Microfiber production by filament winding

Abstract

A method for manufacturing a microfiber implant. The method includes a winding platform and The method uses an apparatus consisting of a feeder head, which is connected to a winding plug. Advance the microfilament towards the take-up platform and wrap it around the The feeder head is then rotated to the position where the microfilament is being wound. The feeder head moves laterally relative to the winding platform. Multiple sweeps can be performed to build up layers of coating, resulting in microfabrication. A fiber patch is obtained, which is then further processed (e.g., by applying a collagen coating). This winding technology creates a microfiber implant. Microfiber implants and devices for winding are also disclosed.

Description

[Technical Field]

[0001] The present invention relates to a microfiber surgical implant for soft tissue repair, such as repair of a rotator cuff tear. This concerns the manufacture of [Background technology]

[0002] Currently, micro-fabrication using additive manufacturing (e.g., 3D printing) Fabrication of tissue-engineered surgical implants using fibers is being investigated. In orthopedic medicine in particular, research into microfiber implants containing collagen is underway. It has advanced enough that it can replace the aligned collagen fibers of natural ligaments and tendons. These collagen fibers provide a foundation for ligament and tendon healing. Implants can be manufactured using electrospinning, wet extrusion, dry spinning, and melt fiber fabrication. FFF 3D printing, traditional biotextile approaches (braiding, knitting, There are many techniques, such as weaving. However, existing technologies have various fatal flaws. High variability, limited porosity leading to poor cell infiltration in vivo, harmful processing solvents FFF printing has problems with scaling and manufacturing complexity, such as using Although it has been explored to create analogues of girdle and tendon, this technique is essentially a simple fused structure. It is limited and cannot mimic the natural structure or strength of the tissue. The technology is complex and expensive for mass production. Alternative technologies for making them are needed. Summary of the Invention

