Stent delivery system
By introducing lockable anchors into the support conveying system, the problem of support slippage during conveying was solved, ensuring the safety of the conveying process.
Patent Information
- Application Number
- CN202411815126.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2023-12-27
- Filing Date
- 2024-12-11
- Publication Date
- 2026-02-17
- Estimated Expiration
- 2044-12-11
AI Technical Summary
Existing balloon-expandable stents are prone to slipping off the balloon during delivery, posing a risk of medical accidents.
A stent delivery system was designed, including a tube, connectors, and anchors. The anchors have locked and unlocked states. By setting the anchors at the proximal end of the stent, the stent is pulled in the locked state to prevent it from slipping out during delivery within the body.
This effectively prevents the stent from slipping out during delivery within the body, ensuring the safety of the delivery process and reducing the occurrence of medical accidents.
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Figure CN120203887B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a stent delivery system. BACKGROUND
[0002] The advantage of the expandable vascular stent over the self-expanding stent is that it can be accurately positioned during release, has a small delivery outer diameter, and can well conform to the shape of the blood vessel after expansion, thereby reducing the stress stimulation to the blood vessel. Therefore, it is currently widely used in the treatment of vascular stenosis, especially in the treatment of iliac artery stenosis. Of course, it also has some extended applications, such as in the reconstruction of aortic branch vessels.
[0003] The balloon-expandable stents on the market usually have the stent directly pressed onto the surface of the folded balloon by special equipment. There is no other force between the stent and the balloon to keep them firmly connected or limit their movement except for friction. This makes it easy for the stent to move relative to the folded balloon or even slide off the balloon when the balloon pushes the stent into the human body cavity. Once the stent slides off the balloon into the body during the delivery of the stent into the body, it will cause catastrophic consequences for the patient. SUMMARY
[0004] Therefore, it is necessary to provide a new stent delivery system that can prevent the stent from sliding off the delivery device into the human blood vessel during the delivery of the stent, thereby avoiding unnecessary medical accidents.
[0005] A stent delivery system includes a tube, a connecting piece, and a stent loading area provided at the distal end of the tube. The stent loading area is used to load a stent. The tube segment near the stent loading area is sleeved with an anchor. The anchor is configured to have a locked state and an unlocked state. When the anchor is in the locked state, the connecting piece connects the anchor and the stent. When the anchor is in the unlocked state, the connecting piece is disconnected from the anchor or the stent.
[0006] In one embodiment, the anchor includes a lock cylinder, and a lock slot is formed in the circumferential side wall of the anchor. An axial through-cylinder hole is formed in the anchor, which penetrates the axial two side walls of the lock slot. The lock cylinder is inserted into the through-cylinder hole and can slide axially along the through-cylinder hole. When the lock cylinder simultaneously penetrates the axial two side walls of the lock slot, the anchor is in the locked state.
[0007] In one embodiment, the connecting piece is flexible and includes a U-shaped connecting piece U-shaped portion connected head to tail. When the anchor is in the locked state, the U-shaped connecting piece U-shaped portion is at least partially sleeved on the lock cylinder in the lock slot.
[0008] In one embodiment, the connector includes a fixed end and a free end. The fixed end is fixedly connected to the distal end of the anchor. The free end includes the loop-shaped portion of the loop connector. When the anchor is in a locked state, the free end hooks onto the bracket and is fitted onto the lock cylinder in the lock groove.
[0009] In one embodiment, the loop-shaped connector includes a fixed portion and a free portion. The fixed portion is fixedly sleeved on the proximal end of the bracket. When the anchor is in a locked state, the free portion is sleeved on the lock cylinder in the lock groove.
[0010] In one embodiment, the perimeter of the loop-shaped portion of the loop connector is greater than or equal to the perimeter of the expanded bracket.
[0011] In one embodiment, the free portion of the loop-shaped connector can extend to a length greater than the distance from the proximal end of the bracket to the locking groove.
[0012] In one embodiment, the tube body is provided with a first cavity, the distal end of the first cavity is connected to the outside on the distal end of the tube body near the anchor, and the lock cylinder can slide axially in the first cavity and pass through the distal end, and then pass through the core hole from the proximal end of the anchor.
[0013] In one embodiment, the stent loading area includes a balloon body on which the stent can be mounted; a fixing member is provided on the proximal surface of the balloon body, one end of the lock cylinder is connected to the fixing member, and the other end can extend to the distal end of the anchor and pass through the core hole.
[0014] In one embodiment, the fastener is elastic, and the balloon body includes a first state of radial contraction and a second state of radial expansion. When the balloon body is in the first state, the lock cylinder can simultaneously pass through both axial side walls of the lock groove; when the balloon body is in the second state, the lock cylinder is at least disengaged from the proximal side wall of the lock groove.
[0015] The beneficial effects of this invention are as follows: Compared with the prior art, this invention provides a stent delivery system, including a tube body, a stent loading area located at the distal end of the tube body, and a connector; the stent loading area is used to load the stent, and an anchoring element is sleeved on the tube section near the stent loading area; the anchoring element is configured to have a locked state and an unlocked state. When the anchoring element is in the locked state, the connector simultaneously connects the anchoring element and the stent; when the anchoring element is in the unlocked state, the connector releases its connection with the anchoring element or the stent; by setting an anchoring element at the proximal end of the stent, the anchoring element is locked before the stent reaches the release position, thereby pulling the stent and preventing the stent from slipping and falling into the blood vessel during delivery in the body, causing unnecessary medical accidents, and ensuring the safety of the stent delivery process. Attached Figure Description
[0016] Figure 1 This is a schematic diagram of the overall structure of the support conveying system of the present invention.
[0017] Figure 2 This is a schematic diagram of the anchoring component structure in Embodiment 1 of the present invention.
[0018] Figure 3 This is a schematic diagram of the fixing hole structure on the anchoring component in Embodiment 1 of the present invention.
