Aortic dissection crevasse plugging device

Abstract

The invention provides an aortic dissection crevasse plugging device. The aortic dissection crevasse plugging device is used for plugging an aortic dissection primary crevasse and / or plugging an aortic dissection secondary crevasse. The aortic dissection crevasse plugging device comprises a plugging support which is of a net-shaped cylindrical structure and arranged on a true cavity of an aortic dissection area in a sleeving mode; the plugging stent comprises a near-end bare section, a middle film covering section and a far-end bare section. The near-end bare section and the far-end bare section are used for fixing the plugging stent and supporting a true cavity blood vessel; the covered graft is arranged on the middle covered section and used for blocking the primary crevasse of the aortic dissection and / or the secondary crevasse of the aortic dissection. The aortic dissection crevasse plugging device can effectively solve the problems that an existing covered stent is mainly used for plugging a near-end primary crevasse and a far-end secondary crevasse cannot be achieved, it is guaranteed that the plugging device is uniform in supporting force, good in stent flexibility and capable of adapting to tortuous blood vessels, and complications of a far-end new crevasse are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an aortic dissection rupture sealing device. Background Art

[0002] Aortic dissection refers to a tear in the aortic intima, blood flows into the arterial wall, the aortic wall is layered and separated, and the vascular lumen is divided into a true lumen and a false lumen by free intimal sheets. The blood flow entrance on the aortic intima is the primary rupture, and there may be multiple secondary ruptures at the distal end of the aorta. At present, aortic endovascular repair is used clinically to treat aortic dissection. Its principle is to implant a covered stent to block the proximal primary rupture, so that blood flows to the true lumen, reshape the true lumen, improve the blood supply to distal organs and limbs, and promote false lumen thrombosis and aortic remodeling.

[0003] However, there are still many technical defects in the existing aortic endovascular repair technology, including the following problems: 1. Covered stents are mainly used to block the proximal primary rupture, but not the distal secondary rupture, which leads to reflux of the secondary rupture and affects the thrombosis process of the false lumen. If the primary rupture and the secondary rupture are blocked at the same time, the intercostal artery will be blocked, increasing the risk of spinal cord ischemia and paraplegia. When the secondary rupture involves the visceral artery, it will also affect the blood supply of the visceral artery.

[0004] 2. The current covered stent adopts a structure in which multiple spaced metal support units are sutured together with the covered graft. The support force is uneven, the flexibility of the stent is poor, and it is difficult to adapt to tortuous blood vessels, leading to complications of new distal ruptures. Among them, the Talos covered stent system of Sinomed Medical has micropores designed in the distal covered segment, and the ZenithDissection Thoracic Aortic Stent System of Cook Medical and the Fabulous Thoracic Aortic Stent System of Weiqiang Medical both adopt the method of proximal covered stent bridging the distal bare stent, which can support the true lumen while reducing the risk of paraplegia, but neither can deal with distal ruptures.

[0005] In the prior art, the occluders and coils currently used for the treatment of distal secondary ruptures are not ideal. The rupture morphology of aortic dissection is significantly different from that of atrial septal and ventricular septal defects, and is more irregular and fragile. Therefore, the internal leakage rate after occlusion is high, and it may even cause the rupture to increase. Bare stents and coils are used to occlude the distal rupture, and multiple layers of bare stents are placed in the rupture area, and coils are placed in the false cavity to promote coagulation. However, if the false cavity is too large and the number of coils is limited, the coagulation-promoting effect is not good. And if the coils are not gathered around the rupture, the possibility of internal leakage is still relatively large.

