Stent delivery device and surgical system
By designing a stent delivery device containing a delivery tube assembly and a stent release assembly, the complex problems of delivery and release operations in the prior art are solved, and the simple release of the stent and the successful implantation of the stylus are achieved, reducing the risk of surgical failure.
Patent Information
- Application Number
- CN202311177900.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-09-12
- Publication Date
- 2025-03-14
AI Technical Summary
The existing delivery and release devices have complex operations on the delivery and release of blood flow guide devices, and may lead to failure of separation of the delivery pusher from the bare stent or touching the sidewall blood vessels or aneurysms, resulting in failure of the surgery.
A stent delivery device is designed, including a delivery tube assembly with an inner cavity and a stent release assembly. The bracket release assembly consists of an elastic deformation member and a limiting tube connected in the axial direction. The elastic deformation member is moved out of the inner cavity of the delivery tube assembly and expands radially outward in the transition state, and pulls the limiting tube to extend and expand the bracket from the limiting tube.
Through the design of the device, the release process of the stent becomes simple and the operation is more intuitive, reducing the risk of surgical failure, ensuring that the stent can be successfully implanted into the blood vessel and reconstructed blood flow pathways.
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Figure CN119606612A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to medical equipment, and in particular to a stent delivery device and a surgical system. Background Art
[0002] Vascular aneurysm refers to an abnormal bulge in the wall of a vascular artery and is the most common cause of spontaneous subarachnoid hemorrhage.
[0003] Currently, it can be delivered to the location of intracranial aneurysms through a delivery catheter by percutaneous puncture, which usually involves delivering vascular implants, such as but not limited to stents, coils, aneurysm occlusion devices, etc., to the lesion location in the blood vessel through a delivery device, and then the vascular implant is released while maintaining the implant design structure to achieve the therapeutic effects of dilating the blood vessels, changing the intracranial arterial blood flow dynamics, and occluding aneurysms. However, the delivery and release of the blood flow guide device by the existing delivery and release device is relatively complicated, and the release and delivery may not be completely separated, resulting in the possibility of failure to separate the delivery pusher delivery device from the bare stent, or causing it to touch the side wall blood vessels, aneurysms, etc., resulting in surgical failure. Summary of the invention
[0004] The technical problem to be solved by the present invention is that, in view of the defects in the prior art, the present invention proposes to provide a stent delivery device and a surgical system.
[0005] The technical solution adopted by the present invention to solve the technical problem is: a stent delivery device for delivering the stent into a blood vessel, comprising:
[0006] a delivery tube assembly having an inner lumen; and
[0007] A stent release assembly is inserted into the inner cavity of the delivery tube assembly, and the stent release assembly includes an elastic deformation member and a limiting tube connected in the axial direction, wherein the elastic deformation member has a compressed state in which the elastic deformation member is radially restricted in the inner cavity of the delivery tube assembly and a free state outside the inner cavity of the delivery tube assembly, and during the transition from the compressed state to the free state, the elastic deformation member moves out of the inner cavity of the delivery tube assembly and expands radially outward, and elastically shortens in the axial direction;
[0008] Wherein, the limiting tube is used to accommodate and radially compress at least part of the stent. When the elastic deformable member is moved out of the inner cavity of the conveying tube assembly, it elastically shortens in the axial direction to pull the limiting tube axially, so that the limiting tube moves relative to the stent, thereby causing the stent to extend from the limiting tube and expand.
[0009] Furthermore, the optimized stent release assembly further comprises a positioning tube axially connected to the elastic deformation member, the positioning tube is passed through the inner cavity of the delivery tube assembly and can slide axially relative thereto, and is limited to the distal end of the delivery tube assembly.
[0010] Further, the positioning tube and / or the limiting tube are optimized to be made of a material having a developing property, or the positioning tube and / or the limiting tube are coated with a developing layer.
[0011] Furthermore, the inner wall surface of the positioning tube is optimized to be provided with a first sliding film.
[0012] Furthermore, the elastic deformation member is optimized to be an elastic shell-like structure with an inner cavity.
[0013] Furthermore, the peripheral wall of the elastic shell-like structure is optimized to be a mesh cage structure or a film structure.
[0014] Further, the elastic deformation member is optimized to include a plurality of elastically bent slender members, and two ends of each of the slender members are respectively connected to the limiting tube and the positioning tube.
[0015] Further, the circumferential arrangement of the slender members is optimized, or the circumferential arrangement of the slender members is optimized.
[0016] Further, preferably, the elastic deformation member includes an elastic unit that at least partially protrudes radially in a natural state.
[0017] Further, preferably, the elastic deformation member includes at least two elastic units connected in the axial direction.
[0018] Furthermore, preferably, the elastic deformation member is a spiral elastic member.
[0019] Furthermore, it is preferred that the stent delivery device includes a stent delivery assembly, which is inserted into the inner cavity of the delivery tube assembly and can slide axially relative to the delivery tube assembly; the stent delivery assembly is connected to the stent and restrains the stent, and the proximal end of the stent delivery assembly is limited to the stent release assembly and slides axially relative to the stent release assembly.
