Lumen stent and stent system

Abstract

The present application relates to a kind of luminal stent and stent system, the luminal stent includes stent body, limiting piece, guide piece and collection piece, the stent body includes at least one body wave, at least one limiting piece and one guide piece are correspondingly provided to one body wave, the limiting piece includes the limiting portion extending along circumference direction, and the limiting portion is located in the axial span range of its corresponding wave;The guide piece includes the guide portion extending towards axial direction;The collection piece passes at least one limiting piece of the body wave and surrounds the body wave, and then it is guided to extend to adjacent body wave by the guide piece.The luminal stent and stent system provided by the present application, the setting of its collection piece, can the luminal stent with deviation is positioned to be radially collected, to realize the recovery or repositioning release of luminal stent, to avoid the situation that the luminal stent of prior art is variously released poorly, only can be removed by surgical operation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a lumen stent and stent system. Background Technology

[0002] Currently, minimally invasive interventional procedures are generally used to implant stents into blood vessels via delivery devices to treat vascular diseases such as aortic aneurysms, aortic dissections, and venous thrombosis. Once implanted, the stents on the market release themselves within the vessel due to their self-expanding properties and are anchored to the vessel by their oversized design. However, once the stent has been deployed and adhered to the vessel wall, its position cannot be moved. If a positioning deviation is found after stent adhesion, leading to postoperative endoleak or stent fenestration displacement, open-chest surgery is required to remove the stent. This not only fails to treat the patient with minimally invasive surgery but also causes significant physical harm. Summary of the Invention

[0003] One technical problem addressed by this invention is how to provide a luminal stent that can be radially contracted and re-released during surgery to address positioning deviations.

[0004] The present invention provides a lumen stent, the lumen stent comprising a stent body, a limiting member, a guide member, and a converging member. The stent body includes at least one main corrugated coil, and each main corrugated coil is provided with at least one limiting member and one guide member. The limiting member includes a circumferentially extending limiting portion, and the limiting portion is located within the axial span range of its corresponding corrugated coil. The guide member includes an axially extending guide portion. The converging member passes through at least one of the limiting members of the main corrugated coil and surrounds the main corrugated coil, and is then guided by the guide member to extend to an adjacent main corrugated coil.

[0005] In one embodiment, the limiting member includes a perforated limiting portion or a snap-on limiting portion disposed circumferentially; Alternatively, the limiting member includes at least one limiting steel sleeve disposed on the main body wave ring, the limiting steel sleeve including a hole-shaped limiting portion extending circumferentially, the limiting portion penetrating the limiting steel sleeve.

[0006] In one embodiment, the guide includes a guide sleeve fixed to the wave rod of the main wave ring, the guide sleeve including a guide hole extending axially.

[0007] In one embodiment, the guide hole extends along the axial direction of the lumen support or at an angle not exceeding 10° with the axial direction of the lumen support on the guide sleeve.

[0008] In one embodiment, the lumen support includes a first main wave ring and a first limiting steel sleeve. The first main wave ring includes a first wave rod and a second wave rod, which are adjacent to each other. The first limiting steel sleeve is disposed on the first wave rod and includes a perforated first limiting portion. The extension line of the perforated first limiting portion is located in the middle 2 / 4 region of the second wave rod divided into four equal parts.

[0009] In one embodiment, the converging element includes one or more converging lines that pass sequentially through the limiting member and the guide member along the circumference and axial direction of the lumen support, thereby converging the main wave loop by the converging lines. The two ends of the converging lines are located on the proximal side and the distal side of the main support, respectively. By fixing one end of the converging line and pulling the other end of the converging line, the main wave loop can be converging radially.

[0010] In one embodiment, the lumen support further includes an axial connector that connects two adjacent main body coils; the convergence line includes a transition section that spans two adjacent main body coils, and the axial connector is located at the position of the transition section or within a range of circumferential deflection of no more than 20° relative to the transition section.

[0011] The present invention also provides a support system, including a conveying device and a lumen support as described in any one of claims 1-7, characterized in that the conveying device includes a first pressing member and a second pressing member, the first pressing member and the second pressing member being movably pressing against each other or releasing the pressing against each other, so as to fix one end of the receiving member or release the fixing of one end of the receiving member.

[0012] In one embodiment, the conveying device includes a handle assembly comprising a fixed handle and a sliding handle. The proximal end of the fixed handle includes a guide rail extending towards the proximal end. The sliding handle is disposed around the guide rail on one side of the proximal end of the fixed handle. The fixed handle includes a groove, a graduated groove, and a convergence adjustment member. The groove extends axially, and the graduated groove is disposed on both axial sides of the groove. The convergence adjustment member is disposed within the groove and is reciprocating axially along the groove, and can swing to both axial sides to engage with the graduated groove, thereby limiting the convergence adjustment member axially.

[0013] In one embodiment, the stent system includes a sheath core assembly and a positioning part. The lumen stent includes a first main body wavering closest to the distal end. The positioning part is disposed on the sheath core assembly and is located within the middle 2 / 4 region of the first main body wavering in the vertical axis, thereby causing the converging member to be deflected through the positioning part to define the axial length of the lumen stent in the axial direction.

[0014] In one embodiment, the stent system includes a sheath core assembly and a positioning part. The lumen stent includes a terminal main wavering closest to the distal end. The positioning part is disposed on the sheath core assembly and corresponds to the position of the first main wavering in the vertical axis. When the converging member extends from the proximal end to the distal end, it passes through the guide and the positioning part corresponding to the first main wavering in sequence. Alternatively, as the converging member extends from the proximal end to the distal end, it passes sequentially through the positioning part and the guide member corresponding to the first main body wave coil.

