Prosthetic valve delivery device and system

Abstract

The application relates to a kind of artificial valve delivery device and system, and the delivery device includes several push tubes, each push tube is coaxially nested and can be axially moved relative to each other, the distal end of the push tube is connected with segmented capsule structure, artificial valve can be loaded in segmented capsule structure after being compressed;The proximal end of the push tube is connected with an adjusting handle, the adjusting handle can control the circumferential and axial movement of the plurality of push tubes, by operating the adjusting handle, the proximal end structure of the segmented capsule structure can be separated, and the distal end part is axially overlapped, the axial length is significantly shortened, the overall axial movement of the capsule structure is controlled to control the release movement of the distal end and the proximal end of the artificial valve respectively;The application greatly reduces the damage to the heart structure of the patient caused by the oversize of the valve loading device.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices for heart surgery, in particular to an artificial valve delivery device and system. BACKGROUND

[0002] Diseases of the heart valves can affect the normal flow of blood, causing abnormal heart function, and bringing pain and even life-threatening to patients. One of the current treatment methods for valve diseases is transcatheter valve replacement. Transcatheter valve replacement is a new type of minimally invasive treatment method for valve replacement, which uses a valve delivery system to deliver an artificial valve to the native valve annulus to replace the native valve.

[0003] An artificial valve is an artificial organ that can be implanted in the heart to replace the native heart valve and allow blood to flow unidirectionally, having the function of a natural heart valve. When delivering an artificial valve, the metal stent of the artificial valve needs to be adjusted to a collapsed state and fixed to the distal end of an artificial valve delivery device. Then the artificial valve and the delivery device are inserted into a small-diameter sheath to form a delivery device. During the intervention, a guide wire is inserted through the femoral artery or transapical approach, and then the artificial valve delivery device is sent to the diseased valve through the guide wire. Then the sheath is withdrawn, and the artificial valve is expanded at the native valve annulus to complete the replacement of the artificial valve.

[0004] However, due to the differences in heart anatomy and physiological state between different patients, and the limitations of existing heart diseases and historical treatment of patients, higher requirements and standards are put forward for the delivery and release of artificial valves in the human body. At present, there is still no artificial valve replacement system that can be applied to all patients with valve diseases.

[0005] Compared with the transapical replacement scheme, the trans-femoral / trans-femoral replacement scheme has smaller instrument specifications and less trauma to the patient's heart. Based on this replacement scheme, how to provide a more compact artificial valve delivery device and system that can be used for more patients has become a technical problem that needs to be solved. SUMMARY

[0006] The present application discloses an artificial valve delivery device and system, which aims to solve the technical problems existing in the prior art.

[0007] The present application adopts the following technical solutions:

[0008] On the one hand, the present application provides an artificial valve delivery device, comprising: a first push tube, a second push tube, a third push tube, a proximal capsule assembly, a distal capsule assembly, a proximal capsule connecting piece, and a valve fixing piece.

[0009] The first push tube is fixed at the distal end of the distal capsule assembly, and the first push tube is arranged in the second push tube and can move axially relative to the second push tube;

[0010] The second push tube is fixed at the distal end of the valve fixing member, the valve fixing member is used for being connected with the distal end connector of the artificial valve and limiting the axial movement of the artificial valve, and the second push tube is arranged in the third push tube and can move axially relative to the third push tube;

[0011] The third push tube is fixed at the proximal capsule connector, and the distal end of the proximal capsule connector is detachably connected with the proximal end of the proximal capsule assembly.

[0012] The proximal capsule connector, the proximal capsule assembly and the distal capsule assembly can be connected axially in sequence and have a capsule shape.

[0013] The proximal capsule assembly and the distal capsule assembly are both in a tubular shape, the proximal capsule assembly is arranged on the outer periphery of the distal capsule assembly, the proximal capsule assembly and the distal capsule assembly are used for accommodating the compressed artificial valve, the outer periphery of the proximal capsule assembly is provided with a spiral guide groove, the spiral guide groove extends axially from the distal end to the proximal end of the proximal capsule assembly, the proximal end of the distal capsule assembly is provided with a sliding block, and the spiral guide groove and the sliding block are in transmission cooperation, so that the proximal capsule assembly can move axially along the outer wall of the distal capsule assembly and is coaxially sleeved with the distal capsule assembly.

[0014] As a preferred technical solution, two spiral guide grooves are symmetrically arranged on the periphery of the proximal capsule assembly, the spiral guide grooves extend from the distal end to the proximal end of the proximal capsule assembly, and the spiral guide grooves are at least closed at the proximal end.

[0015] The proximal end of the distal capsule assembly is symmetrically provided with two sliding blocks, the size and position of the sliding blocks are matched with the spiral guide grooves.

[0016] As a preferred technical solution, the spiral line of the spiral guide groove is a cylindrical spiral line.

[0017] As a preferred technical solution, the proximal end of the spiral guide groove is provided with a stop groove, and the center of the stop groove is offset from the spiral extension direction of the spiral guide groove.

[0018] As a preferred technical solution, the sliding block is in a semispherical shape and extends radially outward.

[0019] As a preferred technical solution, the inner diameter of the proximal capsule assembly is not less than the outer diameter of the distal capsule assembly, and the inner diameter of the distal capsule assembly is not less than the outer diameter of the compressed artificial valve.

[0020] As a preferred technical solution, the sum of the axial lengths of the proximal capsule assembly and the distal capsule assembly is not less than the length of the compressed artificial valve.

[0021] The distal end of the distal capsule assembly is provided with a guide head, and the guide head is conical.

[0022] The preferred technical scheme further comprises a guide member, which is sleeved on the outer periphery of the distal end of the valve fixing member and extends towards the proximal end, and the guide member is axially movable relative to the proximal capsule assembly.

[0023] The preferred technical scheme is characterized in that the valve fixing member is annular, and the distal end of the valve fixing member is provided with a boss; the guide member comprises a connecting portion and a guide portion, the connecting portion is annularly sleeved on the outer periphery of the boss, and the boss is used to limit the axial movement of the guide member towards the proximal end of the valve fixing member.

[0024] The preferred technical scheme is characterized in that the boss is provided with a lug in the circumferential direction, and the inner side of the connecting portion is provided with a clamping groove matched with the lug, and the lug and the clamping groove are used to limit the circumferential movement of the valve fixing member relative to the guide member.

