Conveying assembly and conveying system

Through the combined design of the inner tube, outer tube, line control device and snake bone unit, the problem that the valve prosthesis delivery system cannot be recycled after 100% release of the prosthesis is solved, and the complete recovery and coaxiality of the stent is achieved, reducing the risk of surgery and operation difficulty.

CN120585518APending Publication Date: 2025-09-05SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
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Patent Information

Application Number
CN202410251877.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-03-05
Publication Date
2025-09-05

AI Technical Summary

Technical Problem

The existing valve prosthesis delivery system cannot recover the prosthesis after 100% release of the prosthesis, resulting in a reduced device error tolerance and increased surgical risk. At the same time, it is impossible to maintain the coaxiality between the valve prosthesis and the native valve annulus, affecting the surgical effect.

Method used

The combination design of inner tube, outer tube, line control device, snake bone unit and drive wire is adopted. The complete release or recovery of the stent is achieved through the cooperation of the drive wire and the line control device, and the complex aortic arch anatomical structure is adapted to the multi-directional curvature function of the snake bone unit, ensuring that the valve prosthesis is coaxial with the native valve annulus.

Benefits of technology

The complete recovery of the stent when it is fully expanded is achieved, which reduces the difficulty of operation and surgical risks, improves the fault tolerance of the device, and ensures the coaxiality of the valve prosthesis and the native valve annulus, reducing the probability of perival leakage and regurgitation.

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Abstract

The invention provides a conveying assembly and a conveying system. The conveying assembly comprises an inner pipe, an outer pipe, a wire control device, a snake bone unit and a driving wire. The outer tube wraps at least one part of the inner tube, connecting holes are formed in the two ends of the support in the axial direction of the support, and the driving wire penetrates through the connecting holes. The snake bone unit is connected with the inner pipe, and one end of the driving wire sleeves the wire control device; the outer pipe is movably arranged on the outer side of the drive-by-wire device in a sleeving mode in the axial direction of the inner pipe and used for keeping or releasing connection between the drive wire and the drive-by-wire device. According to the configuration, the outer tube is matched with the drive-by-wire device, complete release or complete recovery of the stent is achieved, the stent can still be completely recovered into the conveying assembly when being completely expanded, the error-tolerant rate of the conveying assembly is increased, and the risk of an operation is reduced; and the snake bone unit is arranged, so that the valve prosthesis can be bent in different directions in the process of conveying and / or recovering the valve prosthesis, and the valve prosthesis can be always coaxial with a valve ring plane of a patient.
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Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a delivery component and a delivery system. Background Art

[0002] Currently available artificial heart valve delivery systems can deliver artificial valve prostheses to specific locations in the human heart to replace diseased valves. These systems primarily consist of a handle assembly, a catheter assembly, and the artificial valve prosthesis. The distal end of the catheter passes through the human artery to the diseased valve, while the handle assembly controls the catheter's curvature and allows for the release and retrieval of the valve prosthesis.

[0003] Currently, commonly used valve prosthesis delivery systems with retrieval functions can only retrieve the prosthesis when it is 70% to 75% released, and cannot retrieve the prosthesis after 100% release. If the operator finds that the prosthesis is implanted too deep or too shallow, or is not coaxial with the native annulus plane after complete release, further retrieval and adjustment are impossible, increasing the operator's difficulty, reducing the device's fault tolerance, and further increasing surgical risks.

[0004] At the same time, the existing self-expanding valve prosthesis delivery system has almost no bending adjustment function. For patients with a small aortic arch bending radius and severe tortuosity, the guide head at the distal end of the delivery component may scratch the aortic blood vessels and cause complications of aortic dissection; for patients with larger heart angles, such as transverse hearts of 60° to 90°, the valve prosthesis cannot be coaxial with the patient's valve annulus plane during the release process.

[0005] Therefore, during the delivery of the valve prosthesis, the existing valve prosthesis delivery system cannot, on the one hand, ensure the coaxiality of the valve prosthesis and the native valve annulus, so that the fully released valve prosthesis cannot fit the native valve annulus well, increasing the probability of paravalvular leakage and regurgitation, deepening the injection depth of the left ventricular outflow tract, and increasing the pacemaker implantation rate; on the other hand, when the valve prosthesis is released to 100%, it cannot be adjusted again. Once the implantation position of the valve prosthesis deviates from the target position, or problems occur in the release process of the valve prosthesis, the surgical risk will be further increased. Summary of the Invention

[0006] The purpose of the present invention is to provide a delivery assembly and a delivery system to solve the problems that the existing valve prosthesis delivery system is unable to recover the prosthesis after 100% release of the prosthesis, resulting in reduced instrument fault tolerance, increased surgical risks, and inability to maintain the coaxiality of the valve prosthesis and the native valve ring, resulting in poor surgical treatment effects.

[0007] In order to achieve the above-mentioned object, the present invention provides a delivery assembly, comprising: an inner tube, an outer tube, a wire control device, a snake unit and a drive wire;

[0008] The outer tube covers at least a portion of the inner tube, the inner tube is used to load the stent, and the stent is provided with connecting holes at both ends along its own axial direction, and the driving wire is passed through the connecting holes;

[0009] The snake unit is connected to the inner tube and is used to bend in multiple directions during the process of transporting and / or retrieving the stent;

[0010] One end of the driving wire is sleeved on the wire-controlled device, and the outer tube is movably sleeved on the outside of the wire-controlled device along the axial direction of the inner tube. The outer tube cooperates with the wire-controlled device to maintain or release the connection between the driving wire and the wire-controlled device to achieve complete release or complete recovery of the stent.

[0011] Optionally, the wire-controlled device is movable along the axial direction of the inner tube, and is used to change the tightness of the driving wire to achieve contraction or release of the stent.

[0012] Optionally, the wire control device includes a first fixed head and a middle tube, the first fixed head is sleeved on the outside of the middle tube, the first fixed head is detachably connected to the driving wire, and the middle tube is movable along the axial direction of the inner tube to drive the first fixed head to move.

[0013] Optionally, the first fixing head includes a body and a thread-withdrawing arm, the body is provided with a slot, one end of the thread-withdrawing arm is connected to the body, and the other end of the thread-withdrawing arm is a free end; the driving wire is sleeved on the free end of the thread-withdrawing arm;

[0014] The outer tube is wrapped around the outer side of the wire control device during transportation so that the free end is embedded in the slot; after the bracket begins to be released, the outer tube moves along the axial direction of the inner tube to change the connection relationship between the free end and the slot;

[0015] The outer tube moves proximally along the axial direction of the inner tube, the wire control device exposes the outer tube, the free end is disconnected from the slot, and one end of the drive wire is detached from the free end, thereby achieving complete release of the stent;

[0016] The wire-controlled device moves proximally along the axial direction of the inner tube, the driving wire is tightened, and the stent contracts; the outer tube moves distally along the axial direction of the inner tube until the outer tube covers the stent, thereby achieving complete recovery of the stent.

[0017] Optionally, the first fixing head further comprises an elastic member, a protruding portion is provided on the side wall of the thread withdrawal arm, one end of the elastic member is connected to the protruding portion, and the other end is connected to a side of the body away from the slot;

[0018] The elastic member drives the free end to separate from the slot.

