Valve prosthesis conveying device and conveying system

Abstract

The invention relates to a valve prosthesis conveying device and conveying system. The delivery device for the valve prosthesis comprises a handle; the interior of the far end of the outer tube is used for loading a valve prosthesis; the release part is movably connected with the handle and used for being connected with the near end of the outer tube, and the release part can drive the outer tube to move in the first direction when moving relative to the handle; the inner tube is used for being arranged in the outer tube in a penetrating mode, the near end of the inner tube is connected with the handle, and the restraining structure at the far end of the inner tube can prevent the valve prosthesis from moving in the first direction, so that when the outer tube moves in the first direction, the valve prosthesis can be released from the far end of the outer tube. The conveying device for the valve prosthesis can implant the venous valve prosthesis into an expected position in a human body in a vascular intervention mode.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a delivery device and a delivery system for a valve prosthesis. Background Art

[0002] Chronic venous insufficiency (CVI) is a syndrome characterized by a series of symptoms and signs caused by abnormal venous valve function, resulting in poor venous blood return and high venous pressure. The main clinical manifestations are lower limb heaviness, fatigue and distending pain, edema, varicose veins, skin nutritional changes and venous ulcers. In severe cases, pulmonary embolism may be triggered. In China, the prevalence of lower extremity venous diseases is 8.89%, and the number of patients is nearly 100 million. Its incidence increases with age and accounts for about 60% of vascular surgical diseases.

[0003] At present, there are no clinical products and established performance standards for venous valve prostheses. Compared with the relatively mature cardiac valve prosthesis devices, venous valve prostheses need to pay more attention to preventing thrombus formation after surgery to avoid long-term anticoagulant therapy after surgery. Some patent documents (such as CN217548310U, CN219021755U) disclose venous valve prostheses. The venous valve prostheses can mimic the biological characteristics of venous valves to prevent blood reflux; have good blood compatibility, are not prone to autologous thrombus formation, and can remain in the body for a long time to maintain normal venous circulation; have self-expansion properties and can be released more smoothly during the operation.

[0004] However, at present, there is no delivery device for venous valve prostheses in the prior art, and it is impossible to implant the venous valve prosthesis into the expected position in the human body through a vascular intervention method. Summary of the Invention

[0005] Based on this, in view of the problem that there is no delivery device for venous valve prostheses in the prior art and it is impossible to implant the venous valve prosthesis into the expected position in the human body through a vascular intervention method, it is necessary to provide a delivery device and a delivery system for a valve prosthesis.

[0006] In the first aspect of the present application, a delivery device for a valve prosthesis is provided. The delivery device for the valve prosthesis includes:

[0007] A handle;

[0008] An outer tube, the interior of the distal end of the outer tube is used for loading the valve prosthesis;

[0009] A release portion, movably connected to the handle and used for connecting to the proximal end of the outer tube. When the release portion moves relative to the handle, it can drive the outer tube to move in a first direction;

[0010] An inner tube, wherein the inner tube is used to be inserted into the outer tube, the proximal end of the inner tube is connected to the handle, and the constraint structure at the distal end of the inner tube can prevent the valve prosthesis from moving in a first direction, so that when the outer tube moves in the first direction, the valve prosthesis can be released from the distal end of the outer tube; the first direction is the direction from the distal end of the outer tube to the proximal end.

[0011] In one embodiment, a restraining member is disposed at the distal end of the inner tube, and the restraining member can prevent the valve prosthesis from moving in the first direction; the restraining structure is the restraining member.

[0012] In one embodiment, the constraint structure is an end surface of the distal end of the inner tube.

[0013] In one embodiment, the restraining member is provided with an axial blocking structure; when the restraining member is located inside the outer tube, the axial blocking structure is used to cooperate with the support foot of the valve prosthesis to prevent the stent from moving axially along the inner tube; when the restraining member is located outside the outer tube, the axial blocking structure allows the support foot to be released radially from the inner tube.

[0014] In one embodiment, the axial blocking structure is a slot, the outer side wall of the slot has a notch, the notch allows the leg of the valve prosthesis to enter or move out of the slot, and the slot can prevent the leg from moving axially along the inner tube when in the outer tube.

[0015] In one embodiment, the restraint member is configured to abut against the valve prosthesis in a second direction, wherein the second direction is opposite to the first direction.

[0016] In one embodiment, the restraining member is disposed on a side of the inner tube away from the handle, and an outer diameter of the restraining member is greater than an outer diameter of the inner tube.

[0017] In one embodiment, the valve prosthesis is arranged between the inner side wall of the distal end of the outer tube and the outer side wall of the inner tube, and the restraining member is protrudingly arranged on the outer side wall of the inner tube.

