CN113081389A - Ascending aorta covered stent and conveying system assembly and using method thereof - Google Patents

Abstract

The invention discloses an ascending aorta covered stent, a conveying system component and a using method thereof, belongs to the technical field of minimally invasive surgery, and is designed for solving the problems that the minimally invasive surgery is difficult to use in the ascending aorta treatment in the prior art. The ascending aorta covered stent and conveying system component comprises a stent conveyor and a covered stent, wherein the stent conveyor comprises an outer sheath tube, an adjustable bent tube, a single-cavity inner middle tube, a single-cavity inner tube, a flexible TIP head, a chronic dilator and an adjusting handle; the covered stent comprises a proximal naked crown stent and a distal covered stent which are connected. The ascending aorta covered stent, the conveying system component and the using method thereof solve the problem that an ascending aorta interlayer is not suitable for minimally invasive surgery, reduce the death rate and complication rate in the operation period, shorten the required hospitalization and postoperative monitoring time, and provide enough axial and radial supporting force and compliance for the outer sheath tube.

Description

Ascending aorta covered stent and conveying system assembly and using method thereof

Technical Field

The invention relates to the technical field of minimally invasive surgery, in particular to an ascending aorta covered stent, a conveying system assembly and a using method thereof.

Background

When the aorta is pathologically dilated by more than 50% of the normal vessel diameter, it is called aortic aneurysm. Aortic aneurysms in the ascending aorta often involve the aortic sinus, which causes aortic insufficiency due to aortic valve insufficiency caused by aortic annular deformation and leaflet separation, and long-term effects on the aortic aneurysm cause heart failure. According to different aortic lesion distributions, aortic dissections can be classified into the following three types according to the DeBakey system: type i dissections originate in the ascending aorta and extend beyond the aortic arch to the descending aorta, and even the abdominal aorta, which is most common. Type ii dissections originate and are confined to the ascending aorta. DeBakey I, II may also be identical to Stanford A.

Among them, the Stanford a type with dissection affecting the ascending aorta is one of the most aggressive vascular system diseases, with higher mortality. Aortic dissection (aortic dissection) is a tear in the middle layer of the aortic wall where there is flowing or coagulated blood. The splitting of the middle layer is generally at the interface between the inner 1/3 and outer 2/3 layers. The interlayer divides the complete aortic wall structure into two parts: the aortic wall comprises a part of aortic wall consisting of an inner membrane layer of the aortic wall and an inner 1/3 layer of the middle layer, and another part of aortic wall consisting of an outer 2/3 layer of the middle layer and an outer membrane layer, wherein the former part is called an inner wall of the interlayer, the latter part is called an outer wall of the interlayer, and a split gap between the inner wall and the outer wall of the interlayer is an interlayer cavity. The aortic dissection located in the ascending aorta of the proximal cleft accounts for 65% of all aortic dissections, 5% of the aortic arch and 30% of the descending aorta.

At present, only open surgery, such as open artificial blood vessel replacement (adopting dacron blood vessel replacement with an artificial main artery valve and implanting coronary artery into dacron blood vessel), and Wheat operation, can be adopted for treatment. When the open surgical operation is carried out, cardiac arrest and extracorporeal circulation are needed, the operation wound is huge, and the death rate and complication rate are high.

Because the ascending aorta has a complex anatomical structure, the heart, valves and coronary arteries are arranged at the front proximal end, the superior brachial artery for supplying blood to the brain and the upper limb is arranged at the back, the blood flow pressure of the ascending aorta is high, the flow rate is high, the pulsation and deformation amplitude of the blood vessel wall is large, and the danger and the weight of the ascending aorta interlayer are high; the stent is difficult to accurately position in a very limited area, the anchoring of the stent needs to overcome the pulsating deformation of the vessel wall, prevent backward displacement and even tear a sandwich layer, and avoid the stent from extending into the sinus in front to prevent the damage to a valve and the blockage of coronary artery, so that the intracavity minimally invasive technology is difficult to be applied to the treatment of ascending aorta.

Disclosure of Invention

One objective of the present invention is to provide an ascending aorta covered stent and a delivery system assembly, which can perform minimally invasive surgery in ascending aorta dissection.

Another object of the invention is to provide a method for using the ascending aorta covered stent and the delivery system component which can carry out minimally invasive surgery in ascending aorta dissection.