[0003] The present invention relates to a microfiber inkjet printer that is manufactured by winding microfilaments using a certain device. This microfiber implant is designed to enhance the function of musculoskeletal tissues (e.g., various types of fibrous connective tissue (e.g., tendons, fascia, ligaments, muscles, dermis) of the Examples of fibrous connective tissue that can be treated include: Rotator cuff tendons, patellar tendon, Achilles tendon, pelvic or abdominal fascia, anterior cruciate ligament, skin, dura mater, etc. Specific uses for microfiber implants include: One such scenario is rotator cuff repair. Other clinical scenarios in which this implant may be used include: The following explains this. In this specification, microfiber patches and microfiber implants are used. In other words, different terms are used to distinguish between different stages of a product. The "bar patch" is an intermediate product made by winding microfilament on a device. After production on the equipment is completed, the microfiber patch becomes the final product. The term "microfiber implant" is sometimes used to refer to a The term "microfiber patch" refers to the final product after necessary post-treatment. An example of this principle is described below. Apparatus: An apparatus for producing microfiber patches. The fiber patch has one or more winding stations for winding one or more microfilaments. Microfilaments: Microfilaments are made of polymers. Any suitable polymer may be used, including synthetic polymers. Examples of suitable polymers include: The following materials are available: polydioxanone (PDO), poly(lactic-co-glycolic acid) (PLGA), poly(L-lactide) Polyether ether ketone (PLLA), polyether ether ketone (PEEK), polycaprolactone (PCL) , ultra-high molecular weight polyethylene (UHMWPE), collagen, carbon fiber, or nanocellulose The microfilaments may be made of a mixture of polymers in any suitable ratio. Microfilaments are very thin (micron-sized diameters). The diameter of the microfilaments may range from 5 to 125 μm. Single filament (monofilament) or multiple filaments (multifilament) or yarn). Winding platform: Microwave is placed on the platform while it rotates. Any structure that can wrap the filaments can be used. Examples of this include ovals, cylinders, The winding platform may be a regular or irregular shape. Depending on factors such as the size of the microfiber patch, any suitable shape may be used. For example, the diameter (or maximum cross-sectional width) of the winding table may be The distance may be in the range of 0.1 to 100 cm. The winding table is coated with a non-stick coating (e.g., Teflon, polytetrafluoroethylene / P TFE) or anodized and wrapped around a microfiber patch to facilitate removal It may also be tapered (narrowed) at one or both ends. ) to facilitate removal of the microfiber patch. For example, the diameter of the microfiber patch can be reduced to facilitate its removal. It can be made smaller. Horizontal loom frame: In one embodiment, the winding platform is mounted on the frame of the loom. The device consists of a loom frame and a microfilament It consists of two or more crossbars (i.e., winding platforms) on which the The crossbars may be of any suitable construction depending on the desired shape of the microfiber implant, etc. For example, the crossbars should be substantially parallel to each other. It may be of any suitable cross-sectional shape, such as cylindrical, oval, square, flat, or polygonal. This crossbar can be used in any suitable position depending on factors such as the size of the microfiber patch. For example, the diameter of each crossbar (or the longest cross-sectional width) ) can be in the range of 0.1 to 100 cm. Furthermore, the size of the desired microfiber patch The length of each crossbar can be any suitable length depending on factors such as the length of the crossbar. For example, the length of each crossbar can be 2.0 to 90 cm. The axis of rotation of the loom frame is substantially parallel to the crossbar. Feeder head: This device feeds the microfilament onto the winding platform. The microfilaments are fed through one or more feeder heads. The microfilaments are fed into the feeder head and then sent out from the feeder head. , is fed from the feeder head and rotates forward toward the winding platform The microfilament is fed to the feeder head and removed from the feeder head. The excretion of chromatofilaments can be achieved by either passive or active means. In a dynamic feeding mechanism, the microfilaments are fed as the winding platform rotates. This is done by rotating the winding platform (i.e., the winding platform is The winding of the microfilament by this mechanism is described below. We will explain further. When winding, the feeder head is positioned relative to the winding platform. The feeder head moves horizontally (translation). The translation of the feeder head is determined by the direction, continuity (continuous) or intermittent), changes in speed, pauses, etc. depending on the specific design of the microfiber patch. The feeder head moves the microfiber towards the winding platform. It may have an adjustable angle to change the directional angle for passing the filaments. The adjustable angle can be dynamic during the manufacturing process. The adjustable angle can be single-axis or multi-axis. The feeder head may be a multi-axis feeder (two or more axes). Multi-axis motion (two or three axes) relative to the winding platform to guide it towards the configuration For example, the feeder head may be configured to and laterally towards / from the winding platform You can move away. The feeder head may also be provided with a coating through which the microfilaments pass. In other equipment designs, the coating can be located outside the feeder head. For example, after the microfilaments leave the feeder head, an external coating bath The coating is for coating the microfilaments. This coating contains a lubricant for the winding, or a microfiber coating. It can serve various beneficial purposes, such as improving the treatment effect of bar