[0018] In one embodiment, the delivery device for the valve prosthesis further comprises an expansion tube, and the expansion tube is used to pass through the outer tube.

[0019] In one embodiment, the release part includes a rotating part and a moving part, the rotating part is connected to the handle and can rotate relative to the handle, the moving part is linked to the rotating part, and when the rotating part rotates, it can drive the moving part to move in the first direction, and the moving part is connected to the proximal end of the outer tube.

[0020] In one embodiment, the distal end of the handle has a hollow threaded section, and the internal thread of the rotating member cooperates with the external thread of the threaded section; the side wall of the threaded section is provided with a longitudinal groove extending parallel to the axial direction; the movable member is located inside the threaded section, and the movable member is rotatably connected to the rotating member through a radial connecting member, and the radial connecting member is penetrated through the longitudinal groove along the radial direction of the threaded section, and the radial connecting member and the longitudinal groove are movably cooperated along the axial direction of the threaded section.

[0021] A second aspect of the present application provides a valve prosthesis delivery system, comprising a valve prosthesis and a valve prosthesis delivery device according to any one of the above embodiments.

[0022] A third aspect of the present application provides a method for delivering a valve prosthesis, comprising the following steps:

[0023] placing a valve prosthesis into the outer tube from the proximal end of the outer tube;

[0024] Matching the distal end of the inner tube with the proximal end of the valve prosthesis, and inserting the inner tube into the outer tube, so that the inner tube drives the valve prosthesis to move to the inside of the distal end of the outer tube;

[0025] Then connecting the proximal end of the outer tube to the release portion;

[0026] The handle is kept stationary, and the release portion is moved relative to the handle to drive the outer tube to move in a first direction so that the valve prosthesis is released from the distal end of the outer tube. The first direction is the direction from the distal end of the outer tube to the proximal end.

[0027] A fourth aspect of the present application provides a method for delivering a valve prosthesis, comprising the following steps:

[0028] Inserting the dilation tube into the outer tube and guiding them together into the desired position in the animal's body;

[0029] Then keep the external tube still and withdraw the dilator tube from the animal;

[0030] placing a valve prosthesis into the outer tube from the proximal end of the outer tube;

[0031] Matching the distal end of the inner tube with the proximal end of the valve prosthesis, and inserting the inner tube into the outer tube, so that the inner tube drives the valve prosthesis to move to the inside of the distal end of the outer tube;

[0032] Then connecting the proximal end of the outer tube to the release portion;

[0033] The handle is kept stationary, and the release portion is moved relative to the handle to drive the outer tube to move in a first direction so that the valve prosthesis is released from the distal end of the outer tube. The first direction is the direction from the distal end of the outer tube to the proximal end.

[0034] For the delivery device and delivery system of the above valve prosthesis, when delivering the valve prosthesis, the operator can introduce the outer tube to the expected position in the human body, and then keep the handle stationary, so that the inner tube connected to the handle also remains stationary. The release part is moved relative to the handle to drive the outer tube to move in the first direction. Since the distal end of the inner tube can prevent the valve prosthesis from moving in the first direction, during the process where the handle and the inner tube remain stationary while the outer tube moves in the first direction, the valve prosthesis is gradually released from the distal end of the outer tube and switches to the extended state until the valve prosthesis is completely released to the expected position in the human body in the extended state. The valve prosthesis can be a venous valve prosthesis. Therefore, the delivery device of the valve prosthesis can implant the venous valve prosthesis to the expected position in the human body through a vascular intervention method. Description of the Drawings

[0035] Figure 1 Schematic structural diagram of the delivery device of the valve prosthesis according to an embodiment.

[0036] Figure 2 For Figure 1 Cross-sectional view of the distal end of the delivery device of the valve prosthesis of

[0037] Figure 3 Schematic structural diagram of the dilatation tube according to an embodiment.

[0038] Figure 4 Schematic diagram of the connection relationship of the release part, outer tube, and handle according to an embodiment.

[0039] Figure 5 Schematic diagram of the connection relationship between the outer tube and the connection seat according to an embodiment.

[0040] Figure 6 For Figure 5 Local enlarged view of area A in

[0041] Figure 7 Schematic structural diagram of the delivery device of the valve prosthesis according to another embodiment.

[0042] Figure 8 For Figure 7 Cross-sectional view of the delivery device of the valve prosthesis of

[0043] Figure 9 For Figure 8 Schematic diagram of the distal end of the delivery device of the valve prosthesis of

[0044] Figure 10 Schematic diagram of the cooperation relationship between the valve stent and the restraint and the outer tube when the valve stent is completely located inside the outer tube according to an embodiment.

