Disclosure of Invention
Accordingly, it is necessary to provide a stent-graft transporting device against the problem of the "bird's beak" phenomenon which is easily caused by the poor adhesion of the stent graft to the vessel wall on the small curve side of the vessel.
A stent-graft delivery device for delivering a stent-graft into a vessel, comprising:
The device comprises a rear release fixing component, a pipe body component, a guide head and a guide head, wherein the rear release fixing component is provided with a plurality of fixing anchor points which are circumferentially arranged, the fixing anchor points are used for limiting and fixing a stent ring of the stent graft, the distance between the fixing anchor points close to a first side of the rear release fixing component and the rear end face of the rear release fixing component is larger than the distance between the fixing anchor points close to a second side of the rear release fixing component and the rear end face of the rear release fixing component, the first side and the second side are opposite to each other in the circumferential direction of the rear release fixing component, the pipe body component is arranged at the rear end of the rear release fixing component and is provided with a stent graft cavity used for accommodating the stent graft, and the guide head is arranged at the front end of the rear release fixing component.
In one embodiment, the rear release fixing assembly comprises a fixing body and a plurality of claw arms, the fixing body comprises a pipe body connecting portion and a plurality of claw arm connecting portions, the claw arm connecting portions are circumferentially arranged on the side surfaces of the pipe body connecting portions in a protruding mode, the claw arms extend from the claw arm connecting portions to the front ends of the pipe body connecting portions along the axis direction parallel to the pipe body connecting portions, the distance between the front surfaces of the claw arm connecting portions close to the first side and the rear end surfaces of the pipe body connecting portions is greater than the distance between the front surfaces of the claw arm connecting portions close to the second side and the rear end surfaces of the pipe body connecting portions, and the fixing anchor points are respectively arranged on the front surfaces of the claw arm connecting portions.
In one embodiment, the front surface of the claw arm connection portion is connected to the front surface of the tube body connection portion.
In one embodiment, the rear release fixing assembly comprises a fixing body and a plurality of claw arms, the fixing body comprises a pipe connecting portion, the claw arms extend from the pipe connecting portion to the front end of the pipe connecting portion along the axis direction parallel to the pipe connecting portion, the distance between the front surface of the pipe connecting portion close to the first side and the rear end surface of the pipe connecting portion is greater than the distance between the front surface of the pipe connecting portion close to the second side and the rear end surface of the pipe connecting portion, and the fixing anchor point is arranged on the front surface of the pipe connecting portion.
In one embodiment, the front end surface of the pipe body connecting portion extends obliquely from the first side to the second side in a direction approaching the rear end surface of the pipe body connecting portion.
In one embodiment, the front end surface of the pipe body connecting portion includes a first front end surface near the first side and a second front end surface near the second side, and a distance between the first front end surface and the rear end surface of the pipe body connecting portion is greater than a distance between the second front end surface and the rear end surface of the pipe body connecting portion.
In one embodiment, the front ends of the respective claw arms remain flush, and the length of the claw arms near the second side is at least twice the length of the claw arms near the first side.
In one embodiment, the front surface of the claw arm connecting portion extends obliquely from the fixing body to the claw arm in a direction offset from the rear end surface of the fixing body.
In one embodiment, the fixing body is provided with a through hole penetrating along the axis direction of the fixing body, the pipe body assembly comprises an inner core pipe, a top pipe and a sheath pipe which are sequentially arranged from inside to outside, the top pipe and the sheath pipe are arranged at intervals to form the film covering cavity, the core pipe is connected to the rear end of the fixing body, and the inner core pipe penetrates through the through hole and is connected to the guide head.
In one embodiment, the guide head comprises an introduction part and a clamping part connected with the introduction part, the diameter of the introduction part gradually increases from the front end to the rear end of the introduction part, the diameter of the clamping part is smaller than the diameter of the rear end of the introduction part, and the clamping part is clamped in a clamping interface formed by surrounding each claw arm.