[0020] Further, the stent delivery assembly preferably includes a guide wire, a first limit member and a second limit member axially spaced and fixed on the guide wire; the second limit member is limitably disposed in the stent, the first limit member is limitably connected to the proximal end of the stent, the first limit member is limitably located in the stent release assembly, and slides axially relative to the stent release assembly.
[0021] Furthermore, it is preferred that a hook portion is provided on the first limiting member, and the hook portion is used to hook the stent when at least part of the stent is compressed in the inner cavity of the delivery tube assembly to allow at least a portion of the stent to move axially; the hook portion is configured to release the radially elastically expanded stent when it is extended out of the inner cavity of the stent release assembly.
[0022] Furthermore, it is preferred that an axial offset structure is formed between the second limiting member and the stent releasing assembly to clamp the stent.
[0023] Further, preferably, the outer diameter of the second position-limiting member is the same as the inner diameter of the stent release assembly; or, the outer diameter of the second position-limiting member is larger than the inner diameter of the stent release assembly.
[0024] Further, it is preferred that the first limiting member and / or the second limiting member is / are made of a material having a developing property, or the first limiting member and / or the second limiting member is / are coated with a developing layer.
[0025] Furthermore, it is preferred that the front end of the guide wire is curved.
[0026] Furthermore, it is preferred that a second sliding film is provided on the inner wall of the delivery pipe assembly.
[0027] Furthermore, preferably, the stent delivery device also includes a loading sheath, the inner diameter of the delivery tube assembly is greater than or equal to the inner diameter of the loading sheath, the distal end of the loading sheath is docked with the proximal end of the delivery tube assembly, and the stent, the stent delivery assembly and the stent release assembly move along the inner cavity of the loading sheath toward the inner cavity of the delivery tube assembly.
[0028] A surgical system comprises a stent delivery device and a stent. The stent delivery device is used to deliver the stent. The stent is configured to have a natural state and a compressed state. The stent expands elastically in the free state and forms an overall bundle in the contracted state.
[0029] The present invention has the following beneficial effects: the stent delivery device provided by the present invention releases the stent to the aneurysm of the blood vessel through the delivery tube assembly and the stent release assembly. The stent is a bare metal stent with a relatively dense mesh. The stent is implanted in the blood vessel to reconstruct the blood flow pathway, reduce the blood flow entering the aneurysm, or even prevent the blood flow from entering the aneurysm. Instead, the blood flow flows along the pathway reconstructed by the stent according to the principle of hemodynamics, thereby reducing the blood flow entering the aneurysm. The present invention uses the elastic deformation member of the stent release assembly. The elastic deformation member has a compressed state radially restricted in the inner cavity of the delivery tube assembly and a free state outside the inner cavity of the delivery tube assembly. In the process of transitioning from the compressed state to the free state, the elastic deformation member moves out of the inner cavity of the delivery tube assembly and expands radially outward, and elastically shortens in the axial direction. When the elastic deformation member moves out of the inner cavity of the delivery tube assembly, it elastically shortens in the axial direction to pull the limiting tube in the axial direction, so that the limiting tube moves relative to the stent, thereby causing the stent to extend out of the limiting tube and expand, so that the release process of the stent is simple and the operation process is simple. BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:
[0031] Figure 1 is a schematic diagram of the three-dimensional structure of a stent delivery device in some embodiments of the present invention;
[0032] Figure 2 yes Figure 1 A schematic diagram of the structure of the middle stent, the stent delivery assembly and the stent release assembly in a natural state;
[0033] Figure 3 yes Figure 1 Schematic diagram of the structure of the middle stent in the unexpanded state;
[0034] Figure 4 yes Figure 1 Schematic diagram of the structure of the stent in a semi-expanded state;
[0035] Figure 5 yes Figure 1 Schematic diagram of the structure of the middle stent in a fully expanded state;
[0036] Figure 6 is a schematic structural diagram of a stent delivery device in some other embodiments of the present invention;
[0037] Figure 7 is a schematic structural diagram of a delivery pipe assembly in some embodiments of the present invention;
[0038] Figure 8 is a schematic diagram of the structure of a stent delivery assembly in some embodiments of the present invention;
[0039] Figure 9-10is a schematic structural diagram of a stent release assembly in some embodiments of the present invention in a compressed state;
[0040] Figure 11-Figure 17 is a schematic diagram of the structure of a stent release assembly in some embodiments of the present invention;
[0041] Fig.18 is a schematic structural diagram of a first position-limiting member in some embodiments of the present invention;
[0042] Fig.19 is a schematic structural diagram of a second stopper and a bracket release assembly in some embodiments of the present invention;
[0043] Figure 20-22 It is a schematic diagram of the state of the loading sheath and delivery tube assembly when operating the stent + stent delivery assembly + stent release assembly in some embodiments of the present invention. DETAILED DESCRIPTION
[0044] Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to make the present invention more thorough and complete, and to fully convey the scope of the present invention to those skilled in the art.
