Intraoperative stent system for aortic type A dissection lesion

Abstract

The utility model relates to the field of cardiac surgery medical surgical instruments, and discloses an intraoperative stent system for aorta A-type dissection lesion, which sequentially comprises an artificial blood vessel section, a stent body section, a stent body section and a stent body section from the near end to the far end, a single branch section; a bare stent section; and a covered stent section. During profound hypothermia circulation arrest, the aortic arch blocking forceps are opened, the system is fed into the descending aorta, and the far-end covered stent section covers and supports the descending aorta dissection; the bare stent section is flush with the left subclavian artery, is arranged at the aortic arch part, and does not hinder the communication between the aorta and three branches on the arch; a single branch is placed on the nearest unknown artery, is close to the surgical field, is easy to implant, and can also prevent the stent from shifting; the near-section artificial blood vessel section can be directly matched with a replaced ascending aorta artificial blood vessel. According to the intraoperative stent system, the existing operation strategy and method for treating the aorta A-type dissection are changed, the time of the profound hypothermia and arrest circulation operation can be greatly shortened, and the intraoperative stent system has the advantages of a traditional operation and interventional therapy.

Description

Technical Field

[0001] The present application relates to the field of cardiac surgical medical instruments, and more specifically, to an intraoperative stent system for aortic type A dissection lesions. Background Art

[0002] Acute aortic dissection is the most dangerous disease in cardiovascular surgery, with a very high risk of death. Once rupture occurs, it is usually difficult to rescue. Surgery and endovascular intervention are the most effective methods for treating aortic dissection. However, for the treatment of lesions involving the aortic arch, the treatment strategy is usually based on open surgery. Because arch lesions involve the treatment of brain branch vessels and anatomical angles, endovascular intervention is relatively difficult, and the existing fully endovascular stent system still faces many problems, with many complications and simple lesion treatment.

[0003] Aortic arch replacement combined with descending aortic stent implantation is currently the standard procedure for treating lesions involving the ascending aorta and descending aortic arch. Due to the complexity of the surgical operation, multiple anastomoses, and the need for deep hypothermia and circulatory arrest technology, the surgical complications and mortality rates are relatively high. Most of the operations are concentrated in some experienced centers, and there are large medical differences between different centers.

[0004] In order to simplify the operation steps of total aortic arch replacement surgery, reduce the number of anastomoses that need to be manually anastomosed, and shorten the time of deep hypothermia and circulatory arrest, new medical devices have been developed in recent years, such as the development of single-branch and multi-branch intraoperative stents, which reduce the number of anastomoses that need to be manually anastomosed during surgery. However, the multi-branch stent blood vessels developed in the past have not been effectively popularized. The main problem is the problem of the angle of the branch stent during surgery being compatible with the anatomy of the autologous blood vessels in the arch, as well as the distal intimal damage after the branch stent is implanted, and the risk of further progression of dissection.

[0005] In response to the above clinical problems, the present application intends to design an intraoperative stent system for treating type A aortic dissection lesions, which simplifies the operation, reduces the surgical risk, and improves the surgical efficacy. Utility Model Content

[0006] The technical problem to be solved by the present application is to overcome the clinical pain points of the traditional ascending aortic arch replacement surgery in the background technology for treating type A aortic dissection, such as complex technology, large number of anastomoses, long operation time, and high complications, and to design an intraoperative stent system to significantly reduce deep hypothermia and circulatory arrest time, reduce the number of surgical anastomoses, shorten the operation time, and improve the efficiency of the operation.

[0007] The present application provides an intraoperative stent system for aortic type A dissection, which comprises, from the proximal end to the distal end:

[0008] Artificial blood vessel segment;

[0009] Single branch segment;

[0010] Bare stent segment; and

[0011] Covered stent segment.

[0012] Optionally, the bare stent segment is a medical memory alloy fine wire woven mesh structure having a plurality of mesh holes.

[0013] Optionally, the apertures of the multiple meshes on the bare stent segment are non-uniformly set, and the meshes at the branch positions on the arch are set with large apertures.

[0014] Optionally, the single-branch segment is a coated stent, including a single-branch skeleton and a coating.

