WO2024094188A1 - Orthopedic implant, strain monitoring system, processing method and device, and medium - Google Patents
Orthopedic implant, strain monitoring system, processing method and device, and medium Download PDFInfo
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- WO2024094188A1 WO2024094188A1 PCT/CN2023/129698 CN2023129698W WO2024094188A1 WO 2024094188 A1 WO2024094188 A1 WO 2024094188A1 CN 2023129698 W CN2023129698 W CN 2023129698W WO 2024094188 A1 WO2024094188 A1 WO 2024094188A1
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- orthopedic implant
- processing
- radio frequency
- tag circuit
- orthopedic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
Definitions
- the present invention is based on Chinese patent application number 202211373450.6, filed on November 4, 2022, and application number 202211373488.3, Chinese patent application number 202211373487.9, filed on November 4, 2022, Chinese patent application number 202211373486.4, filed on November 4, 2022, Chinese patent application number 202211373472.2, filed on November 4, 2022, Chinese patent application number 202211373458.2, filed on November 4, 2022, and Chinese patent application number 202211373458.2, filed on November 4, 2022, and claims the priority of the above-mentioned Chinese patent applications, the contents of the above-mentioned Chinese patent applications are hereby introduced into the present invention as a reference.
- the present invention relates to the technical field of medical devices, and in particular to an orthopedic implant, a strain monitoring system, a processing method, a device and a medium.
- Postoperative monitoring of orthopedics has always been one of the thorny issues in the field of orthopedics.
- the traditional monitoring method is through X-ray films or CT (Computer Tomography).
- CT Computer Tomography
- This method using medical imaging has the problems of low follow-up rate and sampling frequency.
- the information provided by medical imaging is an indirect reflection of the postoperative situation of orthopedics. Especially in the early stage after orthopedics surgery, the information that can be provided is relatively limited and cannot fully reflect the status of orthopedics after surgery.
- the healing tissue at the fracture ends has an obvious change in elastic modulus during the healing process.
- the corresponding mechanical load it shares gradually increases, and the mechanical load shared by the orthopedic implant gradually decreases, causing the corresponding mechanical response of the orthopedic implant to change. Therefore, the progress of fracture healing can be monitored by mechanical monitoring of orthopedic implants.
- strain sensing monitoring can be used: the bone implant strain sensor device is attached to the implant body by bonding, physical fixation, etc., and the mechanical environment signal is obtained by contact strain sensing to monitor the stress and strain of the orthopedic implant.
- the material of the orthopedic implant is stainless steel or titanium alloy, and the matching sensor adopts semiconductor technology, the preparation process is complicated, and the cost is high, which is not conducive to promotion and application, and needs to be improved.
- the present invention provides an orthopedic implant, a strain monitoring system, a processing method, a device and a medium to solve the problems in the related art that the preparation process of orthopedic implants is complicated, the cost is high, and it is not conducive to popularization and application.
- the first aspect of the present invention provides an orthopedic implant, comprising: an orthopedic implant body with biocompatibility; and a radio frequency tag circuit formed by in-situ carbonization at a target position on the surface of the orthopedic implant body, wherein the radio frequency tag circuit cooperates with an external device to sense the resonance peak kurtosis and resonance frequency of the orthopedic implant when it is subjected to stress and strain. Strain monitoring is performed based on the resonance peak-peak degree and/or the resonance frequency; and a packaging body having biocompatibility is provided, wherein the packaging body packages the surface of the tag circuit.
- the shape of the RFID circuit is a square open ring, a multi-toothed open ring or a circular ring, wherein the RFID circuit detects the resonance peak kurtosis and the resonance frequency based on the ring spacing and the opening spacing of the square open ring, the multi-toothed open ring or the circular ring.
- the orthopedic implant further comprises: a multi-channel array, wherein the multi-channel array comprises a plurality of radio frequency tag circuits, each radio frequency tag circuit is distinguished by a different characteristic frequency, and is arranged at a large strain position found during a finite element simulation process to obtain the spatial distribution of stress on the bone implant.
- the orthopedic implant includes one or more of an orthopedic intervertebral fusion cage, an orthopedic intramedullary nail, a posterior approach spinal fixation rod, an orthopedic bone plate and a joint spacer.
- the material of the orthopedic implant body is polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene.
- a second aspect of the present invention provides a strain monitoring system, comprising an orthopedic implant as described in the above embodiment; an external device, wherein the external device obtains the resonance peak-peak degree and resonance frequency of the orthopedic implant, and performs strain monitoring based on the resonance peak-peak degree and/or the resonance frequency, wherein the external device transmits a signal to the bone implant using an antenna in vitro, and the electromagnetic wave in the signal that is consistent with the characteristic frequency of the radio frequency tag circuit will form a trough in the echo, and the characteristic frequency of the radio frequency tag circuit is obtained through the characteristic frequency at the trough, and the strain information is calculated based on the characteristic frequency.
- the external device includes an antenna and a processing terminal, wherein the antenna is connected to the processing terminal, and when the antenna is close to the radio frequency tag circuit on the orthopedic implant, the radio frequency tag circuit senses the resonance peak-peak degree and the resonance frequency, and the processing terminal analyzes the resonance peak-peak degree and/or the resonance frequency, and performs strain monitoring based on the analysis results.
- a third aspect of the present invention provides a method for processing an orthopedic implant, which is used for processing the orthopedic implant described in the above embodiment, wherein the method comprises the following steps: obtaining the type of the orthopedic implant and the material of the orthopedic implant body; designing a label pattern of a radio frequency tag circuit according to the type of the orthopedic implant and the material of the orthopedic implant body, and determining the processing parameters of the orthopedic implant according to the label pattern and the material of the orthopedic implant body; performing in-situ carbonization on a target position on the surface of the orthopedic implant body according to the processing parameters to obtain a radio frequency tag circuit, and encapsulating the surface of the tag circuit using a biocompatible encapsulation body.
- the processing parameters of the orthopedic implant are determined according to the label pattern and the material of the orthopedic implant body, including: when the bone implant material is carbon fiber reinforced polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is adopted; when the bone implant material is polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is adopted; when the label pattern is a square or circular open ring, a first target processing speed and a second target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively; when the label pattern is a toothed shape, a third target processing speed and a fourth target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively, wherein the third target processing speed is greater than the first target processing speed, and the fourth target processing speed is greater than the second target processing speed; the resistance and the peak of the characteristic peak of the orthopedic implant
- designing the label pattern of the radio frequency tag circuit according to the type of the orthopedic implant and the material of the orthopedic implant body includes: determining the stress state of the corresponding bone according to the type of the orthopedic implant; determining the characteristics of the orthopedic implant according to the material of the orthopedic implant body; and designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant.
- designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant includes: modeling the orthopedic implant to simulate the stress state after implantation in the human body; identifying the position where the strain force is greater than a preset value in the simulation result as the processing position of the radio frequency tag circuit; performing finite element simulation on the radio frequency tag circuit in combination with the size of the orthopedic implant, and adjusting the spacing and/or opening distance of the radio frequency tag circuit at the processing position according to the simulation results until the size and characteristic frequency of the radio frequency tag circuit meet the processing requirements of the orthopedic implant, and the characteristic peak of the radio frequency tag circuit is different from the characteristic peak of human tissue and blood.
- the in-situ carbonization is performed at the target position on the surface of the orthopedic implant body according to the processing parameters, including: planning a processing path for the surface of the orthopedic implant body; performing multi-degree-of-freedom processing according to the processing path through a laser, a focusing mirror, a multi-degree-of-freedom mechanical motion mechanism and a scanning galvanometer, wherein the scanning speed of the scanning galvanometer is greater than the movement speed of the multi-degree-of-freedom mechanical motion mechanism, the laser is focused on the surface of the orthopedic implant body through the focusing mirror, and the distance between the laser focusing plane and the area to be in-situ carbonized is controlled to achieve in-situ carbonization processing of any curved surface.
- a fourth aspect of the present invention provides a processing device, comprising: a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the program to implement the orthopedic implant processing method as described in the above embodiment.
- a fifth aspect of the present invention provides a computer-readable storage medium having a computer program stored thereon, the program being executed by a processor to implement the orthopedic implant processing method as described in the above embodiment.
- the present invention has at least the following beneficial effects:
- the embodiment of the present invention can convert a part of the surface of the orthopedic implant body into a radio frequency tag circuit with conductivity and sensing capability by in-situ carbonization.
- the strain force on the orthopedic implant is sensed by the radio frequency tag circuit and communicates with the outside of the body.
- the orthopedic implant body can be endowed with sensing and communication capabilities without destroying the original characteristics of the orthopedic implant body. Since the radio frequency tag circuit is obtained by in-situ carbonization, the bonding between the radio frequency tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, and there will be no problem of significantly increased resonant response frequency.
- the radio frequency tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, thereby avoiding potential electrochemical reactions and not affecting perspective.
- the orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the part other than the radio frequency tag circuit.
- the orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body.
- the biocompatibility and stability of the radio frequency tag circuit are simultaneously guaranteed by partial encapsulation, effectively reducing the difficulty and cost of encapsulation.
- the partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting surgical implantation, which is conducive to promotion and application.
- FIG1 is a structural diagram of an orthopedic implant provided according to an embodiment of the present invention.
- FIG2 is a schematic diagram of a tag circuit provided according to a specific embodiment of the present invention.
- FIG3 is a simulation diagram of a tag circuit provided according to a specific embodiment of the present invention.
- FIG4 is a physical diagram of a tag circuit and an orthopedic implant according to a specific embodiment of the present invention.
- FIG5 is a simulation diagram of the relationship between conductivity and characteristic peak kurtosis according to a specific embodiment of the present invention.
- FIG6 is a graph showing a characteristic peak shift curve measured according to a specific embodiment of the present invention.
- FIG7 is a curve diagram showing the corresponding relationship between characteristic peaks and strains according to a specific embodiment of the present invention.
- FIG8 is a diagram showing the effect of a radio frequency tag circuit on an orthopedic implant according to a specific embodiment of the present invention.
- FIG9 is a simulation diagram of a multi-channel sensor array provided according to a specific embodiment of the present invention.
- FIG10 is a structural diagram of a joint prosthesis provided according to a specific embodiment of the present invention.
- FIG11 is a schematic diagram of an application of an orthopedic bone plate according to an embodiment of the present invention.
- FIG. 12 is a block diagram of a strain monitoring system according to an embodiment of the present invention.
- FIG. 13 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention.
- FIG14 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention.
- FIG. 15 is a structural diagram of a processing device according to an embodiment of the present invention.
- the present invention provides an orthopedic implant, in which a part of the surface of the orthopedic implant body can be converted into a radio frequency tag circuit with conductivity and sensing capability by in-situ carbonization.
- the radio frequency tag circuit senses the strain force on the orthopedic implant and communicates with the outside of the body, which can give the orthopedic implant body the ability of sensing and communication without destroying the original characteristics of the orthopedic implant body.
- FIG1 is a schematic structural diagram of an orthopedic implant provided by an embodiment of the present invention.
- the orthopedic implant 10 includes an orthopedic implant body 11 , a radio frequency tag circuit 12 and a packaging body 13 .
- the orthopedic implant body 11 has biocompatibility
- the radio frequency tag circuit 12 is formed by in-situ carbonization at the target position on the surface of the orthopedic implant body 11, wherein the radio frequency tag circuit 12 cooperates with external equipment to sense the resonance peak-to-peak degree and resonance frequency when the orthopedic implant is subjected to force and strain, and performs strain monitoring based on the resonance peak-to-peak degree and/or resonance frequency
- the package body 13 has biocompatibility
- the package body 13 encapsulates the surface of the tag circuit 12.
- the target position can be selected according to actual conditions, such as the stress concentration part of the orthopedic implant body 11, etc., without specific limitation; the resonance peak peak and resonance frequency belong to strain signals, and the RFID tag circuit transmits the strain signal to the external device.
- the orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the parts other than the RFID tag circuit.
- the orthopedic implant body can be partially encapsulated with a biocompatible package.
- the partial encapsulation can simultaneously ensure biocompatibility and the stability of the RFID tag circuit, effectively reducing the difficulty and cost of packaging. Partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting the surgical implantation, which is conducive to promotion and application.
- the in-situ carbonization method can give the orthopedic implant body the ability of sensing and communication without destroying the original characteristics of the orthopedic implant body.
- the bonding between the RFID tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, nor will there be a problem of a significant increase in the resonant response frequency.
- the RFID tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, avoiding potential electrochemical reactions and not affecting perspective.
- the shape of the RFID circuit 12 is a square open ring, a multi-toothed open ring or a circular ring, and the RFID circuit detects the resonance peak peak and the resonance frequency based on the ring spacing and the opening spacing of the square open ring, the multi-toothed open ring or the circular ring.
- the RFID tag circuit detects the resonance peak peak and resonance frequency based on the ring spacing and opening spacing of a square open ring, a multi-tooth open ring or a circular ring.
- the open rings are mainly different in shape, resonance frequency, etc., but the specific principles are the same. Therefore, the following is specifically explained with a square open ring:
- the square open ring-shaped RFID tag circuit is shown in FIG2
- the simulation schematic diagram of the RFID tag circuit is shown in FIG3
- FIG4 is a physical diagram of the tag circuit 10 and the polyetheretherketone implant.
- the RFID tag circuit detects the peak kurtosis and resonant frequency of the resonance based on the opening spacing of the square open ring or the gap between the two rings or a combination of the above two.
- the principle is that the square open ring can be equivalent to an LRC circuit with a specific resonance frequency.
- the gap spacing When strain is generated on the RFID tag circuit, the gap spacing will change, resulting in a change in the capacitance of the circuit and a corresponding change in the resonance frequency; at the same time, the strain of the RFID tag circuit will also cause a change in the circuit resistance, resulting in a change in the peak kurtosis KU of the detected resonance peak (that is, a change in the sharpness of the peak); therefore, when it is monitored by an antenna in the outside world, the wave at the resonance frequency in the antenna signal will be absorbed to form a trough.
- the position of the trough can be read by a vector network analyzer or other equipment to accurately obtain the resonance frequency of the tag circuit, and then its opening spacing or the spacing between the two rings can be known. The change in the spacing is caused by strain, so the strain information can be calculated.
- the orthopedic implant 10 may have a multi-channel array, wherein the multi-channel array contains multiple radio frequency tag circuits, each radio frequency tag circuit is distinguished by a different characteristic frequency, and is arranged at the large strain position found in the finite element simulation process to obtain the stress spatial distribution on the bone implant; the multi-channel sensor array can reduce the random measurement error of static data by associating and fusing multiple groups of measurement signal sequences, and extract more accurate and reliable Reliable information improves the speed and efficiency of information processing.
- FIG9 a structure of a multi-channel array is shown in FIG9 , which includes a plurality of label circuits, each of which is distinguished by a different characteristic frequency and arranged at the large strain position found during the finite element simulation process to more accurately obtain the stress spatial distribution on the bone implant.
- Discretization mesh Discretize the geometric model into a finite element mesh. The mesh is refined around the SRR opening ring to obtain more accurate results.
- Parametric sweep Create parameters for the conductivity value of the SRR open ring and set the sweep range, for example, it can be set from 1 S/m to 80,000 S/m.
- Run simulation Start the simulation process and run the simulation with different conductivity values in sequence. Each simulation will calculate the response of the SRR open ring and record the change of the characteristic frequency.
- the embodiment of the present invention can obtain the stress concentration points or failure-prone points of the human bone anatomy based on the biomechanical finite element simulation of the human bone anatomy, so as to perform in-situ multi-degree-of-freedom laser processing of sensor circuits in specific areas.
