Stent graft assembly device

Abstract

The present invention discloses a stent graft assembly device for assembling a stent graft, wherein the stent graft includes a compressible or expandable corrugated ring, and the stent graft assembly device includes a collar, wherein the collar is made of a self-expandable material, and the self-expanding force of the collar is less than the radial expansion force of the stent graft. During the compression of the stent graft, the shape of the clamping hole is always adapted to the shape of the stent graft, and the collar can apply radial compression forces of the same magnitude to all circumferential locations of the stent graft, so that all circumferential locations of the stent graft can shrink in the same proportion to reduce the tube diameter, thereby making the cross-sections at different times during the compression process all geometrically similar, thereby improving assembly consistency, ensuring that the fully compressed stent graft can eliminate interference and be smoothly loaded into the sheath, and also avoiding damage to the stent graft during the compression process.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a stent graft assembly device. Background Art

[0002] In the field of interventional medicine, for vascular diseases such as aneurysms and arterial dissections, a delivery system is usually used to implant a covered stent into the lesion site in the corresponding blood vessel, so that the covered stent is released from the delivery system and automatically expands to fit the inner wall of the blood vessel, thereby achieving the therapeutic effect. Before the covered stent is implanted in the body, it is necessary to compress the covered stent to load it into the sheath of the delivery system so that it can be delivered to the lesion site through intervention. When compressing the covered stent, the traditional operation mode generally requires two people to cooperate, and a radial compression force is applied to the covered stent using a cable tie. However, this method makes it difficult to compress the covered stent to a compressed size that is easier to assemble with the sheath, and the stent may be damaged or scrapped. It will also increase the labor intensity of the operator and affect the efficiency of compressing the covered stent. Summary of the Invention

[0003] A technical problem solved by the present invention is how to improve the compression effect and working efficiency of the assembly device on the stent graft.

[0004] The present invention provides a coated stent assembly device for assembling a coated stent, which includes a compressible or expandable wave ring. The coated stent assembly device includes a ring, which is made of a self-expandable material, and the self-expanding force of the ring is less than the radial expansion force of the coated stent.

[0005] In one embodiment, the diameter of the wire constituting the ring is not greater than the diameter of the wire of the corrugated ring.

[0006] In one embodiment, the collar includes a W-shaped structure, and the amplitude of the W-shaped structure on the collar is smaller than the amplitude of the wave ring.

[0007] In one embodiment, the collar is plated with a lubricious coating.

[0008] In one embodiment, the coating is made of titanium alloy material.

[0009] In one embodiment, the stent graft assembly device further includes a sleeve having a second sliding hole, the collar can be received in the second sliding hole, and the inner wall of the distal opening of the second sliding hole is arc-shaped or trumpet-shaped.

[0010] In one embodiment, the wear resistance of the distal end portion of the sleeve is higher than the wear resistance of the collar.

[0011] In one embodiment, the coated support assembly device also includes a sleeve, the sleeve has a second sliding hole, the ring can be received in the second sliding hole, the sleeve includes a flat section, the cross-section of the flat section is roughly rectangular, and the width of the rectangle is smaller than the amplitude of the wave ring.

[0012] In one embodiment, the sleeve comprises a flat section, the cross section of which is substantially rectangular, and the width of the rectangle is smaller than the amplitude of the wave coil.

[0013] A technical effect of an embodiment of the present invention is that when the stent graft is matched with the clamping hole, the length of the collar exposed outside the tube is reduced, thereby reducing the size of the clamping hole in order to compress the stent graft. During the compression of the stent graft, the shape of the clamping hole is always adapted to the shape of the stent graft, and the collar can apply radial compression forces of the same size to the stent graft at all circumferences, so that the stent graft can shrink at the same proportion at all circumferences to reduce the tube diameter, and then the cross-sections at different times during the compression of the stent graft are all geometrically similar figures, thereby improving the assembly consistency of the stent graft, ensuring that the fully compressed stent graft can eliminate interference and be smoothly loaded into the sheath, and also avoiding damage to the stent graft during the compression process. At the same time, there is no need to repeatedly adjust the compression force of the stent graft, thereby improving work efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 A schematic front view of a stent graft provided in one embodiment;

[0015] Figure 2 A schematic diagram of the three-dimensional structure of the assembly device provided in the first embodiment;

[0016] Figure 3 for Figure 2 A schematic cross-sectional structural diagram of the assembly device shown;

[0017] Figure 4 for Figure 2 A schematic cross-sectional view of the sleeve in the assembly device shown;

[0018] Figure 5 for Figure 2 A schematic cross-sectional view of the slide bar in the assembly device shown;

[0019] Figure 6 for Figure 2 A schematic cross-sectional view of the slide bar and the restraining assembly in the assembly device shown;

[0020] Figure 7 for Figure 2 A schematic plan view of the structure of the first example of the restraint assembly in the assembly device shown;

