Embolization devices and embolization systems

Abstract

The present invention provides an embolization device and embolization system. The embolization device includes a spring coil having a storage configuration, an application configuration, and a memory configuration. The memory configuration of the spring coil allows the spring coil to be in the application configuration after being constrained in the fallopian tube. The embolization device of the present invention, with the spring coil as the main structure, is provided with a multi-stage smooth configuration within different length ranges. This ensures that the embolization device can be configured into a supporting segment and a stacking segment after being implanted in the fallopian tube. The multiple supporting segments cooperate to extend deep into the fallopian tube distally, preventing the spring coil from becoming stuck in the fallopian tube, thereby anchoring it in the fallopian tube. The multiple stacking segments collapse and stack into a ball at the proximal end, thereby achieving localized and dense packing of the fallopian tube.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an embolization device and an embolization system. Background Art

[0002] Hydrosalpinx is a common symptom of female infertility. The primary cause of hydrosalpinx is inflammation within the fallopian tubes, ovaries, uterus, or pelvic cavity. In vitro fertilization (IVF) is an effective treatment for infertility and reproductive success. However, studies have shown that hydrosalpinx can significantly affect the implantation and development of a fertilized egg in the uterus, thereby reducing IVF success rates.

[0003] Traditional treatments for hydrosalpinx include salpingectomy, hydrosalpinx aspiration, and proximal ligation, each with its own drawbacks. Salpingectomy can affect ovarian blood flow and egg development; aspiration can only provide a short-term solution to excessive hydrosalpinx but cannot prevent its reflux; and proximal ligation incurs a larger incision, significantly impacting the patient's health.

[0004] Tubal embolization is an emerging surgical procedure for treating hydrosalpinx. The doctor inserts an implantable material, such as a steel coil, stent, or silk thread, into the isthmus of the fallopian tube. Because the diameter of the implanted material is larger than the isthmus, it becomes lodged in the isthmus, physically blocking the backflow of hydrosalpinx from the fimbria or ampulla into the uterine cavity.

[0005] However, current tubal embolization products, particularly coils, have significant shortcomings, resulting in low success rates and reliability. The main reasons are as follows: 1) Coils are often thicker and harder in diameter, poorly matching the fallopian tube. Coils often remain straight in the fallopian tube, resulting in poor sealing performance. 2) Current coils have poor push-through performance. Due to the multi-fold structure of the fallopian tube, coils can easily become lodged within the tube after being pushed through the catheter. They lack the ability to penetrate distally, occupying significant proximal space and even exposing themselves to the uterine cavity. Summary of the Invention

[0006] The purpose of the present invention is to provide an embolization device and an embolization system to solve the problem that the current spring coils are mostly in a straight state after being delivered to the fallopian tube, resulting in low occlusion performance, and the current spring coils are easily stuck in the fallopian tube due to their own wrinkled structure during delivery.

[0007] To solve the above technical problems, according to one aspect of the present invention, an embolization device is provided, comprising a spring coil, wherein the spring coil has a storage configuration, an application configuration, and a memory configuration, wherein the memory configuration of the spring coil enables the spring coil to be in the application configuration after being constrained in the fallopian tube;

[0008] When the spring coil is in the storage configuration, the spring coil is constrained in the catheter, and the configuration of the spring coil is adapted to the tubular configuration of the catheter;

[0009] When the spring coil is in the application configuration, the distal end of the spring coil is configured as a plurality of arc-shaped support segments, the plurality of support segments being sequentially connected along the axial direction of the spring coil, and the plurality of support segments being sequentially deflected around the axis of the spring coil; the proximal end of the spring coil is configured as a plurality of connected stacking segments, the plurality of stacking segments being collapsed and stacked on each other along the axial direction of the spring coil;

