Intelligent bone implant

Abstract

An intelligent bone implant comprises a support shell and a base, and an inner cavity of the support shell is filled with filler materials; the support shell and the base are detachably connected, the support shell is provided with a tail end opening, and the tail end opening is communicated with an inner cavity of the support shell. The internal filler can be placed in the internal cavity of the bracket shell through the opening in the tail end; an intelligent acquisition assembly is arranged on the base; the pressure change of the internal cavity is transmitted to the intelligent acquisition assembly by the built-in actuator; the implant can adapt to a complex human physiological environment, and the overall performance of the implant is improved; the internal stress self-adaptive adjusting structure promotes growth and integration of bone tissues and adapts to individual differences of different patients; the acting force and displacement in the implanted bone tissue are obtained, the postoperative growth recovery condition of the corresponding bone tissue is obtained based on modeling analysis, and effective monitoring of the postoperative physical sign indexes is facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implant for bone reconstruction, and in particular to an intelligent bone implant with mechanical support, biological induction and intelligent monitoring functions. Background Art

[0002] Avascular necrosis of the femoral head (ONFH) is a common and difficult-to-treat condition in orthopedics. It stems from a variety of factors that lead to insufficient local blood supply to the femoral head, resulting in bone cell ischemia, necrosis, trabecular fracture, and femoral head collapse. Without effective treatment, approximately 80% of patients will experience femoral head collapse within 1-4 years, leading to joint dysfunction and ultimately requiring total joint replacement surgery. The high cost of total joint replacement surgery places a significant financial burden on patients and society. Furthermore, due to the limited lifespan of artificial joints, young and middle-aged patients face various complications, revisions, and secondary replacements after joint replacement. Furthermore, the difficulty and risks of reoperation further increase the financial burden and significantly reduce patients' quality of life. Recent studies indicate that the incidence of ONFH has been increasing annually in recent years, and the age of onset is trending younger. Early treatment of ONFH to preserve the patient's natural joint function has been a key focus.

[0003] Currently, there are no unified principles or consensus for the treatment of early-stage ONFH, and treatment options are typically determined by physicians based on their knowledge, skills, and experience. Clinical treatment approaches for early-stage ONFH can be categorized as nonsurgical and surgical. Nonsurgical treatment can alleviate symptoms, but there is insufficient evidence to demonstrate that such treatments can prevent femoral head collapse, preserve joint function, delay joint replacement, or cure ONFH. Among the various hip-preserving surgical approaches for early-stage ONFH, core decompression combined with various bone repair biomaterials and / or structural bone support can effectively remove necrotic tissue, reduce intraosseous pressure, improve femoral circulation, promote neovascularization, enhance osteogenesis, reduce the risk of proximal femoral fractures, and enhance the treatment outcome of ONFH. Early removal of diseased tissue, the use of implants to fill and support the damaged area, and promote bone regeneration are key areas of current research and clinical treatment.

[0004] The existing support implants are usually connected to the drill hole in the femoral head by screw threads. The drill hole is located in the femoral head. By applying force to the coronal end of the implant, it is inserted along the insertion direction. These implants can only provide internal support functions and cannot promote the reconstruction of internal microcirculation or promote the rapid integration of bone tissue growth and implants. For example, conventional femoral head necrosis implants such as metal tantalum rods only have mechanical support functions and cannot prevent the development of the pathological process of femoral head necrosis. Its bone integration ability is limited and cannot solve the problem of insufficient blood supply to the femoral head. It cannot continuously release intraosseous pressure or metabolic products during the bone integration process. It is difficult for metal tantalum rods to achieve ideal bone integration at the lesion site, which may lead to bone resorption at the bone integration interface, and then cause collapse again.

[0005] Timely monitoring of the internal recovery state of the femoral head after implantation is also an important issue. Existing implants do not have intelligent functions, and postoperative tissue recovery can only be evaluated through external detection methods such as X-rays and MRI. It is impossible to obtain the mechanical changes and displacement data inside the bone tissue in real time, resulting in a "monitoring blind spot" in the postoperative recovery stage. In clinical practice, subtle changes such as early microfractures (displacement <0.5mm) or interface bone absorption are difficult to detect in time through external images, and the best time for intervention is often missed, increasing the risk of secondary collapse. Therefore, there is an urgent need to develop a bone implant that can effectively remove necrotic tissue, provide reliable mechanical support, promote bone integration, rebuild bone microcirculation, and facilitate status monitoring feedback.