[0025] The preferred technical scheme is characterized in that the guide portion comprises a guide rod and a guide head; one end of the guide rod is connected to the proximal end of the connecting portion, the other end of the guide rod is connected to the guide head and extends towards the proximal end; and the inner side of the proximal capsule assembly is provided with a sliding groove matched with the guide head, and the sliding groove extends towards the proximal end in the axial direction.

[0026] The preferred technical scheme is characterized in that the connecting portion is provided with at least two guide portions in the circumferential direction, and the adjacent guide portions are uniformly or symmetrically distributed in the circumferential direction; and the inner side of the proximal capsule assembly is provided with at least two sliding grooves in the circumferential direction, and the positions of the sliding grooves are matched with the positions of the guide portions.

[0027] The preferred technical scheme is characterized in that the proximal end of the guide rod extends axially outward from the proximal end of the distal capsule assembly; and the guide rod expands radially outward along the connecting portion and is attached to the inner wall of the distal capsule assembly.

[0028] The preferred technical scheme is characterized in that at least the proximal end of the sliding groove is closed, and is used to limit the axial movement of the guide head.

[0029] The preferred technical scheme further comprises a fourth push tube and a fifth push tube coaxially arranged;

[0030] The fourth push tube is sleeved on the outer periphery of the third push tube, and the fourth push tube is axially movable relative to the third push tube;

[0031] The fifth push tube is sleeved on the outer periphery of the fourth push tube, and the fifth push tube is axially movable relative to the fourth push tube.

[0032] The preferred technical scheme further comprises an adjusting handle, the adjusting handle is connected to the proximal ends of the first push tube, the second push tube, the third push tube, the fourth push tube and the fifth push tube, respectively, and the adjusting handle is used to drive the circumferential and axial movements of the push tubes.

[0033] In another aspect, the present application also provides an artificial valve delivery system comprising the artificial valve delivery device according to any one of the above and an artificial valve.

[0034] As a preferred technical solution, the artificial valve comprises a valve support, a distal end connector is arranged at a distal end of the valve support, and the distal end connector is matched with the valve fixing member.

[0035] As a preferred technical solution, the artificial valve comprises a self-expanding artificial valve.

[0036] The technical solution adopted by the present application can achieve the following beneficial effects:

[0037] (1) The present application mainly provides an artificial valve delivery device, which mainly comprises a plurality of push tubes, each of which is coaxially sleeved and can move axially relative to each other, a segmented capsule structure is connected to the distal end of the push tube, and the artificial valve can be loaded in the segmented capsule structure after being compressed; the proximal end of the push tube is connected with an adjusting handle, which can control the circumferential and axial movement of the plurality of push tubes, by controlling the adjusting handle, the proximal end structure of the segmented capsule structure can be separated, the distal end part can be axially overlapped, and the overall axial movement of the capsule structure can be controlled to control the release movement of the distal end and the proximal end of the artificial valve respectively.

[0038] (2) The segmented capsule structure at the distal end of the delivery device mainly comprises a proximal end capsule connector, a proximal end capsule assembly and a distal end capsule assembly, which are axially connected to form a generally capsule-shaped structure, when the artificial valve is released, the proximal end capsule connector and the proximal end capsule assembly are separated to control the release of the proximal end of the artificial valve; the inner and outer cavities of the proximal end capsule assembly and the distal end capsule assembly can be overlapped, which can effectively shorten the axial length of the capsule structure, so as to overcome the space constraint inherent in the anatomy of the heart, and reduce the damage to the structure of the patient's heart caused by the oversized loading device during the release of the distal end of the artificial valve.

[0039] (3) A valve fixing member is arranged in the segmented capsule structure for loading the compressed artificial valve, a limiting groove is arranged on the valve fixing member, which can connect the distal end connector of the artificial valve; before the artificial valve is separated from the valve fixing member, the proximal end capsule assembly can be controlled to move axially by the circumferential rotation of the distal end capsule assembly, which is beneficial to the recycling and releasing operation of the artificial valve, so as to ensure that the artificial valve can be released at the optimal position.

[0040] (4) When the delivery device is withdrawn from the patient, the proximal end capsule assembly and the distal end capsule assembly maintain a relative overlapping position relationship, the axial length of the segmented capsule structure can be halved, and the secondary damage to the patient caused by the withdrawal of the delivery device can be effectively reduced.

[0041] (5) The artificial valve delivery system according to another aspect of the present application comprises the artificial valve delivery device and the self-expanding artificial valve, and the artificial valve can be released after being delivered to the desired position by operating the adjusting handle at the proximal end of the delivery device, and the artificial heart valve can be self-expanded after being released to achieve the purpose of valve replacement. BRIEF DESCRIPTION OF DRAWINGS

[0042] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced as follows, which form a part of the present application. The schematic embodiments of the present application and the description and explanation thereof do not constitute an improper limitation on the present application. In the drawings:

[0043] Figure 1 Fig. 1 is a schematic diagram of the partial structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 1;

[0044] Figure 2 Fig. 2 is a schematic diagram of the partial exploded structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 1;

[0045] Figure 3A Fig. 3 is an initial state diagram of the artificial valve delivery device in a preferred embodiment disclosed by the present application 1 during delivery;

[0046] Figure 3B Fig. 4 is a state diagram of the artificial valve delivery device in a preferred embodiment disclosed by the present application 1 during delivery, in which the proximal end of the artificial valve is released;

[0047] Figure 3C Fig. 5 is a state diagram of the artificial valve delivery device in a preferred embodiment disclosed by the present application 1 during delivery, in which the distal end of the artificial valve is released;

[0048] Figure 4 Fig. 6 is a schematic diagram of the partial exploded structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 2;

[0049] Figure 5 Fig. 7 is a schematic diagram of the partial exploded structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 2;

[0050] Figure 6 Fig. 8 is a schematic diagram of the partial cross-sectional structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 2 in the initial state;

[0051] Figure 7 Fig. 9 is a schematic diagram of the partial cross-sectional structure of the artificial valve delivery device in a preferred embodiment disclosed by the present application 2 when the distal end of the artificial valve is released.

