WO2022257163A1

WO2022257163A1 - Blood vessel connecting device and preparation method therefor

Info

Publication number: WO2022257163A1
Application number: PCT/CN2021/100519
Authority: WO
Inventors: 杜广武; 陈剑锋
Original assignee: 上海畅迪医疗科技有限公司
Priority date: 2021-06-09
Filing date: 2021-06-17
Publication date: 2022-12-15
Also published as: CN113425474A

Abstract

A blood vessel connecting device and a preparation method therefor, the blood vessel connecting device comprising a nickel-titanium woven stent (3) and a connecting pipe (1), wherein the nickel-titanium woven stent (3) and the connecting pipe are each covered with a polytetrafluoroethylene coating film (2) to make the device an integrated structure. A film-coated stent of the blood vessel connecting device may be released into a collateral blood vessel (a head arm trunk artery, a left common carotid artery, or a left subclavian artery) of an aortic arch, and the connecting pipe (1) is used for connecting a collateral artificial blood vessel of a four-branch artificial blood vessel, so that the collateral artificial blood vessel of the four-branch artificial blood vessel and the aortic collateral blood vessel can be suture-free, thereby reducing the time needed for an aortic arch replacement surgery.

Description

A kind of blood vessel connection device and preparation method thereof

technical field

The invention belongs to the technical field of medical devices, and relates to a blood vessel connection device and a preparation method thereof.

Background technique

The human aortic wall is divided into three layers: inner, middle, and outer. Aortic dissection is caused by various reasons when the elastic layer of the inner layer of the aorta is torn, and blood flows into the aortic wall through the tear. , causing the media and adventitia to peel off, and blood pools to form a cavity in the artery wall. The continuous impact of blood flow will cause serious damage to the structure of the aortic wall, which may cause a series of serious problems. Because the aorta is close to the heart, the pressure is often high. Once the dissection ruptures, the blood of the heart will flow out of the rupture rapidly, causing acute massive bleeding, and eventually hemorrhagic shock or cardiac tamponade and sudden death.

Aortic dissection is the most critical and complicated disease in cardiac surgery. If timely and effective treatment is not carried out, the chance of rupture of the aortic dissection is very high. Once a rupture occurs, it is very dangerous, and it is a clinical critical illness with a high mortality rate. Generally, for patients with ruptured aortic dissection and sent to the hospital, the mortality rate reaches 50% within 48 hours, and the mortality rate increases by 1% for every additional hour, and the mortality rate reaches 65%-75% within two weeks. Once aortic dissection is found, surgical treatment should be performed in time to avoid dissection rupture.

At present, there are more than 2,000 hospitals in the United States that can perform cardiovascular surgery, while China has less than 300, and all of them are concentrated in large cities. The development of cardiac surgery in small and medium-sized cities is relatively slow, and there are even fewer hospitals that can perform large-vessel surgery. Aortic dissection surgery has high requirements for the surgeon. Now some provincial hospitals are not able to perform acute aortic dissection surgery, and it is difficult to transfer patients in a timely and rapid manner. It takes time for experts from other places to go to the surgery, so preoperative The waiting rate is high. According to the data from the International Acute Aortic Dissection Registry, the average time from onset to diagnosis of type A dissection in western countries is 3.9 hours, and the average time from diagnosis to operation is 5.3 hours. There is still a lack of relevant data in my country. It is conservatively estimated that the time from onset to operation is about 4.5 days, which is far from the level in foreign countries. The distribution of medical resources in my country is uneven, and there are limited units that can independently carry out the treatment of aortic dissection. Patients often need to be transported long distances to large diagnosis and treatment centers for surgery. For patients with aortic dissection who require strict bed rest after onset, the process of transport may hasten the death of the patient. According to incomplete statistics, there are about 200,000 new cases of aortic dissection in my country every year, and under current conditions, about 90% of the patients still cannot receive timely and effective treatment and die or face death at any time. According to statistics from the White Paper on Cardiac Surgery and Extracorporeal Circulation Data in China, in 2015, 12,828 cases of aortic dissection were treated in China; in 2016, 15,593 cases were treated; in 2017, 19,585 cases were treated; in 2018, 22,898 cases were treated. It can be seen that with the development of my country's economy and medical level, the number of patients receiving treatment for aortic dissection is increasing year by year, but most patients still lose their lives without timely and effective treatment.