[0019] Optionally, the body has a plurality of protrusions arranged along its circumference, and the slots are formed between adjacent protrusions;

[0020] The thread withdrawal arm is adapted to the clamping slot.

[0021] Optionally, the conveying component also includes a fixing part, which is sleeved on the inner tube, and the fixing part is provided with a plurality of threading holes arranged along the circumference of the inner tube. The driving wire is passed through at least two of the connecting holes and at least two of the threading holes to connect the bracket and the inner tube.

[0022] Optionally, the fixing member includes a second fixing head and a third fixing head arranged along the axial direction of the inner tube, and the bracket is arranged between the second fixing head and the third fixing head along the axial direction of the inner tube;

[0023] The bracket is provided with a plurality of connection holes at both ends along its axial direction, wherein the connection hole located at the proximal end of the bracket is a first connection hole, and the connection hole located at the distal end of the bracket is a second connection hole; the second fixing head is provided with a plurality of first threading holes, and the third fixing head is provided with a plurality of second threading holes;

[0024] The conveying assembly includes two driving wires, one of which is wound around the outer wall of the inner tube at the proximal end of the second fixed head, and after being sequentially passed through one of the first threading holes, at least two of the first connecting holes, and another of the first threading holes, one end is sleeved on the inner tube, and the other end is sleeved on the wire control device; the other driving wire is wound around the outer wall of the inner tube at the distal end of the third fixed head, and after being sequentially passed through one of the second threading holes, at least two of the second connecting holes, and another of the second threading holes, one end is sleeved on the inner tube, and the other end is sleeved on the wire control device.

[0025] Optionally, the snake-bone unit is formed by sequentially connecting a plurality of snake-bone sub-units, and the connection between two adjacent snake-bone sub-units can be relatively bent, and the bending direction between the two adjacent connections is set at an angle.

[0026] Optionally, the conveying assembly further comprises a fastener, wherein the inner wall of the serpentine subunit has through holes arranged opposite to each other along the radial direction of the inner tube, and the corresponding through holes in adjacent serpentine subunits penetrate in the radial direction of the inner tube to form a through hole, and the fastener is passed through the through hole to connect two adjacent serpentine subunits;

[0027] The connection between adjacent snake-bone sub-units can be bent in a direction perpendicular to the connection line between the through holes.

[0028] Optionally, the snake bone subunit is provided with the through holes at both ends along its own axis, and a line connecting the two through holes at one end and a line connecting the two through holes at the other end are perpendicular to each other.

[0029] Optionally, the serpentine unit is arranged parallel to the axial direction of the inner tube, and a plurality of protrusions arranged along its own circumference are provided on the outer wall of the serpentine sub-unit located at the distal end, and an axial hole is opened on the protrusion, and the axial hole is used to pass the bending wire, and the serpentine sub-unit located at the distal end is driven to bend by the bending wire, so as to drive the serpentine sub-units connected thereto to bend in turn.

[0030] Optionally, the snake bone unit has a claw segment, which is connected to the proximal side of the snake bone sub-unit located at the proximal end, and the proximal end of the snake bone unit is connected to the inner tube through the claw segment.

[0031] In order to achieve the above object, the present invention further provides a delivery system, comprising: a handle assembly, a bending control wire, and the delivery assembly as described above;

[0032] The handle assembly includes a first drive unit, a second drive unit and a bending drive unit. The first drive unit is connected to the wire control device and is used to drive the wire control device to move axially along the inner tube; the second drive unit is connected to the outer tube and is used to drive the outer tube to move axially along the inner tube; the bending drive unit is connected to the snake bone unit through the bending control wire and is used to drive the snake bone unit to bend or maintain bending.

[0033] Optionally, the first driving unit includes a first fixing seat, a first threaded member and a first knob;

[0034] The first fixing seat is connected to the wire control device, the first fixing seat is fixedly connected to the first threaded member, the first knob is threadedly connected to the first threaded member, and the first knob rotates around its own axis to drive the first fixing seat and the wire control device to move through the first threaded member.

[0035] Optionally, the second driving unit includes a second fixing seat, a second threaded member and a second knob;

[0036] The second fixing seat is connected to the outer tube, the second fixing seat is fixedly connected to the second threaded member, the second knob is cooperatively connected to the second threaded member, and the second knob rotates around its own axis to drive the second fixing seat and the outer tube to move through the second threaded member.

[0037] Optionally, the bending drive unit includes: a third knob and a third threaded member;

[0038] The third threaded member is connected to the bending control wire, and the third knob is provided with an external threaded section. The third threaded member is sleeved on the external threaded section. The third knob rotates around its own axis to change the tightness of the bending control wire through the third threaded member, thereby driving the snake bone unit to bend or maintain bending.

[0039] Compared with existing conveying components, this application has the following advantages:

[0040] (1) On the one hand, one end of the driving wire is sleeved on the wire control device, and the driving wire is passed through the connecting holes at both ends of the stent. The stent is released or recovered by the cooperation between the driving wire and the wire control device. On the other hand, an outer tube is sleeved on the outside of the wire control device. The stent is fully released or recovered by the cooperation between the outer tube and the wire control device, so that the stent can still be fully recovered into the delivery component when it is fully expanded, which reduces the operating difficulty and surgical risk of the operator and improves the fault tolerance of the delivery component.

[0041] (2) The connection between two adjacent snake bone sub-units can be relatively bent, and the bending direction between the two adjacent connection parts is set at an angle, that is, the connection between two adjacent snake bone sub-units can be bent in different directions during the process of delivering and / or retrieving the stent, realizing multi-directional bending of the inner tube, which can better adapt to the complex anatomical structure requirements of the aortic arch, and at the same time avoid the delivery component from scratching the aortic blood vessel during delivery, and ensure that the valve prosthesis and the native valve ring always remain coaxial, further improving the operability of the delivery component and reducing the surgical risk. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 A schematic diagram of a conveying assembly provided by an embodiment of the present invention during use;

[0043] Figure 2 A schematic structural diagram of a first conveying assembly provided in an embodiment of the present invention;

[0044] Figure 3 A schematic diagram of the state of the first conveying assembly during the conveying process provided by an embodiment of the present invention;

[0045] Figure 4 A schematic diagram of the state of the first delivery assembly provided by an embodiment of the present invention when the stent begins to be released;

[0046] Figure 5 A schematic diagram of the state of the first delivery assembly provided by an embodiment of the present invention when the stent is fully released;

[0047] Figure 6A schematic diagram of the state of the wire control device and the outer tube provided in an embodiment of the present invention when the stent is not fully released;

[0048] Figure 7 A schematic diagram of the state of the wire control device and the outer tube provided in an embodiment of the present invention when the stent is fully released;

[0049] Figure 8 A schematic diagram of the positional relationship between the first fixing head and the middle tube provided in an embodiment of the present invention;

[0050] Figure 9 A schematic structural diagram of a wire withdrawal arm provided in an embodiment of the present invention;

[0051] Figure 10 A schematic structural diagram of an elastic member provided in an embodiment of the present invention;

[0052] Figure 11 A schematic structural diagram of a bracket provided in an embodiment of the present invention;

[0053] Figure 12 A structural cross-sectional view of a second fixing head provided in an embodiment of the present invention;

