Fiber wool loading device, fiber wool spring coil for embolism and preparation method thereof

Abstract

The present invention belongs to the technical field of medical devices, and in particular, relates to a fiber wool loading device, a spring coil with fiber wool for embolization, and a preparation method thereof. The fiber wool loading device of the present invention comprises a device body, on which are provided: at least one fixed position for loading the spring coil, a plurality of winding sites are provided on the fixed position, and the winding sites are arranged in sequence and at intervals along the extension direction of the fixed position, and the winding sites are used to determine the loading position of the fiber wool on the spring coil; and at least one cutting position, which is used to guide the cutting tool to cut and separate the fiber filaments wound on the device body to form fiber wool. In the present invention, by regularly winding the fiber filaments, efficient loading of fiber wool for at least one spring coil can be achieved, and at the same time, the controllability and stability of parameters such as the loading site, loading spacing, length, and quantity of the fiber wool can be ensured.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a fiber wool loading device, a fiber wool spring coil for embolism and a preparation method thereof. Background Art

[0002] Gianturco first invented Cotton Tails and wool coils in 1975, marking the beginning of endovascular embolization for peripheral arterial aneurysms. For decades, coils have been the mainstay of embolization therapy, and coil technology has also seen explosive growth, but there is still controversy over whether the fiber hair on the coil is beneficial. There is literature showing that the fiber hair on the coil increases thrombosis and can achieve faster embolization, which is beneficial for immediate embolization. In addition, coils with fiber hair can significantly reduce the number of embolization coils used, helping to reduce the cost of embolization surgery.

[0003] Different fiber parameters (number, length, spacing, etc.) in fiber-hair coil products will lead to different thrombosis effects, which in turn affect the product's scope of application and immediate and long-term embolic effects. There are large differences in the fiber parameters of fiber-hair coil products from different manufacturers. For example, the detachable coil of Covidien uses a unique loading process to wrap Nylon or PGLA microcilia on the AxiumTM coil platform. The fiber parameters are 0.02mm in diameter, 2mm in length, 2mm in fiber site spacing, and 1 fiber per site; the fiber parameters used in some specifications of Boston Scientific's Interlock coil are 0.02mm in diameter, 18mm in length, 3mm in fiber site spacing, and 48 fibers per site. Therefore, the certainty of fiber parameters in fiber-hair coil products and the stability during the production process directly affect the product's scope of application and performance. However, in the prior art, there is a lack of devices that can efficiently, stably and controllably load fiber hair on coils. Summary of the invention

[0004] The present invention provides a fiber wool loading device, a fiber wool spring coil for embolism and a preparation method thereof, which are used to solve at least one of the above technical problems.

[0005] A first aspect of the present invention provides a fiber wool loading device, comprising a device body,

[0006] The device body is provided with:

[0007] At least one fixed position, which is used to load the spring coil, wherein the fixed position is provided with a plurality of winding sites, wherein the winding sites are sequentially spaced along the extension direction of the fixed position, and the winding sites are used to determine the loading position of the fiber hair on the spring coil; and

[0008] At least one cutting position is used to guide a cutting tool to cut and separate the fiber filaments wound around the device body to form fiber wool.

[0009] In one embodiment, the device body comprises at least two fixing positions and at least two cutting positions, wherein the fixing positions and the cutting positions both extend along the length direction of the device body.

[0010] Furthermore, the number of the fixing positions is the same as the number of the cutting positions, and the fixing positions and the cutting positions are alternately arranged along the circumferential direction of the device body.

[0011] In one embodiment, the winding sites on each of the fixed positions are arranged at equal intervals along the extension direction of the fixed position.

[0012] Furthermore, the winding sites at different fixed positions are staggered with each other in the length direction of the device body.

[0013] In one embodiment, the offset spacing between the winding sites at two adjacent fixed positions is the ratio of the site spacing to the number of fixed positions.

[0014] In one embodiment, the fixing position is provided with a fixing groove, and the fixing groove extends along the length direction of the device body to load the spring coil.

[0015] In one embodiment, site grooves are provided on the winding sites, the site grooves extend along the circumference of the device body, and the site grooves and the fixing grooves intersect each other perpendicularly to determine the loading position of the fiber hair on the spring coil.

[0016] In one embodiment, the cutting position is provided with a cutting groove, and the cutting groove extends along the length direction of the device body to guide the cutting tool to cut the fiber filaments in the cutting groove.

[0017] In one embodiment, both ends of the device body are provided with connection sites for connecting the winding device.

[0018] The second aspect of the present invention provides a method for preparing a spring coil with fiber hair for embolism, wherein the fiber hair is loaded on the spring coil using the above-mentioned fiber hair loading device, and the method comprises the following steps:

[0019] Step 1: Fix at least one spring coil at a corresponding fixed position on the device body;

[0020] Step 2: Winding the fiber filaments around the device body along a preset trajectory and around a selected winding position;

[0021] Step 3: guiding the cutting tool to cut and separate the fiber filaments wound around the device body along the selected cutting position to form fiber wool, thereby producing at least one spring coil with fiber wool.

[0022] In one embodiment, the method further includes the step of preparing a spring coil before step 1:

[0023] Step 01: Use the molding die to mold the spring body into a set shape;

[0024] Step 02: Fix the hook at the proximal end of the spring body and make a distal ball cap at the distal end of the spring body to form a spring coil.