[0019] Figure 4 This is a schematic diagram of the first pipe section and the disconnection groove structure in Embodiment 1 of the present invention.
[0020] Figure 5 This is a schematic diagram of the structure in Embodiment 1 of the present invention, showing the lock cylinder passing through the first tube section.
[0021] Figure 6 This is a schematic cross-sectional view of the first pipe segment in Embodiment 1 of the present invention.
[0022] Figure 7 This is a schematic cross-sectional view of the first pipe segment of the pipe body in another embodiment of the present invention.
[0023] Figure 8 This is a schematic diagram of the fixed connection structure between the anchor and the connector in Embodiment 1 of the present invention.
[0024] Figure 9 This is a schematic diagram of the anchoring component in the unlocked state in Embodiment 2 of the present invention.
[0025] Figure 10 This is a schematic diagram of the connecting component structure after the support is expanded in Embodiment 2 of the present invention.
[0026] Figure 11 This is a schematic diagram of the connecting parts structure before the support is expanded in Embodiment 2 of the present invention.
[0027] Figure 12 This is a schematic diagram of the anchoring component structure in Embodiment 3 of the present invention.
[0028] Figure 13 This is a schematic diagram of the upper groove of the anchoring component in Embodiment 3 of the present invention.
[0029] Figure 14 This is a schematic diagram of the base structure in Example 4 of the present invention.
[0030] Figure 15 This is a schematic diagram of step one in embodiment five of the present invention.
[0031] Figure 16 This is a schematic diagram of step two in embodiment five of the present invention.
[0032] Figure 17 This is a schematic diagram of balloon inflation in step two of embodiment five of the present invention.
[0033] Figure 18 This is a schematic diagram of step three in embodiment five of the present invention.
[0034] Figure 19 This is a schematic diagram of the support conveying system in Embodiment Six of the present invention.
[0035] Figure 20 This is a schematic diagram of the connection structure between the fixing member and the lock core in Embodiment Six of the present invention.
[0036] Figure 21 This is a schematic diagram of the balloon body in the second state in Embodiment Six of the present invention.
[0037] Figure 22 This is a schematic diagram of the balloon body in the first state in Embodiment Six of the present invention.
[0038] Figure 23 This is a schematic diagram of the structure of the balloon body when it expands to the maximum balloon diameter in Embodiment 6 of the present invention.
[0039] Figure 24 This is a schematic diagram of the structure of the anchoring member in Embodiment 7 of the present invention when a wire hole is provided.
[0040] Figure 25 This is a schematic diagram of the structure of the connector hooked onto the lock cylinder when the balloon body is not expanded in Embodiment 7 of the present invention.
[0041] Figure 26 This is a schematic diagram of the state structure of the connecting piece disengaging from the lock cylinder during the expansion of the balloon body in Embodiment 7 of the present invention. Detailed Implementation
[0042] To better understand the concept of the present invention, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention.
[0043] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.
[0044] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.
[0045] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator, and "proximal" refers to the end closest to the operator. For example, during stent implantation, the end that enters the body is the distal end, and the end that the operator holds or manipulates is the proximal end. "Axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.
[0046] Example 1:
[0047] Please see Figure 1 and Figure 2The support conveying system 100 provided in this application typically includes a support conveyor and a support 5. The support conveyor typically includes a tube body 1, a support loading area 4 located at the distal end of the tube body 1, and a base 6 located at the proximal end of the tube body 1. The support loading area 4 is typically used to load the support 5. An anchoring element 2 is fitted onto the tube body 1 near the support loading area 4. The anchoring element 2 is preferably a cylindrical structure, with a connecting hole 22 axially formed. The diameter of the connecting hole 22 is equal to the diameter of the tube body 1. The anchoring element 2 is fitted onto the tube body 1 through the connecting hole 22 and fixed to the tube body 1 by adhesive or welding. The anchoring element 2 can be made of metal or polymer materials, preferably stainless steel (304 or 316L) or polyetheretherketone (PEEK). The anchoring element 2 is configured to have a locked state and an unlocked state. When the anchoring element 2 is in the locked state, the connecting element... The anchor 2 and the stent 5 are connected by hooking or fixing. When the anchor 2 is in the unlocked state, the connector is released from the connection with either the anchor 2 or the stent 5. It can be understood that when the anchor 2 is in the unlocked state, the connector is released from at least one of the anchor 2 or the stent 5, allowing the stent 5 to be in a free state detached from the anchor 2. This is usually done when the stent 5 is safely delivered to the release position, allowing the stent 5 to remain in the blood vessel and the delivery device to be safely withdrawn from the blood vessel. When the anchor 2 is in the locked state, it is usually during the delivery of the stent 5 to the target area within the blood vessel. During this process, the stent 5 is usually in an unexpanded folded state. At this time, it is necessary to ensure that the stent 5 is securely installed in the stent loading area 4 to prevent slippage. Connecting the stent 5 and the anchor 2 through the connector effectively prevents slippage and ensures safe arrival at the designated delivery position.
[0048] The support 5 can be a film-coated support, which includes an expandable metal skeleton (wavering) and a film covering the surface of the metal skeleton; or it can be a bare support without a film. When the connector is connected, it is movably or fixedly connected to the skeleton or wavering near the support 5. The connector can be connected to a portion of the wavering or all of the wavering during the connection process with the skeleton or wavering near the support 5, which can be set according to specific needs.