[0015] One technical effect of an embodiment of the present invention is that the lumen stent provided by the present invention has a converging component that can radially converge a lumen stent with positioning deviation, thereby realizing the retrieval or repositioning and release of the lumen stent, so as to avoid the situation in the prior art where the lumen stent can only be removed by surgery when various release problems occur. Attached Figure Description Figure 1 This is a schematic diagram of the structure of a lumen support in one embodiment of the present invention; Figure 2 for Figure 1 A left view of the main waveguide of the lumen support cooperating with the converging element from a perspective; Figure 3 This is a schematic diagram of the structure of the limiting member in one embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of a guide member in one embodiment of the present invention; Figure 5 for Figure 1 Another perspective on the structure (in) Figure 1 Based on the right view, rotate 90° counterclockwise along the circumference of the lumen support. Figure 6 This is a schematic diagram of the structure of a guide member in one embodiment of the present invention; Figure 6a for Figure 6 A cross-sectional view along the AA direction; Figure 7 A schematic diagram of the structure of the first main wave loop and the beam-receiving line in one embodiment of the present invention; Figure 8This is a schematic diagram of the structure of the lumen support in another embodiment of the present invention; Figure 8a for Figure 8 Enlarged view of point B in the middle; Figure 9 A schematic diagram of the guide component in another embodiment of the present invention; Figure 9a for Figure 9 A cross-sectional view along the CC direction; Figure 10 This is a schematic diagram of the support system in one embodiment of the present invention; Figure 11 (a) is a schematic diagram of the connection between the guide head and the inner sheath core in one embodiment of the present invention; Figure 11 (b) is a schematic diagram of the connection between the card and the outer sheath core in one embodiment of the present invention; Figure 12 for Figure 11 A structural diagram showing the assembled state of the guide head and card components; Figure 13 (a) A schematic diagram of the structure of the conveying device without clamps and slots, provided in another embodiment of the present invention, in which the first pressing member and the second pressing member are not pressing against each other; Figure 13 (b) A schematic diagram of a structure in which the conveying device does not have a clamp or a slot, and the first pressing member and the second pressing member press against each other to compress the take-up line. Figure 14 This is a partial structural schematic diagram of the conveying device in one embodiment of the present invention; Figure 15 This is a schematic diagram illustrating the connection relationship between the positioning part, the first main wave coil, and the beam-receiving line in one embodiment of the present invention (this part of the diagram corresponds to...). Figure 14 At point D in the diagram, but to make it easier to see the relationship between the convergence line and the positioning part, the lumen support is in a naturally expanded state, and the covering is omitted. Figure 16 This is a schematic diagram illustrating the connection relationship between the positioning part and the first main body wave coil and the beam-receiving line in another embodiment of the present invention (this part of the diagram corresponds to...). Figure 14 At point D in the diagram, but to make it easier to see the relationship between the convergence line and the positioning part, the lumen support is in a naturally expanded state, and the covering is omitted. Figure 17 for Figure 15 Enlarged view of point E in the middle.

[0016] 100. Lumen support; 10. Support body; 11. Main body waveguide; 11a. First main body waveguide; 11b. Second main body waveguide; 111. First wave rod; 112. Second wave rod; 20. Coating; 30. Limiting component; 30a. First limiting steel sleeve; 30b. Second limiting steel sleeve; 31. Hole-shaped first limiting part; 32. Hole-shaped second limiting part; 40. Guide component; 40a. First guide sleeve; 40b. Second guide sleeve; 41. First guide hole; 42. Second guide hole; 43. Third guide hole; 44. Fourth guide hole; 50. Retracting component; 501. Transition section; 51. First retracting line; 52. Second retracting line; 300. Support system; 30. Conveying device; 31. Handle assembly; 311. Fixed handle; 3111. Slide groove; 3112. Scale groove; 3113. Contraction adjustment component; 312. Sliding handle; 313. Guide rail; 314. Control component; 315. Safety buckle; 32. Sheath tube; 33. Sheath core assembly; 331. Inner sheath core; 332. Outer sheath core; 3321. Positioning part; 34. Locking element; 341. Claw; 342. Connecting part; 343. Second pressing element; 35. Guide head; 351. Snap-fit ​​part; 3511. Snap-fit ​​surface; 3512. Snap-fit ​​step; 352. Slot; 353. First pressing element; 36. Support rod Detailed Implementation To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0017] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0018] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0019] This invention provides a lumen stent 100, such as Figure 1 As shown, the lumen stent 100 includes a stent body 10 and a membrane 20. The stent body 10 is a tubular structure with openings at both ends. The stent body 10 includes at least one main corrugated coil 11. In this embodiment, the stent body 10 includes a plurality of main corrugated coils 11 arranged axially. The plurality of main corrugated coils 11 are arranged axially and connected by the tubular membrane 20. In other embodiments, the lumen stent may also be a bare stent without a membrane. The plurality of main corrugated coils are connected to adjacent main corrugated coils by axial connectors to form a stent as a whole. This will not be described in detail here.

