Valve prosthesis conveying device and conveying system

Abstract

The utility model 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 field of medical device technology, and in particular 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 poor venous return and excessive venous pressure due to abnormal venous valve function. The main clinical manifestations are heaviness, fatigue and pain in the lower limbs, edema, varicose veins, skin nutritional changes and venous ulcers. In severe cases, pulmonary embolism may occur. In China, the prevalence of lower extremity venous disease is 8.89%, and the number of patients is about 100 million. Its incidence increases with age, accounting 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 relatively mature heart valve prosthesis devices, venous valve prostheses need to pay more attention to not forming thrombi after surgery and avoid long-term anticoagulation treatment after surgery. Some patent documents (such as CN217548310U, CN219021755U) disclose venous valve prostheses, which can imitate the biological characteristics of venous valves to prevent blood reflux; have good blood compatibility, are not prone to autologous thrombi, 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 surgery.

[0004] However, there is no delivery device for venous valve prosthesis in the current prior art, and it is impossible to implant the venous valve prosthesis into a desired position in the human body through vascular intervention. Utility Model Content

[0005] Based on this, it is necessary to provide a valve prosthesis delivery device and delivery system to address the problem that there is no delivery device for venous valve prosthesis in the current prior art and that venous valve prosthesis cannot be implanted into the desired position in the human body through vascular intervention.

[0006] In a first aspect, the present application provides a delivery device for a valve prosthesis, the delivery device for a valve prosthesis comprising:

[0007] handle;

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

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

[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 support foot 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] In the above-mentioned valve prosthesis delivery device and delivery system, when delivering the valve prosthesis, the operator can guide the outer tube into the desired position in the human body, and then keep the handle still, so that the inner tube connected to the handle remains still. 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, the valve prosthesis is gradually released from the distal end of the outer tube and switched to the extended state while the handle and the inner tube remain still and the outer tube moves in the first direction, until the valve prosthesis is completely released in the extended state to the desired position in the human body. The valve prosthesis can be a venous valve prosthesis, and therefore, the valve prosthesis delivery device can implant the venous valve prosthesis into the desired position in the human body through vascular intervention. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 Schematic diagram of the structure of a delivery device for a valve prosthesis according to one embodiment.

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

[0037] Figure 3 It is a schematic structural diagram of an expansion tube according to an embodiment.

[0038] Figure 4 The figure is a schematic diagram of the connection relationship among the release part, the outer tube and the handle of one embodiment.

[0039] Figure 5 The figure is a schematic diagram of the connection relationship between the outer tube and the connecting seat in one embodiment.

[0040] Figure 6 for Figure 5 A partial enlarged view of area A.

[0041] Figure 7 FIG. 4 is a schematic structural diagram of a delivery device for a valve prosthesis according to another embodiment.

[0042] Figure 8 for Figure 7 Cross-sectional view of a delivery device for a valve prosthesis.

[0043] Fig. 9 for Figure 8 Schematic diagram of the distal end of a delivery device for a valve prosthesis.

[0044] Fig.10 It is a schematic diagram of the matching relationship between the valve stent of one embodiment, the restraining member and the outer tube when the valve stent is completely located in the outer tube.

[0045] Fig.11 for Fig.10Schematic diagram of the coordination relationship between the valve stent, the restraint and the outer tube when the valve stent is partially released outside the outer tube.

[0046] Fig.12 for Fig.10 Schematic diagram of the coordination relationship between the valve stent, the restraint and the outer tube when the valve stent is completely released outside the outer tube.

[0047] Explanation of the accompanying drawings: 10, valve prosthesis; 11, support foot; 12, first step surface; 100, handle; 110, threaded section; 200, outer tube; 210, connecting seat; 211, flange; 300, release portion; 310, rotating member; 311, annular groove; 320, moving member; 321, radial connecting member; 322, groove; 400, inner tube; 410, tip structure; 500, restraining member; 510, axial blocking structure; 511, second step surface; 600, expansion tube; 610, tip structure. DETAILED DESCRIPTION

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

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

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

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

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

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

[0054] In the embodiments of the present application, the terms "distal end" and "proximal end" are used, wherein the proximal end refers to the end of the components of the valve stent delivery device close to the operator, and the distal end refers to the other end opposite to the proximal end.

[0055] Please combine Figure 1 and Figure 2One embodiment of the present application provides a delivery device for a valve prosthesis, and 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 in the outer tube 200, and switches to an extended state by its own restoring force after being released to the expected position in the human body outside the outer tube 200. 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 be inserted into the outer tube 200, the proximal end of the inner tube 400 is connected to the handle 100, and the constraint structure at the distal end of the inner tube 400 can prevent the valve prosthesis 10 from moving in a 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 of the outer tube 200 to the proximal end. The second direction is opposite to the first direction.

