Intra-tumor turbulent flow device and compiling method thereof

Abstract

The invention belongs to the technical field of blood shunting auxiliary devices, and particularly provides an intra-tumor turbulent flow device and a weaving method thereof.The intra-tumor turbulent flow device comprises a net body and a platinum marker, the net body is formed by plasticity of an integrally-formed cylindrical net cage, and the upper portion and the lower portion of the net body are an upper layer section and a lower layer section respectively; the tip ends of the upper section and the lower section are opposite, so that the appearance of the net body is hourglass-shaped, the joint of the upper section and the lower section is a reducing section, and platinum markers are arranged on the end surfaces of the upper section and the lower section. The platinum markers are arranged at the upper end and the lower end of the intra-tumor turbulence device, so that the intra-tumor turbulence device can be changed into a column similar to an hourglass shape, and the treatment requirement that the whole intra-tumor turbulence device is embedded in an aneurysm is met; by adopting a treatment mode of completely embedding into the aneurysm, the operation precision of the intratumoral turbulence device in the implanting process can be reduced; the design of the two platinum markers can also improve the developing precision and provide more intuitive operation guidance.

Description

Technical Field

[0001] The invention belongs to the technical field of blood shunt auxiliary devices, and in particular provides an intra-tumor flow disturbance device and a preparation method thereof. Background Art

[0002] Bifurcation aneurysm is a common vascular disease. It is located at the bifurcation of blood vessels and often has a unique morphology and position, which increases the challenge of treatment. Traditional treatment methods include surgical clipping and endovascular coiling techniques. However, these methods have certain limitations. Although craniotomy clipping can effectively clip the aneurysm, it may cause greater trauma and higher risks. Intravascular coiling technology may not achieve the ideal therapeutic effect in some cases, especially for bifurcated aneurysms with complex morphology. In addition, traditional treatment methods often require long-term dual antiplatelet therapy to prevent complications such as thromboembolism, which brings drug-related discomfort and risks to patients.

[0003] Therefore, there is an urgent need to develop a new treatment device that aims to improve the treatment success rate of bifurcation aneurysms, reduce the risk of complications, and reduce the drug burden on patients. In the context of the limitations of current treatment methods, the development of a safer and more effective treatment device has become particularly important.

[0004] At present, the applicability of existing technologies such as conventional cylindrical intra-tumor flow disturbance devices and intra-tumor flow disturbance devices with application number: 202220345035.9 still has room for improvement. Figure 1 and Figure 2 The marking points are connected to both ends of the mesh at the same time, which limits the deformation range of the mesh and has great limitations during implantation. The small diameter part of the waist must correspond to the neck of the aneurysm.

[0005] In addition, refer to Fig.15 and Fig.16 At present, the conventional weaving method is to press one braid on another, and the two braided wires are regularly crossed and circulated. This weaving method is simple and easy to use, but the braided body therefrom still has room for improvement in structural stability and fluid dynamics. Summary of the invention

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is: an intra-tumor flow disturbance device, including a mesh body and a platinum marker, the mesh body is plastically formed by an integrally molded cylindrical mesh box, the upper and lower parts of the mesh body are respectively an upper segment and a lower segment, the tips of the upper segment and the lower segment are relative to each other so that the mesh body has an hourglass shape in appearance, the joint between the upper segment and the lower segment is a variable diameter segment, and platinum markers are arranged on the end faces of the upper segment and the lower segment.

[0007] Furthermore, depressions are arranged at the end surfaces of the upper layer segment and the lower layer segment, and two platinum markers are arranged at the centers of the two depressions.

[0008] Furthermore, the angle of the diameter-changing section is 45°.

[0009] Furthermore, the mesh is woven from platinum-core nickel-titanium alloy wires.

[0010] Furthermore, the upper layer section has a "bowl" shape, and the lower layer section has a "dish" shape.

[0011] A method for preparing an intra-tumor disturbance device, the specific process is as follows:

[0012] The braiding unit is composed of four braiding wires, the first braiding wire, the second braiding wire and the third braiding wire are arranged in parallel with equal intervals, the fourth braiding wire first passes through the same side of the first braiding wire and the second braiding wire in sequence, and then passes through the other side of the third braiding wire after bending, forming a one-over-two braiding method;

[0013] The braiding method of the braiding unit α is cyclically implemented in the extension direction of the braiding wire, and two adjacent braiding units α are staggered by one braiding wire;

[0014] When the braided braid reaches a predetermined length or shape, the braiding operation is stopped, and the remaining braided wires are gathered at the end of the braid and fixed using a platinum marker.