[0045] It should be understood that although the terms "first", "second", "third", etc. may be used to describe various information in the present invention, such information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present invention, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.
[0046] In the description of the present invention, it should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.
[0047] Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, or a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
[0048] In the art, the end closer to the device operator is called the proximal end, and the end farther from the device operator is called the distal end.
[0049] like Figure 1-Figure 2 As shown, a stent delivery device includes a delivery tube assembly 10 and a stent release assembly 30.
[0050] like Figure 1-Figure 6 As shown, the stent 40 has a certain elasticity. It expands elastically in a free state and forms an overall bundle in a contracted state. For example, it can be a bare metal stent with a denser mesh. It is implanted in a blood vessel to reconstruct the blood flow pathway, reduce the blood flow entering the aneurysm, or even prevent the blood flow from entering the aneurysm. The blood flow is caused to flow along the pathway reconstructed by the stent 40 by utilizing the principle of hemodynamics, thereby reducing the blood flow entering the aneurysm.
[0051] Among them, Figure 7 As shown, the delivery tube assembly 10 is a tubular structure containing a circular, elliptical or polygonal internal cavity. During surgery, the delivery tube assembly 10 is first inserted into the blood vessel to establish a passage, which is used to form a channel for the stent release assembly 30 to deliver the release stent 40 to the target blood vessel position through the inner cavity channel.
[0052] Preferably, in the present invention, a pipeline can be used as the delivery tube assembly 10, such as a hypotube as the delivery tube. Further, in the present invention, the hypotube can be made of metal or polymer material, preferably, the hypotube body is a cut metal spiral tube with a pitch gradually decreasing from the proximal end to the distal end, or a polymer material with variable flexibility; further, the metal material can be stainless steel, platinum, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy or cobalt-chromium alloy, and the polymer material includes but is not limited to polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene-propylene copolymer, polyamide, polyimide or nylon.
[0053] The stent release assembly 30 is passed through the inner cavity of the delivery tube assembly 10. The stent release assembly 30 includes an elastic deformable member 32 and a limiting tube 33 connected along the axial direction. The elastic deformable member 32 has a compressed state radially restricted in the inner cavity of the delivery tube assembly 10, and a free state outside the inner cavity of the delivery tube assembly 10. In the process of transforming from the compressed state to the free state, the elastic deformable member 32 moves out of the inner cavity of the delivery tube assembly 10 and expands radially outward, and elastically shortens in the axial direction.
[0054] The position limiting tube 33 is used to accommodate and radially compress at least a portion of the stent 40, that is, the position limiting tube 33 is used to accommodate at least a portion of the stent and radially compress the portion of the stent. When the elastic deformation member 32 is removed from the inner cavity of the delivery tube assembly 10, it elastically shortens in the axial direction to pull the position limiting tube 33 in the axial direction, so that the position limiting tube 33 moves relative to the stent 40, so that the stent extends out of the position limiting tube 33 and expands.
[0055] When in use, the stent delivery device has three states from front to back:
[0056] like Figure 3 As shown, the first state is the unexpanded state of the stent 40, that is, the state when the stent 40 is compressed and restrained in the delivery tube assembly 10: the proximal end of the stent 40 is accommodated and restrained in the limiting tube, and can slide axially relative to the stent release assembly 30, the remaining part of the stent 40 is restrained and limited by the inner surface of the delivery tube assembly 10 and the stent 40 is located as a whole in the delivery tube assembly 10 and cannot expand, the elastic deformable member 32 is in a compressed state having been radially restricted in the inner cavity of the delivery tube assembly 10, and the limiting tube 33 is in the delivery tube assembly 10.
[0057] like Figure 4 As shown, the second state is the semi-expanded state of the stent 40: the distal end of the stent 40 is released from the delivery tube assembly 10, and the stent 40 has a certain elasticity, so that it can expand radially after losing the radial constraint of the inner wall of the delivery tube assembly 10. However, at this time, the proximal end of the stent 40 is still radially compressed and constrained by the limiting tube 33 of the stent release assembly 30, and the elastic deformation member 32 is in a compressed state radially restricted in the inner cavity of the delivery tube assembly 10, and the limiting tube 33 at least partially extends out of the distal end of the delivery tube assembly 10.
[0058] like Figure 5As shown, the third state is the fully expanded state of the stent 40: the stent release assembly 30 slides relatively and extends out of the delivery tube assembly 10, the limiting tube 33 extends out of the distal end of the delivery tube assembly 10, and the elastic deformation member 32 of the stent release assembly 30 extends out of the distal end of the delivery tube assembly 10. The elastic deformation member 32 moves out of the inner cavity of the delivery tube assembly 10 and expands radially outward, and elastically shortens in the axial direction, and elastically shortens in the axial direction to pull the limiting tube 33 in the axial direction, so that the limiting tube 33 moves relative to the stent 40, thereby causing the stent to extend from the limiting tube 33 and expand, and the stent 40 is implanted in the blood vessel to reconstruct the blood flow pathway.