[0006] In summary, future research and development should focus on designing and manufacturing an ideal bone implant with a simplified structure, controllable production, convenient operation, and the ability to effectively promote bone tissue repair. This will provide a more reliable and effective solution for treating osteonecrosis and bone defects, and bring better treatment outcomes and quality of life to patients. Summary of the Invention

[0007] The purpose of the present invention is to overcome the deficiencies of the prior art and to provide a new product structural design. Through innovative structural design, it solves key problems such as low efficiency of bone tissue integration, lack of postoperative monitoring, and poor individual adaptability in the repair of bone injuries, necrosis or defects. By collecting individual data through implantable sensors, the patient's postoperative recovery level can be continuously monitored. The patient's range of motion, number of steps, step length, walking distance and various vital signs data (such as temperature, blood pressure, blood oxygen saturation, etc.) can be measured, and problems with the implant can also be detected to help the patient adjust their gait. It is suitable for joint-preserving treatment of early-stage osteonecrosis, bone defects and other diseases, and is a technical solution that promotes tissue repair by improving intrabone microcirculation and dynamic stress stimulation.

[0008] An intelligent bone implant comprises a support shell and a base, wherein the inner cavity of the support shell is filled with a filler material; the support shell and the base are detachably connected.

[0009] The bracket shell has a tail end opening, and the tail end opening is connected to the internal cavity of the bracket shell; the internal filler can be placed in the internal cavity of the bracket shell through the tail end opening;

[0010] An intelligent collection component is provided on the base; the pressure change of the internal cavity is transmitted to the intelligent collection component by a built-in actuator.

[0011] Furthermore, the head end plug of the built-in actuator extends into the internal cavity of the bracket shell, applying pressure to the inner cavity filler. The pressure change in the internal cavity will cause axial displacement of the plug, which is transmitted to the intelligent collection component.

[0012] Furthermore, the intelligent acquisition component includes a converter, and the tail end of the built-in actuator is in contact with the converter. When the actuator undergoes axial displacement, it can further exert pressure on the converter. The internal circuit of the converter generates current under the action of pressure, providing working power to the intelligent acquisition component.

[0013] Furthermore, the converter also serves as an acquisition device. The intelligent acquisition component also includes a processor. The current signal generated by the converter is digitally processed by the processor and is used to sense physiological parameters.

[0014] Furthermore, the intelligent collection component also includes a signal transmitter. After the above physiological parameters are collected and processed by the processor, they can be transmitted to the outside in a wireless manner through the signal transmitter.

[0015] Furthermore, the built-in actuator includes an elastic member, which applies pressure to the inner cavity filler through a top plug; preferably, the top plug applies uniform pressure to the inner cavity filler, and the upper surface of the top plug forms a circular arc surface.

[0016] Furthermore, the elastic member is a spring or a spring sheet; preferably, the elastic member is composed of a plurality of butterfly springs connected in series.

[0017] Furthermore, the converter uses a piezoelectric device or an induction coil to convert pressure and displacement into current signals.

[0018] Furthermore, a positioning insert is threadedly connected to the connecting seat at the head end of the base, and the outer surface of the positioning insert is positioned and matched with the inner surface of the opening at the tail end of the bracket shell.

[0019] Furthermore, the stent shell is elastic, and the top plug cooperates with the elastic member to form an internal stress maintaining structure of the stent. After being implanted into the bone tissue, the stent shell can continuously drive the stent shell to apply force to the surrounding bone tissue.

[0020] Advantages of the present invention:

[0021] This invention breaks through the bottlenecks of traditional bone implants, namely "single function, lack of monitoring, and individual discomfort," through the three-dimensional innovation of "intelligent energy supply + dynamic stress regulation + precise bioadaptation," and forms a full-cycle solution from surgical implantation to postoperative management. Its advantages cover the three dimensions of technical principles, clinical effects, and engineering manufacturing. It is particularly irreplaceable in the fields of early femoral head necrosis and pediatric bone injuries, and provides a new product architecture for orthopedic implant technology. The production cost of this implant is controllable, it can be mass-produced, and it has achieved good results in clinical applications. It also has the following characteristics:

[0022] Dynamic stress adaptation: It can simulate the physiological load of human movement, continuously stimulate bone tissue growth, and avoid stress concentration or bone resorption caused by static support;

[0023] Intelligent monitoring function: It can collect bone tissue stress, displacement and other parameters in real time without external power supply, and transmit them wirelessly to external equipment to achieve accurate assessment of postoperative status;

[0024] Individualized treatment support: The detachable structure allows for flexible filling of autologous bone, artificial bone, and other materials during surgery. Precise positioning adapts to the anatomical differences of different patients, reducing the difficulty of surgical operation.