[0010] When the spring coil is in the memory configuration, the plurality of support segments include at least two first support segments and at least one second support segment, the at least two first support segments are sequentially arranged around the axis of the spring coil, and two adjacent first support segments around the axis of the spring coil are connected by the second support segment, and the opening direction of the first support segment is opposite to the opening direction of the second support segment; the plurality of stacked segments are sequentially arranged along the axial direction of the spring coil, and the plurality of stacked segments are sequentially deflected around the axis of the spring coil;

[0011] The distal end portion of the spring coil is further configured as an arc-shaped guide segment, and the guide segment is connected to the support segment located at the distal end;

[0012] The proximal portion of the spring coil is further configured as a plurality of arc-shaped transition segments, the plurality of transition segments being sequentially connected along the axial direction of the spring coil and deflected sequentially around the axis of the spring coil, the transition segments on both sides being respectively connected to the support segment at the proximal end and the stacking segment at the distal end;

[0013] The wire diameter of a single wire of the spring coil is 0.035mm-0.055mm; the coil diameter of the spring coil in the storage state is 0.25mm-0.35mm.

[0014] Optionally, the spring ring includes three support segments and four transition segments.

[0015] Optionally, the guide section is configured to be formed from the distal end of the spring coil and rotated forward and downward at an angle A1 in the XZ plane;

[0016] The first support segment is configured to be formed by starting from the proximal end of the guide segment, deflecting upward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane;

[0017] The second support segment is configured to be formed by starting from the proximal end of the first support segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane;

[0018] The third support segment is configured to be formed by starting from the proximal end of the second support segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane;

[0019] The first transition segment is configured to start from the proximal end of the third support segment, deflect downward by an angle A2, deflect rightward by an angle A3, and be formed forward and downward by an angle A5 in the XZ plane;

[0020] The second transition section is configured to be formed by starting from the proximal end of the first transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane;

[0021] The third transition section is configured to be formed by starting from the proximal end of the second transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane;

[0022] The fourth transition section is configured to be formed by starting from the proximal end of the third transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane;

[0023] The stacking segment is configured to be formed by starting from the proximal end of the fourth transition segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A7 in the XZ plane;

[0024] Among them, A3 is less than A2, A2 is less than A6, A6 is less than A5, A5 is less than A4, A4 is less than A1, and A1 is less than or equal to A7;

[0025] The origin of the three-axis coordinate system formed by the X-axis, the Y-axis, and the Z-axis is the starting point, the tangent line on the arc segment where the starting point is located is the X-axis, and the plane defined by the X-axis and the Y-axis is the tangent plane on the arc segment where the starting point is located;

[0026] The front is the direction of travel of the starting point and is the positive direction of the X-axis;

[0027] Along the moving direction of the starting point, the left side of the X axis is the positive direction of the Y axis, and the direction opposite to the opening of the arc segment is the positive direction of the Z axis.

[0028] Optional: A1 is 270°-360°, A2 is 60°, A3 is 45°, A4 is 210°, A5 is 180°, A6 is 150°, and A7 is 360°-540°.

[0029] Optionally, the ratio of R1 to R2 is 3:4, and the ratio of R3 to R2 ranges from 3:2 to 5:2.

[0030] Optionally, the embolization device further includes an inner lining core wire, two ends of the inner lining core wire are respectively connected to two ends of the spring coil, and the inner lining core wire is melted at the distal end of the spring coil.

[0031] Based on another aspect of the present invention, the present invention also provides an embolization system, which includes a delivery device and an embolization device, wherein the spring coil is constrained in a storage form in the catheter of the delivery device, and after the spring coil is implanted from the catheter into the fallopian tube, it is constrained in an application form by the fallopian tube.

[0032] Optionally, the delivery device can retrieve the spring coil in the fallopian tube into the catheter.