[0059] In a specific embodiment, Figure 9-11 As shown, the stent release assembly 30 includes a positioning tube 31, an elastic deformation member 32 and a limiting tube 33 from the proximal end to the distal end; the positioning tube 31 and the limiting tube 33 can both be tubular structures; the two ends of the elastic deformation member 32 are respectively connected to the limiting tube 33 and the positioning tube 31, the positioning tube 31 is passed through the inner cavity of the delivery tube assembly 10 and can slide axially relative to it, and is limited at the distal end of the delivery tube assembly 10. The limiting here means that the positioning tube 31 can slide axially in the inner cavity of the delivery tube assembly 10, and the proximal end of the positioning tube 31 is stopped and limited at the distal end of the delivery tube assembly 10 to prevent the entire stent release assembly 30 from escaping from the inner cavity of the delivery tube assembly 10.
[0060] In some embodiments, the positioning tube 31 and / or the limiting tube 33 are made of a developing material, such as a stainless steel tube, or the positioning tube 31 and / or the limiting tube 33 are coated with a developer so that the positioning tube 31 and / or the limiting tube 33 can be seen in the imaging system, thereby knowing their position and judging the status of the bracket 40.
[0061] In some embodiments, Figure 6 As shown, in order to improve the surface smoothness of the inner wall of the limiting tube 33, a first sliding film 331 is provided on the inner wall of the limiting tube 33. The surface of the first sliding film 331 is smooth, and the sliding property with the bracket 40 and the first limiting member 22 is good. Further, the first sliding film 331 is preferably a PTFE film, which has low friction and slides smoothly with the bracket 40 and the first limiting member 22.
[0062] In a specific embodiment, Figure 9-11 As shown, Fig. 9 A schematic structural diagram of a stent release assembly 30 in an embodiment is shown. At this time, the stent release assembly 30 is subjected to a restraining force in the radial direction or a tensile force in the axial direction, so that the elastic deformable member 32 therein generates elastic internal stress. Fig. 9 and Fig.10 The difference lies in the different structures of the elastic deformation member 32. Fig.10 The stent delivery assembly 30 shown in FIG. 1 is subjected to a restraining force in the radial direction or a tensile force in the axial direction. Fig.10 The elastically deformable member 32 of the stent release assembly 30 is shown in a compressed state radially confined in the lumen of the delivery tube assembly 10. Fig.11 Shown is Fig.10 In the free state outside the inner cavity of the delivery tube assembly 10, the stent release assembly 30 is in a natural state, and is no longer subject to restraint force in the radial direction or tensile force in the axial direction. Fig.10 The elastic deformation member 32 shown has a smaller radial dimension and a longer axial dimension. Fig.11 The elastically deformable member 32 shown has a larger radial dimension and a smaller axial dimension.
[0063] In some embodiments, Fig.12 , Fig.14 As shown, the elastic deformable member 32 is an elastic shell-like structure with an inner cavity. In the compressed state, it is compressed into a bundle, a long strip, or a ball, etc., and is radially restricted in the inner cavity of the conveying pipe assembly 10; when the elastic deformable member 32 is released from the conveying pipe assembly 10, the elastic deformable member 32 of the elastic shell-like structure is no longer constrained by the inner wall of the conveying pipe assembly 10, and at least part of the radial protrusion forms an elastic shell-like structure with an inner cavity, and its diameter becomes larger and the axial dimension is elastically shortened; further, the peripheral wall of the elastic shell-like structure is a mesh cage structure or a film structure. The elastic deformable member 32 of this structure has a good axial recovery rate and recovery strength.
[0064] In some embodiments, the elastic deformable member 32 includes a plurality of elastically bent elongated members 321, and the elongated members 321 may be a single elastic thread, or an elastic bundle composed of a plurality of non-crossed or crossed elastic threads; each elongated member 321 is sequentially arranged in a circumferential direction to form a spindle structure, such as Fig.14 Or the elongated members 321 are cross-arranged to form an elastic net structure, such as Fig.12 or the elongated member is symmetrically distributed up and down with the central axis of the elastic deformation member 32 as the symmetry axis, such as Fig.13 As shown. Both ends of each of the slender pieces 321 are connected to the limiting tube 33 and the positioning tube 31, respectively. The slender pieces 321 are configured to have a compressed state and a natural state. In the compressed state, each slender piece 321 is radially bound by the conveying tube assembly 10 and compressed into a bundle, or a long strip, or a group, and is axially elongated; when the elastic deformation piece 32 is released from the conveying tube assembly 10, the slender piece 321 is no longer bound by the inner wall of the conveying tube assembly 10. In the natural state, the slender piece 32 protrudes radially, and the maximum radial dimension is greater than the inner cavity diameter of the conveying tube assembly 10, and is elastically shortened in the axial direction.
