Conveyor assembly, conveyor system and loading method

Abstract

The present invention discloses a delivery assembly, a delivery system, and a loading method. The delivery assembly includes a delivery channel, a stopper, and a flexible wire. The delivery channel includes an inner sheath tube, an outer sheath tube, and a sheath core tube. The stopper is disposed at the distal end of the gap. The stopper includes multiple first main channels extending through the proximal and distal end faces and / or multiple second main channels extending through the inner and outer walls. The flexible wire is wound around the stopper along the first and / or second main channels, and the flexible wire passes through multiple first wave crests on the same wave coil of the stent to be delivered. The flexible wire compresses the distal end of the stent radially against the stopper. The delivery system includes a delivery assembly and a control assembly. By providing a stopper on the delivery assembly, the wave coil at the distal end of the stent is removably mounted on the stopper using the flexible wire during the stent release process. This prevents the stent from contacting or abutting the vessel wall during release, causing the stent to become directly anchored. Instead, the position of the stent can be continuously adjusted for accurate positioning.

Description

Technical Field

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

[0002] Generally speaking, when using a stent, it is necessary to first load the stent into the delivery assembly, and then use the delivery assembly to transport the stent to the designated position and then release it to achieve the work. When releasing the stent, the delivery assembly is generally withdrawn to allow the stent to expand naturally. The expansion of the stent is natural expansion, and its expansion rate is difficult to estimate. When a part of the stent leaves the delivery assembly, it directly expands naturally and is prone to direct contact with the blood vessel wall. After the stent expands and contacts the blood vessel wall, the stent with a barbed structure will be directly anchored on the blood vessel wall. In this case, the position of the stent is directly locked. Since the release of the stent is achieved by the movement of the outer sheath tube of the delivery assembly relative to the inner sheath core tube, and the stent itself is attached to the outer sheath tube due to its self-expanding properties, the stent in the release stage is easily driven away from the predetermined position by the outer sheath tube, causing the final release position of the stent to shift. Summary of the Invention

[0003] To this end, the present invention provides a delivery assembly, a delivery system and a loading method to solve the problem that when the existing delivery device releases the stent, the stent position is offset or directly contacts the blood vessel wall and becomes anchored.

[0004] The technical solution adopted in the present invention is:

[0005] A delivery assembly is provided, comprising a delivery channel, wherein the delivery channel comprises an inner sheath tube, an outer sheath tube and a sheath core tube, the sheath core tube is passed through the inner sheath tube, and the distal end of the sheath core tube extends from the distal end of the inner sheath tube, the outer sheath tube is sleeved on the outside of the inner sheath tube, and a gap for loading a stent is provided between the outer sheath tube and the sheath core tube; a limiting member, wherein the limiting member is arranged at the distal end of the gap, the limiting member comprises a proximal end face, a distal end face opposite to the proximal end face, an inner wall close to the sheath core tube and an outer wall opposite to the inner wall, the limiting member also comprises a plurality of first main channels passing through the proximal end face and the distal end face and / or a plurality of second main channels passing through the inner wall and the outer wall; a soft wire, the soft wire is wound around the limiting member along the first main channel and / or the second main channel, and the soft wire passes through a plurality of first wave peaks on the same wave circle of the stent to be delivered, and the soft wire compresses the distal end of the stent onto the limiting member along the radial portion.

[0006] In one embodiment, a plurality of the first main channels are parallel to each other.

[0007] In one embodiment, a plurality of the second main channels are parallel or collinear with each other.

[0008] In one embodiment, the proximal surface of the limiting member is concave.

[0009] In one embodiment, the inner sheath is provided with a plurality of branching channels, and the branching channels are connected to the gap for the delivery cord to pass through.

[0010] In one embodiment, a middle piece is further included. The middle piece is located at the proximal end of the delivery channel. The middle piece is provided with a plurality of secondary channels. The plurality of secondary channels are parallel or collinear with each other.

[0011] A conveying system is also provided, comprising the conveying component described above and a control component, wherein the control component comprises a slider and a slide groove fixed to the outer sheath tube, and when the slider moves along the slide groove, it drives the outer sheath tube to move relative to the sheath core tube.

[0012] A method for loading a bracket is also provided, and the steps are as follows:

[0013] S1: The distal end coil of the stent is mounted on a stopper via a flexible wire. The first and second ends of the flexible wire extend along the same or parallel channels of the stopper and are stretched straight, so that the distal end of the stent is radially compressed against the stopper.

[0014] S2 keeps the core tube of the delivery assembly in the same position, while pushing the outer sheath tube of the delivery assembly toward the distal end until the outer sheath tube completely covers the stent.

[0015] In one embodiment, step S1 further includes:

[0016] S11: The distal end of the bracket is tied to the middle piece through a pull wire, and the first end and the second end of the pull wire extend along the same or mutually parallel through hole of the middle piece, and the first end and the second end of the pull wire are kept straight.

[0017] In one embodiment, step S2 further includes:

[0018] After the outer sheath completely covers the stent, S21 releases one end of the pull wire and pulls the other end of the soft wire to retract the pull wire.

