CN110801309A

CN110801309A - Tectorial membrane stent blood vessel composite set for reconstructing aortic arch part and three branches

Info

Publication number: CN110801309A
Application number: CN201910997249.7A
Authority: CN
Inventors: 黄健兵; 杨晓颜; 梅举; 丁芳宝; 汤敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-10-20
Filing date: 2019-10-20
Publication date: 2020-02-18
Anticipated expiration: 2039-10-20
Also published as: CN110801309B

Abstract

① A section of straight tube type artificial aorta blood vessel (1), the said artificial aorta blood vessel (1) includes aorta adventitia (7) and aorta endovascular stent (8), the distal part (8 a) of the said aorta endovascular stent (8) is designed integrally with the outer vascular membrane, the proximal part (8 b) is naked stent that can be released later, ② small stent blood vessel (2), the said small stent blood vessel (2) includes small stent adventitia (9) and small stent endovascular stent (10), the head part (10 a) of the said small stent endovascular stent (10) is designed integrally with the apical part adventitia (9 a) of the small stent endovascular stent (9), the tail part (10 b) is designed separately from the inferior end adventitia (9 b) of the small stent endovascular stent (9), ③ a section of straight tube (11), the arch part and three branches can be reconstructed rapidly by using the said blood vessel assembly, even if there are large branches, the operation of the branch of blood vessel can be reduced, the operation range of normal operation can be simplified, and the operation range of the blood vessel can be simplified.

Description

Tectorial membrane stent blood vessel composite set for reconstructing aortic arch part and three branches

Technical Field

The invention relates to the field of implantable stent blood vessels, in particular to a covered stent assembly for reconstructing an aortic arch part with three branches.

Background

The thoracic aortic aneurysm and aortic dissection are serious lesions which seriously threaten the lives of the masses, and the thoracic aortic aneurysm and aortic dissection are not used for actively treating the natural disability rate and have high death rate. In recent years, the incidence of thoracic aortic aneurysm and aortic dissection has increased significantly with the increase in incidence of hypertension, hyperlipidemia, hyperglycemia, and trauma. Currently, aortic arch replacement surgery under direct vision is still the only option for aortic lesions involving the proximal ascending aorta and aortic arch. At present, the most mature aortic arch replacement operation needs to replace diseased blood vessels with artificial blood vessels under deep low temperature circulation stopping, three branch blood vessels and a distal aortic blood vessel are anastomosed one by one, the number of anastomoses is large, the circulation stopping time is long, the extracorporeal circulation time is long, postoperative bleeding and systemic complications are large, and the aortic arch replacement operation is one of the most serious cardiovascular surgery operations.

Due to the 3 branch vessels emanating from each patient's aortic arch: the unknown artery, the left common carotid artery and the left subclavian artery have different traveling, and the openings of the three branch blood vessels have different distances, arrangement angles and pipe diameters of the branch blood vessels, so that the three branch blood vessels on the arch part formed by the combination have extremely different shapes, and the arch part blood vessels of different patients cannot be completely matched through one prefabricated stent blood vessel. Once the stent vessel is not matched with the target vessel, endovascular repair therapy cannot be well completed.

① the running and diameter difference of three branch blood vessels of human body is large, the variation of the combined three branch blood vessel system is very large, the stent blood vessel used by the Cheng Han Wan group is a blood vessel with fixed size of branch, the stent which highly matches with various blood vessel conditions can not be completely prefabricated, the internal leakage is high, ② three branches are fixed with the main stent blood vessel, when the three branches are implanted, the three branches and the main blood vessel are required to be simultaneously implanted, the operation difficulty is large, the branch blood vessels are easily damaged, or the branch blood vessels can not be simultaneously implanted, and the operation is failed.

The aorta branch stent is specially customized according to the specific anatomical conditions of the patient abroad, but can be only used for interventional therapy, but cannot be used for open surgery, and the customization time is long, so that the aorta branch stent cannot be used for emergency surgery.

