WO2015070792A1

WO2015070792A1 - Intraoperative stent system

Info

Publication number: WO2015070792A1
Application number: PCT/CN2014/091094
Authority: WO
Inventors: 景华; 袁振宇; 朱清; 彭大冬; 高延彬; 李中华; 罗七一
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2013-11-15
Filing date: 2014-11-14
Publication date: 2015-05-21
Also published as: CN104622600B; CN104622600A

Abstract

An intraoperative stent system, comprising an artificial blood vessel portion (4) and a main stent portion (5) sutured together with the artificial blood vessel portion (4); the intraoperative stent system also comprises a side branch stent portion (6), the side branch stent portion (6) transversely extending outward from the artificial blood vessel portion (4) or the main stent portion (5), and connecting to and communicating with the artificial blood vessel portion (4) or the main stent portion (5). The intraoperative stent system saves operation time and reduces operation difficulty.

Description

Intraoperative stent system

Technical field

The present invention relates to an intraoperative stent system that can be used for thoracotomy in the treatment of aortic (including ascending aorta, arch and descending aorta) lesions.

Background technique

In the current medical technology, Stanford type A dissection patients with lesions of the whole aorta (including ascending aorta, arch and descending aorta) are generally treated with median thoracotomy, in which artificial blood vessels are used. The ascending aorta and the arch are replaced and an artificial blood vessel (commonly known as elephant trunk) is delivered into the true cavity of the descending aorta to prepare for secondary surgery or secondary intervention (stent graft implantation). Most patients do not complete the treatment after an operation and therefore require a second operation. However, the second operation is to open the chest from the lower left rib, the operation risk is high, the cost is high, and there is a certain difficulty in connection.

An intraoperative stent system developed afterwards can solve the problem of secondary surgery, and all the treatments can be completed by one operation of the intraoperative stent system. This intraoperative stent system is shown in Figure 1. 1 is a schematic view showing the effect of a prior art thoracotomy, wherein reference numeral 1 denotes a ascending aorta, reference numeral 2 denotes a left subclavian artery, and reference numeral 3 denotes a descending aorta. The intraoperative stent system includes an intraoperative stent portion 400 and an artificial blood vessel 500, and the intraoperative stent portion 400 and the artificial blood vessel 500 are sutured together by a suture opening 700. During surgery, the stent is directly delivered into the true lumen of the descending aorta 3 through the incision of the aorta for therapeutic purposes. The stent material on the stent can be sutured with an artificial blood vessel for surgical replacement to form a complete prosthetic replacement system, thus enabling most patients to achieve a single treatment. The operation using the intraoperative stent system not only completes the original two operations into one operation, but also shortens the operation time and reduces the pain of the patient's secondary surgery.

Conventional treatments for the treatment of aortic lesions using thoracotomy are disclosed in the prior art. law. However, the prior art has the following deficiencies:

(1). Some current thoracotomy uses four-branch artificial blood vessels, three of which are anastomosed to the innominate artery, the left common carotid artery, and the left subclavian artery, but in practice, due to human anatomical problems, The left subclavian artery is located in the deep thoracic cavity and is difficult to operate or even visible. This increases the difficulty of the anastomosis of the branch. Even in a considerable number of operations, it is only necessary to cover the left subclavian artery and then solve the problem by bypass surgery. . In this way, while the difficulty of surgery increases, it also increases long-term complications.

(2). There are some clinical cases of stents in three branches, but the clinical long-term treatment with stents in three branches is not ideal. First of all, this kind of product has the problem that the three branches in the operation are not easy to be aligned at the same time, and it is easy to cause one or several branches to be narrow or even blocked in the later stage. Secondly, after anastomosis, the aortic arch at the anastomosis of the vascular head and the left common carotid artery is prone to long-term lesions. Once the two vessels appear re-lesions, it will be difficult to treat.

(3). Some existing branch brackets are not perfect in the design of the side branches. Firstly, the circumflex circumflex is small, and the collaterals can not ensure that the main body and the side branches are well fitted with the blood vessels after entering the branch vessels, and the joints of the main body and the side branches are prone to stenosis or even blockage. The flexibility of adding the lateral roots is generally a soft membrane design, but this will indirectly cause the joint to be easily narrowed, so the above two points are difficult to balance. Secondly, the side support bracket adopts a wave-shaped design, which makes the bracket easy to be folded at the place where the two bracket sections are handed over; and if the side support bracket is woven by the spiral wire, the bracket section is easily displaced during installation.