[0049] In this embodiment, please continue to refer to Figures 1-3The anchoring member 2 includes a lock cylinder 7, and a lock groove 21 is formed on the side wall of the anchoring member 2. A through hole 23 is formed along the axial direction of the anchoring member 2, penetrating both axial sides of the lock groove 21. The lock cylinder 7 passes through the through hole 23 and can slide axially along the through hole 23. The lock cylinder 7 and the lock groove 21 cooperate to form a locking structure similar to a pin. The through hole 23 penetrates both axial sides of the lock groove 21, so that when the lock cylinder 7 passes between the through holes 23, it forms an axial sealing structure on the lock groove 21, thereby... The connector fitted inside the lock groove 21 is confined within the lock groove 21, forming a confining structure for the connector. When the lock cylinder 7 slides in the through hole 23 and simultaneously passes through both side walls, the lock cylinder 7 blocks the lock groove 21 axially, and the anchor 2 is in a locked state. When the lock cylinder 7 only passes through one side wall, that is, when the lock cylinder 7 only passes through the through hole 23 where the side wall of the anchor 2 is located near the near end of the lock groove 21, the lock cylinder 7 does not completely close the lock groove 21, or does not close the lock groove 21 at all, and the anchor 2 is in an unlocked state.
[0050] In a preferred embodiment, please continue reading Figure 2 and Figure 3 The locking groove 21 is formed between the proximal and distal end faces of the anchor 2, with the groove 21 positioned closer to the proximal end face. This allows the anchor 2 to form a first through-core portion 25 at the proximal end of the locking groove 21 and a second through-core portion 26 at the distal end of the groove 21. The axial length of the second through-core portion 26 is greater than that of the first through-core portion 25. With this configuration, the lock cylinder 7 enters from the proximal end of the first through-core portion 25, exits from the distal end, crosses the locking groove 21, and then enters from the proximal end of the second through-core portion 26, becoming hidden within it, thus forming a locking structure. Because the axial length of the second through-core portion 26 is greater than that of the first through-core portion 25, the lock... When the core 7 is subjected to a non-axial tensile force, it can effectively prevent the lock core 7 from dislodging from the second core-through portion 26, thus avoiding damage to the locking structure. Preferably, the axial length of the second core-through portion 26 is greater than the axial length of the lock groove 21. The core-through hole 23 is spaced apart from the bottom of the lock groove 21, so that when the lock core 7 is locked, a gap is formed between it and the bottom of the lock groove 21, facilitating the fitting of the connecting piece within the lock groove 21. In one embodiment, the anchoring member 2 is a cylindrical structure with an outer diameter of 2-3 mm and a total length of 9-12 mm. It has a core-through hole 23 and a mounting hole for fitting onto the tube body 1, wherein the distal end of the tube body 1 passes through the mounting hole, and the lock core 7 passes through the core-through hole 23. The anchoring member 2 has a groove structure in the middle, the length of which is 3-4 mm, where a rope loop, i.e., a loop-shaped connecting part, passes through. The diameter of the mounting hole is 1.5-2 mm, and the diameter of the core-through hole 23 is 0.4-0.6 mm.
[0051] In a preferred embodiment (not shown in the figure), the lock cylinder 7 is an elastic metal wire with a bent head at its front end. The core hole 23 is located at the distal end of the second core part 26 and has a bent hole section that matches the bent head of the lock cylinder 7. This arrangement allows the bent structure and the bent hole section to form an inverted structure after the front end of the lock cylinder 7 is inserted into the second core part 26 and reaches the bent hole section. This further prevents the lock cylinder 7 from coming out of the second core part 26 when subjected to non-axial tension, thus preventing damage to the locking structure. Since the lock cylinder 7 is an elastic metal wire, when the lock cylinder 7 is pulled back to unlock, only a larger pulling force is needed to pull it out of the core hole 23 of the second core part 26, thus unlocking the lock.
[0052] In this embodiment, please refer to Figure 4 and Figure 5 The proximal end of the tube body 1 is provided with a base 6, which includes a core wire tube 61. A first cavity 11 is provided inside the tube body 1. One end of the first cavity 11 extends to a position near the anchor 2, and the other end communicates with the core wire tube 61. The base 6 is typically located outside the human body during use to establish a passage from the outside to the inside. The locking core 7 enters from the proximal inlet of the core wire tube 61, passes through the core wire tube 61 into the first cavity 11, and extends along the first cavity 11 to the anchor 2, where it connects. The locking core 7 extends within the first cavity 11 and the core wire tube 61 and can slide axially. During use, the operator controls the locking core 7, which exposes the core wire tube 61, at the base 6 position. This controls the axial sliding of the locking core 7 within the first lumen 11 and the core wire tube 61. Preferably, the portion of the locking core 7 exposed within the core wire tube 61 is connected to an operating handle 81 that is easy for the operator to grip. The operating handle 81 and the locking core 7 are connected by an integral injection molding, bonding, or mechanical locking. The base 6 also includes a guide wire tube 63, and the tube body 1 includes a third lumen 12. One end of the third lumen 12 is connected to the guide wire tube 63, and the other end extends through the distal end of the tube body 1. The guide wire tube 63 is used to guide the guide wire of the delivery device to the designated vascular access. The third lumen 12 and the first lumen 11 are usually isolated and independently set up and are not interconnected.
[0053] In this embodiment, please refer to Figure 5 and Figure 9The pipe section containing the first cavity 11 in the pipe body 1 does not extend the entire pipe body 1, but only extends from the proximal end of the pipe body 1 to the proximal end near the anchor 2, and has a certain distance from the anchor 2; and the two ends of the first cavity 11 are connected, and when the lock cylinder 7 extends to the distal end of the first cavity 11 near the anchor 2, it passes through the outside of the pipe body 1; preferably, the pipe section where the pipe body 1 connects to the proximal end of the anchor 2 is provided with a break groove 103, and the part of the pipe body 1 containing the first cavity 11 where the break groove 103 is located is cut off, so that the distal end of the first cavity 11 is connected, the first cavity 11 is connected to the side wall of the break groove 103, and the lock cylinder 7 passes through the side wall and then enters the core hole 23.