Contents of the invention

The invention aims at the problems existing in the treatment of aortic dissection, reduces the treatment difficulty of aortic dissection operation, and provides a blood vessel connection device and a preparation method.

In order to achieve the above technical purpose, the present invention adopts the following technical solutions.

On the one hand, the present invention provides a blood vessel connection device, comprising: a nickel-titanium braided stent and a connecting tube, both of the nickel-titanium braided stent and the connecting tube have a circular tubular structure, and the connection between the nickel-titanium braided stent and the The tubing is covered with Teflon film to make the device a unitary structure.

Further, both the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe are covered with a polytetrafluoroethylene film; or the inner surfaces of the nickel-titanium braided stent and the connecting pipe are covered with a polytetrafluoroethylene film. The outer surface of the connecting pipe is covered with a polytetrafluoroethylene coating, and the coating extends to part of the outer surface of the nickel-titanium braided stent.

Further, the nickel-titanium braided stent has a length of 10mm-50mm and an outer diameter of 8mm-16mm. The setting of the length of the stent here is to ensure the bonding strength between the stent and the side branch vessels of the aortic arch, and at the same time make the length of the nickel-titanium braided stent not too long (after the stent is released to the corresponding side branch vessel, it will be attached to the inner side of the vessel. surface, tightly bonded together, the longer the length of the scaffold, the greater the corresponding bonding force). The setting of the outer diameter of the stent is to ensure that the nickel-titanium braided stent is suitable for connecting the collateral vessels of the aortic arch in most cases.

Further, the connecting pipe has a length of 6mm-20mm, an outer diameter of 6mm-12mm, and a wall thickness of 0.1mm-0.5mm. Here, the length of the connecting tube is set to ensure that the connecting tube has sufficient length to connect with the four-branch artificial blood vessel, and at the same time, the length of the connecting tube is not too long. The setting of the outer diameter is to ensure that the connecting tube is suitable for connecting the side branch artificial blood vessels of the four branch artificial blood vessels.

In a specific embodiment, the tubular nickel-titanium braided stent and the connecting tube have the same diameter or different diameters, and the circular tubular nickel-titanium braided stent and the connecting tube can be of equal or reduced diameter respectively.

Further, the outer surface of the connecting pipe is provided with grooves, and the grooves are distributed continuously or intermittently. During use, the connecting tube will first be inserted into the lumen of the side branch artificial blood vessel of the four-branch artificial blood vessel, and then the two are fixed on the outer surface of the side branch artificial blood vessel with sutures, wire ties or cable ties. The setting of the groove can ensure that the sutures, wire ties or cable ties are not easy to shift after fixing the connecting tube and the side branch artificial blood vessel, and can ensure the connection strength of the connecting tube and the side branch artificial blood vessel.

Still further, the grooves are horizontal grooves or vertical grooves, or both horizontal and vertical grooves are provided.

Still further, the groove depth of the groove is 0.05mm-0.30mm, and the groove width is 0.5mm-2.0mm.

Further, the diameter of the nickel-titanium wire is 0.006"-0.012". The wire diameter setting here is to ensure that the stent has sufficient radial support force without affecting the normal crimping and use of the stent.

Further, the connecting pipe is made of metal material, and the metal material is one of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy material. The selected materials have good biocompatibility and are suitable for long-term implantation in vivo. The connecting pipe is preferably a metal connecting pipe, and may also be a plastic pipe in other embodiments, such as: polytetrafluoroethylene connecting pipe, polyethylene connecting pipe, polypropylene connecting pipe, polyethylene terephthalate connecting pipe, UHMWPE connecting tubing.

Still further, the outer surface of the connecting tube is provided with a through hole, which can be circular or polygonal, and the surface friction of the connecting tube and the side branch artificial blood vessel is increased by setting the through hole on the surface of the connecting tube to ensure that the connecting tube and the connection strength of collateral artificial vessels. In a specific embodiment, the circular tubular connecting pipe is optionally made of metal, and the through holes processed on the surface can be circular or polygonal, so that the metal surface coverage of the connecting pipe is 30%-80%, and the circular or polygonal shape of the connecting pipe surface The polygonal hole can reduce the metal surface coverage of the connecting pipe and reduce the weight of the connecting pipe.

