CN119970302B - Tectorial membrane support system - Google Patents

Abstract

The invention provides a covered stent system which comprises a) a covered stent, i) a positioning component, ii) a first branch vessel windowing component, wherein the first branch vessel windowing component comprises a first sealing area and a first adjusting area, the first sealing area 111 comprises a third opening, the first adjusting area comprises a first opening, a second opening, a first reinforcing structure and a second reinforcing structure, and b) a first branch covered stent is used for being released in the first branch vessel windowing component.

Description

Tectorial membrane support system

Technical Field

The invention relates to a covered stent with a window, which is used for treating vascular diseases involving trunk and branch vessels.

Background

The present invention is suitable for the treatment of conditions involving the trunk and branch vessels, and for convenience of description, the aortic dissection in which the conditions involve the aortic arch and the branches on the arch is taken as an example.

As shown in fig. 1A and 1B, the aortic arch region is composed of an ascending aorta 31, a innominate artery 32, a left common carotid artery 33, a left subclavian artery 34, and a descending aorta 35. Aortic dissection (AorticDissection) refers to a disease in which the media layer breaks due to bleeding within the aortic vessel wall, resulting in separation of the vessel wall and subsequent formation of a true lumen 36 and a false lumen 37, which may or may not be in communication with each other. In most cases, aortic dissection begins with intimal tearing, blood entering the medial layer through the intimal 38 tear, ultimately leading to rupture of the aorta or re-entry into the vacuum lumen through the second intimal tear. Aortic dissection is classified according to the site of dissection involvement into StanfordA-type dissection (dissection involves the ascending aorta), stanfordB-type dissection (dissection involves only the descending aorta) and non-a-type non-B-type dissection (dissection involves the aortic arch without involving the ascending aorta).

Among the newly increased aortic dissection per year, the type a dissection accounts for about 60% and the non-type a, non-B dissection accounts for about 10%.

For the A-type dissection and the non-A-type dissection, as the lesion affects three branch vessels of the ascending aorta and the aortic arch, and the structural relationship between the main trunk and the branch vessels of each part of the patient is different, including the opening positions of the branch vessels, the distances between the branch vessels and the opening directions of the branch vessels, no standardized interventional implantation stent product which is suitable for lesion affecting more than two branch vessels and is suitable for the differences is available so far, so that the surgical open-chest operation under extracorporeal circulation still can be only adopted conventionally. But the surgical operation has the following problems:

1) The operation is complicated and has long time, and the operation is not easy to popularize, as shown in fig. 2, the operation is required to be carried out under the extracorporeal circulation, a doctor resects the whole aortic arch vessel after freeing the vessel, replaces the vessel with the artificial vessel 4, and completes end-to-end suturing (an ascending aorta position 41, a innominate artery position 42, a left common carotid artery position 43, a left subclavian artery position 44 and a descending aorta position 45) between the artificial vessel and an autologous vessel at least at five parts. The operation time is about 6-10 hours, the extracorporeal circulation time is 2-3 hours on average, the aortic blocking time is 1.5-2 hours on average, the deep low temperature stop circulation time is 20-30 minutes on average, in a word, the operation is complex, the time is long, the learning curve of doctors is long, and the popularization is not easy.

2) The deep low temperature stop cycle time is long, which is easy to cause the ischemia of the viscera and the lower limbs, wherein the average time of the deep low temperature stop cycle time is 20-30 minutes, the stop cycle is easy to cause ischemia and hypoxia injury to each viscera, and the deep low temperature is easy to cause the pathophysiology change of each viscera.

3) The end-to-end stitching difficulty of the parts is high, the anastomotic stoma is easy to bleed, and meanwhile, the free serosa joint of the original arch part has more bleeding, so that the hemostasis is difficult.

4) The operation risk is high, and the foreign operation mortality rate is 10-33%. [3] The domestic operation mortality rate is 3.1% -15.5%, the incidence rate of acute respiratory insufficiency is 5% -15%, the incidence rate of nervous system complications is 4% -30%, the incidence rate of renal failure is 5% -12%, and the incidence rate of postoperative hospital infection is about 12%. [4] The onset and lesion development are very rapid (mortality rate of type a interlayer is 40% to 50% at 48 hours after onset) and the transfer route time of patients is long, so many patients die without being treated.