[0006] Therefore, those skilled in the art are in urgent need of a new aortic endovascular repair device that can effectively treat the primary and secondary ruptures of aortic dissection simultaneously or separately, and at the same time, has the advantages of good compliance, uniform distribution of supporting force, supporting the true lumen, reshaping the true lumen without affecting the blood supply of the intercostal arteries and visceral arteries. Summary of the invention

[0007] Therefore, the present invention provides an aortic dissection rupture sealing device. In order to solve the problem that the existing covered stent is mainly used to seal the proximal primary rupture, but cannot seal the distal secondary rupture, while also ensuring that the supporting force of the sealing device is uniform, the stent has good flexibility, can adapt to the tortuous blood vessels, and avoid complications of new distal ruptures. The present invention provides an aortic dissection rupture sealing device, the aortic dissection rupture sealing device is used to seal the primary rupture of aortic dissection, and / or to seal the secondary rupture of aortic dissection; the aortic dissection rupture sealing device comprises: The occluding stent is a mesh cylindrical structure, which is sheathed and fixed on the true lumen of the aortic dissection area; the occluding stent comprises: a proximal bare segment, a middle coated segment and a distal bare segment; the proximal bare segment and the distal bare segment are used to fix the occluding stent and support the true lumen blood vessels; A coated graft is arranged in the middle coated section and is used to block the primary rupture of aortic dissection and / or the secondary rupture of aortic dissection.

[0008] Optionally, the diameter of the occluding stent ranges from 10 mm to 50 mm; wherein the diameter of the occluding stent used to occlude the primary rupture of aortic dissection ranges from 20 mm to 50 mm; the diameter of the occluding stent used to occlude the secondary rupture of aortic dissection ranges from 10 mm to 40 mm; The length of the proximal bare segment ranges from 10 mm to 300 mm, the length of the middle coated segment ranges from 10 mm to 200 mm, and the length of the distal bare segment ranges from 10 mm to 300 mm.

[0009] Optionally, the coated graft is fixedly connected to the occluding stent via sutures.

[0010] Optionally, development marks are provided at both ends of the coated graft in the length direction, for positioning the coated graft under X-ray.

[0011] Optionally, the surface of the coated graft is further provided with a functional coating for improving the anti-leakage performance of the coated graft.

[0012] Optionally, the functional coating is a collagen coating.

[0013] Optionally, the occluding stent is made of metal material, including: one or more combinations of nickel-titanium wire, cobalt-based alloy wire, polymer material, and degradable material; and / or, the coated graft is made of flexible polymer material, including: polyester and / or polytetrafluoroethylene.

[0014] Optionally, the diameter of the stent wire woven into the occluding stent ranges from 0.05 mm to 1.0 mm; The braiding density of the occluding stent varies according to the supporting force, flexibility, and collateral blood flow requirements at different locations of the aortic dissection area; the braiding mesh PPI value of the occluding stent is 5 to 50.

[0015] Optionally, the aortic dissection rupture sealing device cooperates with a delivery system, and its size is adapted to that of an interventional catheter of the delivery system so as to be implanted into a target diseased blood vessel.

[0016] The technical solution of the present invention has the following advantages: 1. The aortic dissection rupture sealing device provided by the present invention is used to seal the primary rupture of aortic dissection and / or to seal the secondary rupture of aortic dissection; the aortic dissection rupture sealing device comprises: The occluding stent is a mesh cylindrical structure, which is sheathed and fixed on the true lumen of the aortic dissection area; the occluding stent comprises: a proximal bare segment, a middle coated segment and a distal bare segment; the proximal bare segment and the distal bare segment are used to fix the occluding stent and support the true lumen blood vessels; A coated graft is arranged in the middle coated section and is used to block the primary rupture of aortic dissection and / or the secondary rupture of aortic dissection.

[0017] In the present invention, the aortic dissection rupture blocking device can be used to block the primary rupture of aortic dissection and the secondary rupture of aortic dissection at the same time. The above-mentioned blocking stent is a mesh cylindrical structure, and also includes a proximal bare segment, an intermediate coated segment and a distal bare segment. The blocking stent is fixedly connected to the true lumen at the two ends of the blocking stent through the above-mentioned proximal bare segment and the distal bare segment, and the true lumen blood vessel is supported at the same time. The above-mentioned structure can provide uniform supporting force and good flexibility, so as to match the tortuous blood vessels, reduce the occurrence of new ruptures, and then achieve the blocking of secondary ruptures of aortic dissection and primary ruptures of aortic dissection.

