A stent delivery system assembly and an artificial valve delivery system assembly

Abstract

The present invention discloses a stent delivery system assembly and an artificial valve delivery system assembly, comprising a radially expandable stent, a delivery device and at least one set of pin connection wires; at least one connection hole is provided on the stent in the circumferential direction; the pin connection wire comprises a head wire and at least one first connection wire, the first connection wire is connected to the delivery device and has a wire hole, after the wire hole passes through the connection hole, the first connection wire is bent at the connection hole, and the wire hole extends circumferentially around the stent for an adjacent first connection wire or the head wire to pass through; the head wire has a first end and a second end, the first end of the head wire is connected to the delivery device, and the second end of the head wire is detachably connected to the delivery device after passing through the connection hole and the wire hole of the first connection wire. The wire control method of the present invention has a short wire withdrawal path, small resistance, and simple wire withdrawal steps, simplifies the structure of the delivery device, and reduces the surgical difficulty at the same time.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an assembly of a stent delivery system and an assembly of an artificial valve delivery system. Background Art

[0002] Transcatheter aortic valve implantation (TAVI) is a new minimally invasive valve replacement technology developed internationally in recent years. The principle is that the valve prosthesis is loaded into the delivery system and delivered to the aortic root through a transcatheter approach. The release of the stent can ensure that the valve is fixed to the aortic valve annulus, replacing the native valve with degenerated function and improving the patient's heart function. This technology can treat aortic valve diseases without thoracotomy and without stopping the heart, eliminating the great trauma caused to patients by previous surgical thoracotomy and cardiac arrest.

[0003] Currently, there are mainly two mechanisms for aortic valve implantation: self-expansion and balloon expansion, each with its own advantages and disadvantages. Among them, balloon expansion can provide stable support force and stability during the release process, but due to the material of its stent, it cannot be retrieved; the advantage of the self-expanding valve prosthesis is that it can be corrected and retrieved and released again in vivo. However, due to the nature of the self-expanding stent, its shape is not conducive to anchoring during the release process.

[0004] Currently, a wire control technology based on a self-expanding valve prosthesis appears. The purpose of wire control is to achieve the release mechanism of balloon expansion on the basis of the self-expanding valve prosthesis, increase the stability during the process, and thus improve the success rate of the operation.

[0005] In the wire control technology, there are two factors directly affecting the success rate of the operation: one is wire withdrawal, that is, the delivery device withdraws the pull wire from the stent. Because during the wire withdrawal process, the friction between the pull wire and the stent always generates a force on the stent, and this force is likely to cause the displacement of the stent, resulting in the failure of the operation; the other is wire breakage, that is, the delivery device end needs to provide a break point, which is a prerequisite for wire withdrawal. The wire breakage mechanism will affect the structure of the delivery device, increase the complexity of the operation, and affect the success rate of the operation.

[0006] In the existing wire control technology, a closed-path wire is required to cover part of the mesh of the stent, that is, the wire passes through at least two connection holes on the stent to form a closed structure around the stent. However, due to the long path of a single wire and the large friction between the wire and the native valve and the stent, it causes a problem of large wire withdrawal resistance, resulting in the stent being easily deformed or displaced.

[0007] Therefore, it is necessary to provide a new wire control structure to ensure the shape and position stability of the stent while withdrawing the wire, simplify the structure of the delivery device, and reduce the difficulty of the operation. Summary of the Invention

[0008] The object of the present invention is to provide a stent delivery system assembly and an artificial valve delivery system assembly, which can ensure the stability of the shape and position of the stent while withdrawing the wire, simplify the structure of the delivery device, reduce the difficulty of surgical operation, and improve the surgical success rate.

[0009] To solve the above technical problems, the present invention provides a stent delivery system assembly, which includes a radially expandable stent, a delivery device, and at least one set of pin connection wires; at least one connection hole is provided on the stent in the circumferential direction; the pin connection wire includes a head wire and at least one first connection wire, the first connection wire is connected to the delivery device and has a wire hole, after the wire hole passes through the connection hole, the first connection wire is bent at the connection hole and extends circumferentially around the stent for adjacent first connection wires or the head wire to pass through; the head wire has a first end and a second end, the first end of the head wire is connected to the delivery device, and the second end of the head wire passes through the connection hole on the stent and the wire hole of the first connection wire and is detachably connected to the delivery device.