[0020] like Figure 1-2 Combination Figure 3-4 As shown, the lumen support 100 also includes a limiting member 30, a guide member 40, and a converging member 50. Each main wave ring 11 is provided with at least one limiting member 30 and one guide member 40. The limiting member 30 and the guide member 40 can be disposed on the membrane 20 of the lumen support 100 or on the wave rod of the main wave ring 11. When a main wave ring 11 is provided with one limiting member 30, the converging member 50 passes through at least one limiting member 30 of the main wave ring and surrounds the main wave ring 11. When a main wave ring 11 is provided with multiple limiting members 30, the multiple limiting members 30 corresponding to the same main wave ring 11 form a group. The converging member 50 passes through the group of limiting members 30 in the circumferential direction to surround the main wave ring 11, and then extends to the adjacent main wave ring 11 through the guide member 40. The converging element 50 can radially converge the luminal stent with positioning deviation, thereby realizing the retrieval or repositioning and release of the luminal stent. This can avoid the situation in the prior art where the luminal stent can only be removed by surgery when various release problems occur.

[0021] The limiting member 30 includes a perforated limiting portion or a snap-on limiting portion arranged circumferentially. The perforated limiting portion can be formed by directly penetrating the main body wave coil 11 to form a perforation, or it can be provided on other limiting members 30 attached to the main body wave coil 11. Figure 3As shown, the limiting member 30 includes at least one limiting steel sleeve disposed on the main wave coil 11. The limiting steel sleeve includes a hole-shaped limiting portion extending circumferentially through the limiting steel sleeve. The limiting member 30 may also include a plurality of hole-shaped limiting portions spaced circumferentially along the lumen support 100, or a plurality of wire-locking limiting portions spaced circumferentially along the lumen support 100. The limiting portion corresponding to the main wave coil 11 is located within the axial span range of its corresponding main wave coil 11, that is, the converging member 50 needs to be limited circumferentially in the main wave coil 11. In this embodiment, a set of limiting members 30 includes a plurality of limiting steel sleeves, which are spaced circumferentially on the wave rod of the main wave coil 11. At least a portion of the limiting steel sleeves overlaps with the axial middle region of the wave rod.

[0022] like Figure 3 Combination Figure 1-2 As shown, each limiting steel sleeve includes a limiting hole extending circumferentially along the lumen support 100, and the limiting hole penetrates the limiting steel sleeve in this direction, so that when the converging member 50 passes through the limiting hole circumferentially, the converging member 50 is limited within the area spanned by the main wave coil 11 and does not detach from the main wave coil 11; it can be understood that the limiting hole can be set in the middle 2 / 4 area of ​​the axial height of the wave rod, so as to limit the converging member 50 in the axial middle area of ​​the area spanned by the main wave coil 11, thereby facilitating the application of force to the axial middle area of ​​the main wave coil 11 when the converging member 50 is converging, preventing the main wave coil 11 from tilting towards the wave crest or trough, thereby providing a uniform and stable radial compressive force to the main wave coil 11, which is beneficial for the main wave coil 11 to achieve stable radial compression under the converging action of the converging member 50.

[0023] Understandably, the limiting steel sleeve can be fixed to the wave rod of the main wave ring 11 by mechanical clamping. Before clamping, a pre-support body with an outer diameter larger than the outer diameter of the condenser 50 is pre-supported in the limiting hole to prevent deformation of the limiting hole. On the other hand, the circumferential extension of the limiting hole along the cavity support 100 only needs to satisfy the requirement that it has an extension component in the circumferential direction, which facilitates the transition of the condenser 50 to the adjacent wave rod of the same main wave ring 11. That is, the extension line of the limiting hole is located in the middle 2 / 4 area of ​​the four equal divisions of the adjacent wave rod, so that the condenser 50 can be transitioned to the middle 2 / 4 area of ​​the four equal divisions of the adjacent wave rod. This ensures that the stress point of the adjacent wave rod subjected to the condenser force of the condenser 50 is also in the middle 2 / 4 area of ​​the four equal divisions of its wave rod, thereby ensuring that the main wave ring 11 is subjected to uniform and stable force as a whole.

[0024] The guide member 40 includes a guide steel sleeve fixed to the wave rod of the main wave ring 11; the guide steel sleeve includes a guide hole extending axially, the extension direction of the guide hole on the guide steel sleeve being along the axial direction of the lumen support 100 or the angle between the guide hole and the axial direction of the lumen support 100 not exceeding 10°, so that the pulling direction of the converging member 50 when converging the main wave ring 11 is not tilted much, so as to achieve better converging of the lumen support 100.

[0025] The converging element 50 includes one or more converging lines. The converging lines pass sequentially through the limiting element 30 and the guide element 40 along the circumference and axial direction of the lumen support 100, thereby converging at least one main corrugation 11. The two ends of the converging lines are located on the proximal side and the distal side of the main support, respectively. By fixing one end of the converging line and pulling the other end of the converging line, the multiple main corrugations 11 of the lumen support 100 can be radially converged, thereby radially converging the lumen support 100.

[0026] In this embodiment, such as Figure 1-5 As shown, the lumen support 100 includes two limiting steel sleeves, two guide steel sleeves, and two receiving lines. Each guide steel sleeve includes two guide holes, which are used by different receiving lines. The limiting steel sleeves and guide steel sleeves are circumferentially spaced on the wave rod of the same main wave ring 11. The two limiting steel sleeves and the two guide steel sleeves are not adjacent in the circumferential direction. In other words, a guide steel sleeve is set between the two limiting steel sleeves. The two limiting steel sleeves and the two guide steel sleeves are respectively set at positions that are four or nearly four-quarters apart in the circumferential direction of the main wave ring 11.