[0056] When the above-mentioned valve prosthesis delivery device delivers the valve prosthesis 10, the operator can introduce the outer tube 200 (for example, through a blood vessel) into the desired position in the human body, and then keep the handle 100 still, so that the inner tube 400 connected to the handle 100 remains still. The release part 300 is moved 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, the valve prosthesis 10 is gradually released from the distal end of the outer tube 200 and switched to the extended state during the process of the handle 100 and the inner tube 400 remaining still and the outer tube 200 moving in the first direction, until the valve prosthesis 10 is completely released to the desired position in the human body in the extended state. The valve prosthesis 10 can be a venous valve prosthesis, and therefore, the valve prosthesis delivery device can implant the venous valve prosthesis into the desired position in the human body through vascular intervention.

[0057] In other embodiments, the valve prosthesis is not limited to a venous valve prosthesis, but may be other valve prostheses, such as a heart valve prosthesis.

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

[0059] Please refer to Figure 2In one embodiment, the restraint 500 is used to abut the valve prosthesis 10 in the second direction. Specifically, the inner tube 400 abuts the valve prosthesis 10 in the second direction through the restraint 500, so that when the inner tube 400 does not move, 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 the outer tube 200, the inner tube 400 and the proximal end of the valve prosthesis 10 cooperate in a manner that the inner tube 400 abuts the valve prosthesis 10 through the restraint 500, so that during the process of the inner tube 400 penetrating the outer tube 200, the restraint 500 continuously pushes the valve prosthesis 10 toward the distal end of the outer tube 200, so that the valve prosthesis 10 is loaded into the distal end of the outer tube 200.

[0060] Furthermore, if Figure 2 As shown, the restraint 500 is disposed on the side of the inner tube 400 away from the handle 100, and the outer diameter of the restraint 500 is larger 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 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 500 with a larger outer diameter, the abutment area of ​​the restraint 500 against the valve prosthesis 10 can be extended as far as possible to the outer edge of the valve prosthesis 10, so that the restraint 500 can abut against the valve prosthesis 10 more reliably and stably.

[0061] Moreover, since the restraint 500 is arranged on the side of the inner tube 400 away from the handle 100 to abut the valve prosthesis 10 in the second direction, that is, the inner tube 400 and the restraint 500 are both located at the proximal end of the valve prosthesis 10, when the valve prosthesis 10 is released, the inner tube 400 and the restraint 500 are withdrawn from the human body from the proximal end of the valve prosthesis 10 without passing through the valve prosthesis 10, thereby preventing the valve prosthesis 10 from displacement and damage.

[0062] like Figure 2 As shown, preferably, the outer diameter of the restraining member 500 gradually expands along the direction in which the restraining member 500 departs from the inner tube 400. In this way, the friction between the restraining member 500 and the inner wall of the outer tube 200 during the process of the restraining 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 restraining member, but the end surface of the distal end of the inner tube directly serves as a restraining structure, and the end surface of the distal end of the inner tube directly abuts against the valve prosthesis in the second direction, so that when the inner tube does not move, 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 toward the distal end of the outer tube, so that the valve prosthesis is loaded into the distal end 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 process of conveying the valve prosthesis 10, the valve prosthesis conveying device keeps the handle 100 stationary and allows the release portion 300 to move relative to the handle 100, i.e., allows the rotating member 310 to rotate relative to the handle 100, so that the rotating member 310 drives the moving member 320 to move in the first direction, i.e., drives the outer tube 200 connected to the moving member 320 to move in the first direction, thereby causing the outer tube 200 to release the valve prosthesis 10. The valve prosthesis 10 can be released by rotating the rotating member 310 relative to the handle 100, which is easy to operate.

[0070] In other embodiments, the release portion may also be in other structural forms, for example, including a slider and an elastic member, the slider is connected to the handle in an axial sliding manner, 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 elastic member exerts a force on the slider toward the distal end of the outer tube. By overcoming the elastic force and slowly pulling the slider toward the proximal end of the handle, the outer tube can also be driven to move toward the proximal end of the handle, thereby causing the outer tube to release 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 cooperates with the external thread of the threaded section 110, so that the rotating member 310 can spirally rotate relative to the threaded section 110 of the handle 100, that is, it moves axially at the same time when rotating. The side wall of the threaded section 110 is provided with a longitudinal groove (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, and the radial connecting member 321 is penetrated in the longitudinal groove along the radial direction of the threaded section 110. The radial connecting member 321 and the longitudinal groove are movably matched along the axial direction of the threaded section 110.