[0025] Biocompatibility and reliability: The material must have good osteoinductivity and fatigue resistance to ensure the safety and effectiveness of long-term implantation.

[0026] Specifically include:

[0027] 1. Integrated innovation of self-power supply and intelligent monitoring;

[0028] Energy supply technology: Through axial micro-displacement of a built-in actuator (elastic element + top plug), the piezoelectric device / induction coil is squeezed, utilizing the piezoelectric effect / electromagnetic induction principle to self-generate operating power, eliminating the need for external batteries or power cords. This completely solves the energy depletion problem of traditional active implants and avoids the risk of secondary surgery to replace batteries. The energy endurance is perfectly matched to the bone healing cycle, significantly improving the long-term reliability of the implant.

[0029] Dual-Function Converter Integrated Design: The converter (piezoelectric device / induction coil) combines both "energy generation" and "signal acquisition," directly converting mechanical stress / displacement into electrical signals. This reduces hardware components, improves energy conversion efficiency, and enables "zero-power" intelligent monitoring. This is the first time that real-time physiological parameter (force / displacement) acquisition has been integrated into a passive implant, filling a gap in existing technology.

[0030] 2. Dynamic internal stress adaptive control system;

[0031] Nonlinear elastic stress output structure: Utilizing butterfly springs in series, dynamic stress output is achieved through nonlinear elastic deformation. This automatically matches the bone healing phase—low stress in the early stages promotes endothelial cell migration, while high stress in the later stages enhances mechanical support. This improves stress adaptation accuracy compared to traditional linear springs and shortens the bone integration period.

[0032] Uniform load transfer and bone tissue stimulation: The top surface of the plug can be designed as a circular arc, which works synergistically with the elastic support shell. This greatly reduces the uniformity of the compressive stress distribution within the filler, avoids local stress concentration that can cause osteoblast apoptosis or material loosening, continuously stimulates osteoblast activity, and increases the rate of new bone formation compared to traditional flat plug structures.

[0033] 3. Detachable precise positioning and modular design;

[0034] Three-dimensional positioning and connection technology: The base and the bracket shell are triple-positioned through a "tapered surface + axial ridge + fine thread" design, minimizing coaxiality errors and increasing axial preload. This allows for precise alignment within a short intraoperative time, improving anti-rotational torque and resolving implant alignment challenges in complex bone cavities (such as the cancellous bone of the femoral head). The accuracy of fit is improved compared to traditional manual shaping.

[0035] Individualized Filling and Expanded Indications: The tail opening allows for intraoperative filling with autologous bone, collagen-nanohydroxyapatite artificial bone, PRP, and other materials. The stent shell can be made of absorbable polylactic acid (PLA) or a gradient elastic modulus material. This adapts to different bone defect scenarios—avoiding secondary surgeries for pediatric patients (PLA stents degrade within 3-5 years), reducing stress shielding for osteoporosis patients, and expanding its clinical indications.

[0036] 4. Intelligent postoperative monitoring and data feedback;

[0037] Real-time wireless transmission of physiological parameters: The processor converts the converter's electrical signals into force, displacement, and other data, which are then transmitted wirelessly. This enables non-invasive, real-time monitoring of postoperative recovery, providing early warning of femoral head collapse, and resolving the "monitoring blind spot" issue of traditional implants, providing a quantitative basis for precision medicine.

[0038] Multimodal signal acquisition and low-power design: The integrated second-order low-pass filter and analog-to-digital converter deliver minimal resting current. Simultaneously acquiring static pressure and dynamic displacement signals, the sensor consumes less power than traditional active sensors, ensuring stable operation in complex physiological environments with low signal transmission latency and high data efficiency.

[0039] 5. Breakthrough innovation in materials and manufacturing processes;

[0040] Porous elastic scaffolds and biocompatibility: 3D-printed porous materials with interconnected pores and an optional silver ion antibacterial coating allow for bone cell incorporation and angiogenesis. Three months after surgery, the density of new blood vessels increases, the infection rate is lower than with traditional metal implants, and biocompatibility is improved.

