Self-expanding stent conveying device and system comprising same

Abstract

The invention relates to a self-expanding stent delivery device and a system comprising the same. The self-expanding stent conveying device comprises a pushing rod; the radial force storage structure extends in the axial direction and is arranged at the far end of the pushing rod, and an inner cavity extending in the axial direction is defined in the radial force storage structure; the positioning line extends in the axial direction and penetrates through an inner cavity of the radial force storage structure; the positioning line is in a natural state; the fixing components are at least arranged at the near end and the far end of the positioning line effective area, and the near end and the far end of the positioning line effective area are fixed to the cavity walls of the inner cavities at the near end and the far end of the radial force storage structure respectively. Through cooperative cooperation of the radial force storage structure, the positioning line and the fixing part, while the auxiliary expansion effect on the self-expanding stent is ensured, displacement of the fixing part possibly caused by release of the radial force storage structure is effectively restrained, and therefore reliable conditions are provided for accurate release of the self-expanding stent.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a self-expanding stent delivery device and a system comprising the same. Background Technology

[0002] Vascular stent implantation is a major minimally invasive interventional procedure for treating vascular stenosis and aneurysms. Self-expanding stents can return to their predetermined shape due to the elasticity of the material after release from restraint. In routine procedures, the stent is compressed and restrained within a delivery catheter, delivered to the target lesion site, and then released via a release mechanism, allowing the stent to expand radially within the blood vessel and provide vascular support.

[0003] In interventional treatment of small blood vessels (such as intracranial vessels), the stents and delivery systems used are relatively small. While a smaller stent diameter helps adapt to the narrow and complex vascular environment, it can also lead to insufficient self-expansion force, resulting in incomplete expansion or poor apposition. Furthermore, the small diameter and high tortuosity of intracranial vessels place higher demands on the stent's apposition and positioning accuracy after deployment.

[0004] To improve stent apposition, segmental braided tubing with self-expanding properties is commonly used clinically as a delivery structure. This type of structure assists in the radial expansion of the stent during deployment and, after deployment, utilizes the resilience of the braided tubing to "massage" the stent, promoting full apposition. Segmental apposition is typically achieved by overlaying a restraining component (such as a contrast ring) onto the braided tubing. However, there are often abrupt geometric changes between the edge of this component and the braided tubing, resulting in an uneven transition. When the edge of the restraining component contacts the stent, scratching can easily occur, increasing the risk of restraining component displacement and potentially causing stent shift. Furthermore, if the stent is not fully deployed and adjustments to its deployment position are needed, and retrieval and secondary deployment are required, the edge of the restraining component may interfere with or become stuck with the distal end of the delivery catheter, further increasing the risk of accidental displacement of the restraining component. Once the segmental restraining component shifts, it can cause unpredictable deformation of the restraining structure, leading to uncontrolled deployment. Additionally, when the component also serves as a contrast marker, the observed contrast location may differ from the actual deployment location, severely affecting the accuracy of contrast localization.

[0005] Therefore, there is an urgent need in the field for a self-expanding support delivery device that can assist the support in unfolding smoothly during the release process and effectively avoid displacement of the restraint components, thereby achieving accurate and safe release of the self-expanding support. Summary of the Invention

[0006] To address the shortcomings of existing technologies, one objective of this invention is to provide a self-expanding support conveying device, comprising: Push lever; A radial force-storing structure extends axially and is disposed at the distal end of the push rod. The radial force-storing structure is configured to have a force-storing state and a release state. In the force-storing state, the radial force-storing structure elongates axially and compresses radially to store radial outward expansion force. In the release state, the radial force-storing structure shortens axially and expands radially to release the radial outward expansion force. The radial force-storing structure internally defines an axially extending inner cavity. A positioning line extends axially and penetrates the inner cavity of the radial energy storage structure; the length of the positioning line is not less than the axial length of the radial energy storage structure in the energy storage state, and the positioning line is in a natural state; the section of the radial energy storage structure corresponding to the positioning line is defined as the effective area of ​​the positioning line. A fixing component is provided at least at the proximal and distal ends of the effective area of ​​the positioning line, and the proximal and distal ends of the effective area of ​​the positioning line are respectively fixed to the inner cavity walls of the proximal and distal ends of the radial power storage structure; in the power storage state, the length of the positioning line between the two fixing components is configured to be equal to the predetermined axial length of the radial power storage structure in the power storage state.