[0021] Figure 8 for Figure 2 A schematic plan view of the structure of a second example of a restraint assembly in the assembly device shown;

[0022] Figure 9 To adopt Figure 2 A schematic diagram of the first corrugation of the collar in the assembly device shown is shown in a natural state;

[0023] Figure 10 for Figure 9 The schematic diagram of the ring after compressing the stent graft into a compressed state;

[0024] Figure 11 for Figure 9 The schematic diagram of the first wave coil after being installed in the sheath tube;

[0025] Figure 12 A schematic diagram of the three-dimensional structure of the assembly device provided in the second embodiment;

[0026] Figure 13 for Figure 12 A schematic cross-sectional structural diagram of the assembly device shown;

[0027] Figure 14 for Figure 13 The enlarged structural diagram at E in the middle;

[0028] Figure 15 for Figure 12 A partial top view of the assembly device shown in FIG. 1 in cooperation with the first wave ring in a natural state;

[0029] Figure 16 for Figure 12 A partial top view of the assembly device shown after compressing the first wave coil to a compressed state;

[0030] Figure 17 A schematic diagram of the three-dimensional structure of the assembly device provided in the third embodiment;

[0031] Figure 18 for Figure 17 A schematic cross-sectional structural diagram of the assembly device shown;

[0032] Figure 19 A schematic diagram of a tooling structure for testing the self-expansion force of the sleeve of the present invention;

[0033] Figures 20 to 22 for Figure 19 The schematic diagram of the structure of the tooling part is shown;

[0034] Figure 23 To utilize Figure 19 The shown figure is a schematic diagram of the tool used to test the self-expansion force of the collar of the present invention. DETAILED DESCRIPTION

[0035] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The accompanying drawings illustrate preferred embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0036] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly attached to the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0037] Furthermore, in the field of medical devices, the end closest to the operator is defined as the "proximal end," and the end farther from the operator is defined as the "distal end." In the present invention, when describing the shape of a component or surface as "substantially" a certain shape, this description is from the perspective of a person skilled in the art. For example, when describing a cross-section as being "substantially circular," the cross-section can be a perfect circle or have slight deviations from a perfect circle; or when describing a cross-section as being "substantially rectangular," the cross-section can be a regular rectangle or a rectangle with chamfered corners.

[0038] See Figure 1 and Figure 3 The stent graft assembly device 10 provided in one embodiment of the present invention is used to install the stent graft 30 into the lumen 21a of the sheath tube 21 (eg Figure 9 ). Specifically, the stent graft 30 is a cylindrical tubular structure. While overcoming the elastic force of the stent graft 30 itself, the stent graft assembly device 10 is used to compress the stent graft 30 from the natural state with the largest diameter to the compressed state with the smallest diameter, so that the diameter of the stent graft 30 in the compressed state is compatible with the size of the lumen 21a of the sheath 21, so that the stent graft 30 in the compressed state can be loaded into the lumen 21a of the sheath 21. When the sheath 21 enters the body, the stent graft 30 is released from the lumen 21a of the sheath 21. The released stent graft 30 will automatically expand from the compressed state until it is tightly attached to the inner wall of the blood vessel, thereby finally realizing the implantation of the stent graft 30 in the body. The stent graft assembly device 10 includes a sleeve 100, a telescopic assembly 200, a restraining assembly 300 and a driving mechanism 400.

[0039] See Figures 1 to 4In some embodiments, the sleeve 100 includes a column section 110 and a flat section 120. The cross section of the column section 110 is generally circular, and the cross section of the flat section 120 is generally rectangular. The flat section 120 is connected to the distal end of the column section 110. During the compression process of the stent graft 30, the distal end surface of the flat section 120 can abut against the surface of the stent graft 30. The cross section of the flat section 120 is generally rectangular. In this embodiment, the length of the rectangle is equal to the diameter of the column section 110, and the width of the rectangle is recorded as A, which is smaller than the diameter of the column section 110. For the wave ring 31 on the stent graft 30, the distance from the trough point to the peak point of the wave ring 31 along the axial direction of the stent graft 30 is defined as the height of the wave ring 31 (i.e., the amplitude). The height of the wave ring 31 is recorded as a, where the value range of A is a / 3<A<a / 2, so that the flat section will not prevent the wave ring from being compressed and entering the sheath. It is understandable that in other embodiments, the length of the cross section of the flat section may not be equal to the diameter of the column section, and may be greater than or less than the diameter of the column section. To avoid damage to the stent, it is preferably longer than the diameter of the unloaded coated stent.

