CN114404104B

CN114404104B - Tectorial membrane support assembly quality

Info

Publication number: CN114404104B
Application number: CN202011171619.0A
Authority: CN
Inventors: 唐江峰; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-10-28
Filing date: 2020-10-28
Publication date: 2025-08-12
Anticipated expiration: 2040-10-28
Also published as: CN114404104A

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

Tectorial membrane support assembly quality

Technical Field

The invention relates to the field of medical equipment, in particular to a tectorial membrane bracket assembly device.

Background

In the interventional medical field, aiming at vascular diseases such as aneurysms, arterial interlayers and the like, a conveying system is generally adopted to implant a covered stent to a lesion position in a corresponding blood vessel, so that the covered stent is released from the conveying system and automatically expands to be attached to the inner wall of the blood vessel, and the treatment effect is achieved. Prior to implantation of the stent graft into the body, the stent graft needs to be compressed to fit into the sheath of the delivery system for delivery to the lesion site by interventional means. When the covered stent is compressed, two persons are generally required to cooperate in the traditional operation mode, and radial compression force is applied to the covered stent by adopting a ribbon method, but the covered stent is difficult to compress to a compression size which is easy to assemble with a sheath tube by the method, the covered stent is damaged or scrapped due to accommodating, meanwhile, the labor intensity of operators is increased, and the working efficiency of compressing the covered stent is affected.

Disclosure of Invention

The invention solves the technical problem of improving the compression effect and the working efficiency of the assembly device on the tectorial membrane bracket.

The invention provides a stent graft assembly device which is used for assembling a stent graft, wherein the stent graft comprises a compressible or expandable wave ring, the stent graft assembly device comprises a lantern ring, the lantern ring is made of a self-expandable material, and the self-expansion force of the lantern ring is smaller than the radial expansion force of the stent graft.

In one embodiment, the wire diameter of the collar is no greater than the wire diameter of the wave ring.

In an embodiment, the collar comprises a W-shaped structure, the amplitude of the W-shaped structure on the collar being smaller than the amplitude of the wave band.

In one embodiment, the collar is coated with a lubricious coating.

In one embodiment, the coating is a titanium alloy material.

In an embodiment, the stent graft assembly device further includes a sleeve, the sleeve has a second sliding hole, the collar may be received in the second sliding hole, and an inner wall of a distal opening of the second sliding hole is arc-shaped or trumpet-shaped.

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

In an embodiment, the stent graft assembly device further comprises a sleeve having a second sliding aperture into which the collar is receivable, the sleeve comprising a flattened section having a generally rectangular cross-section with a width less than the amplitude of the wave band.

In one embodiment, the sleeve comprises a flattened section having a generally rectangular cross-section, the rectangle having a width less than the amplitude of the wave band.

One technical effect of one embodiment of the present invention is that the length of the collar exposed outside the barrel is reduced when the stent graft is mated with the cinching hole, thereby reducing the size of the cinching hole to compress the stent graft. In the compression process of the covered stent, the shape of the tightening hole is always matched with the shape of the covered stent, and the lantern ring can apply radial compression force with the same size to all parts of the circumference of the covered stent, so that all parts of the circumference of the covered stent can be contracted with the same proportion to reduce the pipe diameter, then the cross sections of the covered stent at different moments in the compression process are geometrically similar figures, the assembly consistency of the covered stent is improved, the completely compressed covered stent can be ensured to be smoothly installed in a sheath tube by eliminating interference, and the covered stent is prevented from being damaged in the compression process. Meanwhile, the compression force of the tectorial membrane bracket is not required to be repeatedly adjusted, and the working efficiency is improved.

Drawings

FIG. 1 is a schematic front view of a stent graft according to an embodiment;

fig. 2 is a schematic perspective view of the assembly device according to the first embodiment;

FIG. 3 is a schematic cross-sectional view of the mounting device of FIG. 2;

FIG. 4 is a schematic cross-sectional view of a sleeve of the fitting apparatus of FIG. 2;

FIG. 5 is a schematic cross-sectional view of the slide bar of the assembly device of FIG. 2;

FIG. 6 is a schematic cross-sectional view of the slide bar and the restraint assembly of the assembly device of FIG. 2;

FIG. 7 is a schematic plan view of a restraint assembly of the first example of the assembly device of FIG. 2;

FIG. 8 is a schematic plan view of a second example restraint assembly of the assembly device of FIG. 2;

FIG. 9 is a schematic view of a collar of the assembly device shown in FIG. 2 sleeved with a first wave ring in a natural state;

