CN113119020A

CN113119020A - Covered stent assembling device and covered stent assembling method

Info

Publication number: CN113119020A
Application number: CN201911401832.3A
Authority: CN
Inventors: 唐江峰; 严新火
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2021-07-16
Anticipated expiration: 2039-12-30
Also published as: CN113119020B

Abstract

The invention discloses a covered stent assembling device and a covered stent assembling method. The assembling device includes: the sliding rod is slidably arranged in the sleeve in a penetrating manner; the binding assembly comprises a lantern ring connected with the sliding rod, and the sliding rod can drive the lantern ring to retract into or extend out of the sleeve so as to change the length of the lantern ring exposed out of the sleeve and further change the size of a binding hole surrounded by the lantern ring; and the driving mechanism is connected with the sliding rod and is used for driving the sliding rod to slide relative to the sleeve. In the in-process of tectorial membrane support compression, the shape in cramping the hole all the time with tectorial membrane support's shape looks adaptation, the lantern ring can exert the radial compressive force that the size is the same to each department of tectorial membrane support circumference, make tectorial membrane support circumference can contract in order to reduce the pipe diameter with proportion everywhere, then make the cross section at different moments in the compression process be the geometric similarity figure, improve the assembly uniformity, guarantee that tectorial membrane support after the complete compression can eliminate to interfere and pack into the sheath pipe smoothly, also avoid tectorial membrane support to produce the damage in the compression process.

Description

Covered stent assembling device and covered stent assembling method

Technical Field

The invention relates to the field of medical instruments, in particular to a covered stent assembling device and a covered stent assembling method.

Background

In the field of interventional medical treatment, aiming at vascular diseases such as aneurysm and arterial dissection, a delivery 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 delivery 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 in the body, the stent graft needs to be compressed to fit within the sheath of a delivery system for interventional delivery to the site of the lesion. When the covered stent is compressed, the traditional operation mode generally needs two persons to be matched, and the radial compression force is applied to the covered stent by adopting the ribbon method, but the covered stent is difficult to be compressed to the compression size which is easy to assemble with a sheath tube by the method, and the covered stent is damaged or scrapped due to the accommodation, meanwhile, the labor intensity of operators is increased, and the working efficiency of compressing the covered stent is influenced.

Disclosure of Invention

The invention solves the technical problem of how to improve the compression effect and the working efficiency of the assembly device on the covered stent.

A stent graft assembly device for assembling a stent graft, comprising: a sleeve; the sliding rod is slidably arranged in the sleeve in a penetrating manner; the binding assembly comprises a lantern ring connected with the sliding rod, and the sliding rod can drive the lantern ring to retract into or extend out of the sleeve so as to change the length of the lantern ring exposed out of the sleeve and further change the size of a binding hole surrounded by the lantern ring; and the driving mechanism is connected with the sliding rod and is used for driving the sliding rod to slide relative to the sleeve.

In an embodiment, the sleeve has a proximal end face and a distal end face which are oppositely arranged, a first slide hole and a second slide hole communicated with the first slide hole are arranged in the sleeve, the first slide hole penetrates through the proximal end face of the sleeve, the second slide hole penetrates through the distal end face of the sleeve, the slide rod is matched with the first slide hole, and the collar can be retracted into the second slide hole or extended out of the distal end of the second slide hole.

In one embodiment, the length of the second slide hole is H, the limit travel of the slide rod sliding relative to the sleeve is H, and the total length of the collar is L, wherein H > L/2.

In an embodiment, a sliding groove is further formed in the sleeve, the stent graft assembling device further comprises a limiting bolt, the limiting bolt is fixedly connected with the sliding rod and can slide in the sliding groove, and the limiting bolt can abut against the side wall of the sliding groove to limit the limit stroke of the sliding rod.

In one embodiment, the restraining assembly further comprises an ejector rod penetrating the sleeve, the proximal end of the ejector rod is connected with the sliding rod, and the collar is fixed to the distal end of the ejector rod.

