CN110897760A

CN110897760A - Isolated aortic arch portion and three-branch tectorial membrane support type blood vessel combination external member

Info

Publication number: CN110897760A
Application number: CN201911386814.2A
Authority: CN
Inventors: 黄健兵; 杨晓颜; 梅举; 丁芳宝; 汤敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-29
Filing date: 2019-12-29
Publication date: 2020-03-24

Abstract

The invention discloses a covered stent type blood vessel combination kit for isolating an aortic arch part and three branches, which comprises two artificial blood vessel components, namely ① a section of artificial blood vessel (1) with a stent and three branches, wherein the main body of the artificial blood vessel (1) is a straight cylindrical stent blood vessel and consists of an outer side blood vessel membrane (4) and an inner side stent (5), a proximal part blood vessel membrane (4 a) of the outer side blood vessel membrane (4) and a front end part (5 a) of the inner side stent (5) are integrally designed, middle and distal part blood vessel membranes (4 b, 4 c) of the outer side blood vessel membrane (4) and rear end parts (5 b) (5 b) of the inner side stent (5) are separately designed, a rear end part (5 b) of the inner side stent (5) is a bare stent, the rear end part (5 b) of the inner side stent (5) can be released later, the middle section of the straight cylindrical stent blood vessel has three branches (6 a, 6b, 6 c), ② a section of the branch blood vessel (2) with the aortic arch part and the three branches can be isolated by using the blood vessel components, the covered stent, the aortic arch part and the blood vessel can be conveniently isolated, the wound of the aortic arch part can be conveniently isolated, the aortic arch part of the aortic stent can be conveniently maintained.

Description

Isolated aortic arch portion and three-branch tectorial membrane support type blood vessel combination external member

Technical Field

The invention relates to the field of implantable blood vessels, in particular to a covered stent blood vessel assembly which can be used for 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. At present, the aortic intracavity stent repair is adopted, so that the curative effect is good, the wound is small, and the operation is simple and convenient. However, aortic arch aneurysm and aortic dissection which involve the openings of innominate artery, left common carotid artery and left subclavian artery are always the difficulties of the treatment technology. In order to ensure a secure fixation of the stent within the aorta while preventing blood flow from leaking out of the stent from the proximal or distal end of the stent, currently used aortic vascular stents require an anchoring zone of at least 15mm at the proximal or distal end. When thoracic aortic aneurysm or arterial dissection involves the aortic arch with openings of innominate artery, left common carotid artery and left subclavian artery, the stent in the market at present blocks branch arterial vessels to different degrees when treating the aortic arch, thereby affecting the functions of related limbs to a certain extent; when the occlusion relates to a neck blood vessel, a blood vessel bypass operation is required, the wound is large, and even the treatment by an intracavity technology cannot be carried out. At present, a single-branch stent product is clinically used, but the problem of bow lesion involving innominate artery and left common carotid artery cannot be solved. In clinic, the problem of branch vessel reconstruction is solved by windowing the arch stent, but the operation is complex, the positioning is difficult, the incidence rate of internal leakage is high, and the clinical popularization is difficult.

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 distances among the openings of the three branch blood vessels, the arrangement angles and the thicknesses of the branch blood vessels are different, so that the shape of the combined bow-shaped blood vessel with three branches is greatly different, and different bow-shaped blood vessels cannot be completely matched through one prefabricated bracket. Once the stent is not matched to the vessel, intraluminal repair therapy cannot be completed. The aorta branch stent specially customized according to the specific anatomical condition of a patient abroad is required to align the side hole of the aorta branch stent to a branch artery when the aorta branch stent is implanted into an aorta lesion part, so that the blood flow of the branch artery is ensured to be smooth, and then a small stent is implanted into the branch artery. However, this method has the following disadvantages: the stent is specially customized according to the specific anatomical condition of a patient, the cost is high, and the mass production cannot be realized; 2. the customized bracket takes longer time and cannot be used for emergency operation patients; 3. the operation is complex, each side hole is required to be respectively and accurately aligned to the involved branch artery when the stent is released, if deviation exists, the blood flow of the branch artery can be obstructed, corresponding complications can occur, and the life can be threatened when the deviation is serious.