[0025] A third aspect of the present invention provides a spring coil with fiber hair for embolism, which is made by the above-mentioned preparation method, or the spring coil is loaded with fiber hair by the above-mentioned fiber hair loading device.

[0026] Compared with the prior art, the advantages of the present invention are as follows: in the present invention, a fiber wool loading device is provided with a fixed position for fixing a spring coil, a winding position for winding fiber filaments, and a cutting position for guiding a cutting tool to cut and separate the fiber filaments. Through the regular winding of the fiber filaments, efficient loading of fiber wool for at least one spring coil can be achieved, while ensuring the controllability and stability of parameters such as the loading position, loading spacing, length, and quantity of the fiber wool.

[0027] The fiber hairs loaded on the fiber hair spring coil for embolization of the present invention can play a role in rapid thrombosis, and different clinical use requirements can be met by adjusting parameters such as the loading site, loading spacing, length, and quantity of the fiber hairs. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Hereinafter, the present invention will be described in more detail based on embodiments and with reference to the accompanying drawings.

[0029] Figure 1 It is a schematic diagram of the structure of a spring coil with fiber hair for embolization in one embodiment of the present invention.

[0030] Figures 2A-2D Schematic diagram of the shaped structure of the spring body in the present invention, wherein: Figure 2A Linear spring body, Figure 2B Helical spring body, Figure 2C Diamond-shaped spring body, Figure 2D It is a three-dimensional spring body.

[0031] Figures 3A-3C FIG. 1 is a schematic diagram of the structure of a fiber hair loading device with a circular radial cross section and a fixed position in the present invention, wherein: Figure 3A A three-dimensional diagram of the device. Figure 3BThis is the front view of the device (loaded with spring coils and providing a way to wind the fiber filaments). Figure 3C A side view of the device.

[0032] Figures 4A-4C FIG. 1 is a schematic diagram of the structure of a fiber wool loading device with a circular radial cross section and two fixed positions in the present invention, wherein: Figure 4A A three-dimensional diagram of the device. Figure 4B This is a front view of the device (loaded with spring coils and providing a way to wind the filaments). Figure 4C A side view of the device.

[0033] Figures 5A-5C Schematic diagram of the structure of the fiber wool loading device of the present invention, which has a sheet-shaped radial cross section and two fixed positions, wherein: Figure 5A A three-dimensional diagram of the device. Figure 5B The front view of the device (loaded with spring coils and providing a way to wind the filaments), Figure 5C A side view of the device.

[0034] Figures 6A-6C Schematic diagram of the structure of the fiber wool loading device of the present invention, the radial cross section of which is an equilateral triangle and has three fixed positions, wherein: Fig. 6A A three-dimensional diagram of the device. Figure 6B This is a front view of the device (loaded with spring coils and providing a way to wind the fiber wool). Figure 6C A side view of the device.

[0035] Figures 7A-7C Schematic diagram of the structure of the fiber wool loading device of the present invention, which has a square radial cross section and four fixed positions, wherein: Fig. 7A For the three-dimensional diagram of the device, Figure 7B The front view of the device (loaded with spring coils and providing a fiber wool winding method), Figure 7C A side view of the device.

[0036] Figure 8 Schematic diagram of radial cross-sectional parameters of the fiber wool loading device in the first embodiment of the present invention.

[0037] Fig. 9 Schematic diagram of radial cross-sectional parameters of the fiber wool loading device in the second embodiment of the present invention.

[0038] Fig.10 Schematic diagram of radial cross-sectional parameters of the fiber wool loading device in the third embodiment of the present invention.

[0039] Fig.11 The present invention is a flow chart of a method for preparing a spring coil with fiber hair for embolization.

[0040] Reference numerals:

[0041] 100-spring coil with fiber wool; 110-spring coil; 120-fiber wool;

[0042] 111-spring body; 112-hook; 113-distal ball cap;

[0043] 1111- linear spring body; 1112- helical spring body; 1113- diamond spring body;

[0044] 1114- three-dimensional spring body;

[0045] 1201-single strand fiber hair; 1202-double strand fiber hair; 1203-triple strand fiber hair;

[0046] 200-device body; 210-fixing position; 220-cutting position; 230-connection position;

[0047] 240-winding site; 250-quantity marker;

[0048] 211 -fixing slot; 221 -cutting slot; 231 -connection interface; 241 -site slot.

[0049] In the drawings, the same reference numerals are used for the same components and the drawings are not drawn to scale. DETAILED DESCRIPTION

[0050] The present invention will be further described below in conjunction with the accompanying drawings.

[0051] The first aspect of the present invention provides a fiber wool loading device, comprising a device body 200. The device body 200 is provided with: at least one fixed position 210 and at least one cutting position 220. The fixed position 210 is used to load the spring coil 110, and a plurality of winding positions 240 are provided on the fixed position 210. The winding positions 240 are arranged in sequence and at intervals along the extension direction of the fixed position 210, and the winding positions 240 are used to determine the loading position of the fiber wool 120 on the spring coil 110. The cutting position 220 is used to guide the cutting tool to cut and separate the fiber filaments wound on the device body 200 to form the fiber wool 120.