As global hypertension patients increase year by year, the prevalence of the above diseases increases year by year, due to the characteristics mentioned above, many patients cannot be timely cured in local place and lose lives, so that the disease has become a pain spot for many years for clinicians, and over ten years, doctors in countries worldwide frequently try to use interventional endoluminal repair to treat the disease, so as to reduce the dilemma faced by the clinic, mainly in the following ways:

1) In-situ windowing technology, a straight tubular thoracic aortic stent graft is implanted into an aortic arch region through a catheter, the stent graft of the thoracic aortic stent graft is subjected to in-situ rupture of the membrane during operation at the corresponding positions of three branch blood vessels on the aortic arch, balloon dilatation is carried out on the rupture ports, and the corresponding branch stent graft is implanted one by one through the catheter through the dilated rupture ports. The technology has the following problems that a, after implantation and before the opening of a membrane, the corresponding branch vessel opening is isolated by the thoracic aortic membrane stent and is in an ischemic state, if the ischemic state is too long, serious brain complications are caused, b, the membrane rupture and the opening on the thoracic aortic membrane are physical tearing, the joint between the implanted branch membrane stent and the membrane rupture is not tight, the incidence rate of endoleak is high (blood flows out from a gap between the membrane rupture on the thoracic aortic membrane and the branch membrane stent), the false cavity is continuously enlarged, a patient often needs secondary operation intervention, c, the operation is complicated, the operation time is long and the popularization is difficult, d, the operations such as the operation of the membrane rupture, the implantation of the branch membrane stent are mainly performed through the neck or the artery (for example, the brachial artery) on the right arm, and the branch vessel on the arch are taken as an access (the upper access in the field), the internal parts of the branch vessels are in and out, plaque (most plaque is easy to cause in the branch vessel) to fall off, the brain plaque is easy to cause the brain plaque in the operation, or the branch vessel is damaged and finally falls off.

2) The embedded tunnel and module bridging technology is that a thoracic aortic stent with three internal tunnels is implanted into an aortic arch area through a catheter, the three internal tunnels are used as interfaces for bridging the thoracic aortic stent and the branch stent, wherein the internal tunnels corresponding to the innominate artery and the left common carotid artery respectively extend from the root of each branch vessel to the ascending aorta, the internal tunnels corresponding to the left subclavian artery extend from the root of the left subclavian artery to the descending aorta, the catheter is implanted into the branch stent corresponding to the innominate artery and the left common carotid artery one by one through an upper passage, and the branch stent corresponding to the left subclavian artery is implanted through a femoral artery passage (called a lower passage in the interventional field). The technology also has the following problems that the branch tectorial membrane stents of the innominate artery and the left common carotid artery are implanted through the upper passage, so that the operation time is long, the difficulty is high, a plurality of operations are carried out in the branch blood vessel at the arch part, and the risk that the plaque in the original branch blood vessel is easily shed to cause the cerebral infarction in the operation or the damage of the intima of the branch blood vessel to form the plaque and finally shed to cause the cerebral infarction is easily caused.

3) The hybridization operation is divided into two steps, namely, the surgical bypass operation is carried out between the innominate artery and the left common carotid artery and the left subclavian artery by using an artificial blood vessel from the neck, and then the branched intervention tectorial membrane stent with one innominate artery stent is implanted into the innominate artery in the aortic arch area through the lower passage by using a catheter. Establishing the blood supply between the branch vessels at the site. The technique needs to be carried out in two stages, the operation is complex, the waiting time of a patient is long, the surgical bypass operation of the neck can cause corresponding complications such as bleeding and infection, the reconstruction mode greatly changes the original blood flow mode of the branch on the bow, and the bypass blood vessel can be narrowed or blocked.

The methods have the defects of long operation time, complex operation, various complications, no standard instruments and operation methods and incapability of being popularized in most hospitals.

Disclosure of Invention

The invention provides a covered stent system. In one embodiment, the stent graft system comprises a) a stent graft comprising i) a positioning assembly, ii) a first branch vessel fenestration assembly comprising a first sealing region comprising a third opening, a first adjustment region comprising a first opening, a second opening, a first reinforcement structure, a second reinforcement structure, b) a first branch stent graft for release within the first branch vessel fenestration assembly, the first reinforcement structure maintaining the first opening, the second reinforcement structure maintaining the second opening, the first adjustment region being positioned between the first reinforcement structure and the second reinforcement structure, the first adjustment region allowing the second opening to move relative to the positioning assembly, the first sealing region extending from the second reinforcement structure to the third opening, allowing the first stent graft to release within the first branch vessel fenestration assembly, the first reinforcement structure maintaining the first opening, the second reinforcement structure maintaining the second opening, the first adjustment region being positioned between the first reinforcement structure and the second reinforcement structure, the first sealing region being positioned between the second opening and the positioning assembly, the first sealing region extending from the second reinforcement structure to the third opening, allowing the first stent graft to remain attached to the first stent graft and the first stent graft to the first connection section, thereby leaving the first stent graft to remain attached to the first stent graft section at the first connection section.

The invention further provides a method of implanting a stent graft into a vessel, the vessel comprising a main body, a positioning branch vessel, and a first branch vessel. In one embodiment, the method comprises the steps of a) providing a stent graft system of the present invention, b) feeding the stent graft to the trunk of the vessel, c) aligning the positioning assembly with the positioning branch vessel, d) releasing the stent graft to conform to the trunk inner wall and align the positioning assembly with the root of the positioning branch vessel, e) feeding the first branch stent graft to the first branch vessel through the first branch vessel fenestration assembly, f) releasing the first branch stent graft to align the second opening with the root of the first branch vessel, such that the first sealing region is in planar sealing connection with the first branch stent graft, and the first connecting anchor remains proximal to the first opening of the first regulatory region.