[0018] 2. The aortic dissection rupture sealing device provided by the present invention, the diameter range of the sealing stent is 10 mm to 50 mm; wherein the diameter range of the sealing stent used to seal the primary rupture of aortic dissection is 20 mm to 50 mm; the diameter range of the sealing stent used to seal the secondary rupture of aortic dissection is 10 mm to 40 mm; The length of the proximal bare segment ranges from 10 mm to 300 mm, the length of the middle coated segment ranges from 10 mm to 200 mm, and the length of the distal bare segment ranges from 10 mm to 300 mm.

[0019] In the present invention, the proximal bare segment, the middle coated segment, and the distal bare segment in the above-mentioned length range can be effectively adapted to the true lumen position of the aortic dissection area, so as to be used to block the primary rupture of aortic dissection and the secondary rupture of aortic dissection respectively as needed. Moreover, the occluding stents used to block the primary rupture of aortic dissection and the secondary rupture of aortic dissection are set to different diameter sizes as needed, so as to be effectively adapted to the primary rupture of aortic dissection and the secondary rupture of aortic dissection.

[0020] 3. In the aortic dissection rupture sealing device provided by the present invention, both ends of the coated graft in the length direction are also provided with development marks for positioning the coated graft under X-ray.

[0021] In the present invention, by setting development marks at both ends of the coated graft in the length direction, the above-mentioned development marks can effectively point out the specific position of the coated graft to medical personnel, thereby facilitating medical personnel to achieve the closure of the primary rupture of aortic dissection and the secondary rupture of aortic dissection.

[0022] 4. In the aortic dissection rupture sealing device provided by the present invention, the surface of the coated graft is also provided with a functional coating for improving the anti-leakage performance of the coated graft, and the functional coating is a collagen coating.

[0023] In the present invention, by providing the above-mentioned functional coating on the surface of the coated graft, the anti-leakage performance of the coated graft can be effectively improved, the blocking effect can be increased, and the risk of endoleakage can be greatly reduced.

[0024] 5. The aortic dissection rupture occlusion device provided by the present invention, the occlusion stent is made of metal material, including: nickel-titanium wire, cobalt-based alloy wire, polymer material, degradable material or one or more combinations thereof. The diameter of the stent wire woven into the occlusion stent ranges from 0.05 mm to 1.0 mm; and the braiding density of the occlusion stent varies according to the support force, flexibility, and collateral blood flow requirements at different locations of the aortic dissection area; the braiding mesh PPI value of the occlusion stent is 5 to 50.

[0025] In the present invention, the braiding density of the occluding stent can be adjusted as needed to adapt to the changes in the support force, flexibility, and collateral blood flow requirements at different locations in the aortic dissection area.

[0026] 6. The aortic dissection rupture sealing device provided by the present invention cooperates with a delivery system, and its size is adapted to the interventional catheter of the delivery system so as to be implanted into a target diseased blood vessel.

[0027] In the present invention, the aortic dissection rupture sealing device is an elastic member, which is pre-installed in a delivery system after being compressed and reduced in diameter, and is implanted into a target diseased blood vessel through catheter intervention. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0029] Figure 1 A schematic structural diagram of an aortic dissection breach sealing device for sealing a primary breach of aortic dissection provided by an embodiment of the present invention; Figure 2 A schematic structural diagram of an aortic dissection rupture sealing device for sealing a secondary rupture of aortic dissection at an upper position provided by an embodiment of the present invention; Figure 3 A schematic structural diagram of an aortic dissection rupture sealing device for sealing a secondary rupture of aortic dissection at a lower position provided by an embodiment of the present invention; Figure 4 A schematic diagram of the vascular anatomy of the aortic dissection region provided in an embodiment of the present invention.

[0030] Description of reference numerals: 1-primary aortic dissection; 2-secondary aortic dissection; 3-occluder stent; 4-true lumen; 5-proximal bare segment; 6-middle covered segment; 7-distal bare segment; 8-covered graft; 9-three branches above the aorta; 10-false lumen. DETAILED DESCRIPTION

[0031] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0033] Example 1 See also Figure 4 as well as Figures 1 to 3 As shown, Figure 4 A schematic diagram of the vascular anatomy of the aortic dissection region in this embodiment is shown. Figure 1 The schematic diagram of the structure of the aortic dissection rupture blocking device for blocking the primary rupture of aortic dissection in this embodiment is shown. Figure 1 The positions of the true lumen 4, the three branches 9 on the arch and the false lumen 10 are shown respectively. Figure 2 A schematic structural diagram of the aortic dissection rupture sealing device for sealing a secondary rupture of aortic dissection at the upper side of the present embodiment is shown. Figure 3 A schematic diagram of the structure of the aortic dissection rupture sealing device for sealing the secondary rupture of aortic dissection at the lower side of this embodiment is shown.