FIG. 10 is a schematic view of the collar-to-stent graft of FIG. 9 after compressing the first band to a compressed state;

FIG. 11 is a schematic view of the primary collar of FIG. 9 after being sheathed;

fig. 12 is a schematic perspective view of a mounting device according to a second embodiment;

FIG. 13 is a schematic cross-sectional view of the mounting device of FIG. 12;

FIG. 14 is an enlarged schematic view of the structure of FIG. 13 at E;

FIG. 15 is a partial top view of the assembly device of FIG. 12 mated with a first wave ring in its natural state;

FIG. 16 is a partial top view of the assembly device of FIG. 12 after compressing the first wave ring to a compressed state;

Fig. 17 is a schematic perspective view of a fitting device according to a third embodiment;

FIG. 18 is a schematic cross-sectional view of the mounting device of FIG. 17;

FIG. 19 is a schematic view of a tooling structure for testing the self-expanding force of the collar of the present invention;

Fig. 20 to 22 are schematic structural views of the tooling part shown in fig. 19;

FIG. 23 is a schematic diagram of the collar self-expanding force of the present invention tested using the tooling shown in FIG. 19.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment.

In the field of medical devices, the end closer 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 a certain part or surface is described as "substantially" shaped, it is described in terms of a person skilled in the art that, for example, when a certain section is described as substantially circular, the section may be perfectly circular or slightly deviated from the perfectly circular, or when a certain section is described as substantially rectangular, the section may be regular rectangular or rectangular with chamfers.

Referring to fig. 1 and 3, an stent graft assembly device 10 according to an embodiment of the present invention is used to load a stent graft 30 into a lumen 21a of a sheath 21 (see fig. 9). Specifically, the stent graft 30 has a cylindrical tubular structure, and the stent graft 30 is compressed from a natural state with a maximum pipe diameter to a compressed state with a minimum pipe diameter by using the stent graft assembling device 10 under the condition of overcoming the self elasticity of the stent graft 30, so that the pipe diameter of the stent graft 30 in the compressed state is suitable for the size of the lumen 21a of the sheath 21, and the stent graft 30 in the compressed state is installed in the lumen 21a of the sheath 21. When the sheath 21 enters the body, the covered stent 30 is released from the lumen 21a of the sheath 21, and the released covered stent 30 automatically expands from the compressed state until being closely attached to the inner wall of the blood vessel, thereby finally realizing the implantation of the covered stent 30 in the body. The stent graft assembly device 10 includes a sleeve 100, a telescoping assembly 200, a restraint assembly 300, and a drive mechanism 400.

Referring to fig. 1-4, in some embodiments, the sleeve 100 includes a post segment 110 and a flat segment 120, the post segment 110 being generally circular in cross-section and the flat segment 120 being generally rectangular in cross-section. The flattened section 120 is connected to the distal end of the post section 110, and the distal end face of the flattened section 120 is capable of abutting against the surface of the stent graft 30 during compression of the stent graft 30. The cross section of the flat section 120 is approximately rectangular, in this embodiment, the length of the rectangle is equal to the diameter of the column section 110, the width of the rectangle is denoted as a, the width a is smaller than the diameter of the column section 110, for the wave ring 31 on the film covered support 30, the distance from the trough point to the crest point of the wave ring 31 along the axial direction of the film covered support 30 is defined as the height (i.e. amplitude) of the wave ring 31, the height of the wave ring 31 is denoted as a, wherein the value range of a is a/3< a/2, so that the flat section cannot block the wave ring from entering the sheath after compression. It will be appreciated that in other embodiments, the length of the cross section of the flattened section may be unequal to the diameter of the post section, and may be greater or less than the diameter of the post section, preferably as long as the diameter of the unloaded stent graft, in order to avoid stent failure.

Referring to fig. 4, the end of the post segment 110 remote from the flat segment 120 is the proximal end 101, and the end of the flat segment 120 remote from the post segment 110 is the distal end 102. The sleeve 100 is provided with a first slide hole 111 and a second slide hole 121. The first slide hole 111 extends in the axial direction of the entire sleeve 100 and penetrates the proximal end face of the post segment 110, the first slide hole 111 is located in the post segment 110 entirely, and the second slide hole 121 communicates with the distal bottom wall of the first slide hole 111 and penetrates the distal end face 102. The second slide hole 121 is disposed coaxially with the first slide hole 111, a portion of the second slide hole 121 is located in the column section 110, and another portion of the second slide hole 121 is located in the flat section 120. The first sliding hole 111 and the second sliding hole 121 may be circular holes, and the diameter of the first sliding hole 111 is larger than that of the second sliding hole 121, and in fact, the first sliding hole 111 and the second sliding hole 121 may be regarded as one stepped hole extending axially along the sleeve 100 and penetrating through the proximal end face 101 and the distal end face 102 at the same time, and obviously, the stepped hole is a through hole. A sliding groove 112 is formed in the side circumferential surface of the column section 110, and the sliding groove 112 also extends in the axial direction of the sleeve 100, and the sliding groove 112 communicates with the first sliding hole 111.