[0054] In another embodiment, please refer to Figure 6 and Figure 7 The pipe body 1 includes a first pipe section 101 with a first pipe cavity 11 and a second pipe section 102 without a first pipe cavity 11. The first pipe section 101 is located near the proximal end, and the second pipe section 102 is located near the distal end. The anchor 2 is located on the second pipe section 102 and near the first pipe section 101, with a certain distance between them. The first pipe section 101 can be a pipe that is coaxial with the second pipe section 102 and has an outer diameter larger than the second pipe section 102, so that the pipe body 1 forms a stepped structure at the junction of the first pipe section 101 and the second pipe section 102. The first pipe cavity 11 is located in the part of the first pipe section 101 that extends radially beyond the second pipe section 102, thereby forming a structure in which both ends of the first pipe cavity 11 are connected, so that the lock cylinder 7 can pass through the distal end of the first pipe cavity 11 and then pass through the core hole 23 of the anchor 2.
[0055] In this embodiment, the connector is flexible and can be a biocompatible polymer thread, such as polypropylene (PP), high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), or PET. Since PTFE has good biocompatibility and mechanical strength, it is preferred in this embodiment. The connector 3 includes a folded-back loop-shaped connecting portion 3a, which is used to fit onto the lock cylinder within the lock groove, thereby achieving locking. The connector 3 can be an integrally formed polymer coil, or it can be formed by knotting the ends of a polymer thread to form a loop, or it can be formed by folding back a segment of polymer material to form two segments, with the folded-back portion 3a formed at the fold. The free ends of the two segments away from the loop-shaped connecting portion 3a can be connected to a bracket or an anchor. When the anchor 2 is in the locked state, the loop-shaped connecting part 3a of the connector 3 is fitted into the locking groove 21 to connect the anchor 2, and the connector 3 is connected to the bracket 5, thereby anchoring the bracket 5 and the anchor 2 together to prevent slippage.
[0056] In this embodiment, please refer to Figure 8The fixed connection end of the connector 3 is located on the anchor 2. When the anchor 2 is in the unlocked state, the connector 3 is disconnected from the bracket 5. Preferably, the connector 3 includes a fixed end 31 and a free end 32. The fixed end 31 is fixedly connected to the anchor 2. The connector 3 and the anchor 2 can be fixedly connected in various ways, such as welding, bonding or pressing. A fixing hole 27 can be opened on the far end face of the anchor 2. The fixed end 31 of the connector 3 is connected to the fixing hole 27. The fixing hole 27 can also be opened on the side wall or other positions of the anchor 2. When the anchor 2 is in the locked state, the free end 32 of the connector 3 extends to the near end of the bracket 5 and passes through or wraps around the wave ring or skeleton of the near end of the bracket 5. After hooking the bracket 5, the free end 32 is sleeved in the lock groove 21. At this time, the lock cylinder 7 passes through the core holes 23 on both sides of the lock groove 21 to complete the hook connection between the anchor 2 and the bracket 5. In other embodiments, the connector 3 is at least provided on the free end 32 of the connector, while the fixed end 31 may not have a ring and may be connected to the free end 32 by means of a thread.
[0057] Example 2:
[0058] In this embodiment, please refer to Figure 9 Figure 1 shows that the structure of the conveyor is largely the same as in Embodiment 1, except that the fixed connection end of the connector 3 is located on the bracket 5. When the anchor 2 is in the unlocked state, the connector 3 is disconnected from the anchor 2. Preferably, the connector 3 includes a fixed part 33 and a free part 34. At least the fixed part 33 is fixedly sleeved on the proximal end of the bracket 5. During the manufacturing process of the bracket 5, the connector 3 is passed through the corrugated ring at the proximal end of the bracket 5, thereby sleeved on the bracket 5. To further ensure the reliable connection of the annular connection, the connector 3 can be fitted with a metal plate at one of the corrugated angles. The connector 3 is knotted on the wave rod to ensure that it will not separate from the stent 5 even if it breaks, thus ensuring safety. Furthermore, the connector 3 forms a closed rope loop by tying knots at both ends. When the stent 5 is compressed and not expanded, part of the connector 3 is fixedly sleeved on the proximal end of the stent 5 to form a fixed part 33, and the other part forms a free part 34. When the anchor 2 is in the locked state, the free part 34 (i.e., the free end) of the connector 3 is sleeved in the locking groove 21 to form a connection structure with the anchor 2, preventing the stent 5 from slipping and falling into the blood vessel lumen.
[0059] In this embodiment, the circumference of the connector 3 is greater than the circumference of the stent 5 after expansion. The purpose of this setting is that, firstly, the connector 3 can be tightened as the stent 5 expands, extending and winding around the circumferential loop of the proximal end of the stent 5. Therefore, the circumference of the connector 3 needs to be greater than the circumference of the stent 5 after expansion to avoid the connector 3 restricting the expansion of the stent 5, and also to avoid the expansion of the stent 5 breaking the connector 3. Preferably, the circumference of the connector 3 only needs to be slightly greater than the circumference of the stent 5 after expansion, and does not need to be too long. This is to avoid the connector 3 being too long without being supported by the stent 5, causing the connector 3 to float in the blood vessel after the stent 5 is implanted, resulting in unpredictable problems. In an implemented example, the stent 5 is expected to have a diameter of 2.7 mm in the unexpanded state and a diameter of 10 mm in the expanded state. Therefore, the circumference length L of the connector 3 needs to be slightly greater than the circumference of the expanded stent 5, that is, it needs to be greater than 10*π. Thus, the circumference length L of the connector 3 is 10*π + 3~4 mm.