The stent conveying device can be used for conveying the stent graft into a blood vessel, when the stent graft conveying device is used, the stent graft can be pressed and held into a stent graft cavity of a tube body assembly, and the stent loop at the head end of the stent graft is limited and fixed and then is released to each fixed anchor point of a fixing assembly, and then the stent graft is conveyed and released.
According to the application, the distance between the fixed anchor point close to the first side of the rear release fixing component and the rear end face of the rear release fixing component is controlled to be larger than the distance between the fixed anchor point close to the second side of the rear release fixing component and the rear end face of the rear release fixing component, so that the support ring close to the second side has the freedom degree of sliding the rear end of the rear release fixing component, and when the support ring close to the first side is limited and fixed, the support ring close to the second side can still slide towards the rear end. After the tectorial membrane support implants the blood vessel, when removing the sheath, the tectorial membrane support slides to the rear end under the effect of external force, but under the limiting effect of fixed anchor point, the big curved side of blood vessel is pressed close to the tectorial membrane support whole, and because the support ring that is close to the second side has the gliding degree of freedom to the rear end, the support ring that is close to the second side is driven and is further slided to the rear end, the tectorial membrane support that is close to the second side is backward rolled back, the support ring that reduces the tectorial membrane support head end takes place to warp because of the effect of external force, make the head end of tectorial membrane support can laminate with the blood vessel wall better in the little curved side of blood vessel, thereby reduce the probability that "bird's beak" phenomenon appears after the tectorial membrane support releases.
Drawings
FIG. 1 is a schematic plan view of a stent delivery device according to one embodiment of the present application;
Fig. 2 is a plan view schematically showing a rear release fixing assembly of a first example of the stent delivery device according to the above-described embodiment of the present application;
Fig. 3 is a perspective view showing a rear release fixing assembly of a first example of the stent delivery device according to the above-described embodiment of the present application;
Fig. 4 is a plan view schematically showing a rear release fixing assembly of a second example of the stent delivery device according to the above-described embodiment of the present application;
fig. 5 is a perspective view showing a rear release fixing assembly of a second example of the stent delivery device according to the above-described embodiment of the present application;
fig. 6 is a schematic view showing the stent delivery device according to the above embodiment of the present application when releasing a stent graft in a blood vessel.
Reference numerals 10, post-release fixation assembly, 11, fixation anchor point, 12, first side, 13, second side, 14, fixation body, 141, tube body connection part, 142, claw arm connection part, 15, claw arm, 20, tube body assembly, 21, inner core tube, 22, core tube, 23, jacking tube, 24, sheath tube, 30, guide head, 31, introduction part, 32, clamping part, 40, covered stent, 41, stent ring, 50, blood vessel, 51, large bending side, 52, small bending side.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, directly connected, indirectly connected through an intervening medium, or in communication between two elements or in an interaction relationship between two elements, unless otherwise explicitly specified. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
It will be understood that when an element is referred to as being "fixed" or "disposed" on 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 "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.
Based on the problem that the prior interventional therapy is easy to generate the bird's beak phenomenon due to poor fitting property of the stent graft on the vessel wall at the proximal end and the small curved side of the vessel after release, the application provides a stent transport device which can solve the bird's beak phenomenon generated after release of the stent graft.
Specifically, referring to fig. 1 and 2, the stent delivery device of the present application may include a rear release fixation assembly 10, a tube assembly 20 and a guide head 30, wherein the rear release fixation assembly 10 has a plurality of fixation anchor points 11 circumferentially arranged, the fixation anchor points 11 are used for limiting and fixing a stent ring 41 of the stent graft 40, a distance between the fixation anchor points 11 near a first side 12 of the rear release fixation assembly 10 and a rear end surface of the rear release fixation assembly 10 is greater than a distance between the fixation anchor points 11 near a second side 13 of the rear release fixation assembly 10 and a rear end surface of the rear release fixation assembly 10, wherein the first side 12 and the second side 13 are opposite sides of the rear release fixation assembly 10 in a circumferential direction, the first side 12 of the rear release fixation assembly 10 is available for facing a large curved side 51 of the blood vessel 50 and the second side 13 is available for facing a small curved side 52 of the blood vessel 50 when the stent graft 40 is delivered. The tube assembly 20 is disposed at the rear end of the rear release fixing assembly 10 and has a stent graft cavity for receiving the stent graft 40, and can be fitted into the compressed stent graft 40. The guide head 30 is provided at the front end of the rear release fixing assembly 10, has a guide function, can reduce frictional resistance with the inner wall of the blood vessel 50, and ensures that the device can smoothly pass through the complex curved blood vessel 50 structure.