[0054] Figure 13 A structural cross-sectional view of a third fixing head provided in an embodiment of the present invention;

[0055] Figure 14 A schematic diagram of the connection relationship between the driving wire, the second fixing head, and the wire control device provided in an embodiment of the present invention;

[0056] Figure 15 A schematic diagram of the connection relationship between the driving wire, the third fixing head, and the wire control device provided in an embodiment of the present invention;

[0057] Figure 16 A schematic structural diagram of a second conveying assembly provided in an embodiment of the present invention;

[0058] Figure 17 A schematic structural diagram of an inner tube provided in an embodiment of the present invention;

[0059] Figure 18 A schematic structural diagram of a snake-bone unit provided in an embodiment of the present invention;

[0060] Figure 19 A schematic diagram of the bending of a snake-bone unit provided in an embodiment of the present invention;

[0061] Figure 20 A partial cross-sectional view of a snake-bone unit provided in an embodiment of the present invention;

[0062] Figure 21 A top view of a snake bone unit provided in an embodiment of the present invention;

[0063] Figure 22 A schematic diagram of the connection relationship between the snake bone unit and the inner tube provided in an embodiment of the present invention;

[0064] Figure 23 A schematic structural diagram of a conveying system provided in an embodiment of the present invention;

[0065] Figure 24 A schematic structural diagram of a handle assembly provided in an embodiment of the present invention;

[0066] Figure 25 An exploded view of the structure of the handle assembly provided by an embodiment of the present invention;

[0067] Figure 26 A schematic diagram of the connection relationship between the handle assembly and the bending control wire provided in an embodiment of the present invention;

[0068] The description of each reference numeral is as follows:

[0069] 1-inner tube; 11-second fixing head; 12-third fixing head; 13-snake bone unit; 111-first threading hole; 121-second threading hole; 131-snake bone subunit; 132-through hole; 133-fastener; 134-protrusion; 135-axial hole; 136-claw segment; 137-small hole;

[0070] 2-wire control device; 21-first fixed head; 22-middle tube; 211-body; 212-wire withdrawal arm; 213-protrusion; 214-slot; 215-elastic member; 216-extending portion; 217-pin shaft hole; 218-buckle; 219-connecting portion;

[0071] 3-outer tube; 4-driving wire; 5-bending wire;

[0072] 6-bracket; 61-connection hole; 62-inflow channel; 63-outflow channel; 64-grid unit; 611-first connection hole; 612-second connection hole;

[0073] 7-handle assembly; 71-first drive unit; 72-second drive unit; 73-bending drive unit; 711-first fixing seat; 712-first threaded member; 713-first knob; 721-second fixing seat; 722-second threaded member; 723-second knob; 731-third knob; 732-third threaded member;

[0074] X-axial direction; Y-radial direction; Z-circumferential direction; A-first direction; B-second direction. DETAILED DESCRIPTION

[0075] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0076] As used in this specification, the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features. "One end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which not only include the endpoints, among which "proximal end" generally represents the direction close to the doctor during the operation, and "distal end" generally represents the direction close to the lesion during the operation. The terms "installed", "connected", and "connected" 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 directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in this specification, an element disposed on another element generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements may be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying a spatial positional relationship between the two elements, that is, one element may be in any orientation such as inside, outside, above, below or to one side of another element, unless otherwise clearly indicated in the content. The terms "upper", "lower", "top" and "bottom" are generally relative positional relationships arranged in the direction of gravity; the terms "vertical" and "vertical direction" generally refer to the direction of gravity, which is generally perpendicular to the ground, and "horizontal" and "horizontal plane direction" generally refer to the direction parallel to the ground; for ordinary technicians in this field, the specific meanings of the above terms in this specification can be understood according to specific circumstances.

[0077] The purpose of the present invention is to provide a delivery assembly and a delivery system to solve the problems that the existing valve prosthesis delivery system is unable to recover the prosthesis after 100% release of the prosthesis, resulting in reduced instrument fault tolerance, increased surgical risks, and inability to maintain the coaxiality of the valve prosthesis and the native valve ring, resulting in poor surgical treatment effects.

[0078] As those skilled in the art will appreciate, currently available valve prosthesis delivery systems with a recovery function can only recover the valve prosthesis when the valve prosthesis is partially released (up to 70% to 75% release), and cannot recover the valve prosthesis after the valve prosthesis is 100% released. Once the operator finds that the release position of the valve prosthesis is inconsistent with the target position or the valve prosthesis is incorrectly selected after the valve prosthesis is completely released, the valve prosthesis cannot be recovered again. This places higher demands on the operator's operating accuracy, while also reducing the fault tolerance of the instrument, resulting in increased surgical risks. At the same time, due to the different degrees of aortic arch curvature in different patients, the valve prosthesis delivery system often needs to bend in different directions and at different angles, and the existing valve prosthesis delivery system often cannot adapt well to this requirement, so that the valve prosthesis cannot always remain coaxial with the patient's valve ring plane during the release process. Based on this, the present application proposes a delivery assembly. On the one hand, through the cooperation between the wire control device and the outer tube, the stent can be completely recovered to the delivery assembly when it is fully released, thereby improving the fault tolerance of the instrument and reducing the risk of surgery; on the other hand, by setting a snake bone unit, during the process of delivering and / or recovering the valve prosthesis, it can bend in different directions so that the valve prosthesis can always be coaxial with the patient's valve ring plane.

[0079] Please refer to Figures 1 to 5 As an optional embodiment, the present invention provides a delivery assembly, comprising: an inner tube 1, a wire-controlled device 2, an outer tube 3, a snake-bone unit 13 and a drive wire 4; the outer tube 3 covers at least a portion of the inner tube 1, the inner tube 1 is used to load the stent 6, and the stent 6 is provided with connection holes 61 at both ends along its own axial direction X, and the drive wire 4 is passed through the connection holes 61; the snake-bone unit 13 is connected to the inner tube 1, and is used to bend in multiple directions during the process of delivering and / or recovering the stent 6; one end of the drive wire 4 is sleeved on the wire-controlled device 2; the outer tube 3 is movably sleeved on the outside of the wire-controlled device 2 along the axial direction X of the inner tube 1, and the outer tube 3 cooperates with the wire-controlled device 2 to maintain or release the connection between the drive wire 4 and the wire-controlled device 2 to achieve complete release or complete recovery of the stent 6. It can be understood by those skilled in the art that an artificial valve prosthesis generally includes a stent 6 and a leaflet (not shown in the figure) arranged on the stent 6. As an alternative embodiment, the stent 6 (such as Figure 11As shown in FIG, 6A and 6B, the inlet channel 62 and the outflow channel 63 are respectively arranged at the two ends of the grid unit 64. When the bracket 6 is sleeved on the inner tube 1, the inlet channel 62 is close to the distal end of the inner tube 1, and the outflow channel 63 is far away from the distal end of the inner tube 1. The inlet channel 62 and the outflow channel 63 have at least 6 fulcrums, each of which is provided with a connecting hole 61 for the driving wire 4 to pass through. The diameter of the connecting hole 61 is between 0.4 mm and 0.8 mm. The connecting hole 61 can be a round hole, a square hole, or a hole of other irregular shapes. The number of fulcrums can also be 12, 15 or even more. Figure 11 In the illustrated example, the grid unit 64 is formed by connecting a plurality of diamond-shaped grids in sequence along the axial direction X and the circumferential direction Z of the inner tube 1. In other embodiments, the grid unit 64 may also be formed by connecting triangular grids, hexagonal grids, or grids of other shapes. It should be noted that the actuating wire 4 may be a polymer wire.