[0060] Reference Figures 24-26 In other embodiments, to reduce the constraint of the connector 3 on the circumferential direction of the stent, and to minimize the impact on blood flow caused by excessive floating wires after the stent expands due to the connector 3's circumferential movement, it is also possible that the length of the connector 3 around a local area in the proximal circumferential direction of the stent is greater than or equal to the arc length of the corresponding local area after stent expansion. In this embodiment, the connector 3 is formed into two strands by folding back an integral line segment, such as... Figure 26 The first strand 3b and the second strand 3c, after being folded back from the integrated line segment, have two free ends. Both free ends are connected to and relatively fixed to the near end of the bracket. The fixing method can be to connect to the near end film 52 of the bracket 5, or to connect to the wave ring 51 of the near end of the bracket 5. For example, it can be wrapped around the wave rod of one of the wave rings 51 and fixed relatively to the wave ring 51. For example, after connecting to the wave rod, it can be knotted to form a fixing knot 3d. Other segments can be wrapped upward around the bracket 5 and then extended axially, so that the loop-shaped connection part 3a between the first strand 3b and the second strand 3c can be hooked on the lock cylinder 7. In this embodiment, to ensure that the connector 3 can be stably wound around the outer wall of the support after the support is deployed, multiple fixing rings 53 are provided on the outer wall of the support 5 along its circumferential direction. The connector 3 passes through the fixing rings 53 and can move circumferentially relative to the fixing rings 53. After the support 5 is deployed, the connector 3 is continuously pulled and gradually wound around the outer wall of the support 5 as the support 5 is deployed. In this way, the length of the connector 3 and the fixed positions of the two ends of the free end of the connector 3 with the support can be determined according to the length required when axially hooking onto the lock cylinder 7 and the circumference of the support after deployment. This achieves both the hooking requirements and the fact that the connector 3 can be completely pulled open after the support is deployed, so that the connector 3 is wound around the outer wall of the support 5 in a predetermined direction, avoiding excessive floating wires that affect blood flow. In this connection method, multiple sets of connectors 3 can be provided along the circumferential direction of the support 5. Preferably, such asFigure 26 As shown, two groups can be set.
[0061] Preferably, the length of the other part of the connector 3 is greater than the distance from the proximal end of the bracket 5 to the locking groove 21. It can be understood that in this embodiment, a part of the connector 3 is connected to the proximal end of the compressed bracket 5, and the remaining part forms a free end. The other part is used to lock after being sleeved with the locking groove 21 of the anchor 2. The length of this part needs to be at least greater than the distance from the proximal end of the bracket 5 to the locking groove 21 in order to ensure that the other part of the connector 3 can be sleeved in the locking groove 21. In an implemented embodiment, taking the bracket 5 with a diameter of 2.7 mm in the unexpanded state and a diameter of 10 mm in the expanded state as an example, assuming that the distance from the proximal end of the bracket 5 to the locking groove 21 is L0, then L0 needs to satisfy L0 < (L - 2.7 * π) / 2.
[0062] Example 3:
[0063] In this embodiment, please refer to Figure 12 and Figure 13 The structure of the anchor 2 is largely the same as that in Embodiments 1 and 2, except that a wire groove 24 is provided on the sidewall of the anchor 2 near the circumferential side of the locking groove 21. One end of the wire groove 24 connects to the circumferential side of the locking groove 21, and the other end extends through the distal end face of the anchor 2. The wire groove 24 is used to accommodate the connector 3 sleeved on the anchor 2 when the anchor 2 is in the locked state. When the connector 3 is sleeved on the anchor 2, the wires on both sides of the connector 3 are accommodated in the wire groove 24 after sleeve, which can prevent the connector 3 from rubbing against the sheath or blood vessel wall when the delivery device enters the blood vessels in the human body, thus preventing damage to the blood vessel wall or sheath. It can also effectively prevent the connector 3 from swinging arbitrarily and affecting the passage size of the delivery device during delivery. Preferably, taking the wire diameter of the connector 3 as an example of 0.3mm, the circumferential width H1 of the wire groove 24 is 0.5mm. ~0.7mm; More preferably, to avoid the connector 3 protruding from the surface of the groove 24 after being stored and causing an impact, the depth of the groove 24 needs to be greater than or equal to the wire diameter of the connector 3. Taking the wire diameter of the connector 3 as an example of 0.3mm, the radial depth H2 of the groove 24 is 0.3~0.7mm; In order to avoid the corners of the locking groove 21 of the anchor 2 and the groove 24 being too sharp, which may cause damage to the blood vessel wall or cause the connector 3 to break due to friction, it is preferable to use rounded corners for the edges of the groove 24 and the locking groove 21; The rounded corners can also make the anchor 2 in the unlocked state. When the delivery device is retracted and released, the risk of the locking groove 21 hanging on the connector 3 is effectively avoided. The rounded corner design can provide a certain degree of smoothness when hanging occurs, thereby avoiding the occurrence of hanging.
[0064] For further recommendations, please refer to [link / reference]. Figure 13The side wall of the lock groove 21 near the far end in the axial direction can be transitioned to the adjacent second core part 26 by an arc surface. The core hole 23 is located on the arc surface. In this way, when the anchor 2 is in the unlocked state and the conveyor is retracted and released, it can bend to avoid the risk of the lock groove 21 hanging on the connector 3. This is conducive to the connector 3 sliding directly out of the lock groove 21 after the lock core 7 is unlocked.
[0065] Example 4:
[0066] In this embodiment, please refer to Figure 14 The structure of the delivery device is largely the same as that in Embodiments 1 to 3, except that the proximal end of the locking core 7 is connected to a locking component 8, which is threadedly connected to the opening of the core wire tube 61. The locking component 8 includes an operating handle 81 and a locking nut structure 82 located at the front end of the operating handle 81. The opening of the core wire tube 61 is provided with an external thread, and the locking nut structure 82 can engage with the external thread of the opening to achieve a tightening and locking, thus fixing the locking core 7 to the operating handle 81. This prevents the locking core 7 from being accidentally pulled, which could damage the locking structure between the distal end of the locking core 7 and the anchor 2. When the stent 5 is delivered to the designated blood vessel position, and the operator needs to pull the locking core 7, the operator can unscrew the connection between the locking nut structure 82 and the external thread of the core wire tube 61, thereby pulling the operating handle 81 backward and pulling the locking core 7 out of the second core-penetrating part 26 to release the lock, and the stent 5 is released freely.