[0052] In the present invention, the fiber wool loading device has a fixing position 210 for fixing the spring coil 110, a winding position 240 for winding the fiber filaments, and a cutting position for guiding the cutting tool to cut and separate the fiber filaments. Through the regular winding of the fiber filaments, efficient loading of the fiber wool 120 for not less than one spring coil 110 can be achieved, and at the same time, the controllability and stability of parameters such as the loading position, loading spacing, length, and quantity of the fiber wool 120 can be ensured.

[0053] The fiber hairs 120 loaded on the fiber hair spring coil 100 for embolization of the present invention can play a role in rapid thrombosis, and different clinical use requirements can be met by adjusting parameters such as the loading site, loading spacing, length, and quantity of the fiber hairs 120.

[0054] The spring body 111 with the fiber wool spring coil 100 can be made of platinum, platinum-tungsten alloy, platinum-iridium alloy or nickel-titanium alloy. At the same time, the spring body 111 can be wound on a specific mold and shaped into a linear shape, a spiral shape, a diamond shape, a semi-diamond shape or a three-dimensional shape. Figures 2A-2D The linear spring body 1111, the spiral spring body 1112, the diamond-shaped spring body 1113 and the three-dimensional spring body 1114 are shown in the figure.

[0055] Specifically, the wire diameter of the spring body 111 is 0.05 mm-0.20 mm, the outer diameter is 0.2 mm-0.9 mm, and the pitch of the spiral spring body 1112 is 0.2 mm-1.8 mm.

[0056] The fiber hair 120 can be made of materials such as polyethylene terephthalate, polyamide, glycolide-lactide copolymer or polyethylene. Specifically, the fineness of a single strand of fiber hair 120 is 50D-200D (Denier), and the number of monofilaments is 12-48; the loading spacing A of the fiber hair 120 is 2mm-20mm, the length B of the fiber hair 120 is 2mm-20mm, and the number of strands of the fiber hair 120 at each site is 1-3 strands, that is, according to the different number of strands, the fiber hair 120 includes at least three types: single strand fiber hair 1201, double strand fiber hair 1202 and triple strand fiber hair 1203.

[0057] In one embodiment, the device body 200 includes a fixing position 210 and a cutting position 220. The fixing position 210 and the cutting position 220 are respectively arranged on opposite sides of the device body 200. A plurality of winding sites 240 arranged at intervals are respectively arranged on the fixing position 210 and the cutting position 220. Preferably, the winding sites 240 on the fixing position 210 and the winding sites 240 on the cutting position 220 are staggered along the length direction of the device body. In this embodiment, only one spring coil 110 can be loaded with fiber hair 120, and the structure is simple.

[0058] In another embodiment, the device body 200 includes at least two fixing positions 210 and at least two cutting positions 220, and both the fixing positions 210 and the cutting positions 220 extend in the length direction of the device body 200. In addition, the number of the fixing positions 210 and the cutting positions 220 is the same, and the fixing positions 210 and the cutting positions 220 are alternately arranged at intervals along the circumference of the device body 200, so that the fiber hairs 120 can be efficiently loaded on multiple spring coils 110 at the same time.

[0059] Preferably, the fixing positions 210 and the cutting positions 220 are evenly and alternately distributed along the circumference of the device body 200 , so that the fiber hairs 120 with the same parameters can be loaded on a plurality of spring coils 110 at the same time.

[0060] It should be noted that, in the solution where the device body 200 includes a plurality of fixed positions 210 , the fixed positions 210 also function as the cutting positions 220 of the fiber hairs 120 when the spring coils 110 are not loaded.

[0061] In the present invention, the number and spacing of the winding sites 240 on each fixed position 210 can be set according to the specific design parameters of the loading spacing A of the fiber hair 120 on the spring coil 110 to be loaded and the length of the spring coil 110 to be loaded with the fiber hair 120.

[0062] The winding sites 240 may be distributed at equal intervals or at variable intervals along the extension direction of the fixed position 210 .

[0063] Preferably, the winding sites 240 on each fixed position 210 are arranged at equal intervals along the extension direction of the fixed position 210, and the winding sites 240 on different fixed positions 210 are staggered along the length direction of the device body 200 to facilitate winding of the fiber filaments. Further, the staggered spacing of the winding sites 240 on two adjacent fixed positions 210 is the ratio of the site spacing to the number of fixed positions 210, so as to achieve a uniform winding effect. Among them, the site spacing is the spacing between two adjacent winding sites 240 on the same fixed position.

[0064] In the present invention, the material of the fiber wool loading device can be selected from stainless steel, aluminum alloy, titanium alloy or copper alloy and other materials with good dimensional stability and processing performance. Its length can be set according to the length of the spring coil 110 to be loaded with fiber wool 120, and the outer diameter / side length of the device body 200 can be set according to the length requirement of the fiber wool 120 to be loaded.

[0065] In a specific implementation, the fiber wool loading device can be constructed as a column (such as a cylindrical body) with a radial cross-section shape of a circle, a regular triangle, a square or a sheet (oblong). Figure 3A-Figure 7C When the radial cross-section of the fiber loading device is non-circular, the fixing position 210 can be distributed at the edge or corner of the device body 200 with a smaller shape, and the cutting position 220 is set in the middle of the side of the device body 200.