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 are affected with an aortic arch part and an ascending aorta, can reconstruct blood flow of a branch artery, avoid customizing a bracket, can be produced in batch and used for emergency operation, the two branch type aortic blood vessel systems need to reserve a concave part with a larger space to adapt to the placement of the branch arterial bracket, otherwise, the branch arterial bracket can be seriously twisted and pressed and has unsmooth blood flow, however, the space of the concave part is larger, and the space of the lower part of the concave part of the aortic blood vessel system correspondingly narrows, thereby influencing the blood flow of a main blood vessel cavity.

The application publication number is CN202821490U side branch type covered stent, which comprises a main stent, a side branch stent and a soft connecting part for connecting the main stent and the side branch stent, 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.

The application publication No. CN 108403255A discloses a novel arch stent system and its application method, including main body stent and branch stent, but the system can only be used in open surgery, and can not be used in interventional therapy.

The application publication number is CN 110393605A, which discloses a blood vessel combination device of an aortic arch part covered with a branch covered stent, comprising a section of U-shaped artificial aortic blood vessel with three branches, a covered small stent blood vessel, a straight cylindrical stent blood vessel with a section of naked stent and a section of covered stent, and also can realize intervention treatment of the aortic arch part and the three branches.

Disclosure of Invention

The invention provides a covered stent type blood vessel combination kit for isolating an aortic arch part and three branches, which comprises two artificial blood vessel components, namely ① a section of main body with a stent and an artificial aortic blood vessel (1) with three branches, wherein the main body of the artificial aortic blood vessel (1) is a straight cylindrical stent blood vessel and consists of an outer side blood vessel membrane (4) and an inner side stent (5), a proximal part blood vessel membrane (4 a) of the outer side blood vessel membrane (4) and a front end part (5 a) of the inner side stent (5) are integrally designed, middle and distal part blood vessel membranes (4 b, 4 c) of the outer side blood vessel membrane (4) and a rear end part (5 b) of the inner side stent (5) are separately designed, a rear end part (5 b) of the inner side stent (5) is a bare stent, a rear end part (5 b) of the inner side stent (5) can be released afterwards, a middle section of the straight cylindrical stent blood vessel with three branches (6 a, 6b, 6 c) and ② a section of the branch blood vessel (2) with three branches is placed into the main body with the stent (6 a stent, 6b, 6 c) and the branch (35 c) and the main body with three branches into a target blood vessel branch with the main body branch (35 b) and the main body branch after the branch of the main stent (5) are placed respectively.

Preferably, one section of the main body is provided with a support and an artificial aorta blood vessel (1) with three branches, the three branch blood vessels (6 a, 6b and 6 c) are pure soft blood vessel membranes, the branch blood vessels are designed in a conical shape, the diameter of the near end of each branch blood vessel is 2-6 mm larger than that of the far end of each branch blood vessel, the diameter of the far end of each branch blood vessel is designed according to the maximum diameter of a common target branch blood vessel which is 3-5 mm larger than that of the common target branch blood vessel, and the length of each branch blood vessel is 2-5 cm, so that the fact that the far end of each branch blood vessel can be.

Preferably, the rear end part (5 b) of the inner side bracket (5) is close to the rear end parts (6 b, 6 c) of the outer side vascular membrane (4) in length and is set to be 15-30 cm, the diameter of the main vascular is set to be 22-46 mm, and the main vascular can be manufactured by parting marks at intervals of 2 mm.

Preferably, the section of branch blood vessel (2) with the stent is a section of straight cylindrical stent blood vessel, the upper end part (2 a) is a covered blood vessel with the stent or a bare stent, and the lower end part (2 b) is a bare stent.