[0080] In this embodiment, the stent 6 has a contracted state, an expanded state and a fully released state, wherein the contracted state is a state in which the stent 6 is restricted by the wire control device 2 and cannot be radially expanded (e.g. Figure 3 The expanded state is the state when the stent 6 is expanded outwardly when the wire control device 2 releases the restriction (including the entire process from the beginning of expansion to full expansion of the stent 6, such as Figure 4 The valve prosthesis is released 100% as mentioned above when the stent 6 is fully expanded along its own radial direction Y (the diameter of the stent 6 is at its maximum diameter at this time), the driving wire 4 is kept connected to the wire-controlled device 2, and the outer tube 3 keeps covering the wire-controlled device 2; the fully released state is when the wire-controlled device 2 cooperates with the outer tube 3 to release the driving wire 4 from the wire-controlled device 2 (as shown in FIG. Figure 5The complete release of stent 6 refers to the entire process of stent 6 moving from a contracted state to an expanded state and then to a fully released state. During this process, after stent 6 reaches the lesion location, the wire control device 2 is driven to move to loosen the driving wire 4, releasing the constraint on stent 6, and stent 6 moves from a contracted state to an expanded state. If the release position of stent 6 coincides with the target position, the outer tube 3 is driven to move along the axial direction X of the inner tube 1 and releases the covering effect on the wire control device 2. At this time, the driving wire 4 is separated from the wire control device 2, achieving complete release of stent 6. The complete retraction of stent 6 refers to the entire process of stent 6 moving from a contracted state to an expanded state and then to a contracted state. During this process, after stent 6 reaches the lesion location, the wire control device 2 is driven to move to loosen the driving wire 4, releasing the constraint on stent 6, and stent 6 moves from a contracted state to an expanded state. If the release position of stent 6 does not coincide with the target position, the connection between the driving wire 4 and the wire control device 2 is maintained, and the wire control device 2 is driven to move to tighten the driving wire 4. The stent 6 is constrained by the driving wire 4 and returns from an expanded state to a contracted state, achieving complete retraction of stent 6.

[0081] With such configuration, on the one hand, one end of the driving wire 4 is sleeved on the wire control device 2, and the driving wire 4 is passed through the connecting holes 61 at both ends of the bracket 6, and the release or recovery of the bracket 6 is achieved through the cooperation between the driving wire 4 and the wire control device 2; on the other hand, the outer tube 3 is sleeved on the outside of the wire control device 2, and the complete release or complete recovery of the bracket 6 is achieved through the cooperation between the outer tube 3 and the wire control device 2, so that the bracket 6 can still be completely recovered into the conveying assembly when it is fully expanded, which reduces the operating difficulty and surgical risk of the operator and improves the fault tolerance of the conveying assembly.

[0082] The following combination Figures 1 to 15 , further illustrating the specific structure and principle of the delivery assembly that can achieve complete release and complete recovery of the stent 6.

[0083] In this embodiment, since the driving wire 4 is passed through the connection holes 61 at both ends of the stent 6, when the stent 6 changes from a contracted state to an expanded state, the restrictive effect of the driving wire 4 on both ends of the stent 6 is simultaneously released, and the stent 6 can achieve equal diameter expansion (i.e., the expansion rate at any part of the stent 6 is equal). Figure 3 and Figure 4 When the wire control device 2 moves proximally along the axial direction X of the inner tube 1, the driving wire 4 is tightened to limit the radial expansion Y of the stent 6; when the wire control device 2 moves distally along the axial direction X of the inner tube 1, the driving wire 4 is relaxed to allow the stent 6 to expand and release. Figure 3 As shown, during the delivery process, the stent 6 is not only restricted by the driving wire 4, but the outer tube 3 also covers the stent 6, further restricting the radial expansion Y of the stent 6; Figure 4As shown, after the delivery assembly reaches the lesion location, the outer tube 3 is first driven to move proximally along the axial direction X of the inner tube 1 until the stent 6 is completely exposed, and then the wire control device 2 is driven to move distally along the axial direction X of the inner tube 1 to release the restriction of the driving wire 4 on the stent 6, and the stent 6 changes from a contracted state to an expanded state; if the stent 6 needs to be recovered at this time, the wire control device 2 is driven to move proximally along the axial direction X of the inner tube 1 to tighten the driving wire 4, and the stent 6 changes from an expanded state to a contracted state.

[0084] As an optional embodiment, please refer to Figures 6 to 10 The wire control device 2 includes a first fixed head 21 and a middle tube 22. The first fixed head 21 is sleeved on the outside of the middle tube 22. The first fixed head 21 is detachably connected to the drive wire 4. The middle tube 22 is movable along the axial direction X of the inner tube 1 to drive the first fixed head 21 to move. It should be noted that in this embodiment, the wire control device 2 is provided at the proximal end of the bracket 6 near the handle assembly. The first fixed head 21 is fixedly connected to the middle tube 22, and the connection method can be bonding. The middle tube 22 is sleeved on the outside of the inner tube 1, and its movement range is from the proximal end of the bracket 6 to the proximal end of the inner tube 1. The outer tube 3 is sleeved on the outside of the middle tube 22 and the first fixed head 21, and its movement range is from the distal end of the bracket 6 to the proximal end of the inner tube 1.

[0085] Furthermore, the first fixed head 21 includes a main body 211 and a wire withdrawal arm 212. The main body 211 is provided with a card slot 214 at one end along its own axial direction X. One end of the wire withdrawal arm 212 is connected to the main body 211, and the other end of the wire withdrawal arm 212 is a free end. One end of the driving wire 4 is sleeved on the free end of the wire withdrawal arm 212. The outer tube 3 is covered on the outside of the wire control device 2 during transportation, and the free end is engaged with the card slot 214 by the covering effect of the outer tube 3. After the bracket 6 begins to be released, the outer tube 3 moves along the axial direction X of the inner tube 1 to achieve complete release or complete recovery of the bracket 6. As an alternative embodiment, one end of the main body 211 has a plurality of protrusions 213 arranged along its own circumferential direction Z, and a card slot 214 is formed between two adjacent protrusions 213. The distance between the two protrusions 213 is adapted to the thickness between the two side walls of the wire withdrawal arm 212. It should be noted that in Figures 6 to 9In the example shown, the main body 211 is a cylindrical component, and a plurality of protrusions 213 are provided at one end of the main body 211 close to the bracket 6. A slot 214 that engages with one end of the thread withdrawal arm 212 is formed between two adjacent protrusions 213. Correspondingly, a plurality of connecting parts 219 with pin holes 217 are provided at one end of the main body 211 away from the bracket 6. The connecting parts 219 are arranged in a one-to-one correspondence with the protrusions 213 and are arranged along the axial direction X of the inner tube 1. A pin hole 217 is also provided on one end of the thread withdrawal arm 212. One end of the thread withdrawal arm 212 and the connecting part 219 are passed through the pin hole 217 through a pin (not shown in the figure) to achieve connection, and the other end is engaged with the slot 214 under the covering action of the outer tube 3, and the drive wire 4 is inserted from the free end to be sleeved on the thread withdrawal arm 212. In other embodiments, the protrusion 213 may also be provided at an end of the body 211 away from the bracket 6, and correspondingly, the connecting portion 219 is provided at an end of the body 211 close to the bracket 6. Those skilled in the art may configure this according to actual conditions.