In addition, chinese patent application publication nos. CN102641164A and CN102973303B disclose two branched aortic vascular systems, including an aortic stent vessel and three branched aortic stent vessels, wherein a depression is provided in the middle section of the aortic vessel, the depression is provided with three side holes, and the three branched aortic stent vessels are separately installed in the three side holes. Although the two branch type aortic blood vessel systems can isolate aortic lesions which involve the aortic arch part and ascending aorta, can reconstruct the blood flow of the branch arteries, avoid customizing the stent, and can be produced in batch and used for emergency operations, the two branch type aortic blood vessel systems both need to reserve a concave part with a larger space to adapt to the placement of the branch arterial stent, otherwise the branch arterial stent can be seriously twisted and pressed when the branch opening is varied, and the blood flow is not smooth; in addition, the larger space of the depressed part correspondingly narrows the space of the aortic stent at the lower part, which affects the blood flow of the main aortic blood vessel.

Application publication No. CN 202821490U. It comprises a main bracket, a side bracket and a soft connecting part for connecting the main bracket and the side bracket, and can be used for treating aortic arch part lesion. However, the stent can not completely prefabricate three branches of blood vessels with different calibers, and when the position variation of the branch opening is large, the blood vessel at the opening is easy to be distorted and pressed, and the blood vessel membrane at the branch blood vessel at the large bending side has no support, so that the vascular disease at the large bending side is easy to have internal fistula. The three branch vessels are difficult to place accurately, and particularly when the branch variation is large, the blood flow of the branch vessels and the lumen of the main vessel are affected.

Application publication number is CN 108403255A's a novel bow portion support system and application method thereof, including striding bow main part support, branch support, can predetermine the size of branch support before the art, nevertheless to the patient of A type aorta intermediate layer, because the true chamber pressurized of blood vessel, can not measure the size in the true chamber according to the image before the art to be difficult to the accurate size of selecting the main part support, if select the main part support again after the circulation that stops, three branch of refabrication, then will show to increase and stop the cycle time, increase the operation risk. In addition, when the stent is implanted, the main blood vessel and the three branches must be synchronously implanted, so that the operation difficulty is high, and the blood vessel is easy to damage. Meanwhile, the stent vessel at the near end of the device needs to be clamped after being implanted, the vessel with the metal stent contained in the forceps holder is easy to deform the stent and damage the target vessel outside the vessel, and the near end of the clamped vessel is difficult to perform further anastomosis operation.

Disclosure of Invention

The invention provides a covered stent type blood vessel assembly for reconstructing an aortic arch part and three branches, which can rapidly complete the reconstruction of the arch part and the three branches of blood vessels. The operation can be greatly simplified, the traditional anastomosis of the far-end branch blood vessel is not needed, and the operation time is greatly reduced. Meanwhile, the arch part and the three branch blood vessels are reconstructed in situ, which is more in line with physiology.

The invention provides a covered stent vascular combination device for reconstructing an aortic arch part and three branches, which comprises three artificial vascular components, wherein ① a section of straight cylindrical artificial aortic blood vessel (1), the artificial aortic blood vessel (1) comprises an aortic adventitia (7) and an aortic endovascular stent (8), the distal end part (8 a) of the aortic endovascular stent (8) is designed integrally with an outer vascular membrane, the proximal end part (8 b) is a naked stent capable of being released later, ② a small stent blood vessel (2), the small stent blood vessel (2) comprises a small stent adventitia (9) and a small stent endovascular stent (10), the head end part (10 a) of the small stent endovascular stent (10) is designed integrally with the outer vascular membrane (9 a) at the top end part of the small stent adventitia vascular adventitia (9), the tail end part (10 b) is designed separately from the outer vascular membrane (9 b) at the lower end part of the small stent adventitia (9), ③ a section of straight cylindrical pipeline (11), when the combination device is combined with the aortic arch part and the aortic adventitia large stent and the small stent which need to be selected according to image, the large stent vascular adventitia small stent vascular adventitia position and a middle end part of the small stent vascular adventitia suture the aortic adventitia lower end part (9) of the aortic stent (9 b) of the aortic stent are placed in a vessel adventitia, the aortic stent (1) and a small stent (2) corresponding to the aortic stent (2) and a branch of the aortic stent (1) are placed in a branch of the aortic stent (368) in a target vessel branch, the three artificial vascular stent (2), the aortic stent (368) and a branch is placed in a target vessel branch, the aortic stent (368), and a branch is placed in a target vessel branch after the aortic stent is placed in a target vessel branch is placed, and a target vessel branch is placed in a full-covered with the aortic stent (368), and a branch is placed in a target vessel branch opening, and a target vessel branch is placed.