implants. Examples of suitable coating materials include biological materials (collagen or extracellular matrix Other components of the drug, cells, growth factors, etc.), pharmaceutical agents such as small molecule drugs, calcium phosphosilicate Surface-reactive glass ceramics such as sodium bioactive glass (e.g., "Bioglass"). biomaterials, surfactants such as poloxamers, organic solvents and aqueous solutions (such as buffer solutions and plain water) or materials that promote bonding or joining of the microfilaments (such as resins) etc.) are included. Heating. The device is designed to heat the winding table. The purpose of this heating is explained below. The heat can be generated in any suitable manner, for example by conducting the winding table. The winding table is made of a conductive metal and an electric current is passed through it. The heat generated by the induced electrical resistance Alternatively, a heating element can be placed inside the winding table. In addition, the equipment may be equipped with laser or infrared heaters, The switch may have a separate heat source for applying heat to the switch. Other features: The device is equipped with one or more filament holders and a feeder head. The filament holder can hold a supply of microfilaments that are fed into the nozzle. Examples of rollers include spools, revolving reels, circular trays, spindles, and rollers. If the feeder head has a coating (as described above), the device The filter may further comprise a reservoir for holding and supplying the coating material. connected to the feeder head (e.g., the connecting tube that goes from the reservoir to the coating) Bu). Manufacturing Method: The present invention also provides a method for manufacturing a microfiber implant. This method can use a device such as that described above. The microfiber implant precursor or intermediate is then wound on the fabrication equipment. The microfilament is wound multiple times around the winding table of the device. During the winding process, the winding table rotates around the axis of rotation. The microfilaments fed from the feeder head are then fed to the The microfeed from the feeder head moves towards the winding platform. The output speed of the laminae ranges from 25 to 800 cm / min. The microfilaments are captured on the platform. In conjunction with the translational motion, the material is fed to the feeder head and continuously discharged from the feeder head. The lateral (translational) movement speed of the feeder head can be in the range of 20 to 500 mm / min. The above steps are performed to ensure that the microfilament is wound around the winding platform. This is executed repeatedly to ensure In the case of a loom frame, a single wrap on the crossbar means that the microfilament is wound on the first crossbar. It goes around the first crossbar, then the second crossbar (and then the second crossbar), and then the first crossbar. This loop is one take-up of the microfilament. Multiple such wraps are made to create the microfiber patch. Each winding can be placed adjacent to the previous winding. The windings do not necessarily have to be in contact with each other. Providing a small gap allows for the integration (mechanism) of the microfiber implant with the surrounding tissue. It is useful for forming holes or channels that facilitate mechanical or biological interactions. Filaments (2 or more, e.g., up to 10) are simultaneously placed on the winding platform. It may also be deposited on The microfilament winding can be swept multiple times (two or more times). This allows sets of windings to be stacked on top of each other. Each sweep of the winding on the foam creates a single microfiber patch In this way, the microfiber patches can be stacked on top of each other to create a matte layer. It can be made up of multiple mat layers. The alternating sweeps are in one direction (e.g., reset to the initial position) and forward only), bidirectional (for example, round trip in both forward and reverse directions), or a combination of these The direction may be any direction, such as facing. For example, the first sweep creates a first mat layer, and the second sweep creates a second mat layer on top of the first mat layer. A second mat layer is created, and a third sweep creates a third mat layer on top of the second mat layer, and so on. With multiple sweeps, the process creates a microfiber surface with multiple mat layers. The number of sweeps of the entire winding platform can be set to 3-50. Each sweep creates a mat layer. This can range from 3 to 50 mat layers. Each sweep across the winding table creates a microfiber patch having a Winding platform with 3 to 70 microfilaments per centimeter across You can create a form. The winding process is carried out with varying degrees of continuity, including continuous and intermittent movements and interruptions. The microfiber patch is a single, continuous microfiber patch from start to finish. The microfilaments may be made of filaments. Microfiber patches are made of multiple (two or more) separate strips of microfilament. For example, the microfilament may be cut at the end of each sweep, Each mat layer is made from separate strands of microfilaments. In embodiments where the feeder head comprises a coating tank, the microfilaments The microfiber patch is available in several types. For example, multiple microfilaments of different sizes or material compositions may be used. It is possible to combine black filaments, e.g., one type of microfilament to make one mat layer, then the next using a different type of microfilament A matte layer of Heating or fusing the fibers. The manufacturing method may further include heating the winding table or a portion thereof. In the case of a loom frame, one or more crossbars of the loom frame are heated. Heat may be applied during winding of the microfilament or after winding is complete. The part of the winding that is in contact with the heated part of the winding base (e.g., crossbar) This melts or softens the microfilaments so that they can be thermally bonded. One or more fused regions are formed