[0052] BRIEF DESCRIPTION OF DRAWINGS

[0053] First pushing tube 10; second pushing tube 20; third pushing tube 30; proximal capsule assembly 40, helical guide groove 41, stop groove 42, sliding groove 43; distal capsule assembly 50, sliding block 51, guide head 52; proximal capsule connector 60; valve fixing member 70, limiting groove 71, boss 72, lug 73; guide member 80, guide rod 81, guide head 82, connecting part 83, clamping groove 84; fourth pushing tube 90; fifth pushing tube 100; artificial valve 110, valve stent 111, distal connector 112. DETAILED DESCRIPTION

[0054] In order to make the objects, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be described below in connection with specific embodiments of the present application and corresponding drawings. In the description of the present application, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the context clearly indicates otherwise.

[0055] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connection" should be understood in a broad sense. In addition, in the description of the present application, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance. In this article, "proximal" refers to the end close to the operator along the length direction of the artificial valve delivery device, and "distal" refers to the end away from the operator along the length direction of the artificial valve delivery device.

[0056] As described herein, the "capsule-like", "ring-like", "conical", "hemispherical" and the like structure shapes are not absolute or standard shapes, but can also be approximately related shapes and the like. As can be known by those skilled in the art, in order to achieve respective functions while meeting the requirements of surgical operation, the specific shape / dimension / angle and the like of each structure can be adaptively adjusted. Obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of the present application.

[0057] To solve the problems in the prior art, the embodiment of the present application provides a prosthetic valve delivery device, which comprises a first push tube, a second push tube, a third push tube, a proximal capsule assembly, a distal capsule assembly, a proximal capsule connecting piece, a valve fixing piece, a distal end of the first push tube is fixedly connected with a distal end of the distal capsule assembly, the first push tube is arranged in the second push tube, and the first push tube can move axially relative to the second push tube; a distal end of the second push tube is fixedly connected with a distal end of the valve fixing piece; the valve fixing piece is provided with a limiting groove, the limiting groove is used for being connected with a distal connecting piece of the prosthetic valve, and axial movement of the prosthetic valve is limited; the second push tube is arranged in the third push tube, and the two can move axially relative to each other; a distal end of the third push tube is fixedly connected with the proximal capsule connecting piece; a distal end of the proximal capsule connecting piece is detachably connected with a proximal end of the proximal capsule assembly; the proximal capsule connecting piece, the proximal capsule assembly and the distal capsule assembly can be connected axially in sequence and have a capsule shape; the proximal capsule assembly and the distal capsule assembly are tubular, the proximal capsule assembly is arranged on the outer periphery of the distal capsule assembly, and the proximal capsule assembly and the distal capsule assembly are used for accommodating the compressed prosthetic valve; a spiral guide groove is arranged on the outer periphery of the proximal capsule assembly, the spiral guide groove extends axially from the distal end to the proximal end of the proximal capsule assembly, a slider is arranged on the proximal end of the distal capsule assembly, and the spiral guide groove and the slider are in transmission cooperation, so that the proximal capsule assembly can move axially along the outer wall of the distal capsule assembly and is coaxially nested with the distal capsule assembly.

[0058] Example 1

[0059] The embodiment provides a prosthetic valve delivery device, which can be suitable for delivery and release of artificial mitral valves, artificial tricuspid valves, artificial pulmonary valves or artificial aortic valves; those skilled in the art should understand that the common points of the foregoing several prosthetic valves 110 are that all have metal mesh valve stents 111, and the valve stents 111 have two shapes of collapse and expansion, the valve stents 111 are in a collapsed cylindrical structure when transported in a blood vessel, and are released and expanded when reaching a diseased native valve, the expanded valve stents 111 are radially expanded and have a generally mesh tube shape, and the valve stents 111 in the expanded state can be supported and fixed at a native valve annulus to replace the physiological function of the native valve. Preferably, in the embodiment, the prosthetic valves 110 are all self-expanding prosthetic valves 110, and the valve stents 111 are made of shape memory alloy and can automatically expand radially at body temperature after losing radial constraint.

[0060] Although the above discloses part of the structure of the prosthetic valve 110, it needs to be clarified that, in the embodiment, the prosthetic valve delivery device does not contain the above-mentioned prosthetic valve 110 or valve stent 111, but only exists as a loading and transportation device for the same in the human body.

[0061] Reference Figures 1-3CThe artificial valve delivery device comprises a first pushing tube 10, a second pushing tube 20, a third pushing tube 30, a proximal capsule assembly 40, a distal capsule assembly 50, a proximal capsule connecting piece 60 and a valve fixing piece 70; preferably, it further comprises a fourth pushing tube 90, a fifth pushing tube 100 and an adjusting handle; the first pushing tube 10, the second pushing tube 20, the third pushing tube 30, the fourth pushing tube 90 and the fifth pushing tube 100 are coaxially arranged from inside to outside, and the adjusting handle is connected to the proximal end of each pushing tube for driving the circumferential and axial movement of each pushing tube; the proximal capsule assembly 40, the distal capsule assembly 50, the proximal capsule connecting piece 60 and the valve fixing piece 70 are preferably structurally composed of a capsule type valve loading piece in addition to each pushing tube.

[0062] In a preferred embodiment, the adjusting handle has an axial through inner cavity, the proximal end of each pushing tube is arranged in the inner cavity of the adjusting handle, and a control mechanism is arranged on the adjusting handle and threadedly cooperates with each pushing tube, so that the axial movement or circumferential rotation between each pushing tube can be driven by operating the control mechanism. Specifically, the use and control method of the adjusting handle are the same as those of the handle of the prior art delivery device, and the invention point of the present embodiment is not to control the movement between each pushing tube by the adjusting handle, and even in some embodiments, the movement of each pushing tube can be controlled without the proximal adjusting handle, so the specific structure and use method of the adjusting handle will not be described in detail.

[0063] Preferably, the first pushing tube 10 is arranged at the innermost side of the coaxially arranged pushing tubes, and the inner cavity of the first pushing tube 10 should at least allow a medical guide wire to pass through; those skilled in the art should understand that since medical guide wires have different specifications, different specifications of medical guide wires have different diameters to meet the requirements of different patients or different lesion positions, and under the premise of meeting the requirements during the operation, the inner cavity diameter of the first pushing tube 10 can be adaptively adjusted according to specific conditions, and the optional diameters of the inner cavity are not listed here.