[0040] See Figure 4 The end surface of the column section 110 away from the flat section 120 is the proximal end surface 101, and the end surface of the flat section 120 away from the column section 110 is the distal end surface 102. A first sliding hole 111 and a second sliding hole 121 are defined within the sleeve 100. The first sliding hole 111 extends axially along the entire sleeve 100 and penetrates the proximal end surface of the column section 110, with the entire first sliding hole 111 located within the column section 110. The second sliding hole 121 communicates with the distal bottom wall of the first sliding hole 111 and penetrates the distal end surface 102. The second sliding hole 121 is coaxial with the first sliding hole 111, with a portion of the second sliding hole 121 located within the column section 110 and the remaining portion of the second sliding hole 121 located within the flat section 120. The first sliding hole 111 and the second sliding hole 121 can both be circular holes, with the diameter of the first sliding hole 111 being larger than that of the second sliding hole 121. In practice, the first sliding hole 111 and the second sliding hole 121 can be considered a stepped hole, extending axially along the sleeve 100 and penetrating both the proximal end face 101 and the distal end face 102. Clearly, the stepped hole is a through hole. A sliding groove 112 is defined on the lateral surface of the column section 110. This groove 112 also extends axially along the sleeve 100 and communicates with the first sliding hole 111.

[0041] See Figure 2 、 Figure 3 、 Figure 7 and Figure 8In some embodiments, the restraint assembly 300 includes a collar 310 and a push rod 320. The collar 310 can be formed by winding multiple strands of nickel-titanium wire together to form a rope-like structure with a certain degree of flexibility. The push rod 320 is made of a relatively hard metal or non-metallic material, so that the rigidity of the push rod 320 is greater than the rigidity of the collar 310. The push rod 320 slides with the second slide hole 121. During the sliding process of the push rod 320 in the second slide hole 121, the collar 310 can be driven to retract or extend from the second slide hole 121. When the collar 310 is fixed to the push rod 320, the collar 310 can be surrounded to form a circular clamping hole 313, and the compressed stent graft 30 will be passed through the clamping hole 313. When the entire collar 310 is located outside the second sliding hole 121, the cross-sectional size (diameter) of the clamping hole 313 formed by the collar 310 is the largest. The minimum diameter of the clamping hole 313 when the collar is expanded is recorded as D. The diameter of the stent graft 30 in the natural state is the largest, and the maximum diameter is recorded as d. In order to smoothly pass the stent graft 30 in the natural state into the clamping hole 313 for subsequent compression, the minimum diameter of the clamping hole 313 is made larger than the maximum diameter d of the stent graft 30 (such as Figure 1 ), where D = 1.1d ~ 1.2d. When a portion of the collar 310 is retracted into the second sliding hole 121, the length of the collar 310 exposed outside the second sliding hole 121 is reduced, and the diameter of the tightening hole 313 formed by the collar 310 is reduced, so that the collar 310 can apply radial compression force to the stent graft 30, thereby reducing the diameter of the stent graft 30 to a state equal to the diameter of the tightening hole 313. Therefore, when the collar 310 is gradually retracted into the second sliding hole 121, the diameter of the tightening hole 313 is gradually reduced, and the diameter of the stent graft 30 is also reduced, thereby achieving compression of the stent graft 30. Conversely, when the collar 310 is gradually extended out of the second sliding hole 121, the diameter of the tightening hole 313 is gradually increased.

[0042] See Figure 7 For example, the collar 310 has a first end 311 and a second end 312 that are oppositely disposed, and both the first end 311 and the second end 312 are fixed to the end surface of the push rod 320. Figure 2 and Figure 3When the diameter of the tightening hole 313 is at its maximum, the first end 311 and the second end 312 of the collar 310 are both outside the second sliding hole 121, that is, the entire tightening ring 310 is outside the second sliding hole 121. When the diameter of the tightening hole 313 is smaller than the maximum diameter, the first end 311 and the second end 312 are both inside the second sliding hole 121, that is, a portion of the collar 310 is inside the second sliding hole 121, and the other portion of the collar 310 is exposed outside the second sliding hole 121. When the push rod 320 slides and drives the collar 310 to gradually retract into or extend out of the second sliding hole 121, the sliding stroke of the push rod 320 will be equal to half of the total length of the collar 310 retracted into or extended out of the second sliding hole 121. Figure 8 In other embodiments, the first end 311 of the collar 310 is fixed to the push rod 320, and the second end 312 of the collar 310 is sleeved onto the first end 311. Obviously, when the diameter of the clamping hole 313 is at its maximum, both the first end 311 and the second end 312 of the collar 310 are located outside the second sliding hole 121, that is, the entire collar 310 is located outside the second sliding hole 121. When the diameter of the clamping hole 313 is smaller than the maximum diameter, the first end 311 is located inside the second sliding hole 121, while the second end 312 remains outside the second sliding hole 121. Similarly, a portion of the collar 310 is located inside the second sliding hole 121, while another portion is exposed outside the second sliding hole 121. When the push rod 320 slides and drives the collar 310 to gradually retract or extend into the second sliding hole 121, the sliding stroke of the push rod 320 is equal to the total length of the collar 310 retracted or extended into the second sliding hole 121.