- the external device may include an antenna and a processing terminal, wherein the antenna is connected to the processing terminal, and when the antenna is close to the radio frequency tag circuit on the orthopedic implant, the resonance peak-peak degree and the resonance frequency are sensed at the radio frequency tag circuit, and the processing terminal analyzes the resonance peak-peak degree and/or the resonance frequency, and performs strain monitoring based on the analysis results.
- the processing terminal may be a network vector analyzer, etc., which is not specifically limited here.
- the embodiment of the present invention can use an antenna as a receiver and connect it to a network vector analyzer.
- a network vector analyzer When the antenna is close to the RFID tag circuit on the orthopedic implant, a corresponding peak will appear at the resonant frequency.
- the stress state of the orthopedic implant can be solved, thereby evaluating the bone healing condition.
- the embodiment of the present invention applies radio frequency identification technology to the mechanical state detection of bone implants, which has the advantages of passive sensing, small size, long life, good bio-identity, etc.
- radio frequency identification technology to the mechanical state detection of bone implants, which has the advantages of passive sensing, small size, long life, good bio-identity, etc.
- it can also identify It can distinguish the kurtosis change and has a wider range of applications.
- it can also obtain more information to facilitate the next step of solution.
- the package 13 can be a biocompatible and high dielectric constant material package protection made by depositing a layer of parylene by chemical vapor deposition, for example, polyparaxylene is deposited on the sensing surface by chemical deposition, vacuum evaporation, etc.
- the material of the orthopedic implant body includes but is not limited to polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene.
- polyetheretherketone is a polymer composed of repeating units containing one ketone bond and two ether bonds in the main chain structure. It is a special polymer material with high mechanical strength, high temperature resistance, impact resistance, flame retardancy, acid and alkali resistance, hydrolysis resistance, wear resistance, fatigue resistance, radiation resistance and good electrical properties.
- Carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which concentrates the advantages of polyetheretherketone material and carbon fiber material. It is light in weight and has excellent mechanical properties, chemical corrosion resistance and biocompatibility. After being carbonized by a high-energy laser beam, this type of material can have high conductivity and stress response characteristics. The resin matrix has low electromagnetic interference, which makes it possible to directly convert orthopedic implants themselves into sensor devices.
- PE polyethylene
- the orthopedic implant includes one or more of an orthopedic intervertebral fusion cage, an orthopedic intramedullary nail, a posterior approach spinal fixation rod, an orthopedic bone plate, and a joint spacer.
- embodiments of the present invention can select different orthopedic implant body materials according to different orthopedic implants to better suit actual application scenarios.
- polyetheretherketone is a thermoplastic resin with carbonyl and carboxyl groups linking aromatic rings
- highly cross-linked polyethylene is a chain polyethylene that is cross-linked into a three-dimensional structure by physical, chemical, irradiation and other methods.
- Carbon fiber reinforced polyetheretherketone has a higher elastic modulus and wear resistance, and is not suitable for direct use as a knee joint gasket.
- Highly cross-linked polyethylene has a low melting point and is difficult to carbonize due to its long chain structure. It is easy to form a molten state during laser processing, has large thermal deformation, and is non-conductive.
- the aromatic rings and carbonyl groups of polyetheretherketone are effectively carbonized under the high temperature of the laser to form a highly conductive network.
- the joint gasket can be made of a composite material of highly cross-linked polyethylene and polyetheretherketone, which enhances wear resistance while meeting hardness and mechanical strength requirements, and can realize laser direct processing of conductive patterns to prepare sensors.
- the composite material of polyetheretherketone and highly cross-linked polyethylene can combine the characteristics of the two materials, making the joint gasket easy to carbonize and having good physical properties, which can solve multiple problems of implant elastic modulus and conductive pattern preparation.
- Joint gaskets can be used in joint prostheses.
- the joint prosthesis 20 includes: a first joint 21, a second joint 22 and a joint gasket 23.
- the joint gasket 23 in the joint prosthesis connects the first joint 21 and the second joint 23.
- the first joint and the second joint can be prepared by carbon fiber reinforced polyetheretherketone polymer.
- the outstanding characteristics of carbon fiber are high strength, high modulus and low density. It also has good fatigue resistance, excellent wear resistance and lubricity, good damping performance, good energy absorption and shock absorption performance, which can enhance the compactness of polyetheretherketone polymer, improve strength, load-bearing capacity and wear resistance, ensure its excellent performance and long service life, and enhance user experience.
- the elastic modulus of the joint prosthesis is similar to that of the bone, which reduces shielding and also enables in-situ preparation of the sensor unit.
- the elastic modulus of the joint prosthesis is similar to that of the bone, which reduces shielding and also enables in-situ preparation of the sensor unit.
- it provides patients with intelligent postoperative indicators and monitors the patient's postoperative condition in real time. It solves the problem that the related technology cannot produce joint prostheses with elastic modulus close to that of bones, resulting in a high stress shielding effect.
- the material of the orthopedic intervertebral fusion device can be polyetheretherketone or carbon fiber reinforced polyetheretherketone.
- Polyetheretherketone or carbon fiber reinforced polyetheretherketone has excellent biocompatibility and extremely high specific strength. Its surface can be modified by high-energy beam carbonization to achieve sensor etching.
- carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which concentrates the advantages of polyetheretherketone material and carbon fiber material, is light in weight, and has excellent mechanical properties, chemical corrosion resistance and biocompatibility.
- this type of material can have high conductivity and stress response characteristics after high-energy laser beam carbonization, and its resin matrix has low electromagnetic interference, which makes it possible to directly convert the orthopedic intervertebral fusion device itself into a sensor device.
- intervertebral fusion devices may include cervical fusion devices, posterior thoracolumbar fusion devices, lateral thoracolumbar fusion devices, lateral posterior thoracolumbar fusion devices, etc., which are orthopedic intervertebral fusion devices used to induce fusion between the upper and lower vertebrae into a whole. Therefore, it can be applicable to but not limited to cervical fusion, posterior thoracolumbar fusion, lateral thoracolumbar fusion, and lateral posterior thoracolumbar fusion surgeries, so as to achieve real-time monitoring of the surface strain caused by vertebral force during intervertebral fusion in different positions.
- intervertebral fusion devices are mainly used to treat spinal instability caused by spinal fractures and disc herniation; the intervertebral fusion device is implanted into the patient's defective spine through surgery, serving as a defective spinal prosthesis to assist the patient's spinal position in mechanical support and restore the mechanical stability of the spine; as the spinal bone defect is repaired, the intervertebral fusion device will fuse with the new bone tissue; during the process of spinal bone regeneration, changes in the stability of the intervertebral fusion device cause measurable changes in stress and strain, and the fusion process of the intervertebral fusion device can be monitored by monitoring the stress and strain of the intervertebral fusion device.
- the materials of orthopedic intramedullary nails, posterior approach spinal fixation rods and orthopedic plates can be carbon fiber reinforced polyetheretherketone.
- Carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which combines the advantages of polyetheretherketone and carbon fiber materials. It is lightweight and has excellent mechanical properties, chemical corrosion resistance and biocompatibility. After being carbonized by a high-energy laser beam, this type of material can have high conductivity and stress response characteristics, and its resin matrix has low electromagnetic interference, which makes it possible to directly convert the intramedullary nail itself, the posterior approach spinal fixation rod itself and the orthopedic plate itself into a sensor device.
- the intramedullary nail may include but is not limited to proximal femoral intramedullary nails, femoral intramedullary nails, tibial intramedullary nails, humeral intramedullary nails and other long intramedullary nails, so as to achieve real-time monitoring of the stress and strain conditions at the fracture ends at different locations.
- the spinal fixation rod may include a uniaxial spinal fixation rod and/or a multiaxial spinal fixation rod, which is used for internal fixation of vertebral fractures, multiaxial and multi-segment internal fixation or minimally invasive vertebral surgery, so as to achieve real-time monitoring of the strain of the spinal fixation rod caused by spinal force during vertebral fracture healing and intervertebral fusion for different diseases.
- the bone plate can be applicable to but not limited to the clavicle, proximal humerus, humeral shaft, medial and lateral distal humerus, ulna, radial shaft, distal radius, proximal femur, femoral shaft, distal femur, medial and lateral proximal tibia, tibial shaft, distal tibia, and distal fibula, and based on different plate and nail fixation principles, such as multi-angle locking, single-angle locking, dynamic compression and other schemes, the bone plate can include neutralization plates, support plates, anti-slip plates and bridging plates.
- intramedullary nails are mainly used for In the treatment of femoral shaft fractures, after the fracture site is anatomically reduced, the intramedullary nail is placed into the medullary cavity and locked with the bone screw; as the fracture heals, the proportion of the load shared by the bone increases, and the load on the intramedullary nail decreases;
- the posterior approach spinal fixation rod is mainly used for the treatment of vertebral fractures, usually from the back, and the fixation rod and vertebra are locked by screws to complete the anatomical fixation of the vertebral fracture position;
- the bone plate is mainly used for the treatment of long bone metaphyseal fractures, and the bone plate is implanted through surgery, and the bone screws are used to fix the bone plate and bone to achieve the connection of the bone plate to the broken bone. As the fracture heals, the load sharing of the bone plate decreases.
- a part of the surface of the orthopedic implant body can be converted into a radio frequency tag circuit with conductivity and sensing ability by in-situ carbonization.
- the strain force on the orthopedic implant is sensed by the radio frequency tag circuit and communicated with the outside of the body.
- the orthopedic implant body can be endowed with sensing and communication capabilities without destroying the original characteristics of the orthopedic implant body. Since the radio frequency tag circuit is obtained by in-situ carbonization, the bonding between the radio frequency tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, and there will be no problem of significantly increased resonant response frequency.
- the radio frequency tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, thereby avoiding potential electrochemical reactions and not affecting perspective.
- the orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the part other than the radio frequency tag circuit.
- the orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body.
- the partial encapsulation simultaneously ensures biocompatibility and the stability of the radio frequency tag circuit, effectively reducing the difficulty and cost of the encapsulation.
- the partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting surgical implantation, which is conducive to promotion and application.
- FIG. 12 is a block diagram of a strain monitoring system according to an embodiment of the present invention.
- the strain monitoring system 30 includes an orthopedic implant 10 and an external device 31 .
- the external device 31 obtains the resonance peak-to-peak degree and resonance frequency of the orthopedic implant 10, and performs strain monitoring based on the resonance peak-to-peak degree and/or resonance frequency, wherein the external device uses an antenna in vitro to transmit a signal to the bone implant, and the electromagnetic wave in the signal that is consistent with the characteristic frequency of the radio frequency tag circuit will form a trough in the echo, and the characteristic frequency of the radio frequency tag circuit is obtained through the characteristic frequency at the trough, and the strain information is calculated based on the characteristic frequency.
- the external device includes an antenna and a processing terminal, wherein the antenna is connected to the processing terminal.
- the antenna is close to the radio frequency tag circuit on the orthopedic implant, the resonance peak-peak degree and resonance frequency are sensed at the radio frequency tag circuit.
- the processing terminal analyzes the resonance peak-peak degree and/or resonance frequency and performs strain monitoring based on the analysis results.
- the strain monitoring system proposed in the embodiment of the present invention is provided with the orthopedic implant of the above-mentioned embodiment, so strain monitoring can be achieved without adding circuits and power supplies to the orthopedic implant. This not only avoids potential electrochemical reactions, but also facilitates real-time detection of strain data information, and can provide technical support for achieving personalized health management of patients after surgery.
- the present invention further proposes a method for processing an orthopedic implant, which is used for processing the orthopedic implant of the above embodiments.
- FIG. 13 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention.
- the processing method of the orthopedic implant comprises the following steps:
- step S101 the type of orthopedic implant and the material of the orthopedic implant body are obtained.
- the types of orthopedic implants may include but are not limited to orthopedic intervertebral fusion devices, orthopedic intramedullary nails, posterior approach spinal fixation rods, orthopedic bone plates and joint gaskets;
- the materials of the orthopedic implant body include but are not limited to polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene and other biocompatible materials.
- a label pattern of a radio frequency tag circuit is designed according to the type of the orthopedic implant and the material of the orthopedic implant body, and a processing parameter of the orthopedic implant is determined according to the label pattern and the material of the orthopedic implant body.
- the embodiments of the present invention can comprehensively consider the type of orthopedic implant and the material of the orthopedic implant body to design the label pattern of the radio frequency tag circuit, so that the radio frequency tag circuit can better match the orthopedic implant, and determine the specific processing parameters based on the label pattern and the material of the orthopedic implant body to improve the processing accuracy.
- the processing parameters of the orthopedic implant are determined according to the label pattern and the material of the orthopedic implant body, including: when the bone implant material is carbon fiber reinforced polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is used; when the bone implant material is polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is used; when the label pattern is a square or circular open ring, a first target processing speed and a second target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively; when the label pattern is a toothed shape, a third target processing speed and a fourth target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively, wherein the third target processing speed is greater than the first target processing speed, and the fourth target processing speed is greater than the second target processing speed; the resistance of the orthopedic implant and the
- the first target processing speed can be 50-200cm/min
- the second target processing speed can be 40-100cm/min
- the third target processing speed can be 10-50cm/min
- the fourth target processing speed can be 10-40cm/min. They can be selected according to actual conditions without specific limitation.
- the bone implant material is carbon fiber reinforced polyetheretherketone
- nanosecond, picosecond, or femtosecond pulse laser processing with wavelengths such as infrared, ultraviolet, or green light is used, and the processing parameters are a frequency of 60k-600kHz, a defocus distance of 0-7mm, and a processing speed of 10-200cm/min.
- the bone implant material is polyetheretherketone
- nanosecond, picosecond, or femtosecond pulse laser processing with wavelengths such as infrared, ultraviolet, or green light is used, and the processing parameters are a frequency of 60k-600kHz, a defocus distance of 3-10mm, and a processing speed of 10-100cm/min.
- the processing speeds of 50-200cm/min and 40-100cm/min can be selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone respectively to improve efficiency without affecting the conductor effect of the carbonized pattern;
- the processing speeds of 10-50cm/min and 10-40cm/min can be selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone respectively to improve heat input, ensure the carbonization effect and the conductivity of the pattern, and then ensure the sensitivity of the label circuit when being read by the antenna.
- a label pattern of a radio frequency tag circuit is designed according to the type of orthopedic implant and the material of the orthopedic implant body, including: determining the stress state of the corresponding bone according to the type of orthopedic implant; determining the characteristics of the orthopedic implant according to the material of the orthopedic implant body; and designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant.
- the embodiments of the present invention are different in type and material of orthopedic implants, so the application of bone
- the tag pattern of the RFID tag circuit designed according to the force state and the characteristics of the orthopedic implant is also different, so that the RFID tag circuit can be better matched with the orthopedic implant.
- a label pattern of a radio frequency tag circuit is designed according to the stress state of the bone and the characteristics of an orthopedic implant, including: modeling the orthopedic implant to simulate the stress state after implantation into the human body; identifying the position where the strain force is greater than a preset value in the simulation result as the processing position of the radio frequency tag circuit; performing finite element simulation on the radio frequency tag circuit in combination with the size of the orthopedic implant, and adjusting the spacing and/or opening distance of the radio frequency tag circuit at the processing position according to the simulation result until the size and characteristic frequency of the radio frequency tag circuit meet the processing requirements of the orthopedic implant, and the characteristic peak of the radio frequency tag circuit is distinguished from the characteristic peak of human tissue and blood.
- the preset value can be set based on actual conditions without specific limitation.
- the bone implant is first modeled in Comsol and other simulation software, and its stress state after implantation in the human body is simulated.
- the large strain position is selected as the processing part of the tag circuit to ensure the accuracy and reliability of strain monitoring.
- their elastic modulus, shape, and stress mode are different, resulting in changes in their maximum strain position. Therefore, it is necessary to simulate the strain states of different bone implants and determine the processing position of the tag circuit.