[0010] Preferably, the second end of the head wire has a wire buckle, and a pin shaft is provided on the delivery device, and the wire buckle is sleeved on the pin shaft.

[0011] Preferably, the wire buckle is formed by connecting an open end of the head wire to the head wire itself, or the wire buckle is formed by connecting both open ends of the head wire to the delivery device.

[0012] Preferably, the wire hole is formed by connecting an open end of the first connection wire to the first connection wire itself, or the wire hole is formed by connecting both open ends of the first connection wire to the delivery device.

[0013] Preferably, the stent includes grid units formed by connecting stent rods, grid nodes are formed at the joints of adjacent stent rods, the stent includes multiple layers of grids in the axial direction, at least one connection hole is provided on at least one layer of grids, and the connection hole is provided at the grid node or on the stent rod.

[0014] Preferably, the pin connection wire wraps around the stent at least one week in the circumferential direction, and the sum of the number of the first connection wires and the head wire is equal to the number of connection holes on the same layer of grids of the stent.

[0015] Preferably, at least two of the connection holes are provided on the same layer of the grid. The at least two connection holes include a first connection hole and a second connection hole. The pin connection line includes at least two first connection lines. The at least two first connection lines include a first first connection line and a second first connection line. After the wire hole of the first first connection line passes through the first connection hole, the first first connection line is bent at the first connection hole; after the wire hole of the second first connection line sequentially passes through the second connection hole and the wire hole of the first first connection line, the second first connection line is bent at the second connection hole.

[0016] Preferably, at least two connection holes are provided on the same layer of the grid. The pin connection line includes at least two first connection lines. After the wire hole of the first first connection line in the pin connection line passes through the connection hole, the first connection line is bent at the connection hole; after the wire holes of the other first connection lines sequentially pass through the connection hole and the wire hole of the adjacent first connection line, the first connection line is bent at the connection hole.

[0017] Preferably, in the axial direction, the stent includes an inflow channel and an outflow channel. At least one of the connection holes is provided on at least one layer of the grid located in the inflow channel and at least one layer of the grid located in the outflow channel.

[0018] Preferably, the number of grid layers of the stent is 5 - 11 layers. At least one of the connection holes is provided on the top grid layer, the bottom grid layer and the middle grid layer of the stent.

[0019] Preferably, at least two connection holes are provided on the same layer of the grid. The multiple connection holes on the same layer of the grid are equally spaced in the circumferential direction.

[0020] Preferably, the delivery device includes a catheter and a control component. The first connection line and the head line are connected to the control component. A plurality of cavities are provided in the catheter. The first connection line and the head line pass through the cavities and are connected to the control component. The control component is used to control the tightness of the pin connection line.

[0021] Preferably, the catheter includes an inner core tube. A plurality of the cavities are provided in the inner core tube. The control component is a handle.

[0022] Preferably, the delivery device includes a catheter and a fixing head. The first connection line and the head line are connected to the fixing head. The fixing head is sleeved on the catheter and is coaxially arranged with the catheter. The fixing head can move along the axial direction of the catheter.

[0023] To solve the above technical problems, the present invention also provides an artificial valve delivery system assembly, including the above-mentioned stent delivery system assembly and leaflets connected to the stent and arranged inside the stent.

[0024] The present invention has the following beneficial effects compared with the prior art: The delivery system assembly and the artificial valve delivery system assembly provided by the present invention form at least one set of pin connection lines in the circumferential direction of the stent, and adjacent connection lines are sequentially connected in a pin connection manner to perform wire control on the stent. Compared with the existing wire control structure, it has at least the following advantages:

[0025] 1. The pin connection line adopted in the embodiment of the present invention includes a head wire and at least one connection wire. The first connection wire is connected to the delivery device and has a wire hole. After the wire hole passes through the connection hole, the first connection wire is bent at the connection hole, so that the wire hole extends circumferentially around the stent in the direction of the adjacent connection hole for the adjacent first connection wire or the head wire to pass through; or after the wire hole sequentially passes through the connection hole and the wire hole of the adjacent first connection wire, the first connection wire is bent at the connection hole, so that the wire hole extends in the direction of the adjacent connection hole; the head wire has a first end and a second end. The first end of the head wire is connected to the delivery device, and the second end of the head wire passes through the connection hole and the wire hole of the adjacent first connection wire and is detachably connected to the delivery device. By using the above connection method of the head wire and the first connection wire, only the connection between the head wire and the delivery device needs to be untied, and the restraint of the head wire and other first connection wires on the stent is untied together, that is, the wire removal of the entire stent's pin connection line can be achieved by untying once. Correspondingly, only one wire removal structure for the head wire needs to be provided on the delivery system, instead of setting a wire removal structure for each connection wire or head wire. Therefore, the wire removal steps and the structure of the delivery system are both simplified. In addition, with the above design, the length of the first connection wire only needs to be able to connect to the adjacent connection wire or head wire, and it is not necessary for each connection wire to be connected to the delivery system as in the prior art. Therefore, the path of the connection wire through the stent connection hole is relatively short, and the frictional resistance is small, thereby reducing the influence of the frictional resistance on the stent positioning during the wire removal process.

[0026] 2. In the wire control structure of the present invention, when both open ends of the connection wire are connected to the fixed component or the control component to form a wire hole or a wire buckle, each connection point between the connection wires and between the connection wire and the stent is a double-strand wire. The double-strand wire disperses the tension on the single-strand wire and reduces the risk of the connection wire breaking. Moreover, the direct contact and wear between the single-strand wire and the stent are very severe, while the closed loop formed by the two strands of wire can form a buffer, reduce the pulling wear between the connection wire and the stent, avoid the direct wear at the contact between the connection wire and the stent, and reduce the risk of wire pulling wear.

[0027] 3. The wire control structure provided by the present invention can be a set of pin connection wires that wrap around the bracket at least once. By untying one head wire, all connection wires can be removed, and the operation is simple. It can also be a multi-set of pin connection wires, each set of which has a head wire. By gradually untying the head wires of different sets of pin connection wires, the step-by-step release of the bracket can be achieved. For example, for an asymmetric bracket, multiple sets of pin connection wires are arranged in different regions to perform wire control in different regions according to the performance of each region, such as stiffness, height, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1a 、 Figure 1b is a schematic diagram of the connection structure between the first connection wire and the fixed head in the first embodiment of the present invention;

[0029] Figure 2a 、 Figure 2b 、 Figure 2c is a schematic diagram of the connection structure between the head wire and the fixed head in the first embodiment of the present invention;

[0030] Figure 3a 、 3b 3c, 3d are schematic diagrams of four different connection structures of the head wire in the pin connection wire in the first embodiment of the present invention;

[0031] Figure 4 is a schematic diagram of the structure of the bracket conveying system assembly in the second embodiment of the present invention;

[0032] Figure 5 is a schematic diagram of the friction between the connection wire and the bracket in the embodiment of the present invention;

[0033] Figure 6a is the mesh form of the bracket before being constrained by the pin connection wire in the embodiment of the present invention, Figure 6b is the mesh form of the bracket after being unfolded before being constrained by the pin connection wire, Figure 6c is the mesh form of the bracket after being unfolded after being constrained by the pin connection wire.

[0034] In the figure:

[0035] 1 - fixed head, 2 - first connection wire, 3 - head wire, 4 - bracket, 5 - pin shaft, 10 - pin connection wire, 21 - wire hole, 31 - first end, 32 - second end, 33 - wire buckle, 41 - connection hole, 42 - mesh unit, 43 - bracket rod, 44 - mesh node, 6 - inner core tube, 61 - cavity, 101 - outer wire, 102 - inner wire. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0036] The present invention will be further described below with reference to the drawings and embodiments.