Referring to fig. 2,3, 7 and 8, in some embodiments, the restraint assembly 300 includes a collar 310 and a push rod 320, the collar 310 being formed of a plurality of nickel titanium wires intertwined to form a rope-like structure having a certain flexibility. The ejector rod 320 is made of a relatively hard metal or nonmetal material, so that the rigidity of the ejector rod 320 is greater than that of the sleeve ring 310, the ejector rod 320 is in sliding fit with the second sliding hole 121, and the sleeve ring 310 can be driven to retract into or extend out of the second sliding hole 121 in the sliding process of the ejector rod 320 in the second sliding hole 121. When the collar 310 is fixed to the ejector pin 320, the collar 310 may define a circular tightening hole 313, and the compressed stent graft 30 is inserted into the tightening hole 313. When the collar 310 is located outside the second sliding hole 121, the cross-sectional dimension (diameter) of the tightening hole 313 surrounded by the collar 310 is the largest, the smallest diameter of the tightening hole 313 when the collar is expanded is denoted as D, the pipe diameter of the stent graft 30 in the natural state is the largest, and the largest pipe diameter is denoted as D, so that the minimum diameter of the tightening hole 313 is larger than the largest pipe diameter D (fig. 1) of the stent graft 30 in order to smoothly pass the stent graft 30 in the natural state through the tightening hole 313 for subsequent compression, wherein d=1.1d to 1.2d. When a portion of the collar 310 is retracted into the second slide hole 121, the length of the collar 310 exposed to the outside of the second slide hole 121 is reduced, and the diameter of the tightening hole 313 formed around the collar 310 is reduced, so that the collar 310 can apply a radial compressive force to the stent graft 30, and thus the diameter of the stent graft 30 is reduced to be equal to the diameter of the tightening hole 313. Therefore, when the collar 310 is gradually contracted into the second slide hole 121, the diameter of the tightening hole 313 is gradually reduced, and the pipe diameter of the stent graft 30 is then reduced, thereby achieving compression of the stent graft 30. Conversely, as the collar 310 gradually protrudes into the second slide hole 121, the diameter of the tightening hole 313 gradually increases.

Referring to fig. 7, for example, the collar 310 has a first end 311 and a second end 312 disposed opposite each other, and both the first end 311 and the second end 312 are fixed to an end surface of the push rod 320. Referring to fig. 2 and 3, when the diameter of the tightening hole 313 is maximized, both the first end 311 and the second end 312 of the collar 310 are located outside the second slide hole 121, i.e., the tightening ring 310 is located entirely outside the second slide hole 121. When the diameter of the cinching hole 313 is less than the maximum diameter, both the first end 311 and the second end 312 are positioned within the second slide hole 121, i.e., a portion of the collar 310 is positioned within the second slide hole 121 and another portion of the collar 310 is exposed outside the second slide 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 that is retracted into or extends out of the second sliding hole 121. Referring to fig. 8, in other embodiments, the first end 311 of the collar 310 is fixed on the ejector pin 320, and the second end 312 of the collar 310 is sleeved on the first end 311, and it is obvious that when the diameter of the tightening hole 313 is the largest, both the first end 311 and the second end 312 of the collar 310 are located outside the second sliding hole 121, i.e. the collar 310 is located outside the second sliding hole 121. When the diameter of the cinching hole 313 is less than the maximum diameter, the first end 311 will be located within the second slide hole 121 and the second end 312 will always be located outside the second slide hole 121, as will a portion of the collar 310 located within the second slide hole 121 and another portion of the collar 310 exposed outside the second slide hole 121. When the pushing 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 pushing rod 320 will be equal to the total length of the collar 310 that is retracted into or extends out of the second sliding hole 121.

Referring to fig. 1 to 3, the minimum diameter D of the tightening hole 313 cannot be too small to prevent the film covered stent 30 having a larger diameter from being able to be inserted into the tightening hole 313 in a natural state, and of course, the minimum diameter D of the tightening hole 313 cannot be too large to make the circumference of the collar too large to prevent the length of the collar 310 retracted into the second sliding hole 121 from being too large to reduce the diameter of the tightening hole 313 to be suitable for the diameter of the film covered stent 30, thereby further avoiding the excessive sliding stroke of the push rod 320.