To achieve the purpose, on one hand, the invention adopts the following technical scheme:

an ascending aorta covered stent and conveying system component comprises a stent conveyor and a covered stent, wherein the stent conveyor comprises an outer sheath tube, an adjustable elbow, a single-cavity middle tube, a single-cavity inner tube, a flexible TIP head, a chronic dilator and an adjusting handle, one end of the chronic dilator is connected to the head end of the single-cavity middle tube, the other end of the chronic dilator is connected to the single-cavity inner tube, the single-cavity inner tube is arranged in the single-cavity middle tube in a penetrating mode, and the tail end of the single-cavity middle tube and the tail end of the outer sheath tube are respectively connected to the adjusting handle; the adjusting handle comprises an outer sheath tube moving speed control unit, a bent tube direction adjusting unit, a bare crown stent release unit, a distal end covered stent release unit, a front cleaning opening, a rear cleaning opening and a grab handle; the covered stent comprises a proximal naked crown stent and a distal covered stent which are connected; the distal end covered stent comprises a plurality of annular supporting single rings, a cylindrical film and a reinforcing ring, wherein all the supporting single rings are uniformly arranged on the outer wall of the cylindrical film along the axial direction, and the reinforcing ring is fixed on the inner wall of the tail end of the cylindrical film; be provided with preceding barb and back barb on nearly heart-end bare crown support, preceding barb for back barb is in nearly heart position department, the most advanced towards the telecentric end of preceding barb, the most advanced towards nearly heart-end of back barb.

Especially, outer sheath pipe moving speed control unit includes outer sheath pipe back-removing knob and sets up pipe box, flight, back-removing knob grab handle, fast release switch and the V type elastic steel piece in the knob are removed to outer sheath pipe back, the terminal fixed connection of outer sheath pipe to the pipe box, the pipe box card is gone into in the back-removing knob grab handle, the one end of flight is connected to V type elastic steel piece, other end butt are in fast release is released and is closed, fast release switch is configured to can control the flight with the separation and reunion of the external screw thread of grab handle.

Particularly, the adjustable bent pipe comprises a bendable section, a transition connection ejector rod and a rear flexible multi-cavity pipe which are sequentially connected, and the tail end of the rear flexible multi-cavity pipe is fixedly connected with the adjusting handle; wear to be equipped with many traction wires in the adjustable return bend, all the head end of traction wire fixed connection respectively in the different positions department of bendable section front end, all the afterbody of traction wire passes respectively the different azimuth holes of transitional coupling ejector pin and be connected to behind the back toughness multicavity pipe steering assembly on the adjustment handle.

Particularly, the steering assembly comprises a plurality of bending adjusting sliding blocks, the adjusting handle comprises an X-axis direction adjustable bending knob and a Y-axis direction adjustable bending knob, and the plurality of bending adjusting sliding blocks are respectively connected to the X-axis direction adjustable bending knob or the Y-axis direction adjustable bending knob; and/or, the steering assembly comprises two rotating hand wheels, two straight gears and four racks, each rotating hand wheel is connected with one straight gear, the two racks are respectively meshed with one straight gear from two opposite sides, and the racks are respectively connected to the tail parts of the traction wires.

In particular, the bare crown stent release unit comprises a chronic dilator release knob and a bare crown stent release switch, the tail end of the middle tube in the single cavity is connected with an external thread sliding block, the external thread sliding block is connected to the chronic dilator release knob, and the chronic dilator release knob is configured to control the expansion and contraction of the chronic dilator; the proximal bare crown support is bound on the chronic dilator through an elastic cord fastener, and one end of the elastic cord fastener is connected to the bare crown support release switch.

In particular, the bare crown stent release unit comprises a chronic dilator release knob, a circle of reserved binding wires penetrating into the proximal bare crown stent, a bifilar traction wire and a fixing bolt arranged on a middle tube in the single cavity, wherein the bifilar traction wire winds on the reserved binding wires; the front end of the bifilar traction wire is connected to the fixing bolt, the tail end of the bifilar traction wire is connected to an external thread sliding block, the external thread sliding block is connected to the chronic dilator release knob, and the chronic dilator release knob is configured to drive the reserved constraining wire to be tensioned or loosened through the bifilar traction wire, so that the proximal bare crown stent is forced to be compressed or expanded.

Particularly, distal end covered stent release unit includes tectorial membrane section release switch, distal end covered stent is tied by the mantle on the adjustable return bend, wear to be equipped with in the mantle to draw the silk, the front end of drawing the silk is connected to flexible TIP head, the rear end of drawing the silk is connected to tectorial membrane section release switch, tectorial membrane section release switch is configured as can be through taking out the silk releases distal end covered stent.

In particular, the outer sheath comprises a three-layer structure arranged in sequence from the inside to the outside, the inside being made of PTFE material, the middle layer being made of metal wire wrap or woven mesh and the outer layer being made of PEBAX, PU or PTFE material.

In particular, the cylindrical membrane is made of a biocompatible membrane material.

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

In particular, a metal protective sleeve is arranged inside the outer sheath tube in a penetrating way, and the proximal bare crown stent is at least partially positioned in the metal protective sleeve when in a contraction state.

In particular, the reinforcing ring is diamond-shaped; or the supporting single ring and the reinforcing ring are respectively in a sine line shape, the width of the reinforcing ring is smaller than that of the supporting single ring, and the number of wave heads of the reinforcing ring is more than that of the wave heads of the supporting single ring.