[0037] The present invention provides a stent delivery system assembly, including an annular stent 4, a delivery device, and at least one set of pin connection lines 10; the stent 4 is a self-expanding stent, which can expand radially, and is configured to be radially expandable from a first state to a second state and radially contractible from the second state to the first state. At least one connection hole 41 is provided on the stent 4 in the circumferential direction; in a specific embodiment, please refer to Figure 4 (Only a partial structure of the stent is schematically shown). The stent 4 includes grid units 42 formed by connecting stent rods 43 to form a closed shape. Grid nodes 44 are formed at the joints of adjacent stent rods 43. The stent 4 includes multiple layers of grids in the axial direction, and at least one connection hole 41 is provided on at least one layer of grids; for a retrievable stent, at least two layers of grids are provided with the connection hole 41, and at least one connection hole 41 is provided on the same layer of grids. When multiple connection holes 41 are provided on the same layer of grids, the distribution mode of the connection holes 41 on each layer of grids in the circumferential direction can be continuous or spaced; preferably, the multiple connection holes 41 on the same layer of grids are equally spaced in the circumferential direction. The position of the connection hole 41 can be set at the grid node 44 as shown in Figure 4 or at other stent rods. Taking a valve prosthesis as an example, the stent 4 includes an inflow channel and an outflow channel in the axial direction. According to the direction of blood flow, the outflow channel is located downstream of the inflow channel. The inflow channel corresponds to the part where blood flows into the stent during the operation of the valve prosthesis, and the outflow channel corresponds to the part where blood flows out of the stent during the operation of the valve prosthesis. Preferably, the connection holes 41 are provided on both the inflow channel and the outflow channel. More preferably, at least one connection hole 41 is provided on the grids at the top layer and the bottom layer of the stent 4 respectively. When the length of the stent 4 in the axial direction is relatively long, connection holes 41 can be added in the middle of the stent 4 as needed. For example, when the number of grid layers of the stent is 5 - 11 layers, at least one connection hole 41 is also provided on the middle layer grid of the stent 4. Specifically, on which middle layer grid to set is not limited in the present invention and can be selected according to needs as long as the stent 4 can be loaded and released isodiametrically. By providing pin connection lines 10 on multiple layers of grids to form multiple wire control structures, it can ensure that the stent 4 expands or contracts isodiametrically synchronously, as shown in Figure 6a 、 6b and 6c, avoiding the appearance of a conical profile, thereby avoiding the situation that is not conducive to clinical anchoring and affecting the surgical effect caused thereby. The present invention does not limit the structure of the connection hole 41, as long as it can allow the head wire 3 and / or the first connection wire 2 to pass through. The present invention also does not limit the setting method and setting position of the connection hole 41. For example, the connection hole 41 can also be provided at the grid node at the end of the inflow channel or the outflow channel of the stent, or a connection hole is provided on the lug.

[0038] Embodiment 1

[0039] In this embodiment, the conveying device includes a catheter and a fixing head 1. The fixing head 1 is sleeved on the catheter, and the two are arranged coaxially. The fixing head 1 can move axially along the catheter.

[0040] The pin connection line 10 includes at least one first connection line 2 and a head line 3. The first connection line 2 is connected to the fixing head 1 and has a wire hole 21. For the first first connection line 2, after its wire hole 21 passes through the connection hole 41 on the bracket 4, the first connection line 2 is bent at the connection hole 41, and the wire hole 21 extends circumferentially around the bracket 4 for the next first connection line 2 or the head line 3 to pass through. When the number of connection holes 41 on the same layer of grid is one, the pin connection line 10 includes a first connection line 2 and a head line 3, and the wire hole 21 extends circumferentially around the bracket 4 for the head line 3 to pass through; when the number of connection holes 41 on the same layer of grid is multiple, the connection holes 41 at least include a first connection hole and a second connection hole. The pin connection line 10 includes at least two first connection lines 2. The at least two first connection lines 2 include a first first connection line and a second first connection line. After the wire hole of the first first connection line passes through the first connection hole, the first first connection line is bent at the first connection hole; after the wire hole of the second first connection line sequentially passes through the second connection hole and the wire hole of the first first connection line, the second first connection line is bent at the second connection hole; preferably, the wire hole 21 of the first first connection line extends to the second connection hole; the head line 3 has a first end 31 and a second end 32. The first end 31 of the head line 3 is connected to the fixing head 1, and the second end 32 of the head line 3 passes through the connection hole 41 on the bracket 4 and the wire hole 21 of the adjacent first connection line 2 and is detachably connected to the conveying device. The first connection line 2 and the head line 3 form the pin connection line 10 circumferentially around the bracket 4.

[0041] Therefore, all the connection lines in this embodiment can be divided into two types of structures. The first type is the first connection line 2, and the second type is the head line 3. The difference between the two is that the head line 3 is the first line to be withdrawn in a set of pin connection lines 10, and the second end 32 of the head line 3 should be able to be disconnected to form a free end.