(4). The existing stents are generally straight stents. Because the aortic arch has a three-dimensional twisted shape, the stent cannot be completely attached to the blood vessel after implantation, and is easy to cause endoleak.

(5). The existing artificial blood vessel is equal in diameter, so it cannot adapt to the requirements of the actual variable diameter blood vessel of the human body.

(6). The current operation time is relatively long, which will cause more pain to the patient and bring greater risk of surgery.

Summary of the invention

In view of the above technical problems of the prior art, an object of the present invention is to develop an intraoperative stent system which can save operation time and reduce the difficulty of surgery.

In particular, the present invention provides an intraoperative stent system comprising an artificial blood vessel portion and a body stent portion sewn together with the artificial blood vessel portion, characterized in that the intraoperative stent system Also included is a side support bracket portion that extends laterally outward from the artificial blood vessel portion or the body stent portion and that is in communication with the artificial blood vessel portion or the body stent portion.

Preferably, the main body bracket portion includes a main body bracket and a main body covering tube covering the main body bracket, and the side support bracket portion includes a side support bracket and a side support covering the side support bracket Membrane tube.

Preferably, the side support bracket is woven by a wire in a substantially spiral shape along the circumferential direction.

Preferably, each circumference of the side support bracket has one or more A-shaped vertices for sewing fixation.

Preferably, the main body bracket portion adopts a pre-bending design:

The main body bracket portion is entirely in the shape of a bellows, and the corrugated sides of the main body bracket portion are designed to have different widths and densities; or

A constraint is imposed on the soft side of the body stent portion.

Preferably, in the case where a constraint is applied to the soft side of the body stent portion, the constraint is achieved by stitching or bonding a portion of the soft side of the body stent portion.

Preferably, the body stent portion has a tapered structure to conform to the tapered inner diameter structure of the actual blood vessel.

Preferably, the bracket segments of the body bracket are independent of each other.

Preferably, a positioning ring is provided at a joint portion of the side branch bracket portion with the artificial blood vessel portion or the body bracket portion to keep the opening at the joint portion clear.

Preferably, the positioning ring is annular in its entirety; or the positioning ring has an annular body and one or more flanges extending from the annular body.

Preferably, the main body bracket portion is provided with a main body bracket binding line for positioning the main body bracket and tying the main body bracket, and for cooperating with the main body control guide wire to control the main body Release of the stent.

Preferably, the side support bracket portion is provided with a side support bracket binding line for positioning the side support bracket and tying the side support bracket, and for controlling the guide wire with the side branch Cooperate to control the release of the side support bracket.

The intraoperative stent system of the invention can save operation time and reduce the difficulty of surgery. Moreover, the intraoperative stent system of the present invention is capable of improving the compliance of the side support and making the side support easier to install and secure. In summary, the present invention can facilitate thoracotomy surgery, reduce operation time, reduce the difficulty of surgery, especially the difficulty of anastomosis of the left subclavian artery, and also reduce postoperative complications and improve the success rate and operation of thoracotomy. After the effect.

DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings to be used in the description of the embodiments will be briefly described below. It is apparent that the drawings in the following description are only specific examples of the present invention, and are not intended to limit the scope of the invention. It will be apparent to those skilled in the art that other embodiments and figures may be obtained in accordance with the embodiments of the invention and the accompanying drawings, without departing from the invention.

Fig. 1 is a schematic view showing the effect of a prior art thoracotomy.

2 is a schematic illustration of an intraoperative stent system in accordance with an embodiment of the present invention.

3A to 3C are schematic views of a body bracket portion using a pre-bending design.

Figure 4 is a schematic view of the side support bracket section of the side support bracket portion.

Figure 5 is a schematic illustration of the use of a positioning ring to effect the engagement of the side support portion with the body portion of the intraoperative stent system.

Figure 6 is a schematic view showing the installation of the intraoperative stent system of the present invention.

Fig. 7 is a schematic view showing the structure of a node for controlling a guide wire and a binding line.

Figure 8 is a schematic illustration of an intraoperative stent system in accordance with Example 1 of the present invention.

Figure 9 is a schematic illustration of the morphology of an intraoperative stent system of the present invention after intravascular release.