[0043] See Figures 1 to 3 The minimum diameter D of the tightening hole 313 cannot be too small to prevent the coated bracket 30 with a larger diameter in the natural state from being unable to pass through the tightening hole 313; of course, the minimum diameter D of the tightening hole 313 cannot be too large, which makes the circumference of the ring too large and prevents the length of the ring 310 retracted into the second sliding hole 121 from being too large, so as to reduce the diameter of the tightening hole 313 to adapt to the diameter of the coated bracket 30, and further avoid excessive sliding stroke of the push rod 320.

[0044] After loading one stent coil, to facilitate the push rod's rapid ejection of the collar from the second slide hole, the collar is preferably self-expanding. That is, after being ejected from the second slide hole (i.e., in a natural, unconstrained state), the collar can self-expand into an annular ring, thereby enabling rapid loading of the next collar. It should be noted that when the collar is self-expanding, its self-expanding force F1 must be overcome when pulling the collar into the second slide hole. Furthermore, when the collar compresses the stent graft, the stent coil also exhibits a radial expansion force F2 (i.e., radial expansion force) that resists compression. To save effort during loading (i.e., primarily overcoming the stent graft's radial expansion force F2 rather than the collar's self-expanding force F1 during loading), the sleeve's self-expanding force F1 should be less than the stent graft's radial expansion force F2. For example, this can be achieved by setting the diameter of the loop wire smaller than the diameter of the stent graft wire, or by setting the wire diameter of the stent to be equal to the wire diameter of the loop. The stent coil includes a W-shaped structure, and the loop may also include a W-shaped structure, but the amplitude of the W-shaped structure on the loop is smaller than the amplitude of the W-shaped structure on the stent. In this case, the self-expansion force F1 of the loop will still be smaller than the expansion force of the stent. At the same time, because the loop is repeatedly pulled in and out of the second sliding hole, the loop surface is susceptible to wear by the inner wall of the distal opening of the second sliding hole. Therefore, a smooth coating can be plated on the loop surface. The coating can be made of a material with a certain hardness and a low friction coefficient or lubricity, such as a titanium alloy. Alternatively, the inner wall of the distal opening of the second sliding hole can be configured to have a smooth transition arc or trumpet shape (i.e., the inner diameter of the distal end of the second sliding hole). The arc or trumpet shape can not only reduce the degree of damage to the loop surface, but also reduce the effort when pushing and pulling the loop.

[0045] The self-expansion force of the ring or the expansion force of the corrugated ring can be Figure 19 The tooling 50 shown is used in conjunction with the tensile testing machine. The tooling 50 includes a first mold 51 and a second mold 52. Figure 20 As shown, the first mold 51 is roughly T-shaped, including a pressure piece 511 and a first connecting piece 512. The lower end of the first connecting piece 512 is connected to the upper end surface of the pressure piece 511; a first through hole 513 is provided on the end of the first connecting piece 512 away from the pressure piece 511. The first through hole 513 passes through the surface of the first connecting piece in a direction perpendicular to the length extension direction of the first connecting piece 512, and the first connecting piece 512 can be bolted to the tensile machine through the first through hole 513, thereby driving the pressure piece 511 to move up and down under the action of the tensile machine. Figure 20 and Figure 22 The pressure piece 511 is sheet-shaped and has a certain thickness T1. To ensure that the pressure piece 511 can exert force on the collar during testing, the thickness T1 of the pressure piece 511 is preferably greater than the thickness d of the collar.

[0046] like Figure 21As shown, the second mold 52 includes a receiving member 521 and a second connecting member 522. The upper end of the second connecting member 522 is connected to the lower end surface of the receiving member 521. The receiving member 521 has a receiving space that can accommodate the pressure member 511 of the first mold. Specifically, an opening 525 is formed on the upper end surface of the receiving member 521, and the length L2 of the opening 525 is not less than the length L1 of the pressure member 511. A side opening 524 is also formed on the side of the receiving member 521 to facilitate the placement or removal of the object to be tested. In order to facilitate the observation of the degree of compression of the object to be tested during the test, a window 526 is also provided on the receiving member for the tester to observe. A second through hole 523 is provided on the end of the second connecting member 522 away from the receiving member 521. The second through hole 523 is similar to the first through hole 513 and will not be repeated here. It is understandable that in other embodiments, the first mold and the second mold can also be connected to the tensile testing machine by other methods other than bolting (such as screwing), as long as the test can be successfully carried out.