- finite element simulation of the effect of the tag circuit is carried out in combination with the size of the bone plate. It needs to meet two requirements: one is that its size is suitable for processing on bone implants, and the other is that the characteristic frequency of the processed pattern is clearly distinguishable from the characteristic peaks of human tissue and blood.
- the antenna is modeled according to the size of the bone implant in simulation software such as Comsol, and the characteristic frequency simulation is performed by modifying parameters such as the ring spacing and opening distance. Finally, a tag circuit with a suitable characteristic frequency that can be processed on the bone plate is obtained.
- the embodiments of the present invention can customize sensors based on mechanical characteristics on bone implants with anatomical morphology. Since bone implants have anatomical morphology, such as the bone plate needs to adapt to the bone shape, the intervertebral fusion device needs to be close to the shape of the spine, etc., the surface is an irregular curved surface. According to the actual mechanical properties of human bones, there will be stress concentration in specific parts, so it is necessary to process stress and strain sensors in situ at this location. For bone implants with anatomical morphology, the stress concentration points are first analyzed through finite element simulation, and then the multi-degree-of-freedom laser processing technology is used to in-situ laser process the sensors at the parts to achieve the purpose of customization.
- orthopedic intervertebral fusion devices are mainly used to treat spinal instability caused by spinal fractures and disc herniation; since the intervertebral fusion device needs to adapt to the spine, its shape needs to be similar to the shape of the spine, and its surface is an irregular curved surface. Under different circumstances, stress concentration will exist in its specific parts.
- the spine is the main axis of human movement, it is tightly surrounded and physiologically bent by multiple vertebrae, multiple joints (intervertebral "joints", facet joints), and numerous muscles and ligaments to meet the firmness and mobility (flexibility) of the spine. Its activities have three-dimensional directions (front and back, left and right, rotation) and six degrees of freedom (3 translations, 3 rotations). Therefore, it is necessary to use a multi-degree-of-freedom processing method to perform in-situ multi-degree-of-freedom laser processing sensor circuits in specific areas of the required stress concentration points or failure-prone points, so that the reader and network analyzer can receive stress signals from different radio frequency tag circuits.
- step S103 in-situ carbonization is performed on the target position on the surface of the orthopedic implant body according to the processing parameters to obtain a radio frequency tag circuit, and the surface of the tag circuit is packaged with a biocompatible packaging body.
- the orthopedic implant body since the orthopedic implant body itself has biocompatibility, there is no need to encapsulate the part other than the radio frequency tag circuit.
- the orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body.
- the biocompatibility and stability of the radio frequency tag circuit are guaranteed by partial encapsulation, which effectively reduces the difficulty and cost of packaging.
- partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting the surgical implantation, which is conducive to promotion and application.
- the embodiment of the present invention performs in-situ carbonization on a target position on the surface of an orthopedic implant body according to processing parameters, including: planning a processing path for the surface of the orthopedic implant body; performing multi-degree-of-freedom processing according to the processing path through a laser, a focusing mirror, a multi-degree-of-freedom mechanical motion mechanism and a scanning galvanometer, wherein the scanning speed of the scanning galvanometer is greater than the movement speed of the multi-degree-of-freedom mechanical motion mechanism, the laser is focused on the surface of the orthopedic implant body through the focusing mirror, and the distance between the laser focusing plane and the area to be in-situ carbonized is controlled to achieve in-situ carbonization processing of any curved surface.
- multi-degree-of-freedom processing is required.
- a multi-degree-of-freedom mechanical motion mechanism can be combined with a scanning galvanometer to achieve higher processing efficiency.
- a scanning galvanometer with a scanning speed much faster than that of the multi-degree-of-freedom mechanical motion mechanism can be used.
- processing is required through a scanning galvanometer combined with a mechanical motion structure.
- the surface trajectory is mainly planned offline through CAE (Computer Aided Engineering) path planning simulation to control the multi-degree-of-freedom mechanical equipment to achieve isotropic uniform-speed scanning of the laser on the surface and ensure that the laser optical axis is perpendicular to the surface in real time.
- CAE Computer Aided Engineering
- the present invention can use one or more combinations of scanning galvanometers, robotic arms, multi-axis machine tools, cable-driven robots, etc. to adjust the spatial position of the laser or the position of the device to be carbonized or change the positions of both at the same time, so that the laser can be focused on any point on the surface of the device to be carbonized.
- the laser is focused on a certain point on the surface of the device to be carbonized through a focusing mirror, and the distance between the laser focusing mirror and the point to be carbonized is measured using a coaxial laser rangefinder, thereby controlling the distance between the laser focal plane and the surface to be carbonized during the processing.
- the embodiment of the present invention selects a suitable receiving antenna, and with the help of tools such as a network vector analyzer, it is possible to receive the signal of the passive bone implant sensor in vitro and resolve it to obtain the required information, thereby achieving the goal of real-time detection of the stress state during bone healing.
- a multi-degree-of-freedom laser processing method can be used to achieve carbonization processing of any curved surface, which is suitable for orthopedic implant devices with anatomical structures, thereby achieving in-situ laser processing of any area requiring carbonization processing.
- FIG15 is a schematic diagram of the structure of a processing device provided by an embodiment of the present invention.
- the processing device may include:
- Memory 1501 Memory 1501 , processor 1502 , and a computer program stored in the memory 1501 and executable on the processor 1502 .
- processing equipment also includes:
- the communication interface 1503 is used for communication between the memory 1501 and the processor 1502 .
- the memory 1501 is used to store computer programs that can be executed on the processor 1502 .
- Memory 1501 may include high-speed RAM (Random Access Memory) memory, and may also include non-volatile memory, such as at least one disk storage.
- RAM Random Access Memory
- the communication interface 1503 can be connected to each other through a bus and communicate with each other.
- the bus can be an ISA (Industry Standard Architecture) bus, a PCI (Peripheral Component) bus or an EISA (Extended Industry Standard Architecture) bus, etc.
- the bus can be divided into an address bus, a data bus, a control bus, etc. For ease of representation, only one thick line is used in FIG15, but it does not mean that there is only one bus or one type of bus.
- the memory 1501, the processor 1502 and the communication interface 1503 are integrated on a chip, the memory 1501, the processor 1502 and the communication interface 1503 can communicate with each other through an internal interface.
- Processor 1502 may be a CPU (Central Processing Unit), or an ASIC (Application Specific Integrated Circuit), or one or more integrated circuits configured to implement an embodiment of the present invention.
- CPU Central Processing Unit
- ASIC Application Specific Integrated Circuit
- An embodiment of the present invention further provides a computer-readable storage medium having a computer program stored thereon, and when the program is executed by a processor, the above-mentioned method for processing an orthopedic implant is implemented.
- first and second are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as “first” and “second” may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "N” is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.
- Any process or method description in a flowchart or otherwise described herein may be understood to represent a module, fragment or portion of code comprising one or N executable instructions for implementing the steps of a custom logical function or process, and the scope of the preferred embodiments of the present invention includes alternative implementations in which functions may not be performed in the order shown or discussed, including performing functions in a substantially simultaneous manner or in reverse order depending on the functions involved, which should be understood by technicians in the technical field to which the embodiments of the present invention belong.
- the various parts of the present invention can be implemented by hardware, software, firmware or a combination thereof.
- the N steps or methods can be implemented by software or firmware stored in a memory and executed by a suitable instruction execution system.
- a suitable instruction execution system For example, if implemented by hardware, as in another embodiment, it can be implemented by any one of the following technologies known in the art or their combination: a discrete logic circuit having a logic gate circuit for implementing a logic function on a data signal, a dedicated integrated circuit having a suitable combination of logic gate circuits, a programmable gate array, a field programmable gate array, etc.
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Abstract
Description
相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本发明基于申请号为202211373450.6,申请日为2022年11月04日申请的中国专利、申请号为202211373488.3,申请日为2022年11月04日申请的中国专利、申请号为202211373487.9,申请日为2022年11月04日申请的中国专利、申请号为202211373486.4,申请日为2022年11月04日申请的中国专利、申请号为202211373472.2,申请日为2022年11月04日申请的中国专利、申请号为202211373458.2,申请日为2022年11月04日申请的中国专利提出,并要求上述中国专利申请的优先权,上述中国专利申请的内容在此引入本发明作为参考。The present invention is based on Chinese patent application number 202211373450.6, filed on November 4, 2022, and application number 202211373488.3, Chinese patent application number 202211373487.9, filed on November 4, 2022, Chinese patent application number 202211373486.4, filed on November 4, 2022, Chinese patent application number 202211373472.2, filed on November 4, 2022, Chinese patent application number 202211373458.2, filed on November 4, 2022, and Chinese patent application number 202211373458.2, filed on November 4, 2022, and claims the priority of the above-mentioned Chinese patent applications, the contents of the above-mentioned Chinese patent applications are hereby introduced into the present invention as a reference.
本发明涉及医疗器械技术领域,特别涉及一种骨科植入物、应变监测系统、加工方法、设备及介质。The present invention relates to the technical field of medical devices, and in particular to an orthopedic implant, a strain monitoring system, a processing method, a device and a medium.
骨科术后监测一直是骨科领域棘手的问题之一,传统的监测方式是通过X光平片或CT(Computer Tomography,计算机断层扫描)的方式进行,这种借助医学影像的方法具有随访率和采样频率低的问题,同时医学影像提供的信息是骨科术后情况的间接反应,特别是在骨科术后早期,能提供的信息比较有限,不能详尽地反映出骨科术后的状态。Postoperative monitoring of orthopedics has always been one of the thorny issues in the field of orthopedics. The traditional monitoring method is through X-ray films or CT (Computer Tomography). This method using medical imaging has the problems of low follow-up rate and sampling frequency. At the same time, the information provided by medical imaging is an indirect reflection of the postoperative situation of orthopedics. Especially in the early stage after orthopedics surgery, the information that can be provided is relatively limited and cannot fully reflect the status of orthopedics after surgery.
以骨折的术后愈合监测为例,根据应变理论,骨折断端的愈合组织,在愈合的过程中,具有明显的弹性模量变化,对应的其分担的力学载荷逐步增加,骨科植入物分担的力学载荷逐渐减少,引起骨科植入物产生的相应力学响应变化,因此可以通过对骨科植入物进行力学监测,从而监测骨折愈合的进程。Taking postoperative healing monitoring of fractures as an example, according to strain theory, the healing tissue at the fracture ends has an obvious change in elastic modulus during the healing process. The corresponding mechanical load it shares gradually increases, and the mechanical load shared by the orthopedic implant gradually decreases, causing the corresponding mechanical response of the orthopedic implant to change. Therefore, the progress of fracture healing can be monitored by mechanical monitoring of orthopedic implants.
相关技术中可以通过应变传感监测方式:即将骨植入应变传感器件通过粘接、物理固定等方法附加在植入体上,通过接触式应变传感方式获得力学环境信号,实现对骨科植入物受力应变情况的监测。然而,相关技术中骨科植入物的材质为不锈钢或钛合金材质,配套的传感器采用半导体工艺,制备过程复杂,且成本较高,不利于推广应用,有待改进。In the related technology, strain sensing monitoring can be used: the bone implant strain sensor device is attached to the implant body by bonding, physical fixation, etc., and the mechanical environment signal is obtained by contact strain sensing to monitor the stress and strain of the orthopedic implant. However, in the related technology, the material of the orthopedic implant is stainless steel or titanium alloy, and the matching sensor adopts semiconductor technology, the preparation process is complicated, and the cost is high, which is not conducive to promotion and application, and needs to be improved.
发明内容Summary of the invention
本发明提供一种骨科植入物、应变监测系统、加工方法、设备及介质,以解决相关技术中骨科植入物制备过程复杂、成本较高,不利于推广应用等问题。The present invention provides an orthopedic implant, a strain monitoring system, a processing method, a device and a medium to solve the problems in the related art that the preparation process of orthopedic implants is complicated, the cost is high, and it is not conducive to popularization and application.
本发明第一方面实施例提供一种骨科植入物,包括:具有生物兼容性的骨科植入物本体;在所述骨科植入物本体表面的目标位置处原位碳化形成的射频标签电路,其中,所述射频标签电路与外部设备配合,感应所述骨科植入物受力应变时的谐振峰峰度和谐振频率, 基于所述谐振峰峰度和/或所述谐振频率进行应变监测;具有生物兼容性的封装体,所述封装体对所述标签电路表面进行封装。The first aspect of the present invention provides an orthopedic implant, comprising: an orthopedic implant body with biocompatibility; and a radio frequency tag circuit formed by in-situ carbonization at a target position on the surface of the orthopedic implant body, wherein the radio frequency tag circuit cooperates with an external device to sense the resonance peak kurtosis and resonance frequency of the orthopedic implant when it is subjected to stress and strain. Strain monitoring is performed based on the resonance peak-peak degree and/or the resonance frequency; and a packaging body having biocompatibility is provided, wherein the packaging body packages the surface of the tag circuit.
可选地,所述射频标签电路的形状为方形的开口环、多齿状的开口环或圆形环,其中,所述射频标签电路基于所述方形的开口环、多齿状的开口环或圆形环的环间距和开口间距检测谐振峰峰度和谐振频率。Optionally, the shape of the RFID circuit is a square open ring, a multi-toothed open ring or a circular ring, wherein the RFID circuit detects the resonance peak kurtosis and the resonance frequency based on the ring spacing and the opening spacing of the square open ring, the multi-toothed open ring or the circular ring.
可选地,所述骨科植入物还包括:多通道阵列,其中,所述多通道阵列含多个射频标签电路,每个射频标签电路之间用不同的特征频率进行区分,并排布在有限元仿真过程中发现的大应变位置,以获取骨植入物上的应力空间分布。Optionally, the orthopedic implant further comprises: a multi-channel array, wherein the multi-channel array comprises a plurality of radio frequency tag circuits, each radio frequency tag circuit is distinguished by a different characteristic frequency, and is arranged at a large strain position found during a finite element simulation process to obtain the spatial distribution of stress on the bone implant.
可选地,所述骨科植入物包括骨科椎间融合器、骨科髓内钉、后入路脊柱固定棒、骨科接骨板和关节垫片中的一种或多种。Optionally, the orthopedic implant includes one or more of an orthopedic intervertebral fusion cage, an orthopedic intramedullary nail, a posterior approach spinal fixation rod, an orthopedic bone plate and a joint spacer.
可选地,所述骨科植入物本体的材料为聚醚醚酮、碳纤维增强聚醚醚酮或聚醚醚酮与高交联聚乙烯的复合材料。Optionally, the material of the orthopedic implant body is polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene.
本发明第二方面实施例提供一种应变监测系统,包括如上述实施例所述的骨科植入物;外部设备,所述外部设备获取所述骨科植入物的谐振峰峰度和谐振频率,基于所述谐振峰峰度和/或所述谐振频率进行应变监测,其中,所述外部设备在体外用天线向所述骨植入物发射信号,所述信号中与所述射频标签电路特征频率一直的电磁波会在回波中形成一个波谷,通过所述波谷处的特征频率得到所述射频标签电路的特征频率,基于所述特征频率解算出应变信息。A second aspect of the present invention provides a strain monitoring system, comprising an orthopedic implant as described in the above embodiment; an external device, wherein the external device obtains the resonance peak-peak degree and resonance frequency of the orthopedic implant, and performs strain monitoring based on the resonance peak-peak degree and/or the resonance frequency, wherein the external device transmits a signal to the bone implant using an antenna in vitro, and the electromagnetic wave in the signal that is consistent with the characteristic frequency of the radio frequency tag circuit will form a trough in the echo, and the characteristic frequency of the radio frequency tag circuit is obtained through the characteristic frequency at the trough, and the strain information is calculated based on the characteristic frequency.