In one embodiment, the collar has first and second oppositely disposed ends, both of which are secured to the ejector pin; or the first end is fixed on the fixed push rod, and the second end is sleeved on the first end.

In one embodiment, the sleeve comprises a flat section, the distance between two points that are most distant in the cross-section of the flat section being greater than the line between a line perpendicular to the line between the two points and two points of intersection of the cross-section.

In one embodiment, the cross-section is substantially rectangular, a width of the rectangle being aligned with a direction of length extension of the stent graft, and a width of the rectangle being less than a height of the undulating rings on the stent graft.

In an embodiment, the driving mechanism comprises an assembly table, a support frame and a driver, the slide rod can slide relative to the support frame and is connected with the driver, the sleeve is arranged in the assembly table in a penetrating mode, the sleeve ring and the driver are separated from two opposite sides of the assembly table, and the driver drives the sleeve ring to move towards the driver.

The invention also provides an assembly method of the covered stent, the covered stent comprises a plurality of wave rings, the covered stent is assembled by using the covered stent assembly device, and the assembly method comprises the following steps:

providing a collar surrounding the cinching hole;

threading a wave ring in the tightening hole;

gradually reducing the cross-sectional dimension of the clamping hole to compress the wave ring, and loading the compressed wave ring into a sheath tube; and

separating the collar from the wave ring.

In one embodiment, the sleeve includes a flat section, the flat section has a substantially rectangular cross section, a width direction of the rectangle coincides with a length extension direction of the stent graft during compression of the wave ring, a distal end surface of the flat section abuts against a surface of the stent graft, and the length extension direction of the rectangle is perpendicular to the length extension direction of the stent graft.

One technical effect of one embodiment of the invention is that: when the stent graft is mated with the cinching hole, the length of the collar exposed outside the barrel is reduced, thereby reducing the size of the cinching hole to facilitate compression of the stent graft. In the in-process of tectorial membrane support compression, the shape in cramping the hole all the time with tectorial membrane support's shape looks adaptation, the lantern ring can be to each department of tectorial membrane support circumference exert the radial compressive force that the size is the same, make tectorial membrane support circumference can contract in order to reduce the pipe diameter with proportion everywhere, then make the cross section at different moments in the tectorial membrane support compression process be the geometric similarity figure, improve tectorial membrane support's assembly uniformity, guarantee that tectorial membrane support after the complete compression can eliminate to interfere and pack into the sheath pipe smoothly, also avoid tectorial membrane support to produce in compression process and damage. Meanwhile, the compression force of the covered stent does not need to be debugged repeatedly, and the working efficiency is improved.

Drawings

FIG. 1 is a schematic front view of a stent graft provided in accordance with one embodiment;

fig. 2 is a schematic perspective view of an assembling apparatus according to a first embodiment;

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

FIG. 4 is a cross-sectional view of the sleeve of the mounting device of FIG. 2;

FIG. 5 is a schematic cross-sectional view of a slide bar in the mounting apparatus of FIG. 2;

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

FIG. 7 is a schematic plan view of a first exemplary tie-down assembly of the mounting apparatus of FIG. 2;

FIG. 8 is a schematic plan view of a second exemplary tie-down assembly of the mounting apparatus of FIG. 2;

FIG. 9 is a schematic view of the first wave ring in a natural state fitted with the sleeve in the fitting device of FIG. 2;

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

FIG. 11 is a schematic view of the first wave ring shown in FIG. 9 after being inserted into the sheath;

fig. 12 is a schematic perspective view of an assembling apparatus according to a second embodiment;

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

FIG. 14 is an enlarged view of E in FIG. 13;

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

FIG. 16 is a fragmentary top plan view of the mounting device of FIG. 12 after the first wave ring has been compressed to a compressed state;

fig. 17 is a schematic perspective view of an assembling apparatus according to a third embodiment;

fig. 18 is a cross-sectional structural view of the mounting device of fig. 17.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. 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 "secured 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 as used herein are for illustrative purposes only and do not represent the only embodiments.

