An anchoring device for implantable prosthetic and orthotic seals

Abstract

The application discloses a kind of implant prosthesis and artificial limb sealing fixing device, it is related to medical prosthesis technical field, including: implant prosthesis, fixing piece and support piece, the implant prosthesis with the support piece are all with the fixing piece screw connection, the implant prosthesis is used to implant human body and is consistent with bone marrow cavity, the fixing piece is used to connect with artificial limb, the implant prosthesis is provided with fiber layer, and the fiber layer is used to realize biological seal.The implant prosthesis and artificial limb sealing fixing device of the application can solve the problem of poor air permeability between existing receiving cavity and residual limb and residual end friction.

Description

Technical Field

[0001] This invention relates to the field of medical prosthesis technology, and in particular to a fixation device for sealing implanted prostheses and limbs. Background Technology

[0002] In recent years, due to factors such as disease, traffic accidents, work injuries, and natural disasters, the number of lower and upper limb amputations, including but not limited to femurs, tibias, and fingers, has been increasing year by year, greatly increasing the burden on society. Lower limb amputations have a significant impact on patients' motor function and quality of life. Since prostheses are assistive devices worn on the body, they need to be strictly adapted to the patient's physiological needs. Currently, the most commonly used prostheses in clinical practice are suspension prostheses. These prostheses have an unreasonable biomechanical transmission method, poor ventilation between the socket and the residual limb, and often lead to a series of skin problems such as stump friction. Summary of the Invention

[0003] The purpose of this invention is to provide a fixation device for sealing implanted prostheses and limbs, solving problems such as poor air permeability between the implant cavity and the residual limb, as well as residual friction.

[0004] To achieve the above objectives, the present invention provides the following solution:

[0005] The present invention provides a fixation device for sealing implanted prostheses and prostheses, comprising: an implanted prosthesis, a fixation member, and a support member, wherein the implanted prosthesis and the support member are both threadedly connected to the fixation member, the implanted prosthesis is used for implantation into the human body and conforming to the medullary cavity, the fixation member is used for connection to the prosthesis, and the implanted prosthesis is provided with a fiber layer, the fiber layer being used to achieve a bio-sealing.

[0006] In some specific embodiments, the outer wall of the implanted prosthesis is provided with several through holes and / or several grooves; one end of the implanted prosthesis is provided with an opening, the other end of the implanted prosthesis is closed, a cavity is provided inside the implanted prosthesis, the opening communicates with the cavity, and both the fixation member and the support member can be extended into the cavity through the opening;

[0007] The fibrous layer is located at the end of the implanted prosthesis where the opening is provided.

[0008] In some specific designs, the outer wall of the implanted prosthesis is provided with a first external thread, and the inner wall of the implanted prosthesis is provided with a first internal thread.

[0009] In some specific designs, the outer wall of the fastener is provided with a second external thread, and the inner wall of the fastener is provided with a second internal thread.

[0010] In some specific designs, the support element is a screw.

[0011] In some specific designs, the support, the fixation, and the implanted prosthesis are arranged sequentially from the inside out.

[0012] In some specific designs, the implanted prosthesis, the fixation device, and the support device are all coaxially arranged.

[0013] In some specific embodiments, the fiber layer includes a base fiber layer, a main scaffold structure, and a surface modification layer. The base fiber layer, the main scaffold structure, and the surface modification layer are all formed by constructing several scaffolds. The base fiber layer and the surface modification layer are respectively disposed on both sides of the main scaffold structure. The base fiber layer is used to connect with the implanted prosthesis. Cytokines or antibacterial drugs are disposed within the main scaffold structure.

[0014] In some specific embodiments, the fiber layer is fabricated using electrospinning technology, and the fabrication process of the fiber layer includes:

[0015] Spinning solution preparation: Dissolve the biodegradable polymer in the solution to prepare a spinning solution with a mass fraction of 8%-15%, and stir to form a homogeneous, bubble-free solution;

[0016] Parametric spinning: Electrospinning needles are used with segmented voltage control to prepare fiber layers in stages, including:

[0017] Initial stage: Formation of the basal fibrous layer;

[0018] Main body stage: Constructing the main support structure;

[0019] Final stage: Complete the surface finishing layer.

