CN113081390B

CN113081390B - Bare crown stent release assembly for ascending aorta stent graft delivery system

Info

Publication number: CN113081390B
Application number: CN202110390774.XA
Authority: CN
Inventors: 陆清声; 张小武; 赫明
Original assignee: Suzhou Innomed Medical Device Co ltd
Current assignee: Suzhou Innomed Medical Device Co ltd
Priority date: 2021-04-12
Filing date: 2021-04-12
Publication date: 2025-06-20
Anticipated expiration: 2041-04-12
Also published as: CN113081390A

Abstract

The invention discloses a bare crown stent release assembly for an ascending aorta covered stent delivery system, belongs to the technical field of minimally invasive surgery, and is designed for solving the problems that an existing stent is difficult to accurately reach a set position and the like. The bare crown stent release assembly for the ascending aorta covered stent delivery system comprises a proximal bare crown stent, a chronic dilator and a chronic dilator release knob, wherein the chronic dilator and the chronic dilator release knob are respectively arranged on the ascending aorta covered stent delivery system, the chronic dilator is positioned in the proximal bare crown stent, the chronic dilator release knob is configured to control expansion and contraction of the chronic dilator, and the proximal bare crown stent is configured to expand along with the expansion of the chronic dilator. The bare crown stent release component for the ascending aorta covered stent delivery system can enable the bare crown stent at the near end to be accurately attached to the inner wall of a target lesion blood vessel, and solves the problem that the ascending aorta interlayer is not suitable for minimally invasive surgery.

Description

Bare crown stent release assembly for ascending aorta covered stent delivery system

Technical Field

The invention relates to the technical field of minimally invasive surgery, in particular to a bare coronary stent release assembly for an ascending aorta covered stent delivery system and the ascending aorta covered stent delivery system comprising the bare coronary stent release assembly.

Background

Aortic aneurysms located in the ascending aorta often involve the aortic sinuses, deforming the aortic annulus and separating the leaflets to cause insufficiency of the aortic valve, long term effects leading to heart failure. At present, only open surgery treatment, open chest artificial blood vessel replacement, such as Bentall operation (dacron blood vessel replacement with artificial aortic valve and re-implanting coronary artery into dacron blood vessel), wheats operation and the like, can be adopted. Cardiac arrest and extracorporeal circulation are required during open surgery treatment, and the operation has huge wound, high mortality rate and high complication rate.

Because the anatomy structure of the ascending aorta is complex, the heart, the valve and the coronary artery are arranged at the front proximal end, the arch branch artery for supplying blood to the brain and the upper limb is arranged at the rear, the blood pressure of the ascending aorta is high, the flow speed is high, the pulsation and the deformation amplitude of the vessel wall are large, the criticality of the interlayer of the ascending aorta is high, the stent is forced to be difficult to be accurately positioned in a very limited area, the anchoring of the stent is to overcome the pulsation deformation of the vessel wall, the backward displacement and even the interlayer tearing are prevented, the stent is prevented from extending into the sinus to prevent the damage to the valve and the coronary artery from being blocked, and the intracavitary minimally invasive technology is difficult to be applied to the treatment of the ascending aorta.

Disclosure of Invention

The invention aims to provide a bare crown stent release assembly for an ascending aorta covered stent delivery system, which can enable a proximal bare crown stent to be accurately attached to the inner wall of a target lesion blood vessel.

Another object of the present invention is to propose an ascending aorta covered stent delivery system that enables endoluminal minimally invasive techniques for treatment of the ascending aorta.

In order to achieve the purpose, on one hand, the invention adopts the following technical scheme:

The bare stent release assembly for the ascending aorta covered stent delivery system comprises a proximal bare stent, a chronic dilator and a chronic dilator release knob, wherein the chronic dilator and the chronic dilator release knob are respectively arranged on the ascending aorta covered stent delivery system, the chronic dilator is positioned in the proximal bare stent, the chronic dilator release knob is configured to control the expansion and contraction of the chronic dilator, and the proximal bare stent is configured to expand along with the expansion of the chronic dilator.

In particular, the bare crown stent release assembly further comprises an elastic rope buckle, the proximal bare crown stent is bound on the chronic expander through the elastic rope buckle, and the binding of the proximal bare crown stent can be released when the elastic rope buckle is released.

In particular, the bare crown stent release assembly further comprises a bare crown stent release switch to which one end of the bungee cord clasp is connected, the bare crown stent release switch being configured to release the bungee cord clasp.