[0042] For the first connection line 2 provided in this embodiment, please refer to Figure 1a In an embodiment, both open ends of the first connection line 2 are connected to the fixing head 1 to form a closed structure, so that it has a wire hole 21 near the bracket 4. Please refer to Figure 1b, in another embodiment, an open end of the first connecting line 2 is connected to itself to form a wire hole 21, and the other open end of the first connecting line 2 is connected to the fixing head 1. In other embodiments, the first connecting line 2 may also be entirely composed of a ring-shaped wire, so that it has a wire hole 21 near the bracket 4, and the adjacent first connecting line 2 or the head wire 3 passes through the wire hole 21. As long as a wire hole 21 is formed at one end of the first connecting line 2 near the bracket 4 as a pin hole structure for the adjacent connecting lines to pass through to form a pin connection line 10, the specific shape of the first connecting line 2 is not particularly limited in the present invention. The first connecting line 2 described in the present invention does not necessarily form a closed structure and may be an open-loop structure. For example, the two open ends of the first connecting line 2 are respectively connected to different components of the conveying device to form an open-loop structure.

[0043] The head wire 3 provided by the present invention can have various structures, such as Figure 2a , Figure 3a and Figure 3c shown, the head wire 3 has an open end. In one embodiment, as Figure 2a , Figure 3a shown, the open end of the head wire 3 is provided on other components of the catheter except the fixing head 1, and the open end of the head wire 3 is disconnected to form a cut. As Figure 3c shown, an open end of the head wire 3 is connected to the head wire 3 itself to form a wire buckle 33, the wire buckle 33 is provided at the second end 32 of the head wire 3, and a pin shaft 5 is provided on the fixing head 1 or other components of the catheter, and the wire buckle 33 is sleeved on the pin shaft 5. In another embodiment, as Figure 2b , Figure 2c , Figure 3b , Figure 3d shown, both open ends of the head wire 3 are connected to the fixing head 1 to form a closed loop, or the head wire 3 is composed of a ring-shaped wire and is itself a closed loop. One end of the closed loop, that is, the second end 32 of the head wire 3, is a wire buckle 33, and a pin shaft 5 is provided on the fixing head 1 or other components of the catheter, and the wire buckle 33 is buckled on the pin shaft 5. In other embodiments, the second end 32 of the head wire 3 can be fixed on other components except the fixing head 1 to form an open-loop structure, as long as it is ensured that the second end 32 of the head wire 3 can be disconnected to form a free end.

[0044] Therefore, the connection method of the connecting line and the conveying device, as Figure 3b , 3c and 3d shown: all the first connecting lines 2 are connected to the fixing head 1 to form a closed structure. The head wire 3 can have various embodiments, such as: (1) an open-loop structure; (2) a closed-loop pin connection structure.

[0045] (1) Open-loop structure:

[0046] As Figure 3a shown, the first end 31 of the head wire 3 is fixed on the fixed head 1, and the second end 32 of the head wire 3 is not directly fixed on the fixed head 1, but is arranged on other components of the catheter, so as to form a cut by disconnecting the second end 32 of the head wire 3.

[0047] (2) Closed-loop pin connection structure:

[0048] As Figure 3b and Figure 3c shown, after both open ends of the head wire 3 are fixed on the fixed head 1, the head wire 3 forms a closed structure, that is, it has a wire buckle 33, and the wire buckle 33 forms a pin connection with the pin shaft 5 arranged on the fixed head 1. Or, the head wire 3 is a ring-shaped wire and itself has a wire buckle 33. The first end 31 of the head wire 3 is fixed on the fixed head 1, and the second end 32 of the head wire 3, that is, the wire buckle 33, forms a pin connection with the pin shaft 5 arranged on the fixed head 1. In this way, the wire can be withdrawn by removing the pin shaft 5. The head wire 3 can also have one open end as the first end 31, which is fixed on the fixed head 1, and a wire buckle 33 is arranged at the second end 32 of the head wire 3. The wire buckle 33 can be formed by connecting the other open end of the head wire 3 to the head wire 3 itself. This wire buckle 33 is the reserved pin connection hole, as Figure 3c shown.

[0049] In a specific embodiment, please refer to Figure 3a 、 Figure 3b and Figure 3c . The connection method between the connecting wire and the bracket 4 is as follows: all the first connecting wires 2 and the head wire 3 are circumferentially distributed around the bracket 4 and form pin connections in sequence, covering the bracket 4 at least one week in the circumferential direction. Preferably, the distribution quantity of the connecting wires is equal to the quantity of the connection holes 41 on the same layer of grid of the bracket 4. Of course, as Figure 3d shown, there may also be no connecting wire covering through along the circumferential direction of the bracket 4 between some adjacent connection holes 41; or multiple connecting wires are arranged in some connection holes 41.