[0045] Figure 11 For Figure 10Schematic diagram of the mating relationship between the partially released valve stent outside the outer tube and the restraint and the outer tube.

[0046] Figure 12 For Figure 10 Schematic diagram of the mating relationship between the fully released valve stent outside the outer tube and the restraint and the outer tube.

[0047] Explanation of the reference numerals in the drawings: 10, valve prosthesis; 11, support leg; 12, first step surface; 100, handle; 110, threaded section; 200, outer tube; 210, connecting seat; 211, flange; 300, release part; 310, rotating part; 311, annular groove; 320, moving part; 321, radial connecting part; 322, groove; 400, inner tube; 410, tip structure; 500, restraint; 510, axial blocking structure; 511, second step surface; 600, dilatation tube; 610, tip structure. Detailed implementation manners

[0048] To make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand 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.

[0049] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the 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 thus should not be construed as a limitation to the present application.

[0050] In addition, if there are terms such as "first" and "second", these terms are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly indicating 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 there is a term "plurality", the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0051] In this application, unless otherwise clearly defined and limited, 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 components or the interaction relationship between two components, unless otherwise clearly limited. 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.

[0052] In this application, unless otherwise clearly defined and limited, if there is a description such as the first feature being "on" or "under" the second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are in indirect 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 just means that the first feature is at a higher horizontal level 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 just means that the first feature is at a lower horizontal level than the second feature.

[0053] 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 can 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 manner.

[0054] In the embodiments of this application, terms such as "distal end" and "proximal end" are used. Among them, the proximal end refers to the end of each component of the delivery device of the valve stent that is close to the operator, and the distal end refers to the other end opposite to the proximal end.

[0055] Please refer to Figure 1 and Figure 2, an embodiment of the present application provides a delivery device for a valve prosthesis. The delivery device for the valve prosthesis includes: a handle 100, an outer tube 200, a release portion 300, and an inner tube 400. The interior of the distal end of the outer tube 200 is used to load the valve prosthesis 10. The valve prosthesis 10 in the embodiment of the present application is a self-expanding valve prosthesis, which has a compressed state and an extended state. The valve stent 10 is in a compressed state when it is inside the outer tube 200, and after being released to the expected position in the human body outside the outer tube 200, it switches to the extended state relying on its own restoring force. The release portion 300 is movably connected to the handle 100 and is used to connect to the proximal end of the outer tube 200. When the release portion 300 moves relative to the handle 100, it can drive the outer tube 200 to move in a first direction. The inner tube 400 is used to pass through the outer tube 200. The proximal end of the inner tube 400 is connected to the handle 100. The restraining structure at the distal end of the inner tube 400 can prevent the valve prosthesis 10 from moving in the first direction, so that when the outer tube 200 moves in the first direction, the valve prosthesis 10 can be released from the distal end of the outer tube 200. The first direction is the direction from the distal end to the proximal end of the outer tube 200. The second direction is opposite to the first direction.

[0056] When delivering the valve prosthesis 10 with the above-mentioned delivery device for the valve prosthesis, the operator can introduce the outer tube 200 (for example, through a blood vessel) to the expected position in the human body, and then keep the handle 100 stationary, so that the inner tube 400 connected to the handle 100 also remains stationary. Make the release portion 300 move relative to the handle 100 to drive the outer tube 200 to move in the first direction. Since the distal end of the inner tube 400 can prevent the valve prosthesis 10 from moving in the first direction, during the process that the handle 100 and the inner tube 400 remain stationary while the outer tube 200 moves in the first direction, the valve prosthesis 10 is gradually released from the distal end of the outer tube 200 and switches to the extended state until the valve prosthesis 10 is completely released to the expected position in the human body in the extended state. The valve prosthesis 10 can be a venous valve prosthesis. Therefore, the delivery device for the valve prosthesis can implant the venous valve prosthesis into the expected position in the human body through a vascular intervention method.

[0057] In other embodiments, the valve prosthesis is not limited to being a venous valve prosthesis, and can also be other valve prostheses, such as a heart valve prosthesis, etc.

[0058] Please refer to Figure 2 , in one embodiment, a restraint 500 is provided at the distal end of the inner tube 400, and the restraint 500 can prevent the valve prosthesis 10 from moving in the first direction. In this embodiment, the restraint structure is the restraint 500. The restraint 500 and the distal end of the inner tube 400 can be connected by bonding or other means, or can be integrally formed.