[0067] Preferably, the front end of the lock cylinder 7 and the locking assembly 8 satisfy the following condition: when the locking assembly 8 is tightened into the threaded connection of the core wire tube 61, the front end of the lock cylinder 7 is inserted into the second through core part 26.
[0068] Further preferably, in order to facilitate the sliding of the lock cylinder 7 within the first cavity 11 and reduce the frictional resistance between the lock cylinder 7 and the first cavity 11 and the inner cavity of the core wire tube 61 when the lock cylinder 7 is pulled out from the base 6 end, the surface of the lock cylinder 7 is covered with a lubricating coating, and the lubricating coating is one of a PTFE coating or a Pyrene coating, preferably a PTFE coating.
[0069] In one implemented example, the lock cylinder 7 uses a solid metal wire with a diameter of 0.3 to 0.4 mm, preferably a nickel-titanium alloy wire.
[0070] Example 5:
[0071] In this embodiment, please refer to Figure 15The structure of the delivery device is largely the same as that in Embodiments 1 to 4. The difference is that the delivery device in this embodiment is a balloon catheter. The balloon catheter has a balloon body 41 on the support loading area 4. The two ends of the balloon body 41 are fixedly connected to the outer wall of the tube body 1 by bonding or welding to form a closed internal space. The support 5 is set on the balloon body 41 and expands by the expansion of the balloon body 41. The tube body 1 also includes a second lumen 13. The base 6 includes a balloon inflation line. One end of the second lumen 13 is connected to the balloon inflation line 62, and the other end is connected to the inner cavity of the balloon body 41. The second lumen 13 is used for balloon inflation, and the inflation medium can be gas or liquid.
[0072] In this embodiment, when the delivery device is a balloon catheter, the tube body 1 is a three-lumen tube structure in which the first lumen 11, the second lumen 13, and the third lumen 12 are separated from each other. It should be noted that the tube body 1 is not a three-lumen tube structure in its entirety. The first tube segment 101 has the first lumen 11 and is a three-lumen tube structure, while the second tube segment 102 does not have the first lumen 11 and is a two-lumen tube structure.
[0073] The following example uses the delivery device as a balloon catheter, with one end of the connector 3 fixed to the anchor 2, in conjunction with... Figures 15-18 The working principle of the support conveying system 100 provided in this embodiment is introduced as follows:
[0074] Step 1: Before installing the stent 5, unscrew the locking nut structure 82 from the opening of the core wire tube 61 using the operating handle 81, then retract the locking core 7 so that the distal end of the locking core 7 slides out of the second core-penetrating part 26, and the locking groove 21 is in the unlocked state. When the stent 5 is pressed onto the balloon externally, the connector 3 on the anchor 2 passes through the metal skeleton of the proximal end of the stent 5 and then loops back into the locking groove 21 of the anchor 2. At this time, push the operating handle 81 so that the distal end of the locking core 7 passes into the second core-penetrating part 26, and the locking groove 21 is in the locked state. Push the balloon catheter into the blood vessel along the guidewire. Since the stent 5 and the anchor 2 have been hooked and anchored, the stent 5 will not fall out into the patient's body during delivery.
[0075] Step 2: When the support 5 reaches the designated delivery position, the locking nut structure 82 is unscrewed from the opening of the core wire tube 61 again by operating the handle 81, and the locking core 7 is pulled back so that the far end of the locking core 7 slides out from the second core part 26, and the locking groove 21 is in the unlocked state; at this time, the inflation medium is injected into the balloon through the balloon inflation tube, and the balloon expands to drive the support 5 to expand and release.
[0076] Step 3: After release, remove the inflation medium from the balloon, causing the balloon to contract and fold. Then, withdraw the balloon catheter to disconnect connector 3 from the stent 5.
[0077] Example 6:
[0078] Please see Figure 19 In this embodiment, the structure of the stent delivery system 100 is largely the same as that in embodiments one through five. The difference is that the base 6 may not be provided with a core wire tube and an operating handle. Therefore, the locking cylinder 7 does not need to extend to the proximal end of the base 6. It can be controlled by the operating handle to move in and out of the locking groove 21 of the anchor. In order to enable the stent delivery system to hook the stent 5 to prevent slippage when delivering the stent 5, and to automatically release the hook of the connecting member 3 when the balloon expands, a fixing member 9 can be provided on the proximal surface of the balloon body 41. One end of the locking cylinder 7 is connected to the fixing member 9 for fixation. Here, the fixing member 9 can only be connected to a part of the surface of the balloon body 41 to ensure that the balloon body 41 is connected except for the fixing member 9. Other locations can be expanded via stamping pipes to support and release bracket 5; after the lock cylinder 7 is connected, the other end extends to the far end of the anchor and passes through the core hole of the anchor. Here, the core hole of the anchor passes through both ends of the anchor along the axial direction, and the axial lengths of the first core part and the second core part are equal, so that the lock cylinder 7 of the anchor can be inserted from both the proximal and distal ends of the anchor to pass through the two side walls of the lock groove 21, thereby achieving the connection and locking of the connector 3. At the same time, after the balloon expands, the lock cylinder 7 of the anchor is supported, causing the lock cylinder 7 to detach from the proximal side wall of the lock groove 21. As the lock cylinder 7 is continuously supported, the connector 3 detaches from the free end of the proximal end of the lock cylinder 7, thereby unlocking the connector 3.