In particular, the near-heart-end bare crown stent is respectively bound on the chronic expander through a plurality of elastic rope buckles, all the elastic rope buckles are sequentially connected, and two adjacent elastic rope buckles are separated by a set distance.

In particular, the elastic cord fastener is formed by tying a cord with elastic deformation capability.

In particular, a front barb and a rear barb are arranged on the proximal bare crown support, the front barb is positioned at a proximal end position relative to the rear barb, the tip of the front barb faces towards the distal end, and the tip of the rear barb faces towards the proximal end.

In particular, the angle of inclination of the front barb and the rear barb are both between 30 ° and 45 °.

On the other hand, the invention adopts the following technical scheme:

The utility model provides an ascending aorta tectorial membrane support conveying system, includes the support conveyer, still includes above-mentioned ascending aorta tectorial membrane support conveying system and releases subassembly with naked guan support, the support conveyer includes outer sheath pipe, single intracavity middle tube, single intracavity inner tube and adjustment handle, chronic expander release knob sets up on the adjustment handle.

In particular, one end of a chronic dilator is connected to the head end of the single-lumen inner tube and the other end is connected to the single-lumen inner tube, the single-lumen inner tube is arranged in the single-lumen inner tube in a penetrating manner, the tail end of the single-lumen inner tube and the tail end of the outer sheath tube are respectively connected to the adjusting handle, and the chronic dilator release knob is configured to drive the single-lumen inner tube to move relative to the single-lumen inner tube.

In particular, a metal protective sleeve is arranged on the inner side of the outer sheath tube in a penetrating way, and the proximal bare crown support is at least partially positioned in the metal protective sleeve when in a contracted state.

The chronic expander release knob of the bare crown stent release assembly for the ascending aorta covered stent delivery system can control the chronic expander to expand and contract, and when the chronic expander expands, the proximal bare crown stent can be gradually expanded until the proximal bare crown stent is attached to the inner wall of a target lesion vessel, so that the ascending aorta intra-cavity isolation operation is performed, the ascending aorta interlayer or aneurysm is treated, the problem that the ascending aorta interlayer is not suitable for minimally invasive operation is solved, the death rate and the complication occurrence rate in the operation period are reduced, and the required hospitalization and postoperative monitoring time is shorter. The chronic dilator has the function similar to balloon dilation, improves the adherence of the covered stent, shortens the balloon dilation time, ensures that the anchored covered stent is not shifted any more, and solves the problems that long-time balloon dilation is easy to cause aortic blood flow stagnation, reflux and the like.

Drawings

FIG. 1 is a schematic structural view of an ascending aortic stent graft delivery system according to an embodiment of the present invention;

FIG. 2 is a schematic view of a stent conveyor according to an embodiment of the present invention;

FIG. 3 is a schematic view of the internal structure of a stent conveyer according to an embodiment of the present invention;

FIG. 4 is a schematic view of a stent delivery device according to an embodiment of the present invention after retraction of the outer sheath;

FIG. 5 is a schematic illustration of the structure of a chronic dilator of a stent delivery device according to an embodiment of the present invention after inflation;

FIG. 6 is a schematic structural view of a proximal bare crown stent according to an embodiment of the present invention;

FIG. 7 is a schematic structural view of a stent graft according to an embodiment of the present invention;

fig. 8 to 12 are schematic views of a stent conveyer conveying a stent graft.

In the figure:

100. The stent comprises a stent conveyer, 110, an outer sheath tube, 111, a metal protective sleeve, 120, an adjustable bent tube, 130, a single-cavity inner tube, 140, a single-cavity inner tube, 150, a flexible TIP head, 160, a chronic dilator, 174, a chronic dilator release knob, 176, a bare crown stent release switch, 200, a covered stent, 210, a proximal bare crown stent, 211, front barbs, 212, rear barbs, 220, a distal covered stent, 301 and an external thread slider.

Detailed Description

The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.

The embodiment discloses a bare coronary stent release assembly for an ascending aorta covered stent delivery system and the ascending aorta covered stent delivery system comprising the bare coronary stent release assembly. As shown in fig. 1 to 7, the ascending aorta covered stent delivery system comprises a stent delivery device 100 and a covered stent 200, wherein the stent delivery device 100 comprises an outer sheath 110, a single lumen inner tube 130, a single lumen inner tube 140, a chronic dilator 160, an adjustment handle, and a chronic dilator release knob 174 provided on the adjustment handle. The stent graft 200 includes a proximal bare crown stent 210 and a distal stent graft 220 connected.