可选地,所述外部设备包括天线和处理终端,其中,所述天线与所述处理终端相连,在所述天线靠近所述骨科植入物上的射频标签电路时,所述射频标签电路处感应出谐振峰峰度和谐振频率,所述处理终端分析所述谐振峰峰度和/或所述谐振频率,基于分析结果进行应变监测。Optionally, the external device includes an antenna and a processing terminal, wherein the antenna is connected to the processing terminal, and when the antenna is close to the radio frequency tag circuit on the orthopedic implant, the radio frequency tag circuit senses the resonance peak-peak degree and the resonance frequency, and the processing terminal analyzes the resonance peak-peak degree and/or the resonance frequency, and performs strain monitoring based on the analysis results.
本发明第三方面实施例提供一种骨科植入物的加工方法,所述方法用于上述实施例所述的骨科植入物的加工,其中,所述方法包括以下步骤:获取骨科植入物的类型和骨科植入物本体的材料;根据所述骨科植入物的类型和所述骨科植入物本体的材料设计射频标签电路的标签图案,根据所述标签图案和所述骨科植入物本体的材料确定所述骨科植入物的加工参数;根据所述加工参数对所述骨科植入物本体表面的目标位置处进行原位碳化,得到射频标签电路,并利用具有生物兼容性的封装体对所述标签电路表面进行封装。A third aspect of the present invention provides a method for processing an orthopedic implant, which is used for processing the orthopedic implant described in the above embodiment, wherein the method comprises the following steps: obtaining the type of the orthopedic implant and the material of the orthopedic implant body; designing a label pattern of a radio frequency tag circuit according to the type of the orthopedic implant and the material of the orthopedic implant body, and determining the processing parameters of the orthopedic implant according to the label pattern and the material of the orthopedic implant body; performing in-situ carbonization on a target position on the surface of the orthopedic implant body according to the processing parameters to obtain a radio frequency tag circuit, and encapsulating the surface of the tag circuit using a biocompatible encapsulation body.
可选地,所述根据所述标签图案和所述骨科植入物本体的材料确定所述骨科植入物的加工参数,包括:当骨植入物材料为碳纤维增强聚醚醚酮时,采用红外或紫外或绿光波长的纳秒、皮秒、飞秒脉冲激光加工,当骨植入物材料为聚醚醚酮时,采用红外或紫外或绿光波长的纳秒、皮秒、飞秒脉冲激光加工;当标签图案为方形或圆形开口环时,针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取第一目标加工速度和第二目标加工速度;当标签图案为齿状时,针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取第三目标加工速度和第四目标加工速度,其中,所述第三目标加工速度大于所述第一目标加工速度,所述第四目标加工速度大于所述第二目标加工速度;获取加工过程中骨科植入物的电阻和特征峰的峰度,根据 所述电阻和所述特征峰的峰度调整所述骨科植入物的加工参数。Optionally, the processing parameters of the orthopedic implant are determined according to the label pattern and the material of the orthopedic implant body, including: when the bone implant material is carbon fiber reinforced polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is adopted; when the bone implant material is polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is adopted; when the label pattern is a square or circular open ring, a first target processing speed and a second target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively; when the label pattern is a toothed shape, a third target processing speed and a fourth target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively, wherein the third target processing speed is greater than the first target processing speed, and the fourth target processing speed is greater than the second target processing speed; the resistance and the peak of the characteristic peak of the orthopedic implant during the processing are obtained according to The resistance and the kurtosis of the characteristic peak adjust processing parameters of the orthopedic implant.
可选地,所述根据所述骨科植入物的类型和所述骨科植入物本体的材料设计射频标签电路的标签图案,包括:根据所述骨科植入物的类型确定对应骨骼的应力状态;根据所述骨科植入物本体的材料确定所述骨科植入物的特性;根据所述骨骼的应力状态和所述骨科植入物的特性设计所述射频标签电路的标签图案。Optionally, designing the label pattern of the radio frequency tag circuit according to the type of the orthopedic implant and the material of the orthopedic implant body includes: determining the stress state of the corresponding bone according to the type of the orthopedic implant; determining the characteristics of the orthopedic implant according to the material of the orthopedic implant body; and designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant.
可选地,所述根据所述骨骼的应力状态和所述骨科植入物的特性设计所述射频标签电路的标签图案,包括:对所述骨科植入物进行建模,模拟植入人体后的受力状态;识别模拟结果中应变力大于预设值的位置作为射频标签电路的加工位置;结合所述骨科植入物的尺寸对所述射频标签电路进行有限元仿真,根据仿真结果调整所述加工位置处所述射频标签电路的间距和/或开口距离,直到所述射频标签电路的尺寸和特征频率符合所述骨科植入物的加工要求,且射频标签电路的特征峰区别于人体组织和血液的特征峰。Optionally, designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant includes: modeling the orthopedic implant to simulate the stress state after implantation in the human body; identifying the position where the strain force is greater than a preset value in the simulation result as the processing position of the radio frequency tag circuit; performing finite element simulation on the radio frequency tag circuit in combination with the size of the orthopedic implant, and adjusting the spacing and/or opening distance of the radio frequency tag circuit at the processing position according to the simulation results until the size and characteristic frequency of the radio frequency tag circuit meet the processing requirements of the orthopedic implant, and the characteristic peak of the radio frequency tag circuit is different from the characteristic peak of human tissue and blood.
可选地,所述根据所述加工参数对所述骨科植入物本体表面的目标位置处进行原位碳化,包括:对所述骨科植入物本体表面规划加工路径;通过激光、聚焦镜、多自由度机械运动机构与扫描振镜按照加工路径进行多自由度加工,其中,所述扫描振镜的扫描速度大于所述多自由度机械运动机构的运动速度,所述激光通过所述聚焦镜聚焦于所述骨科植入物本体表面,控制激光聚焦平面与待原位碳化区域之间的距离,实现对任意曲面的原位碳化加工。Optionally, the in-situ carbonization is performed at the target position on the surface of the orthopedic implant body according to the processing parameters, including: planning a processing path for the surface of the orthopedic implant body; performing multi-degree-of-freedom processing according to the processing path through a laser, a focusing mirror, a multi-degree-of-freedom mechanical motion mechanism and a scanning galvanometer, wherein the scanning speed of the scanning galvanometer is greater than the movement speed of the multi-degree-of-freedom mechanical motion mechanism, the laser is focused on the surface of the orthopedic implant body through the focusing mirror, and the distance between the laser focusing plane and the area to be in-situ carbonized is controlled to achieve in-situ carbonization processing of any curved surface.
本发明第四方面实施例提供一种加工设备,包括:存储器、处理器及存储在所述存储器上并可在所述处理器上运行的计算机程序,所述处理器执行所述程序,以实现如上述实施例所述的骨科植入物的加工方法。A fourth aspect of the present invention provides a processing device, comprising: a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the program to implement the orthopedic implant processing method as described in the above embodiment.
本发明第五方面实施例提供一种计算机可读存储介质,其上存储有计算机程序,该程序被处理器执行,以实现如上述实施例所述的骨科植入物的加工方法。A fifth aspect of the present invention provides a computer-readable storage medium having a computer program stored thereon, the program being executed by a processor to implement the orthopedic implant processing method as described in the above embodiment.
由此,本发明至少具有如下有益效果:Therefore, the present invention has at least the following beneficial effects:
本发明实施例可以通过原位碳化的方式,将骨科植入物本体表面的一部分转化为具有导电性和传感能力的射频标签电路,通过射频标签电路感知骨科植入物所受应变力且与体外进行通信,可以在不破坏骨科植入物本体原有特性的基础上,赋予了骨科植入物本体传感和通信的能力,且由于原位碳化得到射频标签电路,因此射频标签电路与基体之间的结合非常牢固,不会随着时间的延长而出现结合不牢固的问题,也不会出现谐振响应频率明显升高的问题;射频标签电路由外部设备激发,无需对骨科植入物增加电路和电源,避免了潜在的电化学反应,且不会影响透视;骨科植入物本体本身具有生物兼容性,因此无需对射频标签电路以外的部分进行封装,利用具有生物兼容性的封装体对骨科植入物本体部分封装即可,通过部分封装同时保障生物相容性和射频标签电路的稳定性,有效降低封装的难度和成本,且部分封装不会改变骨科植入物的原有尺寸,因此也可以保持骨科植入物的外形不影响手术植入,利于推广应用。The embodiment of the present invention can convert a part of the surface of the orthopedic implant body into a radio frequency tag circuit with conductivity and sensing capability by in-situ carbonization. The strain force on the orthopedic implant is sensed by the radio frequency tag circuit and communicates with the outside of the body. The orthopedic implant body can be endowed with sensing and communication capabilities without destroying the original characteristics of the orthopedic implant body. Since the radio frequency tag circuit is obtained by in-situ carbonization, the bonding between the radio frequency tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, and there will be no problem of significantly increased resonant response frequency. The radio frequency tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, thereby avoiding potential electrochemical reactions and not affecting perspective. The orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the part other than the radio frequency tag circuit. The orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body. The biocompatibility and stability of the radio frequency tag circuit are simultaneously guaranteed by partial encapsulation, effectively reducing the difficulty and cost of encapsulation. The partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting surgical implantation, which is conducive to promotion and application.
本发明附加的方面和优点将在下面的描述中部分给出,部分将从下面的描述中变得明显,或通过本发明的实践了解到。 Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention.
图1为根据本发明实施例提供的骨科植入物的结构图;FIG1 is a structural diagram of an orthopedic implant provided according to an embodiment of the present invention;
图2为根据本发明一个具体实施例提供的标签电路的示意图;FIG2 is a schematic diagram of a tag circuit provided according to a specific embodiment of the present invention;
图3为根据本发明一个具体实施例提供的标签电路的仿真图;FIG3 is a simulation diagram of a tag circuit provided according to a specific embodiment of the present invention;
图4为根据本发明一个具体实施例提供的标签电路及骨科植入物的实物图;FIG4 is a physical diagram of a tag circuit and an orthopedic implant according to a specific embodiment of the present invention;
图5为根据本发明一个具体实施例提供的电导率与特征峰峰度间的关系的仿真图;FIG5 is a simulation diagram of the relationship between conductivity and characteristic peak kurtosis according to a specific embodiment of the present invention;
图6为根据本发明一个具体实施例提供的实测特征峰偏移曲线图;FIG6 is a graph showing a characteristic peak shift curve measured according to a specific embodiment of the present invention;
图7为根据本发明一个具体实施例提供的特征峰与应变间对应关系曲线图;FIG7 is a curve diagram showing the corresponding relationship between characteristic peaks and strains according to a specific embodiment of the present invention;
图8为根据本发明一个具体实施例提供的射频标签电路在骨科植入物上的效果图;FIG8 is a diagram showing the effect of a radio frequency tag circuit on an orthopedic implant according to a specific embodiment of the present invention;
图9为根据本发明一个具体实施例提供的多通道传感器阵列的仿真图;FIG9 is a simulation diagram of a multi-channel sensor array provided according to a specific embodiment of the present invention;
图10为根据本发明一个具体实施例提供的关节假体的结构图;FIG10 is a structural diagram of a joint prosthesis provided according to a specific embodiment of the present invention;
图11为根据本发明一个实施例的骨科接骨板的应用示意图;FIG11 is a schematic diagram of an application of an orthopedic bone plate according to an embodiment of the present invention;
图12是本发明实施例的应变监测系统的方框示意图;12 is a block diagram of a strain monitoring system according to an embodiment of the present invention;
图13是本发明实施例的骨科植入物的加工方法的流程图;13 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention;
图14是本发明一个实施例的骨科植入物的加工方法的流程图;FIG14 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention;
图15是本发明实施例的加工设备的结构图。FIG. 15 is a structural diagram of a processing device according to an embodiment of the present invention.
下面详细描述本发明的实施例,所述实施例的示例在附图中示出,其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的,旨在用于解释本发明,而不能理解为对本发明的限制。Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.
下面参考附图描述本发明实施例的骨科植入物、应变监测系统、加工方法、设备及介质。针对上述背景技术中提到的相关技术中骨科植入物制备过程复杂、成本较高,不利于推广应用的技术问题,本发明提供了一种骨科植入物,在该骨科植入物中,可以通过原位碳化的方式,将骨科植入物本体表面的一部分转化为具有导电性和传感能力的射频标签电路,通过射频标签电路感知骨科植入物所受应变力且与体外进行通信,可以在不破坏骨科植入物本体原有特性的基础上,赋予了骨科植入物本体传感和通信的能力。由此,解决了相关技术中骨科植入物制备过程复杂、成本较高,不利于推广应用的技术问题。The orthopedic implant, strain monitoring system, processing method, equipment and medium of the embodiment of the present invention are described below with reference to the accompanying drawings. In view of the technical problems in the related art mentioned in the above background technology that the preparation process of orthopedic implants is complicated, the cost is high, and it is not conducive to the promotion and application, the present invention provides an orthopedic implant, in which a part of the surface of the orthopedic implant body can be converted into a radio frequency tag circuit with conductivity and sensing capability by in-situ carbonization. The radio frequency tag circuit senses the strain force on the orthopedic implant and communicates with the outside of the body, which can give the orthopedic implant body the ability of sensing and communication without destroying the original characteristics of the orthopedic implant body. As a result, the technical problems in the related art that the preparation process of orthopedic implants is complicated, the cost is high, and it is not conducive to the promotion and application are solved.
具体而言,图1为本发明实施例所提供的一种骨科植入物的结构示意图。Specifically, FIG1 is a schematic structural diagram of an orthopedic implant provided by an embodiment of the present invention.
如图1所示,该骨科植入物10包括:骨科植入物本体11、射频标签电路12和封装体13。As shown in FIG. 1 , the orthopedic implant 10 includes an orthopedic implant body 11 , a radio frequency tag circuit 12 and a packaging body 13 .
其中,骨科植入物本体11具有生物兼容性,在骨科植入物本体11表面的目标位置处原位碳化形成的射频标签电路12,其中,射频标签电路12与外部设备配合,感应骨科植入物受力应变时的谐振峰峰度和谐振频率,基于谐振峰峰度和/或谐振频率进行应变监测;封装体13具有生物兼容性,封装体13对标签电路12表面进行封装。 Among them, the orthopedic implant body 11 has biocompatibility, and the radio frequency tag circuit 12 is formed by in-situ carbonization at the target position on the surface of the orthopedic implant body 11, wherein the radio frequency tag circuit 12 cooperates with external equipment to sense the resonance peak-to-peak degree and resonance frequency when the orthopedic implant is subjected to force and strain, and performs strain monitoring based on the resonance peak-to-peak degree and/or resonance frequency; the package body 13 has biocompatibility, and the package body 13 encapsulates the surface of the tag circuit 12.
需要说明的是,目标位置处可以根据实际情况具体选择,比如骨科植入物本体11的应力集中部分等,不作具体限定;谐振峰峰度和谐振频率属于应变信号,射频标签电路将应变信号传递给外部设备。It should be noted that the target position can be selected according to actual conditions, such as the stress concentration part of the orthopedic implant body 11, etc., without specific limitation; the resonance peak peak and resonance frequency belong to strain signals, and the RFID tag circuit transmits the strain signal to the external device.