Preferably, the length of the branch blood vessel (2) with the stent is 2.5-5 cm, the diameter of the blood vessel is 5-25 mm, the number of the type marks is made at intervals of 2mm, and the length of the naked stent of the lower end part (2 b) is 5-15 mm.

Preferably, all the stents are metal stents with good biocompatibility and supporting force, and can be the same stent components of large blood vessel stents on the market such as stainless steel, nickel-titanium alloy and the like, and stent covering films and vascular membranes without stents can be various artificial vascular membrane materials on the market such as polytetrafluoroethylene membranes, polyester fiber membranes, polyamide membranes or polypropylene membranes and the like.

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 invention relates to a tectorial membrane stent type blood vessel combination kit for isolating an aortic arch part and three branches, which adopts the design that a main blood vessel is connected with a branch soft blood vessel and then an independent branch stent blood vessel is respectively implanted, can well adapt to the shape of a target blood vessel and can ensure enough blood vessel support after combination. The use of branch stent blood vessels can fully support each branch blood vessel and prevent branch blood leakage. The integral design of the main vascular membrane and the inner side bracket can ensure enough aorta support and prevent blood leakage. And because the main intravascular stent is released after the branch blood vessel is fixed, the in-situ fixation of the branch blood vessel can be ensured, the oppression to the opening is avoided, and the smoothness of the branch opening is ensured. The application of the assembly can select the most suitable stent vascular system according to the specific vascular form of each patient, and fully maintains the original vascular form. The bracket can be prevented from being customized, the batch production can be realized, the time is effectively saved, and the operation is convenient.

2. The stent vascular assembly, the branch soft blood vessels and the main vascular membrane are designed into a whole, so that the stent tectorial membrane system can be ensured to be complete without blood leakage. And the large caliber and conical design of the branch soft vessel and the design that the soft vessel membrane of the main body vessel is separated from the stent can ensure that the far end of the branch vessel can be respectively placed into a target vessel after being compressed, thereby ensuring the continuity of the main body and the branch vessel membrane.

3. The stent vascular assembly can safely and effectively isolate pathological changes affecting the aortic arch and ascending aorta, and has wide application range and simple stent release procedure. Due to the design of releasing the branch vessel without the stent first, the branch vessel can be matched with the branch artery of the aortic arch part safely and conveniently, the original vessel form is maintained to the maximum extent, the physiological state is more met, the full aortic arch replacement operation can be partially replaced, and the trauma and the risk of the thoracotomy operation are avoided.

4. The invention creatively designs the vascular membrane and the stent separately, and designs the branch vascular membrane and the small stent separately, thereby not only ensuring enough supporting and anchoring areas and good stability, but also preventing internal fistula. Compared with various chimney supports with different designs at home and abroad at present, the chimney support does not need a chimney structure at all, and the branch blood vessel can keep the original shape, so that the defects of various chimney supports, such as pressure deformation and distortion of the branch blood vessel, internal fistula, reduction of an effective lumen of an aorta and the like, can be avoided, and the chimney support is more in line with physiology. Compared with other various stent blood vessels adopting windowing technology, the stent blood vessel has simple operation and positioning, can avoid the occurrence of internal leakage, and does not influence the lumen of the main blood vessel.

Drawings

FIG. 1 is a schematic diagram of a section of a main body with a stent and an artificial aorta with three branches according to the present invention, wherein the rear section of the main body stent is a naked stent capable of being released later;

FIG. 2 is a schematic view of a stented branch vessel of the present invention;

FIG. 3 is a schematic representation of the thoracic aorta and its three branches;

FIG. 4 is a schematic representation of the assembly ① after release in the thoracic aorta and the branches, with the bare stent portion of the posterior stent section of the stent unreleased in the main body vessel;

FIG. 5 is a schematic illustration of the release assembly ② in three branches of the assembly ① wherein the bare stent portion of the posterior segment of the stent within the main body vessel is unreleased;

FIG. 6 is a schematic representation of the main body endovascular stent after release of the bare stent, posterior segment, after release of the three bifurcated inner assemblies ② of assembly ①;

in actual use, after the two components are combined, the stent and the blood vessel are tightly attached to form a complete artificial blood vessel system with the vascular stent, and the components are layered and marked in the figure for understanding.