[0059] Please refer to Figure 2, in one embodiment, the restraint member 500 is configured to abut against the valve prosthesis 10 in the second direction. Specifically, the inner tube 400 abuts against the valve prosthesis 10 in the second direction through the restraint member 500, so that when the inner tube 400 is stationary, the valve prosthesis 10 can be prevented from moving in the first direction. It can be understood that during the process of the inner tube 400 penetrating into the outer tube 200, the cooperation mode between the inner tube 400 and the proximal end of the valve prosthesis 10 is that the inner tube 400 abuts against the valve prosthesis 10 through the restraint member 500. Thus, during the process of the inner tube 400 penetrating into the outer tube 200, the restraint member 500 continuously pushes the valve prosthesis 10 towards the distal end of the outer tube 200, so that the valve prosthesis 10 is loaded into the distal end interior of the outer tube 200.

[0060] Further, as Figure 2 shown, the restraint member 500 is disposed on the side of the inner tube 400 away from the handle 100, and the outer diameter of the restraint member 500 is greater than the outer diameter of the inner tube 400. Since the valve prosthesis 10 is located inside the outer tube 200 in a compressed state and abuts against the inner side wall of the outer tube 200, that is, the outer diameter of the valve prosthesis 10 in the compressed state is equivalent to the inner diameter of the outer tube 200. Therefore, by providing the restraint member 500 with a larger outer diameter, the abutting area of the restraint member 500 against the valve prosthesis 10 can be extended to the outer edge of the valve prosthesis 10 as much as possible, so that the restraint member 500 can abut against the valve prosthesis 10 more reliably and stably.

[0061] Moreover, since the restraint member 500 is disposed on the side of the inner tube 400 away from the handle 100 and abuts against the valve prosthesis 10 in the second direction, that is, both the inner tube 400 and the restraint member 500 are located at the proximal end of the valve prosthesis 10. Therefore, after the valve prosthesis 10 is released, the inner tube 400 and the restraint member 500 are withdrawn from the human body outside the proximal end of the valve prosthesis 10 without passing through the valve prosthesis 10, which can prevent the valve prosthesis 10 from shifting and being damaged.

[0062] As Figure 2 shown, preferably, along the direction away from the inner tube 400, the outer diameter of the restraint member 500 shows a gradually expanding trend. In this way, the friction between the restraint member 500 and the inner side wall of the outer tube 200 during the process of the restraint member 500 entering the outer tube 200 can be reduced.

[0063] In other embodiments, the distal end of the inner tube may not be provided with a restraint member, but the end face of the distal end of the inner tube directly serves as a restraint structure, and the end face of the distal end of the inner tube directly abuts against the valve prosthesis in the second direction. Then, when the inner tube is stationary, the valve prosthesis can be prevented from moving in the first direction. During the process of the inner tube penetrating into the outer tube, the distal end of the inner tube continuously pushes the valve prosthesis towards the distal end of the outer tube, so that the valve prosthesis is loaded into the distal end interior of the outer tube.

[0064] In some application scenarios, when the delivery device of the valve prosthesis is used, the valve prosthesis is loaded into a tube and implanted into a desired position in the human body through a blood vessel. When the tube loaded with the valve prosthesis moves in the blood vessel, it is easy to bend and damage the blood vessel wall.

[0065] To do this, refer to Figure 3 In one embodiment, the delivery device of the valve prosthesis further includes an expansion tube 600, which is used to be inserted into the outer tube 200. In this embodiment, the outer tube 200 and the release portion 300 are designed as separate bodies. When the delivery device of the valve prosthesis is delivering the valve prosthesis 10, the operator can first insert the expansion tube 600 into the outer tube 200, and then introduce the two together through the blood vessels to the expected position in the human body. At this time, the outer tube 200 is kept stationary, and the expansion tube 600 is then withdrawn from the human body. Subsequently, the valve prosthesis 10 is placed into the outer tube 200 from the proximal end of the outer tube 200, the distal end of the inner tube 400 is matched with the proximal end of the valve prosthesis 10, and the inner tube 400 is inserted into the outer tube 200. When the inner tube 400 penetrates the outer tube 200, the inner tube 400 can drive the valve prosthesis 10 to move to the inside of the distal end of the outer tube 200 by cooperating with the proximal end of the valve prosthesis 10, so that the valve prosthesis 10 is loaded into the inside of the distal end of the outer tube 200. Then, the outer tube 200 is connected to the release part 300, and then, the handle 100 is kept stationary, and the release part 300 is moved relative to the handle 100 to drive the outer tube 200 to move in the first direction, so that the valve prosthesis 10 is gradually released from the distal end of the outer tube 200 to the expected position in the human body.