Further, the average thickness of the ePTFE coating (polytetrafluoroethylene coating) is 20 microns-80 microns. The ePTFE coating set here is to ensure that the connecting device does not leak blood during use, and the thickness is not too thick to ensure the bending resistance of the covered stent.

In a second aspect, the present invention provides a method for preparing a vascular connection device, comprising the following steps:

According to the selected size, use a lathe to process the round tubular metal connecting pipe, and deburr and polish the connecting pipe to make its surface smooth;

According to the selected size, nickel-titanium braided stents are braided with nickel-titanium wire, and the braided nickel-titanium braided stents are subjected to high-temperature heat setting treatment, and the heat-set nickel-titanium braided stents are subjected to chemical polishing or electrochemical polishing. Remove the oxide layer on the surface of the stent, followed by chemical passivation treatment (polishing treatment can remove the crystalline oxide layer on the surface of the stent, and chemical passivation treatment can introduce an amorphous oxide layer on the surface of the stent to increase the corrosion resistance of the stent);

Cover the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe with a polytetrafluoroethylene film, so that the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe are completely covered by the polytetrafluoroethylene film, and then perform high-temperature sintering treatment to make the inner and outer surfaces The film of the ePTFE film is closely attached together (the ePTFE film has good biocompatibility, and it will not cause discomfort to the surrounding tissues and the environment after being implanted in the body; the surface friction coefficient of the ePTFE film is low, and it is not easy to form after contact with blood. Thrombus; the biological stability of the ePTFE coating is also very good, no degradation reaction will occur after long-term implantation in the body, and it can maintain stable mechanical strength for a long time);

Skirt the Teflon covering at the end of the NiTi braided stent away from the connecting tube.

Beneficial technical effects achieved by the present invention: the present invention uses the nickel-titanium braided stent and the connecting tube as components of the vascular connection device, and covers the polytetrafluoroethylene coating (ePTFE coating) so that the nickel-titanium braided bracket and the connecting tube are integrated formula structure. It can ensure the simplicity of the operation and shorten the operation time as much as possible. The ePTFE coating has good strength, which can ensure the stable combination of the nickel-titanium braided stent and the connecting tube;

The connecting tube part of the vascular connection device provided in the present invention is connected with the four-branch artificial blood vessel, and the combination of the nickel-titanium stent and the side branch blood vessels of the aortic arch can enable the side branch blood vessels to be suture-free during the aortic arch replacement operation, thereby reducing the aortic arch. The time of replacement operation; the reduction of operation time also shortens the time of deep hypothermia and circulatory arrest accordingly, which can ensure the blood supply of the patient's upper body and brain in time, thereby reducing the postoperative complications of the patient and improving the patient's condition. prognosis and improve quality of life;

The nickel-titanium braided stent part of the vascular connection device provided by the present invention can be released into the collateral vessels (brachiocephalic artery, left common carotid artery and left subclavian artery) of the aortic arch, and the connecting tube part is used to connect the four-branch artificial blood vessels. The side branch artificial blood vessel makes the side branch artificial blood vessel of the artificial blood vessel and the side branch blood vessel of the aorta realize suture-free, which is used to reduce the time of aortic arch replacement operation, and the operation time of aortic dissection operation can also be correspondingly reduced, so that Lower the operating threshold for doctors, further increase the popularity of aortic dissection surgery, enable grass-roots hospitals to have the ability to carry out aortic dissection surgery, and shorten the time from the onset of the disease to the actual treatment of patients (because many local hospitals still lack aortic dissection surgery ability, patients with aortic dissection need to be transferred for treatment after diagnosis), and improve the treatment rate of patients. The blood vessel connection device of the present invention is expected to be widely used in aortic arch replacement surgery, and has certain social and economic benefits.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and thus It should be regarded as a limitation on the scope, and those skilled in the art can also obtain other related drawings based on these drawings without creative work.