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

a method for using an ascending aorta covered stent and a delivery system assembly comprises the following steps:

step 1, pushing a flexible TIP head along a blood vessel until a set position is reached;

step 2, after the covered stent reaches the target disease displacement, removing the outer sheath tube to expose the semi-expanded covered stent; integrally pushing the single-cavity inner tube and the single-cavity inner middle tube forward to expose the proximal bare crown stent;

step 3, withdrawing the single-cavity inner tube and the single-cavity inner middle tube until the chronic dilator is aligned with the proximal bare crown stent; withdrawing the single-lumen inner tube alone to cause the chronic dilator to expand radially, the constrained proximal bare crown stent expanding gradually as the chronic dilator expands;

step 4, adjusting the angle of the proximal bare crown stent in the process of expanding the chronic expander until the proximal bare crown stent is attached to the inner wall of the target lesion blood vessel;

and 5, completely releasing the distal end covered stent, and then independently pushing the single-cavity inner tube forward to separate the chronic dilator from the proximal end bare crown stent, so as to complete the release and angle adjustment of the proximal end bare crown stent.

The stent conveyor of the ascending aorta covered stent and the conveying system component can convey the covered stent for isolating a target lesion blood vessel to a designated position to perform ascending aorta intracavity isolation operation, solves the problem that an ascending aorta interlayer is not suitable for minimally invasive operation, reduces the death rate and complication rate in the operation period, and needs shorter hospitalization and postoperative monitoring time. The outer sheath tube has enough axial and radial supporting force and compliance, and the adjustable bent tube can advance in a blood vessel with serious distortion and a small growth included angle so as to adapt to the circuitous and tortuous of a human vascular system and realize the remote conveying and operation of the covered stent. The setting of preceding barb and back barb makes the naked crown support of proximal end anchor more firm in very limited region, is enough to resist adverse conditions such as blood pressure height, blood flow speed are big, guarantees that the holistic release position of tectorial membrane support and release angle are all enough accurate, and the adherence is better, leaks or takes place to shift in avoiding forming, does not interfere aortic valve and coronary artery entry.

Drawings

FIG. 1 is a schematic structural view of an ascending aorta stent graft and delivery system assembly provided in accordance with an embodiment of the present invention;

FIG. 2 is a schematic diagram of a rack transporter in accordance with an embodiment of the present invention;

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

FIG. 4 is a schematic structural view of the stent transporter according to the embodiment of the present invention after the sheath is retracted;

FIG. 5 is a schematic representation of the stent delivery device after inflation of the chronic dilator;

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 provided in accordance with an embodiment of the present invention;

FIG. 8 is a schematic structural view of an adjustable elbow provided by an embodiment of the present invention;

FIG. 9 is a schematic structural diagram of a transition connecting rod according to an embodiment of the present invention;

FIG. 10 is a schematic view of another preferred construction of a steering assembly provided in accordance with an embodiment of the present invention;

FIG. 11 is a schematic structural view of a distal stent graft provided in accordance with an embodiment of the present invention in a semi-released state;

FIG. 12 is a schematic structural view of a distal stent graft provided in accordance with an embodiment of the present invention in a released state;

FIG. 13 is a schematic view of the manner in which the bungee cord fastener is wrapped in accordance with an embodiment of the present invention;

FIGS. 14 and 15 are schematic structural views of a proximal bare crown stent according to an embodiment of the present invention in a constrained state;

FIGS. 16-20 are schematic views of the process of delivering the stent graft by the stent delivery device.

In the figure:

100. a rack conveyor; 110. an outer sheath tube; 111. a metal protective sleeve; 120. an adjustable bent pipe; 121. a bendable section; 122. a post-malleable multi-lumen tube; 123. drawing wires; 124. bending adjusting slide blocks; 125. the ejector rod is connected in a transition way; 130. a single lumen inner tube; 140. a single-lumen inner tube; 150. a flexible TIP head; 160. a chronic dilator; 171. the back-withdrawing knob of the sheath tube; 172. the knob can be bent in the X-axis direction; 173. a knob capable of being bent in the Y-axis direction; 174. a chronic dilator release knob; 175. a membrane covering section release switch; 176. a bare crown stent release switch; 177. a front cleaning port; 178. cleaning the mouth; 179. a handle; 180. the rope is buckled; 190. a soft film; 191. spinning; 200. covering a membrane stent; 210. a proximal bare crown stent; 211. front barbs; 212. back barbs; 220. a distal covered stent; 221. a supporting single ring; 222. a cylindrical film; 223. a reinforcing ring; 224. a skirt edge; 401. a hand wheel; 402. a spur gear; 403. a rack; 501. retaining the binding filaments; 502. double-strand traction wires; 503. fixing the bolt; 1251. an orientation hole; 1711. pipe sleeve; 1712. a spiral sheet; 1713. withdrawing the knob handle; 1714. a quick release switch; 1715. v-shaped elastic steel sheets.

