Intratumoral turbulence device and method of fabrication

Abstract

The application belongs to the technical field of blood shunt auxiliary devices, and particularly provides an intratumoral turbulence device and a preparation method thereof, which comprises a net body and a platinum marker, the net body is integrally formed by a cylindrical net box, upper and lower parts of the net body are respectively an upper layer section and a lower layer section, the upper layer section and the lower layer section are opposite to each other at the tip end, so that the net body appears as a sandglass shape, a variable diameter section is arranged at the joint of the upper layer section and the lower layer section, and the platinum marker is arranged on the end face of the upper layer section and the lower layer section. The platinum marker is arranged at the upper and lower ends of the intratumoral turbulence device, so that the intratumoral turbulence device can become a columnar shape similar to a sandglass, and is suitable for the treatment requirement of being embedded in an aneurysm as a whole; the treatment mode of being completely embedded in the aneurysm can reduce the operation precision in the implantation process of the intratumoral turbulence device; the design of the two platinum markers can also improve the development precision and provide more intuitive surgical guidance.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of blood shunt auxiliary devices, and particularly provides an intratumoral turbulence device and a preparation method thereof. BACKGROUND

[0002] Bifurcated aneurysm is a common vascular disease located at the bifurcation of blood vessels, often with unique morphology and location, increasing the challenge of treatment. Traditional treatment methods include surgical clipping and endovascular coil techniques, however, these methods have certain limitations. Craniotomy clipping can effectively clip the aneurysm, but may cause greater trauma and higher risk. Endovascular coil techniques may not achieve ideal therapeutic effect in some cases, especially for complex bifurcated aneurysms. In addition, traditional treatment methods often require long-term dual antiplatelet therapy to prevent complications such as thromboembolism, thereby bringing drug-related discomfort and risk to patients.

[0003] Therefore, there is an urgent need to develop a new type of treatment device aimed at improving the success rate of bifurcated aneurysm treatment, reducing the risk of complications, and reducing the drug burden on patients. In the context of limitations of current treatment methods, it is particularly important to develop a safer and more effective treatment device.

[0004] At present, the applicability of existing technologies such as conventional cylindrical intratumoral turbulence devices and intratumoral turbulence devices with application number 202220345035.9 still needs to be improved. Referring to Figure 1 and Figure 2 , the marker points are connected to both ends of the net body at the same time, limiting the deformation range of the net body, and there are great limitations during implantation. The small diameter part of the waist needs to correspond to the aneurysm neck.

[0005] In addition, referring to Figure 15 and Figure 16 , the current conventional braiding method is one press one, and the two braiding wires regularly cross and circulate. This braiding method is simple and easy to use, but the braided body made by this braiding method still needs to be improved in terms of structural stability and fluid dynamics. SUMMARY

[0006] To solve the above technical problems, the technical solution adopted by the present application is: an intratumoral turbulence device, comprising a net body and a platinum marker, the net body is plasticized from an integrally formed cylindrical net box, the upper and lower parts of the net body are respectively an upper layer segment and a lower layer segment, the upper layer segment and the lower layer segment are opposite at the tip end, making the net body appear as a sandglass, the joint between the upper layer segment and the lower layer segment is a variable diameter segment, and the end faces of the upper layer segment and the lower layer segment are both provided with platinum markers.

[0007] Further, the upper layer segment and the lower layer segment are provided with recesses at the end faces, and two platinum markers are arranged at the centers of the two recesses.

[0008] Further, the included angle of the variable diameter segment is 45°.

[0009] Further, the net body is woven by a platinum core and a nickel-titanium alloy wire.

[0010] Further, the upper layer segment is in the shape of a bowl, and the lower layer segment is in the shape of a plate.

[0011] A method for weaving an intratumoral turbulence device is provided, and the specific process is as follows:

[0012] The weaving unit is composed of four weaving wires, the first, second and third weaving wires are distributed in parallel at equal intervals, and the fourth weaving wire is first passed through the same side of the first and second weaving wires, and then passed through the other side of the third weaving wire after bending, thereby forming a weaving method of pressing two wires with one wire.

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

[0014] When the woven body reaches the predetermined length or shape, the weaving operation is stopped, the remaining weaving wires are gathered at the end of the woven body, and platinum markers are used for fixation.

[0015] Further, the fourth weaving wire is defined as a forward weaving unit when it is located below the first and second weaving wires and above the third weaving wire, and vice versa, the fourth weaving wire is defined as a reverse weaving unit when it is located above the first and second weaving wires and below the third weaving wire.