[0027] The lumen stent 100 includes a first convergence line 51, a second convergence line 52, a first main wavering coil 11a, and a second main wavering coil 11b adjacent to the first main wavering coil 11a. The first main wavering coil 11a is disposed at one end of the lumen stent 100. The lumen stent 100 also includes a first guide steel sleeve 40a, a first limiting steel sleeve 30a, a second guide steel sleeve 40b, and a second limiting steel sleeve 30b arranged sequentially along the circumference of the first main wavering coil 11a. The first guide steel sleeve 40a includes a first guide hole 41 and a second guide hole 42; the second guide steel sleeve 40b includes a third guide hole 43 and a fourth guide hole 44; the first limiting steel sleeve 30a includes a perforated first limiting portion 31; and the second limiting steel sleeve 30b includes a perforated second limiting portion 32. Figure 2-5 As shown.

[0028] In this embodiment, such as Figure 4 As shown, the first guide hole 41 extends from the proximal end to the distal end of the first guide sleeve 40a. It is understood that in other embodiments, the first guide hole 41a may also extend to the axial center of the first guide sleeve, i.e., through the guide hole, such as... Figure 6-6aAs shown, this design ensures that when the take-up line extends from the guide to the limiting member or vice versa, it is closer to the middle region of the main wavering coil. This results in a more uniform and stable radial force on the main wavering coil when the take-up line converges onto the cavity support. It is understood that the first guide hole is designed to open at its opening in accordance with the circumferential extension direction of the take-up line, and the opening is rounded to reduce friction with the take-up line.

[0029] The extension direction of the convergence line is described by extending it from the first main wave loop 11a toward the second main wave loop 11b (since the line extends toward both ends, the extension of the convergence line can also be described from the opposite direction), such as Figure 2 Combination Figure 3-4 As shown, the first receiving line 51 passes through the first guide hole 41 of the first guide sleeve 40a and extends circumferentially to the first limiting sleeve 30a and through the perforated first limiting part 31. It continues to extend circumferentially to the third guide hole 43 of the second guide sleeve 40b. At this time, the first receiving line 51 circumferentially wraps around about half a circumference of the first main body wavering 11a. The third guide hole 43 guides the first receiving line 51 to the guide sleeve of the second main body wavering 11b. Further, the first receiving line 51 then repeats the above extension method in the circumferential direction of the second main body wavering 11b to cross about half a circumference of the second main body wavering 11b, and sequentially extends axially to each main body wavering 11, so that the first receiving line 51 sequentially extends circumferentially and axially across each main body wavering 11 within half a circumference of the tube body of the tube support 100, as shown. Figure 5 As shown.

[0030] Understandably, the second convergence line 52 can pass through the second guide hole 42 of the first guide sleeve 40a and extend circumferentially in the opposite direction to the first convergence line 51 to the second limiting sleeve 30b and through the hole-shaped second limiting part 32, and then extend circumferentially to the fourth guide hole 44 of the second guide sleeve 40b, so that the first convergence line 51 and the second convergence line 52 basically cross the entire circumference of the main body wavering 11; at the same time, the fourth guide hole 44 guides the second convergence line 52 to the guide sleeve of the second main body wavering 11b; furthermore, the second convergence line 52 then repeats the above extension method in the circumferential direction of the second main body wavering 11b to cross the other half circumference of the second main body wavering 11b, and sequentially extends axially to each main body wavering 11, so that the second convergence line 52 sequentially extends circumferentially and axially across each main body wavering 11 in the other half circumference range of the tube body of the lumen support 100.

[0031] Among them, such as Figure 7 Combination and Figure 5As shown, the first main wave ring 11a includes a first wave rod 111 and a second wave rod 112. The first wave rod 111 and the second wave rod 112 are adjacent wave rods. Adjacent wave rods refer to the first wave rod 111 and the second wave rod 112 forming a wave crest or trough at the intersection of the two wave rods. The first limiting steel sleeve 30a is provided on the first wave rod 111. The extension line of the extending direction of the hole-shaped first limiting part 31 does not exceed the middle 2 / 4 area of ​​the second wave rod divided into four equal parts. Figure 7 The region between the two dashed lines of the second wave rod 112 is used to allow the convergence line to apply radial force to the middle region of the main wave ring 11 of the lumen support 100, thereby making the main wave ring 11 of the lumen support 100 uniformly radially compressed, and avoiding the trough or peak of the main wave ring 11 from being stressed at one end, which would cause the trough or peak of the other end of the main wave ring 11 to rise.

[0032] It is understandable that in other embodiments, the range by which the receiving line crosses the main wave loop 11 in the circumferential direction does not have to be the entire circumference of the main wave loop 11. It is sufficient that the range it crosses exceeds 80% of the circumference of the main wave loop 11, so that the receiving length of the receiving line is sufficient to radially compress the main wave loop 11 as much as possible.

[0033] In this embodiment, the first guide hole 41, the second guide hole 42, the third guide hole 43 and the fourth guide hole 44 all extend axially; each main wave ring 11 includes two wave rods along the axial direction, so that when the guide steel sleeve is fitted onto the main wave ring 11, its guide steel sleeve extends axially, thereby facilitating the extension direction of the guide hole when it is made along the long axis of the guide steel sleeve and fitted onto the main wave ring 11.