[0007] In the self-expanding support conveying device provided in this application, the radial force-storing structure can store radial expansion force through morphological transformation (radial compression, axial elongation), and release the radial expansion force during the release process to assist the expansion of the conveyed self-expanding support. By placing the fixing components inside the radial force-storing structure, the risk of jamming and displacement caused by external interference can be avoided when retracting the conveying device. The fixing components (which can be made of materials with radiopaque properties) are respectively fixed at the proximal and distal ends of the effective area of ​​the positioning line, and the axial distance between the two fixing components is consistent with the length of the radial force-storing structure in the force-storing state, thereby achieving accurate synchronous positioning of the structure. Since the fixing components are simultaneously fixed at corresponding positions in the effective area of ​​the positioning line and the inner wall of the radial force-storing structure, they can move synchronously with the movement of the radial force-storing structure, ensuring the reliability of the positional correspondence. In addition, since the positioning line itself does not generate radial expansion force, it will not exert a thrust on the fixing components that would cause their displacement, thereby further ensuring the stability of the fixed position. Based on this fixed relationship, the position of the radial energy storage structure can be accurately located, and then the actual release position of the support can be accurately inferred based on the relative position of the self-expanding support with the radial energy storage structure when it is loaded.

[0008] This application, through the coordinated operation of the radial energy storage structure, positioning line, and fixing components, ensures the auxiliary expansion effect on the self-expanding support while effectively suppressing the displacement of the fixing components that may be caused by the release of the radial energy storage structure, thus providing reliable conditions for the precise release of the self-expanding support.

[0009] It should be noted that the length of the positioning line is not less than the axial length of the radial power storage structure in the power storage state, meaning that the total length of the positioning line in its natural state is at least equal to the axial length of the radial power storage structure in the power storage state. In actual assembly, the positioning line can be appropriately extended to facilitate fixed connection with the proximal and distal structures. For example, its proximal end can be extended to connect to the push rod, and its distal end can also be extended to connect to the distal head structure. Correspondingly, the proximal and distal ends of the radial power storage structure may also have a certain axial extension due to manufacturing process or connection and fixation requirements. Typically, but not limitingly, when the radial power storage structure is constructed from a braided mesh tube through segmental binding, the proximal end of the braided mesh tube can extend a section of proximal braided mesh tube for connection to the push rod, and the distal end can also extend a section of distal braided mesh tube for connection to the distal head structure. Such extension sections can usually be pre-shaped or radially constrained to prevent them from exhibiting significant radial expansion force, thereby avoiding interference with the power storage and release behavior of the main body.

[0010] Preferably, the radial energy storage structure includes at least one energy storage unit, each energy storage unit having an axially extending cavity structure; the two ends of the energy storage unit have small outer diameters, and the middle part has an expandable structure with a variable radial dimension; in the energy storage state, the expandable structure radially contracts and axially extends; in the release state, the expandable structure radially expands and axially shortens.

[0011] Preferably, the radial energy storage structure includes two or more energy storage units connected in series along the axial direction; the cavity structure of all energy storage units is designed as a single unit; except for the ends located at the nearest and farthest ends of the radial energy storage structure, the connection between adjacent energy storage units is defined as a segmental connection part; each segmental connection part is independently constructed to be either fixedly connected to the positioning line or not fixedly connected to the positioning line.

[0012] When the radial energy storage structure comprises multiple energy storage units connected in series along the axial direction, it forms a segmented, constrained pipe network structure, where each segment corresponds to one energy storage unit. Multiple energy storage units together constitute the radial energy storage structure, which, on the one hand, ensures that the radial energy storage structure has an axial length matching the support to be transported; on the other hand, the segmented structure enables the gradual convergence and transmission of the axial pushing force, helping to improve the axial pushing force and pushing efficiency.