[0066] The fixing position 210 is provided with a fixing groove 211, which extends along the length direction of the device body 200 to load the spring coil 110. The winding position 240 is provided with a position groove 241, which extends along the circumference of the device body 200, and the position groove 241 and the fixing groove 211 are perpendicularly intersected to determine the loading position of the fiber hair 120 on the spring.

[0067] Specifically, the fixing groove 211 is a U-shaped groove, the width of which is 1.0-1.5 times the outer diameter of the spring ring 110 , and the depth of which is 1.0-4.0 times the outer diameter of the spring ring 110 .

[0068] The site spacing and number of the winding sites 240 can be set according to the loading spacing A of the fiber hairs 120 on the spring coil 110 and the length requirement of the spring coil 110. The depth of the site groove 241 is the same as the depth of the fixing groove 211 or slightly less than 1 times the outer diameter of the spring coil 110, and its width is 0.2mm-0.6mm.

[0069] Meanwhile, the cutting position 220 is provided with a cutting groove 221 , which extends along the length direction of the device body 200 to guide the cutting tool to cut the fiber filaments in the cutting groove 221 .

[0070] Specifically, the cutting groove 221 is a V-shaped groove, and the bottom of the cutting groove 221 is provided with a circular chamfer to facilitate effective cutting by the cutting tool. The size of the cutting groove 221 can be set according to the length B of the fiber hair 120, and the width of the cutting groove 221 is 0.3mm-1.0mm, and the depth is 0.3mm-1.0mm.

[0071] In addition, both ends of the device body 200 are provided with connection sites 230 for connecting with the winding device. Specifically, the connection site 230 is a connection interface 231 between the fiber wool loading device and the automatic or manual winding device. For example, the fiber wool loading device can be connected to the winding device by a detachable connection method such as a threaded connection, a snap connection, or a positioning pin connection.

[0072] like Fig.11 As shown in , the second aspect of the present invention provides a method for preparing a spring coil with fiber hair for embolism, wherein the fiber hair 120 is loaded on the spring coil 110 using the above-mentioned fiber hair loading device, and the method comprises the following steps:

[0073] Step 1: Fix at least one spring coil 110 at a corresponding fixing position 210 on the device body 200 .

[0074] Step 2: Wind the fiber filaments on the device body 200 according to a preset trajectory and select a corresponding winding position 240 .

[0075] Step 3: guiding the cutting tool to cut and separate the fiber filaments wound around the device body 200 along the selected cutting position 220 to form fiber hair 120 , thereby completing the operation of loading the fiber hair 120 on at least one spring coil 110 .

[0076] In the present invention, the fiber wool loading device has a fixing position 210 for fixing the spring coil 110, a winding position 240 for winding the fiber filaments, and a cutting position 220 for guiding the cutting tool to cut and separate the fiber filaments. Through the regular winding of the fiber filaments, efficient loading of the fiber wool 120 for not less than one spring coil 110 can be achieved, and at the same time, the controllability and stability of parameters such as the loading position, loading spacing, length, and quantity of the fiber wool 120 can be ensured.

[0077] Among them, by selecting the winding position 240, the loading position, loading spacing, length, quantity and other parameters of the fiber hair 120 on the spring coil 110 can be controlled. Specifically, according to the Pythagorean theorem, the square of the length value of the fiber hair 120 is equal to the sum of the square of the circumferential arc length between the selected winding position 240 and the corresponding cutting position 220 and the square of the step value of the two in the length direction, such as Figure 8-10 as shown in .

[0078] At the same time, by setting the number of windings of the fiber filament at the selected winding site 240, the number of strands of the fiber hair 120 at each loading site on the spring coil 110 can be controlled.

[0079] Before step 1, the method further includes the steps of preparing the spring coil 110:

[0080] Step 01: The spring body 111 is formed into a set shape by a forming mold.

[0081] Step 02: Fix the hook 112 at the proximal end of the spring body 111 , and make a distal ball cap 113 at the distal end of the spring body 111 to form a spring ring 110 .

[0082] Specifically, the above-set shape is linear, spiral, diamond, semi-diamond or solid.

[0083] Specifically, the hook 112 is welded and fixed to the proximal end of the spring body 111. The hook 112 serves as a connecting component between the spring coil 110 and the conveying system, and can meet the pushing and retracting requirements of the spring coil 110 during the conveying process.

[0084] The distal ball cap 113 is arranged at the distal end of the spring body 111, and can be formed by spot welding and melting the spring body 111 itself, or by dispensing and curing with biocompatible glue. By setting the distal ball cap 113, the damage to blood vessels during the use of the product can be reduced.

[0085] It should be noted that the fiber wool 120 is loaded after the spring coil 110 is shaped. If the spring coil 110 is shaped into a non-linear shape (such as a spiral shape, a diamond shape, a semi-diamond shape or a three-dimensional shape), in step 1, the spring coil 110 to be loaded is straightened and fixed on the corresponding fixed position 210 of the fiber wool loading device. After the operation of loading the fiber wool 120 is completed, it is removed from the fiber wool loading device, and the spring coil 110 will return to its shaped shape.