It will be appreciated that the stent delivery device of the present application can be used to deliver a stent graft 40 into a vessel 50, and when the stent delivery device is in use, the stent graft 40 can be crimped into the lumen of the tubular body assembly 20, and the stent rings 41 at the head end of the stent graft 40 can be retained and fixed at the respective anchor points 11 of the post-release fixation assembly 10, and then the stent graft 40 can be delivered and released. The application enables the bracket ring 41 near the second side 13 to have the freedom of sliding the rear end of the rear release fixing assembly 10 by controlling the distance between the fixing anchor point 11 near the first side 12 of the rear release fixing assembly 10 and the rear end surface of the rear release fixing assembly 10 to be larger than the distance between the fixing anchor point 11 near the second side 13 of the rear release fixing assembly 10 and the rear end surface of the rear release fixing assembly 10, and the bracket ring 41 near the second side 13 can still slide to the rear end when the bracket ring 41 near the first side 12 is limited and fixed.
Thus, as shown in fig. 6, when the covered stent 40 is implanted into the blood vessel 50 and the sheath is removed, the covered stent 40 slides towards the rear end under the action of external force, but under the limiting action of the fixing anchor point 11, the covered stent 40 is entirely close to the large curved side 51 of the blood vessel 50, and the covered stent 41 close to the second side 13 is driven to slide further towards the rear end due to the freedom degree of sliding the stent ring 41 close to the second side 13 towards the rear end, so that the covered stent 40 close to the second side 13 is retracted backwards, the upward tilting of the stent ring 41 at the head end of the covered stent 40 due to the action of external force is reduced, the head end of the covered stent 40 can be better attached to the wall of the blood vessel 50 at the small curved side 52 of the blood vessel 50, and the probability of occurrence of a bird's beak' phenomenon after the covered stent 40 is released is reduced.
Alternatively, as shown in fig. 2 and 3, in some embodiments, the rear release fixing assembly 10 may include a fixing body 14 and a plurality of claw arms 15, the fixing body 14 including a pipe body connecting portion 141 and a plurality of claw arm connecting portions 142, the claw arm connecting portions 142 circumferentially protruding from side surfaces of the pipe body connecting portion 141, the claw arms 15 extending from the claw arm connecting portions 142 toward front ends of the pipe body connecting portions 141 in a direction parallel to an axis of the pipe body connecting portion 141, a distance between a front surface of the claw arm connecting portion 142 near the first side 12 and a rear end surface of the pipe body connecting portion 141 being greater than a distance between a front surface of the claw arm connecting portion 142 near the second side 13 and a rear end surface of the pipe body connecting portion 141, and the fixing anchor points 11 respectively disposed at front surfaces of the claw arm connecting portions 142. In this way, the bracket ring 41 of the film covered bracket 40 can pass through the claw arm 15 and hang against the front surface of the claw arm connecting part 142, the claw arm connecting part 142 cooperates with the claw arm 15 to realize limit fixation, and the front surface of the claw arm connecting part 142 close to the second side 13 is closer to the rear end surface of the fixed pipe body connecting part 141, so that the bracket ring 41 close to the second side 13 has the freedom degree of sliding backwards, and the probability of occurrence of the bird's beak phenomenon after the release of the film covered bracket 40 is reduced.
Preferably, as shown in fig. 2 and 3, in some embodiments, the front surface of the jaw arm connection 142 is connected to the front surface of the tube connection 141. In this way, when the bracket ring 41 passes through the claw arm 15, the pipe body connecting portion 141 can be prevented from interfering with the bracket ring 41, and the radial dimension of the claw arm connecting portion 142 can be reduced, which is advantageous for miniaturization of the rear release fixing assembly 10.