[0013] Preferably, the segment connection portion is formed by a pre-forming process or its configuration is achieved by a limiting and fixing structure.

[0014] The term "segmental connection formed by pre-forming process" means that during the manufacturing process, the energy storage unit is directly pre-formed into an integral structure with segmental connection, so that it naturally exhibits a state of contraction at both ends and expansion in the middle. The term "realizing its configuration through limiting and fixing structure" means that the energy storage structure is first pre-formed into a pipe network with a large and uniform inner diameter, and then a limiting and fixing structure is applied at the corresponding segment. Through the constraint effect of this structure, the local radial dimension is reduced, thereby forming the required segmental connection.

[0015] Preferably, the limiting and fixing structure includes an annular structure sleeved on the outside of the segment connection part, or a fixing structure disposed inside the energy storage unit and fixing the segment connection part; the fixing structure preferably includes any one of a spiral coil, a C-shaped ring, and a circular ring.

[0016] Choosing to fit a ring structure outside the segment connection can reduce the risk of the ring structure falling off, but may increase the probability of relative displacement at the interface between the ring structure and the outer wall of the pipeline. Setting the fixed structure inside the power storage unit and passing the positioning line through the fixed structure can reduce the risk of displacement of the fixed structure due to the expansion of the power storage unit, while avoiding the risk of the fixed structure falling off and entering the body.

[0017] Preferably, the segment connection is not fixedly connected to the positioning line, allowing the positioning line to slide axially relative to the segment connection.

[0018] The positioning line is allowed to slide axially within the segment connection, giving the entire system higher axial compliance and deformation freedom, thus enabling it to better adapt to the vascular environment. When multiple energy storage units are deployed in series, the system can adapt to the curvature changes of the diseased blood vessel and adjust the magnitude of the radial expansion force of a single energy storage unit, avoiding local stress concentration or excessive stretching caused by excessive structural rigidity, thereby improving the safety of the device.

[0019] Preferably, the segment connection is configured to be fixedly connected to the positioning line, and in the stored state, the segment connection is fixed to the positioning line at its corresponding axial position.

[0020] The segmental connector is fixedly connected to the positioning line. Especially when the positioning line is an elastic thread, it effectively enhances the transmission efficiency and stability of the axial pushing force, avoiding energy loss caused by relative sliding of the structure during the pushing process. This structure improves the passability and maneuverability of the delivery device in tortuous vascular paths, making it suitable for vascular environments requiring high pushing force.

[0021] Preferably, when the segment connection is fixed to the positioning line, the axial length of each power storage unit in the power storage state is approximately equal to the axial length of its corresponding positioning line segment.

[0022] Preferably, a protective barrier is provided on the outside of the segment connection portion, and the protective barrier is preferably a heat-shrinkable polymer sleeve.

[0023] The protective barrier effectively helps maintain the predetermined structural shape of the segment connection, such as maintaining the predetermined radial dimension. At the same time, the protective barrier can also stabilize the internal limiting and fixing structure in the preset axial and circumferential positions, thereby enhancing the structural integrity and morphological stability of the connection and preventing component displacement or morphological changes during transportation or release.

[0024] Preferably, the positioning line includes any one or a combination of at least two of the following: a flexible positioning line and an elastic positioning line.

[0025] The flexible positioning line exerts minimal constraint resistance on the radial expansion of the radial energy storage structure in the released state, allowing the radial energy storage structure to utilize more stored energy to assist the expansion of the self-expanding stent. However, lacking elastic recovery capability, the flexible positioning line is prone to deformation or center of gravity shift under gravity in the released state, potentially affecting the symmetry and coaxiality of the expansion of each energy storage unit, and consequently impacting the final expansion uniformity and wall adhesion performance of the self-expanding stent.

[0026] Preferably, the flexible positioning line includes any one or a combination of at least two of ultra-high molecular weight polyethylene fiber lines, polyester lines, polypropylene lines, aramid lines, or blended fiber lines.

[0027] Preferably, the elastic positioning line is made of an elastic material, which is preferably a metal, alloy, polymer material or composite material thereof, and more preferably a nickel-titanium alloy.