Further, in the field of medical instruments, the end closer to the operator is defined as "proximal end", and the end farther from the operator is defined as "distal end".

Referring to FIGS. 1 and 3, one embodiment of the stent graft assembly device 10 of the present invention is configured to load a stent graft 30 into the lumen 21a of a sheath 21 (see FIG. 9). Specifically, the stent graft 30 has a cylindrical tubular structure, and the stent graft assembly device 10 is adapted to compress the stent graft 30 from a natural state in which the diameter of the stent graft is the largest to a compressed state in which the diameter of the stent graft 30 is the smallest, against the elastic force of the stent graft 30 itself, so that the diameter of the stent graft 30 in the compressed state is matched to the size of the lumen 21a of the sheath 21, so that the stent graft 30 in the compressed state is inserted into the lumen 21a of the sheath 21. After the sheath 21 is inserted into the body, the stent graft 30 is released from the lumen 21a of the sheath 21, and the released stent graft 30 will automatically expand from the compressed state until it is closely attached to the inner wall of the blood vessel, thereby finally achieving the implantation of the stent graft 30 in the body. The stent graft assembly device 10 includes a sleeve 100, a telescoping assembly 200, a tie down assembly 300, and a drive mechanism 400.

Referring to fig. 1-4, in some embodiments, sleeve 100 includes a post segment 110 and a flattened segment 120, the post segment 110 having a substantially circular cross-section and the flattened segment 120 having a substantially rectangular cross-section. The flattened section 120 is coupled to the distal end of the post section 110 such that the distal end surface of the flattened section 120 is able to abut the surface of the stent graft 30 during compression of the stent graft 30. The cross section of the flat section 120 is substantially rectangular, the length of the rectangle in this embodiment is equal to the diameter of the column section 110, the width of the rectangle is denoted as a, and the width a is smaller than the diameter of the column section 110; for the wave ring 31 on the covered stent 30, the distance from the valley point to the peak point of the wave ring 31 along the axial direction of the covered stent 30 is defined as the height of the wave ring 31, the height of the wave ring 31 is recorded as a, wherein the value range of A is a/3 < A < a/2, so that the flat section can not block the wave ring from being compressed and sheathed. It will be appreciated that in other embodiments, the length of the cross-section of the flattened section may not be equal to the diameter of the post section, and may be greater or less than the diameter of the post section, preferably up to a diameter greater than the unloaded stent graft to avoid stent damage.