Fig. 1 is a schematic structural view of the inner surface of the vascular connection device provided by a specific embodiment of the present invention after coating;

Fig. 2 is a schematic structural view of a connecting tube of a blood vessel connecting device provided by a specific embodiment of the present invention;

Fig. 3 is a schematic structural view of a connecting tube of a blood vessel connecting device provided by a specific embodiment of the present invention;

The symbols in the figure are defined as follows:

1‐connecting pipe; 2‐inner surface polytetrafluoroethylene coating; 3‐nickel-titanium braided stent; 4‐outer surface polytetrafluoroethylene coating; 5‐through hole; 6‐horizontal groove; 7‐vertical direction groove.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention. In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "horizontal", "vertical", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description , rather than indicating or implying that the referred components must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of the present invention.

Embodiment 1. A blood vessel connection device (as shown in FIG. 1 ), comprising: a nickel-titanium braided stent 3 and a connecting tube 1, both of the nickel-titanium braided stent 3 and the connecting tube 1 have a circular tubular structure, and the The nickel-titanium braided stent 3 and the connecting pipe 1 are covered with a polytetrafluoroethylene coating to make the device an integral structure.

The inner and outer surfaces of the nickel-titanium braided stent 3 and the connecting pipe 1 are covered with a polytetrafluoroethylene film (ePTFE film) to make the device an integrated structure. The schematic diagram of the inner surface film is shown in Figure 1. Film 2 is shown. It should be noted that the polytetrafluoroethylene coating 2 on the inner surface of the end of the nickel-titanium braided stent 3 in FIG. The membrane cannot be understood as limiting the shape of the polytetrafluoroethylene coating 2 on the inner surface of the end of the nickel-titanium braided stent 3 . Fig. 1 is only for the convenience of illustrating the structural schematic diagram of the device after the inner surface is covered with a film. In actual application, the nickel-titanium braided stent and the connecting pipe can be covered with a film after being in close contact, and the distance can also be set within a set distance range ( Such as 1mm) within the film. The ePTFE coating has good strength, which can ensure the stable combination of the nickel-titanium braided stent and the connecting tube. Since the nickel-titanium braided stent is partially transparent, the polytetrafluoroethylene coating on the inner surface can be seen from the outer surface. For the convenience of illustration, all visible inner surface polytetrafluoroethylene films are not shown in Figure 1 Vinyl fluoride film 2. The outer surface coating is not shown in FIG. 1 .

The nickel-titanium braided stent is braided with nickel-titanium wire nickel with a wire diameter of 0.008". The thickness of the polytetrafluoroethylene coating (ePTFE coating) is 50 microns. The connecting pipe 1 is a nickel-titanium alloy with an outer diameter of 8mm Tube, length 10mm, wall thickness 0.3mm.

Embodiment two: on the basis of embodiment one, this embodiment further includes: the surface of connecting pipe 1 is evenly distributed with 8 diameters and is 2.8mm circular through holes 5 (as shown in Figure 3), connecting pipe 1 outer surface There are 2 circles of continuous horizontal direction grooves 6 (as shown in Figure 3 ) in the circumferential direction, the width of the horizontal direction grooves 6 is 2mm, and the depth is 0.2mm. FIG. 3 also shows that four vertical grooves 7 in the vertical direction may be provided in the vertical direction.

In order to further enhance the surface friction of the connecting pipe and reduce the weight of the connecting pipe, in the embodiment, the connecting pipe can be provided with grooves and through holes at the same time, and the positional relationship between the grooves and the through holes is not limited. In a specific embodiment, circular through-holes 5 are optionally arranged at equal intervals at intersections of continuous horizontal grooves 6 and continuous vertical grooves 7 .

Embodiment 3. A blood vessel connection device provided in this embodiment includes: a nickel-titanium braided stent 3 and a connecting tube 1 (as shown in FIG. 1 ). The structure of the connecting tube 1 in this embodiment is shown in FIG. 4 , and the connection Tube 1 is a 316L stainless steel tube with an outer diameter of 10 mm. The connecting pipe 1 has a length of 15 mm and a wall thickness of 0.5 mm. There are three continuous horizontal grooves 6 in the circumferential direction of the outer surface of the connecting pipe 1, the width of the horizontal grooves 6 is 2mm, and the depth is 0.3mm. There are four vertical grooves 7 in the vertical direction on the outer surface of the connecting pipe 1, the width of the vertical grooves 7 is 2mm, and the depth is 0.3mm. Twelve circular through-holes 5 with a diameter of 2.5 mm are evenly distributed on the surface of the connecting pipe 1 , and the circular through-holes 5 can be arranged at the intersection of the horizontal groove 6 and the vertical groove 7 .