Preferably, the straight-barrel-shaped artificial aorta blood vessel (1) is a section of straight-barrel-shaped aorta blood vessel adventitia (7) and is internally provided with an artificial aorta blood vessel stent (8), the front section (7 a) of the aorta blood vessel adventitia (7) is a pure blood vessel, the middle section (7 b) and the medial stent (8 b) are separately designed, the tail section (7 c) and the distal end part (8 a) of the aorta blood vessel stent (8) are integrally designed, the proximal section part (8 b) of the aorta blood vessel stent is a naked stent which can be released later, the length of the aorta blood vessel stent (8) is the same as that of the middle and rear sections (7 b and 7 c) of the main blood vessel, and the blood vessel can automatically adapt to the shape of a target blood vessel and is arc-shaped after.

Preferably, the length of the anterior segment part (7 a) of the aortic adventitia is set to be 2-5 cm, the diameter of the whole stent blood vessel is set to be two types, the small size can be designed to be about 28-35 mm according to the larger size of the diameter of a common target blood vessel, and the large size can be designed to be 45-50 mm in diameter.

Preferably, the small stent vessel (2) comprises a small stent vessel adventitia (9) and a small stent vessel stent (10), wherein the top end part (9 a) of the small stent vessel adventitia is integrally designed with the head end part (10 a) of the small stent vessel stent, the lower end part (9 b) of the small stent vessel adventitia is separately designed with the tail end part (10 b) of the small stent vessel stent, and the lower end part (9 b) of the small stent vessel adventitia can be turned upwards when the stent (10) is completely retracted.

Preferably, the small stent blood vessel adventitia (9) and the small stent blood vessel inner stent (10) are the same in length and about 2-3 cm in length, the lengths of the parts (9 a, 10 a) of the small stent blood vessel adventitia (9) and the small stent blood vessel inner stent (10) which are integrated are about 2-5 mm in length, at least 5mm of the tail end part (10 b) of the small stent blood vessel inner stent is a naked stent, the diameter of the small stent blood vessel (2) is 6-26 mm, and the small stent blood vessel is manufactured by type numbers at intervals of 2 mm.

Preferably, the section of straight-barrel pipeline (11) is a straight-barrel-shaped inelastic pipeline.

Preferably, the length of the straight cylindrical pipe (11) is equivalent to that of the aortic endovascular stent (8) of the component ①, the straight cylindrical pipe is an inelastic pipe, the straight cylindrical pipe is sleeved outside main blood vessels (7 b and 7 c) containing the aortic endovascular stent (8) in use to limit the maximum diameter of the stent after final release, the diameter of the straight cylindrical pipe (11) is 20-50 mm, the straight cylindrical pipe is manufactured by 2mm parting marks, and the straight cylindrical pipe is selected according to the actual diameter of a target far-end blood vessel to better match the far-end blood vessel.

As can be seen from the above description of the structure of the present invention, compared with the prior art, the present invention has the following advantages:

1. the main blood vessel adopts the design that the blood vessel membrane and the stent are separately released, can well adapt to the original blood vessel form, and can ensure sufficient blood vessel support after combination. The branch blood vessel is designed independently, can be selected completely according to the position and the caliber of the target blood vessel, does not need to be customized in advance according to the specific anatomical condition of a patient, is well matched with the branch, and provides enough support.

2. The branch blood vessel is connected with the main blood vessel by suture, and the stent tectorial membrane system can be ensured to be complete without blood leakage. The post-release stent section in the main vessel can ensure enough aorta support after being released, and further fix the branch vessel stent. The application of the assembly can select the most suitable stent-vessel combination system according to the specific vessel morphology of the target vessel, and fully maintain the original vessel morphology. The bracket can be prevented from being customized, the batch production can be realized, the time is effectively saved, and the operation is convenient.