[0033] The embolization device mentioned above uses a spring coil as its main configuration and is provided with a multi-segment smooth configuration within different length ranges to ensure that the embolization device can be constructed into a support segment and a stacking segment after being implanted into the fallopian tube. The multiple support segments cooperate to advance deeper into the distal end to prevent the spring coil from being stuck in the fallopian tube and anchored in the fallopian tube. The multiple stacking segments collapse and stack into a ball at the proximal end, thereby achieving local dense filling of the fallopian tube.

[0034] It should be noted that the embolization system includes the aforementioned embolization device, and therefore also has the beneficial technical effects brought about by the embolization device, which will not be repeated here. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0036] Figure 1 is a schematic diagram of a spring coil of an embolization device in a storage state according to an embodiment of the present invention;

[0037] Figure 2 is a schematic diagram of a spring coil of an embolization device in a memory state according to an embodiment of the present invention;

[0038] Figure 3 is a schematic diagram of a spring coil of an embolization device according to an embodiment of the present invention in an application configuration;

[0039] Figure 4 This is a schematic diagram of the coil being implanted in the fallopian tube when the coil's thread diameter is small;

[0040] Figure 5 This is a schematic diagram of the spring coil being implanted in the fallopian tube when the wire diameter of the spring coil is large;

[0041] Figure 6 This is a schematic diagram of the coil being implanted in the fallopian tube when the coil is in its storage configuration and has a smaller diameter.

[0042] Figure 7 This is a schematic diagram of the coil being implanted in the fallopian tube when the coil is in its storage configuration and has a larger diameter.

[0043] Figure 8 FIG. 1 is a schematic diagram of an inner lining core wire of an embolization device according to an embodiment of the present invention.

[0044] In the attached figure:

[0045] 10-spring coil; 11-guide section; 12-support section; 121-first support section; 122-second support section; 13-transition section; 14-stack section;

[0046] 20- lining core wire;

[0047] 30-catheter;

[0048] 40-Fallopian tube. DETAILED DESCRIPTION

[0049] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0050] As used in the present invention, the singular forms "a", "an", and "the" include plural referents, the term "or" is generally used to include "and / or", the term "several" is generally used to include "at least one", and the term "at least two" is generally used to include "two or more". In addition, the terms "first", "second", and "third" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features specified as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which not only include endpoints, and the terms "mounted", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be a communication between two elements or an interaction relationship between two elements. In addition, as used in the present invention, "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element. It should not be understood as indicating or implying a spatial positional relationship between the two elements. That is, one element can be in any orientation, such as inside, outside, above, below, or to one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0051] It should be noted that the definitions of "proximal" and "distal" in this article are: "proximal" usually refers to the end of the medical device closest to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.

[0052] Figure 1 FIG1 is a schematic diagram of a spring coil 10 of an embolization device according to an embodiment of the present invention in a storage state. Figure 2 FIG. 1 is a schematic diagram of a spring coil 10 of an embolization device according to an embodiment of the present invention in a memory state. Figure 3 FIG. 1 is a schematic diagram of a spring coil 10 of an embolization device according to an embodiment of the present invention in an application state. Figure 1 、 Figure 2 and Figure 3 As shown, one embodiment of the present invention schematically provides an embolization device applied to the fallopian tube 40, the embolization device includes a spring coil 10, the spring coil 10 has a storage form, a memory form and an application form, and the memory form of the spring coil 10 allows the spring coil 10 to be in the application form after being constrained in the fallopian tube 40.

[0053] See Figure 1 When the spring coil 10 is in the storage form, the spring coil 10 is constrained in the catheter 30, and the shape of the spring coil 10 is adapted to the tubular shape of the catheter 30, that is, the spring coil 10 is also roughly tubular in the catheter 30.

[0054] See Figure 3 When the spring coil 10 is in the application form, the spring coil 10 is constrained in the fallopian tube 40, and the distal portion of the spring coil 10 is constructed into a plurality of arc-shaped support segments 12, and the plurality of support segments 12 are sequentially connected along the axial direction of the spring coil 10, and the plurality of support segments 12 are sequentially deflected around the axis of the spring coil 10; the proximal portion of the spring coil 10 is constructed into a plurality of connected stacking segments 14, and the plurality of stacking segments 14 are collapsed and stacked with each other along the axial direction of the spring coil 10.