Drawings

Fig. 1A shows a schematic view of a normal aorta. Fig. 1B shows a schematic view of aortic dissection.

Figure 2 shows five vascular prostheses end-to-end sutured to the autologous vessel during surgery.

Fig. 3 is a front view of a stent graft with a fenestration assembly.

Fig. 4 is a front view of the fenestration assembly.

Fig. 5 is a top view of the fenestration assembly.

Fig. 6 is a front view of the fenestration assembly.

Fig. 7 is a sectional view of the first reinforcing structure (second reinforcing structure) and the first developing structure (second developing structure).

Figure 8 shows the fenestration assembly after delivery of the fenestrated stent with alignment to the root and middle of the left common carotid artery (before the fenestrated stent is unreleased, deployed).

Fig. 9 shows a schematic view of the fenestrated stent after release, deployment.

Fig. 10 shows a schematic view of a branched stent graft loaded in a delivery system being delivered to the left common carotid artery.

Fig. 11 shows a schematic view of the left common carotid artery branch stent graft after release and deployment.

Fig. 12 shows a schematic view of the delivery of a stent graft loaded in a delivery system to a innominate artery, where the second opening is offset from the root of the branch vessel.

Fig. 13A shows a schematic view of the second opening displaced from the root of the branch vessel.

Fig. 13B shows a schematic view of the second opening aligned with the root of a branch vessel.

Fig. 14 shows a schematic view of the innominate arterial branch stent graft after being released and deployed, with the second opening aligned with the root of the branch vessel.

Fig. 15 shows a schematic view of the left subclavian artery branch stent graft after release, deployment, with the second opening aligned with the root of the branch vessel.

Fig. 16 shows clinical CT angiography of clinical trial cases 001-010 preoperatively.

Figure 17 shows clinical CT angiography after 001-010 surgery in clinical trial cases.

Fig. 18 shows velocity cloud and flow line graph comparisons between models with and without sealing zones in a finite element analysis.

Fig. 19 shows a velocity cloud contrast between a model with sealing zones and a model without sealing zones in a finite element analysis.

Detailed Description

The diseases of the trunk and branch blood vessels are serious harm to the life safety of the patient at present and have highest risk, the patient can often lose life due to incapability of timely treatment by carrying out extremely traumatic surgery to the heart center in emergency treatment, and meanwhile, even if timely treatment is obtained, the death rate of the operation per se is as high as 10% -33%, and various postoperative complications are as high as 4% -30%. Is a pain spot which is a long-term trouble for clinical treatment of the patients, and has the main beneficial effects that:

1) The medical device can replace most of direct vision operations which need surgical thoracotomy or thoracotomy, deep low-temperature stop circulation under extracorporeal circulation at present, and only needs catheter intervention implantation to treat related diseases, thereby greatly reducing wounds, reducing high operation mortality and high complications caused by surgical operations, and developing a brand new treatment method for treating diseases involving branch blood vessels;

2) The invention can be implanted into the apparatus through the arterial intervention of the lower limb, is simple to operate, easy to learn and popularize in most middle-grade hospitals, changes the current situation that the patients need emergency treatment to be sent to the big hospitals outside hundreds of the public for surgical operation, ensures that a plurality of patients can be timely and rapidly treated in local nearby hospitals, and greatly improves the survival rate of the patients;

3) The method and the apparatus for catheter intervention are used for treating vascular diseases of lesion involving branch vessels, the cost is far lower than the treatment cost of surgical operation, and the method and the apparatus have good clinical and social significance.

For the treatment of diseases of main and branch blood vessels, the invention provides a covered stent with a window opening assembly, which can reconstruct diseased blood vessels when combined with the branch covered stent, and the diseased aorta is reconstructed by the covered stent provided by the invention for patients with type A and non-A non-B interlayer (including aneurysms, wall hematomas and multiple penetrating ulcers of the part) as the examples.

The invention provides a covered stent system. In one embodiment, the stent graft system comprises a) a stent graft comprising i) a positioning assembly, ii) a first branch vessel fenestration assembly 11, the first branch vessel fenestration assembly 11 comprising a first sealing region 111, a first conditioning region 112, the first sealing region 111 comprising a third opening 1112, the first conditioning region comprising a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcing structure 113, a second reinforcing structure 114, b) a first branch stent graft for release within the first branch vessel fenestration assembly 11, the first reinforcing structure 113 maintaining the first opening 1121, the second reinforcing structure 114 maintaining the second opening 1122, the first conditioning region 112 positioned between the first reinforcing structure 113 and the second reinforcing structure 114, the first conditioning region 112 allowing the second opening 1122 to move relative to the positioning assembly, the first sealing region 1122 extending from the first sealing region to the first anchoring region 1121, the first reinforcing structure 112 extending from the first sealing region to the first anchoring region 1121, and the first sealing region 114 extending to the first anchoring region 112 at a larger diameter than the first sealing region 112.