[0064] In a preferred embodiment, the first pushing tube 10 can be made of a sheath tube or a catheter, and those skilled in the art should understand that when different specifications of guide wires are selected, a catheter or a sheath tube that matches the guide wire should be selected, and different specifications of catheters or sheath tubes have corresponding wall thicknesses, which will not be described in detail. However, whether a catheter or a sheath tube is selected to make the first pushing tube 10, the wall material of the first pushing tube 10 should meet the requirements of having certain mechanical strength in the circumferential, axial and radial directions to transmit the torque from the adjusting handle, so that the first pushing tube 10 can move axially or circumferentially relative to the second pushing tube 20.

[0065] The distal end of the first push tube 10 is fixedly connected with the distal capsule assembly 50. Preferably, the distal capsule assembly 50 is in a substantially tubular shape, and the inner diameter of the distal capsule assembly 50 is not less than the outer diameter of the compressed valve stent 111, so as to limit the releasing movement of the artificial valve 110 in the radial direction. A guide head 52 is arranged at the distal end of the distal capsule assembly 50. The guide head 52 is in a substantially conical shape, and the guide head 52 is located at the farthest end of the whole artificial valve delivery device. The guide head 52 is internally provided with an axially-through cavity, and the cavity is in communication with the first push tube 10. Preferably, the cavity in the guide head 52 and the inner cavity of the first push tube 10 are coaxially arranged and have the same diameter, so as to ensure that the guide wire can pass through smoothly.

[0066] Optionally, the axial length of the distal capsule assembly 50 can be greater than, less than or equal to the axial length of the artificial valve 110.

[0067] Optionally, the guide head 52 and the first push tube 10 are fixedly connected by means of adhesion, hot melting or threads. The distal capsule assembly 50 and the guide head 52 are also fixedly connected by means of adhesion, hot melting or threads.

[0068] In a preferred embodiment, the distal capsule assembly 50 and the guide head 52 can be made of metal such as stainless steel or high-hardness polymer material, so as to facilitate the axial transportation of the whole delivery device in the human body, avoid the radial pressure of the blood pressure in the blood vessel on the delivery device, and avoid the generation of harmful decomposition products due to the instability of the material.

[0069] Preferably, the guide head 52 has a blunt distal end or a streamlined outer shape, so as to avoid scratching the inside of the blood vessel during the delivery along the guide wire, and facilitate the whole delivery device to advance along the blood vessel channel to the distal end.

[0070] Preferably, the second push tube 20 is coaxially arranged on the outer periphery of the first push tube 10, and the inner diameter of the second push tube 20 is not less than the outer diameter of the first push tube 10, so as to ensure that the second push tube 20 and the first push tube 10 can move relative to each other.

[0071] Specifically, the material and specific size of the second push tube 20 can refer to the above-mentioned limitations of the first push tube 10, and will not be repeated here.

[0072] The distal end of the second push tube 20 is fixedly connected with the valve fixing member 70. The valve fixing member 70 is in a substantially annular shape, and a limiting groove 71 is arranged on the valve fixing member 70. The limiting groove 71 is used for connecting with the distal end connecting member 112 of the artificial valve 110, and limiting the axial movement of the artificial valve 110.

[0073] In a preferred embodiment, the artificial valve 110 keeps its axial through state in the compressed state, for sleeving the outer periphery of the second push tube 20, and the two are coaxially arranged; when the distal end connector 112 is matched and connected with the limiting groove 71, the compressed artificial valve 110 and the valve fixing member 70 keep relative fixation, and by pushing the second push tube 20 to the distal end, the artificial valve 110 and the valve fixing member 70 can enter the distal end capsule assembly 50, and the inner cavity wall of the distal end capsule assembly 50 is used for radially restraining the artificial valve 110, so as to limit the release movement of at least the distal end part of the artificial valve 110 in the radial direction.

[0074] Preferably, the limiting groove 71 is arranged as a groove which is axially through and radially outwardly open, and when the artificial valve 110 loses radial restraint, it can directly radially outwardly separate from the valve fixing member 70; in an alternative embodiment, the distal end connector 112 is a generally "racket-shaped" connecting ear, when the "racket-shaped" connecting ear is fixed with the limiting groove 71, the racket handle structure is arranged in the limiting groove 71, and the racket head structure is arranged at the distal end of the limiting groove 71, and the size of the racket head structure is larger than that of the racket handle structure, so as to ensure that the distal end fixing member keeps relative fixation with the limiting groove 71, and the axial movement of the artificial valve 110 is limited by the limiting groove 71.

[0075] Specifically, the number and size of the limiting groove 71 should match the number and size of the distal end connector 112 on the artificial valve 110, because artificial valves 110 of different specifications, different structures, and different manufacturers have different shapes or numbers of distal end connectors 112, therefore, under the premise of meeting the adaptation to the loaded valve stent 111, the shape, number, size, etc. of the limiting groove 71 can be adaptively adjusted according to specific conditions, which will not be described here.

[0076] Preferably, the third push tube 30 is coaxially sleeved on the outer periphery of the second push tube 20, and the inner diameter of the third push tube 30 is not less than the outer diameter of the second push tube 20, so as to ensure that the two can move relative to each other.

[0077] Specifically, the material and specific size of the third push tube 30 can refer to the above-mentioned limitation of the first push tube 10, which will not be described here.

[0078] Preferably, the distal end of the third push tube 30 is fixedly connected with the proximal end capsule connector 60, and the distal end of the proximal end capsule connector 60 is detachably connected with the proximal end of the proximal end capsule assembly 40.

[0079] In a preferred embodiment, the proximal end capsule connector 60 is selected to be the same material as the distal end capsule assembly 50 or the guide head 52, the proximal end capsule connector 60 is generally conical or umbrella-shaped, and the outer periphery is smooth without edges, so as to avoid damage to the blood vessel wall.

[0080] Preferably, the axial length of the proximal capsule assembly 40 can be greater than, or less than or equal to, the axial length of the artificial valve 110.