[0055] See Figure 2 When the spring coil 10 is in the memory form, the plurality of support segments 12 include at least two first support segments 121 and at least one second support segment 122, at least two of the first support segments 121 are arranged in sequence around the axis of the spring coil 10, and the two adjacent first support segments 121 around the axis of the spring coil 10 are connected by the second support segment 122, and the opening direction of the first support segment 121 is opposite to the opening direction of the second support segment 122; the plurality of stacking segments 14 are arranged in sequence along the axial direction of the spring coil 10, and the plurality of stacking segments 14 are deflected in sequence around the axis of the spring coil 10, so as to be smoothly connected in the form of a circular arc transition. The memory form here is also the natural form of the spring coil 10, the form displayed when there is no constraint. Specifically, when the spring coil 10 is in the memory form, the plurality of support segments 12 at the distal end are arranged to form a three-dimensional structure, such as a spherical shape. Furthermore, in the spring coil 10 in the memory configuration, the support segment 12 has a curvature radius of R1, and the stacking segment 14 has a curvature radius of R3, where R1 is smaller than R3, and the curvature radius is increased, ensuring that after being released into the fallopian tube and in the application configuration, a serpentine-like structure can be formed in the fallopian tube 40. Here, the opening of the first support segment 121 can be oriented, for example, radially inward along the spring coil 10, i.e., the opening of the first support segment 121 is oriented substantially perpendicular to the axial direction of the spring coil 10 and toward the axis of the spring coil 10; the opening of the second support segment 122 can be oriented, for example, radially outward along the spring coil 10, i.e., the opening of the second support segment 122 is oriented substantially perpendicular to the axial direction of the spring coil 10 and away from the axis of the spring coil 10.

[0056] In this way, the spring coil 10 is first constrained in the catheter 30 of the delivery device in a stored form, and then implanted into the diseased area in the patient's fallopian tube 40, and the spring coil 10 is released from the catheter 30 into the fallopian tube 40. Due to the configuration of the spring coil 10's own memory form, the distal end of the spring coil 10 will overcome obstacles in the fallopian tube 40 after being released from the catheter 30, and climb toward the fallopian tube 40. During the climbing process, multiple support segments 12 are formed, and the friction resistance of the spring coil 10 in the fallopian tube 40 will gradually increase to a certain distance before it is stuck in the fallopian tube 40. At the same time, the proximal end of the spring coil 10 will collapse and stack together through multiple stacking segments 14, thereby densely embolizing the fallopian tube 40.

[0057] Typically, the spring coil 10 is made of X-ray-detectable materials such as platinum-tungsten, platinum-iridium, and pure platinum. Other metal materials compatible with the human body can also be used, such as stainless steel, titanium, and nickel-titanium alloys. The spring coil 10 can also be constructed using these metal materials in conjunction with imaging points to accommodate different types of observation equipment.

[0058] For example, see Figure 2 , Figure 2 Three support segments 12 are shown, namely two first support segments 121 and one second support segment 122. The two first support segments 121 are arranged approximately around the axis of the spring coil 10 and are connected by a second support segment 122. The openings of the first support segments 121 face downward, and the opening of the second support segment 122 faces upward.

[0059] In practice, a memory-shaped spring coil 10 is first formed through a heat-setting process, and then the spring coil 10 is constrained in the catheter 30 so that the spring coil 10 is in a storage shape. Finally, the spring coil 10 is implanted into the fallopian tube 40. Since the spring coil 10 tends to recover to the memory shape and the spring coil 10 will be constrained by the fallopian tube 40, the spring coil 10 is finally constrained in the fallopian tube 40 in the application shape, thereby treating the fallopian tube 40.