Referring to fig. 4, the end surface of the post segment 110 away from the flattened segment 120 is the proximal end surface 101, and the end surface of the flattened segment 120 away from the post segment 110 is the distal end surface 102. A first slide hole 111 and a second slide hole 121 are provided in the sleeve 100. The first slide hole 111 extends along the axial direction of the whole sleeve 100 and penetrates through the proximal end face of the column section 110, and the first slide hole 111 is entirely positioned in the column section 110; the second slide hole 121 communicates with the distal end bottom wall of the first slide hole 111 and penetrates the distal end surface 102. The second slide hole 121 is coaxially disposed with the first slide hole 111, a part of the second slide hole 121 is located in the column section 110, and another part of the second slide hole 121 is located in the flat section 120. The first slide hole 111 and the second slide hole 121 may be circular holes, and the diameter of the first slide hole 111 is larger than that of the second slide hole 121, and in practice, the first slide hole 111 and the second slide hole 121 may be regarded as a stepped hole extending axially along the sleeve 100 while penetrating through the proximal end surface 101 and the distal end surface 102, and obviously, the stepped hole is a through hole. A sliding groove 112 is formed on a side circumferential surface of the column segment 110, 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 loop 310 and an ejector rod 320, and the loop 310 may be formed by winding a plurality of strands of nitinol wires around each other to form a flexible rope-like structure. The ejector rod 320 is made of metal or nonmetal materials with relatively hard materials, so that the rigidity of the ejector rod 320 is higher than that of the lantern ring 310, the ejector rod 320 is in sliding fit with the second sliding hole 121, and the lantern 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 secured to the ejector pin 320, the collar 310 may enclose a circular tightening hole 313, and the compressed stent graft 30 will be inserted into the tightening hole 313. When the collar 310 is entirely located outside the second slide hole 121, the cross-sectional dimension (diameter) of the clamping hole 313 surrounded by the collar 310 is the largest, the smallest diameter of the clamping hole 313 when the collar is expanded is denoted as D, the tube diameter of the stent graft 30 in the natural state is the largest, and the largest tube diameter is denoted as D, in order to smoothly pass through the clamping hole 313 for subsequent compression of the stent graft 30 in the natural state, the smallest diameter of the clamping hole 313 is larger than the largest tube diameter D of the stent graft 30 (as shown in fig. 1), wherein D is 1.1D-1.2D. After a portion of the collar 310 is retracted into the second slide hole 121, the length of the collar 310 exposed outside the second slide hole 121 is reduced, and the diameter of the tightening hole 313 formed by the collar 310 surrounding the second slide hole 121 is reduced, so that the collar 310 can apply a radial compressive force to the stent graft 30, and the diameter of the tube of the stent graft 30 is reduced to a state equal to the diameter of the tightening hole 313. Thus, as the collar 310 is gradually retracted into the second slide bore 121, the diameter of the cinch hole 313 gradually decreases, and the diameter of the stent graft 30 subsequently decreases, 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 to each other, and both the first end 311 and the second end 312 are fixed on the end surface of the ejector pin 320. Referring to fig. 2 and 3, when the diameter of the tightening hole 313 is the largest, the first end 311 and the second end 312 of the collar 310 are both located outside the second sliding hole 121, i.e., the tightening ring 310 is located entirely 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 located in the second slide hole 121, that is, a part of the collar 310 is located in the second slide hole 121, and another part of the collar 310 is exposed out of the second slide hole 121. When the ejector pin 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 ejector pin 320 is equal to half of the total length of the collar 310 retracting into or extending 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 rod 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, that is, the collar 310 is located outside the second sliding hole 121. When the diameter of the tightening hole 313 is smaller than the maximum diameter, the first end 311 will be located inside the second slide hole 121, and the second end 312 will be located outside the second slide hole 121, and similarly, a part of the collar 310 is located inside the second slide hole 121, and another part of the collar 310 is exposed outside the second slide hole 121. When the ejector 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 ejector rod 320 is equal to the total length of the collar 310 retracting into or extending 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, so as to prevent the stent graft 30 with a larger diameter from being unable to pass through the tightening hole 313 in a natural state; of course, the minimum diameter D of the tightening hole 313 cannot be too large, so that the circumference of the collar is too large, and the collar 310 is prevented from being too large to be retracted into the second sliding hole 121, so as to reduce the diameter of the tightening hole 313 to adapt to the tube diameter of the stent graft 30, and further avoid the push rod 320 from having too large sliding stroke.

Referring to fig. 2 to 6, in some embodiments, the telescopic assembly 200 includes a sliding rod 210 and a limit bolt 220, the sliding rod 210 may be cylindrical, and the sliding rod 210 is slidably engaged with the first sliding hole 111. The sliding rod 210 is provided with a fixing hole 212, the fixing hole 212 extends along the radial direction of the sliding rod 210, and one end of the limiting bolt 220 is matched with the fixing hole 212, so that the connection between the limiting bolt 220 and the sliding rod 210 is realized. The other end of the limit bolt 220 is inserted into the sliding groove 112, and the sliding rod 210 can drive the limit bolt 220 to slide in the sliding groove 112 in the process of sliding in the first sliding hole 111. When the limit bolt 220 abuts against the leftmost side wall of the sliding groove 112, the sliding rod 210 stops sliding to the left; when the limit bolt 220 abuts against the rightmost side wall of the slide groove 112, the slide rod 210 stops sliding further to the right, i.e. the limit bolt 220 limits the limit stroke of the slide rod 210 sliding in the first slide hole 111 by abutting against the side wall of the slide groove 112, and the limit stroke is approximately equal to the length of the slide groove 112 in the axial direction of the slide 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 push rod 320 is inserted into the mounting hole 211, and when the limit bolt 220 is located in the fixing hole 212, the limit bolt 220 applies a pressing force to the push rod 320, so that the push rod 320 is pressed between the slide bar 210 and the limit bolt 220, thereby realizing the fixed connection between the push rod 320 and the slide bar 210.