[0066] Since the expansion tube 600 is first inserted into the outer tube 200 and introduced into the desired position in the human body through the blood vessels together with the outer tube 200, the expansion tube 600 can provide radial support for the outer tube 200, thereby minimizing the possibility that the outer tube 200 is bent or damaged in the blood vessel wall during the introduction into the human body.

[0067] In one embodiment, the distal end of the expansion tube 600 is provided with a tip structure 610 and the tip structure 610 is used to extend out of the distal end of the outer tube 200. Since the tip structure 610 at the distal end of the expansion tube 600 extends out of the distal end of the outer tube 200, the tip structure 610 facilitates the expansion tube 600 and the outer tube 200 to pass through tortuous blood vessels.

[0068] Please refer to Figure 4 In one embodiment, the release portion 300 includes a rotating member 310 and a moving member 320. The rotating member 310 is connected to the handle 100 and can rotate relative to the handle 100. The moving member 320 is linked to the rotating member 310. When the rotating member 310 rotates, it can drive the moving member 320 to move in the first direction. The moving member 320 is connected to the proximal end of the outer tube 200.

[0069] During the delivery of the valve prosthesis, the handle 100 is kept stationary, and the release portion 300 is moved relative to the handle 100, that is, the rotating member 310 is rotated relative to the handle 100. Thus, when the rotating member 310 rotates, it drives the moving member 320 to move in the first direction, that is, drives the outer tube 200 connected to the moving member 320 to move in the first direction, and further causes the outer tube 200 to release the valve prosthesis 10. By rotating the rotating member 310 relative to the handle 100, the release of the valve prosthesis 10 can be achieved, and the operation is convenient.

[0070] In other embodiments, the release portion may also be of other structural forms. For example, it includes a slider and an elastic member. The slider is slidably connected to the handle along the axial direction, and the push block is connected to the handle through the elastic member, and the slider is connected to the proximal end of the outer tube. The acting force of the elastic member on the slider is directed towards the distal end direction of the outer tube. By overcoming the elastic force and slowly pulling the slider towards the proximal end of the handle, the outer tube can also be driven to move towards the direction close to the proximal end of the handle, and further the outer tube releases the valve prosthesis.

[0071] Please refer to Figure 1 、 Figure 4 , in one embodiment, the distal end of the handle 100 has a hollow threaded section 110, and the internal thread of the rotating member 310 is engaged with the external thread of the threaded section 110, so that the rotating member 310 can rotate spirally relative to the threaded section 110 of the handle 100, that is, it moves axially while rotating. The side wall of the threaded section 110 is provided with longitudinal grooves (not shown) extending parallel to the axial direction. The moving member 320 is located inside the threaded section 110, and the moving member 320 is rotatably connected to the rotating member 310 through a radial connecting member 321. The radial connecting member 321 is axially movably engaged with the longitudinal groove along the radial direction of the threaded section 110.

[0072] Keeping the handle 100 stationary and rotating the rotating member 310 relative to the threaded section 110 of the handle 100, the rotating member 310 simultaneously moves axially relative to the threaded section 110 of the handle 100. Since the radial connecting member 321 is axially movably engaged with the longitudinal groove along the radial direction of the threaded section 110, when the rotating member 310 moves axially relative to the threaded section 110 of the handle 100, it can drive the radial connecting member 321 to move axially along the longitudinal groove. Also, since the moving member 320 is rotatably connected to the rotating member 310 through the radial connecting member 321, when the rotating member 310 spirally moves axially relative to the threaded section 110 of the handle 100, it can drive the moving member 320 to translate axially through the radial connecting member 321. In this way, it is ingeniously realized that by rotating the rotating member 310 relative to the handle 100, the release of the valve prosthesis 10 can be achieved, and the operation is convenient.

[0073] In other embodiments, the release portion may also be of other forms, and the rotating member is not limited to being a threaded member.

[0074] As Figure 4 shown, in one embodiment, an annular groove 311 is provided on the inner wall of the rotating member 310. The radial connecting member 321 is fixed to the moving member 320 and is in circumferential rotational cooperation with the annular groove 311. Thus, when the rotating member 310 rotates in a spiral manner, the radial connecting member 321 can rotate relative to the annular groove 311 and drive the moving portion 320 to translate axially.

[0075] In other embodiments, it may also be that an annular groove is provided on the periphery of the moving portion, and the radial connecting member is fixed to the inner wall of the rotating member, which can also achieve that when the rotating member rotates in a spiral manner, the radial connecting member can rotate relative to the annular groove and drive the moving portion to translate axially.

[0076] Please refer to Figures 4 to 6 , in one embodiment, a connecting seat 210 is fixed to the proximal end of the outer tube 200. The connecting seat 210 is snap-connected to the releasing portion 300, and it is convenient for the outer tube 200 to be snap-connected to the releasing portion 300 through the connecting seat 210.