[0020] In some specific solutions, the fiber layer and the implant prosthesis are connected with bio-adhesive. During connection, the bio-adhesive is applied to the connection surface between the implant prosthesis and the fiber layer. Then, the fiber layer is brought into contact with the bio-adhesive, pressure is applied to the fiber layer for curing, and finally sterilization and surface modification are performed.

[0021] The present invention achieves the following technical effects compared to the prior art:

[0022] The implantable prosthesis of the present invention fits snugly against the medullary cavity, and achieves a bio-seal through the fibrous layer on the implantable prosthesis, thereby connecting the implantable prosthesis with the medullary cavity and solving the problems of poor air permeability and residual limb friction in existing implants; by connecting the implantable prosthesis and the support to the fixation component by threads, the implantable prosthesis and the prosthesis do not rotate, avoiding secondary injury. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 A cross-sectional view of a fixation device for sealing implanted prostheses and limbs in some embodiments of the present invention;

[0025] Figure 2 This is a schematic diagram illustrating the application of the fixation device for sealing implanted prostheses and limbs in some embodiments of the present invention.

[0026] Figure 3 for Figure 2 Enlarged view of a portion of point A in the middle;

[0027] Figure 4 This is a schematic diagram of the fiber layer in some embodiments of the present invention;

[0028] Figure 5 A schematic diagram illustrating the interaction mechanism between an implant with a fibrous layer and human epidermal tissue.

[0029] Figure 6 A schematic diagram illustrating the interaction mechanism between implants without a fibrous layer and human epidermal tissue;

[0030] Figure 7 This is a schematic diagram of an electrospinning needle in some embodiments of the present invention;

[0031] In the diagram: 101-Supporting component; 102-Implanted prosthesis; 103-Fixture; 104-Fiber layer; 105-Epidermal layer; 106-Dermal layer; 107-Bone; 108-Bio-adhesive. Detailed Implementation

[0032] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] The purpose of this invention is to provide a fixation device for sealing implanted prostheses and limbs, solving problems such as poor air permeability between the implant cavity and the residual limb, as well as residual friction.

[0034] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0035] like Figures 1 to 5 , Figure 7 As shown, this embodiment provides a fixation device for sealing implanted prostheses and limbs, including: an implanted prosthesis 102, a fixation member 103, and a support member 101. Both the implanted prosthesis 102 and the support member 101 are threadedly connected to the fixation member 103. The implanted prosthesis 102 is used for implantation into the human body and conforms to the medullary cavity of the bone 107. The fixation member 103 is used for connection to the prosthesis. A fiber layer 104 is provided on the implanted prosthesis 102 to achieve a bio-sealing effect. In this embodiment, the implanted prosthesis 102 conforms to the medullary cavity, and the bio-sealing is achieved through the fiber layer 104 on the implanted prosthesis 102, allowing the implanted prosthesis 102 to connect with the medullary cavity, solving existing problems such as poor air permeability between the receiving cavity and the residual limb, and residual end friction. Because both the implanted prosthesis 102 and the support member 101 are threadedly connected to the fixation member 103, the implanted prosthesis 102 and the prosthesis do not rotate, avoiding secondary injury.

[0036] Specifically, in some embodiments, the implanted prosthesis 102 is cylindrical in shape, with an opening at one end and a closed end. A cavity is provided inside the implanted prosthesis 102, and the opening communicates with the cavity. Both the fixation member 103 and the support member 101 can extend into the cavity through the opening. The fiber layer 104 is located at the end of the implanted prosthesis 102 with the opening.

[0037] In some specific embodiments, the outer wall of the implanted prosthesis 102 is provided with a plurality of through holes and / or a plurality of grooves to form a porous structure. The porous structure (i.e., the trabecular bone structure) has a pore size of 200μm-1200μm, a filament diameter of 250μm-700μm, and a porosity of 50%-80%. This type of porous structure is conducive to blood circulation, bone tissue growth and creep. The well-connected channels within the porous structure improve the transport of nutrients, enabling better bone tissue growth, improving initial stability and promoting bone ingrowth.