[0060] It can be understood by those skilled in the art that the storage form, memory form and application form of the spring coil 10 here all refer to the form formed by performing secondary configuration on the spring coil 10 of the primary configuration. The spring coil 10 of the primary configuration is in the shape of a spiral spring, and the secondary configuration is configured on the basis of the spiral spring shape.

[0061] Furthermore, the distal portion of the spring coil 10 is further configured as a guide segment 11, each of which is in the shape of a circular arc. The guide segment 11 is connected to the support segment 12 at the most distal end. The proximal portion of the spring coil 10 is further configured as multiple transition segments 13 in the shape of a circular arc. The multiple transition segments 13 are sequentially connected along the axial direction of the spring coil 10 and deflected sequentially around the axis of the spring coil 10. The transition segments 13 on both sides are respectively connected to the support segment 12 at the most proximal end and the stacking segment 14 at the most distal end. The curvature radius of the guide segment 11 is R1, and the curvature radius of the transition segment 13 is R2, where R1 is smaller than R2, and R2 is smaller than R3. The configuration of the guide section 11 ensures that the distal end of the spring coil 10 is smooth, so that it can navigate in the fallopian tube 40 after being released from the catheter 30. The configuration of the transition section 13 ensures that the thrust can be transmitted normally during the release of the spring from the catheter 30. Preferably, the transition section 13 can also be stacked, thereby increasing the spatial volume of the proximal part and improving the density of the spring coil 10 in embolizing the fallopian tube 40.

[0062] Exemplarily, the spring coil 10 includes three support segments 12 and four transition segments 13 . There is no limitation on the stacking segment 14 , and the spring coil 10 includes two first support segments 121 and one second support segment 122 .

[0063] Specifically, when the spring coil 10 is in the primary configuration of a spiral spring, the guide segment 11 is configured to be formed by rotating the distal end of the spring coil 10 forward and downward at an R1 rotation angle A1 in the XZ plane. The first support segment 12 (i.e., the first first support segment 121) is configured to be formed by rotating the proximal end of the guide segment 11 upward at an angle A2, then to the left at an angle A3, and then to the front and bottom at an R1 rotation angle A4 in the XZ plane. The second support segment 12 (i.e., the second support segment 122) is configured to be formed by rotating the proximal end of the first support segment 12 downward at an angle A2, then to the left at an angle A3, and then to the front and bottom at an R1 rotation angle A4 in the XZ plane. The third support segment 12 (i.e., the second first transition segment 13) is configured to be formed by starting from the proximal end of the second support segment 12, deflecting downward by an angle A2, deflecting to the left by an angle A3, and rotating forward and downward by an angle R1 in the XZ plane. The first transition segment 13 is configured to be formed by starting from the proximal end of the third support segment 12, deflecting downward by an angle A2, deflecting to the right by an angle A3, and rotating forward and downward by an angle R2 in the XZ plane. The second transition segment 13 is configured to be formed by starting from the proximal end of the first transition segment 13, deflecting downward by an angle A2, deflecting to the right by an angle A3, and rotating forward and downward by an angle R2 in the XZ plane. The third transition segment 13 is configured to be formed starting from the proximal end of the second transition segment 13, deflected downward by an angle A2, deflected rightward by an angle A3, and then rotated forward and downward by an angle R2 within the XZ plane. The fourth transition segment 13 is configured to be formed starting from the proximal end of the third transition segment 13, deflected downward by an angle A2, deflected rightward by an angle A3, and then rotated forward and downward by an angle R2 within the XZ plane. The stacking segment 14 is configured to be formed starting from the proximal end of the fourth transition segment 13, deflected downward by an angle A2, deflected leftward by an angle A3, and then rotated forward and downward by an angle R3 within the XZ plane.