[0028] Although the elastic positioning line exerts some constraint resistance on the release of the radial energy storage structure, since it is typically a single line with a diameter less than or equal to the cross-sectional size of the radial energy storage structure's grid support, this resistance is far less than the radial outward expansion force released by the radial energy storage structure and will not significantly affect its auxiliary expansion function. On the other hand, during release, the elastic positioning line can spirally conform to the inner wall of the energy storage unit, thereby evenly distributing its constraint reaction force. This conformation method minimizes the asymmetric effect on the expandable body and effectively avoids eccentric forces on the tubular implant, thus having virtually no adverse impact on the expansion symmetry of the energy storage unit or the uniform expansion of the stent.

[0029] Preferably, the expandable structure is a structure with a hollow pattern, and the hollow structure preferably includes any one or a combination of at least two of the following: a wire weaving structure, a wire binding structure, and a metal tube engraving structure.

[0030] The expandable structure described in this application is a structure with a hollow pattern. Through specific geometric design, it can achieve the deformation effect of radial expansion accompanied by axial contraction, or radial contraction accompanied by axial elongation.

[0031] The filament weaving structure can be understood as a tubular structure formed by the cross-weaving of multiple filaments (such as elastic filaments). After being shaped to a predetermined radial size, it is radially contracted and fixed at predetermined intervals in the axial direction, so that its local radial size is smaller than the shaped size, thereby forming a segmented expandable woven body. The filament binding structure can be understood as multiple filaments (such as elastic filaments) arranged parallel to each other along the generatrix of a cylinder to form a tubular outline. Then, it is radially contracted and fixed at predetermined intervals in the axial direction, so that its local radius is smaller than the initial outline radius, thereby forming an expandable body based on parallel warp threads. The metal tube engraving structure can be understood as a hollowed-out pattern formed by laser engraving or mechanical cutting of a metal tube, which is then shaped to a predetermined radial size. After being radially contracted and fixed at predetermined intervals in the axial direction, its local radial size is smaller than the shaped size, ultimately forming a segmentally expandable hollowed-out tubular structure.

[0032] Preferably, the expandable structure is made of shape memory material, which is preferably a shape memory alloy, and more preferably a nickel-titanium alloy.

[0033] Preferably, the fixing component is selected from any one or a combination of at least two of the following: a fixing ring, a spiral coil, and a C-ring, with a spiral coil being preferred.

[0034] Preferably, the fixing component has non-transmissive linearity.

[0035] Preferably, the fixing component is fixedly sleeved on the positioning line and fixedly connected to the inner cavity wall of the corresponding end of the radial energy storage structure in the energy storage state.

[0036] Preferably, the fixing method includes any one or a combination of at least two of welding, bonding, and snap-fitting.

[0037] Preferably, the axial length of the power storage unit in the released state is 50-95% of its axial length in the power storage state, such as 55%, 58%, 63%, 67%, 75%, 82%, 87%, 93%, etc., preferably 60-80%.

[0038] The axial length of the energy storage unit in the released state is too short compared to its axial length in the energy storage state. This will cause the elastic positioning line to be subjected to greater axial compression, resulting in a greater axial force to resist the axial compression. This will create greater resistance to the axial contraction behavior of the energy storage unit. For the flexible positioning line, more accumulation will occur under the action of gravity, causing the energy storage unit to deform and affecting the auxiliary expansion effect.

[0039] Preferably, the axial length of the segment connection is 4 to 20% of the axial length of the power storage unit in the power storage state, such as 5%, 8%, 13%, 16%, 18%, etc.

[0040] If the ratio of the axial length of the segment connection to the axial length of the energy storage unit in the energy storage state is too high, it will affect the auxiliary expansion effect on the self-expanding support; if it is too low, it will affect the development effect.

[0041] The second objective of this application is to provide a self-expanding stent system, comprising: Self-expanding tubular stent; One of the objectives is the self-expanding support conveying device described above; The self-expanding tubular support is mounted outside the radial energy storage structure of the self-expanding support conveying device.