After the loading of one bracket wave ring is completed, in order to facilitate the push rod to rapidly push the lantern ring out of the second sliding hole, the lantern ring can be self-expanded preferably, namely, the lantern ring can be self-expanded into an annular ring after being pushed out of the second sliding hole (namely, the lantern ring is in an unconstrained natural state), so that the loading of the next wave ring can be rapidly carried out. It should be noted that when the collar has self-expanding properties, the self-expanding force F1 of the collar needs to be overcome when the collar is pulled into the second slide hole, and when the collar compresses the stent graft, the collar of the stent also has an expansion force F2 (i.e., radial expansion force) that resists compression radially, and for the purpose of saving labor when loading (i.e., mainly overcoming the radial expansion force F2 of the stent graft rather than the self-expanding force F1 of the collar when loading), the self-expanding force F1 of the collar should be smaller than the radial expansion force F2 of the stent graft. For example, the wire diameter of the collar is smaller than that of the stent graft, or the wire diameter of the stent graft is equal to that of the wire diameter of the collar, the wave ring of the stent graft comprises a W-shaped structure, the collar can also comprise a W-shaped structure, the amplitude of the W-shaped structure on the collar is smaller than that of the W-shaped structure on the stent graft, and then the self-expansion force F1 of the collar is still smaller than that of the stent graft. Meanwhile, as the collar is repeatedly pulled into and pushed out of the second sliding hole, the surface of the collar is easy to be worn by the inner wall of the distal opening of the second sliding hole, so that a smooth coating can be plated on the surface of the collar, the coating can be made of a material with certain hardness and smaller friction coefficient or lubricating, such as a titanium alloy material, or the inner wall of the distal opening of the second sliding hole can be arranged into a circular arc shape or a horn shape (namely, the inner diameter of the distal end part of the second sliding hole) in a smooth transition manner, and the circular arc shape or the horn shape can not only reduce the damage degree of the surface of the collar, but also save labor when the collar is pushed and pulled to a certain extent.

The self-expanding force of the collar or the expansion force of the wave ring can be tested by adopting the tooling 50 shown in fig. 19 and a pulling machine. The tooling 50 includes a first mold 51 and a second mold 52. As shown in fig. 20, the first mold 51 is substantially T-shaped, and includes a pressing member 511 and a first connecting member 512. Wherein, the lower end of the first connecting piece 512 is connected with the upper end surface of the pressure piece 511, and one end of the first connecting piece 512 far away from the pressure piece 511 is provided with a first through hole 513. The first through hole 513 penetrates the surface of the first connecting piece 512 in a direction perpendicular to the length extending direction of the first connecting piece, and the first connecting piece 512 can be bolted with the tension machine through the first through hole 513, so that the pressure piece 511 is driven to move up and down under the action of the tension machine. Referring to fig. 20 and 22, the pressing member 511 is formed in a sheet shape and has a thickness T1, and in order to ensure that the pressing member 511 can apply force to the collar during testing, the thickness T1 of the pressing member 511 is preferably greater than the thickness d of the collar.

As shown in fig. 21, 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 for receiving the pressing member 511 of the first mold. Specifically, the upper end surface of the receiving member 521 is formed with an opening 525, and the length L2 of the opening 525 is not smaller than the length L1 of the pressing member 511. The side of the accommodating member 521 also forms a side opening 524 for facilitating placement or removal of the object to be measured. In order to facilitate observation of the compression degree of the object to be tested during the test, the accommodating member is further provided with a window 526 for observation by a tester. The second connecting member 522 has a second through hole 523 at an end thereof away from the receiving member 521, and the second through hole 523 is similar to the first through hole 513 and will not be described herein. It will be appreciated that in other embodiments, the first mold and the second mold may be connected to the tensile machine by other means (e.g., bolting) than bolting, so long as a smooth test is ensured.

In order to ensure that the deformation of the measured object is not affected by the accommodating member during the test, the length L2 of the accommodating member should be greater than the maximum length of the measured object during the deformation, for example, when the collar is tested, L2 should be greater than half the circumference of the collar, or one side opening is provided on the accommodating member opposite to the side opening 524, so that the deformation of the measured object is not blocked. Referring again to fig. 22, to ensure that the pressing member can smoothly enter and exit the receiving space of the receiving member 521, the width T2 of the opening 525 of the receiving member 521 is greater than the thickness T1 of the pressing member. Meanwhile, to avoid the object to be measured from being squeezed into the gap between the pressing member 511 and the accommodating member 521, the difference between the width T2 of the opening 525 and the thickness T1 of the pressing member should be smaller than the thickness of the object to be measured, for example, the thickness of the collar, preferably, less than half the thickness of the collar when the collar is tested.