[0050] Please continue to refer to Figure 3a 、 Figure 3b and Figure 3c, the head wire 3 serves as the last connecting wire. The wire hole 21 of the first first connecting wire 2 passes through the connecting hole 41 of the bracket 4, then bends in any direction and extends to the next adjacent connecting hole 41 in that direction. The wire hole 21 of the next first connecting wire 2 needs to pass through the connecting hole 41 of the bracket 4 and the wire hole 21 of the adjacent previous connecting wire at the same time and then bend. For the previous first connecting wire 2, it is equivalent to forming a pinning wire. Distributed circumferentially according to such a rule, except for the first first connecting wire 2, the wire hole 21 of each first connecting wire 2 passes through the bracket connecting hole 41 and the wire hole 21 of the previous adjacent first connecting wire 2 at the same time. Finally, after the head wire 3 passes through the wire hole 21 of the last first connecting wire 2, it can wind around the first first connecting wire 2 at the same time to form a head-to-tail connection, as Figure 3a shown; the head wire 3 can also directly pass through the connecting hole 41 passed through by the first first connecting wire 2 without connecting to the first first connecting wire 2, as Figure 3b and 3c shown.

[0051] In another embodiment, circumferentially around the bracket 4, multiple groups of the pinning connection wires 10 provided by the present invention are adopted, and each group of pinning connection wires 10 has a head wire 3; arranged in this way, the bracket can be gradually released by gradually withdrawing each group of pinning connection wires 10, which is more applicable to the valve prosthesis that needs to be anchored. Or for an asymmetric bracket, a group of pinning connection wires 10 is arranged in a divided area, so as to respectively perform wire control on the bracket according to the performance of each area, such as stiffness, height, etc., to reduce damage to the bracket 4.

[0052] As Figure 3d shown, a group of pinning connection wires 10 is provided on a part of the circumference of the bracket 4, and the head wire 3 therein is connected to the pin shaft 5 on the fixed head 1 by pinning. The present invention does not particularly limit the structure of the pin shaft 5, which can be a metal wire or other wire ropes. In other embodiments, it can also be that an open-loop head wire 3 is provided in each group of pinning connection wires 10.

[0053] When loading or retrieving the bracket 4, move the fixed head 1 along the axial direction of the catheter to make the bracket 4 radially contract to the first state, and both ends of the bracket 4 are constrained by the connecting wires to complete loading / retrieving; when the bracket 4 is transported to the lesion site, move the fixed head 1 along the axial direction of the catheter to make the bracket 4 radially expand to the second state, and the bracket 4 is expanded under the action of the elastic force of the connecting wires to achieve anchoring. The advantage of wire control is that it can enable the self-expanding stent to achieve an equal-diameter and uniform release like a balloon-expandable stent, reducing the axial sliding during the re-anchoring process.

[0054] The method and steps of the final wire withdrawal: Usually, the head wire 3 needs to be withdrawn first. For the head wire 3 of the open-loop structure: The withdrawal method is to disconnect one end of the head wire 3 to make it have a free end. The disconnection method of the head wire 3 can be unclasping, cutting, or releasing the pressure block, etc. Pull out the head wire 3, then the first connecting wire 2 pinned by the head wire 3 is unpinned, and then the first connecting wire 2 is pulled out, and the remaining first connecting wires 2 are pulled out in sequence.

[0055] For the head wire 3 of the closed-loop pinning structure: The pin shaft 5 needs to be removed through the conveying device, and then the subsequent actions after pulling out the head wire 3 remain unchanged, and the first connecting wires 2 are pulled out in sequence.