3. The diameter of the main stent vessel can be freely limited by the independently designed straight tube pipeline, and the diameter of the implanted stent can be quickly matched by directly selecting the diameter according to the actual diameter of the true lumen of the target vessel after the circulation is stopped. And can avoid the pre-manufacture of various models of the main stent vessel and simplify the production process.

4. When the stent vascular assembly is implanted, the main vessel and the three branches can be respectively placed according to the sequence, the implantation is simple, the blood vessels can be better prevented from being damaged, and the accurate positioning of each blood vessel is ensured. The combination can rapidly and safely reconstruct the distal end of the aortic arch and three branch vessels, and has wide application range and simple stent release procedure. And the original blood vessel shape is maintained to the maximum extent, which is more in line with the physiological state. And because the aortic arch part and the branch vessels are reconstructed in the in-situ cavity, the traditional branch vessel anastomosis process is not needed, the operation time can be greatly reduced, and the common risk of bleeding of the branch anastomosis orifice is avoided.

5. The invention creatively provides an aortic arch part covered stent blood vessel assembly with three branch blood vessels, which can quickly reconstruct the aortic arch part and the three branch blood vessels. Compared with the traditional process of replacing the full aortic arch by using the blood vessel with the four bifurcations, the process of operation is greatly simplified, three distal branch anastomotic stoma are avoided, the operation of separating the branch blood vessels is avoided, and the operation time is greatly shortened, so that the wound and the bleeding are reduced. At present, no similar report exists at home and abroad for directly reconstructing the aortic arch part and a three-branch covered stent vascular system which can be completely matched with various vascular conditions of the aortic arch part.

Drawings

FIG. 1 is a schematic view of a straight tubular artificial aorta vessel of the present invention;

FIG. 2a is a small stent vessel of the present invention with the lower stent unreleased;

FIG. 2b is a small stent vessel of the present invention with the stent fully collapsed and the adventitia in a separately designed everted state;

FIG. 3 is a straight cylindrical pipe of the present invention;

FIG. 4 is a schematic representation of the thoracic aorta and its three branches;

FIG. 5 shows the branch vessels after combination with the main vessel, before release;

FIG. 6 is a schematic view of three components in combination;

FIG. 7 the assembly is deployed in the aorta, in the main vessel with the stent released and in the branch vessel with the stent not released.

FIG. 8 shows that the release of the three branch vessels into the target vessel is completed, and the post-release stent (8 b) is not released;

FIG. 9 all stent releases are complete

In actual use, after the three components are combined, the stent of each layer, the blood vessel and the outer sleeve pipeline are tightly attached to form a complete artificial blood vessel system with the vascular membrane stent, and the components are layered and marked in the figure for understanding.

Detailed Description

The reference numerals in the figures denote: 1. a straight tubular artificial aortic blood vessel; 2. a small stent vessel; 3. thoracic aortic arch and bifurcation; 4. innominate artery; 5. the left common carotid artery; 6. the left subclavian artery; 7. a straight-tube-shaped artificial aorta adventitia; 7a, a simple blood vessel part at the front section of the artificial blood vessel; 7b, the middle section of the artificial blood vessel and the corresponding part of the rear release stent; 7c, an artificial blood vessel end section and a stent integrated part; 8. an artificial blood vessel inner side support; 8a, a stent and outer vascular membrane integrated part; 8b, a post-release scaffold moiety; 9. small stent adventitia; 9a, an integral part of the outer membrane and the inner bracket; 9b, the outer membrane is separated from the inner bracket; 10. internal stents for small stent vessels; 10a, a stent and outer vascular membrane integrated part; 10b, a stent and outer vascular membrane separation part; 11. straight tubular pipeline

Fig. 1 to 9 show a stent graft vascular assembly device for reconstructing an aortic arch part and three branches and an application example thereof.