[0019] Beneficial effects of the embodiments of the present invention:

[0020] The delivery assembly of the present invention is provided with a limiter on the delivery assembly. During the release process of the stent, the coil at the distal end of the stent is removably mounted on the limiter using a soft wire. When the distal end of the stent is released, it expands. At this time, the expansion of the stent is restrained by the tension of the soft wire, causing the stent itself to be in a semi-expanded state. At this time, the stent does not contact or abut against the blood vessel wall, causing the stent to be directly anchored, but can continue to adjust its position for accurate positioning. The delivery system of the present invention utilizes the delivery assembly of the present invention, combined with the limiter, to complete the reliable release of the stent. The control assembly of the delivery assembly can directly control the movement of the outer sheath to release the stent. In the loading method of the present invention, the soft wire is first semi-compressed on the distal end of the stent to adjust the stent to the accurate position during the final release process of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of the conveying system in Example 1;

[0022] Figure 2 is a schematic structural diagram of the conveying assembly in Example 1;

[0023] Figure 3 Schematic diagram of the loading process of the endoluminal stent in Example 1;

[0024] Figure 4 This is a schematic diagram of the routing of the limiting member of the conveying assembly in Example 1;

[0025] Figure 5 is a schematic diagram of the wiring of the limiter in another embodiment;

[0026] Figure 6 It is a force diagram when the flexible wire and the bracket are in the first contact state;

[0027] Figure 7 is a force diagram when the flexible wire and the bracket are in the second contact state;

[0028] Figure 8 It is a force diagram when the flexible wire and the bracket are in the third contact state;

[0029] Figure 9 is a force diagram when the flexible wire and the bracket are in the fourth contact state;

[0030] Figure 10 is a schematic diagram of the longitudinal cross-section structure of the middle piece in another embodiment;

[0031] Figure 11 This is a schematic diagram of the wiring of the middleware of the conveying assembly in Example 2;

[0032] Figure 12 This is a schematic diagram of the wiring of the middleware of the conveying assembly in Example 3;

[0033] Figure 13 is a schematic structural diagram of the middle piece of the conveying assembly in Example 4;

[0034] Figure 14 This is a schematic diagram of the wiring of the middleware of the conveying assembly in Example 4;

[0035] Figure 15 is a schematic structural diagram of the middle piece of the conveying assembly in Example 5;

[0036] Figure 16 This is a schematic diagram of the wiring of the middleware of the conveying assembly in Example 5;

[0037] Figure 17 is a schematic diagram of the operation of the conveying assembly in the loading stage in Example 6;

[0038] Figure 18 This is a schematic diagram of the first-view operation of the position-limiting member in the conveying assembly in Example 7;

[0039] Figure 19 2. This is a schematic diagram showing the working of the limiting member in the conveying assembly in Example 7 from a second perspective;

[0040] Figure 20 This is a schematic diagram of the first-view operation of the position-limiting member in the conveying assembly in Example 8;

[0041] Figure 21 This is a second perspective working diagram of the limiting member in the conveying assembly in Example 8. DETAILED DESCRIPTION

[0042] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the accompanying drawings. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0043] In the description of the present invention, if any directional description is involved, such as "upper," "lower," "front," "back," "left," "right," etc., indicating directions or positional relationships, these are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, be constructed or operate in a specific orientation, and therefore should not be understood as limiting the present invention. If a feature is referred to as being "disposed," "fixed," or "connected" to another feature, it may be disposed, fixed, or connected to the other feature directly or indirectly.

[0044] In the description of the embodiments of the present invention, if the word "several" is mentioned, it means more than one; if the word "plurality" is mentioned, it means more than two; if the word "greater than," "less than," or "exceeds," it should be understood as excluding the number itself; if the word "above," "below," or "within" is mentioned, it should be understood as including the number itself. If the word "first" or "second" is mentioned, it should be understood as distinguishing technical features and should not be understood as indicating or implying relative importance, implicitly specifying the number of the indicated technical features, or implicitly specifying the order of the indicated technical features.

[0045] In addition, unless otherwise defined, the technical and scientific terms used in the embodiments of the present invention have the same meanings as those commonly understood by those skilled in the art. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the relevant listed items.

[0046] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device. "Axial" generally refers to the length of the medical device during delivery, while "radial" generally refers to the direction perpendicular to the "axial" direction of the medical device. This principle is used to define the "axial" and "radial" directions of any component of a medical device.

[0047] For the convenience of description, the implant to be implanted in the embodiments involved in this application is selected as a luminal stent.

[0048] Example 1

[0049] Example 1 provides a delivery assembly and a delivery system, as shown in the attached specification. Figure 1-3 As shown, Figure 1 is a schematic structural diagram of the conveying system 1 in Example 1, Figure 2 is a schematic structural diagram of the conveying assembly 10 in Example 1, Figure 3 It is a schematic diagram of the release process of the luminal stent 30 in Example 1. The delivery system 1 includes a delivery component 10 and a control component 20 for controlling the movement of the delivery component 10. During actual operation, the delivery component 10 is already loaded with the luminal stent 30 to be delivered. The delivery component 10 transports the luminal stent 30 to be delivered to the designated position. The control component 20 controls the movement of the delivery component and releases the luminal stent 30 at that position, completing the entire implantation process.