[0047] To ensure that the receiving piece does not affect the deformation of the object being tested during the test, the length L2 of the receiving piece should be greater than the maximum length of the object being tested during deformation. For example, when testing a ring, L2 should be greater than half the circumference of the ring. Alternatively, a side opening can be provided on the side of the receiving piece opposite to the side opening 524, so that the deformation of the object being tested is not blocked. Figure 22 To ensure that the pressure member can smoothly enter and exit the receiving space of the receiving member 521, the width T2 of the opening 525 in the receiving member 521 is greater than the thickness T1 of the pressure member. Furthermore, to prevent the object being tested from squeezing into the gap between the pressure member 511 and the receiving member 521, the difference between the width T2 of the opening 525 and the thickness T1 of the pressure member should be less than the thickness of the object being tested. For example, when testing a collar, the width T2 of the opening 525 should be less than the collar's thickness, preferably less than half the collar's thickness.

[0048] It is understood that in other embodiments, the pressure member may also be in the form of a flat plate, that is, the thickness T1 of the pressure member is much greater than the thickness of the collar. In this case, the pressure member is substantially a flat plate perpendicular to the first connecting member. In this case, the receiving member of the second mold can be modified accordingly.

[0049] like Figure 23 As shown, after the first mold 51 and the second mold 52 are connected to a tensile testing machine (not shown), the restraint assembly 300 is placed into the receiving space of the receiving member 521 through the side opening 524 of the second mold. The tensile testing machine is operated to apply downward pressure, causing the first mold 51 to move downward and compress the restraint assembly 300 until the restraint assembly 300 is folded in half (i.e., similar to the state in which the ring is completely received in the second slide hole). The downward movement of the first mold 51 is stopped. The reading on the tensile testing machine sensor at this time is the self-expansion force of the ring. It is understood that the ring can also be tested multiple times and the self-expansion force of the ring can be measured by averaging.

[0050] It is understandable that a tensile testing machine can also be used to directly test the self-expansion force of the ring when the ring is unloaded (i.e., there is no object in the ring), such as by directly connecting the tensile testing machine to the drive mechanism 400 of the bracket assembly device, and then pulling the ring toward the proximal end into the second sliding hole. The maximum self-expansion force of the tensile testing machine ring in this process is measured.

[0051] The collar can be made of a material with a certain degree of rigidity and self-expansion, such as multiple strands of nickel-titanium wire, or it can consist of only a single nickel-titanium wire. The sleeve has good toughness and is not susceptible to plastic deformation. During use, the distal ends of the collar and sleeve's flat sections will wear. To achieve cost savings and ease of operation, the distal end of the flat section should have a higher hardness than the collar. In other words, the wear resistance of the distal end of the flat section should be higher than that of the collar. Thus, if the collar is damaged, it can be quickly and easily replaced without having to replace the entire device.

[0052] See also Figures 2 to 6 In some embodiments, the telescopic assembly 200 includes a slide rod 210 and a stopper pin 220. The slide rod 210 may be cylindrical and slideably engage with the first slide hole 111. The slide rod 210 has a fixing hole 212 extending radially along the slide rod 210. One end of the stopper pin 220 engages with the fixing hole 212, thereby connecting the stopper pin 220 to the slide rod 210. The other end of the stopper pin 220 is inserted into the slide groove 112. As the slide rod 210 slides in the first slide hole 111, it can drive the stopper pin 220 to slide in the slide groove 112. When the stopper 220 abuts the leftmost sidewall of the slide groove 112, the slide bar 210 stops sliding leftward; when the stopper 220 abuts the rightmost sidewall of the slide groove 112, the slide bar 210 stops sliding rightward. That is, the stopper 220 abuts the sidewall of the slide groove 112 to limit the maximum sliding travel of the slide bar 210 in the first slide hole 111. This maximum travel is approximately equal to the length of the slide groove 112 along the axial direction of the slide bar 210. The stopper 220 may be a screw, etc.

[0053] The slide bar 210 also has a mounting hole 211 extending through the distal end surface of the slide bar 210 and extending axially therefrom. The mounting hole 211 can communicate with the fixing hole 212. A push rod 320 is inserted into the mounting hole 211. When the stop bolt 220 is located in the fixing hole 212, the stop bolt 220 applies a pressing force to the push rod 320, causing the push rod 320 to press between the slide bar 210 and the stop bolt 220, thereby achieving a fixed connection between the push rod 320 and the slide bar 210.