① A section of straight tube type artificial aorta blood vessel (1), the artificial aorta blood vessel (1) includes aorta adventitia (7) and aorta endovascular stent (8), the distal part (8 a) of the aorta endovascular stent (8) is designed with the outer vascular membrane as an organic whole, the proximal part (8 b) is a naked stent which can be released later, ② small stent blood vessel (2), the small stent blood vessel (2) includes small stent adventitia (9) and small stent endovascular stent (10), the head part (10 a) of the small stent endovascular stent (10) is designed with the top part adventitia (9 a) of the small stent adventitia (9) as an organic whole, the tail part (10 b) is designed with the bottom part adventitia (9 b) of the small stent vascular adventitia (9) separately, ③ a section of straight tube (11)

When the stent is combined, the size of a branch stent blood vessel and the positions of three branch openings which need to be selected are determined according to images, the openings are arranged at the corresponding positions of the middle section (7 b) of the adventitia of the artificial aorta blood vessel (1), the openings are respectively sutured with the adventitia blood vessel end of the small stent blood vessel (2), the outer membrane (9 b) at the lower end part of the outer membrane (9) of the small stent blood vessel is upwards overturned, the part, with the stent, of the small stent blood vessel (2) is placed in the outer membrane lumen of the artificial aorta blood vessel (1), the straight tube pipeline (11) is sleeved on the combined part, openings are arranged at the corresponding branch openings, when the stent is used, the blood vessel sleeved part formed by combining ①, ② and ③ is placed in an aorta, after the branch openings are in place, the three small stent blood vessels (2) are sequentially sent into the corresponding target branch blood vessels to be released, finally, the proximal end part (8 b) of the aortic stent (8) released after the artificial aorta blood vessel (1) is released, after the whole aortic arch part and the proximal end of the three branch blood vessels are covered by a.

When the combined member is used, the independent design of the stent vessel can ensure the complete matching of the size and the position of each branch vessel. The post-release design of the proximal part (8 b) of the main intravascular stent can better ensure the maintenance of the shape of the main vessel with branches and provide enough intravascular support.

The branch blood vessel is connected with the blood vessel membrane of the main blood vessel by suture anastomosis, so that the integrity of the whole structure of the blood vessel membrane can be ensured, and the occurrence of leakage in the branch after operation can be prevented.

When the assembly is implanted, the main blood vessel is firstly implanted, and then the blood vessels are respectively sent into the branch blood vessels, so that the accurate positioning of each component can be ensured, the assembly is respectively implanted, the operation is convenient, and the damage to the target blood vessel can be avoided. After the stents are released successively, the complete support and isolation of the whole aortic arch part and the near ends of the three branches can be provided, the original blood vessel shape is kept, the smooth blood flow is ensured, and the physiological requirements are met.

The foregoing is only a preferred embodiment of the present invention and is not intended to limit the present invention in any manner. Although the present invention has been described with reference to the preferred embodiments, it is not intended to be limited thereto. Those skilled in the art can make numerous possible variations and modifications to the disclosed embodiments, or modify equivalent embodiments, without departing from the scope of the invention, using the teachings disclosed above. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical spirit of the present invention should fall within the protection scope of the technical scheme of the present invention, unless the technical spirit of the present invention departs from the content of the technical scheme of the present invention.

The most fundamental innovation of the invention is that the stent of the covered stent vessel for isolating aortic lesions and the artificial vessel are designed separately, and the branch vessel is designed independently. According to the specific use requirement, the positions and the ranges of the pure stent, the pure blood vessel and the blood vessel with the stent can be changed to adapt to other releasing sequences or releasing directions different from the above examples, and finally the complete blood vessel covered stent vascular system is combined.