[0050] The conveying assembly 10 includes a tube body 100, which includes an inner sheath tube 110, an outer sheath tube 120 and an inner sheath core tube 130. The outer sheath tube 120 is sleeved on the outside of the inner sheath tube 110, the inner sheath core tube 130 passes through the inner sheath tube 110 and the distal end of the inner sheath core tube 130 extends from the inner sheath tube 110. There is a gap between the inner sheath core tube 130 located outside the inner sheath tube 110 and the outer sheath tube 120.

[0051] The tube body 100 of the transport assembly 10 also wraps a tip head 140 located at the distal end of the inner sheath core tube 130 . The tip head 140 is hollow in design and is made of a material that is opaque to X-rays.

[0052] The control assembly 20 includes a slider 210 and a housing 220. The inner sheath 110 axially extends through the proximal and distal end faces of the housing 220. The sidewall of the outer sheath 120 near the proximal end is fixedly connected to the slider 210. When the slider 210 moves along the chute, it can drive the outer sheath 120 to move axially. Preferably, the control assembly 20 is configured as a handle, and multiple control units can be provided on the handle, wherein the slider 210 controls the axial movement of the outer sheath 120.

[0053] In another embodiment, under the condition that the slider 210 is retained to control the independent movement of the outer sheath tube 120 , another slider is provided to realize the overall movement of the tube body 100 .

[0054] It should be noted that the slider is only a specific implementation of the conveying system 1 of this embodiment. The conveying system 1 of this embodiment uses a slider to achieve the axial displacement of the outer sheath tube 120. This embodiment does not limit the use of only the slider to achieve the purpose of controlling the axial displacement of the outer sheath tube 120.

[0055] In this embodiment, the endoluminal stent 30 is in a compressed state during the delivery phase, changes from the compressed state to the expanded state during the release phase, and changes from the expanded state to the compressed state during the loading phase.

[0056] During the transport phase, the tubular stent 30 is loaded in the cavity between the distal end of the inner sheath core tube 130 and the distal end of the outer sheath tube 120, and contacts the outer surface of the inner sheath core tube 130. During the entire transport phase, the inner sheath tube 110, the outer sheath tube 120, the inner sheath core tube 130 and the tubular stent 30 move synchronously to ensure that the tubular stent 30 can reach the predetermined position.

[0057] During the release phase, the outer sheath tube 120 moves axially toward the proximal end relative to the inner sheath core tube 130 , and the luminal stent 30 gradually expands as the outer sheath tube 120 withdraws until it is finally released into a natural expanded state.

[0058] Since the expansion of the luminal stent 30 is natural expansion, its expansion speed is difficult to estimate. When a part of the luminal stent 30 leaves the outer sheath 120, it expands naturally and is easy to directly contact the blood vessel wall. And after the luminal stent 30 is partially released and contacts the blood vessel wall, it will be directly anchored (generally, the luminal stent is provided with a barb structure for anchoring) on ​​the blood vessel wall. In this case, the position of the luminal stent 30 is directly locked. And since the release of the luminal stent 30 is carried out by the movement of the outer sheath 120 relative to the inner sheath core tube 130, the luminal stent 30 is easily driven by the outer sheath 120 to leave the predetermined position. Therefore, in this embodiment, a limiter 150 is used to limit the luminal stent 30, as follows:

[0059] In this embodiment, one end of the luminal stent 30 close to the tip head 140 is fixed to the limiter 150 by the soft wire 40. When the luminal stent 30 is released, the limiter 150 cooperates with the soft wire 40 to limit the complete expansion of the luminal stent 30. At this time, the luminal stent 30 is in a semi-expanded state. In this state, the luminal stent 30 can be precisely positioned and adjusted. After the luminal stent 30 reaches the correct position, the soft wire 40 is withdrawn, so that the luminal stent 30 can expand normally in the correct position.

[0060] In this embodiment, the limit member 150 is located at the distal end of the inner sheath core tube 130. The limit member 150 takes the installation position of the tubular bracket 30 (that is, the gap between the inner sheath core tube 130 and the outer sheath tube 120) as the loading section on the inner sheath core tube 130. The limit member 150 is located at the distal end of the loading section, that is, the limit member 150 is located on the side close to the Tip head 140.

[0061] It should be noted that in this embodiment, the soft wire is bound to the bare wave ring of the luminal stent 30 in order to more easily illustrate the method of binding the soft wire. In another embodiment, a small hole can be provided on the covering of the luminal stent 30, and the soft wire passes through the small hole to bind the luminal stent 30; in another embodiment, the wave crest of the luminal stent 30 is not in contact with the covering to allow the soft wire to pass through and achieve binding.