[0086] Furthermore, when the release position of the stent 6 is consistent with the target position, the outer tube 3 moves proximally along the axial direction X of the inner tube 1, releasing the covering effect on the wire control device 2, and the free end is disengaged from the card slot 214, and the driving wire 4 is disconnected from the wire control device 2, thereby achieving the complete release of the stent 6 (the state at this time is as shown in FIG. Figure 7 When the release position of the bracket 6 is inconsistent with the target position, the outer tube 3 covers the wire control device 2, and the free end of the wire withdrawal arm 212 is embedded in the card slot 214 by the covering effect of the outer tube 3, and the driving wire 4 remains connected to the wire control device 2 (the state at this time is as shown in FIG. Figure 6 As shown), at this time, the wire control device 2 moves proximally along the axial direction X of the inner tube 1, the drive wire 4 is tightened, and the bracket 6 contracts; the outer tube 3 moves distally along the axial direction X of the inner tube 1 until the outer tube 3 is wrapped around the bracket 6, so as to achieve complete recovery of the bracket 6. As a preferred embodiment, the first fixed head 21 also includes an elastic member 215, and a protrusion 216 is provided on the side wall of the wire withdrawal arm 212. One end of the elastic member 215 is connected to the protrusion 216, and the other end is connected to the side of the body 211 away from the slot 214; when the wire control device 2 exposes the outer tube 3, the elastic member 215 drives the free end to swing in a direction away from the slot 214 to disengage from the slot 214. With this configuration, the elastic member 215 can drive the wire withdrawal arm 212 to fall off from the slot 214, further ensuring the separation of the drive wire 4 and the wire control device 2. Figures 6 and 7 as well as Figure 8 and Figure 10 In the example shown, a buckle 218 is also provided on the connecting portion 219, and the elastic member 215 is a spring with hooks at both ends, one end connected to the extension portion 216 and the other end connected to the buckle 218. When the outer tube 3 releases the covering effect on the wire control device 2, it can pull the free end of the wire withdrawal arm 212 out of the card slot 214.

[0087] It should be noted that in this embodiment, mechanical release is used to separate the drive wire 4 from the control-wire device 2. In other embodiments, electrolytic release may be used to release the connection between the drive wire 4 and the control-wire device 2. For example, an electrolytic release element and an electrode are included. The drive wire 4 is a conductive wire, one end of which is connected to the inner tube 1 and the other end is connected to the electrolytic release element. The electrode forms an electrical circuit with the drive wire 4 and the electrolytic release element through blood. When the electrical circuit is energized, the electrolytic release element can be corroded, thereby releasing the connection between the drive wire 4 and the control-wire device 2. Of course, it is necessary to ensure that the voltage and current in the electrical circuit are safe voltage and current values ​​relative to the human body.

[0088] Please refer to Figure 2 as well as Figures 11 to 15 The inner tube 1 is also provided with a fixing piece, the bracket 6 is sleeved on the inner tube 1, and the fixing piece is provided with a plurality of threading holes arranged along the circumferential direction Z of the inner tube 1. The driving wire 4 is passed through at least two connecting holes 61 and at least two threading holes to connect the bracket 6 and the inner tube 1. It should be noted that Figure 2 as well as Figures 11 to 15 In the figure, the fixing part includes two fixing heads, which are respectively arranged at the proximal and distal ends of the bracket 6, and each fixing head is provided with a plurality of threading holes, and the driving wire 4 is sequentially passed through the two connecting holes 61 and the two threading holes. Of course, in some other embodiments, three fixing heads can also be provided on the inner tube 1, which are respectively arranged at the proximal end, middle part and distal end of the bracket 6, and the driving wire 4 can also be sequentially passed through three or more connecting holes 61 and threading holes. The number of threading holes on the two fixing heads can be the same or different. Those skilled in the art can select different threading methods according to different requirements such as the inner diameter of the blood vessel and the connection strength of the bracket 6.

[0089] As an optional embodiment, the fixing member includes a second fixing head 11 and a third fixing head 12 arranged along the axial direction X of the inner tube 1, and the bracket 6 is arranged between the second fixing head 11 and the third fixing head 12 along the axial direction X of the inner tube 1; the bracket 6 is provided with a plurality of connecting holes 61 at both ends along its own axial direction X, wherein the connecting hole 61 located at the proximal end of the bracket 6 is a first connecting hole 611, and the connecting hole 61 located at the distal end of the bracket 6 is a second connecting hole 612; a plurality of first threading holes 111 are opened on the second fixing head 11, and a plurality of second threading holes 121 are opened on the third fixing head 12; the delivery assembly includes two drive wires 4 The middle part of one driving wire 4 is wound around the outer wall of the inner tube 1 at the proximal end of the second fixed head 11, and after sequentially passing through one of the first threading holes 111, at least two first connection holes 611, and another first threading hole 111, one end is sleeved on the inner tube 1, and the other end is sleeved on the wire control device 2; the middle part of the other driving wire 4 is wound around the outer wall of the inner tube 1 at the distal end of the third fixed head 12, and after sequentially passing through one of the second threading holes 121, at least two second connection holes 612, and another second threading hole 121, one end is sleeved on the inner tube 1, and the other end is sleeved on the wire control device 2. Figure 14 In the illustrated example, the middle portion of a drive wire 4 is looped around the outer wall of the inner tube 1 at the proximal end of the second fixed head 11, and then both ends pass through one of the first threading holes 111 to the proximal end of the bracket 6, and then pass through one of the first connecting holes 611 from the outside of the bracket 6 into the inside of the bracket 6, and then pass through another first connecting hole 611 from the inside of the bracket 6, and finally pass through another first threading hole 111 to the proximal end of the second fixed head 11, and the two ends are connected to the inner tube 1 and the wire control device 2 respectively. Figure 15 In the illustrated example, after the middle portion of another drive wire 4 is looped around the outer wall of the inner tube 1 at the distal end of the third fixing head 12, both ends of the drive wire 4 pass through one of the second threading holes 121 to the distal end of the stent 6, then pass through one of the second connection holes 612 from the inside of the stent 6 to the outside of the stent 6, then pass through another second connection hole 612 from the outside of the stent 6, and finally pass through another second threading hole 121 to the distal end of the third fixing head 12, and extend proximally along the axial direction X of the inner tube 1, and finally connect the two ends to the inner tube 1 and the wire control device 2 respectively. In other embodiments, the drive wire 4 can also pass through three or more connection holes 61 in sequence to pass back and forth inside and outside the stent 6, preferably through two connection holes 61, otherwise the connection between the drive wire 4 and the stent 6 will be too tight, which is not conducive to the deployment of the stent 6.