[0064] Among them, the X-axis, Y-axis and Z-axis are perpendicular to each other in pairs, the origin of the three-axis coordinate system formed by the X-axis, Y-axis and Z-axis is the starting point, and the tangent on the arc segment where the starting point is located is the X-axis, and the plane defined by the X-axis and the Y-axis is the tangent on the arc segment where the starting point is located. The front is the direction of travel of the starting point and is the positive direction of the X-axis, then the back is defined as the negative direction of the X-axis. Along the direction of travel of the starting point, the left side of the X-axis is the positive direction of the Y-axis, and the right side of the X-axis is the negative direction of the Y-axis. The direction opposite to the opening of the arc segment is the positive direction of the Z-axis, and the direction the same as the opening of the arc segment is the negative direction of the Z-axis. The XZ plane is also the plane defined by the X-axis and the Z-axis. The direction of travel of the starting point is also the direction of the starting point along the above-mentioned configuration (the direction of deflection along which direction, the direction of rotation with the corresponding curvature). It should be noted that the arc segment where the starting point is located refers to the support segment 12, the stacking segment 14 and the transition segment 13. Since these three are all arc-shaped, they correspond to the starting point on the support segment 12, the starting point on the transition segment 13, and the starting point on the stacking segment 14 respectively.

[0065] In summary, during the formation of the spring coil 10 with memory properties, each time an arc segment is formed, the starting point is updated, and the three-axis coordinate system formed by the X-axis, Y-axis, and Z-axis is adjusted accordingly, with a new three-axis coordinate system constructed with the new starting point as a reference. The direction of travel of the starting point can also be understood as the direction of the first-person perspective, that is, the device manufacturer uses the direction of travel (trajectory direction) of the starting point as the viewing direction.

[0066] In one embodiment, A1 is 270°-360°, A2 is 60°, A3 is 45°, A4 is 210°, A5 is 180°, A6 is 150°, and A7 is 360°-540°. The angle A1 of 270°-360° allows the guide section 11 to be approximately annular, providing a spiral shape that facilitates its path through the fallopian tube 40. If the angle is less than 180°, the distal end of the spring coil 10 may easily become stuck on the uneven surface of the fallopian tube 40.

[0067] Preferably, the ratio of R1 to R2 is 3:4, and the ratio of R3 to R2 is in the range of 3:2 to 5:2. Specifically, R1 is 1.5 times the diameter of the fallopian tube 40, R2 is 2 times the diameter of the fallopian tube 40, and R3 is 3-5 times the diameter of the fallopian tube 40. It is understandable that the diameter of the fallopian tube 40 of different patients is different. In this embodiment, the spring coil 10 with the corresponding curvature radius can be selected according to the diameter of the fallopian tube 40 of the patient currently to be treated. For R1, considering that it is more than 1.5 times the diameter of the fallopian tube 40 can ensure that the distal end of the spring coil 10 forms a triangular support shape. R2 should be larger than R1 and needs to have processing technology performance. The setting of the large curvature radius of R3 can ensure that it can be stacked under normal circumstances, that is, after the spring coil 10 is released into the fallopian tube 40, its proximal end portion can collapse and fold.

[0068] Preferably, the primary wire diameter of the spring coil 10 is 0.035mm-0.055mm. The primary wire diameter, i.e., the wire diameter of a single wire of the primary configuration of the spring coil 10, is 0.25mm-0.35mm in the stored configuration (primary coil diameter), which is typically 15%-25% of the diameter of the fallopian tube 40. Generally, the hardness of each part of the spring coil 10 is related to the primary coil diameter, the secondary coil diameter (R1, R2, R3 mentioned above), and the primary wire diameter as follows:

[0069]

[0070] Where K represents the rigidity of the spring coil 10; a, b, and c are all constants and are all greater than 1. The larger K, the harder the spring coil 10, and the smaller K, the softer the spring coil 10. As shown in the above formula, the larger the primary wire diameter, the smaller the primary coil diameter, and the smaller the secondary coil diameter, the greater the rigidity of the spring coil 10, and vice versa. For the present invention, based on the production and processing properties of the product, the primary wire diameter and secondary coil diameter of the same product need to be kept as consistent as possible. This can be achieved by adjusting the secondary coil diameter (R1\R2\R3).