[0062] The flexible wire 40 of this embodiment involves the distribution mode in the limiter 150 and the routing mode in the wave coil of the luminal stent 30. The state of the flexible wire 40 in the limiter 150 is described below:

[0063] Since the soft wire 40 needs to be pulled out normally after the loading process is completed, the material of the soft wire 40 is selected from polymer materials or metal materials. This is because polymer materials have better flexibility and smaller wire diameter than metal materials (such as nickel titanium filaments), making it easier for the soft wire 40 to be pulled out without affecting the stent. Therefore, the material of the soft wire 40 is more preferably a polymer material, including but not limited to PTFE wire, polyester suture, etc. However, it is worth noting that since the soft wire 40 is used to fix the luminal stent 30, the soft wire 40 is easily entangled with the bare wave coil part of the luminal stent 30, resulting in greater friction between the soft wire and the luminal stent 30 when the soft wire 40 is pulled out, resulting in difficulty in pulling out or the soft wire breaking. Therefore, the structure of the limiter 150 needs to be set accordingly to ensure that the soft wire 40 and the luminal stent 30 do not contact or have less contact, and to prevent the soft wire 40 from twisting relative to the wave coil of the luminal stent 30.

[0064] In order to meet the above requirements, the structural design and routing of the limiter 150 are as follows:

[0065] Refer to the instruction manual Figure 4 , Figure 4 This is a schematic diagram of the routing of the stopper 150 of the conveying assembly 10 in Example 1. The stopper 150 is a rotating structure including a hollow channel 1500, through which the inner sheath core tube passes. Furthermore, the stopper 150 is provided with at least three separate and parallel channels, designated as channel 1501, channel 1502, and channel 1503. To prevent the edges of the through-holes from abrading or pulling the flexible cable 40, the edges of the through-holes are rounded.

[0066] The specific routing method of the position of the limiter 150 is as follows: the soft wire 40 passes through the inside of the tubular stent, through the channel 1501 of the limiter 150, then through the channel 1502, and then around the bare wave ring (one or more) of the tubular stent. The soft wire then enters and passes through the channel 1503, then passes back through the channel 1501 and out of the inner cavity of the stent. The position where the soft wire 40 leaves the previous channel and the position where it enters the next channel are located on the same surface of the limiter 150.

[0067] Both ends of the soft wire 40 extend along the branching channel of the inner sheath 110, so that the operator can tighten and withdraw the soft wire 40 through the handle or directly outside the body.

[0068] In another embodiment, in order to ensure the balance of the force exerted by the flexible wire 40 on the luminal stent, refer to the appendix of the specification. Figure 5 As shown, attached Figure 5FIG1 is a schematic diagram of the routing of a retaining member 151 in another embodiment of the present invention. The routing of the flexible wire 40 in the retaining member 151 is the same as in Example 1, with the only difference being that the location where the flexible wire contacts the bare wave coil of the luminal stent is closer to the axis of the retaining member 151. Preferably, the flexible wire 40 enters and exits the retaining member 151 along channel 1511. The line connecting the centers of the openings at the same end of channels 1513 and 1512 intersects the axis of the retaining member 151. The corresponding sheath core tube is provided with an avoidance groove or avoidance hole at this location for the flexible wire to pass through.

[0069] In this embodiment, after the wiring is completed, both ends of the flexible wire 40 are extended from the same through-hole in the same direction to the outside. Simultaneously, both ends of the flexible wire 40 are gently pulled to straighten the portion of the flexible wire between hole 1501 and hole 1502. The stent is then secured to the retaining member 150 by the flexible wire. At this point, the outer sheath 120 is moved axially toward the proximal end relative to the inner sheath core tube 130. The exposed corrugated coils of the stent 30 are secured by the stretched flexible wire 40, preventing them from fully expanding. After the stent 30 is accurately positioned, the flexible wire 40 is released and withdrawn.

[0070] The relative relationship between the soft wire and the bare wave ring of the luminal stent is as follows Figure 6-9 As stated, Figure 6 It is a force diagram of the flexible wire and the luminal stent in the first contact state. Figure 7 It is a force diagram of the flexible wire and the luminal stent in the second contact state. Figure 8 This is a force diagram of the flexible wire and the luminal stent in the third contact state. Figure 9 It is a force diagram when the soft wire and the luminal stent are in the fourth contact state, wherein F1 is the friction force between the soft wire and the bare wave ring 301 of the luminal stent, and F2 is the pulling force required when withdrawing the soft wire 40. In order to facilitate the withdrawal of the soft wire 40, the smaller the value of F2 is, the easier it is to withdraw the soft wire 40, and the smaller the friction force F1 should be.

[0071] It is known that when the flexible cable 40 is tightened, it fixes the bare corrugated ring 301. At this time, the bare corrugated ring 301 has a tendency to expand and return to its original shape, and also has a tendency to follow the movement of the outer sheath (the outer sheath moves relative to the inner sheath to load the stent). The tension of the flexible cable 40 is along its own direction and is equal everywhere. With the upper contact point of the flexible cable 40 and the bare corrugated ring 301 as the base point, the flexible cable 40 includes a first segment to the left of the base point and a second segment to the right of the base point. The pressure between the soft wire 40 and the bare wave ring 301 determines the friction between the two. The pressure between the soft wire 40 and the bare wave ring 301 is the sum of the component of the pulling force on the first section of the soft wire 40 toward the center of the bare wave ring 301 and the component of the pulling force on the second section of the soft wire 40 toward the center of the bare wave ring 301. In specific situations, the smaller the angle between the first section and the second section of the soft wire 40, the greater the sum of the component of the pulling force on the first section of the soft wire 40 toward the center of the bare wave ring 301 and the component of the pulling force on the second section of the soft wire 40 toward the center of the bare wave ring 301, and the greater the friction that needs to be overcome to withdraw the soft wire 40.