[0086] The third aspect of the present invention further provides a spring coil 100 with fiber hair for embolization, which is made by the above-mentioned preparation method, or the spring coil 110 is loaded with fiber hair 120 by the above-mentioned fiber hair loading device.

[0087] Specifically, Figure 1 As shown in the figure, the embolic spring coil with fiber hair 100 made by the above preparation method comprises a spring body 111, a hook 112, a distal ball cap 113 and fiber hair 120. The hook 112 is fixed to the proximal end of the spring body 111, the distal ball cap 113 is fixed to the distal end of the spring body 111, and the fiber hair 120 is arranged at a set position of the spring body 111.

[0088] Embodiment 1

[0089] A platinum-tungsten alloy spring with a wire diameter of 0.1 mm and an outer diameter of 0.6 mm was selected, wound on a cylindrical mold, treated at 600°C for 30 min, and then air-cooled to form a 12×200 mm spiral spring body 1112 (such as Figure 2B ). The hook 112 is made of platinum-iridium alloy, with an outer diameter of 0.85 mm and a length of 1.5 mm, and is welded to the spiral spring body 1112; the distal ball cap 113 is formed by spot welding and melting the spiral spring body 1112 to form a spring coil 110. A single strand of fiber hair 1201 made of polyethylene terephthalate is loaded on the spring coil 110, the fineness of each fiber is 100D (Denier), the number of single filaments is 36, and each loading site is loaded with 1 strand (100D / 36F×1). The length B of the single strand of fiber hair 1201 obtained after cutting is 9 mm, the loading spacing A is 3 mm, and a total of 30 loading sites are loaded. The product design parameters are shown in Table 1.

[0090] Table 1 Design parameter information of the embolization fiber-hair spring coil 100 in Example 1

[0091]

[0092] The fiber wool loading device is designed according to the parameters of the spring coil 110 and the design parameters of the fiber wool 120 .

[0093] In the first embodiment of the present invention, a fiber wool loading device having a circular radial cross section and two fixed positions 210 is selected (eg Figure 4A-4C ).

[0094] The diameter of the device body 200 is 12.0 mm and the length is 150 mm. The width W1 of each fixed groove 211 is 0.7 mm and the depth D1 is 1.4 mm. Two cutting positions 220 are evenly arranged on both sides of the device body 200, and the depth D2 is 1.0 mm; threaded connection sites 230 connected to automatic or manual winding equipment are arranged at both ends of the device body 200; 35 winding sites 240 are evenly distributed on the two fixed positions 210, and the site spacing is 3 mm. The width of the site groove 241 at each winding site 240 is 0.3 mm and the depth is 1.3 mm, and the winding sites 240 on the two fixed positions 210 are staggered by 1.5 mm in the length direction of the device body 200.

[0095] At the same time, this embodiment also provides a second solution similar to the first solution. The second solution uses a fiber wool loading device with a circular radial cross section and only one fixed position 210 (such as Figure 3A-3C ). The dimensions of the device body 200 of the fiber hair loading device and the parameters of the fixing slot 211 and the position slot 241 are the same as those in the first solution. In the second solution, when the loading spacing of the fiber hair 120 is determined, only one length of fiber hair 120 can be loaded. Specifically, Figure 3C The projection C of the length of the fiber hair 120 on the radial cross section is marked.

[0096] When the fiber wool loading device in the first solution is used to load the fiber wool 120 on the spring coil 110, one of the fixed positions 210 can be selected as the position for cutting the fiber wool 120, so that the designed length of the fiber wool 120 can be increased. Figure 4C As shown, the projection C2 of the length of the fiber hair 120 on the cross section is greater than C1.

[0097] At the same time, winding sites 240 with an odd number of site spacings, such as 1 times, 3 times, 5 times, etc., are selected to equally wind the fiber filaments, so that while ensuring uniform winding, different loading spacings and lengths of the fiber hairs 120 can be obtained. In addition, by sequentially selecting gradually increasing loading spacings (for example, sequentially selecting winding sites 240 with an odd number of site spacings, such as 1 times, 3 times, 5 times, etc.) to wind the fiber filaments on the same spring coil 110, variable spacing loading of the fiber hairs 120 on the same spring coil 110 can also be achieved. Specifically, the parameters of the fiber hairs 120 that can be obtained by different schemes in this embodiment are shown in Table 2. The radial cross-sectional parameters of the device body 200 are shown in Table 2. Figure 8 as shown in .

[0098] Table 2

[0099]

[0100] The following specifically describes the parameter detection and simulated performance test of the prepared embolic fiber-hair spring coil 100.

[0101] The spring coil 110 is loaded at the fixed position 210, and 30 sites are evenly wound with a 1-time site spacing (3 mm). A blade is used to cut at the cutting position 220, so that two embolization fiber-bearing spring coils 100 can be prepared at the same time.

[0102] (1) Parameter detection: The outer diameter of the spring coil 110 is 12.1 mm-12.5 mm; the length B of the fiber hair 120 is 9.0 mm-9.3 mm; the loading spacing A of the fiber hair 120 is 2.9 mm-3.3 mm, which can meet the design and tolerance requirements.