[0041] Customized 3D printing and microfluidic integration: Selective laser melting (SLM) based on CT data allows for simultaneous printing of 0.3-0.5mm microfluidic channels for localized drug delivery. This enables precise anatomical adaptation and creates a composite carrier for "structural support + growth factor delivery," reducing systemic drug dosage and promoting improved bone repair efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 Stereoscopic image of stent implant;

[0043] Figure 2 A cross-sectional diagram illustrating the assembly relationship of the various components of the stent implant;

[0044] Figure 3 Schematic diagram of the cross section of the stent implant;

[0045] Figure 4 Schematic diagram of the cross section of the bracket shell;

[0046] Figure 5 Schematic diagram of the built-in actuator;

[0047] Figure 6 Schematic diagram of positioning insert;

[0048] Figure 7 Schematic diagram of the base head;

[0049] Figure 8 Schematic diagram of the base end;

[0050] Figure 9 Schematic diagram of the base cross section;

[0051] Figure 10 Schematic diagram of intelligent acquisition components;

[0052] Figure 11 Tail plug diagram.

[0053] In the figure: the bracket shell 1, the porous part 11, the tail end connecting part 12, the base 2, the connecting seat 21, the positioning insert 22, the head end accommodating cavity 23, the guide hole 24, the tail end accommodating cavity 25, the tail plug 3, the locking member 31, the built-in actuator 4, the force-bearing rod 41, the top plug 412, the elastic member 42, the locking pin 43, the intelligent acquisition component 5, the shell 51, the locking ring 511, the locking ring 512, the converter 521, the electrical signal processing circuit 522, the processor 523, and the signal transmitter 524. DETAILED DESCRIPTION

[0054] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0055] Figure 1 The figure shows the assembled state of the stent. The stent comprises: a stent housing 1 and a base 2. The stent, as a support implant, can be provided for insertion into a surgical site (such as a hole in a bone), and in this particular example, into the femoral head. It should be noted that the deep outer inner side of the support implant in the implanted bone is called the head end, and the shallow outer side is called the tail end.

[0056] The bracket shell 1 includes a porous portion 11 at the head end and a connecting portion 12 at the tail end. The porous portion 11 can be a porous material with integral gaps connected by 3D metal printing. A connecting portion is provided at the tail end of the porous portion 11. The connecting portion of the bracket shell 1 has an inner cavity opening, and its inner cavity opening is connected to the internal cavity of the bracket shell 1. The internal filler can be placed into the internal cavity of the bracket shell 1 through the inner cavity opening. The bracket shell 1 is cup-shaped and forms a longitudinally extending inner cavity. The porous portion 11 has a cylindrical outer wall surface and a cylindrical inner wall surface. The cylindrical inner wall surface defines the inner cavity and is made of porous material. The relative elastic properties of the porous material enable the bracket shell 1 to produce slight deformations.

[0057] The stent shell 1 is made of 3D-printed porous materials with interconnected voids, and a silver ion antibacterial coating is optional on the surface. Bone cells are allowed to grow in and angiogenesis occurs. Three months after surgery, the density of new blood vessels increases, the infection rate is lower than that of traditional metal implants, and biocompatibility is improved. In addition, the stent shell can be customized, and laser melting (SLM) molding is performed on the selected area based on the patient's personal CT data. 0.3-0.5mm microchannels are simultaneously printed on the stent shell for local drug delivery. After implantation into the human body, auxiliary drugs can be introduced using external equipment, and characteristic guided delivery can be achieved, so that drugs can be precisely delivered to the individual patient area, achieving precise anatomical adaptation, and using the stent shell as a composite carrier of "structural support + growth factor delivery" to reduce systemic drug dosage and promote bone repair efficiency.

[0058] The inner cavity of the stent shell 1 can be filled with the following fillers, such as healthy autologous bone, allogeneic bone, artificial bone, bioactive materials, etc., to promote the repair of surrounding bones; autologous bone can be selected from bone tissue materials drilled during the main surgery. By backfilling, intraoperative loss is avoided, and the use of autologous bone helps bone repair. Artificial bone induction materials can be selected from one or more of artificial bone synthesized by "collagen + sodium alginate + nanohydroxyapatite", artificial bone synthesized by "collagen + nanohydroxyapatite", hydroxyapatite (HA), tricalcium phosphate (TCP), and bidirectional calcium phosphate (BCP). Bioactive materials include, for example, platelet-rich plasma (PRP).