In particular, the radial dimension of the jaw arm coupling 142 may be set to zero, i.e., the fixing body 14 does not include the jaw arm coupling 142, and the jaw arm 15 is directly coupled to the front surface of the tube coupling 141. Thus, as shown in fig. 5, in some embodiments, the rear release fastening assembly 10 may include a fastening body 14 and a plurality of claw arms 15, the fastening body 14 including a pipe body connecting portion 141, the claw arms 15 extending from the pipe body connecting portion 141 toward a front end of the pipe body connecting portion 141 in a direction parallel to an axis of the pipe body connecting portion 141, a front surface of the pipe body connecting portion 141 near the first side 12 being spaced from a rear end surface of the pipe body connecting portion 141 by a greater distance than a front surface of the pipe body connecting portion 141 near the second side 13 is spaced from the rear end surface of the pipe body connecting portion 141, and the fastening anchor point 11 being provided at the front surface of the pipe body connecting portion 141. In this way, the bracket ring 41 of the film covered bracket 40 can pass through the claw arm 15 and hang on the front surface of the pipe body connecting part 141, the pipe body connecting part 141 can be in limit fixation by matching with the claw arm 15, and the front surface of the pipe body connecting part 141 close to the second side 13 is closer to the rear end surface of the fixed pipe body connecting part 141, so that the bracket ring 41 close to the second side 13 has the freedom degree of sliding backwards, and the probability of the phenomenon of bird's beak' after the film covered bracket 40 is released is reduced.
Alternatively, when the front surface of the claw arm connecting portion 142 and the front end surface of the tube body connecting portion 141 are connected or the claw arm 15 is directly connected to the front surface of the tube body connecting portion 141, it is possible to control the distance between the fixing anchor point 11 near the first side 12 and the rear end surface of the rear release fixing assembly 10 to be greater than the distance between the fixing anchor point 11 near the second side 13 and the rear end surface of the rear release fixing assembly 10 by controlling the shape of the front surface of the tube body connecting portion 141. For example, the front end surface of the fixing body 14 is inclined, or a plurality of front end surfaces are provided.
Alternatively, as shown in fig. 2 and 3, in some embodiments, the front end surface of the pipe body connecting portion 141 extends obliquely from the first side 12 to the second side 13 in a direction approaching the rear end surface of the pipe body connecting portion 141, so that the distance between each fixing anchor point 11 and the rear end surface of the pipe body connecting portion 141 assumes a stepwise distribution that decreases in order from the first side 12 to the second side 13, and the degree of freedom in which the bracket ring 41 can slide toward the rear end increases in order from the first side 12 to the second side 13. Thus, since the anterior-posterior length of the vessel 50 gradually decreases from the greater curved side 51 to the lesser curved side 52 of the vessel 50, the distance the stent ring 41 slides to the posterior end gradually increases from the first side 12 to the second side 13 during sheath removal, and the upward tilting of the stent ring 41 can be more uniformly controlled, so that the stent graft 40 on the lesser curved side 52 is more adhered to the vessel 50.
Alternatively, as shown in fig. 4, in some embodiments, the front end surface of the pipe body connecting portion 141 includes a first front end surface near the first side 12 and a second front end surface near the second side 13, and the distance between the first front end surface and the rear end surface of the pipe body connecting portion 141 is greater than the distance between the second front end surface and the rear end surface of the pipe body connecting portion 141, such that the minimum distance between the fixing anchor point 11 near the first side 12 and the rear end surface of the pipe body connecting portion 141 is greater than the distance between the fixing anchor point 11 near the second side 13 and the rear end surface of the pipe body connecting portion 141. Thus, during sheath removal, stent ring 41 adjacent first side 12 is constrained from sliding rearward or a small distance, such that stent graft 40 adjacent first side 12 engages major curved side 51, and stent ring 41 adjacent second side 13 slides rearward a large distance, such that stent graft 40 adjacent second side 13 engages vessel 50 wall of minor curved side 52.