[0042] The third objective of this application is to provide a self-expanding stent system, comprising: Self-expanding tubular stent; One of the objectives is the self-expanding support conveying device; the self-expanding tubular support is mounted outside the radial energy storage structure of the self-expanding support conveying device; A catheter or sheath used to deliver a self-expanding tubular stent loaded on a self-expanding stent delivery device.

[0043] Typically, a catheter or sheath forms a passage within the body, and a self-expanding tubular stent, mounted on a self-expanding stent delivery device, is delivered within that passage.

[0044] Compared with the prior art, this application has the following beneficial effects: This application utilizes a radial energy storage structure, positioning lines, and fixing components in synergy to ensure the auxiliary expansion of the self-expanding support while effectively suppressing the displacement of the fixing components that may be caused by the release of the radial energy storage structure, thus providing reliable conditions for the precise release of the self-expanding support. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of the self-expanding support conveyor device in the power storage state. Figure 2 This is a schematic diagram showing the positional relationship of the spiral coil 600 on the positioning line 300; Figure 3 A schematic diagram of the radial structure of the spiral coil 600, the positioning line 300, and the pipeline 700; Figure 4 A schematic diagram of the radial energy storage structure release state of the self-expanding support conveying device provided in Example 2; Figure 5This is a schematic diagram of the radial structure of the developing ring 610, the positioning line 300, and the tubing network 700. Figure 6 This is a schematic diagram showing the positional relationship of the developing ring 610 on the positioning line 300. Detailed Implementation

[0046] The technical solution of the present invention will be further explained and described below with reference to specific embodiments. However, it should be noted that the specific embodiments are only a specific implementation and explanation of the essence of the technical solution of the present invention, and should not be construed as a limitation on the scope of protection of the present invention.

[0047] Example 1 like Figures 1-3 ( Figure 1 This is a schematic diagram of the self-expanding support conveyor device in the power storage state. Figure 2 This is a schematic diagram showing the positional relationship of the spiral coil 600 on the positioning line 300; Figure 3 As shown in the schematic diagram of the radial structure of the spiral coil 600, positioning line 300, and pipeline 700, Embodiment 1 provides a self-expanding support conveying device, comprising: Push rod 100; A radial energy storage structure 200 extends axially and is disposed at the distal end of the push rod 100. The radial energy storage structure 200 has an energy storage unit 210, which is formed by the knotting of segments of a mesh tube 700 woven with elastic threads. The radial energy storage structure 200 is in a storage state when it is stretched axially and contracted radially, and in a release state when the external force is removed, it contracts axially and expands radially. A positioning line 300 extends axially and penetrates the inner cavity of the radial energy storage structure 200; the length of the positioning line 300 is slightly greater than the axial length of the radial energy storage structure 200 in the energy storage state, and the positioning line 300 is in a natural state; the portion of the positioning line 300 corresponding to the radial energy storage structure 200 is defined as the effective area 301 of the positioning line; the positioning line 300 is a nickel-titanium alloy wire; The fixing component 400 is a developing spiral coil 600, which is disposed at the proximal and distal ends of the effective area 301 of the positioning line. The developing spiral coil is internally coated with adhesive and fixed to the positioning line 300, while its externally coated with adhesive is fixed to the inner cavity wall of the proximal and distal ends of the radial energy storage structure 200. In the energy storage state, the length of the positioning line between the fixing components 400 is equal to the predetermined axial length of the radial energy storage structure 200 in the energy storage state.