[0059] The filler can be in granular form and inserted into the stent lumen via an instrument. The instrument is then operated to apply a compressive force to compact the filler. Alternatively, the filler can be processed into a colloid form and injected into the lumen via a syringe, where it solidifies. Once compacted or solidified within the lumen, the filler develops sufficient mechanical strength. The elasticity of the porous material ensures that the elastic force generated by slight deformations ensures that the stent shell 1 tightly wraps and compresses the filler within, thereby forming a complete implant.

[0060] In other embodiments, the opening at the rear end of the stent shell allows for intraoperative filling with different materials such as autologous bone, collagen-nanohydroxyapatite artificial bone, and PRP. Additionally, the stent shell can be made of absorbable polylactic acid (PLA) or a gradient elastic modulus material. This multiple choice of internal and external materials allows for adaptation to different bone defect scenarios. For example, a degradable stent shell can avoid secondary surgery for pediatric patients (PLA stents degrade in 3-5 years), while a gradient elastic modulus material can be used to reduce stress shielding in osteoporosis patients. The combination of different external and internal materials expands the scope of clinical indications.

[0061] The tail end opening of the connecting portion of the bracket housing 1 also serves as a positioning and mounting member for positioning and matching installation with the base 2 .

[0062] The stent further includes a base 2, which is made of solid material. The outer surface of the base 2 may be provided with threads or a roughened surface to increase friction with the bone during implantation, thereby facilitating stronger attachment of the stent to the bone. The bottom end of the base 2 is provided with a recessed hole or groove for connecting to external instruments for surgical procedures. A connecting seat 21 is provided at the head end of the base 2. The connecting seat 21 is a cylindrical body formed coaxially with the base 2.

[0063] The outer periphery of the connector 21 is formed with external threads for threaded connection to the positioning insert 22. The positioning insert 22 is annular in shape with internal threads machined inside, which are threadedly connected to the connector 21. Fine-pitch threads are used between the positioning insert 22 and the connector 21 to enhance the precision of the threaded connection. By replacing different positioning inserts 22, it is possible to adapt different bases to different bracket housings, providing a flexible bone implant product with flexible and adjustable combination options.

[0064] The positioning insert 22 is mated and connected to the positioning fixture of the connecting portion. The outer surface of the positioning insert 22 is positioned and mated with the inner surface of the positioning fixture (i.e., the tail end opening) of the connecting portion. Both can adopt the same cylindrical or conical shape. When conical, the taper of the positioning fixture of the connecting portion and the positioning insert 22 at the head end of the base 2 are consistent.

[0065] In addition, when the positioning mounting member and the positioning insert 22 are fitted together, the relative rotation between the two must be restricted. When both are cylindrical or conical, corresponding axial protrusions and grooves are formed on their circumferential surfaces to provide axial guidance and restrict rotation. Figure 4 、 6 As shown, evenly distributed axial protrusions are formed on the surface of the positioning insert 22, and correspondingly, axial grooves are also formed on the inner surface of the positioning mounting piece (ie, the tail end opening).

[0066] The base and the bracket housing are triple-positioned through a "tapered surface + axial protrusion + fine-pitch thread," minimizing coaxiality errors and increasing axial preload. This allows for precise alignment within a short intraoperative time, improving anti-rotational torque and resolving challenges associated with implant alignment in complex bone cavities (such as the cancellous bone of the femoral head). The fit is improved compared to traditional methods.

[0067] In other embodiments, both can adopt a polygonal prism structure. When the positioning mount and the positioning insert 22 are mated and installed, the polygonal profile can provide axial guidance while also restricting rotation. Furthermore, the polygonal prism can have a certain taper, with the positioning mount at the connection portion and the positioning insert 22 at the head end of the base 2 maintaining the same taper. When the positioning mount and the positioning insert 22 are mated and installed, the polygonal profile can provide axial guidance while also restricting rotation.

[0068] When the positioning mounting member and the positioning insert 22 adopt a tapered structure, the insertion length can also be limited in the axial direction. That is, the length is limited. After the positioning mounting member and the positioning insert 22 are installed together, the tapered profiles of the two form an axial matching positioning and limit.

[0069] In addition, the connecting seat 21 also serves as a mounting seat for the built-in actuator 4. A head end accommodating chamber 23 and a tail end accommodating chamber 25 are formed in the base 2. A cylindrical head end accommodating chamber 23 is formed at the center of the connecting seat 21, and a guide hole 24 is formed at the tail end of the head end accommodating chamber 23. The guide hole 24 connects the tail end accommodating chamber 25 and the head end accommodating chamber 23. The head end accommodating chamber 23 is used to install the built-in actuator 4. The built-in actuator 4 includes a force-bearing rod 41, a top plug 412 and an elastic member 42. The head end of the force-bearing rod 41 is connected to the top plug 412. The top plug 412 is in the shape of a circular plate, and its outer contour matches the inner cavity of the bracket housing 1. When the inner cavity is filled, the top plug 412 is used to extend from the tail end opening to block the inner cavity. The force-bearing rod 41 is a columnar rod, the head end of which is connected to the top plug 412, and the tail end passes through the guide hole 24 and enters the tail end accommodating chamber 25.