[0103] (2) Simulated performance test: A simulated catheter with an inner diameter of 1.0 mm and a length of 130 cm and a standard Luer connector was connected to a rotary hemostatic valve, and a simulated delivery test was performed in the presence of perfusion fluid. After the fiber wool spring coil 100 was introduced into the simulated catheter, the fiber wool spring coil 100 was conveyed in one direction until the hook 112 was about 1 cm away from the end of the simulated catheter, and then the fiber wool spring coil 100 was slowly pulled back by the delivery system until the hook 112 was about 1 cm away from the simulated catheter seat, thereby completing one simulated delivery and withdrawal cycle. The delivery and withdrawal process was repeated until five simulated delivery and withdrawal cycles were completed. After the cycle was completed, the spring coil 110, hook 112, and distal ball cap 113 were observed to be normal without obvious deformation. It was observed that there was no detached fiber wool 120 inside the simulated catheter. The perfusion fluid recovered during the filtration test did not contain detached fiber wool 120, which met the loading performance requirements of the fiber wool 120.

[0104] Embodiment 2

[0105] A platinum-tungsten alloy spring with a wire diameter of 0.08 mm and an outer diameter of 0.3 mm was selected, wound on a diamond-shaped mold, treated at 580°C for 40 min, and then air-cooled to form a diamond-shaped spring body 1113 (such as 2mm / 6mm×80mm) with a small end diameter of 2mm, a large end diameter of 6mm, a pitch of 0.5mm, a total of 8 turns, and a total length of 80mm (2mm / 6mm×80mm). Figure 2C). The hook 112 is made of platinum-iridium alloy, with an outer diameter of 0.40 mm and a length of 1.3 mm. It is welded on the diamond-shaped spring body 1113; the distal ball cap 113 is formed by spot welding and melting the diamond-shaped spring body 1113 to form a spring coil 110. The double-strand fiber hair 1202 made of polyhexamethylene adipamide (nylon 66) is loaded on the spring coil 110. The fineness of each fiber is 50D (Denier), the number of monofilaments is 24, and 2 strands (50D / 24F×2) are loaded at each loading site. The length B of the double-strand fiber hair 1202 obtained after cutting is 12 mm, the loading spacing A is 4 mm, and there are 15 loading sites in total. The product design parameters are shown in Table 3.

[0106] Table 3 Design parameter information of the embolization fiber-hair spring coil 100 in Example 2

[0107]

[0108] According to the parameters of the spring coil 110 and the design parameters of the fiber wool 120, the fiber wool loading device is designed.

[0109] In this embodiment, a fiber wool loading device having a basic sheet shape and two fixed positions 210 is selected (eg Figure 5A-5C ).

[0110] Among them, the outer dimensions of the device body 200 are 12mm wide, 2mm thick, and 150mm long. The width W1 of the fixed groove 211 is 0.4mm and the depth D1 is 1.0mm; two cutting positions 220 are evenly arranged, and the depth D2 is 1.0mm. Positioning pin-type connection sites 230 connected to automatic or manual winding equipment are arranged at both ends of the device body 200. 25 winding sites 240 are evenly arranged on the two fixed positions 210, respectively, with a site spacing of 4mm. The width of the site groove 241 at each winding site 240 is 0.3mm, the depth is 0.9mm, and the winding sites 240 on the two fixed positions 210 are staggered by 2mm in the length direction of the device body 200. In addition, a number mark 250 of the winding site 240 is arranged on one side of the device body 200.

[0111] In this embodiment, cutting is performed at two cutting positions 220 to reduce the design length of the fiber hair 120. Figure 5C The projection C1 of the length of the fiber hair 120 on the cross section is shown to be smaller than C2.

[0112] At the same time, winding sites 240 with an odd number of site spacings, such as 1 times, 3 times, 5 times, etc., are selected to equally wind the fiber filaments, so that while ensuring uniform winding, different loading spacings and lengths of the fiber hairs 120 can be obtained. In addition, by sequentially selecting gradually increasing loading spacings on the same spring coil 110 (for example, sequentially selecting winding sites 240 with a spacing of 1 times, 3 times, 5 times, etc. from the starting site) to wind the fiber filaments, variable spacing loading of the fiber hairs 120 on the same spring coil 110 can also be achieved. Specifically, the parameters of the fiber hairs 120 that can be obtained by different schemes in this embodiment are shown in Table 4. The radial cross-sectional parameters of the device body 200 are shown in Table 4. Fig. 9 as shown in .

[0113] Table 4

[0114]

[0115] The following specifically describes the parameter detection and simulated performance test of the prepared embolic fiber-hair spring coil 100.

[0116] One of the fixed positions 210 is selected to load the spring coil 110, and the other fixed position 210 is not loaded with the spring coil 110. 15 winding positions 240 are selected to be evenly wound with a 1-times site spacing (4 mm), and a blade is used to cut at the unloaded fixed position 210 to obtain a fiber wool spring coil 100 for embolization.

[0117] (1) Parameter detection: The diameter of the small end of the spring coil 110 is 2.0 mm-2.2 mm, the diameter of the large end is 6.1 mm-6.2 mm, the length B of the fiber hair 120 is 12.0 mm-12.2 mm, and the loading spacing A of the fiber hair 120 is 4.1 mm-4.3 mm, which can meet the design and tolerance requirements.