[0071] The inventors have found through practice that, for the lumen of the fallopian tube 40, see Figure 4 If the primary wire diameter is too thin, the spring coil 10 will immediately become a ball after being pushed out of the catheter 30 and will not be able to crawl deep into the fallopian tube 40, that is, it will not be able to be in the above-mentioned application form in the fallopian tube 40; Figure 5 If the primary wire diameter is too thick, the spring coil 10 will become stiff and straight, making it difficult to bend and push in the fallopian tube 40; Figure 6 If the primary coil diameter is too small, the overall rigidity of the spring coil 10 will be large, and the distal end of the spring coil 10 will lose its elasticity and become stuck at the proximal end of the fallopian tube, unable to move further distally. Figure 7 If the primary coil diameter is too large, the spring coil 10 will be stuck in the narrow part of the fallopian tube 40 and will not be easy to extend toward the fallopian tube 40.

[0072] Figure 8 FIG is a schematic diagram of an inner lining core wire of an embolization device according to an embodiment of the present invention. Figure 8 Preferably, the embolization device further includes an inner lining core wire 20, the two ends of the inner lining core wire 20 are respectively connected to the two ends of the spring coil 10, and the inner lining core wire 20 is melted at the distal end of the spring coil 10, thereby increasing the rigidity of the distal end of the spring coil 10.

[0073] Based on the above-mentioned embolization device, this embodiment also provides an embolization system, which includes a delivery device and an embolization device. The spring coil 10 is constrained in a storage form in the catheter 30 of the delivery device. After the spring coil 10 is implanted from the catheter 30 into the fallopian tube 40, it is constrained in an application form by the fallopian tube 40.

[0074] Furthermore, the delivery device can retrieve the spring coil 10 from the fallopian tube into the catheter 30. During the release process of the spring coil 10, if the spring coil 10 has not yet been released from the delivery device, and if the release effect of the spring coil 10 in the fallopian tube 40 is not ideal or the release position deviates from the lesion site, the spring coil 10 can be retrieved into the catheter 30 by the delivery device and stored in a storage state, and the spring coil 10 can be released again, thereby adjusting the position of the spring coil 10 in the fallopian tube 40 to achieve the best release effect and enhance the treatment effect.

[0075] Although the present invention is disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. Any person skilled in the art can utilize the above disclosed technical content to make many possible changes and modifications to the technical solution of the present invention without departing from the scope of the technical solution of the present invention, or modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

Claims

1. An embolization device, characterized in that: The spring coil comprises a storage configuration, an application configuration, and a memory configuration, wherein the memory configuration of the spring coil enables the spring coil to be in the application configuration after being constrained in the fallopian tube; When the spring coil is in the storage configuration, the spring coil is constrained in the catheter, and the configuration of the spring coil is adapted to the tubular configuration of the catheter; When the spring coil is in the application configuration, the distal end of the spring coil is configured as a plurality of arc-shaped support segments, the plurality of support segments being sequentially connected along the axial direction of the spring coil, and the plurality of support segments being sequentially deflected around the axis of the spring coil; the proximal end of the spring coil is configured as a plurality of connected stacking segments, the plurality of stacking segments being collapsed and stacked on each other along the axial direction of the spring coil; When the spring coil is in the memory configuration, the plurality of support segments include at least two first support segments and at least one second support segment, the at least two first support segments are sequentially arranged around the axis of the spring coil, and two adjacent first support segments around the axis of the spring coil are connected by the second support segment, and the opening direction of the first support segment is opposite to the opening direction of the second support segment; The plurality of stacked segments are sequentially arranged along the axial direction of the spring coil, and the plurality of stacked segments are sequentially deflected around the axis of the spring coil; The distal end portion of the spring coil is further configured as an arc-shaped guide segment, and the guide segment is connected to the support segment located at the distal end; The proximal portion of the spring coil is further configured as a plurality of arc-shaped transition segments, the plurality of transition segments being sequentially connected along the axial direction of the spring coil and deflected sequentially around the axis of the spring coil, the transition segments on both sides being respectively connected to the support segment at the proximal end and the stacking segment at the distal end; Furthermore, when the spring coil is in the memory shape, the curvature radius of the support section and the guide section is R1, the curvature radius of the transition section is R2, and the curvature radius of the stacking section is R3, R1 is smaller than R2, and R2 is smaller than R3; The wire diameter of a single wire of the spring coil is 0.035mm-0.055mm; the coil diameter of the spring coil in the storage state is 0.25mm-0.35mm.