Referring to fig. 2 and 3, a driving mechanism 400 is connected to the slide bar 210, and the driving mechanism 400 is used for driving the slide bar 210 to slide back and forth in the first slide hole 111. When the sliding rod 210 slides in the first sliding hole 111 in a reciprocating manner, the sliding rod 210 drives the push rod 320 to slide in the second sliding hole 121 in a reciprocating manner, so that the push 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 slide hole 121 is denoted as H, the limit stroke of the slide rod 210 sliding in the first slide hole 111 is denoted as H, and the total length of the loop 310 is denoted as L (i.e. the perimeter of the loop), and of course, the limit stroke of the slide 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 a value equal to the minimum diameter of the stent graft 30, the sliding rod 210 and the pushing rod 320 must have sufficient sliding strokes so as to reduce the length of the collar 310 exposed outside the second sliding block sufficiently; meanwhile, considering that the collar 310 has certain flexibility, in order to prevent the collar 310 retracted into the second sliding hole 121 from being further retracted into the first sliding hole 111, thereby causing the collar 310 entering the first sliding hole 111 to be difficult to return into the second sliding hole 121, H, h and L satisfy the following relationship: h is more than H and more than L/2. In short, when the sliding rod 210 slides to reach the limit stroke h, the collar 310 will only retract into the second slide hole 121 and not into the first slide hole 111, and a sufficient length of the collar 310 retracts into the second slide hole 121, so that the minimum diameter of the tightening hole 313 can be adapted to the minimum tube diameter of the stent graft 30.

Referring to fig. 2 and 3, in some embodiments, the driving mechanism 400 is a handle 410, and the handle 410 is connected to an end of the sliding bar 210. The sliding rod 210 and the push rod 320 can be made to slide back and forth by applying a force directly to the handle 410, so that the diameter of the tightening hole 313 can be reduced or increased. When the stent graft assembly device 10 including the handle 410 is used to install the stent graft 30 into the sheath 21, the operation is as follows:

first, referring to fig. 9, a pushing force is applied to the handle 410, so that the sliding rod 210 and the pushing rod 320 bring the collar 310 to be completely located outside the second sliding hole 121. At this time, the length of the collar 310 is maximized, and the diameter of the tightening hole 313 surrounded by the collar is maximized. The stent graft 30 in a natural state is inserted into the clamping holes 313, and only one wave ring 31 can be matched with one clamping hole 313 at a time, and at this time, one wave ring 31 of the stent graft 30 closest to the sheath 21 is matched with the clamping holes 313, and for convenience of description, the one wave ring 31 of the stent graft 30 closest to the sheath 21 is referred to as a first wave ring 31 a. Meanwhile, the distal end of the flat section 120 abuts against the surface of the stent graft 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.

Secondly, referring to fig. 10 and 11, two hands of one operator are respectively positioned at two sides of the collar 310 to hold the stent graft 30, one hand of the other operator holds the sleeve 100, and the other hand of the other operator applies a pulling force to the handle 410, so that the collar 310 is gradually retracted into the second sliding hole 121, thereby gradually reducing the size of the fastening hole 313, then the pipe diameter of the first wave ring 31a is gradually reduced to a value of a compressed state to be matched with the pipe cavity 21a of the sheath pipe 21, and then the first wave ring 31a in the compressed state is loaded into the pipe cavity 21a of the sheath pipe 21.