Detailed Description

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

The present embodiment discloses an ascending aorta stent graft and delivery system assembly, which, as shown in fig. 1, includes a stent transporter 100 and a stent graft 200. As shown in fig. 2 to 5, the stent transporter 100 includes an outer sheath tube 110, an adjustable elbow 120, a single-lumen inner middle tube 130, a single-lumen inner tube 140, a flexible TIP head 150, a chronic dilator 160, and an adjusting handle, wherein one end of the chronic dilator 160 is connected to the head end of the single-lumen inner middle tube 130 and the other end is connected to the single-lumen inner tube 140, the single-lumen inner tube 140 is inserted into the single-lumen inner middle tube 130, and the end of the single-lumen inner middle tube 130 and the end of the outer sheath tube 110 are respectively connected to the adjusting handle; the adjusting handle comprises an outer sheath tube moving speed control unit, a bent tube direction adjusting unit, a bare crown stent release unit, a distal end covered stent release unit, a front cleaning opening 177, a rear cleaning opening 178 and a grab handle 179. The chronic dilator 160 has a function similar to balloon dilatation, improves the adherence of the stent graft 200, shortens the balloon dilatation time, ensures that the anchored stent graft 200 does not shift any more, and solves the problems of aortic blood flow retardation, backflow and the like easily caused by long-time balloon dilatation.

As shown in FIGS. 6 and 7, the stent graft 200 includes a proximal bare crown stent 210 and a distal stent graft 220 connected together. The distal end membrane holder 220 comprises a plurality of annular support single rings 221, a cylindrical film 222 and a reinforcing ring 223, wherein all the support single rings 221 are uniformly arranged on the outer wall of the cylindrical film 222 along the axial direction, and the reinforcing ring 223 is fixed on the inner wall of the tail end of the cylindrical film 222.

The distal end stent graft 220 is preferably made of nickel titanium wire; the single support ring 221 is preferably formed of a sinusoidal wire shape (or referred to as a wavy wire shape) of nitinol in a ring-like configuration. The proximal bare crown stent 210 is preferably formed by carving a plurality of diamond structures sequentially connected by a nickel-titanium alloy material through laser, all the diamond structures are wound into a circle, the uniformly arranged diamond structures have certain radial force and simultaneously reduce the stimulation to the inner wall of the blood vessel, and the inner wall of the blood vessel is uniformly stressed.

A front barb 211 and a rear barb 212 are arranged on the proximal bare crown stent 210, the front barb 211 is positioned at the proximal position relative 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 front barb 211 and the rear barb 212 are each inclined at an angle of 30-45 deg. with respect to the surface of the proximal bare crown stent 210 body. After the proximal bare crown stent 210 is released, the front barbs 211 and the rear barbs 212 are slowly pressed into the inner wall of the blood vessel respectively by utilizing the ball expansion-like function of the chronic dilator 160, so that the proximal bare crown stent 210 can be anchored at a set position more firmly and reliably, and the risk of displacement of the proximal bare crown stent 210 is reduced; the anterior barb 211 and the posterior barb 212 are small in area and have little effect on aortic blood flow. The arrangement of the barbs and the support single ring 221 are sinusoidal (or called wavy), which improves the tightness of the head end of the proximal bare crown stent 210.

The proximal bare crown stent 210 consists of a proximal part and a distal part, wherein the proximal part is in a flared trumpet shape, and the flared inclination angle is 10-30 degrees; the distal end is in a straight cylinder shape and is fixedly connected to the inner wall of the head end of the cylindrical film 222. The outer side of the distal end has a skirt 224, and the skirt 224 is inclined toward the proximal end.

The stent conveyor 100 of the ascending aorta covered stent and conveying system component can convey the covered stent 200 for isolating a target lesion blood vessel to a designated position to carry out ascending aorta intracavity isolation operation to treat ascending aorta dissection or aneurysm, is particularly suitable for treating A-type aorta dissection ascending aortic aneurysm, solves the problem that the ascending aorta dissection is not suitable for minimally invasive operation, reduces the mortality and complication rate in the operation period, and requires shorter hospitalization and postoperative monitoring time. The sheath tube 110 has sufficient axial and radial supporting force and compliance, and the adjustable elbow 120 can advance in a blood vessel with serious distortion and a small growth included angle so as to adapt to the circuitous and tortuous of a human vascular system and realize the remote delivery and operation of the covered stent 200. The arrangement of the front barb 211 and the rear barb 212 ensures that the proximal bare crown stent 210 is anchored more stably in a very limited area, so that adverse conditions such as high blood pressure and high blood flow speed can be resisted, the overall release position and release angle of the covered stent 200 are ensured to be accurate enough, the adherence is better, internal leakage or displacement is avoided, and the aortic valve and coronary artery inlet are not interfered.

On the basis of the structure, the sheath tube moving speed control unit comprises a sheath tube withdrawing knob 171, a pipe sleeve 1711, a spiral piece 1712, a withdrawing knob grab handle 1713, a quick-release switch 1714 and a V-shaped elastic steel piece 1715, wherein the pipe sleeve 1711, the spiral piece 1712, the withdrawing knob grab handle 1713, the quick-release switch 1714 and the V-shaped elastic steel piece 1715 are arranged in the sheath tube withdrawing knob 171, the tail end of the sheath tube 110 is fixedly connected to the pipe sleeve 1711, the pipe sleeve 1711 is clamped in the withdrawing knob grab handle 1713, one end of the spiral piece 1712 is connected to the V-shaped elastic steel piece 1715, and. The fast release switch 1714 can be pressed or loosened to control the clutch between the spiral piece 1712 and the external thread of the grab handle 179, so as to control the fast and slow axial movement speed of the sheath tube 110. Specifically, the sheath tube 110 can be moved slowly in the axial direction by rotating the knob grip 1713 while releasing the quick release switch 1714; the sheath 110 is moved axially quickly by rotating the knob 1713 while pressing the quick release switch 1714.