[0072] Therefore, from Figures 6 to 8 The value of F1 gradually increases, and Figure 8 In the case where the flexible wire 40 passes through the bare wave ring 301 of the luminal stent, the two ends of the flexible wire 40 are parallel to each other or the angle formed between them is small, which is easy to occur. Figure 9 The entanglement phenomenon in the flexible wire 40 can cause the friction of the flexible wire 40 itself to cause the flexible wire 40 to be locked, making it impossible to withdraw.

[0073] In this embodiment, the soft wire 40 is routed along the direction of channel 1501 - the bare wave coil of the tubular stent - channel 1502. Since the bare wave coil of the tubular stent is very close to the limiter 150, the angle between the two sides of the soft wire 40 located on the adjacent two sides of the bare wave coil is large (preferably greater than 90°). After the soft wire 40 is straightened, the friction between the soft wire and the tubular stent is small. Moreover, since the soft wire 40 passes through the first side and the second side of the bare wave coil of the tubular stent along two different channels, the soft wire 40 will not be entangled.

[0074] In another embodiment, the surface of the stopper close to the luminal stent is a concave surface (that is, the proximal end surface of the stopper is a concave surface), such as Figure 10 As shown, Figure 10 It is a schematic diagram of the longitudinal cross-sectional structure of the limiter in another embodiment. After being set in this way, the limiter and the tubular cavity bracket partially overlap in the axial direction, that is, the end of the bare wave ring 301 of the tubular cavity bracket is located in the concave cavity of the area formed by the concave surface of the limiter, thereby avoiding the existence of a gap between the tubular cavity bracket and the limiter in the axial direction, which makes the outer sheath tube easy to bend at the gap position, and then makes the outer sheath tube easy to break at the bending position when the bracket is released.

[0075] In addition, the limiter can make the distance between the tubular stent and the proximal end of the limiter in the axial direction, so that the angle formed by the first side and the second side of the bare wave ring 301 of the tubular stent by the soft wire 40 can be larger, and the friction between the soft wire 40 and the bare wave ring of the tubular stent can be smaller.

[0076] Example 2

[0077] The parts of the conveying assembly and conveying system of Example 2 that are the same as those of the conveying assembly and conveying system of Example 1 are not described here in detail. The main difference between the two is that Figure 11 As shown, Figure 11 This is a schematic diagram of the routing of the limiter of the conveying assembly in Example 2. To prevent the flexible wire 40 from getting tangled when it first enters the line-in side of the limiter 250 and when it finally leaves the limiter 250 and returns to the starting position, the limiter 250 of Example 2 is provided with four channels, namely channel 2501, channel 2502, channel 2503 and channel 2504. The specific routing method is as follows:

[0078] The soft wire 40 passes through the inside of the tubular stent, through the channel 2503 of the limiter 250, then through the channel 2501, and then around the bare wave ring (one or more) of the tubular stent. The soft wire 40 then passes through the channel 2502, then exits from the channel 2504 and passes back through the inner cavity of the stent. The position where the soft wire 40 leaves the previous channel and the position where it enters the next channel are located on the same surface of the limiter 250.

[0079] Example 3

[0080] The same parts of the delivery assembly and delivery system of Example 3 as those of Example 1 are not described here. The main difference between the two is that the stopper is provided with a partial or whole protrusion on the side close to the luminal stent, and the protrusion is provided with a circumferential channel, such as Figure 12 As shown, Figure 12 This is a schematic diagram of the routing of the limiter of the conveying assembly in Example 3. The protrusion 351 can be a plurality of local protrusions or a whole protrusion. The protrusion 351 is provided with a transverse or oblique channel. In this embodiment, two transverse channels are used as an example. Channel 3501 and channel 3502 are arranged opposite to each other. The routing method is as follows:

[0081] The soft wire 40 passes through the inside of the tubular stent, radially passes through the channel 3501 of the limiter 350 from the outside to the inside, and then bypasses the bare wave ring (one or more) of the tubular stent. The soft wire 40 then passes through the channel 3502 radially from the inside to the outside and passes back through the inner cavity of the stent. The position where the soft wire 40 leaves the previous channel and the position where it enters the next channel are located on the same surface of the limiter 350.

[0082] When the two ends of the soft wire 40 are pulled, the soft wire 40 is stretched straight through the first and second sides of the bare wave ring of the luminal stent, and the angle between the two is nearly 180°, and the friction between the soft wire 40 and the bare wave ring of the luminal stent is close to 0.