[0054] See Figure 2 and Figure 3The driving mechanism 400 is connected to the slide rod 210 and is used to drive the slide rod 210 to slide back and forth in the first slide hole 111. When the slide rod 210 slides back and forth in the first slide hole 111, the slide rod 210 drives the push rod 320 to slide back and forth in the second slide hole 121, and then the push rod 320 drives the collar 310 to retract or extend from the second slide hole 121, ultimately reducing or increasing the diameter of the clamping hole 313. Figure 4 As shown, the length of the second sliding hole 121 is denoted as H, the maximum sliding stroke of the sliding rod 210 in the first sliding hole 111 is denoted as h, and the total length of the collar 310 is denoted as L (i.e., the circumference of the collar). Of course, the maximum sliding stroke of the sliding rod 210 is equal to the maximum sliding stroke of the push rod 320. In order to reduce the diameter of the clamping hole 313 to a state equal to the minimum diameter of the stent graft 30, the sliding rod 210 and the push rod 320 must have sufficient sliding stroke to sufficiently reduce the length of the collar 310 exposed outside the second slider. At the same time, considering the certain flexibility of the collar 310, to prevent the collar 310 retracted into the second sliding hole 121 from further retracting into the first sliding hole 111, thereby making it difficult for the collar 310 that has entered the first sliding hole 111 to return to the second sliding hole 121, H, h, and L must satisfy the following relationship: H>h>L / 2. In short, when the sliding rod 210 slides to the limit stroke h, the ring 310 will only retract into the second sliding hole 121 and will not enter the first sliding hole 111, and the ring 310 is retracted into the second sliding hole 121 with sufficient length so that the minimum diameter of the tightening hole 313 can be adapted to the minimum tube diameter of the coated bracket 30.

[0055] See Figure 2 and Figure 3 In some embodiments, the drive mechanism 400 is a handle 410 connected to the end of the slide bar 210. By directly applying force to the handle 410, the slide bar 210 and the push rod 320 can be caused to slide back and forth, thereby reducing or increasing the diameter of the clamping hole 313. When the stent graft assembly device 10 including the handle 410 is used to install the stent graft 30 into the sheath tube 21, the operation process is as follows:

[0056] First, see Figure 9, apply a thrust to the handle 410 so that the slide rod 210 and the push rod 320 drive the collar 310 to be completely located outside the second slide hole 121. At this time, the length of the collar 310 is the largest, and the diameter of the tightening hole 313 formed by it is the largest. Insert the stent graft 30 in its natural state into the tightening hole 313. One tightening hole 313 can only cooperate with one wave ring 31 at a time. At this time, the wave ring 31 of the stent graft 30 closest to the sheath 21 cooperates with the tightening hole 313. For the convenience of description below, the wave ring 31 of the stent graft 30 closest to the sheath 21 is recorded as the first wave ring 31a. At the same time, the distal end of the flat section 120 is against the surface of the coating outside the first wave ring 31a, and the width extension direction of the flat section is perpendicular to the length extension direction of the stent graft.

[0057] Second, see Figure 10 and Figure 11 , one operator holds the coated stent 30 with both hands on both sides of the ring 310, and the other operator holds the sleeve 100 with one hand and applies tension to the handle 410 with the other hand, so that the ring 310 gradually retracts into the second sliding hole 121, thereby gradually reducing the size of the tightening hole 313, and then gradually reducing the diameter of the first wave ring 31a to the value of the compressed state to adapt to the lumen 21a of the sheath tube 21, and then the first wave ring 31a in the compressed state is installed into the lumen 21a of the sheath tube 21.

[0058] Since the tightening hole 313 is circular and matches the shape of the first wave ring 31a, the ring 310 can apply the same radial compression force to all circumferential parts of the first wave ring 31a, and all circumferential parts of the first wave ring 31a can shrink in the same proportion to reduce the tube diameter, thereby making the cross-sections of the first wave ring 31a at different times during the compression process geometrically similar, ensuring that the cross-section of the first wave ring 31a is always circular rather than elliptical or other irregular shapes, that is, the cross-sectional shape of the first wave ring 31a is consistent with the cross-sectional shape of the lumen 21a of the sheath tube 21, thereby improving the assembly consistency of the first wave ring 31a and avoiding the first wave ring 31a from being unable to be installed in the sheath tube 21 or even being damaged due to uneven shrinkage. At the same time, in the process of the ring 310 compressing the first wave coil 31a, the end of the flat section 120 is always in contact with the first wave coil 31a. Since the cross-sectional width A of the flat section 120 is greater than 1 / 3 of the length a of the first wave coil 31a and less than 1 / 2 of the length a of the first wave coil 31a, when the flat section 120 is in contact with the first wave coil 31a, the flat section 120 does not cover the entire first wave coil 31a in the axial direction of the coated bracket 30, so that a certain length of the end of the coated bracket 30 close to the sheath tube 21 is left for the operator to hold; and, in the process of the first wave coil 31a being installed into the sheath tube 21, the flat section 120 will not interfere with the sheath tube 21 to hinder the installation of the first wave coil 31a; at the same time, the end face of the flat section 120 in contact with the first wave coil 31a has a reasonable area, thereby effectively preventing the flat section 120 from generating a large pressure on the first wave coil 31a, thereby avoiding damage to the first wave coil 31a. It is understandable that, in other embodiments, the distal end surface of the flat section may also be configured as an arc structure that is recessed toward the proximal end, so that the flat section is more adaptable to the outer surface of the stent.