[0065] In a specific embodiment, the elastic deformation member 32 includes an elastic unit 322 that at least partially protrudes radially in a natural state. Fig.17As shown, the elastic unit 322 is configured to have a compressed state and a natural state. In the compressed state, the elastic unit 322 is compressed into a bundle, a strip, or a group by the radial conveying tube assembly 10, and is axially elongated; when the elastic deformable member 32 is released from the conveying tube assembly 10, the elastic unit 322 is no longer bound by the inner wall of the conveying tube assembly 10. In the natural state, the elastic unit 322 at least partially protrudes in the radial direction, and the maximum radial dimension is greater than the inner cavity diameter of the conveying tube assembly 10, and is elastically shortened in the axial direction. The elastic deformable member 32 of this structure has a good axial recovery rate and recovery strength.
[0066] In a specific embodiment, the elastic deformation member 32 includes at least two elastic units 322 connected in the axial direction. Figure 15-16 As shown, the elastic unit 322 is configured to have a compressed state and a natural state. In the compressed state, the elastic unit 322 is compressed into a bundle, a long strip, or a group by the radial conveying tube assembly 10, and is axially elongated; when the elastic deformable member 32 is released from the conveying tube assembly 10, the elastic unit 322 is no longer bound by the inner wall of the conveying tube assembly 10. In the natural state, the elastic unit 322 at least partially protrudes in the radial direction, and the maximum radial dimension is greater than the inner cavity diameter of the conveying tube assembly 10, and is elastically shortened in the axial direction. Adjacent elastic units 322 are connected end to end, and a concave is formed at the end where the elastic units 322 are connected end to end. This design not only makes the diameter small after elastic expansion (natural state), reducing the restriction by the inner diameter of the blood vessel, but also makes the difference between the length in the natural state and the length in compression larger, which is conducive to the release of the stent 40.
[0067] In some embodiments, Figure 10-11 As shown, the axial recovery rate and recovery strength of the stent release assembly 30 are improved. The elastic deformation member 32 is a spiral elastic member. The elastic deformation member 32 is a spiral structure in a natural state, that is, it is shaped into a spiral style; when the spiral elastic member is in the delivery tube assembly, it is bound by the radial delivery tube assembly 10 and compressed into a bundle, or a long strip, or a group, and axially elongated, and a wavy structure is formed by the spiral structure, such as Fig.10 As shown; when the spiral elastic member is released from the delivery tube assembly 10, the spiral elastic member is no longer bound by the inner wall of the delivery tube assembly 10 in a natural state, the spiral elastic member protrudes radially, and the maximum radial dimension is greater than the inner cavity diameter of the delivery tube assembly 10, and is elastically shortened in the axial direction, such as Fig.11 shown.
[0068] In some specific embodiments, the stent delivery device of the present invention also includes a stent delivery assembly 20, which is passed through the inner cavity of the delivery tube assembly 10 and can slide axially relative to the delivery tube assembly 10; the stent delivery assembly 20 is connected to the stent 40 and restrains the stent 40, and the proximal end of the stent delivery assembly 20 is limited in the stent release assembly 30 and slides axially relative to the stent release assembly 30. The limit here means that the proximal end of the stent delivery assembly 20 can slide axially in the inner cavity of the stent release assembly 30, and the proximal end of the stent delivery assembly 20 is stopped and limited at the distal end of the stent release assembly 30.
[0069] like Figure 8 As shown, the stent delivery assembly 20 includes a guide wire 21, a first stopper 22 and a second stopper 23 fixed on the guide wire 21 at intervals. Further, the front end of the guide wire 21 is preferably bent. By rotating the guide wire 21 around the axial direction, the bent front end is selected to enter one of the branch vessels at the bifurcation, so as to facilitate the control of the advancing direction of the guide wire 21. The stent delivery assembly 20 is arranged in the inner cavity of the delivery tube assembly 10 and can slide forward and backward relative to the delivery tube assembly 10 along the axial direction; the stent release assembly 30 is arranged in the inner cavity of the delivery tube assembly 10 and can slide axially relative to the delivery tube assembly 10. The stent release assembly 30 has an inner cavity and at least the middle part is an elastic deformation member 32. The elastic deformation member 32 is bound by the delivery tube assembly 10 in a contracted state, and the whole is bundled. In a natural state, it expands radially outward, and its diameter becomes larger while the axial size decreases. When radially expanding outward, the distal end of the stent release assembly 30 can be withdrawn toward the proximal end.
[0070] The guide wire 21 is passed through the positioning tube 31, the elastic deformation member 32 and the limiting tube 33 from the proximal end, and extends out of the positioning tube 31; a part of the bracket 40 is located in the limiting tube 33 and the other part is located outside the limiting tube 33. Specifically, the proximal end of the bracket 40 is arranged in the limiting tube 33, that is, the first limiting member 22 is arranged in the limiting tube 33 and can move axially along the limiting tube 33, and the second limiting member 23 and the main body of the bracket 40 are arranged on the outside of the limiting tube 33; the elastic deformation member 32 can expand radially outward when extending out of the conveying tube assembly 10, and its diameter becomes larger and its axial size decreases during radial expansion. Since the elastic deformation member 32 is connected to the limiting tube 33, the radial outward expansion of the elastic deformation member 32 reduces the axial size of the elastic deformation member 32. If the position of the positioning tube 31 is kept unchanged, the limiting tube 33 is axially withdrawn from the distal end to the proximal end, that is, Figure 9-11 The middle stopper 33 moves from left to right, thereby releasing the bracket 40 from the stopper 33. At this time, the first stopper 22 is also released from the distal end (i.e. Figure 9-11The left end of the support 40 is released, the support 40 elastically expands so that the connection with the first limiting member 22 is automatically released, and the support 40 is fully expanded in the radial direction.