[0081] Preferably, the proximal capsule assembly 40 is substantially tubular, with an inner diameter not less than the outer diameter of the distal capsule assembly 50, and the proximal capsule assembly 40 is coaxially sleeved on the outer periphery of the distal capsule assembly 50, and the proximal capsule assembly 40 can move axially and circumferentially relative to the distal capsule assembly 50; in a preferred embodiment, the proximal capsule assembly 40 is made of the same material as the distal capsule assembly 50 or the guide head 52.

[0082] Reference Figure 1 In the initial state, the proximal capsule connector 60, the proximal capsule assembly 40 and the distal capsule assembly 50 are axially connected in sequence and are substantially capsule-shaped; preferably, the distal end of the proximal capsule connector 60 is connected to the proximal end of the proximal capsule assembly 40, the maximum outer diameter of the proximal capsule connector 60 is the same as the outer diameter of the proximal capsule assembly 40, the inner diameter of the proximal capsule assembly 40 is not less than the outer diameter of the distal capsule assembly 50, and the distal end of the proximal capsule assembly 40 is connected to the proximal end of the distal capsule assembly 50 in the initial state, the connection between the three is smooth transition, and there is no edge or barb.

[0083] Preferably, the sum of the axial lengths of the proximal capsule assembly 40 and the distal capsule assembly 50 is not less than the length of the compressed artificial valve 110, so as to ensure that the two can completely cover and accommodate the artificial valve 110 in the initial state. Under this condition, the axial lengths of the proximal capsule assembly 40 and the distal capsule assembly 50 can be the same or different; the axial length of the proximal capsule assembly 40 can be greater than or less than the axial length of the distal capsule assembly 50.

[0084] As Figure 2 In a preferred embodiment, the outer periphery of the proximal capsule assembly 40 is provided with a spiral guide groove 41, the spiral guide groove 41 extends axially from the distal end to the proximal end of the proximal capsule assembly 40, the proximal end of the distal capsule assembly 50 is provided with a sliding block 51, the spiral guide groove 41 and the sliding block 51 are in transmission cooperation, when the first push tube 10 is rotated, the distal capsule assembly 50 rotates circumferentially, and the proximal capsule assembly 40 can move axially along the outer wall of the distal capsule assembly 50 to the distal end, and is coaxially sleeved with the distal capsule assembly 50, so as to release the distal end of the artificial valve 110.

[0085] Preferably, the outer periphery of the proximal capsule assembly 40 is provided with at least two spiral guide grooves 41, the adjacent spiral guide grooves 41 are uniformly distributed or symmetrically distributed along the circumference, so that the proximal capsule assembly 40 is more stable during the axial movement relative to the distal capsule assembly 50.

[0086] In a preferred embodiment, two helical guide grooves 41 are symmetrically arranged along the circumference of the proximal capsule assembly 40, the distal ends of the helical guide grooves 41 are open to the distal end of the proximal capsule assembly 40, and the proximal ends of the helical guide grooves 41 are closed and arranged at the proximal end of the proximal capsule assembly 40; correspondingly, the proximal end of the distal capsule assembly 50 is symmetrically provided with two sliding blocks 51, the size and position of the sliding blocks 51 correspond to the helical guide grooves 41. In another preferred embodiment, the distal ends of the helical guide grooves 41 are closed to avoid accidental disconnection of the proximal capsule assembly 40 and the distal capsule assembly 50 during loading or delivery, at this time, the sliding blocks 51 can be arranged in the helical guide grooves 41 during the pre-assembly of the proximal capsule assembly 40 and the distal capsule assembly 50.

[0087] Preferably, the helix of the helical guide groove 41 is a cylindrical helix, and those skilled in the art should understand that the helix is a sinusoidal curve along the outer circumference of the cylinder, and has an equidistant helix, so that when the operator rotates the first push tube 10, the distal capsule assembly 50 can drive the proximal capsule assembly 40 to move axially at a constant speed, which is more convenient for controlling the release of the prosthetic valve 110 during the operation.

[0088] Preferably, the sliding block 51 has a support arm extending towards the proximal end and a hemispherical structure, and in a free state, the sliding block 51 slightly extends radially outward relative to the distal capsule assembly 50; referring to Figure 3A In an initial state, the sliding block 51 is limited in the cavity of the proximal capsule assembly 40 and is in a radially compressed state; referring to Figure 3B When the distal capsule assembly 50 is rotated by a certain amplitude, the hemispherical structure of the sliding block 51 can smoothly slide into the helical guide groove 41 of the proximal capsule assembly 40, and under the extension of the support arm radially outward, the hemispherical structure can be effectively limited in the helical guide groove 41 and guide the distal axial movement of the proximal capsule assembly 40 relative to the distal capsule assembly 50, and the two can finally coaxially overlap, the length of the overlapping part is consistent with the axial extension length of the helical guide groove 41; after the proximal capsule assembly 40 and the distal capsule assembly 50 are overlapped, the axial length of the capsule valve loading device can be roughly halved, and at this time, the proximal part of the prosthetic valve 110 is released.

[0089] Preferably, the proximal end of the helical guide groove 41 is provided with a stop groove 42, and the center of the stop groove 42 is offset from the helical extension direction of the helical guide groove 41; referring to Figure 3CWhen the slider 51 reaches the stop groove 42 in the spiral guide groove 41, the proximal capsule assembly 40 cannot be controlled to continue moving towards the distal capsule assembly 50 by twisting the adjusting handle any more. The slider 51 can be stably stopped in the stop groove 42 due to the turning of the track path of the stop groove 42 relative to the spiral guide groove 41. At this time, the proximal capsule assembly 40 and the distal capsule assembly 50 are axially moved as a whole to a more distal end by pushing the adjusting handle connected with the first push tube 10, so as to completely release the distal end of the prosthetic valve 110.

[0090] In the present embodiment, the method for using the prosthetic valve delivery device is as follows:

[0091] According to the requirements of the operation, the patient is punctured at the femoral artery or the femoral vein; the fourth push tube 90 and the fifth push tube 100 are controlled by the adjusting handle to realize the bending change of a certain space angle, and the capsule type valve carrier is delivered to the expected heart valve replacement position, such as the mitral valve annulus or the aortic valve annulus, through the puncture access.