In one embodiment, the sealing region extends from the second reinforcing structure to the third opening 1112, the extension extending from the second reinforcing structure in the direction of the adjustment region.

In one embodiment, the sealing region extends from the second reinforcing structure to the third opening 1112, the extension being from the second reinforcing structure in the other direction of the adjustment region.

In one embodiment, the sealing region extends from the second reinforcing structure to the third opening 1112, the extension being from the second reinforcing structure in both the direction of the adjustment region and in the other direction.

In one embodiment, the first reinforcing structure 113 includes a first developing structure 115, the second reinforcing structure 114 includes a second developing structure 116, or the first accommodating region 112 includes a third developing structure 117.

In one embodiment, the positioning assembly comprises a positioning sealing area and a positioning adjusting area, wherein the positioning sealing area comprises a positioning third opening, and the positioning adjusting area comprises a positioning first opening, a positioning second opening, a positioning first reinforcing structure and a positioning second reinforcing structure.

In one embodiment, the stent graft further comprises a positioning branch stent graft for implantation of the positioning assembly.

In one embodiment, the first connection anchor segment includes a flange bracket and a flange cover.

In one embodiment, the relative sizes of the first, second, and third openings 1121, 1122, 1112 are selected from one or more of a) the first opening 1121 is larger than the second opening 1122, b) the second opening 1122 is larger than the third opening 1112, c) the first opening 1121 is equal to the second opening 1122, d) the second opening 1122 is equal to the third opening 1112.

In one embodiment, the first adjustment zone 112 or the first sealing zone 111 is a flexible cylindrical or frustoconical film.

In one embodiment, the shape of the first opening 1121, the second opening 1122, or the third opening 1112 is circular or circular-like.

In one embodiment, the first reinforcing structure 113 or the second reinforcing structure 114 is made of a super-elastic material (metal, alloy, polymer, etc.).

In one embodiment, the connection of the first sealing region 111 to the first branched stent graft is a planar connection.

In one embodiment, the stent graft system further comprises a second branched vascular fenestration assembly and a second branched stent graft, wherein the second branched vascular fenestration assembly comprises a second sealing region and a second adjusting region, the second sealing region comprises a third opening 1112, the second adjusting region comprises a first opening 1121, a second opening 1122, a first reinforcing structure 113 and a second reinforcing structure 114, the second branched stent graft comprises a second connecting anchor section, the diameter of the second connecting anchor section after release is larger than the first opening 1121 of the second adjusting region, the second connecting anchor section is reserved at the proximal end of the first opening 1121 of the second adjusting region, the positioning assembly is used for implanting a left common carotid artery, the first branched vascular fenestration assembly is used for implanting a innominate artery, and the second branched vascular fenestration assembly is used for implanting a left subclavian artery.

The invention further provides a method of implanting a stent graft into a vessel, the vessel comprising a main body, a positioning branch vessel, and a first branch vessel. In one embodiment, the method comprises the steps of a) providing a stent graft system of the present invention, b) feeding the stent graft to the trunk of the vessel, c) aligning the positioning assembly with the positioning branch vessel, d) releasing the stent graft to conform to the trunk inner wall and align the positioning assembly with the root of the positioning branch vessel, e) feeding the first branch stent graft to the first branch vessel through the first branch vessel fenestration assembly 11, f) releasing the first branch stent graft to align the second opening with the root of the first branch vessel, and maintaining the first sealing region 111 in planar sealing connection with the first branch stent graft and the first connecting anchor segment at the proximal end of the first opening 1121 of the first regulatory region.

In one embodiment, the vessel is an aortic arch, and the positioning branch vessel or the first branch vessel is selected from one of a left common carotid artery, a innominate artery, and a left subclavian artery.

In one embodiment, the blood vessel is the abdominal aorta and the positioning branch blood vessel or the first branch blood vessel is selected from one of the group consisting of the trunk abdominal, the left renal artery, the right renal artery, and the superior mesenteric artery.

In one embodiment, the blood vessel is an aortic root and an ascending aorta, and the positioning branch vessel or the first branch vessel is selected from one of a left coronary artery and a right coronary artery.

In one embodiment, the vessel is any artery or vein having two or more branches, and the positioning branch vessel or the first branch vessel is selected from one of the branches of the vessel.