Figure 10 is a schematic illustration of an intraoperative stent system in accordance with Example 2 of the present invention.

detailed description

The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the drawings in the embodiments of the present invention. It is apparent that the described embodiments are only a part of the embodiments of the present application, and not all of them. All other embodiments obtained by a person of ordinary skill in the art based on the specific embodiments described herein below, without departing from the scope of the invention, should fall within the scope of the present invention.

2 is a schematic illustration of an intraoperative stent system in accordance with an embodiment of the present invention. As shown in FIG. 2, the intraoperative stent system of the present invention includes an artificial blood vessel portion 5 and a body stent portion 4 that is sewn together with the artificial blood vessel portion 5. The intraoperative stent system further includes a side support stent portion 6 extending laterally outwardly from the artificial blood vessel portion 5 and connected and communicating with the artificial blood vessel portion 5. The intraoperative stent system is a single branch structure as a whole, and belongs to a side branch type intraoperative stent system.

The main body bracket portion 4 includes a main body bracket and a main body laminating tube covering the main body bracket. The side support bracket portion 6 includes a side support bracket and a side branch covered tube covering the side support bracket.

In addition, in some other embodiments of the present invention, the position of the side support bracket portion 6 may also be different from the above design. Specifically, the side support bracket portion 6 may also extend laterally outward from the main body bracket portion 4. And connected to the main body bracket portion 4 and communicated.

The side support of the side support bracket portion 6 may be substantially spiraled by a wire in the circumferential direction Braided. Each circumference of the side support bracket of the side support bracket portion 6 has one or more A-shaped vertices 10 for sewing fixation.

As shown in FIG. 2, the main body bracket portion 4 is provided with a main body bracket binding line 9 for positioning the main body bracket and tying the main body bracket, and for cooperating with the main body control guide wire to control the The release of the main body bracket. In Fig. 2, reference numeral 7 denotes the distal end of the intraoperative stent system, and reference numeral 8 denotes the proximal end of the intraoperative stent system.

The main body bracket of the main body bracket portion 4 and the side support bracket of the side support bracket portion 6 may be made of a metal or non-metal material such as nickel-titanium alloy, cobalt-based alloy, stainless steel, nylon or polyurethane; the main body covered tube and the side support The material of the film tube and the corresponding binding line may be selected from a polymer material (for example, polytetrafluoroethylene, nylon, polyester, polyester, polypropylene, etc.); the artificial blood vessel portion 5 may be made of a material other than the above materials, and may also be coated. To ensure that the blood will not leak.

The side branch stent portion 6 is intended to be placed into the left subclavian artery 2 during surgery. Because the left subclavian artery 2 is located in the deeper thoracic cavity, this design can avoid suturing the side branch stent, reducing the difficulty of anastomosis and the operation time. This surgical method has the advantages of large intraoperative benefit (low difficulty, short time) and low long-term risk (even if the branch is blocked, it will not cause acute complications and is easy to handle). At the same time, such a design does not have the following disadvantages of the three-branch stent: in the operation, the three branches are not easy to be aligned at the same time; the branch is likely to cause stenosis or even blockage in the later stage; once the innominate artery and the left common carotid artery are resected, it is difficult to perform the re- lesion. deal with.

3A-3C are schematic views of the main body bracket portion 4 in a pre-bent design, wherein FIG. 3A is a schematic view showing a pre-bend design by applying a constraint on the soft side 14 of the main body bracket portion 4, and FIG. 3B is a main body bracket portion 4. The corrugations of the rigid side 15 and the soft side 14 are designed to have different widths and densities to form a pre-bend design, and FIG. 3C is a schematic view of the pre-bend angle of the main body bracket portion 4. As shown in FIG. 3A, a constraint is imposed on the soft side 14 of the body stent portion 4 while no constraint is imposed on the rigid side 15. This constraint can be achieved by constraining, bonding or otherwise constraining a portion of the soft side 14 of the body stent portion 4. The constraint point 11 is schematically illustrated in Figure 3A. In the picture In 3A, reference numeral 12 denotes the distal end of the main body bracket portion 4, and reference numeral 13 denotes the proximal end of the main body bracket portion 4. As shown in FIG. 3B, the main body bracket portion 4 is entirely in the shape of a bellows, and the corrugations of the rigid side 15 and the soft side 14 of the main body bracket portion 4 are designed to have different widths and densities, that is, the main body of the main body bracket portion 4. The corrugations of side 15 and soft side 14 are designed to have different pitches to form body bracket portion 4 in a pre-bent design. In Fig. 3B, reference numeral 12 denotes the distal end of the main body bracket portion 4, and reference numeral 13 denotes the proximal end of the main body bracket portion 4. As shown in Fig. 3C, the distal end 12 and the proximal end 13 of the main body bracket portion 4 can form an angle α by the above-described pre-bending, which is formed by the central axis of the distal end 12 of the main body bracket portion 4 and the main body bracket portion. The central axis of the proximal end 13 of 4 is enclosed. It will be understood by those skilled in the art that in the case where the main body bracket portion 4 is bent around a center point, the side of the main body bracket portion 4 closest to the center point is generally referred to as "soft side" or "small curved side", and The side of the main body bracket portion 4 that is furthest from the center point is generally referred to as a "rigid side" or a "large curved side".