[0072] Keep the handle 100 immovable, make the rotating member 310 rotate relative to the threaded section 110 of the handle 100, then the rotating member 310 moves axially relative to the threaded section 110 of the handle 100 at the same time. Because the radial connecting member 321 is arranged in the longitudinal groove along the radial direction of the threaded section 110, the radial connecting member 321 is movably connected with the longitudinal groove along the axial direction of the threaded section 110, therefore, when the rotating member 310 moves axially relative to the threaded section 110 of the handle 100, the radial connecting member 321 can be driven to move axially along the longitudinal groove. Because the moving member 320 is rotatably connected with the rotating member 310 through the radial connecting member 321, therefore, when the rotating member 310 moves around the axial spiral relative to the threaded section 110 of the handle 100, the moving member 320 can be driven to translate axially through the radial connecting member 321. In this way, the rotation of the rotating member 310 relative to the handle 100 can be cleverly realized to realize the release of the valve prosthesis 10, and the operation is convenient.

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

[0074] like Figure 4 As shown, in one embodiment, the inner wall of the rotating member 310 is provided with an annular groove 311. The radial connecting member 321 is fixed to the moving member 320 and cooperates with the annular groove 311 to rotate circumferentially, so that when the rotating member 310 rotates helically, the radial connecting member 321 can rotate relatively in the annular groove 311 and drive the moving part 320 to translate axially.

[0075] In other embodiments, an annular groove may be provided on the peripheral side of the moving part, and the radial connecting member may be fixed to the inner wall of the rotating member. When the rotating member rotates helically, the radial connecting member may rotate relatively in the annular groove and drive the moving part to translate axially.

[0076] Please combine Figures 4 to 6 In one embodiment, a connecting seat 210 is fixed to the proximal end of the outer tube 200 , and the connecting seat 210 is snap-fitted with the release portion 300 , so that the outer tube 200 and the release portion 300 are conveniently snap-fitted with each other through the connecting seat 210 .

[0077] Specifically, the outer wall of the connection seat 210 is provided with a flange 211 extending in the circumferential direction, and the movable portion 320 is provided with a groove 322 opening toward the outer tube 200. The side wall of the groove 322 is provided with a protrusion (not shown), and by squeezing the proximal end of the connection seat 210 into the groove 322, the flange 211 is elastically deformed to enter between the protrusion and the bottom wall of the groove 322, thereby realizing the clamping connection between the connection seat 210 and the movable portion 320.

[0078] In other embodiments, the connection form between the connection seat and the release portion may adopt other connection structures in the prior art, which is not limited thereto.

[0079] Please refer to Figures 7 to 9 In one embodiment, the 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 located inside the outer tube 200, so that 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 is protrudingly arranged on 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 set up an expansion tube. The inner tube 400 can be inserted into the outer tube 200, and the valve prosthesis 10 can be placed between the inner wall of the distal end of the outer tube 200 and the outer wall of the inner tube 400. The outer tube 200 and the release part 300 can be pre-assembled to facilitate batch assembly. There is no need for on-site installation before surgery, which reduces the operation time.

[0081] It can be understood that during the process of the inner tube 400 passing through the outer tube 200, the inner tube 400 and the proximal end of the valve prosthesis 10 cooperate in such a way that the valve prosthesis 10 is sleeved on the distal end of the inner tube 400 and located inside the outer tube 200, and the inner tube 400 abuts against the valve prosthesis 10 through the restraint 500, so that during the process of the inner tube 400 passing through the outer tube 200, the restraint 500 continuously pushes the valve prosthesis 10 toward the distal end of the outer tube 200, thereby allowing the valve prosthesis 10 to be loaded into the distal end of the outer tube 200.

[0082] like Figure 7 As shown, in one 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.

[0083] When the valve prosthesis delivery device in some technical solutions is used, the valve prosthesis is loaded into a tube body and implanted into a desired position in the human body through a blood vessel. When the valve prosthesis is about to be completely released from the tube body but has not been completely released, the valve prosthesis is stretched due to its self-expansion force and is prone to suddenly jump forward from the tube body, resulting in an unstable release process and an inaccurate release position.

[0084] To do this, combine Figures 10 to 12 In one embodiment, the constraint 500 is provided with an axial blocking structure 510. When the constraint 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 constraint 500 is located outside the outer tube 200, the axial blocking structure 510 allows the leg 11 to be released from the radial direction of the constraint 500.