[0056] Embodiment 2

[0057] The connection relationship between the pinning wire and the bracket 4 in the medical delivery system assembly provided in this embodiment is the same as that in Embodiment 1. Different from Embodiment 1, the other ends of the first connecting wire 2 and the head wire 3 are not connected to the fixed head 1, but are connected to the control component. The control component in this embodiment is a handle (not shown in the figure). Specifically, please refer to Figure 4 , the conveying device includes a catheter. The catheter includes a plurality of cavities. An inner core tube 6 with a plurality of cavities 61 can be arranged in the catheter. The first connecting wire 2 and the head wire 3 that make up the pinning wire 10 are respectively connected to the handle (not shown in the figure) after passing through the corresponding cavities 61 on the inner core tube 6. The first connecting wire 2 and the head wire 3 can be directly connected to the handle end, or can be connected to the handle through an intermediate transition part such as a thin wire. Specifically, one end of the thin wire is connected to the first connecting wire 2 or the head wire 3, and the other end of the thin wire is connected to the handle, so as to achieve the purpose of controlling the pulling wire and the bracket by controlling the thin wire. The pin shaft 5 is arranged in one of the cavities 61 of the inner core tube 61. During loading or recovery, the power source at the handle end pulls the pinning wire 10 on the inflow channel and the outflow channel, so that both ends of the bracket 4 are radially contracted to the first state by the pinning wire 10 and the loading / recovery is completed; when the bracket 4 is conveyed to the lesion site, the power source at the handle end is controlled to relax the pinning wire 10, so that the bracket 4 is radially expanded to the second state under the action of elastic force, thereby realizing anchoring.

[0058] The method and steps of the final wire withdrawal: Remove the pin shaft 5 by controlling the power source at the handle end, and then pull out the head wire 3. Then the first connecting wire 2 pinned by the head wire 3 is unpinned, and then the first connecting wire 2 is pulled out, and the remaining first connecting wires 2 are pulled out in sequence.

[0059] This embodiment also provides an artificial valve delivery system assembly, including the above-mentioned stent delivery system assembly and leaflets connected to the stent 4 and arranged inside the stent 4. Further, a skirt is provided on the inner surface or / and the outer surface of the stent 4.

[0060] In the prior art, a connecting wire covering part of the grid requires a closed path, and the wire removal is complicated. In the present invention, adjacent connecting wires are connected in sequence by pin connection to control the bracket. The present invention has at least the following advantages compared with the prior art wire control structure:

[0061] 1. The embodiment of the present invention adopts a pin-connected wire including a head wire and at least one connecting wire. The first connecting wire is connected to the conveying device and has a wire hole. After the wire hole passes through the connecting hole, the first connecting wire is bent at the connecting hole so that the wire hole extends circumferentially around the bracket in the direction of the adjacent connecting hole for the adjacent first connecting wire or the head wire to pass through; or after the wire hole sequentially passes through the connecting hole and the wire hole of the adjacent first connecting wire, the first connecting wire is bent at the connecting hole so that the wire hole extends in the direction of the adjacent connecting hole; the head wire has a first end and a second end. The first end of the head wire is connected to the conveying device, and the second end of the head wire passes through the connecting hole and the wire hole of the adjacent first connecting wire and is detachably connected to the conveying device. By using the above connection method of the head wire and the first connecting wire, only the connection between the head wire and the conveying device needs to be untied, and the restraint of the head wire and other first connecting wires on the bracket is untied together, that is, the wire removal of the pin-connected wire of the entire bracket can be realized by untying once. Correspondingly, only one unlocking structure for the head wire needs to be provided on the conveying system, and there is no need to provide an unlocking structure for each connecting wire or head wire. Therefore, both the wire removal steps and the structure of the conveying system are simplified. In addition, with the above design, the length of the first connecting wire only needs to be able to be connected to the adjacent connecting wire or head wire, and there is no need for each connecting wire to be connected to the conveying system as in the prior art. Therefore, the path of the connecting wire passing through the bracket connecting hole is relatively short, and the frictional resistance is small, thereby reducing the influence of the frictional resistance on the bracket positioning during the wire removal process.

[0062] 2. In the wire control structure of the present invention, when both open ends of the connecting wire are connected to the fixed component or the control component to form a wire hole or a wire buckle, each connection point between the connecting wires and between the connecting wire and the bracket is a double-strand wire. The double-strand wire disperses the tension on the single-strand wire and reduces the risk of the connecting wire breaking. Moreover, the direct contact between the single-strand wire and the bracket causes severe wear, while the closed loop formed by the two strands of wire can form a buffer, reducing the pulling wear between the connecting wire and the bracket, avoiding the direct wear at the contact between the connecting wire and the bracket, and reducing the risk of wire pulling wear.