[0079] In this embodiment, please refer to Figures 19-20 The fixation element 9 is elastic, specifically it can be an elastic polymer ring, such as polyester material; the polymer ring can be bonded or fused to the surface of the balloon body 41 circumferentially, and expands and contracts synchronously with the expansion and contraction of the balloon body 41; the nickel-titanium wire can also be an elastic polymer rod, and the locking core 7 is configured to have an elastic force that presses the end away from the fixation element 9 toward the tube body in both the natural state and the stressed state, thereby preventing the locking core 7 from shaking or shifting and affecting the blood vessel; wherein, the balloon body 41 includes a first state of radial contraction and a second state of radial expansion. When the balloon body 41 is in the first state The locking core 7 passes through both axial side walls of the locking groove 21. At this time, the connecting piece 3 is at least partially located in the locking groove 21 and is hooked by the locking core 7, which can prevent the stent 5 from slipping off the balloon body 41 and falling into the blood vessel, causing danger. When the balloon body 41 is in the second state, the balloon body 41 is expanded by the pressure. While the stent 5 expands, the fixing piece 9 on the surface of the balloon body 41 is raised in the radial position relative to the tube body, thereby pulling the locking core 7 out of the locking groove 21 so that the locking core 7 does not pass through the locking groove 21. At this time, the connecting piece 3 can be removed from the locking groove 21 to release the hook with the anchor. Then the stent 5 is released to the designated position, and the stent 5 will not be pulled when the tube body is withdrawn.
[0080] In one embodiment, see Figure 21 When the balloon body 41 is in the second state, the locking core 7 is pulled out from the locking groove 21 and at least separated from the proximal side wall of the locking groove 21. Furthermore, the head end of the locking core 7 away from the fixation member 9 is placed inside the core-penetrating part. In this way, during the retraction process of the tube body after the stent 5 is released, the head end of the locking core 7 can be further prevented from being placed and swinging arbitrarily, thus avoiding any impact on the inner wall of the blood vessel.
[0081] In another embodiment, when the connector 3 is located near the end of the support 5, as the balloon body 41 expands, the connector 3 is automatically pulled back and retracted by the support 5 to surround the surface of the support 5, thereby forming a structure in which the connector 3 is automatically withdrawn from the locking groove 21, thus effectively avoiding the possibility of the anchoring component hooking the connector 3 when the tube body is retracted.
[0082] In some embodiments, please refer to Figure 22 The locking groove 21 of the anchor has an arc-shaped transition at the opening of the core hole on the side wall away from the balloon body 41. This allows the locking core 7, which is away from the fixing member 9, to be better inserted back into the core part of the anchor on the side away from the balloon body 41 when the balloon body 41 completes the expansion and release of the stent 5 and retracts after depressurization. This avoids the locking core 7 causing scratches or punctures to the blood vessels during retraction.
[0083] In this embodiment, the lock cylinder 7 is connected to the balloon body 41 by means of the fixing member 9, which can effectively reduce the length of the lock cylinder 7 and reduce the steps of controlling the lock cylinder 7 during the operation. This can effectively avoid the problem of the lock cylinder 7 being difficult to control due to excessive friction when it passes through the tube, and at the same time reduce the number of surgical steps to improve surgical efficiency.
[0084] In other embodiments, please refer to Figures 22-23 To further ensure that the balloon body 41 can avoid the risk of the connector 3 detaching from the lock groove 21 and causing the bracket 5 to lose its hook prematurely during the process of releasing the bracket 5 by pressing the release bracket 5, specifically, the axial length L2 of the lock cylinder 7 is made to satisfy the following: when the balloon body 41 expands to the maximum balloon diameter, the proximal end of the lock cylinder 7 away from the fixing member is at least flush with the distal side wall 211 of the lock groove 21, or is contained within the distal side wall 211 of the anchor member 2. That is, when the balloon expands to the maximum balloon diameter, it has a radius R1, and the distance between the fixing member 9 and the distal side wall 211 of the anchor member 2 is L3, satisfying R12+L3. 2≤L22; and, half of the total length L1 of the connector 3 when it is in a stretched state is less than or equal to the axial length L2 of the lock cylinder 7, and the connector 3 is elastic. With this configuration, during the expansion of the balloon 41, the bracket 5 expands along with the balloon 41. The balloon 41 expands first, and the bracket 5 expands later. Thus, when the balloon 41 has not expanded to its maximum diameter, since half of L1 is less than the axial length L2 of the lock cylinder 7, L1 reaches the distal sidewall 211 of the lock groove 21 before the proximal end of the lock cylinder 7 away from the fixing member. At this time, since the proximal end of the lock cylinder 7 away from the fixing member has not reached the distal sidewall 211, there is still a continuous hooking effect on the connector 3 until the proximal end of the lock cylinder 7 away from the fixing member is flush with the distal sidewall 211 of the anchor 2. At the same time as the bracket 5 is fully expanded and released, the hooking of the connector is released, completing the entire unlocking and release process of the bracket 5.
[0085] Example 7:
[0086] In order to further ensure that the connector 3 can be disengaged and to improve the disengagement speed of the connector 3, this embodiment proposes a preferred solution based on embodiment six. It should be understood that some structures can be referred to embodiment six, and will not be repeated here. Only the differences from embodiment six are described in detail here.
[0087] See Figures 24-26 The anchoring member 2 includes an anchoring common joint 2a extending along the entire axial length of the anchoring member 2, a distal anchoring part 2b located at the distal end, and a proximal anchoring part 2c located at the proximal end. The distal anchoring part 2b and the proximal anchoring part 2c are axially spaced apart, and the locking groove 21 is formed at the gap between them. The distal anchoring part 2b and the proximal anchoring part 2c are provided with coaxial distal through hole 231 and proximal through hole 232.
[0088] In this embodiment, the proximal end of the proximal anchoring part 2c extends axially toward the distal end to form a proximal anchoring extension part 2c1. The proximal anchoring extension part 2c1 is located on the side of the central axis of the through hole 23. A wire hole 2c11 is provided on the proximal anchoring extension part 2c1 in the radial direction. The connector 3 can pass through the wire hole 2c11 so that the loop-shaped connecting part 3a on the connector 3 hooks onto the lock cylinder 7. In this way, the wire hole 2c11 forms a limit on the connector 3. When the lock cylinder 7 is disengaged from the proximal through hole 232 on the proximal anchoring part 2c, the connector 3 is limited and its axial movement distance with the lock cylinder 7 is limited, so that the connector 3 can be quickly disengaged from the lock cylinder 7 to achieve unlocking. At the same time, the lock cylinder 7 does not need to move too far axially.