[0077] Specifically, a circumferentially extending flange 211 is provided on the outer wall of the connecting seat 210, and a groove 322 with an opening facing the outer tube 200 is provided on the moving portion 320. A protrusion (not shown) is provided on the side wall of the groove 322. By pressing the proximal end of the connecting seat 210 into the groove 322, the flange 211 enters between the protrusion and the bottom wall of the groove 322 through elastic deformation, thereby realizing the snap connection between the connecting seat 210 and the moving portion 320.

[0078] In other embodiments, the connection form between the connecting seat and the releasing portion may adopt other connection structures in the prior art, and no limitation is imposed thereon.

[0079] Please refer to Figures 7 to 9 , in one embodiment, a valve prosthesis 10 is arranged between the inner side wall of the distal end of the outer tube 200 and the outer side wall of the inner tube 400, that is, the valve prosthesis 10 is sleeved outside the inner tube 400 and is located inside the outer tube 200. Thus, the valve prosthesis 10 is located between the inner side wall of the distal end of the outer tube 200 and the outer side wall of the inner tube 400. The restraining member 500 protrudes from the outer side wall of the inner tube 400, and the restraining member 500 cooperates with the valve prosthesis 10 to limit the movement of the valve prosthesis 10 relative to the inner tube 400.

[0080] In this embodiment, there is no need to provide a dilatation tube. The inner tube 400 can be inserted through the outer tube 200, and the valve prosthesis 10 can be placed between the inner side wall of the distal end of the outer tube 200 and the outer side wall of the inner tube 400. The outer tube 200 and the releasing portion 300 can be pre-assembled, which is convenient for batch assembly, eliminates the need for on-site installation during the upcoming operation, and reduces the operation time.

[0081] Understandably, during the process of inserting the inner tube 400 into the outer tube 200, the cooperation mode between the inner tube 400 and the proximal end of the valve prosthesis 10 is that the valve prosthesis 10 is sleeved on the distal end of the inner tube 400 and located inside the outer tube 200. The inner tube 400 abuts against the valve prosthesis 10 through the restraint member 500. Thus, during the process of inserting the inner tube 400 into the outer tube 200, the restraint member 500 continuously pushes the valve prosthesis 10 towards the distal end of the outer tube 200, so that the valve prosthesis 10 is loaded into the distal end inside the outer tube 200.

[0082] As Figure 7 shown, in an embodiment, the distal end of the inner tube 400 is provided with a tip structure 410 and the tip structure 410 extends out of the distal end of the outer tube 200. The tip structure 410 at the distal end of the inner tube 400 facilitates the inner tube 400 and the outer tube 200 to pass through tortuous blood vessels together.

[0083] When the delivery device of the valve prosthesis in some technical solutions is in use, the valve prosthesis is loaded into the tube body and implanted into the expected position in the human body through blood vessels. When the valve prosthesis is about to be completely released but not completely released from the tube body, due to the self-expansion force, the valve prosthesis extends and is likely to suddenly jump forward from the front of the tube body, resulting in an unstable release process and inaccurate release position.

[0084] For this reason, please refer to Figures 10 to 12 , in an embodiment, the restraint member 500 is provided with an axial blocking structure 510. When the restraint member 500 is located inside the outer tube 200, the axial blocking structure 510 is used to cooperate with the leg 11 of the valve prosthesis 10 to prevent the leg 11 from moving axially along the inner tube 400. When the restraint member 500 is located outside the outer tube 200, the axial blocking structure 510 allows the leg 11 to be disengaged along the radial direction of the restraint member 500.

[0085] Specifically, the leg 11 of the valve prosthesis 10 can achieve cooperation or disengagement with the axial blocking structure 510 by generating a position change in the radial direction of the restraint member 500. The cooperation mode between the leg 11 of the valve prosthesis 10 and the axial blocking structure 510 is that the leg 11 moves radially inward along the restraint member 500 to the axial blocking structure 510, so as to cooperate with the axial blocking structure 510. On the contrary, the leg 11 moves radially outward along the restraint member 500, so as to be able to disengage from the axial blocking structure 510 and disengage from it.