可以理解的是,骨科植入物本体本身具有生物兼容性,因此无需对射频标签电路以外的部分进行封装,利用具有生物兼容性的封装体对骨科植入物本体部分封装即可,通过部分封装同时保障生物相容性和射频标签电路的稳定性,有效降低封装的难度和成本,且部分封装不会改变骨科植入物的原有尺寸,因此也可以保持骨科植入物的外形不影响手术植入,利于推广应用;原位碳化的方式可以在不破坏骨科植入物本体原有特性的基础上,赋予了骨科植入物本体传感和通信的能力,同时使得射频标签电路与基体之间的结合非常牢固,不会随着时间的延长而出现结合不牢固的问题,也不会出现谐振响应频率明显升高的问题;射频标签电路由外部设备激发,无需对骨科植入物增加电路和电源,避免了潜在的电化学反应,且不会影响透视。It is understandable that the orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the parts other than the RFID tag circuit. The orthopedic implant body can be partially encapsulated with a biocompatible package. The partial encapsulation can simultaneously ensure biocompatibility and the stability of the RFID tag circuit, effectively reducing the difficulty and cost of packaging. Partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting the surgical implantation, which is conducive to promotion and application. The in-situ carbonization method can give the orthopedic implant body the ability of sensing and communication without destroying the original characteristics of the orthopedic implant body. At the same time, the bonding between the RFID tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, nor will there be a problem of a significant increase in the resonant response frequency. The RFID tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, avoiding potential electrochemical reactions and not affecting perspective.
在本发明的一个实施例中,射频标签电路12的形状为方形的开口环、多齿状的开口环或圆形环,射频标签电路基于方形的开口环、多齿状的开口环或圆形环的环间距和开口间距检测谐振峰峰度和谐振频率。In one embodiment of the present invention, the shape of the RFID circuit 12 is a square open ring, a multi-toothed open ring or a circular ring, and the RFID circuit detects the resonance peak peak and the resonance frequency based on the ring spacing and the opening spacing of the square open ring, the multi-toothed open ring or the circular ring.
需要说明的是,射频标签电路基于方形的开口环、多齿状的开口环或圆形环的环间距和开口间距检测谐振峰峰度和谐振频率,其中,开口环主要是形状、谐振频率等不同,但具体原理一致,因此下面具体以方形的开口环进行阐述:It should be noted that the RFID tag circuit detects the resonance peak peak and resonance frequency based on the ring spacing and opening spacing of a square open ring, a multi-tooth open ring or a circular ring. Among them, the open rings are mainly different in shape, resonance frequency, etc., but the specific principles are the same. Therefore, the following is specifically explained with a square open ring:
具体而言,方形的开口环形状的射频标签电路如图2所示,射频标签电路的仿真示意图如图3所示,图4为标签电路10及聚醚醚酮植入物的实物图。射频标签电路基于方形的开口环的开口间距或两环间隙或结合以上二者检测谐振峰峰度和谐振频率,其原理为该方形的开口环可以被等效为一个LRC电路,具有特定的谐振频率。当射频标签电路上产生应变后,缺口间距会发生变化,导致电路的电容改变,谐振频率相应改变;同时,射频标签电路应变也会带来电路电阻变化,导致检测到谐振峰的峰度KU发生改变(也就是峰的尖锐程度发生变化);因此当在外界用天线对其进行监测时,天线信号中谐振频率处的波会被吸收形成一个波谷,通过矢量网络分析仪等设备读取该波谷的位置即可准确得到标签电路谐振频率,进而得知其开口间距或两环之间间距,而该间距的变化是由应变引起的,因此即可计算出应变信息。Specifically, the square open ring-shaped RFID tag circuit is shown in FIG2 , the simulation schematic diagram of the RFID tag circuit is shown in FIG3 , and FIG4 is a physical diagram of the tag circuit 10 and the polyetheretherketone implant. The RFID tag circuit detects the peak kurtosis and resonant frequency of the resonance based on the opening spacing of the square open ring or the gap between the two rings or a combination of the above two. The principle is that the square open ring can be equivalent to an LRC circuit with a specific resonance frequency. When strain is generated on the RFID tag circuit, the gap spacing will change, resulting in a change in the capacitance of the circuit and a corresponding change in the resonance frequency; at the same time, the strain of the RFID tag circuit will also cause a change in the circuit resistance, resulting in a change in the peak kurtosis KU of the detected resonance peak (that is, a change in the sharpness of the peak); therefore, when it is monitored by an antenna in the outside world, the wave at the resonance frequency in the antenna signal will be absorbed to form a trough. The position of the trough can be read by a vector network analyzer or other equipment to accurately obtain the resonance frequency of the tag circuit, and then its opening spacing or the spacing between the two rings can be known. The change in the spacing is caused by strain, so the strain information can be calculated.
在具体检测过程中,由于射频标签电路基于不同的开口环的环间距和开口间距所检测的谐振锋峰度和谐振频率有所不同,因此,电导率与特征峰峰度间的关系的仿真图如图5所示,实测特征峰偏移曲线如图6所示,在具体应用时,特征峰与应变间对应关系曲线如图7所示,射频标签电路在骨科植入物上的效果如图8所示。In the specific detection process, since the resonance peak kurtosis and resonance frequency detected by the RFID tag circuit are different based on the ring spacing and opening spacing of different open rings, the simulation diagram of the relationship between conductivity and characteristic peak kurtosis is shown in Figure 5, and the measured characteristic peak offset curve is shown in Figure 6. In specific applications, the corresponding relationship curve between characteristic peak and strain is shown in Figure 7, and the effect of the RFID tag circuit on orthopedic implants is shown in Figure 8.
在本发明的一个实施例中,骨科植入物10可以具有多通道阵列,其中,多通道阵列含多个射频标签电路,每个射频标签电路之间用不同的特征频率进行区分,并排布在有限元仿真过程中发现的大应变位置,以获取骨植入物上的应力空间分布;多通道传感器阵列可以通过关联融合多组测量信号序列以降低静态数据的随机测量误差,提取出更加准确和可 靠的信息,提升信息处理的速度和效率。In one embodiment of the present invention, the orthopedic implant 10 may have a multi-channel array, wherein the multi-channel array contains multiple radio frequency tag circuits, each radio frequency tag circuit is distinguished by a different characteristic frequency, and is arranged at the large strain position found in the finite element simulation process to obtain the stress spatial distribution on the bone implant; the multi-channel sensor array can reduce the random measurement error of static data by associating and fusing multiple groups of measurement signal sequences, and extract more accurate and reliable Reliable information improves the speed and efficiency of information processing.
具体而言,多通道阵列的一种结构如图9所示,其包含多个标签电路,每个标签电路之间用不同的特征频率进行区分,并将其排布在有限元仿真过程中发现的大应变位置,以更为准确地获取骨植入物上的应力空间分布。Specifically, a structure of a multi-channel array is shown in FIG9 , which includes a plurality of label circuits, each of which is distinguished by a different characteristic frequency and arranged at the large strain position found during the finite element simulation process to more accurately obtain the stress spatial distribution on the bone implant.
而针对有限元仿真过程中发现的大应变位置的具体实现过程如下:The specific implementation process for the large strain position found during the finite element simulation is as follows:
(1)准备几何模型:按照实际加工图纸创建SRR(Split Ring Resonator,开口谐振环)开口环和双臂螺旋读取天线的几何模型。(1) Prepare the geometric model: Create the geometric model of the SRR (Split Ring Resonator) split ring and the two-arm spiral reading antenna according to the actual processing drawings.
(2)定义材料属性:为基底和SRR开口环分别定义对应的材料属性为聚醚醚酮和碳,对于SRR开口环,使用参数化的电导率值,以便在后续的仿真中进行变化。将天线的材料定义为铜。(2) Define material properties: Define the corresponding material properties for the substrate and SRR open ring as PEEK and carbon, respectively. For the SRR open ring, use the parameterized conductivity value so that it can be changed in subsequent simulations. Define the material of the antenna as copper.
(3)设置边界条件:采用集总端口的方法设置天线的输入和输出。(3) Setting boundary conditions: Use the lumped port method to set the input and output of the antenna.
(4)选择物理场:选择电磁场的频域物理场,以模拟电磁波的传播和SRR开口环的响应,确保模型中包括适当的电磁物理方程。(4) Select the physics: Select the frequency domain physics of the electromagnetic field to simulate the propagation of electromagnetic waves and the response of the SRR open ring, ensuring that the appropriate electromagnetic physics equations are included in the model.
(5)离散化网格:将几何模型离散化为有限元网格。在SRR开口环周围对网格进行加密以获取更准确的结果。(5) Discretization mesh: Discretize the geometric model into a finite element mesh. The mesh is refined around the SRR opening ring to obtain more accurate results.
(6)参数化扫描:为SRR开口环的电导率值创建参数,并设置扫描范围,比如可以设置为1S/m至80000S/m等。(6) Parametric sweep: Create parameters for the conductivity value of the SRR open ring and set the sweep range, for example, it can be set from 1 S/m to 80,000 S/m.
(7)运行仿真:启动仿真过程,依次使用不同的电导率值运行仿真。每次仿真都会计算SRR开口环的响应,并记录特征频率的变化。(7) Run simulation: Start the simulation process and run the simulation with different conductivity values in sequence. Each simulation will calculate the response of the SRR open ring and record the change of the characteristic frequency.
(8)分析和可视化:对每次仿真的结果进行分析和可视化,绘制S11回波曲线以观察特征峰的变化。(8) Analysis and visualization: Analyze and visualize the results of each simulation, and draw the S11 echo curve to observe the changes in the characteristic peaks.
(9)得出结论:电导率对SRR开口环特征频率的峰度有显著影响,当电导率大于预设电导率,比如10000S/m等时,可以观测到较为显著的特征峰,满足实际的监测和传感需求。(9) It is concluded that conductivity has a significant effect on the peakness of the SRR open ring characteristic frequency. When the conductivity is greater than the preset conductivity, such as 10000 S/m, a more significant characteristic peak can be observed, which meets the actual monitoring and sensing needs.
由此,本发明实施例可以根据人体骨解剖形态的生物力学有限元仿真,获得人体骨解剖形态的应力集中处或易失效处,从而进行特定区域原位多自由度激光加工传感电路。Therefore, the embodiment of the present invention can obtain the stress concentration points or failure-prone points of the human bone anatomy based on the biomechanical finite element simulation of the human bone anatomy, so as to perform in-situ multi-degree-of-freedom laser processing of sensor circuits in specific areas.
在本发明的一个实施例中,外部设备可以包括天线和处理终端,其中,天线与处理终端相连,在天线靠近骨科植入物上的射频标签电路时,射频标签电路处感应出谐振峰峰度和谐振频率,处理终端分析谐振峰峰度和/或谐振频率,基于分析结果进行应变监测。In one embodiment of the present invention, the external device may include an antenna and a processing terminal, wherein the antenna is connected to the processing terminal, and when the antenna is close to the radio frequency tag circuit on the orthopedic implant, the resonance peak-peak degree and the resonance frequency are sensed at the radio frequency tag circuit, and the processing terminal analyzes the resonance peak-peak degree and/or the resonance frequency, and performs strain monitoring based on the analysis results.
其中,处理终端可以是网络矢量分析仪等,在此不做具体限定。The processing terminal may be a network vector analyzer, etc., which is not specifically limited here.
举例而言,在进行应力监测时,本发明实施例可以采用一个天线作为接收器,将其与网络矢量分析仪相连。在将天线靠近骨科植入物上的射频标签电路时,在谐振频率处会出现对应的峰值,通过分析该峰的频率、峰度等信息,即可对骨科植入物的应力状态进行解算,从而对骨愈合情况进行评估。For example, when performing stress monitoring, the embodiment of the present invention can use an antenna as a receiver and connect it to a network vector analyzer. When the antenna is close to the RFID tag circuit on the orthopedic implant, a corresponding peak will appear at the resonant frequency. By analyzing the frequency, kurtosis and other information of the peak, the stress state of the orthopedic implant can be solved, thereby evaluating the bone healing condition.
由此,本发明实施例将射频识别技术运用于骨植入物的力学状态检测中,具有无源传感、体积小、寿命长、生物相同性好等优点,除了识别标签特征峰频率变化外,还可以识 别其峰度变化,具有更广泛的应用范围,同时也可以获取更多信息便于下一步解算。Therefore, the embodiment of the present invention applies radio frequency identification technology to the mechanical state detection of bone implants, which has the advantages of passive sensing, small size, long life, good bio-identity, etc. In addition to identifying the change in the frequency of the characteristic peak of the tag, it can also identify It can distinguish the kurtosis change and has a wider range of applications. At the same time, it can also obtain more information to facilitate the next step of solution.
在本发明的一个实施例中,封装体13可以为由化学气相沉积法沉积一层派瑞林制得的具有生物兼容性以及高介电常数的材料封装保护,比如利用化学沉积方法、真空蒸镀等方法将聚对二甲苯沉积在传感表面。In one embodiment of the present invention, the package 13 can be a biocompatible and high dielectric constant material package protection made by depositing a layer of parylene by chemical vapor deposition, for example, polyparaxylene is deposited on the sensing surface by chemical deposition, vacuum evaporation, etc.
在本发明的一个实施例中,骨科植入物本体的材料包括但不限于聚醚醚酮、碳纤维增强聚醚醚酮或聚醚醚酮与高交联聚乙烯的复合材料。In one embodiment of the present invention, the material of the orthopedic implant body includes but is not limited to polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene.
具体而言,聚醚醚酮是在主链结构中含有一个酮键和两个醚键的重复单元所构成的高聚物,属特种高分子材料,具有机械强度高、耐高温、耐冲击、阻燃、耐酸碱、耐水解、耐磨、耐疲劳、耐辐照及良好的电性能。Specifically, polyetheretherketone is a polymer composed of repeating units containing one ketone bond and two ether bonds in the main chain structure. It is a special polymer material with high mechanical strength, high temperature resistance, impact resistance, flame retardancy, acid and alkali resistance, hydrolysis resistance, wear resistance, fatigue resistance, radiation resistance and good electrical properties.
碳纤维增强聚醚醚酮是碳纤维增强的聚醚醚酮复合材料,集中了聚醚醚酮材料和碳纤维材料的优势,质量轻,且具有优异的力学性能、耐化学腐蚀性能和生物兼容性,且此类材料经高能激光束碳化后可以具有高导电性及应力响应特性,其树脂基体电磁干扰较小,这为直接将骨科植入物本身转化为传感器件提供了可能。Carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which concentrates the advantages of polyetheretherketone material and carbon fiber material. It is light in weight and has excellent mechanical properties, chemical corrosion resistance and biocompatibility. After being carbonized by a high-energy laser beam, this type of material can have high conductivity and stress response characteristics. The resin matrix has low electromagnetic interference, which makes it possible to directly convert orthopedic implants themselves into sensor devices.
高交联聚乙烯经过交联改性的PE可使其性能得到大幅度的改善,不仅显著提高了PE的力学性能、耐环境应力开裂性能、耐化学药品腐蚀性能、抗蠕变性和电性能等综合性能,而且非常明显地提高了耐温等级。The performance of highly cross-linked polyethylene (PE) can be greatly improved after cross-linking modification. It not only significantly improves the comprehensive properties of PE such as mechanical properties, environmental stress cracking resistance, chemical corrosion resistance, creep resistance and electrical properties, but also significantly improves the temperature resistance level.
在本发明的一个实施例中,骨科植入物包括骨科椎间融合器、骨科髓内钉、后入路脊柱固定棒、骨科接骨板和关节垫片中的一种或多种。In one embodiment of the present invention, the orthopedic implant includes one or more of an orthopedic intervertebral fusion cage, an orthopedic intramedullary nail, a posterior approach spinal fixation rod, an orthopedic bone plate, and a joint spacer.
可以理解的是,本发明实施例可以根据骨科植入物的不同,选择不同的骨科植入物本体材料,以更好的适用于实际应用场景。It is understandable that the embodiments of the present invention can select different orthopedic implant body materials according to different orthopedic implants to better suit actual application scenarios.