[0092] Reference Figure 3A As the initial shape of the prosthetic valve delivery device when it is delivered to the expected release position in the human body, only the slider 51 of the distal capsule assembly 50 is in overlapping contact with the inner cavity of the proximal capsule assembly 40 at this time, the slider 51 is in a radially compressed state at this time, and the slider 51 is not located in the spiral guide groove 41. The relative position between the distal capsule assembly 50 and the proximal capsule assembly 40 is kept unchanged during the delivery of the capsule type valve carrier in the human body by the radial support force of the slider 51, so as to prevent the proximal capsule assembly 40 from moving earlier than expected, thereby preventing the risk of the prosthetic valve 110 being released in advance.

[0093] The third push tube 30 can be axially moved independently of the fourth push tube and the fifth push tube 100, so as to drive the proximal capsule connector 60 and the proximal capsule assembly 40 and the distal capsule assembly 50 connected therewith to adjust the final release position of the prosthetic valve 110.

[0094] When the capsule type valve carrier is delivered into the heart valve annulus, the position of the interface between the proximal capsule assembly 40 and the distal capsule assembly 50 and the plane of the heart valve annulus is adjusted. The adjusting handle connected with the first push tube 10 is twisted to drive the distal capsule assembly 50 to rotate in place in the circumferential direction, so that the slider 51 is slid in the circumferential direction into the spiral guide groove 41. At this time, the proximal capsule assembly 40 is driven to move axially relative to the distal capsule assembly 50, at which time the inner cavities and the outer walls of the two are overlapped. As the twisting angle of the adjusting handle increases, the overlapping part also increases. Figure 3B As shown in FIG. 6, after the proximal capsule assembly 40 and the distal capsule assembly 50 are overlapped, the proximal end of the prosthetic valve 110 gradually stretches due to the disappearance of the radial constraint at the proximal end, and the skirt of the prosthetic valve 110 is exposed.

[0095] refer to Figure 3C When the slider 51 reaches the stop groove 42 within the spiral guide groove 41, it is no longer possible to control the proximal capsule assembly 40 to continue moving towards the distal capsule assembly 50 by twisting the adjusting handle. The stop groove 42 marks a turn in the track path relative to the spiral guide groove 41, allowing the slider 51 to remain stably within the stop groove 42. At this point, by pushing the adjusting handle connected to the first push tube 10, the proximal capsule assembly 40 and the distal capsule assembly 50 are moved axially towards the distal end as a whole.

[0096] Once the distal connector 112 of the artificial valve 110 is fully exposed to the proximal capsule assembly 40, the valve fixation member 70 can no longer restrain the radial movement of the artificial valve 110, and the artificial valve 110 can be fully extended and released.

[0097] After the artificial valve 110 is fully deployed, the inner diameter of the valve stent 111 is larger than the outer diameter of the capsule-shaped valve loading device. The capsule-shaped valve loading device can be withdrawn through the axial inner cavity of the artificial valve 110. By pulling the adjusting handle to control the first push tube 10 to drive the proximal capsule assembly 40 and the distal capsule assembly 50 to retract, the proximal capsule assembly 40 and the distal capsule assembly 50 remain in contact during this process. Figure 3C The relative positions are adjusted until the proximal capsule assembly 40 contacts the distal surface of the proximal capsule connector. Finally, the artificial valve delivery device is withdrawn from the body by controlling the adjustment handle.

[0098] Example 2

[0099] This embodiment provides an artificial valve delivery device. Unlike Embodiment 1, this embodiment also includes a guide structure; the various features already included in Embodiment 1 are naturally inherited in this embodiment.

[0100] As can be seen from the above embodiment 1, when the proximal capsule assembly 40 moves axially as the distal capsule assembly 50 rotates, there may be a certain degree of undesirable circumferential rotation. This undesirable circumferential rotation may cause the incompletely released artificial valve 110 to rotate circumferentially, ultimately causing the artificial valve 110 to shift in the position of release in the heart, or causing the artificial valve 110 to be twisted to a certain extent, resulting in poor valve replacement effect or even failure.

[0101] Based on the above reasons, refer to Figures 4-7In the embodiment, the guiding member 80 is sleeved on the distal end of the valve fixing member 70 and extends towards the proximal end. The sliding groove 43 is arranged on the inner side of the proximal capsule assembly 40 and is matched with the guiding head 82. The sliding groove 43 extends axially towards the proximal end, so that the guiding member 80 can move axially relative to the proximal capsule assembly 40 and the guiding member 80 can be separated axially from the valve fixing member 70.

[0102] Preferably, since the sliding groove 43 and the spiral guide groove 41 are both arranged on the inner side of the proximal capsule assembly 40, in order to ensure that the spiral of the spiral guide groove 41 does not interfere with the arrangement of the sliding groove 43, the spiral guide groove 41 is projected along the cylindrical straight line direction to be arranged as a profile of less than one half of a circle, which can provide sufficient accommodation space for the arrangement of the sliding groove 43 on the inner side of the proximal capsule assembly 40.

[0103] Preferably, the valve fixing member 70 is substantially annular, and the distal end of the valve fixing member 70 is provided with a boss 72. The guiding member 80 includes a connecting portion 83 and a guiding portion. The guiding portion extends towards the proximal end, and the connecting portion 83 is annularly sleeved on the outer periphery of the boss 72. The boss 72 is used to limit the axial movement of the guiding member 80 towards the proximal end of the valve fixing member 70.

[0104] Preferably, the boss 72 is provided with a lug 73 in the circumferential direction, and the inner side of the connecting portion 83 is provided with a clamping groove 84 matched with the lug 73. The lug 73 and the clamping groove 84 are used to limit the circumferential movement of the valve fixing member 70 relative to the guiding member 80.

[0105] In a preferred embodiment, when the distal end connecting member 112 of the artificial valve 110 is arranged as a connecting lug structure, a certain distance is required between the valve fixing member 70 and the connecting portion 83 of the guiding member 80 to accommodate the "racket-shaped" structure of the connecting lug.

[0106] Preferably, the guiding portion includes a guiding rod 81 and a guiding head 82. One end of the guiding rod 81 is fixedly connected to the proximal end of the connecting portion 83, and the other end is connected to the guiding head 82 and extends towards the proximal end. In an alternative implementation, the guiding portion is made of a metal material or a high-strength polymer material. The guiding head 82 is bent outward from the proximal end of the guiding rod 81, so that the two are more integrated and the volume of the entire capsule-type valve loading device is reduced.