[0086] When the restraint member 500 is located within the outer tube 200, the axial blocking structure 510, the outer tube 200 cooperate with the feet 11 of the valve prosthesis 10 to prevent the valve prosthesis 10 from moving axially along the inner tube 400. At the same time, since the valve prosthesis 10 is in a compressed state, under the radial compression of the outer tube 200, the radial force received by the feet 11 restricts them to the position where they cooperate with the axial blocking structure 510, thereby preventing them from disengaging from the axial blocking structure 510. Thus, when the valve prosthesis 10 has not been fully released during the release process and the restraint member 500 is within the outer tube 200, the feet 11 are restricted radially by the inner wall of the outer tube 200 and axially by the axial blocking structure 510. Therefore, by the simultaneous cooperation of the axial blocking structure 510 and the outer tube 200 with the feet 11, it is possible to prevent the valve prosthesis 10 from experiencing a forward jump phenomenon (i.e., suddenly jumping axially away from the inner tube 400) due to self-expansion.

[0087] Until the valve prosthesis 10 is completely released from the outer tube 200 and the axial blocking structure 510 of the restraint member 500 also emerges from the distal end of the outer tube 200, the outer tube 200 cannot radially restrict the valve prosthesis 10 and the feet 11. Thus, under the action of the radial restoring force of the valve prosthesis 10, the position of the feet 11 changes outward in the radial direction of the restraint member 500, disengaging from the axial blocking structure 510, and then being completely released to the expected position within the human body.

[0088] Please refer to Figures 10 to 12 , in one embodiment, the restraint member 500 is provided with a card slot, and the axial blocking structure 510 is a card slot. The notch on the outer side wall of the card slot allows the feet 11 of the valve prosthesis 10 to enter or exit the card slot, that is, it allows the feet 11 to enter or exit the card slot along the radial direction of the restraint member 500, and cooperate with or disengage from the card slot. When the card slot is within the outer tube 200, it can prevent the feet 11 from moving axially along the inner tube 400.

[0089] Specifically, the feet 11 have a boss protruding radially outward along the valve prosthesis 10, and the boss has a first step surface 12 facing (which can be obliquely or directly) the distal end of the valve prosthesis 10. The groove wall of the card slot has a second step surface 511 facing (which can be obliquely or directly) the proximal end of the restraint member 500. When the feet 11 cooperate with the card slot, the second step surface 511 is opposite to the first step surface 12, so that the second step surface 511 can block the movement of the first step surface 12, that is, prevent the valve prosthesis 10 from experiencing a forward jump due to self-expansion.

[0090] It can be understood that the proximal end of the card slot also has a groove wall, and this groove wall faces the second direction. Therefore, it can prevent the feet 11 from moving in the first direction, that is, it plays a role in preventing the valve prosthesis from moving in the first direction.

[0091] In other embodiments, the axial blocking structure is not limited to a card slot. For example, it includes a distal blocking block and a proximal blocking block arranged at intervals along the axis, and the distal blocking block is located on the distal side of the proximal blocking block. The support leg has a boss that protrudes radially inward of the valve prosthesis. When the boss is located between the distal blocking block and the proximal blocking block, the support leg can be prevented from moving back and forth along the axis.

[0092] An embodiment of the present application further provides a delivery system for a valve prosthesis, including a valve prosthesis and a delivery device for the valve prosthesis according to any of the above embodiments.

[0093] An embodiment of the present application further provides a method for delivering a valve prosthesis, including the following steps:

[0094] S100: Insert the dilatation tube 600 into the outer tube 200 and introduce them together into the expected position in the animal body.

[0095] S200: Then keep the outer tube 200 stationary and withdraw the dilatation tube 600 from the animal body.

[0096] S300: Place the valve prosthesis 10 into the proximal end of the outer tube 200 from the proximal end of the outer tube 200.

[0097] S400: Mate the distal end of the inner tube 400 with the proximal end of the valve prosthesis 10, and insert the inner tube 400 into the outer tube 200 so that the inner tube 400 drives the valve prosthesis 10 to move to the inside of the distal end of the outer tube 200.

[0098] The mating of the distal end of the inner tube 400 with the proximal end of the valve prosthesis 10 can be a direct mating, or it can be a mating with the proximal end of the valve prosthesis 10 through a restraint 500 with the inner tube 400.

[0099] S500: Connect the distal end of the outer tube 200 to the release portion 300.

[0100] S600: Keep the handle 100 stationary, and move the release portion 300 relative to the handle 100 to drive the outer tube 200 to move in the first direction, so that the valve prosthesis 10 is released from the distal end of the outer tube 200.