It will be appreciated that in other embodiments the pressure member may be planar, i.e. the thickness T1 of the pressure member is substantially greater than the thickness of the collar, in which case the pressure member is substantially planar perpendicular to the first connector. At this time, the receiving member of the second mold is modified accordingly.

As shown in fig. 23, after the first mold 51 and the second mold 52 are respectively connected to a tensile machine (not shown), the restraint assembly 300 is placed in the accommodating space of the accommodating member 521 from the side opening 524 of the second mold, and the tensile machine is controlled to apply downward pressure, so that the first mold 51 moves downward to compress the restraint assembly 300 until the restraint assembly 300 is in a folded state (i.e., a state in which the collar is completely retracted into the second sliding hole), and the downward movement of the first mold 51 is stopped, and at this time, the reading on the sensor of the tensile machine is the self-expansion force of the collar. It will be appreciated that multiple tests may be performed on the collar and the self-expansion force of the collar measured by averaging.

It will be appreciated that the self-expanding force of the collar may also be tested directly by the tensioner without the collar being loaded (i.e., without any object being placed within the collar), such as by the tensioner being directly coupled to the drive mechanism 400 of the stent assembly device and then pulling the collar proximally into the second slide aperture, the maximum tensioner collar self-expanding force during this process.

The collar can be made of a material with certain rigidity and self-expansion performance, for example, the collar is formed by winding a plurality of strands of nickel-titanium wires, and can also only comprise one nickel-titanium wire. The sleeve has good toughness and is not easy to generate plastic deformation. In the use, the wearing and tearing can all take place for the distal end portion of the flat section of lantern ring and telescopic, from saving aspects such as cost and operation simplicity degree, the distal end portion hardness of flat section should be higher than the lantern ring, and the wear resistance of the distal end portion of flat section should be higher than the wear resistance of lantern ring promptly to when the lantern ring is impaired, can conveniently change the lantern ring fast, and need not replace whole device.

Referring also to fig. 2-6, in some embodiments, the telescoping assembly 200 includes a slide bar 210 and a stop bolt 220, the slide bar 210 may be cylindrical, and the slide bar 210 slidably engages the first slide aperture 111. The slide bar 210 is provided with a fixing hole 212, the fixing hole 212 extends along the radial direction of the slide bar 210, and one end of the limit bolt 220 is matched with the fixing hole 212, so that the limit bolt 220 is connected with the slide bar 210. The other end of the limiting bolt 220 is inserted into the sliding slot 112, and the sliding rod 210 can drive the limiting bolt 220 to slide in the sliding slot 112 in the sliding process of the first sliding hole 111. When the stop bolt 220 abuts against the leftmost side wall of the sliding groove 112, the sliding rod 210 stops sliding leftwards, and when the stop bolt 220 abuts against the rightmost side wall of the sliding groove 112, the sliding rod 210 stops sliding rightwards, namely the stop bolt 220 abuts against the side wall of the sliding groove 112 to limit the limit stroke of the sliding rod 210 sliding in the first sliding hole 111, and the limit stroke is approximately equal to the length of the sliding groove 112 along the axial direction of the sliding rod 210. The stop bolt 220 may be a screw or the like.

The slide bar 210 is further provided with a mounting hole 211, the mounting hole 211 penetrates through the distal end face of the slide bar 210, the mounting hole 211 extends along the axial direction of the slide bar 210, and the mounting hole 211 can be communicated with the fixing hole 212. The pushing rod 320 is inserted into the mounting hole 211, and when the limiting bolt 220 is located in the fixing hole 212, the limiting bolt 220 will apply a pressing force to the pushing rod 320, so that the pushing rod 320 is pressed between the sliding rod 210 and the limiting bolt 220, and thus the fixed connection between the pushing rod 320 and the sliding rod 210 is achieved.