2. The embolization device according to claim 1, characterized in that The spring ring includes three support segments and four transition segments.

3. The embolization device according to claim 2, characterized in that: The guide section is configured to be formed from the distal end of the spring coil and rotated forward and downward at an angle A1 in the XZ plane; The first support segment is configured to be formed by starting from the proximal end of the guide segment, deflecting upward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane; The second support segment is configured to be formed by starting from the proximal end of the first support segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane; The third support segment is configured to be formed by starting from the proximal end of the second support segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A4 in the XZ plane; The first transition segment is configured to start from the proximal end of the third support segment, deflect downward by an angle A2, deflect rightward by an angle A3, and be formed forward and downward by an angle A5 in the XZ plane; The second transition section is configured to be formed by starting from the proximal end of the first transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane; The third transition section is configured to be formed by starting from the proximal end of the second transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane; The fourth transition section is configured to be formed by starting from the proximal end of the third transition section, deflecting downward by an angle A2, deflecting rightward by an angle A3, and rotating forward and downward by an angle A6 in the XZ plane; The stacking segment is configured to be formed by starting from the proximal end of the fourth transition segment, deflecting downward by an angle A2, deflecting leftward by an angle A3, and rotating forward and downward by an angle A7 in the XZ plane; Among them, A3 is less than A2, A2 is less than A6, A6 is less than A5, A5 is less than A4, A4 is less than A1, and A1 is less than or equal to A7; The origin of the three-axis coordinate system formed by the X-axis, Y-axis, and Z-axis is the starting point, the tangent line on the arc segment where the starting point is located is the X-axis, and the plane defined by the X-axis and the Y-axis is the tangent plane on the arc segment where the starting point is located; The front is the direction of travel of the starting point and is the positive direction of the X-axis; Along the moving direction of the starting point, the left side of the X axis is the positive direction of the Y axis, and the direction opposite to the opening of the arc segment is the positive direction of the Z axis.

4. The embolization device according to claim 3, characterized in that: A1 is 270°-360°, A2 is 60°, A3 is 45°, A4 is 210°, A5 is 180°, A6 is 150°, and A7 is 360°-540°.

5. The embolization device according to claim 1, characterized in that: The ratio of R1 to R2 is 3:4, and the ratio of R3 to R2 ranges from 3:2 to 5:

2.

6. The embolization device according to claim 1, characterized in that: The embolization device further comprises an inner lining core wire, two ends of the inner lining core wire are respectively connected to two ends of the spring coil, and the inner lining core wire is melted at the distal end of the spring coil.

7. An embolization system, characterized in that: The invention comprises a delivery device and the embolization device according to any one of claims 1 to 6, wherein the spring coil is constrained in a storage form in the catheter of the delivery device, and is constrained in an application form by the fallopian tube after being implanted from the catheter into the fallopian tube.

8. The embolization system according to claim 7, characterized in that: The delivery device can retrieve the spring coil from the fallopian tube into the catheter.

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