In one embodiment, the step (d) further comprises i) delivering a positioning branch stent graft to the positioning vessel through the positioning assembly, wherein the positioning assembly comprises a positioning sealing area and a positioning adjustment area, the positioning sealing area comprises a positioning third opening, the positioning adjustment area comprises a positioning first opening, a positioning second opening, a positioning first reinforcing structure and a positioning second reinforcing structure, the positioning branch stent graft comprises a positioning connecting anchoring section, the diameter of the positioning connecting anchoring section after release is larger than that of the positioning first opening, the positioning connecting anchoring section is kept at the proximal end of the positioning adjustment area first opening, ii) releasing the positioning branch stent graft, the positioning sealing area and the positioning branch stent graft are in face-shaped sealing connection, and the first connecting anchoring section of the positioning branch stent graft is kept at the proximal end of the positioning adjustment area first opening.

The invention mainly solves the technical problems that:

1) The sealing area of the windowing component is of a cylindrical or truncated cone-shaped flexible film structure, the sealing performance between the windowing component and the branch film-covered bracket can be ensured by the flexible film structure, internal leakage is effectively prevented, and the problem of possible internal leakage after the branch film-covered bracket is implanted in various windowing design principles is solved;

2) The adjusting area of the windowing component can enable the position and the angle of the second opening 1122 of the windowing component to be movable and adjustable in a certain range so as to adapt to anatomical structure differences of most main and branch blood vessels;

3) The structure of the windowing component does not limit the access position of the branch tectorial membrane stent system, can be implanted into the branch tectorial membrane stent through femoral artery (lower passage), avoids the problem of postoperative brain complications caused by falling plaque on the inner wall of a branch vessel possibly caused by the entrance of technologies such as embedded tunnel, module bridging and the like from an upper passage, shortens the operation time, and is convenient for doctors to operate and popularize the operation;

4) The fenestration of the invention has a reinforcing structure, after the covered stent is implanted into a blood vessel, the vessel wall and lesion parts (false cavity, hematoma and the like) can be isolated, the fenestration shape can be maintained even when the covered stent is pressed in the blood vessel, the blood flow of a branch blood vessel is maintained, the problem of cerebral blood supply possibly caused by the fact that other technologies only have a concave structure is solved, and meanwhile, the over-selection of a guide wire in operation (the over-selection refers to that a guide pipe or the guide wire selectively enters a target branch blood vessel) is facilitated.

5) The window opening assembly has a developing structure, and can clearly display the position of the window opening assembly under X rays in the conveying process and the super-selecting process, so that the positioning of the covered stent in the operation, the super-selecting of the guide wire and the positioning of the branched covered stent in the operation are facilitated.

The above characteristics of the present invention are suitable for the repair and reconstruction of most anatomical differential lesions (including interlayer tumors, true aneurysms, wall-to-wall hematomas, multiple penetrating ulcers) of the main and branch vessels, such as between the aortic arch and the three branch vessels on the arch, as well as between the abdominal aorta and the left and right renal arteries, superior mesenteric arteries, and trunk abdominal arteries, etc., as examples.

In one embodiment of the invention, cooperation between the various components within the stent graft system is effective in preventing endoleak problems that may occur after implantation of the branched stent graft. In one embodiment, the diameter of the connecting anchoring section of the branched stent graft after release is larger than the first opening 1121 of the adjusting region and anchored at the proximal end, which is the main means for fixing the branched stent graft. The connecting and anchoring section of the branch tectorial membrane bracket bears most of the force for fixing the branch tectorial membrane bracket, and can prevent the branch tectorial membrane bracket from separating from the windowing component, thereby preventing III-type internal leakage. The first reinforcement structure 113 and the second reinforcement structure 114 can maintain the shape of the first opening 1121 and the second opening 1122 when the branch vessel structure difference and the fenestration assembly are dislocated, so that the over-selection of the guide wire is facilitated, and simultaneously, the second opening 1122 of the adjusting region can automatically adjust the position when the branch stent graft is released, so that the second opening 1122 is automatically aligned to the root of the branch vessel, thereby correcting the dislocation and preventing the branch stent graft from kinking. After the branch tectorial membrane support is released and unfolded, the sealing area is a cylindrical or truncated cone-shaped flexible membrane structure, and the surface-to-surface sealing is formed between the flexible membrane structure and the branch tectorial membrane support, so that internal leakage is effectively prevented.

The invention relates to a covered stent with a windowing component, which is used for treating vascular diseases of main and branch blood vessels affected by pathological changes. The device of the invention is a film covered stent with a window opening component 1, which consists of the window opening component, a columnar film 12 and a stent ring 13 (shown in figure 3). The fenestration assembly is comprised of a sealing region, a conditioning region, a first opening 1121, a second opening 1122, a third opening 1112, a first reinforcing structure 113, a second reinforcing structure 114, a first developing structure 115, a second developing structure 116, and a third developing structure 117 (as shown in fig. 4 and 5). Wherein the third developing structure 117 is an optional component.

A covered stent 1 with a windowing component is used for treating vascular diseases of a main trunk and branch blood vessels, is an assembly body formed by combining a plurality of components through a certain process, and at least comprises a windowing component.

The windowing component is a connecting structure of a covered stent 1 with windowing and a branched covered stent, and is an assembly body formed by combining a plurality of components through a certain process.