[0015] Optionally, the single-branch skeleton is a Z-shaped stent structure, a spiral stent structure or a cross-mesh stent structure.

[0016] The preferred Z-shaped stent structure provides both significant radial force and some longitudinal support. The Z-shaped stent mentioned in the present application is preferably made of standard medical grade stainless steel and soldered using silver standard solder (0 lead / 0 tin); or made of memory metal such as nickel titanium alloy.

[0017] Optionally, the single-branch skeleton is a Z-shaped bracket structure, and the Z-shaped bracket structure includes a plurality of Z-shaped bracket units. Among two adjacent Z-shaped bracket units, the crest of one Z-shaped bracket unit and the trough of the other Z-shaped bracket unit are arranged correspondingly in the axial direction.

[0018] Optionally, the single-branch skeleton is a spiral stent structure, and the end of the spiral stent structure is a closed loop.

[0019] The coating is arranged on the outside of the single-branch skeleton; or

[0020] The coating is arranged inside the single-branch framework; or

[0021] The coating is arranged on both inner and outer sides of the single-branch frame.

[0022] Optionally, the coated stent segment includes a coated stent skeleton and a coating, and the coated stent skeleton is a Z-shaped stent structure, a spiral stent structure or a cross-mesh stent structure.

[0023] When the above-mentioned intraoperative stent system is in use, during deep hypothermic circulatory arrest, the aortic arch blocking clamp is opened, and the stent system is delivered into the descending aorta, with the distal covered stent segment covering and supporting the descending aorta dissection; the bare stent segment is level with the left subclavian artery, and the bare stent segment is set in the aortic arch, which does not hinder the connection between the aorta and the three branches on the arch; the single branch is placed in the most proximal innominate artery, close to the surgical field of view, easy to insert, and can also prevent the stent from shifting; the proximal artificial blood vessel segment can be directly anastomosed with the replaced ascending aorta artificial blood vessel.

[0024] The bare stent segment adopts a weaving process and has a natural mesh. Non-uniform mesh settings can also be considered. A large aperture setting is adopted at the supra-arch branch position to avoid window processing and effectively ensure blood flow in the supra-arch branch.

[0025] The ascending aorta segment dissection is the area of ​​Type A dissection that bears the greatest stress and is most prone to rupture. The proximal artificial blood vessel setting retains the classic artificial blood vessel ascending aorta replacement method, allowing this product to achieve the therapeutic effects of traditional surgical operations while absorbing the advantages of intravascular interventional treatment to the greatest extent.

[0026] In summary, this application has the following beneficial effects:

[0027] 1. The intraoperative stent system of the present application changes the existing surgical strategies and methods for treating type A aortic dissection, can greatly reduce the time of deep hypothermia and circulatory arrest surgery, and has the advantages of both traditional surgery and interventional treatment.

[0028] 2. The unique non-uniform large-pore design of the bare stent segment in the aortic arch has natural mesh, which avoids the need for window opening, effectively ensures blood flow in the branches above the arch, and also ensures support for the lesser curvature of the arch.

[0029] 3. The setting of the proximal artificial blood vessel segment retains the advantages of the classic artificial blood vessel ascending aorta replacement surgery and eliminates the defects and disadvantages of the current fully endovascular products. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a schematic diagram of the use status of the stent system during surgery in an embodiment of the present application;

[0031] Figure 2 Schematic diagram of the overall structure of the intraoperative stent system in the embodiment of the present application;

[0032] Figure 3 is a schematic structural diagram of a single-branch skeleton in another embodiment of the present application;

[0033] Figure 4 is a schematic structural diagram of a single-branch skeleton in another embodiment of the present application;

[0034] Figure 5is a schematic structural diagram of a single-branch skeleton in another embodiment of the present application;

[0035] Figure 6 is a schematic diagram of an embodiment of the present application for showing the positional relationship between the coating and the single-branch skeleton;

[0036] Figure 7 is a schematic diagram of the positional relationship between the coating and the single-branch skeleton in another embodiment of the present application;

[0037] Figure 8 is a schematic diagram of the positional relationship between the coating and the single-branch skeleton in another embodiment of the present application;

[0038] Fig. 9 It is a schematic structural diagram of a bare stent segment in another embodiment of the present application.