The target lesion blood vessel sometimes has abnormal growth angle distortion, so that the adjustable bending function is required to be used in the process of conveying the covered stent 200 by the stent conveyor 100, as shown in fig. 8 and 9, the adjustable bending pipe 120 comprises a bendable section 121, a transition connection ejector rod 125 and a rear flexible multi-cavity tube 122 which are sequentially connected, and the tail end of the rear flexible multi-cavity tube 122 is fixedly connected with an adjusting handle; a plurality of pulling wires 123 are arranged in the adjustable bent pipe 120. The head ends of all the traction wires 123 are fixedly connected to different positions of the front end of the bendable section 121 respectively; the tail portions of all the pull wires 123 are connected to the steering assembly on the adjustment handle after passing through the different orientation holes 1251 of the transition joint stem 125 and the rear flexible multi-lumen tubing 122, respectively. The preferable number of the drawing wires 123 is four, and four circular azimuth holes 1251 are symmetrically arranged in the middle shaft of the transition connection ejector rod 125. The bendable section 121 is preferably laser-engraved from a metal tube and can be bent in the radial direction; the bendable section 121 may also be a multi-lumen tube having a front section with a hardness less than a rear section. The built-in traction wire 123 can avoid cutting the inner wall of the blood vessel, and the use is safer.

The specific structure of the steering assembly is not limited, and the bendable section 121 can be pulled to turn by the corresponding traction wire 123. Preferably, the steering assembly may include a plurality of bending adjustment sliders 124, the adjustment handle includes an X-axis direction adjustable bending knob 172 and a Y-axis direction adjustable bending knob 173, and the plurality of bending adjustment sliders 124 are respectively connected to the X-axis direction adjustable bending knob 172 or the Y-axis direction adjustable bending knob 173. Wherein, the X/Y axis direction takes the cross section of the blood vessel as a reference plane, and a vertical coordinate system is formed in the reference plane. The number of the bending adjusting sliders 124 is preferably four, and the tail of each traction wire 123 is connected with one bending adjusting slider 124. Of the four bending adjustment sliders 124, two are left-handed external threads, the other two are right-handed external threads, and both the X-axis direction adjustable bending knob 172 and the Y-axis direction adjustable bending knob 173 have left-handed and right-handed internal threads. The four traction wires 123 are drawn by rotating the adjustable bending knob 172 in the X-axis direction and the adjustable bending knob 173 in the Y-axis direction, so that any bending direction and angle of the bendable section 121 can be realized, and the proximal bare crown support 210 can turn within a range of 360 degrees.

As shown in fig. 10, another preferred structure of the steering assembly is: the device comprises two rotating handwheels 401, two straight gears 402 and four racks 403, wherein each rotating handwheel 401 is connected with one straight gear 402, the two racks 403 are respectively meshed with one straight gear 402 from two opposite sides, and each rack 403 is respectively connected to the tail part of one traction wire 123. The spur gear 402 can be driven to rotate by rotating the hand wheel 401, so that the rack 403 is driven to move, and the soft section at the head end of the multi-cavity pipe is pulled to bend by the traction wire 123.

On the basis of the above-described structure, as shown in fig. 11 to 13, the bare crown stent release unit includes a chronic dilator release knob 174 and a bare crown stent release switch 176, the distal end of the middle tube 130 in the single lumen is connected to an externally threaded slider 301, the externally threaded slider 301 is connected to the chronic dilator release knob 174, and the chronic dilator release knob 174 is configured to control the expansion and contraction of the chronic dilator 160.

The proximal bare crown stent 210 is bound on the chronic dilator 160 through the elastic cord fastener 180, and the proximal bare crown stent 210 is slowly released along with the expansion of the chronic dilator 160; after the elastic cord fastener 180 is removed, the proximal bare crown stent 210 is completely released. After the proximal bare crown stent 210 is completely released, the chronic dilator 160 can still be used to perform a similar "balloon-back" action on the proximal bare crown stent 210.

The bungee cord lock 180 is preferably tied as shown in fig. 13, the proximal bare crown stent 210 is collapsed and sleeved on the outer sidewall of the chronic dilator 160, and the bungee cord lock 180 ties together each node of the proximal bare crown stent 210. One end of the bungee cord buckle 180 is free and the other end is connected to the bare crown stent release switch 176. After the proximal bare crown stent 210 is positioned, the distal covered stent 220 is completely released, and then the release switch 176 is extracted to complete the complete release of the proximal bare crown stent 210.