具体而言,(1)聚醚醚酮为羰基和羧基链接芳环的热塑性树脂,高交联聚乙烯为链状聚乙烯经过物理、化学、辐照等方法交联为三维结构。碳纤维增强聚醚醚酮具有更高的弹性模量及耐磨损性质,不适用于直接用作膝关节垫片。高交联聚乙烯因其长链结构熔点较低、较难碳化,激光加工过程容易形成熔融态、热变形大、且不导电。聚醚醚酮的芳环及碳氧基团在激光高温作用下有效碳化并形成高导电网络。Specifically, (1) polyetheretherketone is a thermoplastic resin with carbonyl and carboxyl groups linking aromatic rings, and highly cross-linked polyethylene is a chain polyethylene that is cross-linked into a three-dimensional structure by physical, chemical, irradiation and other methods. Carbon fiber reinforced polyetheretherketone has a higher elastic modulus and wear resistance, and is not suitable for direct use as a knee joint gasket. Highly cross-linked polyethylene has a low melting point and is difficult to carbonize due to its long chain structure. It is easy to form a molten state during laser processing, has large thermal deformation, and is non-conductive. The aromatic rings and carbonyl groups of polyetheretherketone are effectively carbonized under the high temperature of the laser to form a highly conductive network.
因此,关节垫片可以采用高交联聚乙烯与聚醚醚酮复合材料,在满足硬度及机械强度基础上增强了耐磨性,并且可以实现激光直接加工导电图案制备传感器。采用聚醚醚酮与高交联聚乙烯的复合材料可以综合两种材料的特性,从而使关节垫片便于碳化且具有较好的物理性能,可以解决植入物弹性模量与导电图案制备多个问题。Therefore, the joint gasket can be made of a composite material of highly cross-linked polyethylene and polyetheretherketone, which enhances wear resistance while meeting hardness and mechanical strength requirements, and can realize laser direct processing of conductive patterns to prepare sensors. The composite material of polyetheretherketone and highly cross-linked polyethylene can combine the characteristics of the two materials, making the joint gasket easy to carbonize and having good physical properties, which can solve multiple problems of implant elastic modulus and conductive pattern preparation.
关节垫片可以应用于关节假体中,如图10所示,关节假体20包括:第一关节21、第二关节22和关节垫片23,关节假体中关节垫片23连接第一关节21和第二关节23,第一关节和第二关节均可以采用碳纤维增强聚醚醚酮聚合物制备得到,而碳纤维突出的特点就是高强度、高模量、低密度,同时还具有抗疲劳性能好、耐磨耗性和润滑性优异、良好的阻尼性能、良好的吸能减震性能,可以增强聚醚醚酮聚合物的紧密度,提升强度、承载能力和耐磨性,保证其使用性能优良且寿命长,提升用户使用体验。Joint gaskets can be used in joint prostheses. As shown in Figure 10, the joint prosthesis 20 includes: a first joint 21, a second joint 22 and a joint gasket 23. The joint gasket 23 in the joint prosthesis connects the first joint 21 and the second joint 23. The first joint and the second joint can be prepared by carbon fiber reinforced polyetheretherketone polymer. The outstanding characteristics of carbon fiber are high strength, high modulus and low density. It also has good fatigue resistance, excellent wear resistance and lubricity, good damping performance, good energy absorption and shock absorption performance, which can enhance the compactness of polyetheretherketone polymer, improve strength, load-bearing capacity and wear resistance, ensure its excellent performance and long service life, and enhance user experience.
由此,关节假体与骨骼弹性模量相近降低屏蔽的同时也实现传感单元的原位制备,并 应用于人体各个关节,为患者提供智能术后指标,并实时监测患者术后情况。解决了相关技术中无法制备出与骨骼弹性模量相近的关节假体导致应力屏蔽效应较高等问题。Therefore, the elastic modulus of the joint prosthesis is similar to that of the bone, which reduces shielding and also enables in-situ preparation of the sensor unit. Applied to various joints of the human body, it provides patients with intelligent postoperative indicators and monitors the patient's postoperative condition in real time. It solves the problem that the related technology cannot produce joint prostheses with elastic modulus close to that of bones, resulting in a high stress shielding effect.
(2)骨科椎间融合器的材料可以为聚醚醚酮或碳纤维增强聚醚醚酮,聚醚醚酮或碳纤维增强聚醚醚酮具有优良的生物兼容性和极高的比强度,其表面可通过高能束碳化改性,实现传感器刻蚀。以碳纤维增强聚醚醚酮为例,碳纤维增强聚醚醚酮是碳纤维增强的聚醚醚酮复合材料,集中了聚醚醚酮材料和碳纤维材料的优势,质量轻,且具有优异的力学性能、耐化学腐蚀性能和生物兼容性,且此类材料经高能激光束碳化后可以具有高导电性及应力响应特性,其树脂基体电磁干扰较小,这为直接将骨科椎间融合器本身转化为传感器件提供了可能。(2) The material of the orthopedic intervertebral fusion device can be polyetheretherketone or carbon fiber reinforced polyetheretherketone. Polyetheretherketone or carbon fiber reinforced polyetheretherketone has excellent biocompatibility and extremely high specific strength. Its surface can be modified by high-energy beam carbonization to achieve sensor etching. Taking carbon fiber reinforced polyetheretherketone as an example, carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which concentrates the advantages of polyetheretherketone material and carbon fiber material, is light in weight, and has excellent mechanical properties, chemical corrosion resistance and biocompatibility. Moreover, this type of material can have high conductivity and stress response characteristics after high-energy laser beam carbonization, and its resin matrix has low electromagnetic interference, which makes it possible to directly convert the orthopedic intervertebral fusion device itself into a sensor device.
基于不同的伤患位置,椎间融合器可以包括颈椎融合器、后入路胸腰椎融合器、侧方入路胸腰椎融合器、侧后入路胸腰椎融合器等用于诱导上下椎体间融合成为整体的骨科椎间融合器,从而可以适用但不限于颈椎融合、后入路胸腰椎融合、侧方入路胸腰椎融合、侧后入路胸腰椎融合手术,以实现针对不同位置的椎间融合进程中椎体受力引发的表面应变情况的实时监测。Based on different injury locations, intervertebral fusion devices may include cervical fusion devices, posterior thoracolumbar fusion devices, lateral thoracolumbar fusion devices, lateral posterior thoracolumbar fusion devices, etc., which are orthopedic intervertebral fusion devices used to induce fusion between the upper and lower vertebrae into a whole. Therefore, it can be applicable to but not limited to cervical fusion, posterior thoracolumbar fusion, lateral thoracolumbar fusion, and lateral posterior thoracolumbar fusion surgeries, so as to achieve real-time monitoring of the surface strain caused by vertebral force during intervertebral fusion in different positions.
具体地,椎间融合器主要用于治疗脊柱骨折、间盘突出引起的脊柱失稳;将椎间融合器通过外科手术植入患者缺损脊椎处,作为缺损脊柱假体辅助患者脊柱位置的力学支撑,恢复脊柱力学稳定;随着脊柱骨缺损的修复,椎间融合器将与新生骨组织融合;在脊柱骨再生的过程中,椎间融合器的稳定性变化引起了可测量的应力应变变化,通过对椎间融合器应力应变的监测可以实现对椎间融合器融合进程的掌握。Specifically, intervertebral fusion devices are mainly used to treat spinal instability caused by spinal fractures and disc herniation; the intervertebral fusion device is implanted into the patient's defective spine through surgery, serving as a defective spinal prosthesis to assist the patient's spinal position in mechanical support and restore the mechanical stability of the spine; as the spinal bone defect is repaired, the intervertebral fusion device will fuse with the new bone tissue; during the process of spinal bone regeneration, changes in the stability of the intervertebral fusion device cause measurable changes in stress and strain, and the fusion process of the intervertebral fusion device can be monitored by monitoring the stress and strain of the intervertebral fusion device.
(3)骨科髓内钉、后入路脊柱固定棒和骨科接骨板的材料可以为碳纤维增强聚醚醚酮,碳纤维增强聚醚醚酮是碳纤维增强的聚醚醚酮复合材料,集中了聚醚醚酮材料和碳纤维材料的优势,质量轻,且具有优异的力学性能、耐化学腐蚀性能和生物兼容性,且此类材料经高能激光束碳化后可以具有高导电性及应力响应特性,其树脂基体电磁干扰较小,这为直接将髓内钉本身、后入路脊柱固定棒本身和骨科接骨板本身转化为传感器件提供了可能。(3) The materials of orthopedic intramedullary nails, posterior approach spinal fixation rods and orthopedic plates can be carbon fiber reinforced polyetheretherketone. Carbon fiber reinforced polyetheretherketone is a carbon fiber reinforced polyetheretherketone composite material, which combines the advantages of polyetheretherketone and carbon fiber materials. It is lightweight and has excellent mechanical properties, chemical corrosion resistance and biocompatibility. After being carbonized by a high-energy laser beam, this type of material can have high conductivity and stress response characteristics, and its resin matrix has low electromagnetic interference, which makes it possible to directly convert the intramedullary nail itself, the posterior approach spinal fixation rod itself and the orthopedic plate itself into a sensor device.
基于不同的骨折或伤患位置,髓内钉可以包括但不限于股骨近端髓内钉、股骨髓内钉、胫骨髓内钉、肱骨髓内钉等长骨髓内钉,以实现针对不同位置的骨折端处受力应变情况的实时监测。Based on different fracture or injury locations, the intramedullary nail may include but is not limited to proximal femoral intramedullary nails, femoral intramedullary nails, tibial intramedullary nails, humeral intramedullary nails and other long intramedullary nails, so as to achieve real-time monitoring of the stress and strain conditions at the fracture ends at different locations.
脊柱固定棒可以包括单轴脊柱固定棒和/或多轴脊柱固定棒,用于椎骨骨折内固定、多轴多节段内固定或椎骨微创手术,以实现针对不同病症的椎骨骨折愈合、椎间融合进程中脊柱受力引起的脊柱固定棒应变情况的实时监测。The spinal fixation rod may include a uniaxial spinal fixation rod and/or a multiaxial spinal fixation rod, which is used for internal fixation of vertebral fractures, multiaxial and multi-segment internal fixation or minimally invasive vertebral surgery, so as to achieve real-time monitoring of the strain of the spinal fixation rod caused by spinal force during vertebral fracture healing and intervertebral fusion for different diseases.
根据不同的骨折伤患位置和用途,如图11所示,接骨板可以适用但不限于锁骨、肱骨近端、肱骨干、肱骨远端内外侧、尺骨、桡骨干、桡骨远端、股骨近端、股骨干、股骨远端、胫骨近端内外侧、胫骨干、胫骨远端、腓骨远端,并基于不同的板、钉的固定原理,如多角度锁定、单一角度锁定、动态加压等方案,接骨板可以包括中和板、支撑板、防滑板和桥接板等类型。According to different fracture injury locations and uses, as shown in Figure 11, the bone plate can be applicable to but not limited to the clavicle, proximal humerus, humeral shaft, medial and lateral distal humerus, ulna, radial shaft, distal radius, proximal femur, femoral shaft, distal femur, medial and lateral proximal tibia, tibial shaft, distal tibia, and distal fibula, and based on different plate and nail fixation principles, such as multi-angle locking, single-angle locking, dynamic compression and other schemes, the bone plate can include neutralization plates, support plates, anti-slip plates and bridging plates.
具体地,髓内钉、后入路固定棒和接骨板均用于骨折后固定,其中,髓内钉主要用于 治疗股骨骨干骨折,实现骨折患处解剖复位后将髓内钉置入髓腔,以骨钉锁定;随着骨折愈合,骨分担负载比例增大,髓内钉负载减小;后入路脊柱固定棒主要用于椎骨骨折的治疗,通常是从背部入路,通过螺钉实现固定棒与椎骨的锁定,完成对椎骨断裂位置的解剖固定;接骨板主要用于长骨干骺端骨折的治疗,通过外科手术将接骨板植入,通过骨钉固定接骨板与骨,实现接骨板对断骨的连接。随着骨折愈合,接骨板承受负载分担减小。Specifically, intramedullary nails, posterior approach fixation rods and bone plates are all used for post-fracture fixation. Among them, intramedullary nails are mainly used for In the treatment of femoral shaft fractures, after the fracture site is anatomically reduced, the intramedullary nail is placed into the medullary cavity and locked with the bone screw; as the fracture heals, the proportion of the load shared by the bone increases, and the load on the intramedullary nail decreases; the posterior approach spinal fixation rod is mainly used for the treatment of vertebral fractures, usually from the back, and the fixation rod and vertebra are locked by screws to complete the anatomical fixation of the vertebral fracture position; the bone plate is mainly used for the treatment of long bone metaphyseal fractures, and the bone plate is implanted through surgery, and the bone screws are used to fix the bone plate and bone to achieve the connection of the bone plate to the broken bone. As the fracture heals, the load sharing of the bone plate decreases.
根据本发明实施例提出的骨科植入物,可以通过原位碳化的方式,将骨科植入物本体表面的一部分转化为具有导电性和传感能力的射频标签电路,通过射频标签电路感知骨科植入物所受应变力且与体外进行通信,可以在不破坏骨科植入物本体原有特性的基础上,赋予了骨科植入物本体传感和通信的能力,且由于原位碳化得到射频标签电路,因此射频标签电路与基体之间的结合非常牢固,不会随着时间的延长而出现结合不牢固的问题,也不会出现谐振响应频率明显升高的问题;射频标签电路由外部设备激发,无需对骨科植入物增加电路和电源,避免了潜在的电化学反应,且不会影响透视;骨科植入物本体本身具有生物兼容性,因此无需对射频标签电路以外的部分进行封装,利用具有生物兼容性的封装体对骨科植入物本体部分封装即可,通过部分封装同时保障生物相容性和射频标签电路的稳定性,有效降低封装的难度和成本,且部分封装不会改变骨科植入物的原有尺寸,因此也可以保持骨科植入物的外形不影响手术植入,利于推广应用。According to the orthopedic implant proposed in the embodiment of the present invention, a part of the surface of the orthopedic implant body can be converted into a radio frequency tag circuit with conductivity and sensing ability by in-situ carbonization. The strain force on the orthopedic implant is sensed by the radio frequency tag circuit and communicated with the outside of the body. The orthopedic implant body can be endowed with sensing and communication capabilities without destroying the original characteristics of the orthopedic implant body. Since the radio frequency tag circuit is obtained by in-situ carbonization, the bonding between the radio frequency tag circuit and the substrate is very strong, and there will be no problem of loose bonding over time, and there will be no problem of significantly increased resonant response frequency. The radio frequency tag circuit is excited by an external device, and there is no need to add circuits and power supplies to the orthopedic implant, thereby avoiding potential electrochemical reactions and not affecting perspective. The orthopedic implant body itself has biocompatibility, so there is no need to encapsulate the part other than the radio frequency tag circuit. The orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body. The partial encapsulation simultaneously ensures biocompatibility and the stability of the radio frequency tag circuit, effectively reducing the difficulty and cost of the encapsulation. The partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting surgical implantation, which is conducive to promotion and application.
其次参照附图描述根据本发明实施例提出应变监测系统。Next, a strain monitoring system according to an embodiment of the present invention is described with reference to the accompanying drawings.
图12是本发明实施例的应变监测系统的方框示意图。FIG. 12 is a block diagram of a strain monitoring system according to an embodiment of the present invention.
如图12所示,该应变监测系统30包括骨科植入物10和外部设备31。As shown in FIG. 12 , the strain monitoring system 30 includes an orthopedic implant 10 and an external device 31 .
其中,外部设备31获取骨科植入物10的谐振峰峰度和谐振频率,基于谐振峰峰度和/或谐振频率进行应变监测,其中,外部设备在体外用天线向骨植入物发射信号,信号中与射频标签电路特征频率一直的电磁波会在回波中形成一个波谷,通过波谷处的特征频率得到射频标签电路的特征频率,基于特征频率解算出应变信息。Among them, the external device 31 obtains the resonance peak-to-peak degree and resonance frequency of the orthopedic implant 10, and performs strain monitoring based on the resonance peak-to-peak degree and/or resonance frequency, wherein the external device uses an antenna in vitro to transmit a signal to the bone implant, and the electromagnetic wave in the signal that is consistent with the characteristic frequency of the radio frequency tag circuit will form a trough in the echo, and the characteristic frequency of the radio frequency tag circuit is obtained through the characteristic frequency at the trough, and the strain information is calculated based on the characteristic frequency.