[0090] In another embodiment, please refer to Figures 16 to 21The snake bone unit 13 is formed by connecting a plurality of snake bone sub-units 131 in sequence. The connection between two adjacent snake bone sub-units 131 can be relatively bent, and the bending direction between the two adjacent connections is set at an angle. Figure 16 In the illustrated example, the delivery assembly is provided with a wire control device 2, an outer tube 3, and a snake unit 13, wherein the outer tube 3 can be movably sleeved on the outside of the wire control device 2, and the wire control device 2 can be movably sleeved on the outside of the snake unit 13; Figures 20 to 21 In the example shown, the snake bone sub-unit 131 located at the distal end of the snake bone unit 13 is the first snake bone sub-unit 131, and is arranged in sequence from the distal end to the proximal end along the axial direction X of the snake bone unit 13. The connection between the first snake bone sub-unit 131 and the second snake bone sub-unit 131 can be bent along the first direction A, and the connection between the second snake bone sub-unit 131 and the third snake bone sub-unit 131 can be bent along the second direction B. The angle between the first direction A and the second direction B is α, and the angle α satisfies 0°<α≤180°.

[0091] In this embodiment, when the conveying component needs to bend along the first direction A, a bending force along the first direction A is applied to the first section of the serpentine subunit 131. At this time, the connection between the first section of the serpentine subunit 131 and the second section of the serpentine subunit 131 is bent along the first direction A, and in turn drives the serpentine subunit 131 connected thereto to bend; at this time, if the conveying component needs to bend along the second direction B, a bending force along the second direction B is applied to the first section of the serpentine subunit 131. At this time, the connection between the first section of the serpentine subunit 131 and the second section of the serpentine subunit 131 does not bend, and the bending force is transmitted to the connection between the second section of the serpentine subunit 131 and the third section of the serpentine subunit 131. The connection between the second section of the serpentine subunit 131 and the third section of the serpentine subunit 131 is bent along the second direction B, and in turn drives the serpentine subunit 131 connected thereto to bend. At this time, the serpentine unit 13 appears as follows Figure 19 The state shown is bent in multiple directions, thereby realizing multi-directional bending of the snake bone unit 13.

[0092] With such a configuration, the connection between two adjacent snake bone sub-units 131 can be relatively bent, and the bending direction between the two adjacent connections is set at an angle, that is, the connection between two adjacent snake bone sub-units 131 can be bent in different directions during the process of transporting and / or retrieving the stent 6, thereby realizing multi-directional bending of the same inner tube 1, which can better adapt to the complex anatomical structure requirements of the aortic arch, and at the same time avoid the delivery component from scratching the aortic blood vessel during the delivery process, and ensure that the valve prosthesis and the native valve ring always remain coaxial, further improving the operability of the delivery component and reducing the surgical risk.

[0093] The following combination Figures 16 to 22, further explaining the specific structure and principle of the conveying component that can achieve multi-directional bending.

[0094] As an optional embodiment, the conveying component also includes a fastener 133. The inner wall of the serpentine sub-unit 131 has through holes 132 that are relatively arranged along the radial direction Y of the inner tube 1. The corresponding through holes 132 in the two adjacent serpentine sub-units 131 pass through the radial direction Y of the inner tube 1 to form a through hole 132. The fastener 133 is passed through the through hole 132 to connect the two adjacent serpentine sub-units 131; the connection between the two adjacent serpentine sub-units 131 can be bent in a direction perpendicular to the line between the two through holes 132. It should be noted that the fastener 133 is a pin, which is passed through the two through holes 132 set along the radial direction Y of the inner tube 1, and can limit the rotation and displacement of the serpentine unit 13 along the line between the two through holes 132. In the direction perpendicular to the line between the two through holes 132, the serpentine unit 13 can bend to the maximum angle. Figure 18 and Figure 20 In the illustrated example, the bending direction of the connection between the first and second serpentine subunits 131 is the same as the bending direction of the connection between the third and fourth serpentine subunits 131, and the bending direction of the connection between the second and third serpentine subunits 131 is the same as the bending direction of the connection between the fourth and fifth serpentine subunits 131, and the two units are arranged sequentially according to this rule. Of course, in other embodiments, the bending directions of the connection between any two adjacent serpentine subunits 131 can also be different, for example, changing in a gradual manner, that is, the angles of the bending directions of the connection between any two adjacent serpentine subunits 131 are equal. In this arrangement, the serpentine unit 13 can form a relatively gentle curve when bending, thereby better preventing the delivery assembly from scratching the inner wall of the blood vessel during delivery. Those skilled in the art can configure the bending direction of the serpentine unit 13 according to the patient's aortic arch anatomical structure.

[0095] As a preferred embodiment, the snake bone subunit 131 is provided with through holes 132 at both ends along its own axial direction X, and the line between the two through holes 132 at one end and the line between the two through holes 132 at the other end are perpendicular to each other. As can be seen from the above, the bending direction of the snake bone unit 13 is related to the through holes 132. Figure 20For example, the connection between the first and second snake subunits 131 is curved perpendicular to the paper, while the connection between the second and third snake subunits 131 is curved left-right, and so on. This arrangement ensures that the curvature of two adjacent connections is perpendicular to each other, allowing adjacent snake subunits 131 to bend to the maximum possible angle, better accommodating the aortic arch anatomy of patients with severe aortic arch tortuosity or large heart angles.

[0096] Please refer to Figure 18 and Figure 21 The snake unit 13 is arranged parallel to the axial direction X of the inner tube 1. The outer wall of the snake sub-unit 131 at the distal end is provided with a plurality of protrusions 134 arranged along its own circumferential direction Z. The protrusions 134 are provided with axial holes 135 extending along the axial direction X of the inner tube 1. The axial holes 135 are used to pass the bending wire, and the bending wire drives the snake sub-unit 131 at the distal end to bend, thereby driving the snake sub-units 131 connected to it to bend in turn. Figure 21 In the illustrated example, four protrusions 134 are provided on the outer wall of the distal snake bone subunit 131, and two protrusions 134 are set as a group. The two protrusions 134 in the same group are arranged along the radial direction Y of the inner tube 1, and the line between the two protrusions 134 in one group and the line between the two protrusions 134 in the other group are perpendicular to each other. Figure 18 and Figure 20 The bending direction of the serpentine unit 13 in the inner tube 1 is adapted. As a preferred embodiment, the axial hole 135 is provided in a one-to-one correspondence with the through hole 132, and the axial hole 135 and the through hole 132 are arranged along the axial direction X of the inner tube 1. With this configuration, when the bending control wire 5 is passed through the axial hole 135 and applies a bending force to the serpentine unit 13, the direction of the bending force is consistent with the bending direction of the serpentine unit 13, reducing the bending stress on the connection between the two serpentine sub-units 131, improving the durability of the serpentine unit 13, and also ensuring the safety performance of the conveying assembly during use. Of course, in other embodiments, the outer wall of the distal serpentine sub-unit 131 can also be provided with six, eight, or even more protrusions 134. It should be noted that the number of protrusions 134 should be adapted to the number of bending directions of the serpentine unit 13, and the protrusions 134 should correspond one-to-one with the through holes 132 and be arranged along the axial direction X of the inner tube 1.