As shown in fig. 2, 3, 14 and 15, the bare crown stent release unit can be another structure, specifically, it includes a chronic dilator release knob 174, a retaining tie wire 501 penetrating into a circle in the bare crown stent 210 at the proximal end, a double-stranded pull wire 502 and a fixing latch 503 arranged on the middle tube 130 in the single lumen, the double-stranded pull wire 502 is wound on the retaining tie wire 501; the front end of the bifilar traction wire 502 is connected to the fixing latch 503, the tail end of the bifilar traction wire 502 is connected to the external thread sliding block 301, the external thread sliding block 301 is connected to the chronic dilator release knob 174, the chronic dilator release knob 174 is configured to be capable of driving the reserved restraining wire 501 to be tightened or loosened through the bifilar traction wire 502, and the near-core end bare crown stent 210 is forced to be compressed or expanded through the reserved restraining wire 501. Wherein the double-stranded traction wire 502 is made of a smooth metal wire or a polymer wire.

As shown in FIGS. 2 and 11, the distal stent graft release unit includes a stent graft release switch 175, and the distal stent graft 220 is tethered to the adjustable elbow 120 by a flexible membrane 190. The soft film 190 is preferably a rectangular sheet structure having a width of 5mm to 10mm, and channels are formed at both ends of the soft film 190. A filament 191 is threaded through the soft membrane 190, the front end of the filament 191 is connected to the flexible TIP head 150, the rear end of the filament 191 is connected to the cover segment release switch 175, and the cover segment release switch 175 is configured to release the distal cover stent 220 by pulling away the filament 191. The center line of the soft membrane 190 is fixedly connected to the distal end stent graft 220, and when the filament 191 is drawn out, the distal end stent graft 220 is completely released from the proximal end to the distal end in sequence.

On the basis of the above structure, the outer sheath 110 preferably comprises three layers arranged from inside to outside in sequence, the inner layer is made of PTFE material with smooth surface, the middle layer is made of metal wire wrap or woven mesh, and the outer layer is made of PEBAX, PU or PTFE material, so that the outer sheath has good compliance, and has sufficient support, bending resistance and inner and outer surface smoothness in the radial and axial directions.

The cylindrical membrane 222 is preferably made of a biocompatible membrane material, in particular, a biocompatible membrane material, preferably dacron or ePTFE.

On the basis of the above structure, the metal protective sleeve 111 with a length of 10mm to 15mm is inserted into the inner side of the outer sheath 110, and the proximal bare crown stent 210 is at least partially located in the metal protective sleeve 111 when in the contracted state, so as to avoid damaging the inner wall of the outer sheath 110 when the proximal bare crown stent 210 is contracted in the outer sheath 110.

The reinforcing ring 223 is annular as a whole, but the shape of the reinforcing ring 223 in the radial direction is not limited. The reinforcing ring 223 can be diamond-shaped, and the strength is higher; the reinforcing ring 223 may have a sine line shape like the supporting single ring 221, the width of the reinforcing ring 223 is smaller than the width of the supporting single ring 221, and the number of wave heads of the reinforcing ring 223 is greater than the number of wave heads of the supporting single ring 221, so that the processing is more convenient.

The using method of the ascending aorta covered stent and the delivery system component comprises the following steps:

step 1, constructing a channel, as shown in fig. 16 and 17, pushing the flexible TIP head 150 along the blood vessel until reaching the set position. Considering that the stent transporter 100 made of a four-layer structure is relatively stiff, the outer sheath 110 may be withdrawn first at a location with a large turn, and the stent graft 200 may be delivered to the target lesion site using the adjustable bend 120.

Step 2, after the covered stent 200 reaches the target disease displacement, as shown in fig. 18 and 19, the outer sheath 110 is removed, and the semi-expanded covered stent 200 is exposed; the single lumen inner tube 140 and the single lumen inner middle tube 130 are pushed forward as a whole, exposing the proximal bare crown stent 210.

Step 3, withdrawing the single-lumen inner tube 140 and the single-lumen inner middle tube 130 until the chronic dilator 160 is aligned with the proximal bare crown stent 210; after the release angle is adjusted, the single-lumen inner tube 140 is withdrawn individually, allowing the chronic dilator 160 to expand radially, and the constrained proximal bare crown stent 210 gradually expands as the chronic dilator 160 expands.

And 4, adjusting the angle of the proximal bare crown stent 210 in the process of expanding the chronic dilator 160 until the proximal bare crown stent 210 is attached to the inner wall of the target lesion blood vessel. That is, in the process of releasing the proximal bare crown stent 210, the angle of the proximal bare crown stent 210 can be adjusted at any time as needed.

Step 5, as shown in fig. 20, the drawstring 191 is firstly drawn out, and the distal covered stent 220 is completely released; the single intraluminal tube 140 is then advanced alone to slowly retract the chronic dilator 160 until the chronic dilator 160 is completely separated from the proximal bare crown stent 210, completing the release and angular adjustment of the proximal bare crown stent 210.