Because the fastening 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 in the circumferential direction of the first wave ring 31a, all parts in the circumferential direction of the first wave ring 31a can contract in the same proportion to reduce the pipe diameter, and then the cross sections of the first wave ring 31a at different moments in the compression process are all geometric similar figures, so that the cross section of the first wave ring 31a is ensured to be circular instead of elliptical or other irregular shapes all the time, namely, the cross section shape of the first wave ring 31a is consistent with the cross section shape of the pipe cavity 21a of the sheath pipe 21, the assembly consistency of the first wave ring 31a is improved, and the first wave ring 31a cannot be installed in the sheath pipe 21 or even damaged due to uneven contraction is avoided. Meanwhile, in the process that the first wave ring 31a is compressed by the lantern ring 310, the end of the flat section 120 is always in contact with the first wave ring 31a, and because the cross-sectional width a of the flat section 120 is greater than 1/3 of the length a of the first wave ring 31a and less than 1/2 of the length a of the first wave ring 31a, when the flat section 120 is in contact with the first wave ring 31a, the entire first wave ring 31a is not covered by the flat section 120 in the axial direction of the stent graft 30, so that a certain length is left at one end of the stent graft 30 close to the sheath 21 for the operator to hold; in addition, in the process of installing the first wave ring 31a into the sheath 21, the flat section 120 does not interfere with the sheath 21 to prevent the installation of the first wave ring 31 a; meanwhile, the end face of the flat section 120 contacting the first wave ring 31a has a reasonable area, so that the flat section 120 is effectively prevented from generating large pressure 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 surface of the flattened section may be provided with a proximally concave rounded configuration, such that the flattened section is more compliant with the outer surface of the stent.

Third, after the first wave ring 31a is installed in the sheath 21, a pushing force is applied to the handle 410, so that the sliding rod 210 and the pushing rod 320 drive the sleeve ring 310 to be located outside the second sliding hole 121. The other wave rings 31 are sequentially compressed one by one in the manner of fitting the first wave ring 31a to fit into the sheath 21, and finally the entire stent graft 30 is assembled with the sheath 21.

For the traditional assembly mode adopting the binding belt assembly, due to the fact that the plurality of wave rings 31 are compressed at one time, the compression force is difficult to coordinate, so that the compression degree of each wave ring 31 is inconsistent, and the circumferential parts of the same wave ring 31 are difficult to contract in the same proportion, so that the compressed wave rings 31 cannot be simultaneously installed in the sheath tube 21, and even the covered stent 30 is damaged. In addition, in the assembly process, high operation skill is required to well coordinate the compression force, and the assembly can be successfully realized through repeated debugging, 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 all parts in the circumferential direction of the wave ring 31 can contract in the same proportion, so that the wave ring 31 is quickly installed in the sheath 21, and the purposes of reducing labor intensity and improving working efficiency can be achieved.

Referring to fig. 12-14, in some embodiments, the drive mechanism 400 includes an assembly table 420, a support bracket 430, and a driver 440. The supporting frame 430 includes a supporting leg 433 and a first mounting plate 431 and a second mounting plate 432 connected to the supporting leg 433, the upper end of the supporting leg 433 is fixedly connected to the mounting platform 420, the lower end of the supporting leg 433 can be placed on a load-bearing object such as the ground, and the first mounting plate 431 is located above the second mounting, that is, the first mounting plate 431 is closer to the mounting platform 420 than the second mounting plate 432. The column section 110 of the sleeve 100 is inserted into the mounting platform 420, and the column section 110 can be fixed on the bearing platform by means of bolts, etc., at this time, the flat section 120 and the collar 310 are located on the upper side of the mounting platform 420, and the other parts of the column section 110 are located on the lower side of the bearing platform. Bearings 434 are mounted on the first mounting plate 431 and the second mounting plate 432, the slide bar 210 is inserted into the bearings 434, and the bearings 434 are provided, so that the sliding resistance of the slide bar 210 can be reduced, and the accuracy of the sliding track can be improved. The driver 440 includes a step member 441, a first elastic member 443, and a mounting tube 442, wherein the step member 441 is fixed to a portion of the sliding rod 210 between the first mounting plate 431 and the second mounting plate 432, the mounting tube 442 is fixed below the second mounting plate 432, the first elastic member 443 is accommodated in a cavity of the mounting tube 442, and a lower end of the sliding rod 210 abuts against the first elastic member 443. When the stent graft assembly device 10 including the tread member 441 is used to install the stent graft 30 into the sheath 21, the operation process is different compared to the above-described stent graft assembly device 10 including the handle 410 in that:

when the operator holds the wave ring 31 by hand on the mounting table 420 and inserts the wave ring 31 into the fastening hole 313 (see fig. 15), the foot is used to apply the treading force to the treading member 441, the sliding rod 210 moves downward and presses the first elastic member 443, the first elastic member 443 stores energy, and the sliding rod 210 causes the loop 310 to compress the wave ring 31 (see fig. 16) until the wave ring 31 is inserted into the sheath tube 21. After one of the wave rings 31 is assembled, the treading force applied to the treading member 441 is released, at this time, the first elastic member 443 releases energy, the sliding rod 210 and the push rod 320 automatically slide to enable the lantern ring 310 to fully extend out of the second sliding hole 121, that is, the lantern ring can automatically return to compress the other wave rings 31 one by one. This operation may reduce one operator and the labor cost of operating the stent graft assembly device 10. Otherwise see the operation of the stent graft assembly 10 described above, including the handle 410.

Referring to fig. 17-18, in some embodiments, the drive mechanism 400 includes an assembly table 420, a support bracket 430, and a driver 440. The supporting frame 430 comprises a supporting leg 433 and a first mounting plate 431 connected with the supporting leg 433, the upper end of the supporting leg 433 is fixedly connected with the mounting platform 420, the lower end of the supporting leg 433 can be placed on a load-bearing object such as the ground, the column section 110 of the sleeve 100 is arranged in the mounting platform 420 in a penetrating mode, the column section 110 can be fixed on the mounting platform 420 in a bolt connection mode and the like, at the moment, the flat section 120 and the lantern ring 310 are located on the upper side of the mounting platform 420, and other parts of the column section 110 are located on the lower side of the mounting platform 420. The actuator 440 includes a cylinder 444, a second elastic member 446 and a control valve 445, the cylinder 444 is fixed on the first mounting plate 431 and electrically connected to the control valve 445, the piston 444a of the cylinder 444 is connected to the sliding rod 210, and the second elastic member 446 is located in the bore of the cylinder 444 and abuts against the sliding rod 210. Compared with the stent graft assembling device 10 comprising the stepping piece 441, the operation process is different in that:

also, only one operator is needed, when the operator holds the wave ring 31 on the mounting table 420 by hand and inserts the wave ring 31 into the fastening hole 313, the operator can apply a pressing force stepped on the control valve 445 by foot, the control valve 445 will make the piston 444a of the cylinder 444 drive the sliding rod 210 to move downwards and press the second elastic member 446, the second elastic member 446 stores energy, and the sliding rod 210 makes the loop 310 compress the wave ring 31 until the wave ring 31 is installed into the sheath tube 21. When one wave ring 31 is assembled, the second elastic member 446 releases energy, and the sliding rod 210 and the push rod 320 automatically slide to allow the loop 310 to fully extend out of the second sliding hole 121, so as to sequentially compress the other wave rings 31 one by one. This operation also reduces the labor cost of operating the stent graft assembly 10 by eliminating one operator, and the driving of the slide bar 210 is powered by the cylinder 444 which further reduces the labor intensity, as well as the other similarities to the above-described operation of the stent graft assembly 10 including the handle 410.

Referring to fig. 9 to 11, the present invention further provides a delivery system 20, wherein the delivery system 20 comprises a sheath 21, a delivery push rod 22, a fixed anchor 23, a sharp tip 24, an auxiliary push rod 25 and the above-mentioned stent graft assembling device 10. During assembly, the bare wave ring 31b of the stent graft 30 is first hung from the anchor 23, then the first wave ring 31a closest to the sheath 21 is compressed by the stent graft assembly device 10 to be loaded into the sheath 21, then the wave rings 31 on the stent graft 30 are individually compressed in sequence in a direction gradually away from the sheath 21 (i.e., in a direction gradually closer to the anchor 23) to be loaded into the sheath 21, and finally the stent graft assembly device 10 is removed to allow the sheath 21 to implant the stent graft 30 into the body.