The reference numerals in the figures denote: 1. a section of main body is provided with a bracket and an artificial aorta blood vessel with three branches; 2. a branch vessel with a stent; 2a, the upper section of a branch blood vessel with a stent can be a covered stent or a bare stent; 2b, a section of the lower section of the branch blood vessel with the stent is a naked stent; 3. thoracic aorta and upper branches of the arch; 4. the section of the main body is provided with a stent and an outer membrane of the main body blood vessel of the artificial aorta with three branches; 4a, the front end of the main vascular adventitia and the inner side support are integrated; 4b, a part with three branch blood vessels is arranged in the middle section of the adventitia of the main blood vessel; 4c, the rear end of the adventitia of the main blood vessel; 5. a section of stent with a stent and a stent in the main vessel of the artificial aorta with three branches; 5a, integrating the front end of the main intravascular stent with the adventitia; 5b, a naked stent part which can be released backwards at the rear end of the main intravascular stent; 6. a branch vessel of an artificial aorta vessel with a main body provided with a stent and three branches (the three branches are respectively marked as 6a, 6b and 6 c); 7. innominate artery; 8. the left common carotid artery; 9. the left subclavian artery.

Detailed Description

The following description of the embodiments of the present invention refers to the accompanying drawings

The assembly comprises two artificial blood vessel components, namely a covered stent type blood vessel combination kit for isolating the aortic arch and three branches, ① a section of main body with a stent and an artificial aortic blood vessel (1) with three branches, wherein the main body of the artificial aortic blood vessel (1) is a straight cylindrical stent blood vessel and consists of an outer side blood vessel membrane (4) and an inner side stent (5), a proximal part blood vessel membrane (4 a) of the outer side blood vessel membrane (4) is integrally designed with a front end part (5 a) of the inner side stent (5), middle and distal part blood vessel membranes (4 b and 4 c) of the outer side blood vessel membrane (4) are separately designed with a rear end part (5 b) of the inner side stent (5), a rear end part (5 b) of the inner side stent (5) is a naked stent, the rear end part (5 b) of the inner side stent (5) can be released later, and the middle section (6 b) of the straight cylindrical stent with three branches (6 a and 6 c) with a branch (84 b and a branch of the blood vessel (84).

When the assembly is used, the assembly ① is firstly placed into an arch part, the three branch blood vessels are placed into corresponding target blood vessels, the released bare stent in the rear section of the main blood vessel is kept not to be released, the assembly ② is then implanted into the three branch blood vessels, and finally the rear section bare stent in the main blood vessel is released.

The component ① has three branch artificial aorta blood vessels, the back part of main blood vessel is released after naked support, it can fix the front end support to prevent shift when operating branch blood vessel.

After the front half part of the component ① is released, the components ② are respectively placed in the main blood vessel cavity of the component ① to the three branch blood vessels in sequence to form the support of the branch blood vessels, and meanwhile, the branch blood vessels with the stent are overlapped with the branch blood vessel membranes of the component ①, so that the artificial blood vessel membranes of the branch blood vessels can be fully supported and covered, and blood leakage is prevented.

The design of the naked support at the bottom of the branch vessel with the support of the component ②, when the component is implanted, the component partially extends into the main vessel cavity, the opening part of the branch vessel can be guaranteed to support, the opening stenosis is avoided, and the blood flow in the main vessel is not influenced.

After the front section of the component ① and the component ② are released, the naked stent which can be released partially in the main blood vessel is released finally, the complete stent with the blood vessel covered film support of the main blood vessel can be completed, the design of the naked stent can ensure the smooth blood flow of the branches, and simultaneously the substrate of the component ② can be supported, so that the blood vessel of the branch stent is further fixed.