[0039] Figure numerals: 1, artificial blood vessel segment; 2, single-branch segment; 21, single-branch skeleton; 211, Z-shaped stent unit; 22, coating; 3, bare stent segment; 4, coated stent segment. DETAILED DESCRIPTION

[0040] The structure and effect of the present application are further described in detail below in conjunction with the embodiments. It is to be understood that the specific embodiments described herein are only used to explain the invention, rather than to limit the invention. It should also be noted that, for ease of description, only part of the invention, rather than all of the structure, is shown in the accompanying drawings. It should be understood that the invention does not limit its application to the details of the structure and arrangement of the components described in the following description or shown in the accompanying drawings. The invention can have other embodiments, or can be implemented or implemented in a variety of ways. In addition, the wording and terminology used here are for illustrative purposes and should not be considered as limiting.

[0041] In this application, "proximal end" refers to the end close to the operator during normal operation, that is, the proximal end in the direction of aortic blood flow; "distal end" refers to the section that first enters the patient's body during normal operation, that is, the distal end in the direction of aortic blood flow.

[0042] Example: Intraoperative stent system for aortic type A dissection

[0043] The present application embodiment discloses a stent system for aortic type A dissection during surgery, referring to Figure 1 and Figure 2 The intraoperative stent system has a four-section structure including an artificial blood vessel segment 1, a single branch segment 2, a bare stent segment 3 and a covered stent segment 4. When the intraoperative stent system is used, the artificial blood vessel segment 1, the single branch segment 2, the bare stent segment 3 and the covered stent segment 4 are arranged from the proximal end to the distal end.

[0044] In this embodiment, the artificial blood vessel segment 1 is a conventional technology, and various organic fibers can be used. In the case of requiring elasticity, fibers formed of polyurethane or the like can also be used. From the viewpoint of water absorption and degradation resistance, polyester fibers are preferably used, such as fibers formed of polyethylene terephthalate, polybutylene terephthalate, etc. Copolyester fibers formed by copolymerizing polyethylene terephthalate, polybutylene terephthalate, and aliphatic dicarboxylic acids such as isophthalic acid and adipic acid as acid components can also be used.

[0045] In this embodiment, the single-branch segment 2 is a coated stent, including a single-branch skeleton 21 and a coating 22. The single-branch skeleton 21 is a Z-shaped stent structure, a spiral stent structure or a cross-net stent structure. Figure 2 The single branch segment 2 is a Z-shaped stent structure, which provides both significant radial force and some longitudinal support, wherein the Z-shaped stent is preferably made of standard medical grade stainless steel and soldered with silver standard solder (0 lead / 0 tin); or made of memory metal such as nickel titanium alloy. More preferably, referring to Figure 3 The Z-shaped support structure includes a plurality of Z-shaped support units 211. In two adjacent Z-shaped support units 211, the crest of one Z-shaped support unit 211 and the trough of another Z-shaped support unit 211 are arranged correspondingly in the axial direction, thereby further improving the support strength. In other embodiments, referring to Figure 4 , the single-branch skeleton 21 is a spiral stent structure, and the end of the spiral stent structure is a closed loop. Similarly, the spiral stent structure is also preferably made of standard medical grade stainless steel and soldered using silver standard solder (0 lead / 0 tin); or made of memory metal such as nickel titanium alloy. In other embodiments, refer to Figure 5 The single-branch skeleton 21 is a cross-mesh stent structure. Similarly, the cross-mesh stent structure is preferably made of standard medical-grade stainless steel and soldered with silver standard solder (0 lead / 0 tin); or made of memory metal such as nickel-titanium alloy. In addition, the positional relationship between the coating 22 and the single-branch skeleton 21 can also exist in the following three ways: Figure 6 As shown, the coating 22 is arranged outside the single-branch skeleton 21; Figure 7 As shown, the coating 22 is arranged inside the single-branch skeleton 21; Figure 8 As shown, the coating 22 is arranged on both the inner and outer sides of the single-branch skeleton 21 .