As shown in FIGS. 3A and 3B, the main body bracket portion 4 may have a tapered structure to conform to the tapered inner diameter structure of the actual blood vessel. Each main body bracket section of the main body bracket part 4 has a wave-shaped design, and the main body bracket section of the main body bracket part 4 is not designed with reinforcing ribs, and the main brackets of the main body bracket part 4 are independent of each other without connection constraints, and thus the bracket The flexibility is greatly increased so that after release the stent will be able to adapt to the three-dimensional morphology of the actual blood vessel. The above design enables the implanted stent to adhere to the blood vessel to a greater extent, thereby reducing the occurrence of endoleak.

4 is a schematic view showing the preparation of the side support bracket section of the side support bracket portion 6. As shown in FIG. 4, the side support bracket segments of the side support bracket portion 6 can be formed by using a substantially spiral wire. Specifically, all the bracket segments of the side support brackets of the side support bracket portion 6 are separated by a wire. The circumferential direction is woven in a substantially spiral shape. The left side graph in Fig. 4 shows the shape before the spiral winding preparation, and the right side figure in Fig. 4 shows the shape after the spiral winding preparation. The design can maintain the roundness of the side support bracket when it is deployed, so that it fits well with the blood vessel, and can effectively prevent the folding and the root narrowing. In the prior art, the flexibility of the root portion of the side support bracket portion 6 is generally soft. Membrane design, which indirectly causes the area to be easily narrowed, and the substantially circular design of the present invention formed by a single wire can simultaneously ensure root flexibility and roundness, and allows the side support portion 6 to be turned to any Keep the opening in the direction while keeping it open.

As shown in Fig. 4, each side of the side support bracket of the side support bracket portion 6 has one or more A-shaped vertices for sewing fixation. The height of the A-shaped apex 10 relative to the helically extending trajectory projection is the height of the A-shaped apex 10. Such a design having the A-shaped apex 10 can avoid the problem that the side support bracket of the purely annular structure is easily moved relative to the side support film, and can avoid problems such as difficulty in installation and deployment.

Figure 5 is a schematic illustration of the use of a positioning ring 16 to effect engagement of the side support portion 6 with the body portion of the intraoperative stent system. The left side diagram in Figure 5 shows three different embodiments of the positioning ring 16, and the right side figure in Figure 5 shows the positioning ring on the body portion of the intraoperative stent system in accordance with one embodiment of the present invention. Top view of 16. As shown in the right side of Fig. 5, the main body portion of the intraoperative stent system is provided with a side hole 17 for communicating with the side branch bracket portion 6, wherein the positioning is provided along the circumference of the side hole 17. Ring 16. The body portion of the intraoperative stent system shown in Figure 5 can be the artificial blood vessel portion 5 or the body stent portion 4. That is, a positioning ring 16 is provided at a joint portion of the side branch bracket portion 6 with the artificial blood vessel portion 5 or the main body bracket portion 4 to keep the opening at the joint portion clear.

The left side diagram in Figure 5 shows three different embodiments of the positioning ring 16, wherein in the rightmost embodiment, the positioning ring 16 is generally annular; in the leftmost embodiment, the positioning ring 16 has an annular body 19 and a flange 18 extending from the annular body 19 for securing the retaining ring 16; in an intermediate embodiment, the retaining ring 16 has an annular body 19 and two slaves The annular body 19 extends out of a flange 18 for securing the retaining ring 16 and the two flanges 18 extend in two opposite directions, respectively. The flange 18 can make the positioning ring 16 not easy to rotate when it is sewn to the laminating tube, thereby facilitating the fixing of the positioning ring 16. With the above settings, even if the position is not aligned or slightly displaced when the stent is released during surgery, The degree of stenosis of the opening at the junction can be reduced to maximize blood flow.