[0089] Continue reading Figures 24-26To prevent the lock cylinder 7 from detaching from the distal core hole 231 of the distal anchoring part 2b as the balloon body 41 expands, thus affecting the retraction of the delivery device, in other embodiments, such as... Figure 25 As shown, a stepped portion 2b1 is formed in the distal core hole 231 of the distal anchoring portion 2b. For example, the distal core hole 231 includes a large hole at the proximal end and a small hole at the distal end, which are coaxially arranged. The stepped portion 2b1 is formed between the large hole and the small hole. An elastic element m is placed inside the distal core hole 231. The elastic element m is sleeved on the lock cylinder 7. A stop portion 71 is provided on the outer periphery of the lock cylinder 7. The distal end of the elastic element m abuts against the stepped portion 2b1 and is relatively fixed. The proximal end of the elastic element m abuts against the stop portion 71. In the natural state, the loop-shaped connecting portion 3a of the connector 3 passes through the wire hole 2c11 and hooks onto the lock cylinder 7. In this state, the elastic element m is in an unfolded state, so that the proximal end of the lock cylinder 7 always extends into the proximal core hole 232 under the action of elastic force, which ensures the stability of the lock and prevents the lock cylinder 7 from being disengaged at will.
[0090] As the balloon body 41 expands, the force provided by the expansion is greater than the elastic force of the elastic element m, causing the lock cylinder 7 to be continuously supported. The proximal end of the lock cylinder 7 continuously moves towards the distal end. At this time, the elastic element m will be continuously compressed, and the U-shaped connecting part 3a of the connecting member 3 will disengage from the lock cylinder 7. As the elastic element m continues to compress, the lock cylinder 7 will stop moving after moving to the maximum range. When the balloon body 41 is depressurized, the lock cylinder 7 will move towards the proximal end under the elastic force of the elastic element 7. Finally, the free end of the proximal end of the lock cylinder 7 will re-enter the proximal core hole 232.
[0091] In other implementations, such as Figure 25 and Figure 26 As shown, the proximal core hole 232 is flared, wider at the far end and narrower at the near end, facilitating the smooth re-entry of the proximal free end of the lock cylinder 7 into the proximal core hole 232. To improve locking stability, an elastic sleeve n is fitted inside the proximal core hole 232. The shape of the elastic sleeve n is adapted to the proximal core hole 232. After the elastic sleeve n is fitted inside the proximal core hole 232, it is fixed to the proximal anchoring part 2c by the bottom locking member. The elastic sleeve n can elastically abut against the proximal free end of the lock cylinder 7 inserted therein, thereby improving the stability and locking stability of the lock cylinder 7. The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention; therefore, the scope of protection of the present invention should be determined by the scope of the claims.
Claims
1. A support conveying system, characterized in that, The device includes a pipe body, a connector, and a support loading area located at the distal end of the pipe body. The support loading area is used to load a support. An anchor is sleeved on a section of the pipe body near the support loading area. The anchor is configured to have a locked state and an unlocked state. The connector is configured to connect the anchor and the support simultaneously when the anchor is in the locked state. When the anchor is in the unlocked state, the connector is disconnected from the anchor or bracket. The anchor includes a lock cylinder, and a lock groove is provided on the circumferential sidewall of the anchor. The anchor has a through hole along the axial direction, which penetrates both axial sidewalls of the lock groove. The lock cylinder passes through the through hole and can slide axially along the through hole. When the lock cylinder passes through both axial sidewalls of the lock groove simultaneously, the anchor is in the locked state. The bracket loading area includes a balloon body, and the bracket can be installed on the balloon body. A fixing member is provided on the proximal surface of the balloon body. One end of the lock cylinder is connected to the fixing member, and the other end can extend to the distal end of the anchor and pass through the through hole. The balloon body is used to support the lock cylinder after expansion, so that the lock cylinder disengages from the proximal sidewall of the lock groove.
2. The support conveying system according to claim 1, characterized in that, The connector is flexible and includes a folded-back U-shaped connecting portion. When the anchor is in the locked state, the U-shaped connecting portion is sleeved on the lock cylinder in the lock groove.
3. The support conveying system according to claim 2, characterized in that, The connector includes a fixed end and a free end. The fixed end is fixedly connected to the far end of the anchor. The free end includes the loop-shaped connecting part. When the anchor is in the locked state, the free end hooks onto the bracket and its loop-shaped connecting part is sleeved on the lock cylinder in the lock groove.
4. The support conveying system according to claim 3, characterized in that, The connector includes a fixed part and a free part. The fixed part is connected to the proximal end of the bracket. The free part includes the loop-shaped connecting portion. When the anchor is in the locked state, the loop-shaped connecting portion of the free part is sleeved on the lock cylinder in the lock groove.
5. The support conveying system according to claim 4, characterized in that, The connector surrounds the proximal end of the support, and the circumference of the connector is greater than or equal to the circumference of the expanded support; or, The connector is located around the proximal end of the support in a localized area, and the length of the connector is greater than or equal to the arc length of the corresponding localized area after the support is expanded.
6. The support conveying system according to claim 5, characterized in that, The free portion of the connector can extend to a length greater than the distance from the proximal end of the bracket to the locking groove.
7. The support conveying system according to claim 2, characterized in that, The tube body is provided with a first cavity, and the far end of the first cavity is connected to the outside on the far end side of the tube body near the anchor. The lock cylinder can slide axially in the first cavity and pass through the far end, and then pass through the core hole from the near end of the anchor.
8. The support conveying system according to claim 1, characterized in that, The fastener is elastic, and the balloon body includes a first state of radial contraction and a second state of radial expansion. When the balloon body is in the first state, the lock cylinder can pass through both axial side walls of the lock groove simultaneously. When the balloon body is in the second state, the lock cylinder is at least disengaged from the proximal side wall of the lock groove.
Citation Information
Patent Citations
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