on the bar patch. These fused regions are microfiber It may act as a boundary or area of ​​stability for the bar implant. If the underlayer (e.g. collagen coating) is microfilament or microfiber In the situation where it is applied to a bar patch, heating causes the binder to fuse with it (e.g., (e.g., melting, hardening, transition from liquid to gel / solid). The microfiber implant is reinforced. There are many variations in this heating process. For example, Another example is to heat the individual crossbars to different temperatures. Alternatively, in addition to heating the winding table, the microfiber The fiber patch is then exposed to another heat source (such as a laser or infrared heater) and the fused area is then It can also be formed. In addition to heating the winding table, ultra-thin films are used to form fused areas on the microfiber patch. Sonic welding can be used to create a structural pattern on the microfiber patch. Welded continuously or in selected areas. Welded to microfiber patch Other techniques for creating regions include compression, hot plasma, cold plasma, and chemical solvents. Yet another option is to use a microfilament winding machine after the winding is complete. One method involves coating a microfiber patch with an adhesive layer of binder material. The binder material may be a solvating polymer (PCL, PLA, PDO, etc.) or a suitable Other biocompatible chemicals in solvents may also be used. applied to selected portions of the fiber patch, where they can form a fused area. . Post-winding processing and other: The microfiber patches made on the machine are or further processed outside the device, e.g., a microfiber patch (e.g., fused area) These openings may include forming openings (e.g., holes or channels) in the They are used to firmly grasp instruments during surgical deliveries and to hold sutures. The opening can be made by any method such as drilling, laser cutting, blade cutting, perforation, burning, or melting. Another example of a different processing technique is a microfiber patch. Relatively large microfiber patches are made of smaller individual sized microfibers - Cutting into implants (i.e. batch manufacturing). The microfiber patches produced on the device may be removed from the reel by any suitable method. For example, by sliding the winding table laterally towards one end. It can also be removed from the winding stand. This microfiber patch is the final product. or a medium for further processing to make a microfiber implant. If the microfiber patch is an intermediate product, the manufacturing process may further include: Drilling, final detailing, coating application, laser spot welding for reinforcement, One or more steps, such as chemical treatment to crosslink the microfilaments, application of adhesive, etc. For example, microfiber patches contain binders that help bind the fibers together. Examples of binders include polyvinylpyrrolidone (PVP), hydroxypropyl polymers such as pill cellulose, microcrystalline cellulose, and polyethylene glycol (PEG); These include biological materials such as collagen and platelet-rich plasma. The coating is freeze-dried. The final product of the manufacturing process is a microfiber implant. Microfine particles, including variations in shape, size, composition, and surface smoothness / roughness Many variations in bar implant design are possible. The process can also create microfiber implants with complex three-dimensional shapes. . Microfiber implants: This is how microfiber implants are made. Thus, another aspect of the present invention is that In such cases, the microfiber implant has the following distinguishing features: The distinguishing features can be structural or functional. Microfiber implants can have one or more These openings allow the passage of instruments during operative delivery. It can be used to firmly hold the arthroscope or sutures. Microfiber implants consist of multiple turns of one or more microfilaments. The dimensions of the microfiber implant vary depending on the specific clinical application. The thickness ranges from 0.1 to 25 mm, the length ranges from 1.0 to 40 cm, and the width ranges from 0.1 to 30 cm. The microfiber implant has a surface area ranging from 2.0 to 250 cm2. The fiber implant may have one or more fused regions as described above. The Kurofiber implant has a tensile strength of 100 to 3,500 Newtons (N), suitable for soft tissue repair. It may have strength. The fiber density of the microfiber implant varies depending on the application. "degrees" refers to the angle perpendicular to the winding direction (i.e., crosscut) of the microfilament. Number of microfilament lines (at any depth) in a 1.0 cm span, measured crosswise For example, the fiber density of microfiber implants is 20-7 per centimeter span. The implants will be in the range of 50 microfilaments. Consists of multiple mat layers to increase fiber density or implant thickness For example, a microfiber implant may comprise 3 to 90 mat layers. As explained above, microfiber implants are coated (lyophilized colloidal In this case, collagen may be derived from human, bovine, porcine, aquatic, or Any suitable collagen may be used, including collagen from other species. or synthetically (e.g., chemically synthesized) or recombinantly (e.g., in cell culture). Collagen may be full length or partial length, and may be procollagen, telocollagen, or the like. collagen, atelocollagen, gelatin, etc. can be used. It may be collagen or multiple forms of collagen, or mixed with other extracellular matrix components. In coated implants, the coating may be applied to adjacent Cross-links can be formed between adjacent microfilament strands. The fiber implant can be of any suitable shape depending on the clinical environment in which it is used. The implants are flat, rectangular, square, triangular, diamond, trapezoidal, etc. For example, the implant may be a microfilament. The implant is made by twinning (microfilament winding). It may also be tubular in shape, consisting of an outer shell (of a tubing) and a hollow interior cavity. [Brief explanation of the drawings]