Moreover, it will be understood by those skilled in the art that the number of flanges 18 of the above described positioning ring 16 is not limited to one or two as described above, but may be more than two.

The side branches of prior art intraoperative stent systems are not well designed. Firstly, the prior art intraoperative stent system has a small circumflex circumflex space, and the collateral branch can not ensure a good fit between the main body and the side branch and the blood vessel after entering the branch vessel, and the joint of the main body and the side branch is prone to stenosis or even blockage. Since the root flexibility of the side support bracket portion is generally increased, a soft film design is generally used, which indirectly causes the portion to be easily narrowed. Therefore, according to the prior art, the above two points are difficult to balance. In addition, the wavy design of the side support brackets makes it easy to fold the brackets where the two bracket sections meet; the bracket sections that are woven by the spiral wire are easily displaced during installation. The side support portion of the present invention combines the advantages of both configurations by providing one or more A-shaped vertices on the single-turn helical wire, thereby taking into account the flexibility and stability of the side support portion.

The installation of the intraoperative stent system of the present invention is described below. Figure 6 is a schematic view showing the installation of the intraoperative stent system of the present invention. As shown in Fig. 6, the intraoperative stent system of the present invention can be controlled by an intraluminal aortic stent graft combined with a sheathless guidewire, and an aortic stent graft lashing design can be employed. The delivery system for the intraoperative stent system of the present invention can include an outer tube 20, an inner tube 21, a proximal tapered tip end 23, an ejection head 22, a body control guidewire 24, a side branch control guidewire 25, and the like. The body control guidewire 24 cooperates with the body stent binding line 9 to control the positioning and release of the body stent portion 4, and the side branch control guidewire 25 cooperates with the side support stent binding wire 26 to control the positioning and release of the side support stent portion 6.

Fig. 7 is a schematic view showing the structure of the junction of the guide wire 28 and the binding wire 27. For the convenience of description, the direction in which the vertical paper faces outward is defined as the direction from bottom to top. As shown in Fig. 7, the upper binding line 27 is bent and returned at the coil node, and the control guide wire 28 does not pass through the curved portion of the upper binding line 27 but passes through the outer side thereof; the lower binding line 27 bending and returning at the coil node, controlling the guide wire 28 through the curved portion of the underlying binding line 27; the upper binding line 27 has two terminals, the lower binding line 27 also has two terminals, and the control wire 28 is disposed on the two leading ends of the upper binding wire 27 and one of the lower binding wires 27, and Below the other lead of the binding line 27 below. It should be understood that the binding line 27 shown in FIG. 7 may be the main body bracket binding line 9 or the side support bracket binding line 26 shown in FIG. 6, and the control guide wire 28 shown in FIG. 7 may be as shown in FIG. The body controls the guide wire 24 or the side branch control guide wire 25. When the node structure of the control guide wire 28 and the binding wire 27 shown in Fig. 7 is applied to Fig. 6, the "lower side" refers to the side adjacent to the main body bracket or the side support bracket, and the "upper" means the distance One side of the main body bracket or side bracket.

As shown in FIGS. 6 and 7, the main body bracket portion 4 of the intraoperative stent system of the present invention is provided with a main body support binding line 9 for positioning the main body support and ligating the main body support, and Used to cooperate with the body control guidewire 24 to control the release of the body stent. The side support bracket portion 6 of the intraoperative stent system of the present invention may also be provided with a side support bracket binding line 26 for positioning the side support bracket and tying the side support bracket, and for The collateral control guidewire 25 cooperates to control the release of the side support bracket.

The specific parameter design of the intraoperative stent system of the present invention is discussed below. The specific structural parameters of the intraoperative stent system shown in Figure 2 can be designed as follows: the proximal end 8 of the stent system can have a diameter of 20-50 mm, and the distal end 7 of the stent system can have a diameter of 20-50 mm. The diameters of the proximal end 8 and the distal end 7 may be different from each other; the length of the artificial blood vessel portion 5 may be 20-300 mm, the length of the main body bracket portion 4 may be 40-200 mm; and the length of the side support bracket portion 6 may be 10-50 mm. The diameter of the side support bracket portion 6 may be 6-16 mm; the length of the half circumference of the restraining coil of the body bracket binding line 9 may be 10-30 mm; the height of the A-shaped vertex of the bracket section of the side support bracket of the side support bracket portion 6 It may be 2-15 mm; the height of the band of the main body bracket portion 4 may be 10-20 mm.