The inner surfaces of the nickel-titanium braided stent 3 and the connecting pipe 1 are covered with a polytetrafluoroethylene film, and at the same time, part of the outer surface of the nickel-titanium braided stent and the outer surface of the connecting pipe are covered with a polytetrafluoroethylene film. film4.

Optionally, the outer surface polytetrafluoroethylene film 4 is on the outer surface of the connecting pipe 1 from the outer surface of the nickel-titanium braided stent 3 in contact with the connecting pipe 1 to the end of the nickel-titanium braided stent 3 Extend to achieve covering more outer surface area of the NiTi braided stent 3, and may not completely cover the outer surface of the NiTi braided stent 3, so that not only can increase the joint stability strength of the NiTi braided stent and the connecting tube, but also can reduce the covering film Use the amount to reduce the weight of the device appropriately.

The nickel-titanium braided stent was woven with nickel-titanium wire with a wire diameter of 0.009" to obtain a nickel-titanium braided stent 3 with a length of 35 mm and an outer diameter of 14 mm. In this embodiment, the thickness of the ePTFE coating was 60 microns.

In the above embodiments, the polytetrafluoroethylene coating on the inner surface and the polytetrafluoroethylene coating on the outer surface can respectively adopt a whole piece of coating; or optionally, the polytetrafluoroethylene coating on the inner surface and the polytetrafluoroethylene coating on the outer surface The film is integrated, that is, a whole film, that is, the inner surface of the polytetrafluoroethylene film is covered from the inner surface of the nickel-titanium braided stent and the connecting pipe. After the completion of the covering, the excess film is turned over to cover the outer surface of the connecting pipe and the nickel Part or all of the outer surface of the titanium braided stent.

The nickel-titanium braided stent and the connecting tube of the blood vessel connecting device provided by the present invention are connected through an ePTFE covering, so that it becomes an integrated structure. The purpose of the design of the vascular connection device is to achieve suture-free collateral vessels in aortic arch replacement surgery, thereby reducing operation time. The nickel-titanium stent part of the vascular connection device can be released into the collateral vessels of the aortic arch (brachiocephalic artery, left common carotid artery or left subclavian artery), and the connecting tube part is used to connect the side branch artificial vessels of the four-branch artificial vessels , which can make the side branch artificial blood vessel of the four-branch artificial blood vessel and the aortic side branch blood vessel realize suture-free, which is used to reduce the time of aortic arch replacement surgery.

Embodiment 4. A method for preparing a vascular connection device, comprising the following steps:

According to the selected size, nickel-titanium braided stents are braided with nickel-titanium wire, and the braided nickel-titanium braided stents are subjected to high-temperature heat setting treatment, and the heat-set nickel-titanium braided stents are subjected to chemical polishing or electrochemical polishing. Remove the oxide layer on the surface of the stent, followed by chemical passivation;

Cover the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe with a polytetrafluoroethylene film, so that the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe are completely covered by the polytetrafluoroethylene film, and then perform high-temperature sintering treatment to make the inner and outer surfaces The coatings are tightly bonded together;

Embodiment 5. A method for preparing a vascular connection device, comprising the following steps:

A nickel-titanium tube with an outer diameter of 8 mm was used to process a connecting tube with eight circular through holes 5 with a diameter of 2.8 mm evenly distributed on the surface ( FIG. 3 ). The connecting pipe has a length of 10 mm and a wall thickness of 0.3 mm. The connecting pipe is deburred and polished to make its surface smooth, and 2 circles of continuously distributed horizontal grooves 6 and 4 vertically continuously distributed vertical grooves 7 are processed on the outer surface of the connecting pipe; The punching machine evenly processes 8 through holes on the vertical direction groove 7 of the metal connecting pipe. In this embodiment, the width of the two continuous horizontal grooves 6 in the circumferential direction of the outer surface of the connecting pipe is 2 mm, and the depth is 0.2 mm; the width of the vertical groove 7 on the outer surface of the connecting pipe 1 is 2 mm, and the depth is 0.3 mm. mm. On the vertical groove 7 on the connecting pipe 1 surface, 8 diameters are evenly distributed and are 2.8mm circular through holes 5.