[0107] Preferably, in the initial state, the proximal end of the guiding rod 81 extends axially outward from the proximal end of the distal capsule assembly 50. The guiding rod 81 expands radially outward along the connecting portion 83 and is attached to the inner wall of the distal capsule assembly 50 to control the structure of the entire capsule-type valve loading device to be more compact. When the distal end of the artificial valve 110 is released, the position of the second push tube 20 is kept unchanged, and the first push tube 10 is pushed forward, so that the guiding member 80 and the valve fixing member 70 can be separated.

[0108] Preferably, the width of the guide head 82 is not greater than the width of the inner slide groove 43 of the proximal capsule assembly 40, so that the guide head 82 can always move in the slide groove 43 during the actual assembly and movement, so that the circumferential movement between the proximal capsule assembly 40 and the guide 80 is restricted to each other, and because the circumferential movement between the guide 80 and the valve fixing member 70 is also restricted by the lug 73 and the clamping groove 84, so that the proximal capsule assembly 40 and the valve fixing member 70 can only have axial movement relative to each other, and cannot rotate circumferentially, so as to avoid the artificial valve 110 from being twisted.

[0109] Preferably, the connecting portion 83 is circumferentially provided with at least two guide portions which are the same structure, and adjacent guide portions are uniformly or symmetrically distributed circumferentially; and the proximal capsule assembly 40 is provided with at least two slide grooves 43 circumferentially, and the positions and sizes of the slide grooves 43 are adapted to the guide portions.

[0110] Preferably, at least the proximal end of the slide groove 43 is closed, for limiting the axial movement of the guide head 82.

[0111] In the embodiment, the method for using the artificial valve delivery device is as described in the above embodiment 1, and the difference is that, referring to Figure 6 (not shown in the artificial valve 110), the guide head 82 on the guide 80 is always in the slide groove 43, which restricts the proximal capsule assembly 40 from rotating with the circumferential rotation of the distal capsule assembly 50, and at the same time, the slider 51 can only slide along the spiral guide groove 41 with the rotation of the distal capsule assembly 50, so that the proximal capsule assembly 40 can only move axially relative to the distal capsule assembly 50.

[0112] Referring to Figure 7 (not shown in the artificial valve 110), the slide groove 43 in the proximal capsule assembly 40 is closed at the proximal end to form a limit, for controlling the axial separation of the guide 80 and the valve fixing member 70, so that the guide 80 does not expose the proximal capsule assembly 40, so as to avoid affecting the final withdrawal of the delivery device. At the same time, the second push tube 20 connected with the valve fixing member 70 remains axially fixed relative to the heart, so as to ensure that the artificial valve 110 does not deviate in position in the heart during the movement of the proximal capsule assembly 40 and the distal capsule assembly 50 to a more distal end. When the distal connecting member 112 of the artificial valve 110 is completely exposed from the proximal capsule assembly 40, the valve fixing member 70 can no longer restrict the radial movement of the artificial valve 110, and the artificial valve 110 can be completely stretched and released.

[0113] Example 3

[0114] The embodiment provides an artificial valve delivery system, which comprises the artificial valve delivery device as described in the embodiment 1 or the embodiment 2, and further comprises an artificial valve 110; and each feature already included in the embodiment 1 or the embodiment 2 is naturally inherited in the embodiment.

[0115] In the embodiment, the artificial valve 110 comprises an artificial aortic valve, an artificial mitral valve and an artificial tricuspid valve; preferably, the artificial valve 110 at least comprises a valve stent 111 and valve leaflets.

[0116] Preferably, a distal end connector 112 is arranged at the distal end of the valve stent 111, and the distal end connector 112 is matched with the limiting groove 71 of the valve fixing member 70; in a preferred embodiment, the valve stent 111 is a self-expanding valve stent 111, and the valve stent 111 is made of nickel-titanium alloy; when the artificial valve 110 is loaded on the valve delivery device, the nickel-titanium alloy can be compressed by virtue of the characteristic that the nickel-titanium alloy becomes soft when being cooled, so that the artificial valve 110 can be loaded on the valve fixing member 70 in an ice-water mixture, and pushed into the proximal end capsule assembly 40 and the distal end capsule assembly 50, and kept in a compressed state by the radial constraint of the proximal end capsule assembly 40 and the distal end capsule assembly 50; when the artificial valve 110 reaches the diseased native valve, and is released from the proximal end capsule assembly 40 / distal end capsule assembly 50, the radial self-expansion from the proximal end to the native end can be completed due to the fact that the human body temperature is much higher than the temperature of the ice-water mixture, and finally the artificial valve 110 is gradually separated from the valve fixing member 70.

[0117] Those skilled in the art should understand that the valve stent 111 is generally in the shape of a cylindrical mesh tube, and in some designs, the inflow section of the valve stent 111 is also in the shape of a radially outwardly expanded horn or funnel; since the structures of the valve stents 111 produced by different manufacturers are different, but the main structures are consistent, and the main structures are common prior art, the shapes of each component and the connection modes of each component are not described herein.

[0118] Preferably, the valve leaflets are made of commercialized porcine aortic valve, bovine pericardial valve or porcine pericardial valve, and are used to replace the physiological functions of the native valve leaflets; the valve leaflets are sewn in the valve stent 111 and extend from the proximal end to the distal end.

[0119] In other preferred embodiments, a skirt sealing membrane can also be sewn on the proximal end of the valve stent 111, and is used to prevent the occurrence of complications such as paravalvular leakage after valve replacement.

[0120] In the embodiment, the use method of the artificial valve 110 delivery system is the same as the use method of the artificial valve 110 delivery in the embodiment 1 or the embodiment 2, and is not described herein.

[0121] The embodiments of the present application are described above with reference to the accompanying drawings, but the present application is not limited to the above-described specific embodiments, and the above-described specific embodiments are merely illustrative, but not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims, and all of them belong to the protection of the present application.