The columnar film 12 is a layer of flexible columnar or truncated cone-shaped film attached to the bracket ring 13 by sewing or hot melting, and the material is a biocompatible material.

The bracket ring 13 is a wavy or latticed wire frame.

The sealing area is a layer of flexible cylindrical or truncated cone-shaped film which is adhered to the second opening 1122 of the adjusting area by stitching or hot melting, and the material of the sealing area is a biocompatible material. Alternatively, the sealing region extends from the second opening 1122 both upwardly and downwardly, as shown in FIG. 6.

The adjusting area is a layer of flexible cylindrical or truncated cone-shaped film attached to the cylindrical film 12 by sewing or hot melting, and the two ends of the adjusting area are a first opening 1121 and a second opening 1122, and the material is a biocompatible material.

The first opening 1121 is an opening of the adjustment region on the side close to the columnar coating film 12, and has a circular or circular-like shape.

The second opening 1122 is an opening on the side of the adjustment region away from the columnar film 12, and has a circular or circular-like shape with a diameter or circumference smaller than that of the first opening 1121.

The third opening 1112 is an opening on the side of the sealing region remote from the adjustment region, and has a circular or circular-like shape with a diameter or circumference less than or equal to 1122 the diameter or circumference of the second opening.

The first reinforcing structure 113 is an annular metal attached to the first opening 1121 by sewing or hot melting, and has a super elasticity, such as nickel-titanium alloy, and a certain development effect.

The second reinforcing structure 114 is a ring-shaped metal attached to the second opening 1122 by sewing or hot melting, and has a super-elasticity, such as nickel-titanium alloy, and a certain development effect.

The first developing structure 115 is a spiral metal attached to the first reinforcing structure 113 by winding, and its material has a good developing effect under X-rays, such as platinum alloy, gold. Alternatively, 115 the first development structure is located at the cross-sectional center of the first reinforcement structure 113, as shown in fig. 7.

The second developing structure 116 is a spiral metal attached to the second reinforcing structure 114 by winding, and the material thereof has a good developing effect under X-rays, such as platinum alloy and gold. Alternatively, the second developing structure 116 is located at the center of the cross section of the second reinforcing structure 114, as shown in fig. 7.

The third developing structure 117 is a circular ring or a circular disc-shaped metal attached to the adjusting area by stitching or hot melting, and the material has good developing effect under X-ray, such as platinum alloy and gold.

The functions of the components in this embodiment are described as follows:

the covered stent 1 with the windowing component is used for treating vascular diseases involving branch vessels, reconstructing the branch vessels while reconstructing the main vessels, and keeping the branch vessels unobstructed.

The fenestration assembly, as a structure connected with the branch stent graft, can be combined with the branch stent graft to adapt to different vascular anatomies when the columnar stent graft 12 and the stent ring 13 are fixed in the main blood vessel.

The columnar tectorial membrane 12 ensures that blood flow does not permeate outside the tectorial membrane stent and can play a role in plugging a vascular intima breach or plugging a tumor cavity together with the stent ring 13.

The bracket ring 13 provides radial supporting force, so that the columnar tectorial membrane 12 is firmly supported in the main blood vessel, and the functions of expanding the true lumen of the blood vessel and shrinking the false lumen are supported.

The sealing area can ensure the tightness of the branch tectorial membrane bracket and the windowing component and reduce internal leakage.

The adjustment region allows the second opening 1122 to move and rotate within a range to accommodate different branch vessel anatomies.

The first opening 1121 through which blood flows into the regulated area.

And a second opening 1122 through which blood flows into the sealing region.

Third opening 1112 through which blood flows out of the sealing area.

The first reinforcing structure 113 maintains the shape of the first opening 1121, keeps the blood flow of the branch vessels smooth during and after the operation, and facilitates the over-selection during the operation.

The second reinforcing structure 114 maintains the shape of the second opening 1122, keeps the blood flow of the branch vessels smooth during and after the operation, and facilitates the over-selection during the operation.

The first visualization structure 115 makes the shape of the first opening 1121 more apparent under intraoperative X-rays, thereby facilitating intraoperative positioning of the stent graft 1 with fenestration assembly, over-selection of branches, and positioning of the branched stent graft.

The second visualization structure 116 makes the shape of the second opening 1122 more pronounced during intraoperative X-rays, thereby facilitating intraoperative positioning of the fenestrated stent-graft 1, over-selection of branches, and positioning of branched stent-grafts.

The third development 117 makes the position of the fenestration assembly more visible under the intraoperative X-rays, thereby facilitating intraoperative positioning of the stent graft 1 with fenestration assembly, over-selection of branches, and positioning of the branched stent graft.