[0048] The energy storage unit 210 is made of 16 nickel-titanium alloy wires (0.0015 inches in diameter) using a one-press-one-braiding process to form a braided network with an axial length of 15.5 mm. After heat treatment, it is pre-shaped into a network 700 with an outer diameter of 2.00 ± 0.20 mm. The same type of nickel-titanium alloy wire is used as a positioning line 300 (0.0015 inches in diameter, 15.5 mm in length). Spiral coils 600 (0.5 mm in length, 0.005 inches in outer diameter) are fixed at axial positions of 1 mm, 11.5 mm, and 15 mm respectively. The spiral coils at 1 mm and 11.5 mm serve as fixing components 400. The spiral coil at 15 mm is used to fix and connect to the near-end push rod 100. The network between 0 and 1 mm is used to fix and connect to the far-end head end 500. The far-end head end may have a non-transmittent linearity. Figure 2 A schematic diagram showing the positional relationship of the spiral coil 600 on the positioning line 300 is provided. Figure 3 A structural schematic diagram of the spiral coil 600, positioning line 300, and pipe network 700 is provided. The positioning line 300 is bonded and fixed to the spiral coil 600 and pipe network 700 by an adhesive 800. The positioning method of the positioning line 300 can be understood as follows: after the positioning line 300 through which the spiral coil 600 is inserted into the pipe network 700, the positioning line 300 is straightened, the pipe network 700 is stretched to a contracted state, aligned with the distal end (position 0mm), and the pipe network 700 is circumferentially constrained at the position of the spiral coil 600 by the adhesive 800, forming a power storage structure, and a transition structure at the proximal end of the power storage structure that connects to the push rod 100. The transition structure has a small axial length, so it has no significant radial expansion force. A heat-shrinkable polymer sleeve is fixedly sleeved outside the pipe network 700 at the axial position of the spiral coil 600 as a protective external barrier 900.

[0049] The effective area 301 of the positioning line of the self-expanding support conveying device provided in Example 1 has an axial length of 11 mm in the storage state and 8.5 mm in the release state.

[0050] In other specific embodiments, the positioning line 300 may also be a flexible positioning line.

[0051] In other specific embodiments, the energy storage unit 210 may also be either a metal tube engraving structure or a wire binding structure.

[0052] In other specific embodiments, the length of the pipeline 700, the length of the positioning line 300, and the position of the fixing component 400 can all be selected according to the actual situation.

[0053] Example 2 like Figures 4-6 ( Figure 4A schematic diagram of the radial energy storage structure release state of the self-expanding support conveying device provided in Example 2; Figure 5 This is a schematic diagram of the radial structure of the developing ring 610, the positioning line 300, and the tubing network 700. Figure 6 As shown in the schematic diagram of the positional relationship of the developing ring 610 on the positioning line 300, Embodiment 2 provides a self-expanding support conveying device, which differs from Embodiment 1 only in the radial energy storage structure design, as detailed below: A radial energy storage structure 200 extends axially and is disposed at the distal end of the push rod. The radial energy storage structure 200 has three energy storage units, namely, a first energy storage unit 201, a second energy storage unit 202, and a third energy storage unit 203, from the proximal end to the distal end. The three energy storage units are designed as a single piece, with a diamond-shaped hollow mesh laser-engraved from a metal tube, and then segmentally converged. The unconverged parts form energy storage units, and the segments connecting two adjacent energy storage units are segmental connecting parts 204. The radial energy storage structure 200 is in a stored state when it is axially stretched and radially contracted. When the external force is removed, it is in a released state when it is axially contracted and radially expanded. The diamond-shaped hollow mesh has a variable shape in the stored state and the released state. The positioning line 300 extends axially and penetrates the inner cavity of the radial energy storage structure 200; the length of the positioning line is slightly greater than the axial length of the radial energy storage structure 200 in the energy storage state, and the positioning line 300 is in a natural state; the portion of the positioning line 300 corresponding to the radial energy storage structure 200 is defined as the effective area of ​​the positioning line; the positioning line 300 is an ultra-high molecular weight polyethylene fiber thread. Two fixing components 400 are developing rings 610, respectively disposed at the proximal and distal ends of the effective area of ​​the positioning line. The internal adhesive 101 of the fixing component 400 is fixed to the positioning line 300, while the external adhesive 101 is fixed to the inner cavity wall of the proximal and distal ends of the radial energy storage structure 200. In the energy storage state, the length of the positioning line 300 between the two fixing components 400 is equal to the predetermined axial length of the radial energy storage structure 200 in the energy storage state.

[0054] The two fixing structures 410 are developing rings 610, which are respectively set inside the two segment connecting parts 204. The fixing structure 410 is internally coated with glue and fixed to the positioning line 300, while its externally coated with glue is fixed to the inner cavity wall of the segment connecting part 204.