[0083] Example 4

[0084] The same parts of the conveying assembly and conveying system of Example 4 as those of Example 3 are not described here. The main difference between the two is that the limiting member is further provided with at least two axial channels, such as Figure 13-14 As shown, Figure 13 is a schematic structural diagram of the position limiting member of the conveying assembly in Example 4, Figure 14 This is a schematic diagram of the routing of the limiter of the conveying assembly in Example 4. The limiter 450 is provided with two axial channels and two circumferential channels. The circumferential channels are channel 4501 and channel 4502, and the axial channels are channel 4503 and channel 4504. The routing is as follows:

[0085] The soft wire 40 passes through the inside of the tubular stent, radially passes through the channel 4501 of the limiter 450 from the outside to the inside, then passes through the channel 4503, and then bypasses the bare wave ring (one or more) of the tubular stent. The soft wire 40 then passes through the channel 4504, and then passes out from the channel 4502 radially from the inside to the outside and back through the inner cavity of the stent. The position where the soft wire 40 leaves the previous channel and the position where it enters the next channel are located on the same surface of the limiter 450.

[0086] When the two ends of the soft wire 40 are pulled, the soft wire 40 is stretched straight through the first and second sides of the bare wave ring of the luminal stent, and the angle between the two is nearly 180°, and the friction between the soft wire 40 and the bare wave ring of the luminal stent is close to 0.

[0087] In this embodiment, under the premise of ensuring that the line-entry side of the soft wire 40 that first enters the limiter 450 and the line-exit side that finally leaves the limiter 450 and returns to the starting position are as far apart as possible, when it is necessary to cope with different bracket structures or transportation environments, a limiter 450 with axial channels with different spacings can be selected.

[0088] Example 5

[0089] The parts of the conveying assembly and conveying system of Example 5 that are the same as those of the conveying assembly and conveying system of Example 1 are not described here in detail. The main difference between the two is that both sides of the limiter are provided with partial or overall protrusions, and the protrusions are provided with circumferential channels, such as Figure 15-16 As shown, Figure 15 is a schematic structural diagram of the position limiting member of the conveying assembly in Example 5, Figure 16Schematic diagram of the routing of the position limiting member of the conveying assembly in Example 5. Both sides of the position limiting member 550 are provided with protrusions, respectively denoted as protrusions 551 and 5502. In this embodiment, the protrusion 551 is provided with two circumferential channels arranged opposite to each other, namely, channel 5501 and channel 5502. The protrusion is provided with two circumferential channels arranged opposite to each other, namely, channel 5503 and channel 5504. The routing method is as follows:

[0090] The soft wire 40 passes through the interior of the tubular stent, radially passes through the channel 5501 of the limiter 550 from the inside to the outside, then passes through the channel 5503 radially from the outside to the inside, and then bypasses the bare wave ring (one or more) of the tubular stent. The soft wire 40 then passes through the channel 5505 radially from the inside to the outside, and then passes out of the channel 5502 radially from the outside to the inside and back through the inner cavity of the stent. The position where the soft wire 40 leaves the previous channel and the position where it enters the next channel are located on the same surface of the limiter 550.

[0091] When the two ends of the soft wire 40 are pulled, the soft wire 40 is stretched straight through the first and second sides of the bare wave ring of the luminal stent, and the angle between the two is nearly 180°, and the friction between the soft wire 40 and the bare wave ring of the luminal stent is close to 0.

[0092] Example 6

[0093] The parts of the delivery assembly and delivery system of Example 6 that are the same as those of Example 1 are not described in detail here. The main difference between the two is that Example 6 adds a stopper (referred to as an intermediate piece for distinction) located at the proximal end of the loading section, that is, the stopper and the Tip head are located on opposite sides of the endoluminal stent. Specifically, Figure 17 As shown, Figure 17 It is a working diagram of the conveying assembly in the loading stage in Example 6. The intermediate piece 660 can select any limiter structure in Examples 1-5. The limiter 650 in this embodiment selects the limiter structure in Example 1.

[0094] First, the multiple circumferentially distributed coils on the side of the tip are mounted and fixed on the limiter 650 using the soft wire 40. Both ends of the soft wire 40 can pass through the branching channel of the inner sheath tube, so that the user can operate it outside the delivery assembly or delivery system. Due to the effect of the limiter 650, during the release process of the luminal stent 30, the coils near the tip end of the stent are contracted, and the stent will not adhere to the wall when a small part is released. In other words, in the initial stage of the release of the luminal stent, the expansion of the stent is controlled by the operator. At this time, the position of the stent can also be appropriately adjusted to make the positioning of the stent more accurate, avoiding inaccurate positioning of the stent and the need to recover the entire stent due to inaccurate positioning.

[0095] After ensuring the reliability of the release phase of the tubular stent 30 , the reliability of the loading phase of the tubular stent 30 also needs to be considered. The purpose of setting the middle piece 660 is to cope with the loading phase of the tubular stent 30 .