Ni-Ti stents with a length of 30 mm and an outer diameter of 12 mm were obtained by braiding nickel-titanium wires with a wire diameter of 0.008". The braided Ni-Ti stents were subjected to high-temperature heat setting treatment at 505 °C, and the heat-set stents were In a water bath environment at 30°C, chemical polishing was performed for 2 hours to remove the blue oxide layer on the surface of the stent, and then the stent was passivated at 60°C for 1 hour.

Cover the inner and outer surfaces of the nickel-titanium stent and the metal connecting pipe with an ePTFE film with a thickness of 50 microns, so that the inner and outer surfaces of the nickel-titanium stent and the metal connecting pipe are completely covered by the ePTFE film, and then perform high-temperature sintering treatment to make the inner and outer surfaces Laminates fit tightly together.

Skirt the PTFE coating at the end of the NiTi braided stent away from the metal connecting tube.

Under the water pressure of (16.0±0.3) kPa of the vascular connection device of this embodiment, the amount of water seepage within 10 minutes is 0.

Embodiment 6. A method for preparing a vascular connection device, comprising the following steps:

A 316L stainless steel pipe with an outer diameter of 10 mm was used to process a connecting pipe with 12 circular through holes with a diameter of 2.5 mm evenly distributed on the surface (Fig. 4). The connecting pipe has a length of 15 mm and a wall thickness of 0.5 mm. Deburr and polish the connecting pipe to make its surface smooth; process 3 circles of continuous horizontal grooves 6 on the outer surface of the connecting pipe; use a punch to process 12 vertical grooves 7 on the metal connecting pipe through hole. Each of the three consecutive horizontal grooves 6 in the circumferential direction of the outer surface of the connecting pipe has a width of 2mm and a depth of 0.3mm. There are 4 vertical grooves in the vertical direction on the outer surface of the connecting pipe, each groove has a width of 2mm and a depth of 0.3mm. The 12 circular through-holes with a diameter of 2.5mm are evenly distributed on the vertical groove 7, and a nickel-titanium stent with a length of 35mm and an outer diameter of 14mm is obtained by braiding a nickel-titanium wire with a wire diameter of 0.009". The completed nickel-titanium stent was subjected to high-temperature heat setting treatment at 505°C, and the heat-set stent was chemically polished for 2.5 hours in a water bath environment at 30°C to remove the blue oxide layer on the surface of the stent. Then the stent was treated at 60 Passivation treatment at ℃ for 1 hour.

Cover the inner and outer surfaces of the nickel-titanium stent and the metal connecting pipe with an ePTFE film with a thickness of 60 microns, so that the inner and outer surfaces of the nickel-titanium stent and the metal connecting pipe are completely covered by the ePTFE film, and then perform high-temperature sintering treatment to make the inner and outer surfaces Laminates fit tightly together.

Skirt the PTFE membrane at the end of the stent graft away from the metal connecting tube.

The invention uses the nickel-titanium braided stent and the connecting tube as the components of the blood vessel connection device, and covers the polytetrafluoroethylene coating (ePTFE coating) so that the nickel-titanium braided bracket and the connecting tube form an integrated structure. It can ensure the simplicity of the operation and shorten the operation time as much as possible. The ePTFE coating has good strength, which can ensure the stable combination of the nickel-titanium braided stent and the connecting tube.

In the above embodiments, the effect of setting the groove (horizontal groove or vertical groove) on the connecting tube is: when in use, the connecting tube will first be inserted into the lumen of the side branch artificial blood vessel of the four-branch artificial blood vessel , and then fix the two with sutures, wire ties or cable ties on the outer surface of the collateral graft. The setting of the groove can ensure that the sutures, wire ties or cable ties are not easy to shift after fixing the connecting tube and the side branch artificial blood vessel, and can ensure the connection strength of the connecting tube and the side branch artificial blood vessel.