[0004] [Figure 1] 1 is an example of an apparatus according to the present invention. [Figure 2] A close-up and partial internal view of the feeder head. [Figure 3] Figures 3A-3D show an example of the operation of the device: Figure 3A shows the initial winding of the microfilament. [Figure 4] Figures 3A-3D show an example of the device in operation, and Figure 3B shows the result after rotating the loom frame by 180°. [Figure 5] Figures 3A-3D show an example of the device in operation, and Figure 3C shows the result after the loom frame has been rotated another 360°. [Figure 6] Figures 3A-3D show an example of the device in operation, with Figure 3D showing the result after several revolutions of the loom frame. [Figure 7] Figures 4A-4E show examples of the processing of microfiber patches. Figure 4A shows the result after four round trips have been completed. [Figure 8] Figures 4A-4E are examples of processing of a microfiber patch. Figure 4B shows the result after heating the top and bottom edges of the microfiber patch. [Figure 9] Figures 4A to 4E show examples of processing of microfiber patches, and Figure 4C shows the microfiber patch removed from the metal bar of the loom frame. [Figure 10] Figures 4A-4E show examples of fabricated microfiber patches, and Figure 4D shows the resulting microfiber implant. [Figure 11] 4A to 4E are examples of fabricated microfiber patches, and Fig. 4E is a cross-sectional side view of a microfiber implant. [Figure 12] 10 is another example of a loom frame that can be used in the present invention. [Figure 13] It is a plate-shaped mandrel that serves as the winding table. [Figure 14]This is the mandrel that serves as the winding table. [Figure 15] An example of use is a crossbar for heating. [Figure 16] This is an example of infrared heating. [Figure 17] 1 is an example of a tube-shaped implant. [Figure 18] Figure 11B shows an example of a block-shaped implant for rotator cuff tendon repair, with Figure 11A being a perspective view and Figure 11B being a top view. [Figure 19] Figure 11B shows an example of a block-shaped implant for rotator cuff tendon repair, with Figure 11A being a perspective view and Figure 11B being a top view. DETAILED DESCRIPTION OF THE INVENTION