[0071] When in use, the stent delivery device has three states from front to back:
[0072] like Figure 3 As shown, the first state is the unexpanded state of the stent 40, that is, the state when the stent 40 is compressed and restrained in the delivery tube assembly 10: the stent 40 is sleeved outside the second limit member 23 and restrained in the delivery tube assembly 10, and the proximal end of the stent 40 is connected to the first limit member 22, and the first limit member 22 is limited in the stent release assembly 30 and can slide axially relative to the stent release assembly 30. The limit here is intended to limit the sliding limit position of the first limit member 22 in the stent release assembly 30. In this state, the proximal end of the stent 40 is connected by the first limit member 22, so that the proximal end of the stent 40 is located inside the stent release assembly 30, and the stent 40 is located as a whole in the delivery tube assembly 10, and is restrained by the delivery tube assembly 10 and cannot expand; the elastic deformation member 32 is in a compressed state having been radially restricted in the inner cavity of the delivery tube assembly 10, and the limit tube 33 is in the delivery tube assembly 10. The proximal end of the stent 40 is connected by the first stopper 22, so that the proximal end of the stent 40 and the first stopper 22 can move axially synchronously, and the first stopper 22 is used to control the axial position of the proximal end of the stent 40 relative to the stent release assembly 30. By moving the first stopper 22 axially relative to the stent release assembly 30, the proximal end of the stent 40 can be driven to move axially relative to the stent release assembly 30. In addition, by keeping the axial position of the first stopper 22 relative to the stent release assembly 30 unchanged, the axial position of the proximal end of the stent 40 relative to the stent release assembly 30 can also be kept unchanged, that is, the axial movement of the proximal end of the stent 40 relative to the stent release assembly 30 is limited.
[0073] like Figure 4 As shown, the second state is the semi-expanded state of the stent 40: by pulling the delivery tube assembly 10 proximally relative to the guide wire 21, the distal end of the stent 40 is released from the delivery tube assembly 10, and the stent 40 has a certain elasticity, so that it can expand radially after losing the radial restraint of the delivery tube assembly 10, but at this time the proximal end of the stent 40 is still radially restrained by the stent release assembly 30; the elastic deformable member 32 is in a compressed state having been radially restricted in the inner cavity of the delivery tube assembly 10, and the limiting tube 33 at least partially extends out of the distal end of the delivery tube assembly 10.
[0074] like Figure 5As shown, the third state is the fully expanded state of the stent 40: the delivery tube assembly 10 is pulled proximally, the limiting tube 33 slides relatively and extends out of the delivery tube assembly 10, the elastic deformation member 32 of the stent release assembly 30 moves out of the inner cavity of the delivery tube assembly 10 and expands radially outward, and elastically shortens in the axial direction, and elastically shortens in the axial direction to pull the limiting tube 33 axially, so that the proximal end of the stent 40 extends out from the limiting tube 33 and expands, the first limiting member 22 is released from the distal end of the stent release assembly 30, the stent 40 elastically expands and is disconnected from the first limiting member 22, the stent 40 fully expands in the radial direction, and the stent 40 is implanted in the blood vessel to reconstruct the blood flow pathway.
[0075] In some embodiments, Fig.18 As shown, a hook portion 221 for hooking the bracket 40 is provided on the first limiting member 22. The hook portion 221 can be a protrusion provided at the distal end of the first limiting member 22. When the hook portion 221 is located in the bracket release assembly 30, the hook portion 221 hooks the proximal end of the bracket 40; when the hook portion 221 extends out of the bracket release assembly 30, the bracket 40 elastically expands and automatically disengages from the hook portion 221, thereby improving the radial release effect of the bracket 40, simplifying the release, and avoiding the difficulty of releasing the bracket 40.
[0076] In some embodiments, Fig.19 As shown, an axial dislocation structure is formed between the second stopper 23 and the stent release assembly 30 to clamp the stent 40 so that the stent 40 cannot move autonomously. Further, preferably, the outer diameter of the second stopper 23 is the same as the inner diameter of the stent release assembly 30; or, the outer diameter of the second stopper 23 is larger than the inner diameter of the stent release assembly 30.
[0077] In some preferred embodiments, the first limiting member 22 and / or the second limiting member 23 are made of a material with developing properties, such as the first limiting member 22 and / or the second limiting member 23 are made of stainless steel, so that the first limiting member 22 and / or the second limiting member 23 can be seen in the imaging system, thereby knowing their positions and judging the status of the bracket 40.