Description of the surgical procedure:

in the present invention, the operation for treating vascular diseases in which lesions involve the trunk and branch vessels can be simplified into the following five steps. Here, for convenience of explanation, the aortic arch region is selected as the region to be reconstructed:

i. As shown in fig. 8, the fenestrated stent graft 1 is loaded in a delivery system, and the fenestrated stent graft 1 has three fenestration assemblies corresponding to the innominate artery, the left common carotid artery, and the left subclavian artery, respectively, from left to right. The delivery system is delivered to the designated location by imaging structures (first imaging structure 115, second imaging structure 116, or third imaging structure 117) in the fenestration assembly at the root and middle of the Ji Zuo common carotid artery.

As shown in fig. 9, the fenestrated stent graft 1 is released into the aorta, at this time, the fenestrated stent graft 1 conforms to the inner wall of the aorta and the middle fenestration assembly is aligned with the root of the left main vessel.

As shown in fig. 10, the branched stent graft 2 is loaded in a delivery system and the delivery system is delivered to a designated location by aligning the visualization structure (first visualization structure 115) in the intermediate fenestration assembly with the visualization structure on the branched stent graft (first stent near one end of the heart).

As shown in fig. 11, the branched stent graft 2 of the left common carotid artery is released, at this time, one end of the branched stent graft close to the heart is attached to the sealing area of the fenestration assembly of the fenestrated stent graft 1, and one end far from the heart is attached to the inner wall of the branched blood vessel.

V. as shown in fig. 12, the branched stent graft is loaded in a delivery system and the delivery system is delivered to a designated location by aligning the visualization structure (first visualization structure 115) in the leftmost fenestration assembly with the visualization structure (first stent near one end of the heart) on the branched stent graft. As shown in fig. 13A and 13B, when the second opening 1122 in the leftmost fenestration assembly is misaligned with the innominate arterial root 321, the second opening 1122 can be adjusted in position and angle to align with the innominate arterial root 321 when the guidewire over-select, push-branch stent-graft system and release-branch stent-graft are operated due to the adjustment zone in the fenestration assembly allowing the second opening 1122 to move and rotate over a range.

And (vi) releasing the branch stent graft of the innominate artery, wherein one end of the branch stent graft, which is close to the heart, is attached to a sealing area of a fenestration assembly of the fenestrated stent graft 1, and one end of the branch stent graft, which is far away from the heart, is attached to the inner wall of the branch vessel, as shown in fig. 14.

Step v and step vi are repeated as shown in fig. 15, and a left subclavian artery branch stent graft is implanted to complete the reconstruction of the vessel in the aortic arch region.

For the endovascular treatment of vascular diseases, wherein the lesions involve the trunk and the branch blood vessels, the in-situ windowing technology, the embedded tunnel, the module bridging technology and the like, the problems of anatomical structure difference of the branch blood vessels, internal leakage, implantation of a branch tectorial membrane bracket from a branch telecentric end, complex operation, long operation time and the like are faced with the greatest problems, and the scheme has the following innovation points:

1) The sealing area of the windowing component can ensure the tightness between the windowing component and the branch tectorial membrane bracket, and effectively prevent internal leakage. The sealing area belongs to the plane shape leakage prevention, the leakage-proof effect is far better than that of linear leakage-proof. In one embodiment, the sealing area is a cylindrical or frustoconical flexible membrane structure.

2) The opening position and the angle of the windowing component can be adjusted in a certain range, and the windowing component can adapt to anatomical structure differences of most branch blood vessels due to individual differences. In addition, the specification of the film covered bracket 1 with the windowing component can be greatly reduced, so that the design and production difficulties are reduced, and the stock quantity is reduced. In one embodiment, the adjustment region of the fenestration assembly allows the position and angle of the second opening 1122 to be adjusted within a range that accommodates the anatomical variability that exists in most branched vessels.

3) The structure of the windowing component can not limit the access position of the branch covered stent system, and the access position of the branch covered stent system can be selected according to the actual condition of the blood vessel of a patient, namely, the branch covered stent system can completely enter from the femoral artery (lower passage). The branch tectorial membrane stent system is the first choice from the lower passage, so that the operation is more convenient than that of the upper passage, the postoperative brain complications caused by falling of plaque on the inner wall of a branch blood vessel possibly caused by the upper passage can be reduced, and the operation time is greatly shortened;

4) The fenestration assembly is provided with a first reinforcing structure 113 and a second reinforcing structure 114, can maintain the fenestration shape even when the blood vessel is pressed, maintain the blood flow of the branch blood vessel, and facilitate the super-selection of the guide wire in the operation;

5) The windowing component is provided with a first development structure 115, a second development structure 116 and a third development structure 117, and can clearly display the windowing position under X rays in the conveying process and the super-selection process, thereby facilitating the positioning of the fenestrated stent-graft 1 in the operation, the super-selection of a guide wire and the positioning of the branched stent-graft in the operation, and further improving the success rate of the operation.