[0005] The figures presented herein are intended to aid in the understanding of the invention and to illustrate examples of specific embodiments of the invention. They are not necessarily drawn to scale or to actual proportions. The size of the component elements is adjusted to fit the page size. FIG. 1 is a perspective front view of an example of an apparatus of the present invention. The loom frame 12 is equipped with two cylindrical metal rods 14. The rod 14 is wrapped around a microfiber implant and attached to a side plate 16. The right side plate 16 is attached to the rod 14 and is installed parallel to it. It is removable, allowing for easy removal of the microfiber patch wrapped around it. The metal rod 14 is made of PTFE (polytetrafluoroethylene) to prevent the microfiber patch from adhering. Each side plate 16 is attached to a rotating shaft 18. The left-hand rotating shaft 18 is rotated by a motor and rotates the loom frame 12 around the axis A. The right-hand pivot 18 rotates freely on the fixture. Above the frame 12 of the loom, a stage for feeding microfilaments is arranged. This stage has a feeder head 20 attached to a horizontal beam (not shown). The feeder head 20 is movable laterally relative to the loom frame 12. The moving speed and angle of the feeder head 20 (described later) are determined based on the winding pitch, spacing, and can be varied to tailor the layered mesh or patterning. The magazine includes a spool 22 for storing the microfilament. of microfilament unwound from spool 22 and drawn into feeder head 20 It is a short strand 24. FIG. 2 is an enlarged view of the inside of the feeder head 20. Inside the feeder head 20, The coating solution is an aqueous solvent. The microfilaments 24 pass through the feeder head 20. When the fabric is dipped in this coating 26, it is coated with collagen before proceeding onto the loom frame 12. The feeder head 20 is adjusted to face the frame 12 of the loom. The angle of the direction in which the microfilament 24 is fed (see dashed arrow C) can be changed. 3A-3D are an example of how the device 10 operates. In FIG. 3A, a microfilament strand is The ends of 24 are glued (e.g., with bioadhesive or (The microfilament strand 24 is attached by passive winding or the like.) The frame 12 of the loom is rotated by the power of a motor. 3B shows the frame 12 of the loom rotated 180° and then rotated upward (see dashed arrow R). The results are shown in dashed lines, where the feeder head 20 is moved laterally to the right with high precision by the robot. (See arrow T). This is approaching one complete turn of the microfilament strand 24. The spacing between the 18 windings has been exaggerated for clarity. FIG. 3C shows that the loom frame 12 rotates another 360° and the feeder head 20 moves to the right. FIG. 3D shows the result after the feeder head 20 continues to move to the right and the loom The results are shown after the frame 12 has rotated several times. A single layer 18 of microfiber filaments is woven across the loom frame 12. When finished, the feeder head 20 reverses direction and makes another pass across the loom frame 12. It moves towards the left for the sweep, which places the first winding layer 18 on top of the first sweep. Then, another layer of microfilament windings is laid down. The computer-controlled program sweeps the loom frame 12 two more times to the left and right, for a total of four sweeps. Pull. 4A to 4E are examples of processing a microfiber patch 26. FIG. 4A shows the desired microfiber patch 26. This is the result after four complete turns are completed, enough to create a fiber patch 26. It is a hollow cylinder with a heating element inside. As shown in Figure 4B, the heating element is activated and the micro The upper and lower edges of the microfiber patch 26 are melted and fused together. Two fused regions 28 are formed at the ends of the bar patch 26. As shown in FIG. 4C, the right side plate 16 is made of gold. The microfiber patch 26 is then slid off the right free end of the metal rod 14. As shown in FIG. 4D, the microfiber patch 26 is further The adhesive is then coated with a laser and holes 32 are drilled in the fused areas 28. The final product is a microfiber implant 30. The holes 32 are This facilitates surgical placement and fixation of the implant 30. FIG. 4D also illustrates that the fiber density is along the vertical axis F. This shows how the winding direction is measured across the winding direction (transverse centimeter span) (Units per microfiber) Figure 4E shows a cross-sectional side view of the microfiber implant 30. There are 4 layers 34 stacks of crofilament winding. FIG. 5 shows another example of a loom frame (front view). The loom frame 40 is a microfabric. The fiber implant has two cylindrical metal rods 44 around which it is wrapped. The blades 44 are attached to side plates 46 which hold the blades 44 in parallel alignment with one another. The rod 44 has a tapered end 42. Having a tapered end 42 allows It is useful for facilitating removal of the rolled microfiber patch. 6 is a perspective view showing an example of a plate-shaped mandrel as a winding base. A rotating flat plate 52 is used as the center. Figure 7 is a perspective view showing an example of a mandrel as a winding stand. The mandrel 54 employs a hollow cylinder 56 that rotates about a horizontal axis A. Figure 8 shows an example of the use of crossbars for heating. In this internal view, the hollow rod The cord 60 (as part of the loom frame) has a heating coil 62 inside. is connected to a power source via a power line 64. An electric current flows through the heating coil 62 to heat the rod 60. 9 shows the infrared irradiation and the fused area on the microfiber patch (not shown). An example of how heat is used is shown in Figure 1. Above the mandrel 70 is an infrared heater 72. The wire heater 72 radiates heat to a microfiber patch (not shown) on the mandrel 70, A fused area is formed on the chromofiber patch. Figure 10 shows an example of a tube-shaped implant made from a mandrel. 80 comprises a cylindrical outer shell 82 made of microfilament windings. The implant 80 further comprises a hollow interior cavity 84. The tubular shaped implant 80 Tube-shaped organs such as nerves, respiratory tracts (trachea, etc.), bones, or digestive tracts (esophagus, intestines, etc.) The tube-shaped implant 80 is also particularly useful for repairing these and other body tissues. They are also useful as reinforcing sleeves for other body tissues (e.g., ligaments, tendons, muscles) and as protective materials. It becomes a material and healing coating. Figure 11A (perspective view) and Figure 11B (top view) show a block configuration for rotator cuff tendon repair. An example of an implant is shown. The implant 90 is made of a microfilament winding. The implant 90 further comprises a rectangular block 92 made of a perforated These channels are used to connect the external suturing to the implant site. The implant 90 is further constructed on a block 92 to facilitate arthroscopic delivery. It has a coating of freeze-dried collagen. Experimental content The following is a brief summary of the experimental work carried out to verify the present invention. The described report is currently being submitted for publication in a journal. - Implant prototypes were made using the techniques described above. The prototypes were approximately 14 mm in diameter. μm poly(L-lactide) and trimethylene carbonate microfilament yarns were used. (Non-test samples were also made with polydioxanone and cellulose fibers, and other materials were used.) (The feasibility of the process was demonstrated in the past.) The collagen binder mixture is passed through a trough to form a collagen binder mixture. The filament was wound on a rotating cylindrical drum mandrel. The speed of the feeder head was adjusted so that a 1 cm width could be wound in 97 seconds. The feeder head output filament at a speed of approximately 143 cm / min. The moving speed was approximately 99 mm / min. Each sweep of the feeder head wound 10 strands / cm in width. A total of 11 back and forth sweeps were made on the mandrel. The fiber density of the prototype implant was approximately 110 fibers / cm width. Implant types are available in sizes for tendon repair (2 x 3 x 0.2 mm) or ligament repair (1 x 3 x 0.2 mm). During or after winding, the prototype implant was removed from the mandrel. The implant is then removed from the holder and incubated at 37°C to allow the collagen to gel, making the implant more stable. This implant underwent additional processing (detailed below). For comparison, the same material was produced using a conventional fused fiber (FFF) method with polylactic acid in a 3D printer. This process allowed fabrication of implants close to the size and shape of the prototype. It was designed to print implants with fiber lines. Selection, speed, and height are determined to achieve the tightest possible packing while avoiding welding. Optimized to produce the finest fiber lines possible. The collagen coating was then immersed in a collagen solution to form a gel. Microscopic observation: The prototype implants were observed under a scanning electron microscope and compared with conventional FFF. The fiber arrangement and topology of the prototype implant were analyzed. The implant showed significantly higher fiber alignment, with collagen resin between the fibers. This fiber arrangement was superior to the FFF implants. On average, the diameter of the fibers produced by FFF was over 300 μm. In contrast, the prototype implant had a thickness of approximately 14 μm.