Referring to fig. 2 and 3, a driving mechanism 400 is connected to the sliding rod 210, and the driving mechanism 400 is used for driving the sliding rod 210 to slide reciprocally in the first sliding hole 111. When the sliding rod 210 slides reciprocally in the first sliding hole 111, the sliding rod 210 drives the pushing rod 320 to slide reciprocally in the second sliding hole 121, so that the pushing rod 320 drives the collar 310 to retract into or extend out of the second sliding hole 121, and finally the diameter of the tightening hole 313 is reduced or increased. As shown in fig. 4, the length of the second sliding hole 121 is denoted as H, the limit stroke of the sliding rod 210 sliding in the first sliding hole 111 is denoted as H, the total length of the collar 310 is denoted as L (i.e., the circumference of the collar), and of course, the limit stroke of the sliding rod 210 is equal to the limit stroke of the ejector pin 320. In order to reduce the diameter of the tightening hole 313 to be equal to the minimum pipe diameter of the stent graft 30, it is necessary to have enough sliding stroke of the slide rod 210 and the push rod 320 so that the length of the collar 310 exposed outside the second slide block is sufficiently reduced, and at the same time, considering that the collar 310 has a certain flexibility, in order to prevent the collar 310 retracted into the second slide hole 121 from being retracted further into the first slide hole 111, thereby making it difficult for the collar 310 retracted into the first slide hole 111 to return into the second slide hole 121, H, H and L satisfy the following relationship that H > L/2. In short, when the slide bar 210 slides to the limit stroke h, the collar 310 will retract only into the second slide hole 121 and not into the first slide hole 111, and the collar 310 of sufficient length will retract into the second slide hole 121 so that the minimum diameter of the cinching hole 313 can accommodate the minimum tube diameter of the stent graft 30.

Referring to fig. 2 and 3, in some embodiments, the drive mechanism 400 is a handle 410, the handle 410 being connected to an end of the slide bar 210. By directly applying a force to the handle 410, the slide bar 210 and the push rod 320 can be made to slide reciprocally, and a decrease or increase in the diameter of the pinching holes 313 can be achieved. When the stent graft 30 is loaded into the sheath 21 using the stent graft fitting device 10 including the handle 410, the procedure is as follows:

First, referring to fig. 9, pushing force is applied to the handle 410, so that the slide bar 210 and the push rod 320 drive the collar 310 to be located entirely outside the second slide hole 121. At this time, the collar 310 has the greatest length and the greatest diameter of the tightening hole 313 formed around it. The stent graft 30 in a natural state is fitted into the tightening hole 313, and one tightening hole 313 can be engaged with only one band 31 at a time, at this time, one band 31 of the stent graft 30 closest to the sheath 21 is engaged with the tightening hole 313, and one band 31 of the stent graft 30 closest to the sheath 21 is denoted as a first band 31a for convenience of description. Meanwhile, the distal end of the flat section 120 abuts against the surface of the covering film outside the first wave ring 31a, and the width extension direction of the flat section is perpendicular to the length extension direction of the covering film bracket.

Second, referring to fig. 10 and 11, one operator's hands are separated at both sides of the collar 310 to hold the stent graft 30, and the other operator's hand holds the sleeve 100 and applies a pulling force to the handle 410 by one hand, so that the collar 310 is gradually retracted 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 band 31a to a value in a compressed state to fit the lumen 21a of the sheath 21, and then loading the first band 31a in a compressed state into the lumen 21a of the sheath 21.

Because the tightening hole 313 is circular and is matched with the shape of the first wave ring 31a, the collar 310 can apply radial compression force with the same size to all parts of the circumference of the first wave ring 31a, and all parts of the circumference of the first wave ring 31a can contract in the same proportion to reduce the pipe diameter, so that the cross sections of the first wave ring 31a at different moments in the compression process are geometrically similar, the cross section of the first wave ring 31a is ensured to be always circular instead of elliptical or other irregular shapes, namely, the cross section shape of the first wave ring 31a is consistent with the cross section shape of the lumen 21a of the sheath 21, the assembly consistency of the first wave ring 31a is improved, and the situation that the first wave ring 31a cannot be installed into the sheath 21 or even damaged due to uneven contraction is avoided. Meanwhile, in the process of compressing the first wave ring 31a by the collar 310, the end part of the flat section 120 is always abutted against the first wave ring 31a, and the cross section width A of the flat section 120 is larger than 1/3 of the length a of the first wave ring 31a and smaller than 1/2 of the length a of the first wave ring 31a, when the flat section 120 is abutted against the first wave ring 31a, the flat section 120 does not cover the whole first wave ring 31a in the axial direction of the covered stent 30, so that a certain length is reserved at one end of the covered stent 30, which is close to the sheath tube 21, for an operator to hold, and in the process of loading the first wave ring 31a into the sheath tube 21, the flat section 120 does not interfere with the sheath tube 21 to prevent the loading of the first wave ring 31a, and meanwhile, the end surface of the flat section 120, which is in contact with the first wave ring 31a, has a reasonable area, so that the flat section 120 can not generate large pressure intensity on the first wave ring 31a, and the first wave ring 31a is prevented from being damaged. It will be appreciated that in other embodiments, the distal end face of the flattened section may also be configured in a proximally concave rounded configuration so that the flattened section conforms more to the outer surface of the stent.