[0038] In some specific embodiments, the outer wall of the implanted prosthesis 102 is provided with a first external thread, and the inner wall of the implanted prosthesis 102 is provided with a first internal thread.

[0039] In some specific embodiments, the outer wall of the fastener 103 is provided with a second external thread, which matches the first internal thread, and the inner wall of the fastener 103 is provided with a second internal thread.

[0040] In some specific embodiments, the support member 101 is a screw, and the support member 101 is threadedly connected to the second internal thread. By engaging the outer wall of the support member 101 with the second internal thread of the fixation member 103, one end of the support member 101 extends out from one end of the fixation member 103 and abuts against the inner wall of the closed end of the implanted prosthesis 102, while the other end of the support member 101 is located in the fixation member 103.

[0041] In some specific embodiments, the direction of rotation of the first external thread is opposite to that of the first internal thread, and the direction of rotation of the second external thread is opposite to that of the second internal thread.

[0042] In some specific embodiments, the support member 101, the fixation member 103 and the implanted prosthesis 102 are arranged sequentially from the inside to the outside, and the implanted prosthesis 102, the fixation member 103 and the support member 101 are all coaxially arranged.

[0043] In some specific embodiments, the implanted prosthesis 102 is made of titanium alloy, the fixation member 103 is made of cobalt-chromium-molybdenum material, and the support member 101 is made of cobalt-chromium-molybdenum or titanium alloy material.

[0044] In some specific embodiments, the implantable prosthesis 102 can be custom-made according to the patient's medullary cavity structure. Its characteristics include conforming to the patient's anatomical structure, resulting in a larger contact area between the implantable prosthesis 102 and the patient, reducing stress concentration, and exhibiting good initial stability after implantation. The fibrous layer 104 on the annular bottom wall of the implantable prosthesis 102 enhances the connection between the human epidermal tissue and the implantable prosthesis 102.

[0045] In some specific embodiments, the fiber layer 104 is made of a high molecular polymer and includes a base fiber layer 104, a main scaffold structure, and a surface modification layer. The base fiber layer 104, the main scaffold structure, and the surface modification layer are all formed by constructing several scaffolds. The base fiber layer 104 and the surface modification layer are respectively disposed on both sides of the main scaffold structure. The base fiber layer 104 is used to connect with the implanted prosthesis 102. The main scaffold structure is loaded / embedded with cytokines or antibacterial drugs to reduce inflammatory response and enhance tissue integration speed. The thickness of the fiber layer 104 is 150μm-1200μm, the pore size of the fiber layer 104 is 20μm-120μm, and the porosity of the fiber layer 104 is 30%-70%.

[0046] In some specific embodiments, the fastener 103 is customized according to the needs of the prosthesis. The distal structure of the fastener 103 can be designed to match the prosthesis and can be extended to facilitate the installation of the prosthetic prosthesis and form a stable structure.

[0047] In some embodiments, the support 101 is used to lock the extended fixation member 103 and forms a assemblies with the implanted prosthesis 102 to make its overall structure stable and safe.

[0048] In some specific embodiments, the fiber layer 104 is made using electrospinning technology. The voltage range for electrospinning is set to 15kV-25kV, and the raw material flow rate is 1.0mL / h-1.8mL / h. The preparation process of the fiber layer 104 includes:

[0049] Spinning solution preparation: Dissolve the biodegradable polymer in a solution, including but not limited to PLGA (polylactic acid-glycolic acid copolymer), PCL (polylactic acid), and gelatin. The solution includes but is not limited to organic solvents such as hexafluoroisopropanol and acetic acid. The specific solution is selected according to the biodegradable polymer and prepared into a spinning solution with a mass fraction of 8%-15%. Stir magnetically for 24-48 hours to form a homogeneous, bubble-free solution.

