阅读说明：本技术 一种开放手术用主动脉弓部带分支覆膜支架血管组合装置 (Aortic arch part branch covered stent blood vessel combination device for open surgery ) 是由 黄健兵 于 2018-07-04 设计创作，主要内容包括：本发明公开了一种开放手术用主动脉弓部带分支覆膜支架血管组合装置,包括两个人工血管组件：①一段弧形人工主动脉血管(1),所述弧形人工主动脉血管(1)包括主血管(9)和主血管(9)上的三个分支血管(7),所述主血管(9)内带支架(8),所述支架(8)的近端部分(8a)为可后释放的裸支架；②覆膜小支架血管(2)。使用本血管组件可以在累及主动脉弓部病变需行全弓置换的手术中快速重建主动脉弓部及三分支血管,可最大程度的保留正常血管形态,适用于各种常见分支走形的血管,适用范围广,避免定制支架,可以批量生产,有效减少手术创伤,显著简化手术操作。(The invention discloses a vascular combination device of an aortic arch part branch covered stent for open surgery, which comprises two artificial vascular components: firstly, a section of arc-shaped artificial aorta blood vessel (1), wherein the arc-shaped artificial aorta blood vessel (1) comprises a main blood vessel (9) and three branch blood vessels (7) on the main blood vessel (9), a stent (8) is arranged in the main blood vessel (9), and a proximal part (8 a) of the stent (8) is a naked stent which can be released later; ② covering a small stent blood vessel (2). By using the blood vessel component, the aortic arch part and the three-branch blood vessel can be quickly reconstructed in the operation which involves aortic arch part lesion and needs full-arch replacement, the normal blood vessel form can be furthest kept, the blood vessel component is suitable for various common branch-shaped blood vessels, the application range is wide, the customized support is avoided, the batch production can be realized, the operation wound is effectively reduced, and the operation is obviously simplified.)

1. The utility model provides an aortic arch portion area branch tectorial membrane support blood vessel composite set for open operation, includes two artificial blood vessel subassemblies: firstly, a section of arc-shaped artificial aorta blood vessel (1), wherein the arc-shaped artificial aorta blood vessel (1) comprises a main blood vessel (9) and three branch blood vessels (7) on the main blood vessel (9), a stent (8) is arranged in the main blood vessel (9), and a proximal part (8 a) of the stent (8) is a naked stent which can be released later; covering a small stent blood vessel (2); when in combination, the three coated small stent vessels (2) are sequentially arranged in the three branch vessels (7) of the arc-shaped artificial aorta vessel (1), and then the proximal part (8 a) of the stent (8) in the main vessel (9) is released; the middle and rear sections (9 b, 9 c) of the combined arc-shaped artificial aorta vessel (1) and the three branch vessels (7) are all covered vessels with stents in the whole process.

2. The aortic arch stent graft blood vessel combination device as claimed in claim 1, wherein the main blood vessel (9) is a straight cylindrical blood vessel (9) with an arc shape, the front segment (9 a) is a simple blood vessel, three branch blood vessels (7) are arranged above the middle segment (9 b), the main blood vessel (9) is internally provided with a stent (8), wherein the end part (8 b) of the stent (8) and the end of the blood vessel (9) are integrally designed into a stented blood vessel, the proximal part (8 a) of the stent (8) is a naked stent which is released later, the length of the stent (8) is the same as the length of the middle and rear segments (9 b, 9 c) of the main blood vessel, the arc main blood vessel can also be a straight blood vessel, and the shape which can automatically adapt to the target blood vessel after implantation appears as an arc shape.

3. The aortic arch stent graft combination as claimed in claim 2, wherein three branch vessels (7) are located on the outer side of the middle section (9 b).

4. The aortic arch stent graft blood vessel combination device of claim 3, further comprising three branch blood vessels (7) and the curved artificial aortic blood vessel (9), wherein the connection parts are designed to be conical, the branch blood vessel (7) has a larger opening on the main blood vessel (9) and tapers towards the distal end, so that after the branch blood vessel (7) is implanted, the branch blood vessel has a certain range of motion in all directions while ensuring the sufficient diameter of the opening, thereby adapting to the position and/or angle of different branch walking shapes.

5. The aortic arch stent graft combination as claimed in claim 3, wherein the diameter of the distal end of three branch vessels (7) is 3-5 mm larger than the maximum diameter of the common branch vessel.

6. The aortic arch branch-carrying stent graft blood vessel combination as claimed in claim 1, wherein the small stent graft (2) comprises an upper straight cylindrical small stent graft (10) and a lower stent bottom (11), the upper section (10 a) of the small stent graft (10) is a blood vessel with a stent graft, the lower section (10 b) is a bare stent graft without a stent graft, and the stent bottom (11) is a bell mouth-shaped bare stent graft without a stent graft.