Third, when the first wave ring 31a is installed in the sheath 21, a pushing force is applied to the handle 410, so that the slide bar 210 and the push rod 320 drive the collar 310 to be located outside the second slide hole 121. And then the other wave rings 31 are sequentially compressed one by adopting the above-mentioned loading mode of the first wave ring 31a to be loaded into the sheath 21, so that the whole tectorial membrane bracket 30 and the sheath 21 are assembled finally.

For the traditional assembly mode of adopting the binding band assembly, because a plurality of wave rings 31 are compressed once, the compression force is difficult to coordinate, so that the compression degree of each wave ring 31 is inconsistent, the same proportion shrinkage is difficult to realize at all parts of the circumference of the same wave ring 31, the compressed wave rings 31 cannot be simultaneously installed in the sheath tube 21, and even the tectorial membrane bracket 30 is damaged. In addition, in the assembly process, higher operation skills are required to coordinate the compression force well, and successful assembly can be realized through repeated debugging for many times, so that the labor intensity is high and the working efficiency is low. With the stent graft assembling device 10 of the above embodiment, only one wave ring 31 is compressed at a time, and the wave ring 31 can be contracted in the same proportion around the circumference, so that the wave ring 31 can be quickly installed into the sheath 21, thereby achieving the purposes of reducing labor intensity and improving working efficiency.

Referring to fig. 12-14, in some embodiments, the drive mechanism 400 includes a mounting table 420, a support frame 430, and a driver 440. The support frame 430 includes the stabilizer blade 433 and with the first mounting panel 431 and the second mounting panel 432 of stabilizer blade 433 connection, the upper end and the assembly bench 420 fixed connection of stabilizer blade 433, the lower extreme of stabilizer blade 433 can be placed on the loading thing such as ground, and first mounting panel 431 is located the top of second installation, and first mounting panel 431 is close to assembly bench 420 relatively second mounting panel 432 more. The column section 110 of the sleeve 100 is inserted into the assembly stage 420, the column section 110 can be fixed to the bearing stage by bolting or the like, and at this time, the flat section 120 and the collar 310 are located on the upper side of the assembly stage 420, and the other portion of the column section 110 is located on the lower side of the bearing stage. The bearings 434 are mounted on the first mounting plate 431 and the second mounting plate 432, and the sliding rod 210 is inserted into the bearings 434, so that the sliding resistance of the sliding rod 210 can be reduced and the accuracy of the sliding track can be improved by arranging the bearings 434. The driver 440 includes a pedal 441, a first elastic member 443, and a mounting cylinder 442, the pedal 441 is fixed on a portion of the slide bar 210 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 a cavity of the mounting cylinder 442, and a lower end of the slide bar 210 abuts against the first elastic member 443. When the stent graft 30 is loaded into the sheath 21 using the stent graft fitting device 10 including the stepping piece 441, the operation process is different from that of the stent graft fitting device 10 including the handle 410 described above in that:

only one operator is required, after the operator holds the wave ring 31 with his hand on the assembly table 420 and wears it in the tightening hole 313 (as shown in fig. 15), the foot is used to apply a stepping force to the stepping member 441, the slide bar 210 moves downward and presses the first elastic member 443, the first elastic member 443 stores energy, and the slide bar 210 causes the collar 310 to compress the wave ring 31 (as shown in fig. 16) until the wave ring 31 is installed in the sheath 21. When one of the wave rings 31 is assembled, the stepping force applied to the stepping member 441 is released, and at this time, the first elastic member 443 releases energy, and the slide bar 210 and the push rod 320 automatically slide to make the collar 310 extend out of the second slide hole 121, i.e. the collar can automatically return, so as to sequentially compress the other wave rings 31 one by one. This operation can reduce one operator, and reduce the labor cost of the operation of the stent graft assembling device 10. Other similarities refer to the operation of stent graft assembly device 10 including handle 410 described above.