Claims

1. A stent graft blood vessel combination device for reconstructing an aortic arch part and three branches comprises three artificial blood vessel components, a ① section of straight cylindrical artificial aortic blood vessel (1), the artificial aortic blood vessel (1) comprises an aortic adventitia (7) and an aortic endovascular stent (8), a distal end portion (8 a) of the aortic endovascular stent (8) is integrally designed with an outer vascular membrane, a proximal end portion (8 b) is a naked stent capable of being released later, ② a small stent blood vessel (2), the small stent blood vessel (2) comprises a small stent adventitia (9) and a small stent endovascular stent (10), a head end portion (10 a) of the small stent endovascular stent (10) is integrally designed with an adventitia top end portion (9 a) of the small stent adventitia (9), a section (10 b) is separately designed with an outer vascular membrane (9 b) at the lower end portion of the small stent adventitia (9), ③ section of straight cylindrical pipe (11), when the combination device is combined, the large and small stent graft openings at the tail end portion are determined according to be selected according to images, the image, the large and the small stent graft vascular adventitia middle end portion (9) is placed in the middle end portion of the aortic adventitia vessel (9) and a catheter (1) is placed in a corresponding to the three branch position, the three branch openings of the three branch vessels (7) and a branch stent graft branch vessels (7) are sewn into a branch vessel branch catheter (1) and a branch catheter (2), and a branch catheter (368) is placed in a target branch is placed in a branch catheter (368) after the three branch is placed in a target vessel branch is placed, and a branch is placed in a target vessel branch catheter (368), and a target branch is placed in a target vessel is placed, and a branch is placed in a target vessel opening is placed, and.

2. The stent graft vessel assembly for reconstructing the aortic arch and three branches as claimed in claim 1, wherein the straight cylindrical artificial aortic vessel (1) is a straight cylindrical aortic adventitia (7) with an artificial aortic stent (8) inside, the anterior segment (7 a) of the aortic adventitia (7) is a simple vessel, the middle segment (7 b) and the medial stent (8 b) are separately designed, the end segment (7 c) and the distal segment (8 a) of the aortic endovascular stent (8) are integrally designed, the proximal segment (8 b) of the aortic endovascular stent is a naked stent which can be released afterwards, the length of the aortic endovascular stent (8) is the same as the length of the middle and posterior segments (7 b, 7 c) of the main vessel, and the vessel can automatically adapt to the shape of the target vessel and present an arc shape after implantation.

3. The stent graft vessel assembly as described in claim 2, wherein the anterior segment (7 a) of the aortic adventitia is set to be 2-5 cm in length, the diameter of the entire stent vessel is set to be two types, the small type can be designed to be about 28-35 mm according to the larger type of the common target vessel diameter, and the large type can be designed to be 45-50 mm in diameter.

4. A stent graft vascular assembly as in claim 1, wherein said small stent vessel (2) comprises a small stent vessel adventitia (9) and a small stent vessel stent (10), the apical portion (9 a) of the small stent vessel adventitia being integrally formed with the apical portion (10 a) of the small stent vessel stent, the inferior portion (9 b) of the small stent vessel adventitia being formed separately from the caudal portion (10 b) of the small stent vessel stent, the inferior portion (9 b) of the small stent vessel adventitia being evertable upwardly when the stent (10) is fully retracted.

5. The stent graft vessel assembly for reconstructing the aortic arch and three branches as claimed in claim 4, wherein the small stent vessel adventitia (9) and the small stent vessel stent (10) have the same length of about 2-3 cm, the length of the integral parts (9 a, 10 a) of the small stent vessel adventitia (9) and the small stent vessel stent (10) is about 2-5 mm, the tail end of the tail end part (10 b) of the small stent vessel stent is at least 5mm of a bare stent, the diameter of the small stent vessel (2) is 6-26 mm, and the stent graft vessel assembly is manufactured at intervals of 2 mm.

6. The stent graft vascular assembly of claim 1, wherein the length of straight tubular conduit (11) is a straight tubular inelastic conduit.

7. The stent graft vessel assembly for reconstructing the aortic arch and three branches of claim 6, wherein the length of the straight tubular conduit (11) is equivalent to that of the aortic endovascular stent (8) of the module ①, and is an inelastic conduit, which is used to be sleeved outside the main vessel (7 b, 7 c) containing the aortic endovascular stent (8) to define the maximum diameter of the stent after final release, and the diameter of the straight tubular conduit (11) is 20-50 mm, and is made with 2 mm-spaced type marks, and is selected according to the actual distal target vessel diameter to better match the distal vessel.