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

in a first step, a collar 310 is provided which surrounds a cinch hole 313.

In the second step, the wave ring 31 is inserted into the fastening hole 313.

In the third step, the cross-sectional size (diameter) of the fastening hole 313 is gradually reduced to compress the wave ring 31, and the compressed wave ring 31 is inserted into the sheath 21.

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

For details of the operation of each step, reference is made to the operation of the various stent graft assembly devices 10 described above.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A stent graft assembly device for assembling a stent graft, comprising:

a sleeve; the sliding rod is slidably arranged in the sleeve in a penetrating manner;

the binding assembly comprises a lantern ring connected with the sliding rod, and the sliding rod can drive the lantern ring to retract into or extend out of the sleeve so as to change the length of the lantern ring exposed out of the sleeve and further change the size of a binding hole surrounded by the lantern ring; and

and the driving mechanism is connected with the sliding rod and is used for driving the sliding rod to slide relative to the sleeve.

2. The stent graft assembly device of claim 1, wherein the sleeve has proximal and distal end surfaces that are opposite to each other, a first slide hole and a second slide hole are provided in the sleeve, the first slide hole extends through the proximal end surface of the sleeve, the second slide hole extends through the distal end surface of the sleeve, the slide rod is engaged with the first slide hole, and the collar is retractable into or extendable out of the second slide hole.

3. The stent graft assembly device of claim 2, wherein the second slide hole has a length H, the slide rod slides relative to the sleeve by a limit travel distance H, and the collar has a total length L, wherein H > L/2.

4. The assembly device for the stent graft according to claim 1, wherein the sleeve is further provided with a sliding groove, the assembly device for the stent graft further comprises a limit bolt, the limit bolt is fixedly connected with the sliding rod and can slide in the sliding groove, and the limit bolt can abut against a side wall of the sliding groove to limit the limit stroke of the movement of the sliding rod.

5. The assembly device of claim 1, wherein the restraint assembly further comprises an ejector rod inserted into the sleeve, a proximal end of the ejector rod is connected to the sliding rod, and the collar is fixed to a distal end of the ejector rod.

6. The stent graft assembly device of claim 5, wherein the collar has first and second oppositely disposed ends, both of which are secured to the ejector pin; or the first end is fixed on the fixed push rod, and the second end is sleeved on the first end.

7. The stent graft assembly device of claim 1, wherein the sleeve comprises a flattened section having a cross-section with a distance between two points that are furthest apart that is greater than a line between a line perpendicular to the line between the two points and two intersection points of the cross-section.

8. The stent graft assembly device of claim 7, wherein the cross-section is substantially rectangular, a width of the rectangle being aligned with a direction of a length extension of the stent graft, and a width of the rectangle being less than a height of a wave ring on the stent graft.

9. The stent graft assembly device of claim 1, wherein the drive mechanism comprises an assembly table, a support frame, and a driver, the slide rod is capable of sliding relative to the support frame and connected to the driver, the sleeve is inserted into the assembly table, the collar and the driver are separated on opposite sides of the assembly table, and the driver drives the collar to move towards the driver.

10. A method of assembling a stent graft, wherein the stent graft includes a plurality of undulating rings, and the stent graft is assembled using the stent graft assembling device of any one of claims 1 to 9, comprising the steps of:

providing a collar surrounding the cinching hole;

threading a wave ring in the tightening hole;

separating the collar from the wave ring.

11. The method of assembling a stent graft of claim 10, wherein the sleeve comprises a flattened section having a generally rectangular cross-section, wherein a width of the rectangle is aligned with a length of the stent graft during compression of the undulating ring, wherein a distal end surface of the flattened section abuts a surface of the stent graft, and wherein the length of the rectangle is perpendicular to the length of the stent graft.