[0055] Nickel-Titanium alloy tubing (33.5mm in length) is selected and laser-cut along the axial direction at predetermined positions according to a predetermined pattern to form a hollowed-out mesh tubular structure. The hollowed-out area is composed of a near-rhomboid hollowed-out mesh formed by support columns, which has tensile and variable characteristics. Each support column has a circular cross-section with a diameter of 0.0015 inches. After heat treatment, it is pre-shaped into a hollowed-out tubular structure with an outer diameter of 2.00±0.20mm. A 33.5 mm long ultra-high molecular weight polyethylene (UHMWPE) fiber thread (0.0010 inch diameter) is used. A developing ring 610 (0.5 mm long) is fixed at axial positions of 1.5 mm, 12 mm, 22.5 mm, and 33 mm, respectively, serving as a fixing component 400 and a fixing structure 410. The UHMWPE fiber thread with the developing ring 610 inserted is then passed through the tubular structure, aligning the tubular structure with both ends of the UHMWPE fiber thread. The tubular structure is then gathered at the corresponding position of the developing ring 610 and fixed to the outside of the developing ring 610. Three energy storage units are segmented and limited at positions of 2-12 mm, 12.5-22.5 mm, and 23-33 mm of the tubular structure. The 1.5-33.5 mm region of the tubular structure is the effective area for the positioning line. A heat-shrinkable polymer sleeve is fixedly fitted onto the outside of the tubular structure at the axial positions of the fixing component 400 and the fixing structure 410 (i.e., the developing ring 610) as a protective external barrier 900.

[0056] The effective axial length of the positioning line of the self-expanding support conveying device provided in Example 2 is 32 mm in the storage state and 21.4 mm in the release state.

[0057] In an optional specific embodiment, the fixing structure 410 is only fixedly connected to the inner wall of the tubular structure and not fixedly connected to the ultra-high molecular weight polyethylene fiber line, that is, the ultra-high molecular weight polyethylene fiber line can slide axially in the inner cavity of the fixing structure 410.

[0058] In an optional specific embodiment, after the nickel-titanium alloy tube is engraved, it is heated and pre-shaped to form a power storage unit and a segment connection part.

[0059] In an optional specific embodiment, the developing ring can be replaced with a spiral coil, a C-shaped developing ring, etc.

[0060] In optional embodiments, the ultra-high molecular weight polyethylene fiber thread can be replaced with other flexible positioning threads, such as any one or a combination of at least two of polyester thread, polypropylene thread, aramid thread, or blended fiber thread; in other embodiments, the positioning thread 300 can also be an elastic positioning thread.

[0061] In other specific embodiments, the first energy storage unit 201, the second energy storage unit 202 and the third energy storage unit 203 are designed as a single unit, and can also be any one of a woven wire structure or a wire binding structure.

[0062] In other specific embodiments, the lengths of the first energy storage unit 201, the second energy storage unit 202, and the third energy storage unit 203, the length of the positioning line 300, and the positions of the fixing component 400 and the fixing structure 410 can all be selected according to the actual situation.

[0063] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A self-expanding support conveying device, characterized in that, include: Push lever; A radial energy storage structure extends axially and is disposed at the distal end of the push rod. The radial energy storage structure is configured to have a storage state and a release state. In the storage state, the radial energy storage structure is axially elongated and radially compressed to store radial outward expansion force. In the release state, the radial energy storage structure is axially shortened and radially expanded to release the radial outward expansion force. The radial energy storage structure has an axially extending internal cavity defined inside; A positioning line extends axially and penetrates the inner cavity of the radial energy storage structure; the length of the positioning line is not less than the axial length of the radial energy storage structure in the energy storage state, and the positioning line is in a natural state; the section of the radial energy storage structure corresponding to the positioning line is defined as the effective area of ​​the positioning line. A fixing component is provided at least at the proximal and distal ends of the effective area of ​​the positioning line, and the proximal and distal ends of the effective area of ​​the positioning line are respectively fixed to the inner cavity walls of the proximal and distal ends of the radial power storage structure; in the power storage state, the length of the positioning line between the two fixing components is configured to be equal to the predetermined axial length of the radial power storage structure in the power storage state.