[0034] The present embodiment provides an aortic dissection rupture sealing device, which is used to seal the primary aortic dissection rupture 1 and the secondary aortic dissection rupture 2 or any one of the two; the aortic dissection rupture sealing device cooperates with a delivery system, and its size is adapted to the interventional catheter of the delivery system so as to be implanted into the target diseased blood vessel.

[0035] The aortic dissection rupture sealing device comprises: The occluding stent 3 is a mesh cylindrical structure, which is sleeved and fixed on the true cavity 4 of the aortic dissection area; the occluding stent 3 is a metal material, including: one or more combinations of nickel-titanium wire, cobalt-based alloy wire, polymer material, and degradable material. The occluding stent 3 includes: a proximal bare segment 5, an intermediate coated segment 6, and a distal bare segment 7; the proximal bare segment 5 and the distal bare segment 7 are used to fix the occluding stent 3 and support the true cavity blood vessels; in this embodiment, the length of the above-mentioned proximal bare segment 5 ranges from 10 mm to 300 mm, the length of the intermediate coated segment 6 ranges from 10 mm to 200 mm, and the length of the distal bare segment 7 ranges from 10 mm to 300 mm. In addition, in this embodiment, the diameter range of the occluding stent 3 used to occlude the primary rupture 1 of aortic dissection is 20 mm to 50 mm as needed; the diameter range of the occluding stent 3 used to occlude the secondary rupture 2 of aortic dissection is 10 mm to 40 mm; The coated graft 8 is arranged in the middle coated section 6, and is used to block the primary rupture 1 of aortic dissection and / or the secondary rupture 2 of aortic dissection. The coated graft 8 is made of a flexible polymer material, including: polyester and / or polytetrafluoroethylene. The above-mentioned coated graft 8 is fixedly connected to the blocking stent 3 by sutures. In this embodiment, in order to assist medical personnel in pointing out the specific position of the coated graft 8, it is convenient for medical personnel to block the primary rupture 1 of aortic dissection and the secondary rupture 2 of aortic dissection. The two end positions of the coated graft 8 in the length direction are also provided with development marks for positioning the coated graft 8 under X-ray.

[0036] In this embodiment, in order to improve the anti-leakage performance of the coated graft 8, the surface of the coated graft 8 is coated with a collagen coating, thereby increasing the blocking effect and greatly reducing the risk of internal leakage.

[0037] In this embodiment, it is also specifically disclosed that: the diameter of the stent wire woven into the occluding stent 3 can be adjusted to any value between 0.05 mm and 1.0 mm as needed. Moreover, the stent braiding density of the occluding stent 3 varies according to the support force, flexibility, and collateral blood flow requirements of different positions in the aortic dissection area; the braiding mesh PPI value of the occluding stent 3 is 5 to 50.

[0038] The greater the stent weaving density, the smaller the stent mesh, the greater the impact on branch vessel blood flow, and it is not suitable for branch vessel locations; the greater the stent support force, the more suitable it is for locations that require support, such as sealing segments and true lumen collapse segments; the worse the stent flexibility, the less suitable it is for locations with curved blood vessels.

[0039] The smaller the stent weaving density, the larger the stent mesh, the smaller the supporting force, and the better the flexibility, which is suitable for branch vessel locations and curved vessel locations.

[0040] Among them, Figure 1 The schematic diagram of the structure of the aortic dissection rupture sealing device for sealing the primary rupture of aortic dissection is shown. The proximal bare segment 5 is the location of the blood vessel bend and branch blood vessel. The braiding density at this location is small, and the PPI, i.e., the braiding density, is 5-30. The stent conforms to the blood vessel bend and ensures the branch blood flow. The distal bare segment 7 is the rupture sealing area and the true lumen support area. The braiding density at this location is large, and the PPI, i.e., the braiding density, is 20-50, thereby providing sufficient sealing and supporting force.