[0034] In other embodiments, the guide hole may also be slightly inclined relative to the axial direction, wherein "slightly inclined" means that the extension direction of the guide hole is inclined at no more than 10° relative to the axial direction, such as... Figure 7 As shown, the angle α between the extension direction of the guide hole line L and the axial direction satisfies: α≤10°. The guide hole can be tilted in accordance with the extension direction of the take-up line to facilitate smoother passage of the take-up line through the guide steel sleeve, and to reduce the resistance when the take-up line is pulled and gathered radially to the tube support. In other implementations, such as Figure 8-8a Combination Figure 9-9a As shown, the lumen support 100 can also be provided with only one convergence line 50a. Correspondingly, the structure of its guide is provided with guide holes according to the trend of the convergence line extending along the circumferential and axial directions of the lumen support. The guide includes two guide holes (41b, 42b), and the distal end of the guide hole 41b and the proximal end of the guide hole 42b are in the same circumferential direction, or although they are not in the same circumferential direction, the axial misalignment is not significant. A main waveguide 11 is provided with only one guide 40. The convergence line 50a is first passed through one guide hole 41b on the guide 40 (from... Figure 9-9a The end of the cable passes through the middle, thus placing the receiving wire 50a within the range of a main wave loop 11. Then, the receiving wire passes through the limiting member 30 on the main wave loop 11 for one revolution, and then through another guide hole 42b of the guide member 40. This other guide hole 42b changes the extension direction of the receiving wire from circumferential to axial, thereby facilitating the transition of the receiving wire to the adjacent main wave loop 11. The specific extension direction of the receiving wire is referred to... Figure 8a and Figure 9a The arrow in the image points to the indicated direction. In other embodiments, the lumen support 100 further includes an axial connector 60, such as... Figure 8 As shown, the axial connector 60 connects two adjacent main body wave coils 11; the convergence line includes a transition section 501, which spans two adjacent main body wave coils 11. The axial connector 60 can be set at the position of the transition section 501 or within a range of circumferential deflection of no more than 20° relative to the transition section 501. When the lumen support 100 is converged, it can prevent the positions of adjacent main body wave coils 11 subjected to axial tension from approaching each other axially, thereby preventing the lumen support 100 from shortening axially. It is understandable that when the lumen support 100 is a bare support without a membrane, adjacent main body corrugations can be connected by axial connectors 60, and the connection method between the limiting member 30, the guide member 40 and the main body corrugation 11 is the same as the connection method in the above embodiment.

[0035] The present invention also provides a support system 300, such as Figure 10-11 As shown, the stent system 300 includes the aforementioned lumen stent 100 and a delivery device 30. The delivery device 30 includes a handle assembly 31, a sheath 32, a sheath core assembly 33, and a support rod 36. The sheath core assembly 33 includes an inner sheath core 331 and an outer sheath core 332. The inner sheath core 331, outer sheath core 332, support rod 36, and sheath 32 are sequentially sleeved from the inside to the outside and can move relative to each other along the axial direction. The support rod 36 is sleeved outside the sheath core assembly 33, and the distal end of the support rod 36 is spaced apart from the proximal end of the guide head. This space and the gap between the sheath and the sheath form the loading space for the lumen stent. Figure 14 As shown.

[0036] It is understandable that after the take-up wire passes through the distal end of the lumen support, when it extends axially towards the proximal end of the support system within the sheath 32, a wire cavity (not shown) can be opened axially within the support rod 36, allowing the take-up wire to extend axially into the handle assembly 31 along the wire cavity. Alternatively, the take-up wire can extend axially into the handle assembly 31 through the gap between the support rod 36 and the sheath 32, which is not limited here.

[0037] like Figure 10As shown, the handle assembly 31 includes a fixed handle 311 and a sliding handle 312. The proximal end of the fixed handle 311 includes a guide rail 313 extending towards the proximal end. The proximal end of the sheath 32 is connected to the sliding handle 312. The sliding handle 312 is disposed on one side of the proximal end of the fixed handle 311 around the guide rail 313, so that the sliding handle 312 can slide along the guide rail 313 to drive the sheath 32 to retract, so as to release the lumen support 100 from the distal end of the sheath 32.

[0038] The fixed handle 311 also includes a slide groove 3111, a scale groove 3112, and a convergence adjustment member 3113. The slide groove 3111 extends axially, and the scale groove 3112 is evenly offset on both sides of the slide groove 3111. The convergence adjustment member 3113 includes a slider, which is disposed in the slide groove 3111 and can reciprocate axially along the slide groove 3111. A portion of the slider is disposed in the slide groove and directly or indirectly connected to the proximal end of the convergence line. At the same time, a portion of the slider protrudes from the fixed handle 311 to facilitate operation and allow it to slide axially in the slide groove 3111. When the slider slides in the slide groove 3111, it can swing to both sides axially to embed into the scale groove 3112, thereby limiting the convergence adjustment member 3113 axially. The scale groove 3112 corresponds to the convergence tube support 100 of the convergence line.

[0039] It is understandable that in other embodiments, the retraction adjustment component can also be located at the proximal end of the conveying device (not shown in the figure). The retraction adjustment component can be configured as a pull ring to facilitate pulling the retraction line. In this case, after releasing the pressing relationship between the first and second pressing components and thus releasing the fixation of the far end of the retraction line by the conveying device, the retraction adjustment component at the proximal end of the conveying device can be used to pull the retraction line back until it is completely away from the support. Then, the retraction line and the conveying device can be pulled back together and removed from the body. Removing the retraction line separately from the lumen support can reduce the impact on the position of the released lumen support during line removal. At the same time, a mark can be set on a section of the proximal end of the retraction line to indicate the length of the retraction, thereby indicating the degree of retraction and the degree of withdrawal.