[0078] In some embodiments, in order to improve the surface smoothness of the inner wall of the delivery pipe assembly 10, a second slip film 11 is provided on the inner wall of the delivery pipe assembly 10. Figure 6 As shown, the surface of the second synovial membrane 11 is smooth, and has good sliding properties with the stent 40 and the stent release assembly 30. Further, the second synovial membrane 11 is preferably a PTFE membrane, which has low friction and slides smoothly with the stent 40 and the stent release assembly 30.
[0079] In a specific embodiment, Figure 20-22As shown, the stent delivery device also includes a loading sheath 50, the inner diameter of the delivery tube assembly 10 is greater than or equal to the inner diameter of the loading sheath 50, the distal end of the loading sheath 50 is docked with the proximal end of the delivery tube assembly 10, the stent, the stent delivery assembly and the stent release assembly (in Figure 20-22 The total number of the middle stent + stent delivery assembly + stent release assembly is 60) and moves along the inner cavity of the loading sheath 50 toward the inner cavity of the delivery tube assembly 10; during surgery, the delivery tube assembly is first inserted into the blood vessel to establish a passage. At this time, the distal end of the delivery tube assembly is located inside the blood vessel, and the proximal end is located outside the blood vessel. The distal end of the loading sheath 50 is docked with the proximal end of the delivery tube assembly. The stent, the stent delivery assembly and the stent release assembly are pushed into the loading sheath 50 and the delivery tube assembly, and continue to be pushed forward along the delivery tube assembly to the lesion of the blood vessel. Then the delivery tube assembly 10 is withdrawn proximally to release the stent.
[0080] The present invention provides a surgical system, such as Figure 1-Figure 2 As shown, the surgical system includes the above-mentioned stent delivery device and stent 40, the stent delivery device is used to deliver the stent 40, the stent 40 is configured to have a natural state and a compressed state, the stent 40 elastically expands in the free state, and forms a bundle as a whole in the contracted state. During the operation, the stent delivery device is first inserted into the blood vessel to establish a passage, which is used to form a channel for the blood vessel to be delivered to the target blood vessel position by the stent delivery device, and the stent 40 is released. The stent 40 is implanted in the blood vessel to reconstruct the blood flow passage, reduce the blood flow entering the aneurysm, or even prevent the blood flow from entering the aneurysm, and use the principle of hemodynamics to flow along the passage reconstructed by the stent 40, thereby reducing the blood flow entering the aneurysm.
[0081] The present invention has the following beneficial effects: the stent delivery device provided by the present invention releases the stent to the aneurysm of the blood vessel through the delivery tube assembly and the stent release assembly. The stent is a bare metal stent with a relatively dense mesh. The stent is implanted in the blood vessel to reconstruct the blood flow pathway, reduce the blood flow entering the aneurysm, or even prevent the blood flow from entering the aneurysm. Instead, the blood flow flows along the pathway reconstructed by the stent according to the principle of hemodynamics, thereby reducing the blood flow entering the aneurysm. The present invention uses the elastic deformation member of the stent release assembly. The elastic deformation member has a compressed state radially restricted in the inner cavity of the delivery tube assembly and a free state outside the inner cavity of the delivery tube assembly. In the process of transitioning from the compressed state to the free state, the elastic deformation member moves out of the inner cavity of the delivery tube assembly and expands radially outward, and elastically shortens in the axial direction. When the elastic deformation member moves out of the inner cavity of the delivery tube assembly, it elastically shortens in the axial direction to pull the limiting tube in the axial direction, so that the limiting tube moves relative to the stent, thereby causing the stent to extend out of the limiting tube and expand, so that the release process of the stent is simple and the operation process is simple.
[0082] The scheme of the present invention has been described in detail above with reference to the accompanying drawings. In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments. Those skilled in the art should also be aware that the actions and modules involved in the specification are not necessarily required for the present invention. In addition, it can be understood that the steps in the method of the embodiment of the present invention can be adjusted in order, merged and deleted according to actual needs, and the modules in the device of the embodiment of the present invention can be merged, divided and deleted according to actual needs.
[0083] The embodiments of the present invention have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or improvements to the technology in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.
Claims
1. A stent delivery device, characterized in that: Used for delivering a stent (40) into a blood vessel, comprising: a delivery tube assembly (10) having an inner lumen; and A stent release assembly (30) is inserted into the inner cavity of the delivery tube assembly (10), and the stent release assembly (30) comprises an elastic deformation member (32) and a limiting tube (33) connected in the axial direction, wherein the elastic deformation member (32) has a compressed state radially restricted in the inner cavity of the delivery tube assembly (10) and a free state outside the inner cavity of the delivery tube assembly (10), and in the process of transitioning from the compressed state to the free state, the elastic deformation member (32) moves out of the inner cavity of the delivery tube assembly (10) and expands radially outward, and elastically shortens in the axial direction; The limiting tube (33) is used to accommodate and radially compress at least a portion of the stent (40); when the elastic deformable member (32) is removed from the inner cavity of the delivery tube assembly (10), it elastically shortens in the axial direction to pull the limiting tube (33) in the axial direction, so that the limiting tube (33) moves relative to the stent (40), thereby causing the stent to extend from the limiting tube (33) and expand.