7. The aortic arch stent graft blood vessel combination device as claimed in claim 6, wherein the small stent graft (2) has a diameter of 5-25 mm in the upper stent vessel part (10), and different types of stents are prepared by classification.

Technical Field

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

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 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 three-branch blood vessels on the arch part formed by the combination have extremely different forms, 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 to the target vessel, endovascular repair therapy cannot be completed.

At present, the covered stent blood vessel with three branches used in open surgery is tried, only reported by the Cheng Han Wan group in China, and the three-branch stent blood vessel designed by the three-branch stent blood vessel has obvious defects: the running and diameter differences of three branch blood vessels of a human body are large, the combined three-branch blood vessel system has great variation, and a stent blood vessel used by a Cheng-Han-Wan group is a blood vessel with a branch fixed size, so that the stent which is highly matched with various blood vessel conditions cannot be completely prefabricated, and the internal leakage is high. The three branches are fixed with the main stent blood vessel, and the three branches need to be implanted simultaneously when implanted, so that the operation difficulty is high, and the branch blood vessels are easily damaged. Or cannot be simultaneously inserted, resulting in operation failure.

The aortic branch stents are custom made abroad to fit the patient's specific anatomy, but are only useful for interventional procedures and not for open 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 are affected with the aortic arch part and ascending aorta, can reconstruct blood flow of branch arteries, avoid customizing stents, 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 and blood flow is not smooth, however, the space of the concave part is larger, and the space of the lower part of the concave part correspondingly narrows, so the blood flow supply of the aortic stent is necessarily influenced. Both aortic vascular systems are also only available for interventional procedures.

The application publication No. CN202821490U side branch type covered stent can be used for interventional therapy only. 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.

Disclosure of Invention

The invention provides a stent graft type blood vessel assembly with a branch covered on an aortic arch part, which is used for rapidly finishing the reconstruction of an arch part and a three-branch blood vessel in an open operation. Can greatly simplify the operation, does not need the traditional anastomosis of the far-end branch blood vessels, greatly reduces the extracorporeal circulation time and the deep low temperature circulation stopping time, and reduces the postoperative bleeding and the systemic complications. Meanwhile, the arch part and the three branch blood vessels are rebuilt in situ, which is more in line with physiology.

The invention provides a vascular combination device of an aortic arch part branch covered stent for an open surgery, which comprises two artificial vascular components: firstly, a section of arc-shaped artificial aorta blood vessel (1), wherein the arc-shaped artificial aorta blood vessel (1) comprises a main blood vessel (9) and three branch blood vessels (7) on the main blood vessel (9), a stent (8) is arranged in the main blood vessel (9), and a proximal part (8 a) of the stent (8) is a naked stent which can be released later; covering a small stent blood vessel (2); when in combination, the three coated small stent vessels (2) are sequentially arranged in the three branch vessels (7) of the arc-shaped artificial aorta vessel (1), and then the proximal part (8 a) of the stent (8) in the main vessel (9) is released; the middle and rear sections (9 b, 9 c) of the combined arc-shaped artificial aorta vessel (1) and the three branch vessels (7) are all covered vessels with stents in the whole process.

Preferably, the main blood vessel (9) is a straight cylindrical blood vessel (9) with an arc section, the front section (9 a) is a simple blood vessel, three branch blood vessels (7) are arranged above the middle section (9 b), a stent (8) is arranged in the main blood vessel (9), the end part (8 b) of the stent (8) and the tail end of the blood vessel (9) are integrally designed into a blood vessel with the stent, the proximal part (8 a) of the stent (8) is a naked stent which is released later, the length of the stent (8) is the same as the length of the middle and rear sections (9 b, 9 c) of the main blood vessel, the arc main blood vessel can also be a straight blood vessel, and the arc main blood vessel can automatically adapt to the shape of a target blood vessel after being implanted and.

Preferably, three of the branch vessels (7) are located on the outer side of the arc of the middle section (9 b).

Preferably, the artificial aorta stent also comprises connecting parts between three branch blood vessels (7) and an arc-shaped artificial aorta blood vessel (9), wherein the connecting parts are designed in a cone shape, the openings of the branch blood vessels (7) on the main blood vessel (9) are larger, and the branch blood vessels taper towards the far end, so that after the branch blood vessels (7) are implanted, the openings are ensured to have a certain moving range in each direction while the sufficient pipe diameters are ensured, and the artificial aorta stent is suitable for positions and/or angles of different branch shapes.

Preferably, the diameters of the distal ends of the three branch blood vessels (7) are designed to be 3-5 mm larger than the maximum diameter of the common branch blood vessel.

Preferably, the film-coated small stent blood vessel (2) comprises a small stent blood vessel part (10) in a straight barrel shape at the upper part and a stent bottom part (11) at the lower part, the upper section (10 a) of the small stent blood vessel part (10) is a blood vessel with a film, the lower section (10 b) is a bare stent without a film, and the stent bottom part (11) is in a horn mouth shape and is a bare stent without a film.