[0096] In conjunction with the instructions Figure 1-3 During the loading stage, the outer sheath tube 120 moves axially toward the distal end relative to the inner sheath core tube 130, and the luminal support 30 is gradually compressed as the outer sheath tube 120 advances until it is finally completely compressed. Since the luminal support 30 is in an expanded state at the beginning, a part of the luminal support 30 is pressed against the outer sheath tube 120. In the absence of external force, the movement of the outer sheath tube 120 easily drives the luminal support 120 to move, thereby causing the luminal support 120 and the outer sheath tube 120 to move together, causing the luminal support 120 to shorten or displace, thereby causing assembly failure. Therefore, in order to solve this problem, an intermediate piece 660 is used in Example 6.

[0097] Specifically, when the tubular stent 130 is loaded, the tubular stent 30 is fixed to the middle piece 660 by the pull wire 41, so that the tubular stent 30 is already fixed to the middle piece 660 during pre-assembly. During the loading process, since the tubular stent 30 is fixed to the middle piece 660 located at the proximal end of the loading section, when the outer sheath tube 120 moves axially toward the distal end relative to the inner sheath core tube 130, the tubular stent 30 will not be displaced along with the outer sheath tube 120, thereby ensuring the normal loading.

[0098] In addition, for Example 6, since the pull wire structure of the proximal middle piece 660 only plays a role during assembly, it can be preferably removed after assembly, that is, the pull wire 40 can be withdrawn after loading is completed, so that the conveyor can simultaneously meet the functions of conveying and adjusting position.

[0099] In this embodiment, since the routing of the flexible wire in the corrugated coil of the luminal stent does not interfere with the routing of the flexible wire in the limiter, the routing of the flexible wire in the corrugated coil is described below in conjunction with Example 6, as follows:

[0100] The method of hanging the carrier ring of the limiter 650 refers to Figure 18-19 , Figure 18 This is a first-view working diagram of the position limiting member in the conveying assembly in Example 6. Figure 19 1 is a second perspective working diagram of the position limiting member in the conveying assembly in Example 6. For a more intuitive view, the hollow channel portion of the position limiting member 650 is omitted in the corresponding figure.

[0101] The soft wire 40 passes through channel 6501 - channel 6502 - wave ring 301 - channel 6503 - channel 6501 in sequence. The specific routing method is similar to the routing method in Example 1. The soft wire 40 hangs the bare wave ring 301 of the luminal support 30 on the limiter 650 and retracts it. Specifically, the soft wire 40 passes through multiple wave peaks on the bare wave ring 301. After the soft wire 40 is tightened, the bare wave ring 301 is hung on the limiter 650, and the tightening of the soft wire 40 causes the luminal support 30 to be radially stressed. When the luminal support 30 is partially released, it is in a semi-expanded state due to the tension of the soft wire 40. At this time, the luminal support 30 does not directly contact the blood vessel wall, and the operator can fine-tune or position the position of the luminal support 30.

[0102] In order to balance the force, in this embodiment, the crests of the bare wave ring 301 through which the soft wire 40 passes meet the following requirements: the crests passed by the soft wire 40 are first crests, and there are an equal number of second crests 302 adjacent to each other between the first crests, that is, the spacing between adjacent first crests is the same.

[0103] In another embodiment, the intermediate member 660 is used to radially compress and bind the proximal end of the stent 30. That is, the distal end of the stent 30 is bound to the stopper 650 by a flexible wire, and the proximal end is bound to the intermediate member 660 by a flexible wire. This further ensures that the stent 30 does not move with the movement of the outer sheath when released, and also makes it easier to adjust the position of the stent 30 after release and then fully release it. The ends of the flexible wires passing through the stopper 650 and the intermediate member 660 respectively extend along the internal channel of the inner sheath to the operating end.

[0104] Example 7

[0105] The same parts of the delivery assembly and delivery system of Example 7 as those of Example 6 are not described here. The main difference between the two is that the way the stopper mounts the luminal stent is different. Figure 20-21 , Figure 20 This is a first-view working diagram of the position limiting member in the conveying assembly in Example 7. Figure 21 This is a second perspective working diagram of the limiting member in the conveying assembly in Example 7.

[0106] The flexible wire 40 passes through the channel 7501 , the channel 7502 , the corrugated ring 301 , the channel 7503 , and the channel 7501 in sequence. The specific routing method is similar to that in the seventh embodiment.

[0107] The soft wire 40 hangs all the wave crests on the bare wave ring of the tubular bracket 30 on the limiter 750 and gathers them. That is, the soft wire 40 passes through all the wave crests 303 of the tubular bracket 30, and tightens all adjacent wave crests 303 in series, so that the tubular bracket 30 is compressed by the force close to the limiter 750. Compared with Example 7, the force applied by the soft wire 40 to the tubular bracket 30 is more uniform in this embodiment.

[0108] It should be noted that for Examples 6 and 7, there are multiple options for the structure of the middle piece 660, including but not limited to a structure similar to the limit piece in Examples 1-5. The middle piece in Examples 6 and 7 uses the structure of the limit piece in the previous Examples 1-5 in order to utilize the effect of the limit piece in the previous embodiments to facilitate the withdrawal of the soft wire. It cannot be considered that the structure of the middle piece 660 is the same as the structure of the previous limit piece and is a necessary technical feature for realizing this solution.