[0041] Among them, Figure 2The schematic diagram of the structure of the aortic dissection rupture sealing device for sealing the secondary rupture of aortic dissection at the upper side is shown. The distal bare segment 7 is the branch vessel position, with a small braiding density, PPI, i.e., braiding density of 5-30, to ensure branch blood flow. The proximal bare segment 5 is the rupture sealing area and true lumen support area, with a large braiding density, PPI, i.e., braiding density of 20-50, thereby providing sufficient sealing and supporting force.

[0042] Of course, the present embodiment does not specifically limit the connection method between the coated graft 8 and the occluding stent 3. In other embodiments, the coated graft 8 and the occluding stent 3 may also be fixedly connected by other methods such as bonding.

[0043] Of course, this embodiment does not specifically limit the lengths of the proximal bare segment 5, the middle coated segment 6 and the distal bare segment 7. In other embodiments, the proximal bare segment 5, the middle coated segment 6 and the distal bare segment 7 can also be adjusted to other sizes as needed.

[0044] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A device for sealing aortic dissection, characterized in that: The aortic dissection rupture sealing device is used to seal the primary rupture of aortic dissection (1), and / or to seal the secondary rupture of aortic dissection (2); the aortic dissection rupture sealing device comprises: The occluding stent (3) is a mesh cylindrical structure, which is sleeved and fixed on the true lumen (4) of the aortic dissection area; the occluding stent (3) comprises: a proximal bare segment (5), an intermediate coated segment (6) and a distal bare segment (7); the proximal bare segment (5) and the distal bare segment (7) are used to fix the occluding stent (3) and support the true lumen blood vessels; A coated graft (8), wherein the coated graft (8) is arranged in the middle coated section (6) and is used to block the primary rupture (1) of the aortic dissection and / or the secondary rupture (2) of the aortic dissection.

2. The aortic dissection rupture sealing device according to claim 1, characterized in that: The diameter of the occluding stent (3) ranges from 10 mm to 50 mm; wherein the diameter of the occluding stent (3) used to occlude the primary rupture (1) of aortic dissection ranges from 20 mm to 50 mm; and the diameter of the occluding stent (3) used to occlude the secondary rupture (2) of aortic dissection ranges from 10 mm to 40 mm; The length of the proximal bare section (5) ranges from 10 mm to 300 mm, the length of the intermediate coated section (6) ranges from 10 mm to 200 mm, and the length of the distal bare section (7) ranges from 10 mm to 300 mm.

3. The aortic dissection rupture sealing device according to claim 1, characterized in that: The coated graft (8) is fixedly connected to the occluding stent (3) via sutures.

4. The aortic dissection rupture sealing device according to claim 1, characterized in that: Development marks are also provided at both ends of the coated graft (8) in the length direction, for positioning the coated graft (8) under X-ray.

5. The aortic dissection rupture sealing device according to claim 1, characterized in that: The surface of the coated graft (8) is also provided with a functional coating for improving the anti-leakage performance of the coated graft (8).

6. The aortic dissection rupture sealing device according to claim 5, characterized in that: The functional coating is a collagen coating.

7. The aortic dissection rupture sealing device according to any one of claims 1 to 6, characterized in that: The blocking stent (3) is made of metal material, including: one or more combinations of nickel-titanium wire, cobalt-based alloy wire, polymer material, and degradable material; and / or, The coated graft (8) is made of a flexible polymer material, including polyester and / or polytetrafluoroethylene.

8. The aortic dissection rupture sealing device according to claim 7, characterized in that: The diameter of the stent wire woven into the occluding stent (3) ranges from 0.05 mm to 1.0 mm; Furthermore, the braiding density of the occluding stent (3) varies according to the supporting force, flexibility, and collateral blood flow requirements at different locations of the aortic dissection region; the braiding mesh PPI value of the occluding stent (3) is 5 to 50.

9. The aortic dissection rupture sealing device according to claim 5, characterized in that: The aortic dissection rupture sealing device cooperates with a delivery system, and its size is adapted to the interventional catheter of the delivery system so as to be implanted into a target diseased blood vessel.

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