2. The self-expanding support conveying device as described in claim 1, characterized in that, The radial energy storage structure includes at least one energy storage unit, each energy storage unit having an axially extending cavity structure; the two ends of the energy storage unit have small outer diameters, and the middle part has an expandable structure with a variable radial dimension; in the energy storage state, the expandable structure radially contracts and axially extends; in the release state, the expandable structure radially expands and axially shortens.

3. The self-expanding support conveying device as described in claim 2, characterized in that, The radial energy storage structure includes two or more energy storage units connected in series along the axial direction; the cavity structure of all energy storage units is designed as a single unit; except for the ends located at the nearest and farthest ends of the radial energy storage structure, the connection between adjacent energy storage units is defined as a segmental connection part; each segmental connection part is independently constructed to be either fixedly connected to the positioning line or not fixedly connected to the positioning line. Preferably, the segment connection portion is formed by a pre-forming process or its configuration is achieved by a limiting and fixing structure; Preferably, the limiting and fixing structure includes an annular structure sleeved on the outside of the segment connection portion, or a fixing structure disposed inside the energy storage unit and fixing the segment connection portion; the fixing structure preferably includes any one of a spiral coil, a C-ring, and a circular ring; Preferably, the segment connection portion is not fixedly connected to the positioning line, allowing the positioning line to slide axially relative to the segment connection portion; Preferably, the segment connection is configured to be fixedly connected to the positioning line, and in the stored state, the segment connection is fixed to the positioning line at its corresponding axial position; Preferably, when the segment connection is fixed to the positioning line, the axial length of each power storage unit in the power storage state is approximately equal to the axial length of the effective area of ​​the corresponding positioning line. Preferably, a protective barrier is provided on the outside of the segment connection portion, and the protective barrier is preferably a heat-shrinkable polymer sleeve.

4. The self-expanding support conveying device as described in any one of claims 1 to 3, characterized in that, The positioning line includes any one or a combination of at least two of the following: flexible positioning line and elastic positioning line. Preferably, the elastic positioning line is made of an elastic material, which is preferably a metal, alloy, polymer material or composite material thereof, and more preferably a nickel-titanium alloy.

5. The self-expanding support conveying device as described in claim 2, characterized in that, The expandable structure is a structure with a hollow pattern, and the hollow structure preferably includes any one or a combination of at least two of the following: a wire weaving structure, a wire binding structure, and a metal tube engraving structure. Preferably, the expandable structure is made of shape memory material, which is preferably a shape memory alloy, and more preferably a nickel-titanium alloy.

6. The self-expanding support conveying device as described in any one of claims 1 to 5, characterized in that, The fixing component is selected from any one or a combination of at least two of the following: a fixing ring, a spiral coil, and a C-ring; a spiral coil is preferred. Preferably, the fixing component has non-transmittent linearity; Preferably, the fixing component is fixedly sleeved on the positioning line and is fixedly connected to the inner cavity wall of the corresponding end of the radial energy storage structure in the energy storage state; Preferably, the fixing method includes any one or a combination of at least two of welding, bonding, and snap-fitting.

7. The self-expanding support conveying device as described in any one of claims 2 to 6, characterized in that, The axial length of the energy storage unit in the released state is 50-95% of its axial length in the energy storage state.

8. The self-expanding support conveying device as described in any one of claims 2 to 7, characterized in that, The axial length of the segment connection is 4 to 20% of the axial length of the power storage unit in the power storage state.

9. A self-expanding stent system, characterized in that, The self-expanding stent system includes: Self-expanding tubular stent; The self-expanding support conveying device according to any one of claims 1 to 8; The self-expanding tubular support is mounted outside the radial energy storage structure of the self-expanding support conveying device.

10. A self-expanding stent system, characterized in that, The self-expanding stent system includes: Self-expanding tubular stent; The self-expanding support conveying device according to any one of claims 1 to 8; the self-expanding tubular support is mounted outside the radial energy storage structure of the self-expanding support conveying device; A catheter or sheath used to deliver a self-expanding tubular stent loaded on a self-expanding stent delivery device.

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