[0040] like Figure 11-12As shown, the conveying device 30 also includes a locking member 34 and a guide head 35. The locking member 34 is connected to the distal end of the outer sheath core 332, and the guide head 35 is connected to the distal end of the inner sheath core 331. The locking member 34 includes multiple claws 341 and a connecting portion 342. The multiple claws 341 radiate and disperse from the connecting portion 342 toward the distal end. The connecting portion 342 fixes the multiple claws 341 to the distal end of the outer sheath core 332. Each of the multiple claws 341 can engage with a corresponding slot 352. The proximal end of the guide head 35 is provided with a locking part 351 and a locking groove 352. The locking part 351 is located on the distal side of the locking groove 352. The locking part 351 includes a locking surface 3511 and a locking step 3512. The inner circumferential surface of the sheath tube 32 is fitted onto the locking surface 3511. The distal end face of the sheath tube 32 abuts against the locking step 3512 so that the guide head 35 can be fitted into the distal end of the sheath tube 32, and at the same time, the mating part of the claw 341 and the locking groove 352 is taken into the sheath tube 32.

[0041] Understandably, the post-release structure formed by the clip 34 and the slot 352 can temporarily fix the bare stent at the proximal end of the lumen stent during post-release. Combined with the positioning part that limits the distal end of the lumen stent, it can further limit the axial relative position of the proximal and distal ends of the lumen stent. This can largely avoid the problem of the lumen stent being shortened axially by the convergence of the cable, which would make the lumen stent prone to positioning deviation during re-release.

[0042] The conveying device 30 also includes a first pressing member 353 and a second pressing member 343. The first pressing member 353 and the second pressing member 343 can press against each other or release the pressing. The process of pressing against each other or releasing the pressing can be controlled and adjusted by the handle assembly 31 so as to fix one end (far end) of the gathering member or release one end of the gathering member 50.

[0043] Understandably, the proximal end of the handle assembly 31 also includes a control member 314 and a safety buckle 315. The control member 314 is connected to the proximal end of the outer sheath core 332. By retracting the control member 314, the outer sheath core 332 can be retracted to release the pressing state of the first pressing member 353 and the second pressing member 343, thereby releasing the fixation of the distal end of the take-up line. The safety buckle 315 is detachably disposed between the control member 314 and the tail end of the handle assembly 31. When the safety buckle 315 is fastened between the control member 314 and the tail end of the handle assembly 31, the safety buckle 315 presses the control member 314 toward the distal end, causing the two pressing members at the distal end to press against each other, thereby fixing the distal end of the take-up line. At this time, the control member 314 is axially limited and cannot move axially relative to the fixed handle 311, thereby ensuring the reliability of the fixation of the first pressing member 353 and the second pressing member 343 to the take-up member 50.

[0044] In one implementation, such as Figure 11-12As shown, the first pressing member 353 is disposed at the proximal end of the guide head 35. The first pressing member 353 includes a frustoconical convex surface protruding towards the proximal end. The second pressing member 343 is disposed in the connecting portion 342 within the plurality of claws 341. The second pressing member 342 includes a circular groove recessed towards the proximal end. When the claws 341 engage with the grooves 352, the first pressing member 353 and the second pressing member 343 press against each other. Simultaneously, the distal end of the take-up wire passing through the lumen support 100 is engaged at the grounding point of the first pressing member 353 and the second pressing member 343, thereby fixing the distal end of the take-up wire to the sheath core assembly 33. In this embodiment, the frustoconical convex surface of the first pressing member 353 and the circular groove of the second pressing member 343 form a surface abutment, which can ensure the reliability of fixing the distal end of the take-up wire. In other embodiments, the contact between the first pressing member 353 and the second pressing member 343 can also be point contact pressing or line contact pressing, wherein the point contact can be multiple point contacts to increase the fixing reliability of the take-up wire.

[0045] In other implementations, such as Figure 13 As shown, the conveying device 30 may also omit the locking member 34 and the locking groove 352, and directly provide a locking part 351 at the proximal end of the guide head 35. The first pressing member 353 is provided at the proximal end of the locking part 351, and the second pressing member 343 is provided at the distal end of the outer sheath core 332. The first pressing member 353 includes a circular groove recessed towards the distal end, and the second pressing member 343 includes a frustum protruding towards the distal end. The frustum protruding surface can be embedded in the circular groove to cooperate with each other, so as to realize the surface abutment of the first pressing member 353 and the second pressing member 343.

[0046] In other embodiments, for some more tortuous blood vessels, the flexibility requirement of the stent is higher; the luminal stent 100 may also not have an axial connector, and its stent system 300 may also include a positioning part 3321, such as Figure 14-17 As shown, the lumen support 100 includes a first main body wavering 11a closest to the distal end, and a positioning part 3321 is disposed on the sheath core assembly 33. The positioning part 3321 corresponds to the position of the first main body wavering in the vertical axis. It can be understood that the positioning part 3321 can correspond to the middle 2 / 4 area of ​​the first main body wavering 11a at the end in the vertical axis.