[0006] Cytocompatibility: The implants were cultured with musculoskeletal cells (C2C12 cells) in standard growth medium. Both the prototype and conventional FFF implants induced high metabolic activity in the cells. This was maintained throughout the 3-day culture period. The cells also maintained a healthy morphology. have shown that the prototype implant has high cytocompatibility. Degradation test: The degradation over time of prototype implants and FFF manufactured implants was compared. The test is performed in accordance with ASTM F1635-16 ("Hydrolyzable Polymer Resins and Fabricated Forms for Surgical Implants"). The test was carried out in accordance with the "Standard Test Method for In Vitro Degradation Tests of Various Forms of Biodegradation." To test this, implants were immersed in aqueous solutions at 37°C for up to 16 weeks (requiring biomechanical support). (Related to the post-operative healing period commonly observed in soft tissue orthopedic injuries). The implants showed a small amount of mass loss after 2 weeks, but not after 8 or 16 weeks. In contrast, implants manufactured with FFF showed continuous improvement over the entire 16-week period. Both the prototype implant and the FFF implant showed significant mass loss over 16 weeks. High physical stability (retains shape and structure) and no material destruction (cracks, breakage, thinning) (no conversion) was shown. Tensile and Load / Strain Testing: Biomechanical testing is performed in accordance with ASTM D3039M-017 ("Polymer Matrix"). The test was performed according to the "Standard Test Method for Tensile Properties of Composite Materials." To support the implant, a fiber test cord was attached to the mechanical load tester. The load was gradually increased until the implant failed. The specimen initially maintained a peak load (until failure) of approximately 12 Newtons (N), but after 1 hour in culture medium During the 6-week incubation period, this peak load decreased by more than 30% to 7-9N. The prototype implant performed significantly better. The strain initially maintained a tensile load of 1,332 N and remained at approximately 1,000 N during 16 weeks of culture in the culture medium. For reference, the tensile strength of the human anterior cruciate ligament (ACL) is approximately 1,100-1,500N. This type of implant also exhibits high elasticity, failing at strains of over 70%, and is resistant to repeated loading. When a load was applied, it returned to its original shape and showed a typical plastic hysteresis stress-strain curve. Wicking of platelet-rich plasma: The prototype implant was immersed in platelet-rich plasma. The implant rapidly absorbed approximately three times its weight of plasma, increasing up to five times over the 30-minute test period. It continued to absorb up to a weight of Bioceramic coating: The edges of the prototype implants were coated with carbonate apatite. It was coated with β-tricalcium phosphate and thermally gelled at 37°C. Freeze-dried collagen coating: Immersion in collagen solution allows prototypes to be impregnated. A unified collagen shell casing was formed around the implant. The collagen sponge layer was formed on top of the fibers. The tensile strength (under hydrated conditions) of the prototype implants using the electrospun polymer was compared with that of conventional electrospun polymers. The results are shown in the table below. The implants were compared with samples made with electrospun polymer and freeze-dried collagen. The suture retention strength was approximately 2,000 times higher and the overall strength was approximately 150 times higher. In a close comparison test, the prototype surpassed the suture retention properties of bovine Achilles tendons. The prototype exceeded the suture retention strength of human supraspinatus tendons reported in the literature. Tensile strength was similar to that of conventional rotator cuff tendons. TIFF2025536916000002.tif103158 Conclusion: The technology of this invention allows the creation of implants with fibers similar in size and strength to natural tendons and ligaments. This implant is comparable to similar implants made by conventional manufacturing methods. It was three orders of magnitude stronger than the plant. The foregoing description and examples are merely illustrative and are not intended to be limiting. Each of the aspects and embodiments described may be used individually or in conjunction with other aspects, embodiments, and variations of the invention. Unless otherwise specified, the steps of the method of the present invention may be considered in combination with the examples. The steps are not limited to a particular order of execution. Those skilled in the art will readily appreciate that the steps incorporate the spirit and substance of the present invention. Modified versions and derivations of the embodiments may be realized. are also within the scope of the present invention. Where the word "or" is used herein, the context clearly indicates otherwise. Unless otherwise indicated, the terms "and / or" and "and" are intended to be inclusive. Similarly, for example, the expression "A, B, or C" means A, B, or C, or It means a combination of them.