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

[0017] Further, the tension of the weaving wire needs to be consistent during the weaving process to ensure the uniformity and stability of the structure of the woven body.

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

[0019] The intratumoral turbulence device is provided with platinum markers at the upper and lower ends, and the distance between the two end faces of the net body is not restricted and can change with the deformation of the net body, so that the intratumoral turbulence device can become a columnar shape similar to a sandglass, which is suitable for the treatment requirement of being embedded in an aneurysm as a whole, and 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 capsule and aneurysm neck.

[0020] Meanwhile, the treatment mode of being completely embedded in the aneurysm can reduce the operation precision of the intra-aneurysm turbulence device implantation process, make the operation more flexible, and obviously reduce the operation difficulty;

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

[0022] Meanwhile, the platinum markers are also the convergence points of the platinum core nickel-titanium alloy wires, and the design of the two platinum markers can effectively improve the stability of the net body.

[0023] The size difference design of the upper segment being large and the lower segment being small can adapt to various different morphological bifurcated aneurysms, meanwhile, the larger expansion diameter and height of the upper part provide better stability, and the smaller expansion diameter and height of the lower part are helpful for the endothelialization of the aneurysm neck and arterial reconstruction.

[0024] The preparation method makes each braided wire bear additional pressure at the intersection point, the braided body prepared can bear more complex mechanical environment, has stronger structural stability, the mesh structure of the braided body is more complex, can effectively change the flow path and speed distribution of blood, generate vortex and shear force, the braided wire is also easier to control, and obvious pressure deviation phenomenon does not occur, which is beneficial to the accurate manufacture of the braided body. BRIEF DESCRIPTION OF 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 It is a structural schematic diagram of embodiment one of the application;

[0028] Figure 4 It is a size schematic diagram of embodiment one of the application;

[0029] Figure 5 It is a schematic diagram of the application process of embodiment one of the application;

[0030] Figure 6 It is a structural schematic diagram of embodiment two of the application;

[0031] Figure 7 It is a structural schematic diagram of embodiment three of the application;

[0032] Figure 8 It is a structural schematic diagram of embodiment four of the application;

[0033] Figure 9 It is a structural schematic diagram of embodiment five of the application;

[0034] Figure 10 Structure diagram of embodiment six of the present application;

[0035] Figure 11 Preoperative and postoperative aneurysm diagrams of a web device treatment case in the prior art;

[0036] Figure 12 Preoperative and postoperative aneurysm diagrams of a web device treatment case in the prior art;

[0037] Figure 13 Structure diagram of a case of aneurysm recurrence after a web device treatment in the prior art;

[0038] Figure 14 Structure diagram of another case of aneurysm recurrence after a web device treatment in the prior art;

[0039] Figure 15 Structure diagram of a weaving method in the prior art;

[0040] Figure 16 Structure diagram of a weaving line of a weaving unit in the prior art;

[0041] Figure 17 Structure diagram of a weaving method of the present application;

[0042] Figure 18 Structure diagram of a weaving line of a weaving unit of the present application;

[0043] The reference signs include: 1, upper section; 2, lower section; 3, variable diameter section; 4, recess; 5, platinum marker; α, weaving unit. DETAILED DESCRIPTION

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

[0045] Embodiment one

[0046] Reference Figures 3-4 An intratumoral flow disturbance device includes a net body and a platinum marker 5, the net body is integrally formed by a cylindrical net box, the upper and lower parts of the net body are respectively an upper section 1 and a lower section 2, the upper section 1 and the lower section 2 are opposite at the tip end to make the net body appear as a sandglass, the joint of the upper section 1 and the lower section 2 is a variable diameter section 3, the end faces of the upper section 1 and the lower section 2 are respectively provided with a recess 4, and the platinum marker 5 is arranged in the center of each recess 4.

[0047] The recess 4 can ensure that both end faces of the net body are deformed inwardly in the narrowing deformation process, so that the local protrusion of the net body in the deformation process is avoided, and the situation of extruding the inner wall of the aneurysm is avoided.

[0048] Preferably, the included angle of the variable diameter section 3 is 45°.

[0049] The net body is woven by platinum core nickel-titanium alloy wire;

[0050] Specifically, the platinum core nickel-titanium alloy wire is a composite material, with platinum wire as the core and nickel-titanium alloy as the outer skin. The nickel-titanium alloy can provide good deformation function, and the platinum wire helps to further improve the operation precision.