[0047] In one implementation, such as Figure 15-16 Combination Figure 1 As shown, the luminal stent also includes a second main body wave coil 11b at the secondary end. The second main body wave coil 11b is closer to the proximal end (corresponding to the distal end of the stent system) than the first main body wave coil 11a. When the convergence elements (first convergence line 51, second convergence line 52) extend from the second main body wave coil 11b to the position corresponding to the first main body wave coil 11a, as... Figure 15As shown, the first take-up wire 51 first passes through the positioning part 3321, then passes through the first guide steel sleeve 40a in the direction of the first main body wave coil 11a, and then extends circumferentially along the first main body wave coil to the first limiting steel sleeve 30a and passes through its limiting part, continuing to extend circumferentially to the second guide steel sleeve 40b. At this time, the first take-up wire 51 circumferentially wraps around about half a circumference of the first main body wave coil 11a, and then the first take-up wire 51 extends along the wire cavity of the support rod 36 to the near end of the conveying device; it can be understood that... The second take-up line 52 first passes through the same positioning part or another positioning part 3321, then passes through the first guide steel sleeve 40a in the direction of the first main body wave ring 11a, and then extends circumferentially along the first main body wave ring to the second limiting steel sleeve 30b and passes through its limiting part, and continues to extend circumferentially to the second guide steel sleeve 40b. At this time, the first take-up line 52 circumferentially bypasses about half a circumference of the first main body wave ring 11a, and then the first take-up line 52 extends along the wire cavity of the support rod 36 to the near end of the conveying device. In this embodiment, to ensure the convergence effect of the convergence line on the main waveguide, when the number of limiting members is small, the convergence line can be placed between the main waveguide and the coating when extending circumferentially. In other embodiments, when the limiting members ensure that a limiting member or guide member is provided on every other waveguide, it is sufficient to ensure the convergence effect of the convergence line on the main waveguide. Therefore, when the convergence line passes through a waveguide without a limiting member or guide member, it is not limited whether it is placed between the waveguide and the coating or on the side of the waveguide away from the coating. It is only necessary to ensure that the compression diameter when the main waveguide is converged can be reduced to less than 80% of the diameter when the lumen support naturally expands.

[0048] This allows the positioning part 3321 to limit the axial relative position of the first main body wave coil 11a, preventing the cavity support from shortening axially when the retracting member retracts the cavity support, thus affecting the positioning accuracy during subsequent release. For example... Figure 15 As shown, the order in which the retractor 50 passes through the positioning part 3321 is between the guide corresponding to the first main body wave coil 11a and the guide corresponding to the second main body wave coil 11b. This allows the positioning part to better position the first main body wave coil 11a of the lumen support, preventing the lumen support from shortening axially when the retractor is used to retract the lumen support, thus affecting the positioning accuracy when it is released again.

[0049] In other embodiments, when the converging member extends from the second main wave coil 11b to the first main wave coil 11a, it may first pass through the guide member 40 and the positioning part 3321 corresponding to the first main wave coil 11a, such as... Figure 16As shown, the first take-up wire 51 passes through the first guide steel sleeve 40a and extends circumferentially along the first main body wave coil 11a to the first limiting steel sleeve 30a and passes through its limiting part. It continues to extend circumferentially to the second guide steel sleeve 40b. At this time, the first take-up wire 51 circumferentially wraps around about half a circumference of the first main body wave coil 11a. Then, the first take-up wire 51 passes through the positioning part 3321 and extends along the wire cavity of the support rod 36 to the near end of the conveying device. It can be understood that the second take-up wire 52 passes through the first guide steel sleeve 40a and extends circumferentially along the first main body wave coil to the second limiting steel sleeve 30b and passes through its limiting part. It continues to extend circumferentially to the second guide steel sleeve 40b. At this time, the first take-up wire 52 circumferentially wraps around about half a circumference of the first main body wave coil 11a. Then, the first take-up wire 52 passes through the positioning part 3321 and extends along the wire cavity of the support rod 36 to the near end of the conveying device.

[0050] like Figure 17 As shown, the positioning part 3321 can be configured as a turning hole opened on the outer sheath core 332. The turning hole includes two openings. The gathering member 50 (gathering line 52) enters the outer sheath core 332 from one opening and passes out from the other opening, so that the gathering member 50 is turned by the positioning part 3321, thereby limiting the axial length of the lumen support 100 in the axial direction. When the lumen support 100 is gathered, it is to avoid the positions of adjacent main body wave coils 11 subjected to axial tension from being close to each other in the axial direction, thereby avoiding the axial shortening of the lumen support 100, and thus avoiding the positioning deviation caused by the shortening when the lumen support is released again after releasing the gathering member.

[0051] In other embodiments, the support system 300 may also be provided with an axial connector and a positioning part 3321 to prevent the lumen support 100 from shortening in the axial direction, which is not limited here.

[0052] It is understandable that the direction of the steering hole, whether it extends axially, radially, or obliquely, is not limited here. It is only necessary to ensure that its extension direction is in line with the extension direction of the convergence line, so that the convergence line can slide within the steering hole.