Two specific embodiments of the intraoperative stent system of the present invention are described below.

Example 1:

Figure 8 is a schematic illustration of an intraoperative stent system in accordance with Example 1 of the present invention. Can be as shown in Figure 8. The illustrated size is an intraoperative stent system in which the proximal end 8 of the stent system has a diameter of 30 mm and the distal end 7 of the stent system has a diameter of 26 mm; the length of the artificial blood vessel portion 5 is 70 mm, and the proximal side of the main stent portion 4 The length is 150 mm; the length of the side support bracket portion 6 is 30 mm, the diameter of the side support bracket portion 6 is 10 mm; the length of the half circumference of the binding coil of the main body support binding line 9 is 15 mm; the side support bracket portion 6 is located in the intraoperative stent system The portion of the main body portion having the bracket segment, that is, on the main body bracket portion 4, the height of the A-shaped apex of the bracket portion of the side support bracket of the side support bracket portion 6 is 3 mm, and each ring has an A-shaped apex; The height of the band of the bracket portion 4 is 20 mm. The soft side portion of the main body bracket portion 4 is sewn in the manner shown in Fig. 3A so as to be pre-bent to an initial angle α of 150 degrees.

After the intraoperative stent system is completed, the intraoperative stent system should be installed in the manner shown in Figure 6 and sterilized for use.

The method of establishing extracorporeal circulation, the innominate artery, and the left common carotid artery in the preoperative thoracotomy was the same as the conventional ascending aorta and arch replacement.

In the operation, after the aorta is cut open, the intraoperative stent system of the present invention is sent into the true cavity from the descending aortic opening, and the collateral stent portion 6 is delivered into the left subclavian artery, and then the delivery system is fixed by one hand. The handle is used to ensure that the position of the stent system is immobilized while the other hand grasps the main body control guide wire 24 to pull back, thereby releasing the main body bracket portion 4; then, the rear pull side supports the guide wire 25, thereby releasing the side support bracket portion 6 .

After confirming that the stent system has been fully expanded in the blood vessel, the replacement of the ascending aorta and the aortic arch is performed in a conventional manner. Figure 9 is a schematic illustration of the morphology of an intraoperative stent system of the present invention after intravascular release. In Fig. 9, reference numeral 1 denotes an ascending aorta, reference numeral 2 denotes a left subclavian artery, and reference numeral 3 denotes a descending aorta.

Example 2:

Figure 10 is a schematic illustration of an intraoperative stent system in accordance with Example 2 of the present invention. The intraoperative stent system can be made to the dimensions shown in Figure 10, wherein the proximal end 8 of the stent system has a diameter of 28 mm. The distal end 7 of the system has a diameter of 20 mm; the length of the artificial blood vessel portion 5 is 100 mm, the length of the rigid side of the main body bracket portion 4 is 150 mm; the length of the side support bracket portion 6 is 40 mm, and the diameter of the side support bracket portion 6 is 12 mm. The length of the half-circle of the binding coil of the main body restraint line 9 is 13 mm; the side support portion 6 is located on the portion of the main body portion of the intraoperative stent system without the stent segment, that is, on the artificial blood vessel portion 5, and the side stent portion The height of the A-shaped apex of the bracket section of the side support bracket of 6 is 4 mm, and there are two A-shaped vertices per ring; the height of the band of the main body bracket section 4 is 20 mm. The main body bracket portion 4 pre-bends the main body bracket portion 4 using the rigid-flexible both-side high-corrugation as shown in Fig. 3B so as to be pre-bent to an initial angle α of 150 degrees.

After the stent system is completed, the subsequent installation and release manners are the same as in the first embodiment above.

The intraoperative stent system of the present invention has the following advantages:

(1) The intraoperative stent system of the present invention has one more lateral branch than the conventional intraoperative stent system, and thus can be placed into the left subclavian artery during surgery. Thereby, the operation time can be saved, and the difficulty of suturing the blood vessel at the position of the left subclavian artery can be reduced. At the same time, the intraoperative stent system of the present invention adopts a single-branche design as a whole, and there is no existing three-branch stent system in which the three branches are not easy to be aligned at the same time, and it is easy to cause one or several branches to be narrow or even The problem of blockage.