[0070] An elastic member 42 is sheathed on the outer side of the force-bearing rod 41. The elastic member 42 is placed in the head end accommodating cavity 23, and the two ends of the elastic member 42 press against the top plug 412 and the bottom surface of the head end accommodating cavity 23 respectively. The elastic member 42 applies pressure to the inner cavity filler through the top plug 412. In order to apply uniform pressure to the inner cavity filler, the upper surface of the top plug 412 can form an arc surface. The upper surface of the top plug can be designed as an arc surface, which cooperates with the outer shell of the elastic support to make the compressive stress inside the filler uniform, and the distribution error is greatly reduced, thereby avoiding bone cell apoptosis or material loosening caused by local stress concentration, continuously stimulating osteoblast activity, and increasing the rate of new bone formation compared to the traditional flat top plug structure.

[0071] The elastic member 42 can be a spring or a spring. Figure 5 As shown, elastic member 42 is constructed from multiple butterfly springs connected in series, each with a different elastic coefficient. This elastic system, constructed with multiple butterfly springs in series, exhibits nonlinear elastic parameters, enabling dynamic stress output through nonlinear elastic deformation. This nonlinear dynamic stress output automatically adapts to the stages of bone healing: early low stress promotes endothelial cell migration, while later high stress enhances mechanical support. This improves stress adaptation accuracy compared to traditional single linear springs and shortens the bone integration period.

[0072] The force-bearing rod 41 has a threaded hole formed in its center, opening at its tail end, for threaded engagement with a locking pin 43. The tail end of the force-bearing rod 41 passes through the guide hole 24 and into the tail end receiving cavity 25. The locking pin 43 is screwed into the threaded hole from the tail end receiving cavity 25. The outer diameter of the head of the locking pin 43 is larger than the diameter of the guide hole 24. Under the elastic force of the elastic member 42, the head of the locking pin 43 presses against the top surface of the tail end receiving cavity 25, thereby securing the built-in actuator 4. The bottom surface of the head of the locking pin 43 is formed with a hexagonal socket for screwing the locking pin 43 in place.

[0073] The nail head of the locking nail 43 is located in the tail end accommodating cavity 25, and the top plug 412 mechanically connected to it is located in the bracket shell 1. Under the action of elastic force, the top plug 412 presses the filler toward the head end. The bracket shell can be a porous material with interconnected gaps made by 3D metal printing. After being implanted in the bone, when the bracket shell 1 is subjected to external pressure in the implanted bone tissue and has the elastic effect of the elastic member 42 inside, relative displacement deformation occurs between the inside and outside and an elastic force is generated. The elastic effect brought about will be applied to the surrounding bone tissue through the bracket shell 1. The elastic bracket shell 1 cooperates with the elastic member 42 and the top plug 412 to form an internal stress maintaining structure of the bracket. When implanted in bone tissue, the bracket shell 1 can be continuously driven to apply force to the surrounding bone tissue. Under the action of continuous internal stress application, the surrounding bone tissue can be stimulated to grow, integrate and recover well.

[0074] In addition, there is a sliding clearance fit between the force-bearing rod 41 and the guide hole 24 . Under external pressure in the bone tissue, the top plug 412 and the force-bearing rod 41 will produce axial displacement and transmit it to the locking nail 43 in the tail end accommodating cavity 25 .

[0075] The locking pin 43 transmits physical parameters such as force and displacement to the tail end accommodating chamber 25. The base 2 also includes a tail end accommodating chamber 25. A cylindrical tail end accommodating chamber 25 is formed at the center of the base 2. The tail end accommodating chamber 25 opens at the tail end of the base 2, through which the intelligent data acquisition component 5 is placed. The intelligent data acquisition component 5 comprises a cylindrical housing 51, within which a converter 521, an electrical signal processing circuit 522, a processor 523, and a signal transmitter 524 are arranged in series, forming an electrical connection between them.