[0118] (2) Simulated performance test: A simulated catheter with an inner diameter of 0.53 mm and a length of 130 cm and a standard Luer connector was connected to a rotary hemostatic valve, and a simulated delivery test was performed in the presence of perfusion fluid. After the fiber-wool spring coil 100 was introduced into the simulated catheter, the fiber-wool spring coil 100 was conveyed in one direction until the hook 112 was about 1 cm away from the end of the simulated catheter, and then the fiber-wool spring coil 100 was slowly pulled back by the conveying system until the hook 112 was about 1 cm away from the simulated catheter seat, completing one simulated delivery and withdrawal cycle. Repeat the delivery and withdrawal process until five simulated delivery and withdrawal cycles were completed. After the cycle was completed, the spring coil 110, hook 112, and distal ball cap 113 were observed to be normal without obvious deformation, and no fiber wool 120 was observed to be shed inside the simulated catheter. The perfusion fluid recovered during the filtration test did not have any shed fiber wool 120, which met the loading performance requirements of the fiber wool 120.

[0119] Embodiment 3

[0120] A nickel-titanium shape memory alloy spring with a wire diameter of 0.13 mm and an outer diameter of 0.53 mm was selected, wound on a regular cross hexahedral cylindrical mold, treated at 520° C. for 10 min, and then water-cooled to form a three-dimensional spring body 1114 (such as Figure 2D ). The hook 112 is made of platinum-iridium alloy, with an outer diameter of 0.85mm and a length of 1.5mm. It is welded to the three-dimensional spring body 1114; the distal ball cap 113 is made of glue (1-CN006 from Dymax) and cured by ultraviolet light. Three strands of fiber hair 1203 made of polyhexamethylene adipamide (nylon 66) are loaded on the spring coil 110. The fineness of each fiber is 50D (Denier), the number of monofilaments is 24, and 3 strands are loaded at each loading site (50D / 24F×3). The length B of the three strands of fiber hair 1203 obtained after cutting is 18mm, the loading spacing A is 6mm, and a total of 15 loading sites are loaded. The product design parameters are shown in Table 5.

[0121] Table 5 Design parameter information of the embolization fiber-hair spring coil 100 in Example 3

[0122]

[0123]

[0124] According to the parameters of the spring coil 110 and the design parameters of the fiber wool 120, the fiber wool loading device is designed.

[0125] This embodiment uses a fiber wool loading device 500 (such as a regular triangle in radial cross section and having three fixed positions 210) Figure 6A-6C ).

[0126] The radial cross section of the device body 200 has a side length of 14 mm and a length of 150 mm. The width W1 of each fixed groove 211 is 0.6 mm and the depth D1 is 1.0 mm. Three fiber hair 120 cutting positions 220 are evenly arranged on the three sides of the device body 200, and the depth D2 is 1.0 mm. The two ends of the device body 200 are arranged with snap-on connection sites 230 connected to automatic or manual winding equipment. Multiple winding sites 240 are evenly distributed on each fixed position 210, and the site spacing is 6 mm. The width of the site groove 241 at each winding site 240 is 0.3 mm and the width is 0.9 mm. The winding sites 240 on the three fixed positions 210 are staggered by 2 mm from each other in the length direction of the device body 200.

[0127] In this embodiment, the fiber hair 120 is cut at three cutting positions 220, so that the designed length of the fiber hair 120 can be reduced. Figure 6C The projection C1 of the length of the fiber hair 120 on the cross section is shown to be smaller than C2.

[0128] At the same time, by selecting winding sites 240 with an odd number of site spacing of 1 times, 3 times, etc., respectively, to equally wind the fiber filaments, while ensuring uniform winding, different loading spacings and lengths of the fiber hair 120 can be obtained. In addition, by selecting gradually increasing loading spacings (for example, selecting winding sites 240 with spacings of 1 times, 3 times, etc. from the starting site) to wind the fiber filaments on the same spring coil 110, variable spacing loading of the fiber hair 120 on the same spring coil 110 can also be achieved. Specifically, the parameters of the fiber hair 120 that can be obtained by different schemes in this embodiment are shown in Table 6. The radial cross-sectional parameters of the device body 200 are shown in Table 6. Fig.10 as shown in .

[0129] Table 6

[0130]

[0131] The following specifically describes the parameter detection and simulated performance test of the prepared embolic fiber-hair spring coil 100.

[0132] Load the spring coil 110 at any one of the fixed positions 210, and do not load the other two fixed positions 210. Select 1 time the site spacing (6 mm) to evenly wind 15 winding sites 240. Use a blade to cut at the cutting position 220 on the opposite side of the fixed position 210 where the spring coil 110 is loaded, and an embolization spring coil 100 with fiber wool can be obtained.

[0133] (1) Parameter detection: The diameter of the spring coil 110 is 6.3 mm-6.7 mm, the length B of the fiber hair 120 is 18.2 mm-18.5 mm, and the loading spacing A is 6.1 mm-6.4 mm, which can meet the design and tolerance requirements.