Referring to fig. 17-18, in some embodiments, the drive mechanism 400 includes a mounting table 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 table 420, the lower end of the support leg 433 can be placed on a load such as the ground, the column section 110 of the sleeve 100 is inserted into the assembly table 420, the column section 110 can be fixed to the assembly table 420 by means of bolting or the like, at this time, the flat section 120 and the collar 310 are located on the upper side of the assembly table 420, and the other parts of the column section 110 are located on the lower side of the assembly table 420. The driver 440 includes a cylinder 444, a second elastic member 446, and a control valve 445, the cylinder 444 being fixed on the first mounting plate 431 and electrically connected to the control valve 445, a piston 444a of the cylinder 444 being connected to the slide rod 210, the second elastic member 446 being located in a cylinder tube of the cylinder 444 and abutting against the slide rod 210. In comparison with the above-described stent graft assembling device 10 including the step-on member 441, the operation process thereof is different in that:

Also, only one operator is required, after the operator holds the wave ring 31 with his hand on the assembly table 420 and inserts it into the tightening hole 313, the operator can apply a pressing force to the control valve 445 by his foot, 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 the slide rod 210 causes the collar 310 to compress the wave ring 31 until the wave ring 31 is inserted into the sheath 21. When one of the wave rings 31 is assembled, the second elastic member 446 releases energy, and the slide bar 210 and the push rod 320 automatically slide to extend the collar 310 entirely out of the second slide hole 121, so that the other wave rings 31 are sequentially compressed one by one. This operation also reduces the labor cost of one operator to operate the stent graft assembly device 10, and the driving of the slide 210 by the cylinder 444 further reduces labor intensity, as well as other things similar to the operation of the stent graft assembly device 10 described above including the handle 410.

Referring to fig. 9 to 11, the present invention further provides a delivery system 20, where the delivery system 20 includes a sheath 21, a delivery pushrod 22, a fixed anchor 23, a tip 24, an auxiliary pushrod 25, and the stent graft assembly device 10 described above. In assembly, the bare collar 31b of the stent graft 30 is first hung into the anchor 23, then the first collar 31a closest to the sheath 21 is compressed by the stent graft assembly device 10 to be fitted into the sheath 21, then the collars 31 on the stent graft 30 are sequentially compressed individually in a direction gradually away from the sheath 21 (i.e., a direction gradually closer to the anchor 23) to be fitted into the sheath 21, and finally the stent graft assembly device 10 is withdrawn, so that the sheath 21 implants the stent graft 30 into the body.

The present invention also provides an assembly method for installing a stent graft 30 into a sheath 21 using any of the stent graft assembling devices described above. The assembling method firstly compresses the first wave ring 31a closest to the sheath 21 to be installed in the sheath 21, and then sequentially compresses the wave rings 31 on the covered stent 30 singly to be installed in the sheath 21 along the direction gradually far away from the sheath 21, wherein the operation of compressing the single wave ring 31 to be installed in the sheath 21 mainly comprises the following steps:

In a first step, a collar 310 is provided that surrounds a cinching hole 313.

In the second step, the band 31 is inserted into the tightening hole 313.

In the third step, the cross-sectional dimension (diameter) of the grip hole 313 is gradually reduced to compress the band 31, and the compressed band 31 is fitted into the sheath 21.

Fourth, the cross-sectional dimension (diameter) of the grip hole 313 is restored to the maximum.

For details of the operation of the various stent graft mounting devices 10 described above, reference is made to the details of the operation of the various steps.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. The device for assembling the covered stent is used for assembling the covered stent, and the covered stent comprises a compressible or expandable wave ring and is characterized by comprising a lantern ring and a push rod, wherein the lantern ring is made of a self-expandable material, and the self-expansion force of the lantern ring is smaller than the radial expansion force of the covered stent;

The tectorial membrane support assembly device also comprises a sleeve, wherein the sleeve comprises a flat section, the cross section of the flat section is approximately rectangular, and the width of the rectangle is smaller than the amplitude of the wave ring;

the flat section is provided with a second sliding hole, the lantern ring can be received in the second sliding hole, the push rod is in sliding fit with the second sliding hole, and the lantern ring can be driven to retract into or extend out of the second sliding hole in the sliding process of the push rod in the second sliding hole.

2. The stent graft fitting apparatus of claim 1, wherein a wire diameter constituting said collar is not greater than a wire diameter of said collar.

3. The stent graft fitting apparatus of claim 2, wherein the collar comprises a W-shaped structure, the W-shaped structure on the collar having an amplitude that is less than the amplitude of the wave band.

4. The stent graft fitting apparatus of claim 1, wherein the collar is coated with a lubricious coating.

5. The stent graft fitting apparatus of claim 4, wherein the coating is a titanium alloy material.

6. The stent graft fitting apparatus of claim 1, wherein the inner wall of the distal opening of the second slide aperture is arcuate or flared.

7. The stent graft fitting apparatus of claim 6, wherein the distal portion of the sleeve has a higher wear resistance than the collar.