[0050] Parametric spinning: A chamfered electrospinning needle is used to ensure fiber uniformity. The receiving distance between the electrospinning needle and the receiving plate is set to 12cm-18cm. Segmented voltage control is employed to prepare fiber layer 104 in layers, including:

[0051] Initial stage (0-30min): voltage is 15kV-18kV, spinning solution flow rate is 1.0mL / h-1.2mL / h, forming a base fiber layer 104;

[0052] Main stage (30-90 min): Voltage is 20kV-25kV, and the flow rate of spinning solution is 1.5mL / h-1.8mL / h to construct the main support structure;

[0053] Final stage (90-120 min): voltage is 18kV-22kV, spinning solution flow rate is 1.2mL / h-1.5mL / h, to complete the surface modification layer;

[0054] The basal fiber layer 104 and the main scaffold structure correspond to the dermis layer 106, and the surface modification layer corresponds to the epidermis layer 105. This allows for a better fit between the thickness and structure of the epidermis layer 105 and the dermis layer 106, enabling human tissue to attach and grow.

[0055] By adjusting the voltage gradient and the flow rate of the spinning solution, a three-dimensional gradient scaffold structure with a pore size of 20μm-120μm and a porosity of 30%-70% is obtained, which is suitable for skin cell infiltration and attachment, and enhances soft tissue integration at the interface. The diameter of the fiber layer 104 is 300nm-800nm, and the thickness of the fiber layer 104 is 150μm-1200μm.

[0056] In this embodiment, the material and pore size of the fiber layer 104 can be customized according to the patient's condition, and the thickness of the fiber layer 104 can be matched according to the patient's needs.

[0057] In some specific embodiments, the fiber layer 104 and the implanted prosthesis 102 are connected by a bio-adhesive 108 to reduce the tension on the skin at the interface and avoid epithelial regression and poor bio-sealing. The bio-adhesive 108 is selected from copolymer hydrogels, including but not limited to 2-hydroxyethyl methacrylate (HEMA) and poly(2-hydroxyethyl methacrylate) (pHEMA), and its physicochemical properties can be adjusted by co-crosslinking with other polymers such as PEG. The preparation process of the bio-adhesive 108, taking HEMA (polyhydroxyethyl methacrylate) as an example, includes:

[0058] Prepare a phosphate buffer solution containing 10wt%-15wt% HEMA and 2wt%-5wt% PEGDA (polyethylene glycol diacrylate);

[0059] Add 0.5wt%-1.5wt% of photoinitiator (Irgacure 2959) or thermal initiator (ammonium persulfate / TEMED (tetramethylethylenediamine));

[0060] After ultrasonic degassing, the viscosity of the prepolymer was controlled at 500 mPa·s-1500 mPa·s (25℃).

[0061] When connecting the implanted prosthesis 102 to the fiber layer 104, a 150μm-300μm thick layer of bio-adhesive 108 is applied to the connection surface between the implanted prosthesis 102 and the fiber layer 104. Then, the fiber layer 104 is brought into contact with the bio-adhesive 108, and a pressure of 0.5kPa-1.0 is applied to the fiber layer 104 for curing. The curing process can be either light curing or heat curing. Light curing: irradiation with 365nm ultraviolet light at 10mW / cm²-30mW / cm² for 60-180 seconds. Heat curing: cross-linking at 37℃ and constant humidity for 2-4 hours. Finally, post-treatment is performed, including sterilization and surface modification. Gradient sterilization: dehydration is performed using a gradient of ethanol (30%-50%-70%-90%), followed by sterilization with ethylene oxide for 24 hours, and then drying in a vacuum drying oven. For surface modification, fibronectin solution (concentration of 10μg / mL, overnight at 4℃) is impregnated to enhance cell affinity.

[0062] Soft tissue integration is one of the most crucial steps after an implant (i.e., the implant prosthesis 102 in this embodiment) enters the human body. Good soft tissue integration is the foundation for an effective bio-seal, ensuring a stable tissue-implant interface and preventing implant loosening that could lead to surgical failure. However, implants, especially percutaneous implants, trigger a healing response when penetrating the skin and internal tissues. Poor healing makes it difficult to form a complete epithelial barrier, failing to effectively prevent the invasion of external bacteria and microorganisms. During the healing process at the percutaneous implant interface, epithelial cells may grow downwards and cover the implant surface; this phenomenon is called descending epithelium. Descending epithelium disrupts the bio-seal between the soft tissue and the implant, increasing the risk of infection and potentially leading to implant surgery failure. Furthermore, percutaneous implants need to withstand dynamic stresses during use, such as muscle contraction and joint movement. This requires the skin-implant interface bio-seal to possess sufficient flexibility and stability to adapt to these dynamic changes.