[0076] The converter 521 contacts the head of the locking pin 43. When the locking pin 43 undergoes axial displacement, it can further apply pressure to the converter 521. The converter 521 uses a piezoelectric device, which deforms under pressure, thereby stimulating the piezoelectric effect and generating current. After processing by the internal electrical signal processing circuit 522 (filtering, rectification, and storage), it can provide working power for the processor 523 and signal transmitter 524. Through the axial micro-displacement of the built-in actuator, the piezoelectric device / induction coil is squeezed, and the piezoelectric effect / electromagnetic induction principle is used to self-generate working power as a passive circuit, without the need for external batteries or power cords. This completely solves the energy depletion problem of traditional active implants and avoids the risk of secondary surgery to replace batteries. The energy endurance is fully matched with the bone healing cycle, significantly improving the long-term reliability of the implant. In addition, the use of a commonly used built-in power supply is also another feasible application method. By pre-setting the built-in power supply, it can be used in conjunction with the above-mentioned passive circuit for power supply, or it can be used independently for power supply, improving the safety and stability of the product power supply. The built-in power supply can also be wirelessly charged and charged by an external device.

[0077] The converter can use piezoelectric devices or induction coils to convert pressure and displacement into current signals.

[0078] In addition, the converter 521 also serves as a data acquisition device. The current signal it generates, after digital processing, can represent physical parameters such as the force and displacement transmitted by the locking pin 43 into the tail end accommodating cavity 25. The converter (piezoelectric device / induction coil) has the dual functions of "energy generation" and "signal acquisition," directly converting mechanical stress / displacement into an electrical signal. This reduces the number of hardware components and improves energy conversion efficiency, achieving "zero-power" intelligent monitoring and integrating real-time physiological parameter (force / displacement) acquisition capabilities into passive implants.

[0079] After the above-mentioned physical parameters are collected and processed by the processor 523, they can be transmitted to the outside in a wireless manner through the signal transmitter 524. After the external device receives the internal feedback data, it can perform data analysis to obtain not only physical parameters such as force and displacement, but also the growth and recovery of the corresponding bone tissue after surgery based on the modeling analysis of the physical parameters. This is helpful for the effective monitoring of physical signs and indicators after surgery. The processor is used to convert the converter's electrical signal into data such as force and displacement, and the real-time physiological parameters are wirelessly transmitted through wireless transmission. Non-invasive real-time monitoring of the postoperative recovery state is achieved, early warning of femoral head collapse is given, the problem of "monitoring blind spots" of traditional implants is solved, and a quantitative basis is provided for precision medicine. In addition to the physiological parameters (force / displacement) collected and sensed by the above-mentioned converter, a wider range of physiological parameters such as temperature, blood pressure, blood oxygen, etc. can be monitored by setting other types of sensors.

[0080] The cylindrical shell 51 is used for the built-in converter 521, the electrical signal processing circuit 522, the processor 523, and the signal transmitter 524. The internal circuit of the intelligent acquisition component 5 performs multimodal signal acquisition and adopts a low-power design; it integrates a second-order low-pass filter circuit and an analog-to-digital converter, and the current in the resting state is extremely small. The static pressure and dynamic displacement signals are collected synchronously, and the power consumption is lower than that of traditional active sensors, ensuring that the implant can work stably in complex physiological environments, with low signal transmission delay and high data efficiency. The outer diameter of the cylindrical shell 51 is smaller than the inner diameter of the tail end accommodating cavity 25, so that the cylindrical shell 51 with the converter 521, the electrical signal processing circuit 522, the processor 523, and the signal transmitter 524 can be placed therein.

[0081] The head end of the cylindrical shell 51 is formed with an external thread, which is connected to the internal thread of the head end of the tail end accommodating chamber 25, thereby connecting and fixing the cylindrical shell 51 to the base 2. The converter 521, the electrical signal processing circuit 522, the processor 523, and the signal transmitter 524 are placed inside the cylindrical shell 51. Locking rings 511 / 512 are also connected to the two ends of the cylindrical shell 51. The locking ring is annular and has an external thread on its outer circumference that is connected to the internal thread at the two ends of the cylindrical shell 51. By rotating the locking ring, the converter 521, the processor 523, and the signal transmitter 524 located in the middle are locked and fixed. The locking ring at the head end can be passed through by the head of the locking nail 43, which can press and contact the converter 521 in the middle.