[0085] Specifically, the support leg 11 of the valve prosthesis 10 can achieve matching or dismatching with the axial blocking structure 510 by changing its position in the radial direction of the constraint 500. The matching mode of the support leg 11 of the valve prosthesis 10 and the axial blocking structure 510 is that the support leg 11 moves inwardly along the radial direction of the constraint 500 to the axial blocking structure 510, thereby matching with the axial blocking structure 510. Conversely, the support leg 11 moves outwardly along the radial direction of the constraint 500, thereby disengaging from the axial blocking structure 510 and dismatching with it.

[0086] When the restraining member 500 is located in the outer tube 200, the axial blocking structure 510, the outer tube 200 and the leg 11 of the valve prosthesis 10 cooperate 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 exerted on the leg 11 restricts it to a position that cooperates with the axial blocking structure 510, thereby preventing it from being released from the axial blocking structure 510. In this way, when the valve prosthesis 10 is not completely released during the release process, the restraining member 500 is in the outer tube 200, and the leg 11 is restricted by the inner wall of the outer tube 200 in the radial direction and by the axial blocking structure 510 in the axial direction, so that the axial blocking structure 510 and the outer tube 200 cooperate with the leg 11 at the same time, so that the valve prosthesis 10 can be prevented from jumping forward (i.e., jumping suddenly in the axial direction 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 500 is exposed from the distal end of the outer tube 200, the outer tube 200 cannot radially restrict the valve prosthesis 10 and the support leg 11. As a result, under the radial restoring force of the valve prosthesis 10, the radial position of the support leg 11 changes outward in the restraint 500, and the support leg 11 is released from the axial blocking structure 510, and is then completely released to the expected position in the human body.

[0088] Please combine Figures 10 to 12 In one embodiment, the constraint 500 is provided with a slot, and the axial blocking structure 510 is a slot, which is a notch on the outer wall of the slot. The notch allows the leg 11 of the valve prosthesis 10 to enter or move out of the slot, that is, allows the leg 11 to enter or move out of the slot along the radial direction of the constraint 500, and to match or release the slot. When the slot is in the outer tube 200, it can prevent the leg 11 from moving axially along the inner tube 400.

[0089] Specifically, the leg 11 has a boss protruding outward in the radial direction of the valve prosthesis 10, and the boss has a first step surface 12 facing (which may be oblique or positive) the distal end of the valve prosthesis 10. The slot wall of the clamping slot has a second step surface 511 facing (which may be oblique or positive) the proximal end of the restraining member 500. When the leg 11 is matched with the clamping 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 jumping forward due to self-expansion.

[0090] It can be understood that the proximal end of the slot also has a slot wall, which faces the second direction, so it can prevent the support leg 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 the slot, and for example includes a distal blocking block and a proximal blocking block arranged at intervals along the axial direction, wherein the distal blocking block is located at the distal side of the proximal blocking block. The support leg has a boss protruding radially inwardly along 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 forward and backward along the axial direction.

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

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

[0094] S100: Insert the dilation tube 600 into the outer tube 200 and introduce them together into a desired position in the animal's body.

[0095] S200: Keep the outer tube 200 still and withdraw the dilation tube 600 from the animal's body.

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

[0097] S400 : 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 , 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 distal end of the inner tube 400 may be directly matched with the proximal end of the valve prosthesis 10 , or the inner tube 400 may be matched with the proximal end of the valve prosthesis 10 via a restraining member 500 .

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

[0100] S600 : Keep the handle 100 stationary, and allow the release portion 300 to move relative to the handle 100 to drive the outer tube 200 to move in a 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 of the valve prosthesis comprises: handle; an outer tube, wherein the interior of the distal end of the outer tube is used for loading a valve prosthesis; a release portion, movably connected to the handle and used to be connected to the proximal end of the outer tube, and the release portion can drive the outer tube to move in a first direction when it moves relative to the handle; 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.

2. The delivery device for valve prosthesis according to claim 1, characterized in that: 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; or The restraining structure is the end surface of the distal end of the inner tube.

3. The delivery device for valve prosthesis according to claim 2, characterized in that: 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 support foot 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.

4. The delivery device for valve prosthesis according to claim 3, characterized in that: 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.

5. The delivery device for valve prosthesis according to claim 2, characterized in that: The restraining member 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 valve prosthesis according to claim 2, characterized in that: The restraining member is arranged on a side of the inner tube away from the handle, and the outer diameter of the restraining member is greater than the outer diameter of the inner tube.

7. The delivery device for valve prosthesis according to claim 2, characterized in that: 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.

8. The delivery device for valve prosthesis according to claim 1, characterized in that: It also includes an expansion tube, which is used to penetrate into the outer tube.

9. The delivery device for valve prosthesis according to claim 1, characterized in that: The release part includes 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, and 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 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, 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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