In some embodiments, the front ends of the respective jaw arms 15 remain flush, which facilitates assembly of the guide head 30. The length of the claw arm 15 near the second side 13 is at least twice the length of the claw arm 15 near the first side 12. When the front ends of the jaw arms 15 remain flush, the length of the jaw arms 15 may generally represent the sliding distance of the bracket ring 41, and by controlling the length ratio of the jaw arms 15 to be sufficiently large, it is possible to ensure that the bracket ring 41 near the second side 13 has sufficient degrees of freedom to slide rearward, allowing the bracket ring 41 to have a sufficient range of adjustability to cope with the "bird's beak" phenomenon.
Since the diameter of the fixation body 14 is often smaller than the diameter of the stent ring 41 at the head end of the stent graft 40, the stent ring 41 is normally held at a canted angle when it is retained at the fixation anchor point 11. Thus, as shown in fig. 2 and 4, in some embodiments, the front surface of the claw arm connecting portion 142 extends obliquely from the fixed body 14 to the claw arm 15 in a direction away from the rear end surface of the fixed body 14. In other words, the front surface of the claw arm connecting portion 142 is disposed obliquely such that the outer side of the front surface of the claw arm connecting portion 142 is closer to the front end and the inner side of the front surface of the claw arm connecting portion 142 is closer to the rear end. Thus, by providing the front surface of the claw arm connecting portion 142 obliquely, the front surface of the claw arm connecting portion 142 can be made to more closely fit to the holder ring 41, so that the limit fixation of the rear release fixing member 10 and the holder ring 41 is kept tight when removing the sheath.
Furthermore, in some embodiments, the front surface of the claw arm connection portion 142 may also be implemented as a cambered surface, also enabling the bracket contact surface to conform more to the bracket ring 41.
On the other hand, as shown in FIG. 1, in some embodiments, the fixing body 14 is provided with a through hole penetrating along the axial direction of the fixing body 14, and the pipe body assembly 20 includes an inner core pipe 21, a core pipe 22, a top pipe 23 and a sheath pipe 24 sequentially arranged from inside to outside. Push tube 23 may be used to carry body assembly 20 into vessel 50. The top tube 23 and the sheath tube 24 are arranged at intervals to form a film covering cavity, a film covering bracket 40 which can be held by pressing can be arranged in the film covering cavity, the core tube 22 is connected to the rear end of the fixed main body 14, the inner core tube 21 passes through the through hole and is connected to the guide head 30, and the fixed assembly, the rear release fixed assembly 10 and the guide head 30 form a fixed whole.
It will be appreciated that when the stent graft 40 is delivered to the target site, the push tube 23 is held stationary during sheath removal, the sheath 24 is withdrawn, and the stent graft 40 between the push tube 23 and the sheath 24 is released, at this time, the stent graft 40 is subjected to friction to form a tendency to slide toward the rear end, but due to the limiting fixation of the fixation anchor point 11, the stent graft 40 near the large curved side 51 of the blood vessel 50 integrally abuts the wall of the blood vessel 50 on the large curved side 51, and the stent graft 40 near the small curved side 52 of the blood vessel 50 slides toward the rear end to abut the wall of the blood vessel 50 on the small curved side 52. After sheath 24 is detached, the other components of the delivery device are withdrawn from vessel 50.
In some embodiments, as shown in fig. 1, the guide head 30 includes an introduction part 31 and a clamping part 32 connected to the introduction part 31, and the diameter of the introduction part 31 gradually increases from the front end to the rear end of the introduction part 31, so that the introduction part 31 has a streamline design, can reduce the membrane resistance with the wall of the blood vessel 50, can realize the guide function, and can enable the delivery device to smoothly pass through the complex curved blood vessel 50 structure. The diameter of the clamping part 32 is smaller than that of the rear end of the leading-in part 31, and the clamping part 32 is clamped in the clamping interface formed by surrounding each claw arm 15, so that the guide head 30 can seal the clamping interface formed by surrounding each claw arm 15, and the bracket ring 41 is prevented from sliding out of the claw arms 15 forwards, thereby generating potential safety hazards.
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.