Preferably, the small stent graft vessel (2) is prepared by classifying the upper stent vessel part (10) into various types of stents with the diameter of 5-25 mm.

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 bow-part branch tectorial membrane blood vessel assembly adopts the design that the blood vessel membrane and the bracket are separately arranged, can well adapt to the original blood vessel shape, and can ensure enough blood vessel support after combination. The design of the branch vessel stent-free vascular membrane can adapt to the running distribution of three main branch vessels without being customized according to the specific anatomical condition of a patient. The small covered stent can be freely selected according to the thickness of each branch blood vessel of a patient, can fully support each branch blood vessel and prevent branch 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 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 can rapidly and safely reconstruct the distal end of the aortic arch and three branch vessels, has wide application range and simple stent release procedure. Because the design of releasing the branch vessel without the stent first is adopted, the branch artery at the aortic arch part can be safely and conveniently reconstructed, the original vessel form is maintained to the maximum extent, and the physiological state is better met. Because the distal aortic arch part and the branch vessels are reconstructed in situ, the branch vessel anastomosis process of the traditional operation is not needed.

3. The invention creatively provides a covered stent blood vessel with three branch blood vessels, and an aortic arch part and the three branch blood vessels are quickly reconstructed in an open operation. Compared with the traditional full aortic arch operation using the blood vessel with four bifurcations to replace, the traditional full aortic arch replacement operation is greatly simplified, three distal branch anastomotic stoma are reduced, the operation of separating branch blood vessels is avoided, and the injury and bleeding in the operation are reduced. Greatly reduces the in-vitro circulation time and the deep hypothermia circulation stopping time in the operation and reduces the postoperative systemic complications. At present, no similar intraoperative vascular system with a three-branch covered stent which can completely match various vascular conditions of a human body is reported at home and abroad.

Drawings

FIG. 1 is a schematic view of a three-branched curved artificial aortic vessel of the present invention;

FIG. 2 is a schematic diagram of the connection of a branch vessel and a main vessel of a three-branch curved artificial aortic vessel according to the present invention;

FIG. 3 is a schematic view of a stent graft of the present invention;

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

FIG. 5 is a schematic view of the assembly of (i) an arcuate artificial aortic vessel with three branches after release in the thoracic aorta and its three branches, wherein the proximal portion of the main endovascular stent is not released;

FIG. 6 is a schematic diagram of an artificial blood vessel of component I, which is released in a thoracic aorta, and then components II, which are respectively placed in three branch vessels, covering a small stent blood vessel;

FIG. 7 illustrates a blood vessel portion and a stent proximal portion in a main vessel lumen after release of the first component and the second component;

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.

Detailed Description

The reference numerals in the figures denote: 1. an arcuate artificial aortic vessel with three branches, wherein the main vessel has a stent with a post-releasable proximal portion; 2. coating a small stent blood vessel; 3. thoracic aortic arch and bifurcation; 4. innominate artery; 5. the left common carotid artery; 6. the left subclavian artery; 7. a branch vessel of an artificial main vessel; 8. a stent within an artificial main vessel; 8a, a bare stent portion that can be post-released; 8b, a stent portion integrally designed with the artificial main vessel; 9. a main vessel of an artificial blood vessel; 9a, the anterior segment of the artificial main vessel (the portion in front of the branch vessel); 9b, a part with three branches in the middle section of the artificial main blood vessel; 9c, artificial main vessel posterior segment; 10. the upper part of the straight-tube blood vessel part of the tectorial membrane small bracket blood vessel; 10a, a blood vessel is supported by a blood vessel membrane part on the upper section of the straight-tube blood vessel part; 10b, a bare stent part without a membrane at the lower section of the straight cylindrical blood vessel part; 11. coating the bottom of the blood vessel of the small stent; 12. arc artificial aorta blood vessel main vessel lumen

Fig. 1 to 7 show an aortic arch branch stent graft blood vessel combination device for open surgery and an application example thereof.

The utility model provides an aortic arch portion area branch tectorial membrane support blood vessel composite set for open operation, includes two artificial blood vessel subassemblies: firstly, a section of arc-shaped artificial aorta blood vessel (1), wherein the arc-shaped artificial aorta blood vessel (1) comprises a main blood vessel (9) and three branch blood vessels (7) on the main blood vessel (9), a stent (8) is arranged in the main blood vessel (9), and a proximal part (8 a) of the stent (8) is a naked stent which can be released later; covering a small stent blood vessel (2); when in combination, the three coated small stent vessels (2) are sequentially arranged in the three branch vessels (7) of the arc-shaped artificial aorta vessel (1), and then the proximal part (8 a) of the stent (8) in the main vessel (9) is released; the middle and rear sections (9 b, 9 c) of the combined arc-shaped artificial aorta vessel (1) and the three branch vessels (7) are all covered vessels with stents in the whole process.