Claims

1. A prosthetic valve delivery device, characterized by, Comprise: A first push tube, a second push tube, a third push tube, a proximal capsule assembly, a distal capsule assembly, a proximal capsule connector, a valve fixing member; The distal end of the first push tube is fixedly connected with the distal end of the distal capsule assembly; the first push tube is arranged in the second push tube and can move axially relative to the second push tube; The distal end of the second push tube is fixedly connected with the valve fixing member; the valve fixing member is used to be connected with the distal connector of the artificial valve and limit the axial movement of the artificial valve; the second push tube is arranged in the third push tube and can move axially relative to the third push tube; The distal end of the third push tube is fixedly connected with the proximal capsule connector; the distal end of the proximal capsule connector is detachably connected with the proximal end of the proximal capsule assembly; The proximal capsule connector, the proximal capsule assembly and the distal capsule assembly can be connected axially in sequence and have a capsule shape; The proximal capsule assembly and the distal capsule assembly are both tubular; the proximal capsule assembly is arranged on the outer periphery of the distal capsule assembly; the proximal capsule assembly and the distal capsule assembly are used to accommodate the compressed artificial valve; the outer periphery of the proximal capsule assembly is provided with a spiral guide groove which extends axially from the distal end to the proximal end of the proximal capsule assembly; the proximal end of the distal capsule assembly is provided with a sliding block; the spiral guide groove and the sliding block are in transmission cooperation; the circumferential rotation of the first push tube can make the sliding block slide in the spiral guide groove, drive the proximal capsule assembly to move axially along the outer wall of the distal capsule assembly and coaxially overlap with the distal capsule assembly to expose the proximal end of the artificial valve; the first push tube can also push distally after the sliding block reaches the proximal end of the spiral guide groove, so that the proximal capsule assembly and the distal capsule assembly move axially as a whole to a more distal end to realize the complete expansion and release of the artificial valve.

2. The prosthetic valve delivery apparatus of claim 1, wherein, The proximal capsule assembly is provided with two spiral guide grooves which are symmetrically arranged in the circumferential direction and extend from the distal end to the proximal end of the proximal capsule assembly; the spiral guide grooves are at least proximally closed; The proximal end of the distal capsule assembly is symmetrically provided with two sliding blocks which are matched in size and position with the spiral guide grooves.

3. The prosthetic valve delivery apparatus of claim 2, wherein, The spiral line of the spiral guide groove is a cylindrical spiral line.

4. The prosthetic valve delivery apparatus of claim 2, wherein, The proximal end of the spiral guide groove is provided with a stop groove whose center is offset from the spiral extension direction of the spiral guide groove.

5. The prosthetic valve delivery apparatus of claim 2, wherein, The sliding block is semispherical and extends radially outward.

6. The prosthetic valve delivery apparatus of claim 1, wherein, The inner diameter of the proximal capsule assembly is not less than the outer diameter of the distal capsule assembly; the inner diameter of the distal capsule assembly is not less than the outer diameter of the compressed artificial valve.

7. The prosthetic valve delivery apparatus of claim 1, wherein, The sum of the axial lengths of the proximal capsule assembly and the distal capsule assembly is not less than the length of the compressed artificial valve.

8. The prosthetic valve delivery apparatus of claim 1, wherein, The distal part of the distal capsule assembly is provided with a guide head which is conical; the guide head is provided with an axially through cavity which is in communication with the inner cavity of the first push tube.

9. The prosthetic valve delivery apparatus of claim 1, wherein, Further comprise a guide member; the guide member is arranged on the outer periphery of the distal end of the valve fixing member and extends proximally; the guide member can move axially relative to the proximal capsule assembly.

10. The prosthetic valve delivery apparatus of claim 9, wherein, The valve fixing member is annular, and a boss is arranged at the distal end of the valve fixing member; the guide member comprises a connecting portion and a guide portion, the connecting portion is annularly sleeved on the outer periphery of the boss, and the boss is used to limit the axial movement of the guide member towards the proximal end of the valve fixing member.

11. The prosthetic valve delivery apparatus of claim 10, wherein, The boss is provided with a lug in the circumferential direction, and a clamping groove is arranged on the inner side of the connecting portion and matched with the lug, and the lug and the clamping groove are used to limit the circumferential movement of the valve fixing member relative to the guide member.

12. The prosthetic valve delivery apparatus of claim 9, wherein, The guide portion comprises a guide rod and a guide head; one end of the guide rod is connected to the proximal end of the connecting portion, the other end is connected to the guide head, and the guide rod extends towards the proximal end; a sliding groove matched with the guide head is arranged on the inner side of the proximal end capsule assembly and extends towards the proximal end in the axial direction.

13. The prosthetic valve delivery apparatus of claim 12, wherein, The connecting portion is provided with at least two guide portions in the circumferential direction, and adjacent guide portions are uniformly or symmetrically distributed in the circumferential direction; at least two sliding grooves are arranged in the circumferential direction on the inner side of the proximal end capsule assembly, and the positions of the sliding grooves are matched with the positions of the guide portions.

14. The prosthetic valve delivery apparatus of claim 12, wherein, The proximal end of the guide rod extends outwardly and axially from the proximal end of the distal end capsule assembly; the guide rod expands outwardly in the radial direction of the connecting portion and is attached to the inner wall of the distal end capsule assembly.

15. The prosthetic valve delivery apparatus of claim 12, wherein, At least the proximal end of the sliding groove is closed, which is used to limit the axial movement of the guide head.

16. The prosthetic valve delivery apparatus of claim 1, wherein, A fourth push tube and a fifth push tube are coaxially arranged; The fourth push tube is sleeved on the outer periphery of the third push tube, and the fourth push tube can move axially relative to the third push tube; The fifth push tube is sleeved on the outer periphery of the fourth push tube, and the fifth push tube can move axially relative to the fourth push tube.

17. The prosthetic valve delivery apparatus of claim 16, wherein, An adjusting handle is further included, and the adjusting handle is connected to the proximal end of each push tube, respectively, and is used to drive the circumferential and axial movement of each push tube.

18. A prosthetic valve delivery system, comprising: The artificial valve delivery device and the artificial valve are included.

19. The prosthetic valve delivery system of claim 18, wherein, The artificial valve comprises a valve support, a distal end connecting member is arranged at the distal end of the valve support, and the distal end connecting member is matched with the valve fixing member.

20. The prosthetic valve delivery system of claim 18, wherein, The artificial valve comprises a self-expanding artificial valve. The artificial valve comprises a self-expanding artificial valve.

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