[0051] At the same time, the platinum marker 5 not only has the imaging function, but also is the convergence point of the platinum core nickel-titanium alloy wire and the release point of the instrument (the guide wire mechanism for releasing the intratumoral turbulence device).

[0052] When the recovery operation is performed, the upper segment 1 and the lower segment 2 can be directly collected into the catheter through the platinum marker 5 along the convergence point, without the need to turn over the intratumoral turbulence device, thereby increasing the simplicity of the operation.

[0053] Referring to Figure 5 , the net body can be in the shape of a columnar hourglass, and when there is an embedded use requirement, the intratumoral turbulence device can be embedded in the aneurysm as a whole, so that its application scenario is no longer limited by the shape and position of the aneurysm neck.

[0054] The narrowed part of the variable diameter segment 3 is more easily bent under pressure, so that the intratumoral turbulence device can be better applied to the aneurysm with a curved shape.

[0055] After the intratumoral turbulence device is released in the aneurysm, a four-layer net structure is formed, i.e., the end faces of the upper segment 1 and the lower segment 2 are each one layer, and the side wall of the variable diameter segment 3 forms two layers. When the blood flow flows into the aneurysm axially, it needs to slowly pass through the four-layer net structure to realize stable blood shunt layer by layer, accelerate the thrombosis process in the aneurysm, increase the aneurysm occlusion rate, and reduce complications.

[0056] Usually, the size ratio of each part can be adjusted slightly.

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

[0058] The height H2 of the lower segment 2 is 2-8 mm.

[0059] The height difference H of 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 segment 2 is 2-15 mm.

[0063] Example Two

[0064] Compared with the first embodiment, the difference of the present embodiment is that:

[0065] Referring to Figure 6 , specifically, the upper section 1 is in the shape of a "bowl", and the lower section 2 is in the shape of a "plate", 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 section 1 is greater than the maximum diameter of the lower section 2.

[0067] The intratumoral turbulence device of the present embodiment can be better applied to narrow-necked giant aneurysms (aneurysm diameter greater than 2.5 cm).

[0068] Embodiment three

[0069] Compared with the first embodiment, the difference of the present embodiment is that:

[0070] Referring to Figure 7 , specifically, the upper section 1 is in the shape of a "plate", and 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 section 2 is greater than the maximum diameter of the upper section 1.

[0072] The head end of the intratumoral turbulence device of the present embodiment is smaller, and it is easy to control the release position. After the device enters the aneurysm sac, the upper section 1 is first released and placed at the aneurysm top and the device is stabilized at the aneurysm top.

[0073] At present, the head end of the commonly used WEB intratumoral turbulence device is relatively large, and after complete release, the head end is prone to displacement. The intratumoral turbulence device of the present embodiment can solve this problem.

[0074] Embodiment four

[0075] Compared with the first embodiment, the difference of the present embodiment is that:

[0076] Referring to Figure 8 , specifically, the upper section 1 is in the shape of a "bowl", and the lower section 2 is in the shape of a "plate", and the maximum diameter of the upper section 1 and the lower section 2 is the same.

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

[0078] The intratumoral turbulence device of the present embodiment is suitable for aneurysms with similar size of aneurysm neck and aneurysm top.

[0079] Embodiment five

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

[0081] Referring to Figure 9Specifically, the upper section 1 is in the shape of a cup, and the lower section 2 is in the shape of a plate.

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

[0083] The upper section 1 of the intratumoral turbulence device of the embodiment has a smaller arc of the side wall and a stronger adhesion to the intratumoral wall.

[0084] Embodiment six

[0085] Compared with embodiment four, the difference of the embodiment is that:

[0086] Referring to Figure 10 Specifically, the upper section 1 and the lower section 2 are in the shape of a bowl.

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

[0088] Referring to Figure 11 The web device is used for the turbulence treatment of an aneurysm, and it can be obviously seen that the aneurysm has a recurrence trend 6 months after the operation.

[0089] Referring to Figure 12 The web device is used for the turbulence treatment of an aneurysm, and it can be obviously seen that the aneurysm has a recurrence trend 6 months after the operation.

[0090] Referring to Figure 13 The A and B parts of the figure are aneurysm films of the WEB device implanted in the aneurysm neck, and the C and D parts of the figure are aneurysm films 5 months after the follow-up, and the aneurysm recurs due to the compression of the WEB.

[0091] Referring to Figure 14 The A and B parts of the figure are aneurysm films of the WEB device implanted in the aneurysm neck, and the C and D parts of the figure are aneurysm films 5 months after the follow-up, and the aneurysm recurs due to the compression of the WEB.