Wherein proximal bare stent 210, chronic dilator 160, and chronic dilator release knob 174 together comprise a bare stent release assembly. The chronic dilator 160 and the chronic dilator release knob 174 are disposed on the ascending aortic stent graft delivery system, respectively, the chronic dilator 160 is positioned inside the proximal bare stent 210, the chronic dilator release knob 174 is configured to control the expansion and contraction of the chronic dilator 160, and the proximal bare stent 210 is configured to expand as the chronic dilator 160 expands.

The chronic expander release knob 174 of the bare stent release assembly can control the expansion and contraction of the chronic expander 160 as required, and when the chronic expander 160 expands, the proximal bare stent 210 can be gradually expanded until the proximal bare stent 210 is attached to the inner wall of a target lesion vessel, so that the ascending aorta intracavity isolation operation is performed to treat the ascending aorta interlayer or aneurysm, the problem that the ascending aorta interlayer is not suitable for minimally invasive operation is solved, the death rate and the complication occurrence rate in the operation period are reduced, and the required hospitalization and postoperative monitoring time is shorter. The chronic dilator 160 has the function similar to balloon dilation, improves the adherence of the covered stent 200, shortens the balloon dilation time, ensures that the anchored covered stent 200 is not shifted any more, and solves the problems that long-time balloon dilation is easy to cause aortic blood flow stagnation, reflux and the like.

Based on the above structure, the bare crown stent release assembly further comprises a bungee buckle (not shown), the proximal bare crown stent 210 is bound to the chronic expander 160 by the bungee buckle, and the binding of the proximal bare crown stent 210 can be released when the bungee buckle is released. The proximal bare crown stent 210 is slowly released as the chronic dilator 160 expands, and the proximal bare crown stent 210 is completely released after the bungee cord buckle is withdrawn. After the proximal bare crown stent 210 is fully released, the chronic dilator 160 may still be used to perform a "balloon post-expansion" like action on the proximal bare crown stent 210.

The specific loosening manner of the bungee cord fastener is not limited, and preferably, the bare crown stent release assembly further includes a bare crown stent release switch 176, one end of the bungee cord fastener is connected to the bare crown stent release switch 176, and the bare crown stent release switch 176 is configured to release the bungee cord fastener to complete the complete release of the proximal bare crown stent 210.

In order to improve the binding firmness, the proximal bare crown stent 210 is respectively bound on the chronic expander 160 through a plurality of elastic rope buckles, all the elastic rope buckles are sequentially connected, and two adjacent elastic rope buckles are separated by a set distance, so that the proximal bare crown stent 210 is prevented from being bound by the elastic rope buckles when expanding. Preferably, the bungee cord lock is formed by tying a knot in a cord with elastic deformation capability, allowing a greater range of extension of the proximal bare crown stent 210.

Based on the above structure, as shown in fig. 6 and 7, a front barb 211 and a rear barb 212 are provided on the proximal bare crown support 210, the front barb 211 is located at a proximal position with respect to the rear barb 212, the tip of the front barb 211 faces the distal end, and the tip of the rear barb 212 faces the proximal end.

The arrangement of the front barbs 211 and the rear barbs 212 enables the proximal bare crown stent 210 to be anchored more firmly in a very limited area, is sufficient to resist adverse conditions such as high blood pressure, high blood flow speed and the like, ensures that the overall release position and release angle of the covered stent 200 are accurate enough, has better adherence, avoids forming internal leakage or displacement, and does not interfere with aortic valves and coronary inlets.

The proximal bare crown stent 210 consists of a proximal end and a distal end, wherein the proximal end is in the shape of a flared horn, and the flared angle is 10-30 degrees. The proximal bare crown stent 210 is preferably made of nickel-titanium alloy material and is engraved into a plurality of diamond structures sequentially connected by laser, all diamond structures are wound into a circle, and the uniformly arranged diamond structures have certain radial force, simultaneously reduce the stimulation to the inner wall of the blood vessel, and have uniform stress on the inner wall of the blood vessel.

The front barb 211 and the rear barb 212 each have an inclination angle of 30 deg. -45 deg. with respect to the surface of the body of the proximal bare crown stent 210. After the release of the proximal bare crown stent 210 is completed, the front barbs 211 and the rear barbs 212 are respectively pressed into the inner wall of the blood vessel slowly by utilizing the ball-like expansion function of the chronic dilator 160, so that the proximal bare crown stent 210 can be anchored at the set position more firmly and reliably, the risk of displacement of the proximal bare crown stent 210 is reduced, the areas of the front barbs 211 and the rear barbs 212 are small, the influence on the aortic blood flow is very small, and the tightness of the head end of the proximal bare crown stent 210 is improved.