[0082] After the intelligent acquisition component 5 assembled with the converter 521, the electrical signal processing circuit 522, the processor 523, and the signal transmitter 524 is placed into the tail end accommodating chamber 25, the opening of the tail end accommodating chamber 25 needs to be closed. The tail plug 3 is a cylinder, and the external thread on its outer circumference cooperates with the internal thread at the tail end of the tail end accommodating chamber 25, so that the opening of the tail end accommodating chamber 25 is closed by the tail plug 3. A locking member 31 is provided on the tail plug 3. A accommodating chamber is provided on the edges of the tail plug 3, and the accommodating chamber is used to place the locking spring. In cooperation with the locking recess at the tail end of the tail end accommodating chamber 25, preferably, two accommodating chambers can be used and arranged symmetrically. The locking spring includes a cylinder having an internal elastic body and a hemispherical protrusion on the head. Under the action of external pressure, the hemispherical protrusion will compress the internal elastic body. The locking piece 31 is placed in the accommodating cavity. When the tail plug 3 is threadedly connected to the base 2, when the tail plug 3 is rotated to a predetermined position, the hemispherical protrusion pops out and enters the locking recess to form a positioning and tightening effect, thereby positioning and tightening the threaded connection between the tail plug 3 and the base 2.

[0083] In addition, the various components of the stent can be prepared by 3D printing technology or by non-3D printing technology (such as subtractive manufacturing, vapor deposition or sintering, etc.). The stent can be processed into any other shape as needed. The present stent is a porous titanium alloy stent. The material of the stent can also be tantalum, titanium-tantalum alloy, nickel-titanium alloy, pure titanium, cobalt alloy, calcium phosphate, hydroxyapatite, polylactic acid (PLA), lactic acid-glycolic acid copolymer (PLGA), polyvinyl lactone (PCL), coral or bioceramics.

[0084] Finally, it should be noted that the foregoing description is merely an explanation of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail, those skilled in the art will be able to modify the aforementioned technical solutions or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. An intelligent bone implant, comprising a support shell and a base, characterized in that: The inner cavity of the bracket shell is filled with filler material; the bracket shell and the base are detachably connected. The bracket shell has a tail end opening, and the tail end opening is connected to the internal cavity of the bracket shell; the internal filler can be placed in the internal cavity of the bracket shell through the tail end opening; An intelligent collection component is provided on the base; the pressure change of the internal cavity is transmitted to the intelligent collection component by a built-in actuator.

2. The intelligent bone implant according to claim 1, characterized in that: The head end plug of the built-in actuator extends into the internal cavity of the bracket shell and applies pressure to the inner cavity filler. The pressure change in the internal cavity will cause axial displacement of the plug and transmit it to the intelligent collection component.

3. The intelligent bone implant according to claim 2, characterized in that: The intelligent acquisition component includes a converter. The tail end of the built-in actuator is in contact with the converter. When the actuator undergoes axial displacement, it can further apply pressure to the converter. The internal circuit of the converter generates current under the action of pressure, providing working power to the intelligent acquisition component.

4. The intelligent bone implant according to claim 3, characterized in that: The converter also serves as an acquisition device. The intelligent acquisition component also includes a processor. The current signal generated by the converter is digitally processed by the processor and is used to sense physiological parameters.

5. The intelligent bone implant according to claim 4, characterized in that: The intelligent collection component also includes a signal transmitter. After the above physiological parameters are collected and processed by the processor, they can be transmitted to the outside in a wireless manner through the signal transmitter.

6. The intelligent bone implant according to claim 2, characterized in that: The built-in actuator includes an elastic member, which applies pressure to the inner cavity filler through a top plug; preferably, the top plug applies uniform pressure to the inner cavity filler, and the upper surface of the top plug forms a circular arc surface.

7. The intelligent bone implant according to claim 6, characterized in that: The elastic member is a spring or a spring sheet; preferably, the elastic member is composed of a plurality of butterfly springs connected in series.

8. The intelligent bone implant according to claim 3, characterized in that: The converter uses piezoelectric devices or induction coils to convert pressure and displacement into current signals.

9. The intelligent bone implant according to claim 1, characterized in that: A positioning insert is threadedly connected to the connecting seat at the head end of the base, and the outer surface of the positioning insert is positioned and matched with the inner surface of the opening at the tail end of the bracket shell.

10. The intelligent bone implant according to claim 6, characterized in that: The stent shell is elastic, and the top plug cooperates with the elastic member to form an internal stress maintaining structure of the stent. After being implanted in the bone tissue, the stent shell can be continuously driven to apply force to the surrounding bone tissue.

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