[0015] Further, the fourth braided wire is located below the first braided wire and the second braided wire and the fourth braided wire is located above the third braided wire as a forward braiding unit, and conversely, the fourth braided wire is located above the first braided wire and the second braided wire and the fourth braided wire is located below the third braided wire as a reverse braiding unit;

[0016] During the compilation process, forward compilation units and reverse compilation units are used alternately.

[0017] Furthermore, the tension of the braiding wire needs to be kept consistent during the braiding process to ensure the uniformity and stability of the braided structure.

[0018] The beneficial effects of using the present invention are:

[0019] Platinum markers are set at both the upper and lower ends of the intra-tumor flow-disturbing device. The distance between the two end faces of the mesh is not constrained and can change with the deformation of the mesh, so that the intra-tumor flow-disturbing device can be transformed into a columnar shape similar to an hourglass, which is suitable for the treatment needs of being buried in the aneurysm as a whole. Its application scenario is no longer limited by the shape and position of the aneurysm neck, and it can be placed in the aneurysm neck according to the size and shape of the aneurysm sac and the aneurysm neck.

[0020] At the same time, the treatment method of completely burying the device inside the aneurysm can reduce the operating accuracy of the implantation process of the flow disturbance device inside the aneurysm, making the operation more flexible and significantly reducing the difficulty of the operation;

[0021] The design with two platinum markers can also improve imaging accuracy, provide more intuitive surgical guidance, and help ensure the accuracy of treatment;

[0022] At the same time, the platinum marker is also the convergence point of the platinum core nickel-titanium alloy wire. The design of two platinum markers can effectively improve the stability of the mesh;

[0023] The design of a larger upper segment and a smaller lower segment can adapt to various shapes of bifurcated aneurysms. At the same time, the larger expanded diameter and height of the upper part provide better stability, while the smaller expanded diameter and height of the lower part contribute to endothelialization and arterial reconstruction of the aneurysm neck.

[0024] This weaving method causes each braided wire to bear additional pressure at the intersection, so that the woven braided body can withstand more complex mechanical environments and has stronger structural stability. The mesh structure of the braided body is more complex, which can effectively change the flow path and velocity distribution of blood and generate eddy currents and shear forces. The braided wire is also easier to control and there will be no obvious pressure deviation phenomenon, which is conducive to the precise manufacturing of the braided body. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural schematic diagram of the prior art;

[0026] Figure 2 It is a schematic diagram of the application effect of the prior art;

[0027] Figure 3 This is a schematic diagram of the structure of Embodiment 1 of the present invention;

[0028] Figure 4 This is a schematic diagram of the dimensions of the first embodiment of the present invention;

[0029] Figure 5 This is a schematic diagram of the application process of the first embodiment of the present invention;

[0030] Figure 6 This is a schematic diagram of the structure of Embodiment 2 of the present invention;

[0031] Figure 7 This is a schematic diagram of the structure of Embodiment 3 of the present invention;

[0032] Figure 8 This is a schematic diagram of the structure of Embodiment 4 of the present invention;

[0033] Fig. 9 This is a schematic diagram of the structure of Embodiment 5 of the present invention;

[0034] Fig.10 This is a schematic diagram of the structure of Embodiment 6 of the present invention;

[0035] Fig.11 Schematic diagram of aneurysm before and 6 months after the operation in a case of flow disturbance treatment by a web device in the prior art;

[0036] Fig.12 Schematic diagram of aneurysm before and 6 months after the perturbation treatment of the present invention;

[0037] Fig.13 A schematic diagram of a case of using a web device in the prior art to treat postoperative aneurysm recurrence;

[0038] Fig.14 A schematic diagram of another case of treating postoperative aneurysm recurrence using a web device in the prior art;

[0039] Fig.15 A schematic diagram of a preparation method for the prior art;

[0040] Fig.16 A schematic diagram of the braiding line direction of a braiding unit in the prior art;

[0041] Fig.17 It is a schematic diagram of the preparation method of the present invention;

[0042] Fig.18 A schematic diagram of the braiding line direction of the braiding unit of the present invention;

[0043] The reference numerals include: 1, upper layer segment; 2, lower layer segment; 3, variable diameter segment; 4, depression; 5, platinum marker; α, compilation unit. DETAILED DESCRIPTION

[0044] The present invention is described in detail below with reference to the accompanying drawings.