In the using method, the distal end covered stent 220 and the proximal end bare crown stent 210 are released respectively in sequence. By arranging the adjustable elbow 120 and the chronic dilator 160, the release angle of the proximal bare crown support 210 can be adjusted while the proximal bare crown support is slowly released, so that the proximal bare crown support 210 can be anchored at a target position more accurately, and can be anchored accurately even if the target position is extremely limited, thereby realizing the completion of a minimally invasive operation in a diseased blood vessel of an ascending aorta with an abnormally complex physiological anatomical structure and extremely high critical importance.

In the prior art, when the covered stent is released, the near end of the covered stent is released first, the far end of the covered stent is in a contracted state, the covered stent is in a 'pocket' shape, a 'storm' effect is easily formed, the impact of blood flow on the covered stent is increased, the near cardiac end of the covered stent is easily displaced in serious cases, even the interlayer is broken due to stimulation to the inner wall of a blood vessel, and the covered stent is not suitable for ascending aorta with an abnormal and complex current physiological anatomical structure.

The ascending aorta covered stent and conveying system component can sequentially release the distal end covered stent 220 and the proximal end bare crown stent 210 step by step, after the outer sheath tube 110 is removed, the distal end covered stent 220 bound by the soft membrane 190 with the diameter of 10mm-15mm or a binding wire is released in half, the flexibility is enhanced, the storm effect is reduced, and the safety and the feasibility of the minimally invasive surgery are further improved.

It should be noted that the foregoing is only a preferred embodiment of the present invention and the technical principles employed. 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, although the present invention has been described in greater detail by the above embodiments, the present invention is not limited to the above embodiments, and may include other equivalent embodiments without departing from the spirit of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims (13)

1. An ascending aorta covered stent and conveying system assembly comprises a stent conveyor (100) and a covered stent (200), and is characterized in that the stent conveyor (100) comprises an outer sheath tube (110), an adjustable elbow (120), a single-cavity inner middle tube (130), a single-cavity inner tube (140), a flexible TIP head (150), a chronic dilator (160) and an adjusting handle, one end of the chronic dilator (160) is connected to the head end of the single-cavity inner middle tube (130), the other end of the chronic dilator is connected to the single-cavity inner tube (140), the single-cavity inner tube (140) is arranged in the single-cavity inner middle tube (130) in a penetrating mode, and the tail end of the single-cavity inner middle tube (130) and the tail end of the outer sheath tube (110) are respectively connected to the adjusting handle; the adjusting handle comprises an outer sheath tube moving speed control unit, a bent tube direction adjusting unit, a bare crown stent release unit, a distal end covered stent release unit, a front cleaning opening (177), a rear cleaning opening (178) and a grab handle (179);

the covered stent (200) comprises a proximal naked crown stent (210) and a distal covered stent (220) which are connected with each other; the distal end covered stent (220) comprises a plurality of annular supporting single rings (221), a cylindrical film (222) and a reinforcing ring (223), wherein all the supporting single rings (221) are uniformly arranged on the outer wall of the cylindrical film (222) along the axial direction, and the reinforcing ring (223) is fixed on the inner wall of the tail end of the cylindrical film (222);

be provided with preceding barb (211) and back barb (212) on proximal end bare crown support (210), preceding barb (211) for back barb (212) are in proximal position department, the most advanced distal end of orientation of preceding barb (211), the most advanced proximal end of orientation of back barb (212).

2. The ascending aorta stent graft and delivery system assembly according to claim 1, wherein the sheath moving speed control unit comprises a sheath withdrawing knob (171), and a sleeve (1711), a helical blade (1712), a withdrawing knob handle (1713), a quick release switch (1714) and a V-shaped elastic steel blade (1715) which are arranged in the sheath withdrawing knob (171), wherein the tail end of the sheath (110) is fixedly connected to the sleeve (1711), the sleeve (1711) is clamped in the withdrawing knob handle (1713), one end of the helical blade (1712) is connected to the V-shaped elastic steel blade (1715), the other end of the helical blade abuts against the quick release switch (1714), and the quick release switch (1714) is configured to control the clutch of the helical blade (1712) and the external thread of the handle (179).

3. The ascending aorta stent graft and delivery system assembly according to claim 1, wherein the adjustable elbow (120) comprises a bendable section (121), a transition connection mandrel (125) and a rear flexible multi-lumen tube (122) which are connected in sequence, and the end of the rear flexible multi-lumen tube (122) is fixedly connected with the adjustment handle; wear to be equipped with many haulage wires (123) in adjustable return bend (120), all the head end of haulage wire (123) fixed connection respectively in the different positions department of bendable section (121) front end, all the afterbody of haulage wire (123) passes respectively different azimuth holes (1251) of transitional coupling ejector pin (125) and be connected to behind back toughness multi-chamber pipe (122) on the adjustment handle turn to the subassembly.