[0063] 3. The wire control structure provided by the present invention can be a set of pin connection wires that wrap around the bracket at least once. Unraveling one head wire can achieve the removal of all connection wires, and the operation is simple. It can also be provided with multiple sets of pin connection wires, and each set of pin connection wires has a head wire. By unraveling the head wires of different sets of pin connection wires step by step, the step-by-step release of the bracket can be achieved. For example, for an asymmetric bracket, multiple sets of pin connection wires are arranged in different regions, and wire control can be performed in different regions according to the performance of each region, such as stiffness, height, etc.

[0064] Although the present invention has been disclosed above with preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be defined by the claims.

Claims

1. A stent delivery system assembly, characterized in that, Comprising a radially expandable stent, a delivery device, and at least one set of pin connection wires; At least one connection hole is circumferentially provided on the stent. The stent includes grid units formed by connecting stent rods. Grid nodes are formed at the joints of adjacent stent rods. The stent includes multiple layers of grids axially. At least one connection hole is provided on at least one layer of grids, and the connection hole is provided at a grid node or on a stent rod; The pin connection wire includes a head wire and at least one first connection wire. The first connection wire is connected to the delivery device and has a wire hole. After the wire hole passes through the connection hole, the first connection wire is bent at the connection hole. The wire hole extends circumferentially around the stent for adjacent first connection wires or the head wire to pass through; The head wire has a first end and a second end. The first end of the head wire is connected to the delivery device. The second end of the head wire passes through the connection hole and the wire hole of the first connection wire and is detachably connected to the delivery device; The pin connection wire circumferentially wraps the stent at least once, and the sum of the number of the first connection wires and the head wire is equal to the number of connection holes on the same layer of grids of the stent.

2. The stent delivery system assembly according to claim 1, wherein The second end of the head wire has a wire buckle, and a pin shaft is provided on the delivery device, and the wire buckle is sleeved on the pin shaft.

3. The stent delivery system assembly according to claim 2, wherein, The wire buckle is formed by connecting an open end of the head wire to the head wire itself, or the wire buckle is formed by connecting both open ends of the head wire to the delivery device.

4. The stent delivery system assembly according to claim 1, wherein, The wire hole is formed by connecting an open end of the first connection wire to the first connection wire itself, or the wire hole is formed by connecting both open ends of the first connection wire to the delivery device.

5. The stent delivery system assembly according to claim 1, characterized in that, At least two connection holes are provided on the same layer of grids. The at least two connection holes include a first connection hole and a second connection hole. The pin connection wire includes at least two first connection wires. The at least two first connection wires include a first first connection wire and a second first connection wire. After the wire hole of the first first connection wire passes through the first connection hole, the first first connection wire is bent at the first connection hole; After the wire hole of the second first connection wire sequentially passes through the second connection hole and the wire hole of the first first connection wire, the second first connection wire is bent at the second connection hole.

6. The stent delivery system assembly according to claim 1, wherein, The stent includes an inflow channel and an outflow channel axially. At least one connection hole is provided on at least one layer of grids located in the inflow channel and at least one layer of grids located in the outflow channel.

7. The stent delivery system assembly according to claim 6, wherein The number of grid layers of the stent is 5 - 11 layers, and at least one connection hole is provided on the top grid layer, the bottom grid layer, and the middle grid layer of the stent.

8. The stent delivery system assembly according to claim 1, wherein At least two connection holes are provided on the same layer of grids, and the at least two connection holes are equally spaced circumferentially.

9. The stent delivery system assembly according to any one of claims 1-4, characterized in that, The delivery device includes a catheter and a control component. The first connection wire and the head wire are connected to the control component. Multiple cavities are provided in the catheter. The first connection wire and the head wire pass through the cavities and are connected to the control component. The control component is used to control the tightness of the pin connection wire.

10. The stent delivery system assembly according to claim 9, characterized in that, The catheter includes an inner core tube, and a plurality of the cavities are arranged in the inner core tube, and the control component is a handle.

11. The stent delivery system assembly according to any one of claims 1-4, characterized in that, The delivery device includes a catheter and a fixing head. The first connecting wire and the head wire are connected to the fixing head. The fixing head is sleeved on the catheter and is coaxially arranged with the catheter, and the fixing head can move along the axial direction of the catheter.

12. An artificial valve delivery system assembly, characterized in that, It includes the stent delivery system assembly according to any one of claims 1-11 and leaflets connected to the stent and arranged inside the stent.

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