[0045] Embodiment 1

[0046] Reference Figure 3-Figure 4 A tumor disturbance device includes a mesh body and a platinum marker 5. The mesh body is plastically formed by an integrally formed cylindrical mesh box. The upper and lower parts of the mesh body are an upper segment 1 and a lower segment 2 respectively. The tips of the upper segment 1 and the lower segment 2 are opposite to each other so that the mesh body has an hourglass shape in appearance. The joint between the upper segment 1 and the lower segment 2 is a reducing segment 3. Recesses 4 are arranged at the end faces of the upper segment 1 and the lower segment 2, and platinum markers 5 are arranged in the center of the two recesses 4.

[0047] Among them, the depression 4 can ensure that the two end faces of the mesh body are deformed inward during the narrowing deformation process, thereby avoiding the situation in which the mesh body is locally bulged during the deformation process and the inner wall of the aneurysm is squeezed.

[0048] Preferably, the angle of the diameter-reducing section 3 is 45°.

[0049] The mesh is woven from platinum-core nickel-titanium alloy wire;

[0050] Specifically, the platinum core nickel-titanium alloy wire is a composite material, with platinum wire as the wire core and nickel-titanium alloy sheath wrapped on the outside. Nickel-titanium alloy can provide good deformation function, and platinum wire helps with intraoperative imaging, which helps to further improve the accuracy of surgical operations;

[0051] At the same time, the platinum marker 5 not only has a developing function, but also serves as the convergence point of the platinum-core nickel-titanium alloy wire and the release point of the instrument (the guide wire mechanism that releases the intratumoral flow disturbance device);

[0052] During the recovery operation, both the upper segment 1 and the lower segment 2 can be directly put into the catheter along the convergence point through the platinum marker 5, without turning over the intratumoral flow disturbance device, thus increasing the simplicity of the operation.

[0053] Reference Figure 5 The mesh body can be in an hourglass-shaped column. When there is a need for embedded use, the intra-tumor flow disturbance device can be completely buried in the aneurysm, so that its application scenario is no longer limited by the shape and position of the aneurysm neck.

[0054] The narrowed portion of the variable diameter section 3 is more likely to be compressed and bent, so that the intra-aneurysm flow disturbance device can be better applied to aneurysms with curved shapes;

[0055] After the intra-tumor flow disturbance device is released into the aneurysm, a four-layer mesh structure is constructed in three dimensions, that is, the end faces of the upper segment 1 and the lower segment 2 are respectively one layer, and the side wall of the variable diameter segment 3 forms two layers. When the blood flows axially into the aneurysm, it needs to slowly pass through the four-layer mesh structure to achieve stable blood diversion layer by layer, accelerate the process of thrombosis formation in the aneurysm, increase the aneurysm occlusion rate, and reduce complications.

[0056] Normally, the size ratio of each part can be fine-tuned;

[0057] Specifically, the height H1 of the upper section 1 is 2-8 mm;

[0058] The height H2 of the lower layer section 2 is 2-8 mm;

[0059] The height difference H between the two platinum markers 5 is 2-10 mm;

[0060] The waist diameter L is 1-5 mm;

[0061] The maximum diameter L1 of the upper segment 1 is 2-15 mm;

[0062] The maximum diameter L2 of the lower layer section 2 is 2-15 mm.

[0063] Embodiment 2

[0064] Compared with the first embodiment, the present embodiment is different in that:

[0065] Reference Figure 6 Specifically, the upper section 1 is in a "bowl" shape, the lower section 2 is in a "plate" shape, and the height of the upper section 1 is about 3-4 times the height of the lower section 2;

[0066] The maximum diameter of the upper layer section 1 is greater than the maximum diameter of the lower layer section 2.

[0067] The intra-aneurysm flow disturbance device of this embodiment can be better applied to giant aneurysms with narrow necks (aneurysm diameter greater than 2.5 cm).