2. The stent delivery device according to claim 1, characterized in that: The stent release assembly (30) further comprises a positioning tube (31) axially connected to the elastic deformation member (32); the positioning tube (31) is inserted into the inner cavity of the delivery tube assembly (10) and can slide axially relative thereto, and is limited to the distal end of the delivery tube assembly (10).
3. The stent delivery device according to claim 2, characterized in that: The positioning tube (31) and / or the limiting tube (33) are made of a material having a developing property, or the positioning tube (31) and / or the limiting tube (33) are coated with a developing layer.
4. The stent delivery device according to claim 2, characterized in that: The inner wall surface of the limiting tube (33) is provided with a first sliding film (331).
5. The stent delivery device according to claim 1, characterized in that: The elastic deformation member (32) is an elastic shell-like structure with an inner cavity.
6. The stent delivery device according to claim 5, characterized in that: The peripheral wall of the elastic shell-like structure is a mesh cage structure or a film structure.
7. The stent delivery device according to claim 2, characterized in that: The elastic deformation member (32) comprises a plurality of elastically bent slender members (321), and two ends of each of the slender members (321) are respectively connected to the limiting tube (33) and the positioning tube (31).
8. The stent delivery device according to claim 7, characterized in that: The slender members (321) are arranged sequentially in the circumferential direction, or the slender members (321) are arranged crosswise, or the slender members (321) are arranged symmetrically.
9. The stent delivery device according to claim 1, characterized in that: The elastic deformation member (32) comprises an elastic unit (322) which at least partially protrudes radially in a natural state.
10. The stent delivery device according to claim 1, characterized in that: The elastic deformation member (32) comprises at least two elastic units (322) connected in the axial direction.
11. The stent delivery device according to claim 1, characterized in that: The elastic deformation member (32) is a spiral elastic member.
12. The stent delivery device according to claim 1, characterized in that: The stent delivery device includes a stent delivery component (20), which is inserted into the inner cavity of the delivery tube component (10) and can slide axially relative to the delivery tube component (10); the stent delivery component (20) is connected to the stent (40) and restrains the stent (40), and the proximal end of the stent delivery component (20) is limited in the stent release component (30) and slides axially relative to the stent release component (30).
13. The stent delivery device according to claim 12, characterized in that: The stent delivery assembly (20) includes a guide wire (21), a first limit member (22) and a second limit member (23) axially spaced and fixed on the guide wire (21); the second limit member (23) is limit-set in the stent, the first limit member (22) is limit-connected to the proximal end of the stent (40), and the first limit member (22) is limit-located in the stent release assembly (30) and slides axially relative to the stent release assembly (30).
14. The stent delivery device according to claim 13, characterized in that: A hook portion (221) is provided on the first limiting member (22), and the hook portion (221) is used to hook the stent (40) when at least part of the stent (40) is compressed in the inner cavity of the conveying tube assembly (10), so as to allow at least a part of the section of the stent (40) to move axially; the hook portion (221) is configured to release the radially elastically expanded stent (40) when it extends out of the inner cavity of the stent release assembly (30).
15. The stent delivery device according to claim 13, characterized in that: An axially dislocated structure is formed between the second limiting member (23) and the bracket release assembly (30) to clamp the bracket.
16. The stent delivery device according to claim 15, characterized in that: The outer diameter of the second position-limiting member (23) is the same as the inner diameter of the stent release assembly (30); or the outer diameter of the second position-limiting member (23) is greater than the inner diameter of the stent release assembly (30).
17. The stent delivery device according to claim 13, characterized in that: The first limiting member (22) and / or the second limiting member (23) are made of a material having a developing property, or the first limiting member (22) and / or the second limiting member (23) are coated with a developing layer.
18. The stent delivery device according to claim 13, characterized in that: The front end of the guide wire (21) is bent.
19. The stent delivery device according to claim 1, characterized in that: The inner wall of the delivery pipe assembly (10) is provided with a second sliding film (11).
20. The stent delivery device according to claim 1, characterized in that: The stent delivery device also includes a loading sheath (50), the inner diameter of the delivery tube assembly (10) is greater than or equal to the inner diameter of the loading sheath (50), the distal end of the loading sheath (50) is docked with the proximal end of the delivery tube assembly (10), and the stent (40), the stent delivery assembly (20) and the stent release assembly (30) move along the inner cavity of the loading sheath (50) toward the inner cavity of the delivery tube assembly (10).
21. A surgical system, characterized in that: It comprises a stent delivery device and a stent as described in any one of claims 1-20, wherein the stent delivery device is used to deliver the stent, and the stent (40) is configured to have a natural state and a compressed state, and the stent (40) elastically expands in a free state and forms an overall bundle in a contracted state.