[0109] In conclusion, there is a conveying method for Example 6 and Example 7. During the loading stage of the bracket, the proximal end of the bracket is tied to the middle piece by a pull wire, and the first and second ends of the pull wire are extended along the same or mutually parallel middle piece channel and straightened. At the same time, also in this stage, the distal end of the bracket is tied to the limiter by a soft wire, and the first and second ends of the soft wire are extended along the same or mutually parallel limiter channel, keeping the first and second ends of the soft wire straightened. After the loading of the bracket is completed, release any end of the pull wire to take out the pull wire, and then transport the bracket to the designated destination, and then half-release the bracket. At this time, the distal end of the bracket is still in a retracted state. After confirming that the bracket is in the correct position, release one end of the soft wire and take out the soft wire, thereby completely releasing the bracket.

[0110] The conveying method corresponding to Examples 1-5 is as follows: during the loading stage of the stent, the distal end of the stent is tied to the limiter through a soft wire, and the first and second ends of the soft wire are extended along the same or respectively parallel limiter channel, and the first and second ends of the soft wire are kept straight, so that the distal end of the stent is radially compressed on the limiter. After the stent is loaded, it is transported to the designated destination, and then the stent is half-released. At this time, the distal end of the stent is still in a compressed state. After confirming that the position of the stent is accurate, one end of the soft wire is released and the soft wire is taken out, thereby completely releasing the stent.

[0111] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

[0112] The above specifically describes the embodiments of the present invention. However, the present invention is not limited to these embodiments. Persons skilled in the art may make various equivalent modifications or substitutions without departing from the spirit of the present invention. These equivalent modifications or substitutions are all within the scope of the claims of this application. Furthermore, the embodiments of the present invention and the features therein may be combined with one another unless there is a conflict.

Claims

1. A conveying assembly, characterized in that: include A delivery channel, comprising an inner sheath tube, an outer sheath tube and a sheath core tube, wherein the sheath core tube is disposed within the inner sheath tube, and the distal end of the sheath core tube extends from the distal end of the inner sheath tube, the outer sheath tube is sleeved on the outside of the inner sheath tube, and a gap is formed between the outer sheath tube and the sheath core tube for loading a stent; a limiter, the limiter being disposed at the distal end of the gap, the limiter comprising a proximal end face, a distal end face opposite to the proximal end face, an inner wall close to the sheath core tube, and an outer wall opposite to the inner wall, the limiter further comprising a plurality of first main channels penetrating the proximal end face and the distal end face and / or a plurality of second main channels penetrating the inner wall and the outer wall; A soft wire passes through the limiter along the first main channel and / or the second main channel, and after the soft wire passes through multiple first wave peaks on the same wave circle of the stent to be delivered, it passes through the limiter along the first main channel and / or the second main channel, the soft wire compresses the distal end of the stent on the limiter along the radial part, the contact point between the soft wire and the stent is the base point, and the angle between the two sections of the soft wire on both sides of the base point is greater than 90°.

2. The conveying assembly according to claim 1, characterized in that The plurality of first main channels are parallel to each other.

3. The conveying assembly according to claim 1, characterized in that The plurality of second main channels are parallel to or collinear with each other.

4. A conveying assembly according to claim 1, characterized in that: The proximal end surface of the limiting member is a concave surface.

5. A conveying assembly according to claim 1, characterized in that: The inner sheath is provided with a plurality of branch line channels, which are connected to the gap for the delivery soft wire to pass through.

6. A conveying assembly according to claim 1, characterized in that: The invention also includes a middle piece, which is located at the proximal end of the delivery channel. The middle piece is provided with a plurality of secondary channels, and the plurality of secondary channels are parallel or collinear with each other.

7. A conveying system, characterized in that: The conveying component includes any one of claims 1-6, and also includes a control component, wherein the control component includes a slider and a slide groove fixed to the outer sheath tube, and when the slider moves along the slide groove, it drives the outer sheath tube to move relative to the sheath core tube.

8. A loading method comprising the conveying assembly according to any one of claims 1 to 6, comprising the following steps: S1: The distal end coil of the stent is mounted on a stopper via a flexible wire. The first and second ends of the flexible wire extend along the same or parallel channels of the stopper and are stretched straight, so that the distal end of the stent is radially compressed against the stopper. The contact point between the flexible wire and the stent is the base point, and the angle between the two sections of the flexible wire on either side of the base point is greater than 90°. S2 keeps the core tube of the delivery assembly in the same position, while pushing the outer sheath tube of the delivery assembly toward the distal end until the outer sheath tube completely covers the stent.

9. The loading method according to claim 8, characterized in that: Step S1 further includes: S11: The proximal end of the stent is tied to the middle piece through a pull wire, and the first end and the second end of the pull wire extend along the same or mutually parallel through hole of the middle piece, and the first end and the second end of the pull wire are kept straight.

10. The loading method according to claim 9, characterized in that: Step S2 further includes: After the outer sheath completely covers the stent, S21 releases one end of the pull wire and pulls the other end of the pull wire to retract it.

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