The specific manner in which the chronic dilator 160 is expanded and contracted is not limited, and preferably, one end of the chronic dilator 160 is connected to the head end of the single-lumen inner tube 130 and the other end is connected to the single-lumen inner tube 140, the single-lumen inner tube 140 is threaded into the single-lumen inner tube 130, the distal end of the single-lumen inner tube 140, and the distal end of the outer sheath tube 110 are respectively connected to adjustment handles, and the chronic dilator release knob 174 is configured to be capable of driving the single-lumen inner tube 140 to move relative to the single-lumen inner tube 130. Preferably, the end of the single lumen inner tube 140 is connected to an externally threaded slider 301, the externally threaded slider 301 being connected to a chronic dilator release knob 174.

When the distance between the head end of the single-lumen inner tube 140 and the head end of the single-lumen inner tube 130 is gradually increased, the chronic expander 160 is axially elongated and radially reduced, so that the contraction of the chronic expander 160 is realized, and when the distance between the head end of the single-lumen inner tube 140 and the head end of the single-lumen inner tube 130 is gradually reduced, the chronic expander 160 is axially contracted and radially expanded, so that the expansion of the chronic expander 160 is realized.

On the basis of the above structure, as shown in fig. 2 and 3, a metal protective tube 111 with a length of 10mm-15mm is inserted into the inner side of the outer sheath tube 110, and the proximal bare crown stent 210 is at least partially positioned in the metal protective tube 111 when in a contracted state, so that the inner wall of the outer sheath tube 110 is prevented from being damaged when the proximal bare crown stent 210 is contracted in the outer sheath tube 110.

The use method of the ascending aorta covered stent delivery system comprises the following steps:

Step 1, build the channel, as shown in fig. 8 and 9, pushing the flexible TIP head 150 along the blood vessel until the set position is reached. Considering the stiffness of the stent delivery device 100, which is made of a four-layer structure, the sheath 110 can be removed first at the location of the greater turns, and the stent graft 200 can be delivered to the target lesion using the adjustable bend 120.

Step 2, after the stent graft 200 reaches the target lesion position, as shown in fig. 10 and 11, the outer sheath 110 is removed to expose the semi-expanded stent graft 200, and the single-lumen inner tube 130 are pushed forward as a whole to expose the proximal bare crown stent 210.

And 3, withdrawing the single-cavity inner tube and the single-cavity inner middle tube 130 until the chronic dilator is aligned with the proximal bare crown stent 210, and after the release angle is adjusted, withdrawing the single-cavity inner tube independently to expand the chronic dilator along the radial direction, wherein the constrained proximal bare crown stent 210 is gradually expanded along with the expansion of the chronic dilator.

And 4, adjusting the angle of the proximal bare crown stent 210 in the process of expanding the chronic expander until the proximal bare crown stent 210 is attached to the inner wall of the target lesion vessel. That is, the angle of the proximal bare crown stent 210 can be adjusted as desired at any time during the release of the proximal bare crown stent 210.

Step 5, as shown in fig. 12, the distal covered stent 220 is completely released by first drawing out the filament, and then the single lumen inner tube 140 is pushed forward alone to slowly shrink the chronic dilator until the chronic dilator is completely separated from the proximal bare crown stent 210, thereby completing the release and angle adjustment of the proximal bare crown stent 210.

In this method of use, the distal covered stent 220 and the proximal bare crown stent 210 are released sequentially. By arranging the adjustable bent pipe 120 and the chronic expander, the release angle of the proximal bare crown stent 210 can be adjusted while the proximal bare crown stent is slowly released, so that the proximal bare crown stent 210 can be accurately anchored on a target position, even if the target position is extremely limited, the proximal bare crown stent can be accurately anchored, and therefore, the minimally invasive operation can be completed in an ascending aortic lesion vessel with extremely complex physiological anatomy structure and extremely high criticality.

In the prior art, when the covered stent is released, the proximal end is released first, the distal end is contracted, the covered stent at the moment is like a pocket, a storm effect is easy to form, the impact of blood flow on the covered stent is increased, the proximal end of the covered stent is easy to shift when serious, and even the covered stent is stimulated to the inner wall of a blood vessel, so that an interlayer is broken, and the covered stent is not suitable for an ascending aorta with a current physiological anatomy structure which is extremely complex.