[0068] Embodiment 3

[0069] Compared with the first embodiment, the present embodiment is different in that:

[0070] Reference Figure 7 Specifically, the upper section 1 is in the shape of a "dish", the lower section 2 is in the shape of a "bowl", and the height of the lower section 2 is about 3-4 times the height of the upper section 1;

[0071] The maximum diameter of the lower layer section 2 is greater than the maximum diameter of the upper layer section 1.

[0072] The head end of the intra-tumor disturbance device of this embodiment is smaller, and the release position is easy to control. After the device enters the aneurysm sac, the upper layer segment 1 is first released and placed on the top of the aneurysm to stabilize the device on the top of the aneurysm.

[0073] The currently more common WEB intratumor flow disturbance device has a relatively large head end, which is prone to head end displacement after being fully released. The intratumor flow disturbance device of this embodiment can specifically solve this problem.

[0074] Embodiment 4

[0075] Compared with the first embodiment, the present embodiment is different in that:

[0076] Reference Figure 8 Specifically, the upper layer section 1 has a "bowl" shape, the lower layer section 2 has a "dish" shape, and the upper layer section 1 and the lower layer section 2 have the same maximum diameter;

[0077] The height of the upper section 1 is about 2-3 times the height of the lower section 2.

[0078] The intra-tumor flow disturbance device of this embodiment is suitable for aneurysms whose neck and top are similar in size.

[0079] Embodiment 5

[0080] Compared with the fourth embodiment, the difference of this embodiment is:

[0081] Reference Fig. 9Specifically, the upper section 1 has a "cup" shape, and the lower section 2 has a "disc" shape;

[0082] The height of the upper section 1 is about 3-4 times the height of the lower section 2.

[0083] The upper segment 1 of the intra-tumor flow disturbance device of this embodiment has a smaller curvature of the side wall and a stronger adhesion to the inner wall of the tumor capsule.

[0084] Embodiment 6

[0085] Compared with the fourth embodiment, the difference of this embodiment is:

[0086] Reference Fig.10 , specifically, the upper section 1 and the lower section 2 are both in a "bowl" shape;

[0087] The height of upper section 1 is approximately the same as that of lower section 2.

[0088] Reference Fig.11 , using a web device for aneurysm perturbation treatment, it can be clearly seen that the aneurysm has a tendency to recur 6 months after the operation;

[0089] Reference Fig.12 , using the present invention for flow disturbance treatment, no aneurysm recurrence trend was found 6 months after the operation;

[0090] Reference Fig.13 Part A and Part B in the figure are the aneurysm films of the residual aneurysm neck after the WEB device was implanted. Part C and Part D in the figure are the aneurysm films at the 5-month follow-up. The aneurysm recurred due to WEB compression.

[0091] Reference Fig.14 Part A and Part B of the figure are aneurysm films of aneurysms treated with the WEB device, and Part C and Part D of the figure are aneurysm films at 6-month follow-up, in which the aneurysm obviously recurred.

[0092] It can be seen that compared with the currently commonly used web devices, the present invention has a better therapeutic effect on aneurysms.

[0093] The intra-tumor flow disturbance device of this embodiment has relatively balanced performance.

[0094] Embodiment 7

[0095] Reference Fig.17 and Fig.18 , a method for preparing an intra-tumor disturbance device, the specific process is as follows:

[0096] The braiding unit α is composed of four braiding wires, the first braiding wire, the second braiding wire and the third braiding wire are arranged in parallel with equal spacing, and the fourth braiding wire first passes through the same side of the first braiding wire and the second braiding wire in sequence, and then passes through the other side of the third braiding wire after bending, forming a braiding method of one braiding wire on top of two braiding wires;

[0097] The braiding method of the braiding unit α is cyclically implemented in the extension direction of the braiding wire, and two adjacent braiding units α are staggered by one braiding wire;

[0098] When the braided braid reaches a predetermined length or shape, the braiding operation is stopped, and the remaining braided wires are gathered at the end of the braid and fixed using a platinum marker.

[0099] Specifically, the fourth braided wire is located below the first braided wire and the second braided wire and the fourth braided wire is located above the third braided wire as a forward braiding unit, and conversely, the fourth braided wire is located above the first braided wire and the second braided wire and the fourth braided wire is located below the third braided wire as a reverse braiding unit;

[0100] During the compilation process, forward compilation units and reverse compilation units are used alternately.