[0063] In this embodiment, the fiber layer 104 prepared by electrospinning technology is connected to the implant prosthesis 102, which improves the integration effect between soft tissue and implant prosthesis 102, strengthens the interfacial bio-encapsulation, and avoids loosening and failure of implant prosthesis 102 caused by epithelial descending and infection. The working principle is as follows: Figure 5 As shown (the mechanism of interaction between the implant without fibrous layer 104 and human epidermal tissue is as follows) Figure 6 (As shown). The fibrous layer 104 in this embodiment possesses biomimetic characteristics; its suitable porosity and uniform main scaffold structure provide the possibility for cell ingrowth and the formation of proto-tissue-like structures. The fibrous layer 104 is implanted laterally into the surrounding skin tissue, and the gaps allow for the longitudinal ingrowth of new capillaries, providing nutrient supply and material exchange pathways for tissue cells. The interface between the fibrous layer 104 and the implant prosthesis 102 is fixed using bio-adhesive 108. As the wound gradually heals, the tissue gradually integrates with the surface of the implant prosthesis 102 along the fibers, forming a good bio-sealing structure.

[0064] In this embodiment, the implanted prosthesis 102 can be customized according to the patient's medullary cavity. The first internal thread on the inner wall and the first external thread on the outer wall facilitate adjustment of the required height. The first external thread fits and fixes the implanted prosthesis 102 to the patient's medullary cavity, enabling the implanted prosthesis 102 to achieve initial stability. The porous structure of the outer wall of the implanted prosthesis 102 can achieve good bone ingrowth, resulting in good stability in the later stage and preventing loosening of the implanted prosthesis 102. The advantage of the threaded structure of the implanted prosthesis 102 is that the implanted position of the implanted prosthesis 102 can be easily adjusted according to the real-time situation during the operation without causing damage. The second external thread of the fixation member 103 connects with the first internal thread of the implanted prosthesis 102 to realize the connection between the prosthesis and the implanted prosthesis 102 and form a stable structure. The distal end of the fixation member 103 (i.e., the end closer to the prosthesis) can be customized according to the proximal structure of the prosthesis. At the same time, the second internal thread of the fixation member 103 can be adjusted according to the weight-bearing and required height of the prosthesis to achieve the ideal effect. The support 101 allows the fixation 103 and the implanted prosthesis 102 to achieve secure locking and stable connection.

[0065] Electrospinning technology utilizes a strong electric field to transform polymers into extremely fine fibers, with fiber diameters reaching the nanometer scale. In this embodiment, the fiber layer 104 prepared by electrospinning technology provides a main scaffold structure similar to the natural extracellular matrix (ECM). This structure facilitates the adhesion, proliferation, and differentiation of soft tissue cells, thereby promoting soft tissue integration and enhancing bio-encapsulation. The porous structure formed by the main scaffold structure of fiber layer 104 serves to fix the skin-implanted prosthesis 102, reducing tension on the skin at the interface, avoiding potential risks such as epithelial regression, enhancing the bio-sealing effect, and improving the initial stability of the implanted prosthesis 102. The fiber layer 104 prepared by electrospinning technology is conducive to cell penetration and angiogenesis, facilitating nutrient transport and recovery at the wound site, thereby accelerating the integration and repair process of soft tissue. When preparing fiber layer 104, biopolymer materials loaded with drugs or cytokines can be selected to improve soft tissue integration efficiency and avoid inflammation. Through this embodiment, the implanted prosthesis 102 and the prosthesis implanted into the bone achieve a good connection, allowing it to restore some physiological functions and improve aesthetics.