[0097] Please refer to Figure 17 and Figure 22The serpentine unit 13 has a claw section 136, which is connected to the proximal side of the serpentine sub-unit 131 located at the proximal end. The distal end of the serpentine unit 13 is connected to the inner tube 1, and the proximal end of the serpentine unit 13 is connected to the inner tube 1 through the claw section 136. It should be noted that the serpentine unit 13 can be made of metal material, and the inner tube 1 can be made of polymer material and metal material in sections, wherein the connection part between the inner tube 1 and the bracket 6 can be made of metal material, and the other parts can be made of polymer material; the distal end of the serpentine unit 13 is welded to the second fixing head 11 on the inner tube 1, and the proximal end of the serpentine unit 13 is hot-melted with the inner tube 1 through the claw section 136, wherein a plurality of small holes 137 are also provided on the claw section 136. During hot melting, it should be ensured that a sufficient amount of polymer material can fill the small holes 137 to ensure the connection strength between the serpentine unit 13 and the inner tube 1.

[0098] In another embodiment, please refer to Figures 23 to 25 The present invention also provides a delivery system, comprising: a handle assembly 7, a bending control wire 5, and the delivery assembly as described above; the handle assembly 7 comprises a first drive unit 71, a second drive unit 72, and a bending drive unit 73, the first drive unit 71 being connected to the wire control device 2 for driving the wire control device 2 to move along the axial direction X of the inner tube 1; the second drive unit 72 being connected to the outer tube 3 for driving the outer tube 3 to move along the axial direction X of the inner tube 1; the bending drive unit 73 being connected to the snake bone unit 13 through the bending control wire 5 for driving the snake bone unit 13 to bend or maintain bending.

[0099] As an optional embodiment, the first driving unit 71 includes a first fixing seat 711, a first screw member 712 and a first knob 713; the first fixing seat 711 is connected to the wire control device 2, the first fixing seat 711 is fixedly connected to the first screw member 712, the first knob 713 is threadedly connected to the first screw member 712, and the first knob 713 rotates around its own axis to drive the first fixing seat 711 and the wire control device 2 to move through the first screw member 712. Figure 24 and Figure 25 In the illustrated example, the first fixing seat 711 is connected to the middle tube 22, and the first fixing seat 711 is fixedly connected to the first threaded member 712. The first threaded member 712 has an external thread, and the first knob 713 has an internal thread, and the external thread is adapted to the internal thread. The first knob 713 is passed through the first threaded member 712. The first knob 713 changes the relative axial X position between the first threaded member 712 and the first knob 713 by rotating around the axis, thereby driving the first threaded member 712 to move along the axial direction X of the inner tube 1, thereby driving the first fixing seat 711 and the middle tube 22 to move, and finally realizing the movement of the wire control device 2 along the axial direction X of the inner tube 1.

[0100] As another optional embodiment, the second driving unit 72 includes a second fixing seat 721, a second threaded member 722 and a second knob 723; the second fixing seat 721 is connected to the outer tube 3, the second fixing seat 721 is fixedly connected to the second threaded member 722, the second knob 723 is matched with the second threaded member 722, and the second knob 723 rotates around its own axis to drive the second fixing seat 721 and the outer tube 3 to move through the second threaded member 722. Figure 24 and Figure 25 In the illustrated example, the second fixing seat 721 is connected to the outer tube 3, and the second fixing seat 721 is fixedly connected to the second threaded member 722. The second threaded member 722 has an external thread, and the second knob 723 has an internal thread, and the external thread is adapted to the internal thread. The second knob 723 is passed through the second threaded member 722. The second knob 723 rotates around its axis to change the relative axial X position between the second threaded member 722 and the second knob 723, thereby driving the second threaded member 722 to move along the axial direction X of the inner tube 1, thereby driving the second fixing seat 721 and the outer tube 3 to move.

[0101] As an optional embodiment, the bending drive unit 73 includes: a third knob 731, a third threaded member 732; the third threaded member 732 is connected to the bending control wire 5, the third knob 731 is provided with an external thread section, the third threaded member 732 is sleeved on the external thread section, and the third knob 731 rotates around its own axis X to change the tightness of the bending control wire 5 through the third threaded member 732, thereby driving the snake bone unit 13 to bend or maintain bending. It should be noted that the bending control wire 5 can be a braided metal wire (stainless steel wire, nickel titanium wire, etc.) or a polymer wire. Figure 26 In the illustrated example, the third threaded member 732 has an internal thread that matches the external thread section of the third knob 731. The third threaded member 732 is connected to the bending control wire 5. The third knob 731 rotates about its axis to change the relative axial X position between the third threaded member and the third knob 731, driving the third threaded member 732 to move along the axial X direction of the inner tube 1, thereby tightening or loosening the bending control wire 5 to control the magnitude of the bending force applied by the bending control wire 5 to the snake bone unit 13, thereby achieving control of the bending direction and bending angle of the snake bone unit 13. Figure 24 In the illustrated example, there are four bending drive units 73, which correspond one-to-one to the bending directions of the snake bone unit 13. In some other embodiments, the bending drive units 73 may also be provided with six, eight or more. Those skilled in the art can configure this according to the number of bending directions of the snake bone unit 13.

[0102] In summary, the delivery assembly provided in the embodiment of the present invention includes: an inner tube, an outer tube, a wire-controlled device, a snake-bone unit and a driving wire; the catheter unit covers at least a portion of the inner tube, the inner tube is used to load the stent, and the stent is provided with connecting holes at both ends along its own axial direction, and the driving wire is passed through the connecting holes; the snake-bone unit is connected to the inner tube, and is used to bend in multiple directions during the process of delivering and / or recovering the stent; one end of the driving wire is sleeved on the wire-controlled device; the outer tube is movably sleeved on the outside of the wire-controlled device along the axial direction of the inner tube, and the outer tube cooperates with the wire-controlled device to maintain or release the connection between the driving wire and the wire-controlled device to achieve complete release or complete recovery of the stent.

[0103] With this configuration, on the one hand, one end of the driving wire is sleeved on the wire control device, and the driving wire is passed through the connection holes at both ends of the stent. The stent is released or retracted through the cooperation of the driving wire and the wire control device. On the other hand, an outer tube is sleeved on the outer side of the wire control device. Through the cooperation of the outer tube and the wire control device, the stent is fully released or fully retracted, so that the stent can still be fully retracted into the delivery assembly when fully expanded, reducing the operator's operating difficulty and surgical risks, and improving the fault tolerance of the delivery assembly.

[0104] Furthermore, the connection between two adjacent snake bone sub-units can be relatively bent, and the bending direction between the two adjacent connections is set at an angle, that is, the connection between two adjacent snake bone sub-units can be bent in different directions during the process of delivering and / or retrieving the stent, realizing multi-directional bending of the same inner tube, which can better adapt to the complex anatomical structure requirements of the aortic arch, and at the same time avoid the delivery component from scratching the aortic blood vessel during delivery, and ensure that the valve prosthesis and the native valve ring always remain coaxial, further improving the operability of the delivery component and reducing surgical risks.