Claims

1. A method for manufacturing a microfiber implant, characterized by comprising the steps of: Something that happens. (a) An apparatus consisting of: Winding platform with a rotating shaft Feeder head moves laterally relative to the winding platform (b) Rotating the winding platform around the axis of rotation (c) Feeding microfilaments into the feeder head (d) Microfilament is fed from the feeder head and directed to the winding platform. Advance the microfilament (e) Winding of microfilament on the winding platform (f) moving the feeder head laterally relative to the rewinding platform; and (g) Repeat steps (b) to (f) to separate the microfilament on the winding platform. Multiple rolls of the fabric are then made to create a microfiber patch. (h) After the microfiber patch is wound, it is processed and the microfiber implant is The finished product is created.

2. 10. The method of claim 1, further comprising performing multiple sweeps of the winding. Each sweep of the binding creates a single mat layer, and multiple sweeps build up mat layers. thing.

3. 3. The method of claim 2, wherein the number of sweeps is between 3 and 50.

4. 3. The method of claim 2, wherein the sweep is between 3 and 70 sweeps per centimeter across the winding table. This is a device for winding microfilaments.

5. The method of claim 1, further comprising: Heating the scraping platform or part of it.

6. The method of claim 1, wherein the feeder head feeds the winding plate at a speed in the range of 20 to 500 mm / min. Moves laterally relative to the platform.

7. 10. The method of claim 1, wherein the microfilaments are fed from the feeder head at a speed of 25 to 800 cm / min. The output speed is in the range of

8. 2. The method of claim 1, wherein the angle of the feeder head is adjustable, thereby The direction angle for feeding the microfilament toward the winding table is changed. Something that can be done. The method includes adjusting the orientation angle of the feeder head during winding. This includes:

9. The method of claim 1 further comprises coating the microfiber patch with collagen after winding. Processing the input.

10. In the method according to claim 9, the collagen coating is frozen and freeze-dried as a post-winding treatment. This further includes:

11. The method of claim 1 further comprises forming openings in the microfiber patch as a post-processing step. of.

12. 12. The method of claim 11, wherein the opening is a channel through the microfiber patch. thing.

13. The method of claim 1, wherein the microfilaments are wound by rotation of the winding platform. It moves forward by the rotational traction force of the

14. Microfibers produced by the method of claim 1

15. Microfiber implants consisting of: A plurality of windings of microfilaments, the microfilaments being 5 to 125 Diameters in the μm range A coating made of a material that bonds the microfilament windings together Channels through the microfiber implant Microfiber implants are placed across the winding for a span of 1 cm. Fiber densities ranging from 20 to 750 microfilaments per fiber.

16. The microfiber implant according to claim 15, wherein the microfilament winding Those having areas where the rings are fused together.

17. The microfiber implant of claim 15, having a thickness in the range of 0.1 to 25 mm and a length of 1.0 Characterized by a range of 0.1 to 30 cm and a width of 0.1 to 30 cm.

18. 16. The microfiber implant of claim 15, wherein the binder is a microfilament. Forms bridges between laterally adjacent lines.

19. The microfiber implant according to claim 15, characterized in that it has a three-dimensional shape. Something that is done.

20. 16. The microfiber implant of claim 15, wherein the binder is freeze-dried collagen. thing.

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