1) Clinical CTA:

The tectorial membrane stent system manufactured by the technology of the invention develops 10 cases of clinic, and CTA after operation shows that no internal leakage exists between the branch tectorial membrane stent and the windowing component, the branch tectorial membrane stent has good alignment, the operation time is the shortest of only 61 minutes, the average is only 112 minutes, and CTA before operation and CTA after operation are respectively shown in figure 16 and figure 17.

2) Finite element analysis:

Through finite element analysis, for models without sealing areas, there is endoleak between the fenestration assembly and the branch stent graft. For the mold with the sealing area, there is no internal leakage in the same place. Specifically, fig. 18 and 19 show the same. Fig. 18 shows a velocity cloud and flow diagram, the left diagram is a model without a sealing area, the flow line between the windowing component and the branch film-covered bracket is regular, internal leakage exists, the right diagram is a model with a sealing area, vortex exists between the windowing component and the branch film-covered bracket, and internal leakage does not exist. FIG. 19 shows a velocity cloud plot, the left plot is a model without a sealing zone, the flow rate between the fenestration assembly and the branch stent graft is greater than 0.05m/s with internal leakage, and the right plot is a model with a sealing zone, the flow rate between the fenestration assembly and the branch stent graft is 0, with no internal leakage.

Claims (11)

1. A stent graft system comprising:

a. a stent graft comprising:

i. A positioning assembly;

a first branch vessel fenestration assembly, the first branch vessel fenestration assembly comprising a first sealing zone and a first regulation zone, the first sealing zone comprising a third opening;

The first adjusting area comprises a first opening, a second opening, a first reinforcing structure and a second reinforcing structure;

b. A first branched stent graft for release within the first branched vessel fenestration assembly;

The method is characterized in that:

The first reinforcing structure maintains the shape of the first opening, and the second reinforcing structure maintains the shape of the second opening;

The first adjustment zone is located between the first reinforcing structure and the second reinforcing structure;

The first adjusting area is a flexible cylindrical or truncated cone-shaped film, and allows the second opening to move and rotate within a certain range relative to the positioning assembly so as to adapt to anatomical structure differences of branch blood vessels;

The first sealing area extends from the second reinforcing structure to the third opening to form a flexible cylindrical or truncated cone-shaped film, so that the connection between the first branch film covered bracket and the first sealing area is planar when the first branch film covered bracket is released to form planar sealing connection, and

The first branch tectorial membrane support comprises a first connection anchor section, the first connection anchor section comprises a flange support and a flange tectorial membrane, the diameter of the first connection anchor section after release is larger than that of the first opening of the first adjusting area, so that the first connection anchor section is reserved at the near-center end of the first opening of the first adjusting area.

2. The stent graft system of claim 1, wherein said sealing zone extends from said second reinforcing structure to said third opening, said extension extending from said second reinforcing structure in the direction of said adjustment zone.

3. The stent graft system of claim 1, wherein said sealing region extends from said second reinforcing structure to said third opening, said extension extending from said second reinforcing structure in another direction of said adjustment region.

4. The stent graft system of claim 1, wherein said sealing zone extends from said second reinforcing structure to said third opening, said extending being from said second reinforcing structure in both the direction of said adjustment zone and in the other direction.

5. The stent graft system of claim 1, wherein:

The first reinforcing structure comprises a first developing structure;

The second reinforcing structure comprises a second developing structure, or

The first regulation region includes a third development structure.

6. The stent graft system of claim 1, wherein the positioning assembly comprises a positioning seal zone and a positioning adjustment zone, wherein the positioning seal zone comprises a positioning third opening, and wherein the positioning adjustment zone comprises a positioning first opening, a positioning second opening, a positioning first reinforcing structure, and a positioning second reinforcing structure.

7. The stent graft system of claim 6, wherein said stent graft further comprises a positioning branch stent graft for implantation of said positioning assembly.

8. The stent graft system of claim 1, wherein the relative sizes of said first opening, said second opening and said third opening are selected from one or more of the following:

a. The first opening is larger than or equal to the second opening;

b. the second opening is greater than or equal to the third opening.

9. The stent graft system of claim 1, wherein the first opening, the second opening, or the third opening is circular or circular-like in shape.

10. The stent graft system of claim 1, wherein either the first reinforcing structure or the second reinforcing structure is made of a superelastic material.

11. The stent graft system of claim 1, wherein said stent graft system further comprises a second branched vascular fenestration assembly and a second branched stent graft;

The second branched blood vessel windowing component comprises a second sealing area and a second adjusting area, wherein the second sealing area comprises a third opening, and the second adjusting area comprises a first opening, a second opening, a first reinforcing structure and a second reinforcing structure;

the second branch tectorial membrane bracket comprises a second connecting and anchoring section, and the diameter of the second connecting and anchoring section after release is larger than that of the first opening of the second adjusting area, so that the second connecting and anchoring section is reserved outside the second adjusting area;

the positioning component is used for being implanted into a left common carotid artery, the first branch vascular windowing component is used for being implanted into a innominate artery, and the second branch vascular windowing component is used for being implanted into a left subclavian artery.