[0105] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A conveying assembly, characterized in that: include: Inner tube, outer tube, remote control, snake unit and drive wire; The outer tube covers at least a portion of the inner tube, the inner tube is used to load the stent, and the stent is provided with connecting holes at both ends along its own axial direction, and the driving wire is passed through the connecting holes; The snake unit is connected to the inner tube and is used to bend in multiple directions during the process of transporting and / or retrieving the stent; One end of the driving wire is sleeved on the wire-controlled device; the outer tube is movably sleeved on the outside of the wire-controlled device along the axial direction of the inner tube, and the outer tube cooperates with the wire-controlled device to maintain or release the connection between the driving wire and the wire-controlled device to achieve complete release or complete recovery of the stent.

2. The conveying assembly according to claim 1, wherein The wire-controlled device is movable along the axial direction of the inner tube and is used to change the tightness of the driving wire to achieve the contraction or release of the stent.

3. The conveying assembly according to claim 1, wherein: The wire control device includes a first fixed head and a middle tube. The first fixed head is sleeved on the outside of the middle tube. The first fixed head is detachably connected to the driving wire. The middle tube is movable along the axial direction of the inner tube to drive the first fixed head to move.

4. The conveying assembly according to claim 3, wherein: The first fixing head includes a body and a thread-withdrawing arm, the body is provided with a slot, one end of the thread-withdrawing arm is connected to the body, and the other end of the thread-withdrawing arm is a free end; the driving wire is sleeved on the free end of the thread-withdrawing arm; The outer tube is wrapped around the outer side of the wire control device during transportation so that the free end is embedded in the slot; after the bracket begins to be released, the outer tube moves along the axial direction of the inner tube to change the connection relationship between the free end and the slot; The outer tube moves proximally along the axial direction of the inner tube, the wire control device exposes the outer tube, the free end is disconnected from the slot, and one end of the drive wire is detached from the free end, thereby achieving complete release of the stent; The wire-controlled device moves proximally along the axial direction of the inner tube, the driving wire is tightened, and the stent contracts; the outer tube moves distally along the axial direction of the inner tube until the outer tube covers the stent, thereby achieving complete recovery of the stent.

5. The conveying assembly according to claim 4, characterized in that The first fixing head further comprises an elastic member, a protruding portion is provided on the side wall of the thread withdrawal arm, one end of the elastic member is connected to the protruding portion, and the other end is connected to a side of the body away from the clamping slot; The elastic member drives the free end to separate from the slot.

6. The conveying assembly according to claim 4, wherein: The body has a plurality of protrusions arranged along its circumference, and the slots are formed between adjacent protrusions; The thread withdrawal arm is adapted to the clamping slot.

7. The conveying assembly according to claim 1, wherein: The conveying assembly also includes a fixing part, which is sleeved on the inner tube. The fixing part is provided with a plurality of threading holes arranged along the circumference of the inner tube. The driving wire is passed through at least two of the connecting holes and at least two of the threading holes to connect the bracket and the inner tube.

8. The conveying assembly according to claim 7, wherein: The fixing member includes a second fixing head and a third fixing head arranged along the axial direction of the inner tube, and the bracket is arranged between the second fixing head and the third fixing head along the axial direction of the inner tube; The bracket is provided with a plurality of connection holes at both ends along its axial direction, wherein the connection hole located at the proximal end of the bracket is a first connection hole, and the connection hole located at the distal end of the bracket is a second connection hole; the second fixing head is provided with a plurality of first threading holes, and the third fixing head is provided with a plurality of second threading holes; The conveying assembly includes two driving wires, one of which is wound around the outer wall of the inner tube at the proximal end of the second fixed head, and after being sequentially passed through one of the first threading holes, at least two of the first connecting holes, and another of the first threading holes, one end is sleeved on the inner tube, and the other end is sleeved on the wire control device; the other driving wire is wound around the outer wall of the inner tube at the distal end of the third fixed head, and after being sequentially passed through one of the second threading holes, at least two of the second connecting holes, and another of the second threading holes, one end is sleeved on the inner tube, and the other end is sleeved on the wire control device.

9. The conveying assembly according to claim 1, wherein: The snake-bone unit is formed by sequentially connecting a plurality of snake-bone sub-units. The connection between two adjacent snake-bone sub-units can be relatively bent, and the bending direction between the two adjacent connections is set at an angle.

10. The conveying assembly according to claim 9, wherein: The conveying assembly further includes a fastener, wherein the inner wall of the serpentine subunit has through holes arranged opposite to each other along the radial direction of the inner tube, and the corresponding through holes in adjacent serpentine subunits penetrate in the radial direction of the inner tube to form a through hole, and the fastener is passed through the through hole to connect two adjacent serpentine subunits; The connection between adjacent snake-bone sub-units can be bent in a direction perpendicular to the connection line between the through holes.

11. The conveying assembly according to claim 10, wherein: The snake bone subunit is provided with the through holes at both ends along its axial direction, and the line connecting the two through holes at one end is perpendicular to the line connecting the two through holes at the other end.

12. The conveying assembly according to claim 10, wherein: The serpentine unit is arranged parallel to the axial direction of the inner tube, and a plurality of protrusions arranged along its own circumference are provided on the outer wall of the serpentine sub-unit at the distal end. An axial hole is opened on the protrusion, and the axial hole is used to pass the bending wire, and the bending wire is used to drive the serpentine sub-unit at the distal end to bend, so as to drive the serpentine sub-units connected thereto to bend in turn.

13. The conveying assembly according to claim 9, wherein: The snake bone unit has a claw section, and the claw section is connected to the proximal side of the snake bone sub-unit located at the proximal end. The proximal end of the snake bone unit is connected to the inner tube through the claw section.

14. A conveying system, characterized in that: include: A handle assembly, a bending control wire, and a delivery assembly as claimed in any one of claims 1 to 13; The handle assembly includes a first drive unit, a second drive unit and a bending drive unit. The first drive unit is connected to the wire control device and is used to drive the wire control device to move axially along the inner tube; the second drive unit is connected to the outer tube and is used to drive the outer tube to move axially along the inner tube; the bending drive unit is connected to the snake bone unit through the bending control wire and is used to drive the snake bone unit to bend or maintain bending.

15. The delivery system according to claim 14, wherein: The first driving unit includes a first fixing seat, a first threaded member and a first knob; The first fixing seat is connected to the wire control device, the first fixing seat is fixedly connected to the first threaded member, the first knob is threadedly connected to the first threaded member, and the first knob rotates around its own axis to drive the first fixing seat and the wire control device to move through the first threaded member.

16. The delivery system according to claim 14, wherein: The second driving unit includes a second fixing seat, a second threaded member and a second knob; The second fixing seat is connected to the outer tube, the second fixing seat is fixedly connected to the second threaded member, the second knob is cooperatively connected to the second threaded member, and the second knob rotates around its own axis to drive the second fixing seat and the outer tube to move through the second threaded member.

17. The delivery system according to claim 14, wherein: The bending drive unit includes: a third knob and a third threaded member; The third threaded member is connected to the bending control wire, and the third knob is provided with an external threaded section. The third threaded member is sleeved on the external threaded section. The third knob rotates around its own axis to change the tightness of the bending control wire through the third threaded member, thereby driving the snake bone unit to bend or maintain bending.