[0046] In this embodiment, the bare stent segment 3 is a medical memory alloy fine wire woven mesh structure, having a plurality of mesh holes, which can be woven by one or more silk threads, and the mesh holes are formed during the weaving process and have a uniform pore size (such as Figure 2As shown). Preferably, in other embodiments, the apertures of the multiple meshes on the stent segment may be non-uniformly set, and the meshes at the branch positions on the arch may be set with large apertures (such as Fig. 9 As shown in the figure, fenestration is avoided and the blood flow of the supra-arch branches is effectively guaranteed.

[0047] In this embodiment, the coated stent segment 4 includes a coated stent skeleton and a coating, and the coated stent skeleton is a Z-shaped stent structure, a spiral stent structure or a cross-net stent structure. It is worth noting that the positional relationship between the coated stent skeleton and the coating can refer to the positional relationship between the coating 22 and the single-branch skeleton 21 in the above-mentioned single-branch segment 2; the Z-shaped stent structure, spiral stent structure and cross-net stent structure of the coated stent skeleton can also refer to the stent structure of the single-branch skeleton 21 in the above-mentioned single-branch segment 2.

[0048] When the above intraoperative stent system is used, during deep hypothermic circulatory arrest, the aortic arch clamp is opened, and the stent system is sent into the descending aorta. The distal covered stent segment 4 covers and supports the descending aorta dissection; the bare stent segment 3 is level with the left subclavian artery, and the bare stent segment 3 is set in the aortic arch, which does not hinder the connection between the aorta and the three branches on the arch; the single branch segment 2 is placed in the nearest segment of the innominate artery, close to the surgical field, easy to insert, and can also prevent the stent from shifting; the proximal artificial blood vessel segment 1 can be directly anastomosed with the replaced ascending aorta artificial blood vessel. The ascending aorta segment dissection is the area of ​​type A dissection that bears the greatest stress and is most prone to rupture. The proximal artificial blood vessel setting retains the classic artificial blood vessel ascending aorta replacement method, so that this product has the efficacy of traditional surgical operations while absorbing the advantages of intravascular interventional treatment to the greatest extent.

[0049] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A stent system for intraoperative treatment of aortic type A dissection, characterized in that: From proximal to distal, they include: Artificial blood vessel segment (1); Single branch segment (2); Bare stent segment (3); and stent graft segment (4); The bare stent segment (3) is a medical memory alloy fine wire woven mesh structure having a plurality of mesh holes; The apertures of the multiple meshes on the bare stent segment (3) are non-uniformly arranged, and the meshes at the branch positions on the arch are arranged with large apertures.

2. The intraoperative stent system for aortic type A dissection according to claim 1, characterized in that: The single-branch segment (2) is a coated stent, comprising a single-branch skeleton (21) and a coated stent (22).

3. The intraoperative stent system for aortic type A dissection according to claim 2, characterized in that: The single-branch skeleton (21) is a Z-shaped stent structure, a spiral stent structure or a cross-net stent structure.

4. The intraoperative stent system for aortic type A dissection according to claim 3, characterized in that: The single-branch skeleton (21) is a Z-shaped bracket structure, which comprises a plurality of Z-shaped bracket units (211). In two adjacent Z-shaped bracket units (211), the wave crest of one Z-shaped bracket unit (211) and the wave trough of the other Z-shaped bracket unit (211) are arranged correspondingly in the axial direction.

5. The intraoperative stent system for aortic type A dissection according to claim 3, characterized in that: The single-branch skeleton (21) is a spiral stent structure, and the end of the spiral stent structure is a closed loop.

6. The intraoperative stent system for aortic type A dissection according to claim 2, characterized in that: The coating (22) is arranged on the outside of the single-branch skeleton (21); or The coating (22) is arranged on the inner side of the single-branch skeleton (21); or The coating (22) is arranged on both inner and outer sides of the single-branch frame (21).

7. The intraoperative stent system for aortic type A dissection according to claim 1, characterized in that: The coated stent segment (4) comprises a coated stent framework and a coating, and the coated stent framework is a Z-shaped stent structure, a spiral stent structure or a cross-net stent structure.

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