[0066] The implantable prosthesis and prosthesis sealing fixation device of the present invention can make a certain joint area perfect and aesthetically pleasing, restore its physiological function, and fix the implantable prosthesis 102 and the prosthesis through the fixation member 103. At the same time, the implanted prosthesis and prosthesis do not rotate, thus avoiding secondary damage.

[0067] In the description of this invention, it should be understood that the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0068] In the description of this invention, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0069] If this invention discloses or relates to components or structural parts that are fixedly connected to each other, then, unless otherwise stated, a fixed connection can be understood as: a detachable fixed connection (e.g., using bolts or screws) or a non-detachable fixed connection (e.g., riveting, welding). Of course, a fixed connection can also be replaced by an integral structure (e.g., manufactured in one piece using a casting process) (except where it is obviously impossible to use an integral molding process).

[0070] In addition, unless otherwise stated, the terms used in any of the technical solutions disclosed in this invention to indicate positional relationships or shapes include states or shapes that are similar to, close to, or approximate with those states or shapes.

[0071] Any component provided by this invention can be assembled from multiple individual components or can be a single component manufactured by a one-piece molding process.

[0072] It should be noted that the structures, proportions, sizes, etc., depicted in the accompanying drawings of this specification are only used to complement the content disclosed in the specification, so as to enable those skilled in the art to understand and read them, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0073] It should also be noted that in the embodiments of this application, the same reference numerals are used to denote the same component or the same part.

[0074] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0075] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A fixation device for sealing implanted prostheses and limbs, characterized in that: include: The implant includes an implantable prosthesis, a fixator, and a support. The implantable prosthesis and the support are both threadedly connected to the fixator. The implantable prosthesis is used to be implanted into the human body and fits the medullary cavity. The fixator is used to connect to the prosthesis. The implantable prosthesis is provided with a fiber layer, which is used to achieve a bio-sealing. The fiber layer is made using electrospinning technology. The fiber layer includes a base fiber layer, a main scaffold structure, and a surface modification layer. The base fiber layer, the main scaffold structure, and the surface modification layer are all formed by constructing several scaffolds. The base fiber layer and the surface modification layer are respectively disposed on both sides of the main scaffold structure. The base fiber layer is used to connect with the implanted prosthesis. Cytokines or antibacterial drugs are disposed within the main scaffold structure. The base fiber layer and the main support structure correspond to the dermis, and the surface modification layer corresponds to the epidermis.

2. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The outer wall of the implant is provided with several through holes and / or several grooves; one end of the implant is provided with an opening, the other end of the implant is closed, a cavity is provided inside the implant, the opening communicates with the cavity, and both the fixation member and the support member can be extended into the cavity through the opening; The fibrous layer is located at the end of the implanted prosthesis where the opening is provided.

3. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The outer wall of the implanted prosthesis is provided with a first external thread, and the inner wall of the implanted prosthesis is provided with a first internal thread.

4. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The outer wall of the fastener is provided with a second external thread, and the inner wall of the fastener is provided with a second internal thread.

5. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The support component is a screw.

6. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The support, the fixation, and the implanted prosthesis are arranged sequentially from the inside out.

7. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The implanted prosthesis, the fixation component, and the support component are all coaxially arranged.

8. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The preparation process of the fiber layer includes: Spinning solution preparation: Dissolve the biodegradable polymer in the solution to prepare a spinning solution with a mass fraction of 8%-15%, and stir to form a homogeneous, bubble-free solution; Parametric spinning: Electrospinning needles are used with segmented voltage control to prepare fiber layers in stages, including: Initial stage: Formation of the basal fibrous layer; Main body stage: Constructing the main support structure; Final stage: Complete the surface finishing layer.

9. The fixation device for sealing implanted prostheses and limbs according to claim 1, characterized in that: The fiber layer and the implant are connected with bio-adhesive. During connection, the bio-adhesive is applied to the connection surface between the implant and the fiber layer. Then, the fiber layer is brought into contact with the bio-adhesive, pressure is applied to the fiber layer, and curing is performed. Finally, sterilization and surface modification are carried out.

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