[0053] The intraoperative retractable release process of the luminal stent 100 is as follows: Taking the stent system 300 with a post-release mechanism 34 as an example, the delivery device 30 of the stent system 300 delivers the luminal stent 100 into the blood vessel along the guidewire. After positioning the luminal stent 100 at the lesion location, the retraction adjustment member 3113 is moved away from the scale groove 3112 and into the axial sliding groove 3111 position. The sliding handle 312 is then pulled back, causing the sheath 32 to retract, thereby releasing the luminal stent 100 from the sheath 32. Since the retraction adjustment member 3113 is not limited by the scale groove 3112, that is, the retraction member 5... The proximal end of the 0 is released from fixation, allowing the lumen stent 100 to expand freely without being restricted by the sheath 32. Under the action of the convergence line, the convergence adjustment member 3113 slides towards the distal end along the axial groove 3111. If, during or after the free expansion of the lumen stent 100, inaccurate circumferential or axial positioning or misalignment is found, the convergence adjustment member 3113 can be retracted along the groove 3111, causing it to move proximally, thereby ensuring the lumen stent 100 is aligned with the convergence line. Radial compression occurs under the contraction action. Different scale grooves 3112 correspond to different degrees of compression of the lumen support 100. The lumen support 100 is contracted to a degree that allows it to move freely in the axial and circumferential directions (the radial compression ratio should be less than 80%, which can be the ratio of the lumen diameter under compression to the lumen diameter under natural expansion) by using the scale markings of the scale grooves 3112. Subsequently, the lumen support 100 is adjusted and repositioned, and then the contraction adjustment component 3113 is moved away from the scale groove. 3112 enters the groove 3111 position, causing the lumen stent 100 to expand naturally and be released back into the blood vessel; after confirming that the lumen stent 100 is accurately released, the safety buckle 315 is released, and the control component 314 is pulled back, so that the first pressing component 353 and the second pressing component 343 are released from pressure, thereby releasing the fixed relationship between the delivery device 30 and the distal end of the receiving line. Then, the delivery device 30 is gradually pulled back, so that the receiving line is gradually detached from the lumen stent 100, and thus withdrawn from the human body together with the delivery device 30.

[0054] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0055] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A lumen stent, characterized in that, The lumen support includes a support body, a limiting member, a guide member, and a converging member. The support body includes multiple main corrugated coils arranged axially. Each main corrugated coil is correspondingly provided with at least one limiting member and one guide member. The limiting member includes at least one limiting steel sleeve disposed on the main corrugated coil. The limiting steel sleeve includes a circumferentially extending hole-shaped limiting portion that penetrates the limiting steel sleeve and is located within the axial span range of its corresponding corrugated coil. The guide member includes a guide steel sleeve fixed to the corrugated rod of the main corrugated coil. The guide member includes a guide portion extending axially. The device is configured as a guide hole; the gathering member passes through at least one of the limiting members of the main body wavering and surrounds the main body wavering, and then extends to an adjacent main body wavering guided by the guide member; the gathering member includes one or more gathering lines, which pass through the limiting member and the guide member in sequence along the circumference and axial direction of the lumen support, thereby gathering the main body wavering by the gathering lines. The two ends of the gathering lines are located on the proximal side and the distal side of the support body, respectively. By fixing one end of the gathering line and pulling the other end of the gathering line, the main body wavering can be gathered radially.

2. The lumen stent according to claim 1, characterized in that, The extension direction of the guide hole on the guide sleeve is along the axial direction of the lumen support or the angle between the guide hole and the axial direction of the lumen support does not exceed 10°.

3. The lumen stent according to claim 1, characterized in that, The lumen support includes a first main wave ring and a first limiting steel sleeve. The first main wave ring includes a first wave rod and a second wave rod, which are adjacent to each other. The first limiting steel sleeve is disposed on the first wave rod and includes a perforated first limiting part. The extension line of the perforated first limiting part is located in the middle 2 / 4 area of ​​the second wave rod divided into four equal parts.

4. The lumen stent according to claim 1, characterized in that, The lumen support also includes an axial connector that connects two adjacent main body wave coils; the convergence line includes a transition section that spans two adjacent main body wave coils, and the axial connector is located at the position of the transition section or within a range of circumferential deflection of no more than 20° relative to the transition section.

5. A stent system, comprising a delivery device and a lumen stent as described in any one of claims 1-4, characterized in that, The conveying device includes a first pressing member and a second pressing member, which are movably pressed against each other or released from pressing, so as to fix one end of the gathering member or release the fixation of one end of the gathering member.

6. The support system according to claim 5, characterized in that, The conveying device includes a handle assembly comprising a fixed handle and a sliding handle. The proximal end of the fixed handle includes a guide rail extending towards the proximal end. The sliding handle is disposed around the guide rail on one side of the proximal end of the fixed handle. The fixed handle includes a slide groove, a graduated groove, and a convergence adjustment member. The slide groove extends axially, and the graduated groove is disposed on both sides of the slide groove axially. The convergence adjustment member is disposed within the slide groove and can reciprocate axially along the slide groove and can swing to both sides axially to engage with the graduated groove, thereby limiting the convergence adjustment member axially.

7. The support system according to claim 5, characterized in that, The stent system includes a sheath core assembly and a positioning part. The lumen stent includes a first main body wavering closest to the distal end. The positioning part is disposed on the sheath core assembly, and the positioning part corresponds to the middle 2 / 4 region of the first main body wavering in the vertical axis, thereby causing the convergence member to be turned through the positioning part to define the axial length of the lumen stent in the axial direction.

8. The support system according to claim 5, characterized in that, The stent system includes a sheath core assembly and a positioning part. The lumen stent includes a terminal main wavering closest to the distal end. The positioning part is disposed on the sheath core assembly, and the positioning part corresponds to the position of the first main wavering in the vertical axis. When the converging member extends from the proximal end to the distal end, it passes through the guide and the positioning part corresponding to the first main wavering in sequence. Alternatively, as the converging member extends from the proximal end to the distal end, it passes sequentially through the positioning part and the guide member corresponding to the first main body wave coil.

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