Preferably, the main blood vessel (9) is a straight cylindrical blood vessel (9) with an arc section, the front section (9 a) is a simple blood vessel, three branch blood vessels (7) are arranged above the middle section (9 b), a stent (8) is arranged in the main blood vessel (9), the end part (8 b) of the stent (8) and the tail end of the blood vessel (9) are integrally designed into a blood vessel with the stent, the proximal part (8 a) of the stent (8) is a naked stent which is released later, the length of the stent (8) is the same as the length of the middle and rear sections (9 b, 9 c) of the main blood vessel, the arc main blood vessel can also be a straight blood vessel, and the arc main blood vessel can automatically adapt to the shape of a target blood vessel after being implanted and.

Preferably, three of the branch vessels (7) are located on the outer side of the arc of the middle section (9 b).

Preferably, the artificial aorta stent also comprises connecting parts between three branch blood vessels (7) and an arc-shaped artificial aorta blood vessel (9), wherein the connecting parts are designed in a cone shape, the openings of the branch blood vessels (7) on the main blood vessel (9) are larger, and the branch blood vessels taper towards the far end, so that after the branch blood vessels (7) are implanted, the openings are ensured to have a certain moving range in each direction while the sufficient pipe diameters are ensured, and the artificial aorta stent is suitable for positions and/or angles of different branch shapes.

Preferably, the diameters of the distal ends of the three branch blood vessels (7) are designed to be 3-5 mm larger than the maximum diameter of the common branch blood vessel.

Preferably, the film-coated small stent blood vessel (2) comprises a small stent blood vessel part (10) in a straight barrel shape at the upper part and a stent bottom part (11) at the lower part, the upper section (10 a) of the small stent blood vessel part (10) is a blood vessel with a film, the lower section (10 b) is a bare stent without a film, and the stent bottom part (11) is in a horn mouth shape and is a bare stent without a film.

Preferably, the small stent graft vessel (2) is prepared by classifying the upper stent vessel part (10) into various types of stents with the diameter of 5-25 mm.

When the stent artificial blood vessel external member is used, the components are implanted in sequence (firstly, the proximal part 8a of the main blood vessel stent is not released), the components are placed in sequence, and finally, the proximal part 8a of the main blood vessel stent is released to form the complete stent artificial blood vessel external member, so that the original blood vessel shape can be well maintained, and the lesion of the aortic arch part blood vessel can be isolated.

The assembly is an arc-shaped artificial aorta blood vessel with three branches, the three branch blood vessels are designed into cone-shaped soft blood vessels, the autonomous blood vessel cavity is in a funnel shape upwards, the far-end opening has a certain range of motion, and the far-end opening can be guaranteed to be placed in three target branch blood vessels with different angles and intervals better.

After the release of the main blood vessel and the branch blood vessel of the assembly I is finished, the assemblies II are respectively placed to the three branch blood vessels through the cavity of the main blood vessel of the assembly I in sequence to form the support of the branch blood vessels, and meanwhile, the tectorial membrane part of the small stent blood vessel is overlapped with the branch blood vessel membrane of the assembly I, so that the artificial blood vessel membrane of the branch blood vessel can be fully supported and covered, and the blood leakage is prevented. The design of the horn-shaped bare support at the bottom of the small support blood vessel can ensure that an artificial blood vessel membrane at the opening part of the branch blood vessel is fully attached to the wall to ensure that the opening part of the branch blood vessel is smooth, the bare support does not influence the blood flow of a main blood vessel cavity, and meanwhile, the wide bottom bare support can fix the opening part of the branch blood vessel to avoid the slipping of the small support. The independent design of the small stent vessel can ensure that the stent vessel with the corresponding diameter is selected individually for each branch vessel, and the adaptability is good.

After the release of the blood vessel part and the assembly II is finished, the naked stent part (8 a) is released in the main blood vessel cavity of the assembly I, the naked stent part (8 a) is completely overlapped with the main blood vessels (9 b and 9 c), and the blood vessel covered stent support with the blood vessels (9 b and 9 c) can be finished. The 8a section of the blood vessel membrane-free bare stent is designed to be correspondingly supported in a blood vessel (9 b) with a branch blood vessel section, so that the blood flow of the branch can be ensured to be smooth, and meanwhile, the wide base of the component II can be supported to further fix the branch blood vessel. The 9c section of the complete stent blood vessel can ensure that the posterior section blood vessel has no blood leakage.

The components are sequentially released to form a complete covered stent system with a three-branch aortic arch part, so that vascular lesions of the aortic arch part can be completely isolated, and blood can 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 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.