具体地,外部设备包括天线和处理终端,其中,天线与处理终端相连,在天线靠近骨科植入物上的射频标签电路时,射频标签电路处感应出谐振峰峰度和谐振频率,处理终端分析谐振峰峰度和/或谐振频率,基于分析结果进行应变监测。Specifically, the external device includes an antenna and a processing terminal, wherein the antenna is connected to the processing terminal. When the antenna is close to the radio frequency tag circuit on the orthopedic implant, the resonance peak-peak degree and resonance frequency are sensed at the radio frequency tag circuit. The processing terminal analyzes the resonance peak-peak degree and/or resonance frequency and performs strain monitoring based on the analysis results.
需要说明的是,前述对骨科植入物实施例的解释说明也适用于该实施例的应变监测系统,此处不再赘述。It should be noted that the above explanations of the orthopedic implant embodiment are also applicable to the strain monitoring system of this embodiment, and will not be repeated here.
根据本发明实施例提出的应变监测系统,由于设置有上述实施例的骨科植入物,因此无需对骨科植入物增加电路和电源即可实现应变监测,不仅避免了潜在的电化学反应,而且便于实时检测应变数据信息,可以为实现患者的术后个性化健康管理提供技术支持。The strain monitoring system proposed in the embodiment of the present invention is provided with the orthopedic implant of the above-mentioned embodiment, so strain monitoring can be achieved without adding circuits and power supplies to the orthopedic implant. This not only avoids potential electrochemical reactions, but also facilitates real-time detection of strain data information, and can provide technical support for achieving personalized health management of patients after surgery.
基于上述实施例,本发明还提出了一种骨科植入物的加工方法,该方法用于上述实施例的骨科植入物的加工。Based on the above embodiments, the present invention further proposes a method for processing an orthopedic implant, which is used for processing the orthopedic implant of the above embodiments.
图13是本发明实施例的骨科植入物的加工方法的流程图。 FIG. 13 is a flow chart of a method for processing an orthopedic implant according to an embodiment of the present invention.
如图13所示,该骨科植入物的加工方法包括以下步骤:As shown in FIG13 , the processing method of the orthopedic implant comprises the following steps:
在步骤S101中,获取骨科植入物的类型和骨科植入物本体的材料。In step S101, the type of orthopedic implant and the material of the orthopedic implant body are obtained.
其中,骨科植入物的类型可以包括但不限于骨科椎间融合器、骨科髓内钉、后入路脊柱固定棒、骨科接骨板和关节垫片;骨科植入物本体的材料包括但不限于聚醚醚酮、碳纤维增强聚醚醚酮或聚醚醚酮与高交联聚乙烯的复合材料等具有生物兼容性的材料。Among them, the types of orthopedic implants may include but are not limited to orthopedic intervertebral fusion devices, orthopedic intramedullary nails, posterior approach spinal fixation rods, orthopedic bone plates and joint gaskets; the materials of the orthopedic implant body include but are not limited to polyetheretherketone, carbon fiber reinforced polyetheretherketone or a composite material of polyetheretherketone and highly cross-linked polyethylene and other biocompatible materials.
在步骤S102中,根据骨科植入物的类型和骨科植入物本体的材料设计射频标签电路的标签图案,根据标签图案和骨科植入物本体的材料确定骨科植入物的加工参数。In step S102, a label pattern of a radio frequency tag circuit is designed according to the type of the orthopedic implant and the material of the orthopedic implant body, and a processing parameter of the orthopedic implant is determined according to the label pattern and the material of the orthopedic implant body.
可以理解的是,本发明实施例可以综合考虑骨科植入物的类型和骨科植入物本体的材料设计射频标签电路的标签图案,使得射频标签电路可以更好与骨科植入物匹配,并基于标签图案和骨科植入物本体的材料确定具体加工参数,提升加工的精度。It can be understood that the embodiments of the present invention can comprehensively consider the type of orthopedic implant and the material of the orthopedic implant body to design the label pattern of the radio frequency tag circuit, so that the radio frequency tag circuit can better match the orthopedic implant, and determine the specific processing parameters based on the label pattern and the material of the orthopedic implant body to improve the processing accuracy.
在本发明一个实施例中,根据标签图案和骨科植入物本体的材料确定骨科植入物的加工参数,包括:当骨植入物材料为碳纤维增强聚醚醚酮时,采用红外或紫外或绿光波长的纳秒、皮秒、飞秒脉冲激光加工,当骨植入物材料为聚醚醚酮时,采用红外或紫外或绿光波长的纳秒、皮秒、飞秒脉冲激光加工;当标签图案为方形或圆形开口环时,针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取第一目标加工速度和第二目标加工速度;当标签图案为齿状时,针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取第三目标加工速度和第四目标加工速度,其中,第三目标加工速度大于第一目标加工速度,第四目标加工速度大于第二目标加工速度;获取加工过程中骨科植入物的电阻和特征峰的峰度,根据电阻和特征峰的峰度调整骨科植入物的加工参数。In one embodiment of the present invention, the processing parameters of the orthopedic implant are determined according to the label pattern and the material of the orthopedic implant body, including: when the bone implant material is carbon fiber reinforced polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is used; when the bone implant material is polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with infrared, ultraviolet, or green wavelengths is used; when the label pattern is a square or circular open ring, a first target processing speed and a second target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively; when the label pattern is a toothed shape, a third target processing speed and a fourth target processing speed are selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone, respectively, wherein the third target processing speed is greater than the first target processing speed, and the fourth target processing speed is greater than the second target processing speed; the resistance of the orthopedic implant and the kurtosis of the characteristic peak are obtained during the processing, and the processing parameters of the orthopedic implant are adjusted according to the resistance and the kurtosis of the characteristic peak.
其中,第一目标加工速度可以为50-200cm/min,第二目标加工速度可以为40-100cm/min,第三目标加工速度可以为10-50cm/min,第四目标加工速度可以为10-40cm/min,可根据实际情况进行具体选定,不做具体限定。Among them, the first target processing speed can be 50-200cm/min, the second target processing speed can be 40-100cm/min, the third target processing speed can be 10-50cm/min, and the fourth target processing speed can be 10-40cm/min. They can be selected according to actual conditions without specific limitation.
具体而言,当骨植入物材料为碳纤维增强聚醚醚酮,采用红外或紫外或绿光等波长的纳秒、皮秒、飞秒脉冲激光加工,其加工参数为频率60k-600kHz,离焦距离为0-7mm,加工速度为10-200cm/min。当骨植入物材料为聚醚醚酮时,采用红外或紫外或绿光等波长的纳秒、皮秒、飞秒脉冲激光加工,其加工参数为频率60k-600kHz,离焦距离为3-10mm,加工速度为10-100cm/min。当标签图案为方形或圆形开口环时,因为其线条较粗,可以针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取50-200cm/min、40-100cm/min的加工速度,以提升效率,同时不影响碳化图案的导线效果;当标签图案为齿状时,因为其线条较细,可以针对碳纤维增强聚醚醚酮和聚醚醚酮分别选取10-50cm/min、10-40cm/min的加工速度,以提升热输入,保障碳化效果和图案的电导率,进而保障标签电路被天线读取时的灵敏度。Specifically, when the bone implant material is carbon fiber reinforced polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with wavelengths such as infrared, ultraviolet, or green light is used, and the processing parameters are a frequency of 60k-600kHz, a defocus distance of 0-7mm, and a processing speed of 10-200cm/min. When the bone implant material is polyetheretherketone, nanosecond, picosecond, or femtosecond pulse laser processing with wavelengths such as infrared, ultraviolet, or green light is used, and the processing parameters are a frequency of 60k-600kHz, a defocus distance of 3-10mm, and a processing speed of 10-100cm/min. When the label pattern is a square or circular open ring, because its lines are thicker, the processing speeds of 50-200cm/min and 40-100cm/min can be selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone respectively to improve efficiency without affecting the conductor effect of the carbonized pattern; when the label pattern is serrated, because its lines are thinner, the processing speeds of 10-50cm/min and 10-40cm/min can be selected for carbon fiber reinforced polyetheretherketone and polyetheretherketone respectively to improve heat input, ensure the carbonization effect and the conductivity of the pattern, and then ensure the sensitivity of the label circuit when being read by the antenna.
在本发明一个实施例中,根据骨科植入物的类型和骨科植入物本体的材料设计射频标签电路的标签图案,包括:根据骨科植入物的类型确定对应骨骼的应力状态;根据骨科植入物本体的材料确定骨科植入物的特性;根据骨骼的应力状态和骨科植入物的特性设计射频标签电路的标签图案。In one embodiment of the present invention, a label pattern of a radio frequency tag circuit is designed according to the type of orthopedic implant and the material of the orthopedic implant body, including: determining the stress state of the corresponding bone according to the type of orthopedic implant; determining the characteristics of the orthopedic implant according to the material of the orthopedic implant body; and designing the label pattern of the radio frequency tag circuit according to the stress state of the bone and the characteristics of the orthopedic implant.
可以理解的是,本发明实施例由于骨科植入物类型和材料的不同,因此基于骨骼的应 力状态和骨科植入物的特征所设计出的射频标签电路的标签图案也有所不同,使得射频标签电路可以更好与骨科植入物相匹配。It is understandable that the embodiments of the present invention are different in type and material of orthopedic implants, so the application of bone The tag pattern of the RFID tag circuit designed according to the force state and the characteristics of the orthopedic implant is also different, so that the RFID tag circuit can be better matched with the orthopedic implant.
在本发明一个实施例中,根据骨骼的应力状态和骨科植入物的特性设计射频标签电路的标签图案,包括:对骨科植入物进行建模,模拟植入人体后的受力状态;识别模拟结果中应变力大于预设值的位置作为射频标签电路的加工位置;结合骨科植入物的尺寸对射频标签电路进行有限元仿真,根据仿真结果调整加工位置处射频标签电路的间距和/或开口距离,直到射频标签电路的尺寸和特征频率符合骨科植入物的加工要求,且射频标签电路的特征峰区别于人体组织和血液的特征峰。In one embodiment of the present invention, a label pattern of a radio frequency tag circuit is designed according to the stress state of the bone and the characteristics of an orthopedic implant, including: modeling the orthopedic implant to simulate the stress state after implantation into the human body; identifying the position where the strain force is greater than a preset value in the simulation result as the processing position of the radio frequency tag circuit; performing finite element simulation on the radio frequency tag circuit in combination with the size of the orthopedic implant, and adjusting the spacing and/or opening distance of the radio frequency tag circuit at the processing position according to the simulation result until the size and characteristic frequency of the radio frequency tag circuit meet the processing requirements of the orthopedic implant, and the characteristic peak of the radio frequency tag circuit is distinguished from the characteristic peak of human tissue and blood.
其中,预设值可以基于实际情况进行设定,不做具体限定。Among them, the preset value can be set based on actual conditions without specific limitation.
具体而言,首先在Comsol等仿真软件中对骨植入物进行建模,并模拟其植入人体后的受力状态,选取其中的大应变位置作为标签电路的加工部分,以保障应变监测的准确定和可靠性。针对不同类型、材料的骨植入物,其弹性模量、形状、受力方式均不同,导致其最大应变位置产生变化。因此需要对对不同骨植入物应变状态进行各自仿真,并确定标签电路的加工位置。Specifically, the bone implant is first modeled in Comsol and other simulation software, and its stress state after implantation in the human body is simulated. The large strain position is selected as the processing part of the tag circuit to ensure the accuracy and reliability of strain monitoring. For bone implants of different types and materials, their elastic modulus, shape, and stress mode are different, resulting in changes in their maximum strain position. Therefore, it is necessary to simulate the strain states of different bone implants and determine the processing position of the tag circuit.
同时,结合骨板的尺寸对标签电路的效果进行有限元仿真,其需要满足两个需求,一个是其尺寸适合在骨植入物上进行加工,另一个是加工后的图案特征频率与人体组织和血液的特征峰有明显区分。At the same time, finite element simulation of the effect of the tag circuit is carried out in combination with the size of the bone plate. It needs to meet two requirements: one is that its size is suitable for processing on bone implants, and the other is that the characteristic frequency of the processed pattern is clearly distinguishable from the characteristic peaks of human tissue and blood.
在Comsol等仿真软件中根据骨植入物的尺寸对天线进行建模,并通过修改环间距、开口距离等参数进行特征频率仿真,最终的得到特征频率合适且可以加工在骨板上的标签电路。The antenna is modeled according to the size of the bone implant in simulation software such as Comsol, and the characteristic frequency simulation is performed by modifying parameters such as the ring spacing and opening distance. Finally, a tag circuit with a suitable characteristic frequency that can be processed on the bone plate is obtained.
在此基础上,本发明实施例可以在具有解剖形态骨植入物上,根据力学特征的定制传感器,由于骨植入物具有解剖形态,如骨板需要适应骨形,椎间融合器需要与脊椎形状相近等,因此表面为不规则曲面。根据人体骨的实际力学性质,在特定部位会存在应力集中的现象,因此需要在该位置原位加工应力应变传感器。而对于解剖形态的骨植入物,首先通过有限元仿真分析其应力集中处,再使用多自由度激光加工技术对部位原位激光加工传感器,达到定制的目的。On this basis, the embodiments of the present invention can customize sensors based on mechanical characteristics on bone implants with anatomical morphology. Since bone implants have anatomical morphology, such as the bone plate needs to adapt to the bone shape, the intervertebral fusion device needs to be close to the shape of the spine, etc., the surface is an irregular curved surface. According to the actual mechanical properties of human bones, there will be stress concentration in specific parts, so it is necessary to process stress and strain sensors in situ at this location. For bone implants with anatomical morphology, the stress concentration points are first analyzed through finite element simulation, and then the multi-degree-of-freedom laser processing technology is used to in-situ laser process the sensors at the parts to achieve the purpose of customization.
举例而言,由于骨植入物具有解剖形态,因此需要根据人体骨解剖形态的生物力学有限元仿真,获得人体骨解剖形态的应力集中处或易失效处,从而进行特定区域原位多自由度激光加工传感电路。其中,骨科椎间融合器主要用于治疗脊柱骨折、间盘突出引起的脊柱失稳;由于椎间融合器需要去适应脊椎,因此形状需与脊椎形状相近,其表面为不规则曲面,在不同情况下其特定部位会存在应力集中的情况,并且由于脊柱是人体运动的主轴,由多个椎体、多重关节(椎间“关节”、椎小关节)、众多肌肉和韧带紧紧围绕、生理弯曲,以满足脊柱的坚固性和可动性(柔韧性),其活动有三维方向(前后、左右、旋转)和六个自由度(3个平动、3个转动),因此需要采用多自由度加工方式对所需应力集中处或易失效处进行特定区域原位多自由度激光加工传感电路,使得读取其及网分析仪能够接收来自不同的射频标签电路的应力信号。 For example, since bone implants have anatomical morphology, it is necessary to obtain stress concentration points or failure-prone points of human bone anatomical morphology based on biomechanical finite element simulation of human bone anatomical morphology, so as to perform in-situ multi-degree-of-freedom laser processing sensor circuits in specific areas. Among them, orthopedic intervertebral fusion devices are mainly used to treat spinal instability caused by spinal fractures and disc herniation; since the intervertebral fusion device needs to adapt to the spine, its shape needs to be similar to the shape of the spine, and its surface is an irregular curved surface. Under different circumstances, stress concentration will exist in its specific parts. In addition, since the spine is the main axis of human movement, it is tightly surrounded and physiologically bent by multiple vertebrae, multiple joints (intervertebral "joints", facet joints), and numerous muscles and ligaments to meet the firmness and mobility (flexibility) of the spine. Its activities have three-dimensional directions (front and back, left and right, rotation) and six degrees of freedom (3 translations, 3 rotations). Therefore, it is necessary to use a multi-degree-of-freedom processing method to perform in-situ multi-degree-of-freedom laser processing sensor circuits in specific areas of the required stress concentration points or failure-prone points, so that the reader and network analyzer can receive stress signals from different radio frequency tag circuits.