4. The ascending aorta stent graft and delivery system assembly according to claim 3, wherein the steering assembly comprises a plurality of bending adjustment sliders (124), the adjustment handle comprises an X-axis direction adjustable bending knob (172) and a Y-axis direction adjustable bending knob (173), and the plurality of bending adjustment sliders (124) are respectively connected to the X-axis direction adjustable bending knob (172) or the Y-axis direction adjustable bending knob (173); and/or the presence of a gas in the gas,

the steering assembly comprises two rotating hand wheels (401), two straight gears (402) and four racks (403), wherein each rotating hand wheel (401) is connected with one straight gear (402), the two racks (403) are respectively meshed with one straight gear (402) from two opposite sides, and the racks (403) are respectively connected to the tail part of the traction wire (123).

5. The ascending aorta stent graft and delivery system assembly according to claim 1, wherein the bare crown stent release unit comprises a chronic dilator release knob (174) and a bare crown stent release switch (176), the distal end of the single endoluminal middle tube (130) is connected to an externally threaded slider (301), the externally threaded slider (301) is connected to the chronic dilator release knob (174), and the chronic dilator release knob (174) is configured to control the expansion and contraction of the chronic dilator (160); the proximal bare crown stent (210) is tied to the chronic dilator (160) by a bungee cord lock (180), one end of the bungee cord lock (180) being connected to the bare crown stent release switch (176).

6. The ascending aorta stent graft and delivery system assembly according to claim 1, wherein the bare crown stent release unit comprises a chronic dilator release knob (174), a loop of retaining tie wire (501) threaded into the proximal bare crown stent (210), a bifilar pull wire (502), and a retaining latch (503) disposed on the single-lumen middle tube (130), the bifilar pull wire (502) being looped over the retaining tie wire (501); the front end of the double-strand traction wire (502) is connected to the fixing bolt (503), the tail end of the double-strand traction wire (502) is connected to the external thread sliding block (301), the external thread sliding block (301) is connected to the chronic dilator release knob (174), and the chronic dilator release knob (174) is configured to be capable of driving the reserved restraining wire (501) to be tensioned or loosened through the double-strand traction wire (502), so that the proximal end bare crown stent (210) is forced to be compressed or expanded.

7. The ascending aorta stent graft and delivery system assembly according to claim 1, wherein the distal stent graft release unit comprises a stent graft release switch (175), the distal stent graft (220) is constrained by a soft membrane (190) on the adjustable elbow (120), a wire draw (191) is threaded through the soft membrane (190), a front end of the wire draw (191) is connected to the flexible TIP (150), a rear end of the wire draw (191) is connected to the stent graft release switch (175), and the stent graft release switch (175) is configured to release the distal stent graft (220) by pulling away the wire draw (191).

8. The ascending aorta stent graft and delivery system assembly according to any one of claims 1 to 7, wherein the outer sheath (110) comprises a three-layer structure sequentially arranged from inside to outside, the inner side is made of PTFE material, the middle layer is made of metal wire wrap or woven mesh, and the outer layer is made of PEBAX, PU or PTFE material.

9. The ascending aorta stent graft and delivery system assembly according to any one of claims 1 to 7, wherein the cylindrical membrane (222) is made of a biocompatible membrane material.

10. The ascending aorta stent graft and delivery system assembly according to any one of claims 1 to 7, wherein the inclination angles of the front barb (211) and the rear barb (212) are each between 30 ° and 45 °.

11. The ascending aorta stent graft and delivery system assembly according to any one of claims 1 to 7, wherein a metal protective sleeve (111) is disposed inside the outer sheath (110), and the proximal bare crown stent (210) is at least partially disposed in the metal protective sleeve (111) in a contracted state.

12. The ascending aorta stent graft and delivery system assembly according to any one of claims 1 to 7, wherein the reinforcement ring (223) is diamond-shaped; or, the supporting single ring (221) and the reinforcing ring (223) are respectively in a sine line shape, the width of the reinforcing ring (223) is smaller than that of the supporting single ring (221), and the wave head number of the reinforcing ring (223) is more than that of the supporting single ring (221).

13. A method for using an ascending aorta covered stent and a delivery system component is characterized by comprising the following steps:

step 1, pushing a flexible TIP head (150) along a blood vessel until a set position is reached;

step 2, after the covered stent (200) reaches the target disease displacement, removing the outer sheath (110) and exposing the semi-expanded covered stent (200); integrally pushing the single-cavity inner tube (140) and the single-cavity inner middle tube (130) forward to expose the proximal bare crown stent (210);

step 3, withdrawing the single-lumen inner tube (140) and the single-lumen inner tube (130) until the chronic dilator (160) is aligned with the proximal bare crown stent (210); withdrawing the single-lumen inner tube (140) alone, radially expanding the chronic dilator (160), the constrained proximal bare crown stent (210) being gradually expanded as the chronic dilator (160) is expanded;

step 4, adjusting the angle of the proximal bare crown stent (210) in the process of expanding the chronic expander (160) until the proximal bare crown stent (210) is attached to the inner wall of the target lesion blood vessel;

and 5, completely releasing the distal end covered stent (220), and then independently pushing the single-cavity inner tube (140) forward to separate the chronic dilator (160) from the proximal end bare crown stent (210) so as to complete the release and angle adjustment of the proximal end bare crown stent (210).

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