[0092] Therefore, compared with the commonly used web device, the aneurysm treatment effect of the embodiment is better.

[0093] The intratumoral turbulence device of the embodiment has a relatively balanced performance.

[0094] Embodiment seven

[0095] Referring to Figure 17 and Figure 18 A method for compiling an intratumoral turbulence device, and the specific process is as follows:

[0096] The weaving unit α is composed of four braided wires, the first, second and third braided wires are evenly distributed in parallel, and the fourth braided wire is first passed from the same side of the first and second braided wires, and then bent to pass from the other side of the third braided wire, forming a weaving method of one pressing two;

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

[0098] When the woven body reaches the predetermined length or shape, the weaving operation is stopped, the remaining braided wires are gathered at the end of the woven body, and a platinum marker is used for fixation.

[0099] Specifically, the fourth braided wire is defined as being located below the first and second braided wires and above the third braided wire as a forward weaving unit, and vice versa, the fourth braided wire is defined as being located above the first and second braided wires and below the third braided wire as a reverse weaving unit;

[0100] The forward and reverse weaving units are alternately used during the weaving process.

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

[0102] The weaving method of one pressing two makes each braided wire bear additional pressure at the intersection, and this mutual supporting structure significantly enhances the strength of the entire woven body, so that the woven body can withstand more complex mechanical environment and has stronger structural stability;

[0103] The intratumoral turbulence device made of the woven body is less likely to deform or break during use;

[0104] And the mesh structure of the woven body is more complex, which can effectively change the flow path and speed distribution of blood, generate vortex and shear force, and the intratumoral turbulence device can promote intratumoral thrombosis during use.

[0105] Since the woven body woven by the one pressing two method has stronger structural stability, the braided wire is easier to control during the weaving process, and there is no obvious pressure deviation phenomenon, which is beneficial to the accurate weaving of the woven body;

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

[0107] In addition, the braided wire is easier to control, which means that the concern for the braided wire being offset by pressure during braiding can be reduced, thereby improving the braiding efficiency from the side.

[0108] The above merely illustrates the preferred embodiments of the present application, and for those skilled in the art, many changes can be made to the specific embodiments and application ranges according to the idea of the present application, as long as these changes do not deviate from the concept of the present application, and all of them belong to the protection scope of the present application.

Claims

1. A method for preparing an intratumoral turbulence device, the method comprising: providing a net body and a platinum marker, the net body being integrally formed from a cylindrical net box, the net body having an upper section and a lower section, the upper section and the lower section being oppositely pointed to form a sandglass shape, the upper section and the lower section being connected at a variable diameter section, the upper section and the lower section each having a platinum marker disposed on an end face thereof; and preparing the intratumoral turbulence device by: providing four braiding wires, the first, second, and third braiding wires being equally spaced and parallel to each other, the fourth braiding wire being passed through the first and second braiding wires from the same side and then being passed through the third braiding wire from the other side to form a two-pressing-one braiding method; and repeating the braiding method of the braiding unit in the extension direction of the braiding wires, the adjacent two braiding units being staggered by one braiding wire; stopping the braiding operation when the braided body reaches a predetermined length or shape, and gathering the remaining braiding wires at the end of the braided body and fixing the braiding wires using the platinum marker. The fourth braiding wire is defined as being on the lower side of the first and second braiding wires and on the upper side of the third braiding wire as a forward braiding unit, and vice versa. The forward and reverse braiding units are alternately used during the braiding process. The tension of the braiding wires is kept consistent during the braiding process to ensure the uniformity and stability of the braided body structure. The end face of the upper section and the lower section each has a recess, and the two platinum markers are disposed at the center of the two recesses. The variable diameter section has an included angle of 45°.

2. The method of claim 1, wherein the intratumoral turbulence device is configured to: The net body is braided from a platinum core nickel-titanium alloy wire. The upper section has a "bowl” shape, and the lower section has a "dish” shape.

3. The method of claim 1, wherein the method further comprises: ​ 4. The method of claim 1, wherein the intratumoral turbulence device is configured to have a length of about 1 mm to about 10 mm. ​ 5. The method of claim 1, wherein the intratumoral turbulence device is formed by: ​ 6. The method of claim 1, wherein the intratumoral turbulence device is configured to have a length of about 1 mm to about 10 mm. ​ 7. The method of claim 1, wherein the method further comprises: ​

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