follow the vascular pathway of the femoral vein so that the sheath 121 in the implant delivery tube 12 passes through the atrial septum and is delivered to the diseased valve ring. In particular, since the delivery device is delivered through the femoral vein, it is less invasive and has a wider audience than, for example, the apical route.

[0086] Then, when the sheath tube 121 is delivered to the designated lesion position, the control handle 2 can be used to adjust the angle of the inner tube to be coaxial with the valve ring, and then the control handle 2 can be used to drive the sheath tube 121 to contract, so that the sheath tube 121 gradually contracts into a mutually overlapping structure, so as to release the valve prosthesis 3 to the designated position and detach from the delivery device. In the process of releasing the valve prosthesis 3, the inner tube 115 can be controlled to bend so that the set delivery track remains unchanged, thereby maintaining the stability of the coaxiality between the sheath tube 121 and the valve ring after entering the mitral valve.

[0087] Finally, after the valve prosthesis 3 is completely released, the sheath 121 can be unfolded and closed with the conical head 111 (i.e., a part of the conical head 111 penetrates into the inner cavity of the sheath 121) by controlling the handle 3, and the delivery device is withdrawn to the outside of the body to complete the replacement operation of the entire artificial valve. Among them, since the sheath 121 includes a plurality of sheath sections that are connected in sequence, when releasing the valve prosthesis, the space occupied by the withdrawn sheath section is greatly reduced compared to the space occupied by the traditional sheath, so that the sheath can easily withdraw through the curved channel in the inner cavity of the inner tube 115, and at the same time, the influence on the bending control of the inner tube 115 during the withdrawal process is also reduced, avoiding the occurrence of problems such as movement caused by the withdrawal of the sheath 121, and thus helping to maintain the stability of the release of the valve prosthesis 3.

[0088] It should be noted that the artificial valve delivery device provided in the embodiment of the present application is also applicable to operations such as loading, delivery and release of other implants such as aortic valve prosthesis, mitral valve prosthesis, tricuspid valve prosthesis, etc., and the present application does not impose any restrictions on this.

[0089] 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.

[0090] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An implant delivery tube for loading and delivering an implant, characterized in that: The implant delivery tube comprises, from the proximal end to the distal end: an outer tube, the outer tube being sleeved on at least a portion of the controllably bendable inner tube; and A sheath tube, wherein the inner cavity of the sheath tube is suitable for accommodating the implant, the sheath tube is arranged at the distal end of the outer tube, the sheath tube is a telescopic structure, and its length increases or decreases in the axial direction as the outer tube moves in the axial direction; The sheath tube comprises at least two sheath tube sections; the at least two sheath tube sections are sequentially sleeved from the inside to the outside and any two adjacent sheath tube sections are movably connected, so that the sheath tube forms a cylindrical telescopic structure; The at least two sheath tube segments at least include a distal sheath tube segment and a proximal sheath tube segment, the inner diameter of the distal sheath tube segment is greater than the inner diameter of the proximal sheath tube segment; when the sheath tube is in a fully extended state, the distal end of the distal sheath tube segment forms the farthest end of the sheath tube, and the proximal end of the proximal sheath tube segment forms the closest end of the sheath tube; The proximal end of the distal sheath tube segment is fixedly connected to the distal end of the outer tube, and when the outer tube drives the distal sheath tube segment to move, the distal sheath tube segment drives the other sheath tube segments to move, so as to realize the extension and retraction of the sheath tube; When the sheath is in a fully expanded state, the length of the sheath is less than or equal to the sum of the lengths of all sheath segments; when the sheath is in a fully contracted state, the length of the sheath is greater than or equal to the length of the longest of all sheath segments; The at least two sheath tube segments further include a limiting component disposed at the proximal end of the proximal sheath tube segment; the limiting component is used for performing unidirectional limiting during the telescopic movement of the proximal sheath tube segment in relative motion toward the distal end.

2. The conveying pipe according to claim 1, characterized in that: A hardness reinforcement member is also arranged in the distal sheath tube segment to enhance the hardness of the distal sheath tube segment.

3. The conveying pipe according to claim 1, characterized in that: The outer tube and the distal sheath tube segment are provided with metal mesh layers with different densities, so that the hardness of the distal sheath tube segment is higher than that of the outer tube.

4. The conveying pipe according to claim 1, characterized in that: Among the at least two movably connected sheath tube segments, two adjacent sheath tube segments are slidably connected.

5. The conveying pipe according to claim 4, characterized in that: One of the two adjacent sheath tube segments is provided with a guide rail extending in the axial direction, and the other of the two adjacent sheath tube segments is provided with a sliding block corresponding to the guide rail.

6. The conveying pipe according to claim 1, characterized in that: Among the at least two movably connected sheath tube segments, two adjacent sheath tube segments are connected by static friction.

7. The conveying pipe according to claim 1, characterized in that: The sheath tube is made of metal.

8. The conveying pipe according to claim 7, characterized in that: The metal is a shape memory alloy.

9. An implant delivery system for loading and delivering an implant, characterized in that: The implant delivery system comprises, from the proximal end to the distal end: A control handle, comprising a body and a control component, wherein the control component is disposed on the body; and A catheter, comprising a first tube and an implant delivery tube as claimed in any one of claims 1 to 8, wherein the implant delivery tube is sleeved on the outside of the first tube; Wherein, the body of the control handle is connected to the first tube, and the control component of the control handle is connected to the outer tube of the implant delivery tube, for controlling the movement of the implant delivery tube relative to the first tube.

10. The conveying system according to claim 9, characterized in that When the implant delivery tube moves toward the distal end of the first tube, the length of the sheath becomes longer; when the implant delivery tube moves away from the proximal end of the first tube, the length of the sheath becomes shorter; When the implant delivery tube and the first tube remain relatively stationary in the axial direction, the length of the sheath tube remains unchanged.

11. The delivery system according to claim 9, characterized in that The first pipe member includes a conical head, an inner core tube, a fixed head and a controllable inner tube connected in sequence; the inner tube is connected to the body of the control handle; Wherein, the sheath tube in a fully expanded state is at least sleeved on the inner core tube and the fixing head, and the outer tube is at least sleeved on a portion of the inner tube.

12. The delivery system according to claim 11, characterized in that The fixing head is provided with a groove for fixing the implant.

13. The delivery system according to claim 9, characterized in that The catheter further comprises: a second tube, sleeved on the proximal end of the implant delivery tube and radially spaced apart from the implant delivery tube; Wherein, the second pipe is fixedly connected to the body of the control handle.

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