[0134] (2) Simulated performance test: A simulated catheter with an inner diameter of 1.0 mm and a length of 130 cm and a standard Luer connector was connected to a rotary hemostatic valve, and a simulated delivery test was performed in the presence of a perfusion fluid. After the prepared fiber wool spring coil 100 was introduced into the simulated catheter, the fiber wool spring coil 100 was unidirectionally conveyed until the hook 112 was about 1 cm away from the end of the simulated catheter, and then the fiber wool spring coil 100 was slowly pulled back by the conveying system until the hook 112 was about 1 cm away from the simulated catheter seat, completing one simulated delivery and withdrawal cycle, and repeating the delivery and withdrawal process until five simulated delivery and withdrawal cycles were completed. After the cycle was completed, the spring coil 110, hook 112, and distal ball cap 113 were observed to be normal in shape without obvious deformation, and no fiber wool 120 was observed to be shed inside the simulated catheter. The perfusion fluid recovered during the filtration test did not have any shed fiber wool 120, which met the fiber wool loading performance requirements.

[0135] In the present invention, the fiber wool loading device with a circular radial cross section and one fixed position 210 is used as a basis, and the fiber wool loading device with a regular triangle radial cross section and three fixed positions 210 is used as an extension. There is also a fiber wool loading device with a square cross section and four fixed positions 210 (such as Figures 7A-7C The fiber wool loading device of the present invention can realize efficient, stable and controllable loading solutions of fiber wool 120 of various specifications under specific design parameters.

[0136] Although the present invention has been described with reference to preferred embodiments, various modifications may be made thereto and parts thereof may be replaced by equivalents without departing from the scope of the present invention. In particular, the various technical features mentioned in the various embodiments may be combined in any manner as long as there are no structural conflicts. The present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A fiber wool loading device, characterized in that: It comprises a device body (200), The device body (200) is provided with: A fixed position (210) for loading the spring coil (110), wherein a plurality of winding sites (240) are arranged on the fixed position (210), wherein the winding sites (240) are arranged in sequence and spaced apart along the extension direction of the fixed position (210), and wherein the winding sites (240) are used to determine the loading position of the fiber hair (120) on the spring coil (110); and A cutting position (220) for guiding a cutting tool to cut and separate fiber filaments wound around the device body (200) to form fiber hairs (120); The device body (200) comprises at least two fixed positions (210) and at least two cutting positions (220), the fixed positions (210) and the cutting positions (220) both extending along the length direction of the device body (200), and the number of the fixed positions (210) and the number of the cutting positions (220) are the same, and the fixed positions (210) and the cutting positions (220) are alternately arranged at intervals along the circumference of the device body (200); The winding sites (240) of the fixed positions (210) are all provided with site grooves (241), and the site grooves (241) are all extended along the circumference of the device body (200). When the fixed positions (210) are not loaded with the spring coil (110), they also have the function of the cutting positions (220).

2. The fiber wool loading device according to claim 1, characterized in that: The winding sites (240) on each of the fixed positions (210) are arranged at equal intervals along the extension direction of the fixed position (210). Furthermore, the winding locations (240) at different fixed positions (210) are staggered with respect to each other in the length direction of the device body (200).

3. The fiber wool loading device according to claim 2, characterized in that: The offset spacing of the winding sites (240) on two adjacent fixed positions (210) is the ratio of the site spacing to the number of fixed positions (210).

4. The fiber wool loading device according to any one of claims 1 to 3, characterized in that: The fixing position (210) is provided with a fixing groove (211), and the fixing groove (211) extends along the length direction of the device body (200) to load the spring coil (110).

5. The fiber wool loading device according to claim 4, characterized in that: The location groove (241) and the fixing groove (211) intersect each other perpendicularly to determine the loading position of the fiber hair (120) on the spring coil (110).

6. The fiber wool loading device according to any one of claims 1 to 3, characterized in that: The cutting position (220) is provided with a cutting groove (221), and the cutting groove (221) extends along the length direction of the device body (200) to guide the cutting tool to cut the fiber filaments in the cutting groove (221).

7. The fiber wool loading device according to any one of claims 1 to 3, characterized in that: Both ends of the device body (200) are provided with connection sites (230) for connecting winding equipment.

8. A method for preparing a fiber-hair spring coil for embolism, characterized in that: Using the fiber wool loading device according to any one of claims 1 to 7 to load fiber wool (120) on a spring coil (110) comprises the following steps: Step 1: fixing at least one spring coil (110) at a corresponding fixing position (210) on the device body (200); Step 2: Winding the fiber filaments around the device body (200) along a preset trajectory and around a selected winding position (240); Step 3: guiding the cutting tool to cut and separate the fiber filaments wound around the device body (200) along the selected cutting position (220) to form fiber hair (120), thereby producing at least one spring coil with fiber hair (100).

9. The preparation method according to claim 8, characterized in that: Before step 1, the method further includes the steps of preparing the spring coil (110): Step 01: The spring body (111) is formed into a set shape by a forming die; Step 02: Fix the hook (112) at the proximal end of the spring body (111), and make a distal ball cap (113) at the distal end of the spring body (111) to form a spring ring (110).

10. A spring coil with fiber hair for embolism, characterized in that: It is manufactured by the preparation method described in any one of claims 8 to 9, or it is loaded with fiber wool (120) on the spring coil (110) by the fiber wool loading device described in any one of claims 1 to 7.

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