在步骤S103中,根据加工参数对骨科植入物本体表面的目标位置处进行原位碳化,得到射频标签电路,并利用具有生物兼容性的封装体对标签电路表面进行封装。In step S103, in-situ carbonization is performed on the target position on the surface of the orthopedic implant body according to the processing parameters to obtain a radio frequency tag circuit, and the surface of the tag circuit is packaged with a biocompatible packaging body.
可以理解的是,本发明实施例在原位碳化形成射频标签电路之后,由于骨科植入物本体本身具有生物兼容性,因此无需对射频标签电路以外的部分进行封装,利用具有生物兼容性的封装体对骨科植入物本体部分封装即可,通过部分封装同时保障生物相容性和射频标签电路的稳定性,有效降低封装的难度和成本,且部分封装不会改变骨科植入物的原有尺寸,因此也可以保持骨科植入物的外形不影响手术植入,利于推广应用。It can be understood that after the radio frequency tag circuit is formed by in-situ carbonization in the embodiment of the present invention, since the orthopedic implant body itself has biocompatibility, there is no need to encapsulate the part other than the radio frequency tag circuit. The orthopedic implant body can be partially encapsulated using a biocompatible encapsulation body. The biocompatibility and stability of the radio frequency tag circuit are guaranteed by partial encapsulation, which effectively reduces the difficulty and cost of packaging. In addition, partial encapsulation will not change the original size of the orthopedic implant, so the appearance of the orthopedic implant can be maintained without affecting the surgical implantation, which is conducive to promotion and application.
在本发明的一个实施例中,本发明实施例根据加工参数对骨科植入物本体表面的目标位置处进行原位碳化,包括:对所述骨科植入物本体表面规划加工路径;通过激光、聚焦镜、多自由度机械运动机构与扫描振镜按照加工路径进行多自由度加工,其中,扫描振镜的扫描速度大于多自由度机械运动机构的运动速度,激光通过聚焦镜聚焦于骨科植入物本体表面,控制激光聚焦平面与待原位碳化区域之间的距离,实现对任意曲面的原位碳化加工。In one embodiment of the present invention, the embodiment of the present invention performs in-situ carbonization on a target position on the surface of an orthopedic implant body according to processing parameters, including: planning a processing path for the surface of the orthopedic implant body; performing multi-degree-of-freedom processing according to the processing path through a laser, a focusing mirror, a multi-degree-of-freedom mechanical motion mechanism and a scanning galvanometer, wherein the scanning speed of the scanning galvanometer is greater than the movement speed of the multi-degree-of-freedom mechanical motion mechanism, the laser is focused on the surface of the orthopedic implant body through the focusing mirror, and the distance between the laser focusing plane and the area to be in-situ carbonized is controlled to achieve in-situ carbonization processing of any curved surface.
需要说明的是,为实现附形加工,需要采用多自由度加工,具体地,可以通过结合多自由度机械运动机构与扫描振镜,以实现更高的加工效率,对于近似平面区域加工,可采用扫描速度远大于多自由度机械运动机构的扫描振镜,而在曲面曲率较大的区域,需通过扫描振镜结合机械运动结构进行加工,主要通过CAE(Computer Aided Engineering,计算机辅助工程)路径规划仿真对曲面轨迹进行离线规划,以控制多自由度机械设备实现激光对曲面的等离焦匀速扫描,并保证激光光轴与曲面实时垂直。It should be noted that in order to achieve conformal processing, multi-degree-of-freedom processing is required. Specifically, a multi-degree-of-freedom mechanical motion mechanism can be combined with a scanning galvanometer to achieve higher processing efficiency. For processing in approximately planar areas, a scanning galvanometer with a scanning speed much faster than that of the multi-degree-of-freedom mechanical motion mechanism can be used. In areas with large surface curvature, processing is required through a scanning galvanometer combined with a mechanical motion structure. The surface trajectory is mainly planned offline through CAE (Computer Aided Engineering) path planning simulation to control the multi-degree-of-freedom mechanical equipment to achieve isotropic uniform-speed scanning of the laser on the surface and ensure that the laser optical axis is perpendicular to the surface in real time.
具体而言,本发明可以使用扫描振镜、机械臂、多轴机床、索驱动机器人等其中的一种或多种组合来调整激光器激光的空间位姿或待碳化器件的位姿或同时改变两者位姿,所达到的目的为:激光可以聚焦于待碳化器件的表面任意一处。激光通过聚焦镜聚焦于待碳化器件表面的某处,使用同轴激光测距测得激光聚焦镜距待碳化处的距离,从而实现控制加工过程中激光焦平面与待碳化表面的距离。Specifically, the present invention can use one or more combinations of scanning galvanometers, robotic arms, multi-axis machine tools, cable-driven robots, etc. to adjust the spatial position of the laser or the position of the device to be carbonized or change the positions of both at the same time, so that the laser can be focused on any point on the surface of the device to be carbonized. The laser is focused on a certain point on the surface of the device to be carbonized through a focusing mirror, and the distance between the laser focusing mirror and the point to be carbonized is measured using a coaxial laser rangefinder, thereby controlling the distance between the laser focal plane and the surface to be carbonized during the processing.
下面将通过一个具体实施例对骨科植入物的加工方法进行阐述,如图14所示,包括以下步骤:The following will describe a method for processing an orthopedic implant through a specific embodiment, as shown in FIG14 , comprising the following steps:
(1)根据骨骼应力状态及骨科植入物特性设计射频标签电路;(1) Design RFID tag circuits based on bone stress state and orthopedic implant characteristics;
(2)在骨科骨科植入物本体上加工射频标签电路的标签图案,并对骨科骨科植入物本体的加工位置处进行封装;(2) processing a label pattern of a radio frequency label circuit on the orthopedic implant body, and encapsulating the processed position of the orthopedic implant body;
(3)将加工得到的骨科植入物安放至对应位置,比如膝关节软骨假体、髓内钉、脊柱融合器等,并在体外使用读取其及网分析仪接收射频标签电路的应力信号,并对获取的传感器信息进行后处理以及医学评估。(3) Place the processed orthopedic implants in the corresponding positions, such as knee cartilage prostheses, intramedullary nails, spinal fusion devices, etc., and use a reader and network analyzer in vitro to receive the stress signal of the RFID tag circuit, and post-process and medically evaluate the acquired sensor information.
由此,本发明实施例选择了合适的接收天线,在网络矢量分析仪等工具的帮助下,即可实现在体外接受无源骨植入物传感器的信号,并将其解算得到需要的信息,达到实时检测骨骼愈合过程中应力状态的目标。Therefore, the embodiment of the present invention selects a suitable receiving antenna, and with the help of tools such as a network vector analyzer, it is possible to receive the signal of the passive bone implant sensor in vitro and resolve it to obtain the required information, thereby achieving the goal of real-time detection of the stress state during bone healing.
需要说明的是,前述对骨科植入物实施例的解释说明也适用于该实施例的骨科植入物 的加工方法,此处不再赘述。It should be noted that the above explanations of the orthopedic implant embodiment are also applicable to the orthopedic implant of this embodiment. The processing method will not be described here.
根据本发明实施例提出的骨科植入物的加工方法,使用多自由度激光加工方法可以实现任意曲面的碳化加工,适用于具有解剖结构的骨科植入物器件,从而实现对需要碳化加工的任意区域进行原位激光加工。According to the processing method of orthopedic implants proposed in an embodiment of the present invention, a multi-degree-of-freedom laser processing method can be used to achieve carbonization processing of any curved surface, which is suitable for orthopedic implant devices with anatomical structures, thereby achieving in-situ laser processing of any area requiring carbonization processing.
图15为本发明实施例提供的加工设备的结构示意图。该加工设备可以包括:FIG15 is a schematic diagram of the structure of a processing device provided by an embodiment of the present invention. The processing device may include:
存储器1501、处理器1502及存储在存储器1501上并可在处理器1502上运行的计算机程序。Memory 1501 , processor 1502 , and a computer program stored in the memory 1501 and executable on the processor 1502 .
处理器1502执行程序时实现上述实施例中提供的骨科植入物的加工方法。When the processor 1502 executes the program, the orthopedic implant processing method provided in the above embodiment is implemented.
进一步地,加工设备还包括:Furthermore, the processing equipment also includes:
通信接口1503,用于存储器1501和处理器1502之间的通信。The communication interface 1503 is used for communication between the memory 1501 and the processor 1502 .
存储器1501,用于存放可在处理器1502上运行的计算机程序。The memory 1501 is used to store computer programs that can be executed on the processor 1502 .
存储器1501可能包含高速RAM(Random Access Memory,随机存取存储器)存储器,也可能还包括非易失性存储器,例如至少一个磁盘存储器。Memory 1501 may include high-speed RAM (Random Access Memory) memory, and may also include non-volatile memory, such as at least one disk storage.
如果存储器1501、处理器1502和通信接口1503独立实现,则通信接口1503、存储器1501和处理器1502可以通过总线相互连接并完成相互间的通信。总线可以是ISA(Industry Standard Architecture,工业标准体系结构)总线、PCI(Peripheral Component,外部设备互连)总线或EISA(Extended Industry Standard Architecture,扩展工业标准体系结构)总线等。总线可以分为地址总线、数据总线、控制总线等。为便于表示,图15中仅用一条粗线表示,但并不表示仅有一根总线或一种类型的总线。If the memory 1501, the processor 1502 and the communication interface 1503 are implemented independently, the communication interface 1503, the memory 1501 and the processor 1502 can be connected to each other through a bus and communicate with each other. The bus can be an ISA (Industry Standard Architecture) bus, a PCI (Peripheral Component) bus or an EISA (Extended Industry Standard Architecture) bus, etc. The bus can be divided into an address bus, a data bus, a control bus, etc. For ease of representation, only one thick line is used in FIG15, but it does not mean that there is only one bus or one type of bus.
可选的,在具体实现上,如果存储器1501、处理器1502及通信接口1503,集成在一块芯片上实现,则存储器1501、处理器1502及通信接口1503可以通过内部接口完成相互间的通信。Optionally, in a specific implementation, if the memory 1501, the processor 1502 and the communication interface 1503 are integrated on a chip, the memory 1501, the processor 1502 and the communication interface 1503 can communicate with each other through an internal interface.
处理器1502可能是一个CPU(Central Processing Unit,中央处理器),或者是ASIC(Application Specific Integrated Circuit,特定集成电路),或者是被配置成实施本发明实施例的一个或多个集成电路。Processor 1502 may be a CPU (Central Processing Unit), or an ASIC (Application Specific Integrated Circuit), or one or more integrated circuits configured to implement an embodiment of the present invention.
本发明实施例还提供一种计算机可读存储介质,其上存储有计算机程序,该程序被处理器执行时实现如上的骨科植入物的加工方法。An embodiment of the present invention further provides a computer-readable storage medium having a computer program stored thereon, and when the program is executed by a processor, the above-mentioned method for processing an orthopedic implant is implemented.
在本说明书的描述中,参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不是必须针对的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任一个或N个实施例或示例中以合适的方式结合。此外,在不相互矛盾的情况下,本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例 的特征进行结合和组合。In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or N embodiments or examples in a suitable manner. In addition, those skilled in the art may refer to different embodiments or examples described in this specification and different embodiments or examples in detail without contradiction. features to combine and assemble.
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中,“N个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "N" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.
流程图中或在此以其他方式描述的任何过程或方法描述可以被理解为,表示包括一个或N个用于实现定制逻辑功能或过程的步骤的可执行指令的代码的模块、片段或部分,并且本发明的优选实施方式的范围包括另外的实现,其中可以不按所示出或讨论的顺序,包括根据所涉及的功能按基本同时的方式或按相反的顺序,来执行功能,这应被本发明的实施例所属技术领域的技术人员所理解。Any process or method description in a flowchart or otherwise described herein may be understood to represent a module, fragment or portion of code comprising one or N executable instructions for implementing the steps of a custom logical function or process, and the scope of the preferred embodiments of the present invention includes alternative implementations in which functions may not be performed in the order shown or discussed, including performing functions in a substantially simultaneous manner or in reverse order depending on the functions involved, which should be understood by technicians in the technical field to which the embodiments of the present invention belong.
应当理解,本发明的各部分可以用硬件、软件、固件或它们的组合来实现。在上述实施方式中,N个步骤或方法可以用存储在存储器中且由合适的指令执行系统执行的软件或固件来实现。如,如果用硬件来实现和在另一实施方式中一样,可用本领域公知的下列技术中的任一项或他们的组合来实现:具有用于对数据信号实现逻辑功能的逻辑门电路的离散逻辑电路,具有合适的组合逻辑门电路的专用集成电路,可编程门阵列,现场可编程门阵列等。It should be understood that the various parts of the present invention can be implemented by hardware, software, firmware or a combination thereof. In the above embodiment, the N steps or methods can be implemented by software or firmware stored in a memory and executed by a suitable instruction execution system. For example, if implemented by hardware, as in another embodiment, it can be implemented by any one of the following technologies known in the art or their combination: a discrete logic circuit having a logic gate circuit for implementing a logic function on a data signal, a dedicated integrated circuit having a suitable combination of logic gate circuits, a programmable gate array, a field programmable gate array, etc.
本技术领域的普通技术人员可以理解实现上述实施例方法携带的全部或部分步骤是可以通过程序来指令相关的硬件完成,所述的程序可以存储于一种计算机可读存储介质中,该程序在执行时,包括方法实施例的步骤之一或其组合。A person skilled in the art may understand that all or part of the steps in the method for implementing the above-mentioned embodiment may be completed by instructing related hardware through a program, and the program may be stored in a computer-readable storage medium, which, when executed, includes one or a combination of the steps of the method embodiment.
尽管上面已经示出和描述了本发明的实施例,可以理解的是,上述实施例是示例性的,不能理解为对本发明的限制,本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。 Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.
Claims (14)
Applications Claiming Priority (12)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211373458.2A CN115414137A (en) | 2022-11-04 | 2022-11-04 | Tag circuit, bone implant, bone strain detection system and method |
| CN202211373487.9 | 2022-11-04 | ||
| CN202211373458.2 | 2022-11-04 | ||
| CN202211373486.4A CN115414104A (en) | 2022-11-04 | 2022-11-04 | Posterior approach spine fixing rod and monitoring system for strain of fixing rod caused by spine stress |
| CN202211373472.2 | 2022-11-04 | ||
| CN202211373450.6 | 2022-11-04 | ||
| CN202211373450.6A CN115414158A (en) | 2022-11-04 | 2022-11-04 | Processing method, device, equipment, monitoring system and medium of intelligent joint prosthesis |
| CN202211373487.9A CN115414105A (en) | 2022-11-04 | 2022-11-04 | Stress and strain monitoring system and method for orthopedic intramedullary nail and human fracture end |
| CN202211373488.3 | 2022-11-04 | ||
| CN202211373472.2A CN115414107A (en) | 2022-11-04 | 2022-11-04 | Bone fracture plate for orthopedics department, system and method for monitoring skeletal strain of human body and storage medium |
| CN202211373488.3A CN115414162A (en) | 2022-11-04 | 2022-11-04 | Orthopedic intervertebral fusion cage, strain monitoring system and method caused by vertebral body fusion |
| CN202211373486.4 | 2022-11-04 |
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