The effect of setting the through hole on the connecting tube is: the through hole can be circular or polygonal, and the surface friction force of the connecting tube and the side branch artificial blood vessel is increased by setting the through hole on the surface of the connecting tube to ensure that the connecting tube and the side branch artificial blood vessel connection strength. In a specific embodiment, the circular tubular connecting pipe is optionally made of metal, and the through holes processed on the surface can be circular or polygonal, so that the metal surface coverage of the connecting pipe is 30%-80%, and the circular or polygonal shape of the connecting pipe surface The polygonal hole can reduce the metal surface coverage of the connecting pipe and reduce the weight of the connecting pipe.

It should be noted that in the above embodiments, horizontal grooves and vertical grooves are provided at the same time, and they are all distributed continuously. In other embodiments, horizontal grooves or vertical grooves can be selected according to actual application conditions. , the grooves in the horizontal direction or the grooves in the vertical direction may be discontinuously distributed. The positional relationship between the groove and the through hole and the positional relationship between the groove, the through hole, the horizontal direction groove and the vertical direction groove are not limited; when implementing the present invention, those skilled in the art can determine according to the actual situation. More details.

In the above embodiments, the through holes are uniformly arranged at equal intervals. In other embodiments, the positions of the through holes can be set according to actual application needs, and can be set at equal intervals or irregularly, and no specific limitation is required for this.

The above are only preferred embodiments of the present invention, and the present invention is not limited to the content of the embodiments. For those skilled in the art, various changes and modifications can be made within the scope of the technical solutions of the present invention, and any changes and modifications made are within the protection scope of the present invention.

Claims

A vascular connection device, characterized in that it comprises: a nickel-titanium braided stent and a connecting tube, both of the nickel-titanium braided stent and the connecting tube have a circular tubular structure, covering the nickel-titanium braided stent and the connecting tube A PTFE coating makes the device a unitary structure.
A blood vessel connection device according to claim 1, wherein the inner and outer surfaces of the nickel-titanium braided stent and the connecting tube are covered with polytetrafluoroethylene film; or the nickel-titanium braided stent and the The inner surface of the connecting pipe is covered with a polytetrafluoroethylene film, and the outer surface of the connecting pipe is covered with a polytetrafluoroethylene film and the film extends to part of the outer surface of the nickel-titanium braided stent.
The vascular connection device according to claim 1, characterized in that, the length of the nickel-titanium braided stent is 10mm-50mm, and the outer diameter is 8mm-16mm.
A blood vessel connection device according to claim 1, characterized in that the length of the connecting tube is 6mm-20mm, the outer diameter is 6mm-12mm, and the wall thickness is 0.1mm-0.5mm.
The blood vessel connection device according to claim 1, characterized in that grooves are provided on the outer surface of the connecting tube, and the grooves are distributed continuously or intermittently.
The blood vessel connection device according to claim 5, wherein the groove is a horizontal groove or a vertical groove, or both a horizontal groove and a vertical groove are provided.
The blood vessel connection device according to claim 5, characterized in that, the groove depth of the groove is 0.05mm-0.30mm, and the groove width of the groove is 0.5mm-2.0mm.
A blood vessel connection device according to claim 1, wherein the connecting tube is made of metal material, and the metal material is one of 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy material.
The blood vessel connection device according to claim 1, wherein a through hole is provided on the outer surface of the connection tube.
A method for preparing a vascular connection device, comprising the following steps:

According to the selected size, use a lathe to process the round tubular metal connecting pipe, and deburr and polish the connecting pipe to make its surface smooth;

According to the selected size, nickel-titanium braided stents are braided with nickel-titanium wire, and the braided nickel-titanium braided stents are subjected to high-temperature heat setting treatment, and the heat-set nickel-titanium braided stents are subjected to chemical polishing or electrochemical polishing. Remove the oxide layer on the surface of the stent, followed by chemical passivation;

Cover the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe with a polytetrafluoroethylene film, so that the inner and outer surfaces of the nickel-titanium braided stent and the connecting pipe are completely covered by the polytetrafluoroethylene film, and then perform high-temperature sintering treatment to make the inner and outer surfaces The coatings are tightly bonded together;

Skirt the Teflon covering at the end of the NiTi braided stent away from the connecting tube.