The ascending aorta covered stent and the conveying system component can sequentially release the distal covered stent 220 and the proximal bare crown stent 210 step by step, after the outer sheath tube 110 is removed, the distal covered stent 220 bound by a soft membrane or a binding wire with the diameter of 10mm-15mm is semi-released, the storm effect is reduced while the flexibility is enhanced, and the safety and feasibility of the minimally invasive surgery are further improved.

Note that the above is only a preferred embodiment of the present invention and the technical principle applied. It will be understood by those skilled in the art that the present invention is not limited to the particular embodiments described herein, but is capable of various obvious changes, rearrangements and substitutions as will now become apparent to those skilled in the art without departing from the scope of the invention. Therefore, while the invention has been described in connection with the above embodiments, the invention is not limited to the embodiments, but may be embodied in many other equivalent forms without departing from the spirit or scope of the invention, which is set forth in the following claims.

Claims

1. The bare stent release assembly for the ascending aorta covered stent delivery system is characterized by comprising a proximal bare stent (210), a chronic dilator (160) and a chronic dilator release knob (174), wherein the chronic dilator (160) and the chronic dilator release knob (174) are respectively arranged on the ascending aorta covered stent delivery system, the chronic dilator (160) is positioned inside the proximal bare stent (210), the chronic dilator release knob (174) is configured to control the expansion and contraction of the chronic dilator (160), the proximal bare stent (210) is configured to expand along with the expansion of the chronic dilator (160), and the chronic dilator release knob (174) controls the expansion and contraction of the chronic dilator (160) according to requirements.

2. The bare crown stent delivery assembly for an ascending aortic stent graft delivery system according to claim 1, further comprising a bungee cord clip by which the proximal bare crown stent (210) is cinched to the chronic dilator (160), the bungee cord clip being released to release the restraint of the proximal bare crown stent (210).

3. The bare crown stent release assembly for an ascending aortic stent delivery system according to claim 2, further comprising a bare crown stent release switch (176), wherein one end of the bungee cord clip is connected to the bare crown stent release switch (176), and wherein the bare crown stent release switch (176) is configured to release the bungee cord clip.

4. The bare crown stent delivery assembly for an ascending aortic stent graft delivery system according to claim 2, wherein the proximal bare crown stent (210) is bound to the chronic dilator (160) by a plurality of bungee cords, respectively, all of the bungee cords being connected in sequence and two adjacent bungee cords being spaced apart by a set distance.

5. The bare stent delivery assembly for an ascending aortic stent delivery system according to claim 4, wherein the bungee cord fastener is formed by a knot of a cord having elastic deformation capability.

6. The bare crown stent delivery assembly for an ascending aortic stent delivery system according to any one of claims 1 to 5, wherein a front barb (211) and a rear barb (212) are provided on the proximal bare crown stent (210), the front barb (211) being in a proximal position relative to the rear barb (212), the tip of the front barb (211) being distal and the tip of the rear barb (212) being proximal.

7. The bare crown stent delivery assembly for an ascending aortic stent delivery system according to claim 6, wherein the anterior barb (211) and the posterior barb (212) are each angled between 30 ° -45 °.

8. An ascending aorta covered stent delivery system comprising a stent delivery device (100), further comprising a bare crown stent delivery assembly for an ascending aorta covered stent delivery system according to any of claims 1 to 7, the stent delivery device (100) comprising an outer sheath (110), a single lumen inner tube (130), a single lumen inner tube (140) and an adjustment handle, a chronic dilator release knob (174) being disposed on the adjustment handle.

9. The ascending aortic stent delivery system according to claim 8, wherein a chronic dilator (160) is connected at one end to a head end of the single lumen inner tube (130) and at the other end to the single lumen inner tube (140), the single lumen inner tube (140) is threaded into the single lumen inner tube (130), the ends of the single lumen inner tube (130), the single lumen inner tube (140) and the outer sheath tube (110) are each connected to the adjustment handle, and the chronic dilator release knob (174) is configured to drive movement of the single lumen inner tube (140) relative to the single lumen inner tube (130).

10. The ascending aortic stent graft delivery system according to claim 8, wherein a metal protective sleeve (111) is threaded inside the outer sheath (110), the proximal bare stent (210) being at least partially within the metal protective sleeve (111) when in a contracted state.