[0059] Third, after the first corrugated ring 31a is installed in the sheath tube 21, a thrust is applied to the handle 410, so that the slide rod 210 and the push rod 320 drive the collar 310 to be completely located outside the second slide hole 121. The same method for installing the first corrugated ring 31a is then used to compress the other corrugated rings 31 one by one and install them into the sheath tube 21, ultimately completing the assembly of the entire stent graft 30 and the sheath tube 21.

[0060] For the traditional assembly method using a restraining band, since multiple coils 31 are compressed at a time, it is difficult to coordinate the compression force, resulting in inconsistent compression degrees of each coil 31, and it is also difficult to achieve the same proportional contraction at all circumferential locations of the same coil 31, resulting in the compressed coils 31 being unable to be simultaneously loaded into the sheath 21, and even causing damage to the stent graft 30. In addition, during the assembly process, high operating skills are required to coordinate the compression force well, and it is also necessary to go through repeated debugging to achieve successful assembly, resulting in high labor intensity and low work efficiency. For the stent graft assembly device 10 of the above embodiment, only one coil 31 is compressed at a time, and all circumferential locations of the coil 31 can be contracted at the same proportion, so that the coil 31 can be quickly loaded into the sheath 21, which can achieve the purpose of reducing labor intensity and improving work efficiency.

[0061] See Figures 12 to 14 In some embodiments, the driving mechanism 400 includes an assembly platform 420, a support frame 430, and a driver 440. The support frame 430 includes a support leg 433 and a first mounting plate 431 and a second mounting plate 432 connected to the support leg 433. The upper end of the support leg 433 is fixedly connected to the assembly platform 420, and the lower end of the support leg 433 can be placed on a support object such as the ground. The first mounting plate 431 is located above the second mounting plate, that is, the first mounting plate 431 is closer to the assembly platform 420 than the second mounting plate 432. The column section 110 of the sleeve 100 is inserted into the assembly platform 420. The column section 110 can be fixed to the support platform by bolt connection or other means. At this time, the flat section 120 and the collar 310 are located on the upper side of the assembly platform 420, and the other parts of the column section 110 are located on the lower side of the support platform. Bearings 434 are installed on both the first mounting plate 431 and the second mounting plate 432. The slide rod 210 is inserted into the bearings 434. By providing the bearings 434, the sliding resistance of the slide rod 210 can be reduced and the accuracy of the sliding trajectory can be improved. The driver 440 includes a pedal 441, a first elastic member 443 and a mounting cylinder 442. The pedal 441 is fixed to the portion of the slide rod 210 located between the first mounting plate 431 and the second mounting plate 432. The mounting cylinder 442 is fixed below the second mounting plate 432. The first elastic member 443 is accommodated in the cavity of the mounting cylinder 442. The lower end of the slide rod 210 abuts against the first elastic member 443. When the stent graft assembly device 10 including the pedal 441 is used to install the stent graft 30 into the sheath tube 21, compared with the stent graft assembly device 10 including the handle 410, the difference in its operation process is that:

[0062] Only one operator is required. When the operator holds the wave ring 31 on the assembly platform 420 and inserts it into the clamping hole 313 (as shown in FIG. Figure 15), and then use the foot to apply a pedal force to the pedal member 441, the slide rod 210 moves downward and squeezes the first elastic member 443, the first elastic member 443 stores energy, and at the same time the slide rod 210 causes the ring 310 to compress the wave ring 31 (such as Figure 16 ) until the corrugated coil 31 is installed in the sheath tube 21. When one of the corrugated coils 31 is assembled, the pedal force applied to the pedal member 441 is released. At this time, the first elastic member 443 releases energy, and the slide bar 210 and the push rod 320 automatically slide to allow the collar 310 to extend completely out of the second slide hole 121, that is, the collar can automatically return to its original position so as to compress the other corrugated coils 31 one by one in sequence. This operation can reduce one operator and reduce the labor cost of operating the stent graft assembly device 10. For other similarities, please refer to the operation process of the stent graft assembly device 10 including the handle 410.

[0063] See Figures 17 and 18 In some embodiments, the driving mechanism 400 includes an assembly platform 420, a support frame 430, and a driver 440. The support frame 430 includes a support leg 433 and a first mounting plate 431 connected to the support leg 433. The upper end of the support leg 433 is fixedly connected to the assembly platform 420, and the lower end of the support leg 433 can be placed on a support object such as the ground. The column section 110 of the sleeve 100 is inserted into the assembly platform 420. The column section 110 can be fixed to the assembly platform 420 by bolt connection or other means. At this time, the flat section 120 and the collar 310 are located on the upper side of the assembly platform 420, and the other parts of the column section 110 are located on the lower side of the assembly platform 420. The actuator 440 includes a cylinder 444, a second elastic member 446, and a control valve 445. The cylinder 444 is fixed to the first mounting plate 431 and electrically connected to the control valve 445. The piston 444a of the cylinder 444 is connected to the slide rod 210. The second elastic member 446 is located in the cylinder barrel of the cylinder 444 and abuts against the slide rod 210. Compared with the above-mentioned stent graft assembly device 10 including the pedal member 441, the operation process of the actuator 440 is different in that:

[0064] Similarly, only one operator is required. After the operator holds the corrugated ring 31 on the assembly table 420 and inserts it into the tightening hole 313, he or she can use his or her foot to apply a pressing force to the control valve 445. The control valve 445 will cause the piston 444a of the cylinder 444 to drive the slide rod 210 to move downward and squeeze the second elastic member 446. The second elastic member 446 stores energy, and at the same time, the slide rod 210 causes the collar 310 to compress the corrugated ring 31 until the corrugated ring 31 is installed in the sheath 21. When one corrugated ring 31 is assembled, the second elastic member 446 releases energy, and the slide rod 210 and the push rod 320 automatically slide to allow the collar 310 to extend completely out of the second slide hole 121, so that the other corrugated rings 31 can be compressed one by one. This operation can also reduce one operator, reducing the labor cost of operating the coated stent assembly device 10, and the drive of the slide rod 210 is powered by the cylinder 444, which further reduces the labor intensity. For other similarities, please refer to the above-mentioned operation process of the coated stent assembly device 10 including the handle 410.

[0065] See Figures 9 to 11 The present invention also provides a delivery system 20, which includes a sheath 21, a delivery push rod 22, a fixing anchor 23, a pointed head 24, an auxiliary push rod 25 and the above-mentioned stent graft assembly device 10. During assembly, the bare wave coil 31b of the stent graft 30 is first hung on the fixing anchor 23, and then the first wave coil 31a closest to the sheath 21 is compressed by the stent graft assembly device 10 to be installed in the sheath 21. Then, in a direction gradually away from the sheath 21 (i.e., in a direction gradually approaching the fixing anchor 23), the wave coils 31 on the stent graft 30 are compressed one by one in sequence to be installed in the sheath 21. Finally, the stent graft assembly device 10 is withdrawn, so that the sheath 21 implants the stent graft 30 into the body.

[0066] The present invention also provides an assembly method, wherein the assembly method utilizes any of the above-described stent graft assembly devices to install a stent graft 30 into a sheath tube 21. The assembly method first compresses the first corrugation 31a closest to the sheath tube 21 to install it into the sheath tube 21. Subsequently, the corrugations 31 on the stent graft 30 are sequentially compressed individually in a direction gradually moving away from the sheath tube 21 to install them into the sheath tube 21. The operation of compressing individual corrugations 31 to install them into the sheath tube 21 primarily includes the following steps:

[0067] In the first step, a collar 310 is provided which is surrounded by a clamping hole 313 .

[0068] In the second step, the corrugated ring 31 is inserted into the clamping hole 313 .

[0069] In the third step, the cross-sectional size (diameter) of the tightening hole 313 is gradually reduced to compress the corrugated ring 31 , and the compressed corrugated ring 31 is installed into the sheath tube 21 .

[0070] The fourth step is to restore the cross-sectional size (diameter) of the clamping hole 313 to the maximum.

[0071] For specific operational details of each step, please refer to the operating procedures of the various stent graft assembly devices 10 described above.

[0072] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0073] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A stent graft assembly device for assembling a stent graft, wherein the stent graft comprises a compressible or expandable corrugated coil, characterized in that: The stent graft assembly device includes a collar and a push rod, wherein the collar is made of a self-expandable material, and the self-expanding force of the collar is smaller than the radial expansion force of the stent graft; The stent graft assembly device further includes a sleeve, the sleeve including a flat section, the cross section of the flat section is substantially rectangular, and the width of the rectangle is smaller than the amplitude of the wave coil; The flat section has a second sliding hole, the collar can be received in the second sliding hole, the push rod is in sliding cooperation with the second sliding hole, and the push rod can drive the collar to retract into or extend out of the second sliding hole during the sliding process in the second sliding hole.

2. The stent graft assembly device according to claim 1, characterized in that: The diameter of the wire constituting the collar is not greater than the diameter of the wire of the wave ring.

3. The stent graft assembly device according to claim 2, characterized in that: The collar includes a W-shaped structure, and the amplitude of the W-shaped structure on the collar is smaller than the amplitude of the wave ring.

4. The stent graft assembly device according to claim 1, characterized in that: The collar is plated with a smooth coating.

5. The stent graft assembly device according to claim 4, characterized in that: The coating is made of titanium alloy material.

6. The stent graft assembly device according to claim 1, characterized in that: The inner wall of the distal opening of the second sliding hole is arc-shaped or trumpet-shaped.

7. The stent graft assembly device according to claim 6, characterized in that: The wear resistance of the distal end portion of the sleeve is higher than that of the collar.

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