(2) The side support bracket portion may be formed by a substantially spiral wire, and the side support bracket of the side support bracket portion may be braided by a wire. Thereby, the roundness of the stent can be maintained, the flexibility of the side stent can be improved, and long-term stenosis and obstruction can be prevented.

(3) Each side of the side support bracket has one or more A-shaped vertices for sewing fixation. Thereby, the problem that the side support bracket of the purely annular structure is easily moved relative to the side support film can be avoided, and problems such as difficulty in installation and deployment can be avoided.

(4). The main body bracket portion is pre-bent during suturing, so that after the release, the stent will be able to adapt to the three-dimensional shape of the actual blood vessel. The design of the invention can make the stent and the blood vessel after the implantation adhere to a large extent, so that the occurrence of endoleak can be reduced.

(5) A positioning ring is used at a position where the root of the side support portion is combined with the main body portion of the intraoperative stent system to maintain the shape of the opening. Thereby, the degree of stenosis of the opening can be reduced, and the blood flow can be kept as high as possible.

(6) The main body covering tube of the main body bracket portion is made of a reduced diameter, whereby the gradual inner diameter of the actual blood vessel can be adhered.

The invention can facilitate thoracotomy surgery, reduce operation time, reduce the difficulty of surgery, especially the difficulty of anastomosis of the left subclavian artery, and also reduce postoperative complications and improve the success rate and postoperative effect of thoracotomy.

The above description is only some specific embodiments of the present application. It should be noted that those skilled in the art can make various combinations or make some improvements and modifications to the above embodiments without departing from the principles and inventive concepts of the present invention. And variations are also considered to fall within the scope of the invention and the inventive concept.

Claims

An intraoperative stent system comprising an artificial blood vessel portion and a body stent portion sewn together with the artificial blood vessel portion,

It is characterized by:

The intraoperative stent system further includes a side support stent portion extending laterally outward from the artificial blood vessel portion or the body stent portion, and the artificial blood vessel portion or the body stent Partially connected and connected.
The intraoperative stent system of claim 1 wherein:

The main body bracket portion includes a main body bracket and a main body covering tube covering the main body bracket,

And the side support bracket portion includes a side support bracket and a side support film tube covering the side support bracket.
The intraoperative stent system of claim 2, wherein:

The side support bracket is woven by a wire in a substantially spiral shape along the circumferential direction.
The intraoperative stent system of claim 3 wherein:

Each circumference of the side support bracket has one or more A-shaped vertices for sewing fixation.
The intraoperative stent system according to any one of claims 1 to 4, characterized in that:

The main body bracket portion is entirely a bellows, and the corrugated sides of the main body bracket portion are designed to have different widths and densities such that the main body bracket portion has a pre-bent shape.
The intraoperative stent system according to any one of claims 1 to 4, characterized in that:

The body holder portion has a pre-bent shape by applying a constraint on the soft side of the body holder portion.
The intraoperative stent system of claim 6 wherein:

The constraint is achieved by stitching or bonding a portion of the soft side of the body stent portion.
The intraoperative stent system according to any one of claims 1 to 4, characterized in that:

The body stent portion has a tapered structure to conform to the tapered inner diameter structure of the actual blood vessel.
The intraoperative stent system according to any one of claims 2 to 4, characterized in that:

The body bracket includes a plurality of bracket segments, and each bracket segments are independent of each other.
The intraoperative stent system according to any one of claims 1 to 4, characterized in that:

A positioning ring is disposed at a joint portion of the side branch bracket portion with the artificial blood vessel portion or the body bracket portion to keep the opening at the joint portion clear.
The intraoperative stent system of claim 10, wherein:

The positioning ring is annular in its entirety.
The intraoperative stent system of claim 10, wherein:

The locating ring has an annular body and one or more flanges extending from the annular body.
The intraoperative stent system according to any one of claims 2 to 4, characterized in that:

The main body bracket portion is provided with a main body bracket binding line for positioning the main body bracket and tying the main body bracket, and for cooperating with the main body control guide wire to control release of the main body bracket.
The intraoperative stent system according to any one of claims 2 to 4, characterized in that:

The side support bracket portion is provided with a side support bracket binding line, the side support bracket binding line is used for positioning the side support bracket and binding the side support bracket, and is used for cooperation with the side branch control guide wire to control the The release of the side support stent.