The

components

① and ② are completely released to form a complete aortic arch part covered stent system with three branches, which can completely isolate vascular lesion of the aortic arch part and maintain the in-situ reconstruction of the three branches to allow blood to pass through the cavity of the combined system.

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 point of the invention is that the stent of the covered stent blood vessel for isolating aortic lesion and the artificial vascular membrane are designed separately, and the branch blood vessel is firstly implanted with the soft vascular membrane. 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, and the straight cylinder shape of each component is adjusted to be a cone shape with a thick proximal end and a tapered shape towards a distal end so as to adapt to other releasing sequences or releasing directions different from the above examples, match with the target blood vessel shape and finally combine into the complete blood vessel covered with the stent graft.

Claims

1. A covered stent type blood vessel combination kit for isolating an aortic arch part and three branches comprises two artificial blood vessel components, namely ① a section of main body with a stent and an artificial aortic blood vessel (1) with three branches, wherein the main body of the artificial aortic blood vessel (1) is a straight cylindrical stent blood vessel and consists of an outer side blood vessel membrane (4) and an inner side stent (5), a proximal part blood vessel membrane (4 a) of the outer side blood vessel membrane (4) and a front end part (5 a) of the inner side stent (5) are integrally designed, middle and distal parts blood vessel membranes (4 b, 4 c) of the outer side blood vessel membrane (4) and a rear end part (5 b) of the inner side stent (5) are separately designed, a rear end part (5 b) of the inner side stent (5) is a naked stent, the rear end part (5 b) of the inner side stent (5) can be released backwards, a middle section of the straight cylindrical stent blood vessel with three branches (6 a, 6b, 6 c), ② a section of the branch (2) with the stent is a branch (2), and when the main body with the aortic arch part and the three branches are combined, the main body is used, the main body of the main body with the main stent (83, the main blood vessel stent (6 a branch with the three branches is placed into a branch, the main blood vessel stent (6 b), the main blood vessel (6 b) and the branch (6 c) and the branch (35) are placed into a branch with three branch of the main blood vessel branch (5) and the branch (5.

2. The combination set of claim 1, wherein a main section of the blood vessel (1) has a stent and an artificial aorta with three branches, the three branches (6 a, 6b, 6 c) are pure soft vascular membranes, the branches are designed to be tapered, the diameter of the proximal end of the blood vessel is 2-6 mm larger than that of the distal end of the blood vessel, the diameter of the distal end of the blood vessel is 3-5 mm larger than that of the common target branch, and the length of the blood vessel is 2-5 cm, so that the compressed distal end of each branch can be inserted into the target blood vessel, and the combination set can be adapted to different positions and angles of the branches.

3. The aortic arch exclusion three-branch covered stent type vascular assembly kit according to claim 1, wherein the rear portion (5 b) of the medial stent (5) is set to be 15-30 cm in length similar to the rear portions (6 b, 6 c) of the lateral vascular membrane (4), and the diameter of the main vessel is set to be 22-46 mm, which can be manufactured with 2mm division.

4. The combination set of claim 1, wherein the branch vessel (2) with stent is a straight cylindrical stent vessel, the upper end portion (2 a) is a stent-covered vessel or a bare stent, and the lower end portion (2 b) is a bare stent.

5. The combination set of covered stent type vessel for isolating aortic arch and three branches as claimed in claim 4, wherein the length of the branch vessel (2) with stent is 2.5-5 cm, the diameter of vessel is 5-25 mm, the number of the division is 2mm, the length of the bare stent at the lower end part (2 b) is 5-15 mm.

6. The combination set of claim 1-5, wherein all stents are metallic stents with good biocompatibility and supporting force, and can be made of the same stent components as those of the commercially available large vascular stents such as stainless steel and nickel-titanium alloy, and the stent-covered and stentless vascular membranes can be made of various commercially available artificial vascular membrane materials such as polytetrafluoroethylene membrane, polyester fiber membrane, polyamide membrane or polypropylene membrane.