[0101] In the above-mentioned method for delivering the valve prosthesis, the operator can first insert the expansion tube 600 into the outer tube 200, and then introduce the two together through the blood vessels to the desired position in the human body. At this time, the outer tube 200 is kept stationary, and the expansion tube 600 is then withdrawn from the human body. Subsequently, the valve prosthesis 10 is placed into the outer tube 200 from the proximal end of the outer tube 200, the distal end of the inner tube 400 is matched with the proximal end of the valve prosthesis 10, and the inner tube 400 is inserted into the outer tube 200. During the process of the inner tube 400 inserting into the outer tube 200, the inner tube 400 can drive the valve prosthesis 10 to move to the inside of the distal end of the outer tube 200 by matching with the proximal end of the valve prosthesis 10, so that the valve prosthesis 10 is loaded into the distal end of the outer tube 200. Then, the outer tube 200 is connected to the release part 300, and then, the handle 100 is kept stationary, and the release part 300 is moved relative to the handle 100 to drive the outer tube 200 to move in the first direction, so that the valve prosthesis 10 is gradually released from the distal end of the outer tube 200 to the expected position in the human body. Since the expansion tube 600 is first inserted into the outer tube 200, it is introduced into the expected position in the human body through the blood vessel together with the outer tube 200. The expansion tube 600 can provide radial support for the outer tube 200, so as to avoid the outer tube 200 from being bent or damaging the blood vessel wall during the introduction into the human body.

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

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

Claims

1. A delivery device for a valve prosthesis, characterized in that, the delivery device for the valve prosthesis comprises: a handle; an outer tube, the interior of the distal end of which is used for loading the valve prosthesis; a release part, movably connected to the handle and used for connecting to the proximal end of the outer tube, and when the release part moves relative to the handle, it can drive the outer tube to move in a first direction; an inner tube, the inner tube is used to be disposed within the outer tube, the proximal end of the inner tube is connected to the handle, and the restraint structure at the distal end of the inner tube can prevent the valve prosthesis from moving in the first direction, so that when the outer tube moves in the first direction, the valve prosthesis can be released from the distal end of the outer tube; the first direction is the direction from the distal end of the outer tube pointing to the proximal end.

2. The delivery device for a valve prosthesis according to claim 1, characterized in that, a restraint is provided at the distal end of the inner tube, and the restraint can prevent the valve prosthesis from moving in the first direction through the restraint; the restraint structure is the restraint; or the restraint structure is the end face at the distal end of the inner tube.

3. The delivery device for a valve prosthesis according to claim 2, characterized in that, the restraint is provided with an axial blocking structure; when the restraint is located within the outer tube, the axial blocking structure is used to cooperate with the strut of the valve prosthesis to prevent the stent from moving axially along the inner tube; when the restraint is located outside the outer tube, the axial blocking structure allows the strut to be disengaged axially along the inner tube.

4. The delivery device for a valve prosthesis according to claim 3, characterized in that, the axial blocking structure is a card slot, the outer side wall of the card slot has a notch, the notch allows the strut of the valve prosthesis to enter or exit the card slot, and when the card slot is within the outer tube, it can prevent the strut from moving axially along the inner tube.

5. The delivery device for a valve prosthesis according to claim 2, characterized in that, the restraint is used to abut against the valve prosthesis in a second direction, and the second direction is opposite to the first direction.

6. The delivery device for a valve prosthesis according to claim 2, characterized in that, the restraint is provided on the side of the inner tube away from the handle, and the outer diameter of the restraint is greater than the outer diameter of the inner tube.

7. The delivery device for a valve prosthesis according to claim 2, characterized in that, the valve prosthesis is disposed between the inner side wall of the distal end of the outer tube and the outer side wall of the inner tube, and the restraint protrudes from the outer side wall of the inner tube.

8. The delivery device for a valve prosthesis according to claim 1, characterized in that, it further comprises a dilatation tube, and the dilatation tube is used to be disposed within the outer tube.

9. The delivery device for a valve prosthesis according to claim 1, characterized in that, the release part comprises a rotating member and a moving member, the rotating member is connected to the handle and can rotate relative to the handle, the moving member is linked to the rotating member, when the rotating member rotates, it can drive the moving member to move in the first direction, and the moving member is connected to the proximal end of the outer tube.

10. The delivery device for a valve prosthesis according to claim 9, characterized in that, The distal end of the handle has a hollow threaded section, and the internal thread of the rotating member cooperates with the external thread of the threaded section; the side wall of the threaded section is provided with a longitudinal groove extending parallel to the axial direction; the movable member is located inside the threaded section, and the movable member is rotatably connected to the rotating member through a radial connecting member, and the radial connecting member is penetrated through the longitudinal groove along the radial direction of the threaded section, and the radial connecting member and the longitudinal groove are movably cooperated along the axial direction of the threaded section.

11. A delivery system for a valve prosthesis, It is characterized in that The invention comprises a valve prosthesis and a delivery device for the valve prosthesis according to any one of claims 1 to 10.

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