[0101] Specifically, the tension of the braiding wire needs to be kept consistent during the braiding process to ensure the uniformity and stability of the braided structure.

[0102] The one-on-two braiding method makes each braided wire bear additional pressure at the intersection. This mutually supporting structure significantly enhances the strength of the entire braid, allowing the braided body to withstand more complex mechanical environments and have stronger structural stability.

[0103] The intra-tumor flow-disturbing device made of the braided body is less likely to be deformed or broken during use;

[0104] Moreover, the mesh structure of the braided body is more complex, which can effectively change the flow path and velocity distribution of blood, generate eddy currents and shear forces, and when the intratumoral flow disturbance device is in use, these eddy currents and shear forces help promote intratumoral thrombosis.

[0105] Since the braided body woven by the one-wire-over-two method has stronger structural stability, the braided wire is easier to control during the weaving process, and there will be no obvious pressure deviation phenomenon, which is conducive to the precise weaving of the braided body;

[0106] Therefore, based on this weaving method, weaving parameters (including the thickness, material, and density of weaving wire) can be expanded, and the woven braid can also better adapt to the treatment needs of different tumors;

[0107] In addition, the braided wire is easier to control, which also means that the concern about the compression and deviation of the braided wire can be reduced during the braiding process, thereby improving the braiding efficiency from the side.

[0108] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, many changes can be made in the specific implementation methods and application scopes based on the ideas of the present invention. As long as these changes do not deviate from the concept of the present invention, they all belong to the protection scope of the present invention.

Claims

1. An intra-tumor flow disturbance device, characterized in that: It includes a mesh body and a platinum marker. The mesh body is plastically formed by an integrally formed cylindrical mesh box. The upper and lower parts of the mesh body are respectively an upper segment and a lower segment. The tips of the upper segment and the lower segment are opposite to each other, so that the mesh body has an hourglass shape in appearance. The joint between the upper segment and the lower segment is a variable diameter segment. Platinum markers are arranged on the end faces of the upper segment and the lower segment.

2. According to the intra-tumor flow disturbance device of claim 1, it is characterized by: The end surfaces of the upper layer section and the lower layer section are both provided with depressions, and two platinum markers are arranged in the centers of the two depressions.

3. According to the intra-tumor flow disturbance device of claim 1, it is characterized by: The angle of the diameter-changing section is 45°.

4. The intra-tumor flow disturbance device according to claim 1, characterized in that: The mesh body is woven from platinum-core nickel-titanium alloy wires.

5. The intra-tumor flow disturbance device according to claim 1, characterized in that: The upper layer section has a "bowl" shape, and the lower layer section has a "dish" shape.

6. A method for preparing an intra-tumor flow disturbance device, used for preparing an intra-tumor flow disturbance device as claimed in any one of claims 1 to 5, characterized in that: The specific process is as follows: The braiding unit is composed of four braiding wires, the first braiding wire, the second braiding wire and the third braiding wire are arranged in parallel with equal intervals, the fourth braiding wire first passes through the same side of the first braiding wire and the second braiding wire in sequence, and then passes through the other side of the third braiding wire after bending, forming a one-over-two braiding method; The braiding method of the braiding unit α is cyclically implemented in the extension direction of the braiding wire, and two adjacent braiding units α are staggered by one braiding wire; When the braided braid reaches a predetermined length or shape, the braiding operation is stopped, and the remaining braided wires are gathered at the end of the braid and fixed using a platinum marker.

7. A method for preparing an intra-tumor flow disturbance device according to claim 6, characterized in that: The fourth braided wire is located below the first braided wire and the second braided wire and the fourth braided wire is located above the third braided wire as a forward braiding unit, and conversely, the fourth braided wire is located above the first braided wire and the second braided wire and the fourth braided wire is located below the third braided wire as a reverse braiding unit; During the compilation process, forward compilation units and reverse compilation units are used alternately.

8. The method for preparing an intra-tumor flow disturbance device according to claim 6, characterized in that: During the weaving process, the tension of the braiding wire must be kept consistent to ensure the uniformity and stability of the braided structure.

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