The present disclosure relates to the field of wireless sensing, particularly to a CFR-PEEK orthopedic implant and a preparation method therefor, and a wireless sensing device.
Monitoring of postoperative healing in orthopedics has always been an important and difficult research topic. In the process of postoperative rehabilitation, different weight bearing and activity patterns will affect a force suffered by and a slight motion of a fracture part, thereby having an irreversible influence on the healing of the part.
Currently, the most commonly used postoperative observation method is an X-ray plain film or X-Ray Computer Tomography (CT). However, the ionizing radiation of X-rays and the inconvenience of follow-up visits result in a low sampling frequency for this method, and fail to meet a demand on convenient monitoring at any time.
Therefore, if real-time detection and continuous monitoring of an orthopedic injury part can be performed, surgery and postoperative rehabilitation can be guided better, thereby a complication can be found and treated more timely.
The present disclosure is made based on the inventor's discovery and understanding of the following facts and issues.
As described above, an X-ray plain film or X-Ray CT cannot conveniently detect healing of an injured part at any time. A method of additionally adhering a sensor to an orthopedic implant and detecting the healing of an injured part by using an extracorporeal antenna to detect signals has obvious shortcomings: the additionally adhered sensor is adhered to a metal implant by a glue, after working in a body for a long time, the viscosity of the adhesion layer (i.e., the glue layer) decreases, which leads to a poor adherence of the sensor to the metal implant matrix, resulting in a stiffness mismatch problem, which consequently leads to a decrease in the capacitance C and the inductance L of the whole system. According to the resonant frequency calculation formula RRF=1/(2π√{square root over (L·C)}), when the capacitance and the inductance decrease, the resonant frequency will increase, making the resonant response frequency of the sensor itself high, which consequently affects a difficulty of in-vitro detecting and the wireless-sensing-signal receiving, meanwhile, the sensitivity of the sensor will also be greatly reduced, which is not conducive to real-time detection and continuous monitoring of the injured part.
Carbon fiber reinforced polyether-ether-ketone (CFR-PEEK) has comprehensive performance such as excellent mechanical performance, chemical erosion resistance performance and biological compatibility, etc. Through a large number of experimental studies, the inventor found that a patterned carbonization layer can be formed by performing surface carbonization of the CFR-PEEK, the carbonization layer can be used to sense a mechanical change, temperature change or chemical change of an injured part in a body, and these changes can be transferred to an external terminal through signal conversion and transmission, so that healing of the injured part can be known via signals obtained from the terminal.
In view of this, it is one aspect of the present disclosure to provide a CFR-PEEK orthopedic implant, including a CFR-PEEK matrix and a patterned carbonization layer. The patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix. Thus, the patterned carbonization layer formed in situ on the CFR-PEEK matrix may be used to sense a mechanical signal, temperature signal or chemical signal, and may be used in conjunction with an in-vitro probe or an in-vivo signal transduction device to detect and monitor the healing of an injured part in real time, so that a complication can be found in time, and surgery and postoperative rehabilitation can be guided better.
According to embodiments of the present disclosure, the CFR-PEEK orthopedic implant further includes a circuit structure which is provided near the patterned carbonization layer. The circuit structure includes a Wheatstone bridge circuit, an ADC module and a Bluetooth module. The circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module.
According to embodiments of the present disclosure, the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal; the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal. Thus, patterned carbonization layers having different shapes can be used to feed back different signals, which can reflect healing of an injured part more comprehensively.
It is another aspect of the present disclosure to provide a method for preparing a CFR-PEEK orthopedic implant, including: providing a CFR-PEEK matrix; and performing in-situ carbonization of a surface of the CFR-PEEK matrix, to form a patterned carbonization layer. Thus, the patterned carbonization layer may be formed by using in-situ carbonization, the CFR-PEEK orthopedic implant is used to treat fractures, etc., and the patterned carbonization layer formed by in-situ carbonization may be used to sense a mechanical signal, temperature signal, chemical signal of an injured part, which is conducive to real-time detection and monitoring of the injured part, timely detection of a complication, and better guidance for surgery and postoperative recovery.
According to embodiments of the present disclosure, the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal; the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal.
According to embodiments of the present disclosure, the in-situ carbonization is performed by laser irradiation.
According to embodiments of the present disclosure, the laser irradiation adopts ultraviolet nanosecond laser, and adopts a power of 5 W-10 W, a repetition frequency of 40 kHz-100 kHz, a scanning speed of 20-110 mm/s, and a defocusing amount of 2-10 mm.
It is still another aspect of the present disclosure to provide a wireless sensing device, including the aforementioned CFR-PEEK orthopedic implant, and the CFR-PEEK orthopedic implant is used to be implanted into a human body or an animal body. Thus, the wireless sensing device has all the features and advantages of the aforementioned CFR-PEEK orthopedic implant, which are not repeated here. In general, the wireless sensing device can detect in real time and continuously monitor the healing of the injured part, and can better guide surgery and postoperative healing.
According to embodiments of the present disclosure, the CFR-PEEK orthopedic implant further includes a circuit structure which is provided near the patterned carbonization layer. The circuit structure includes a Wheatstone bridge circuit, an ADC module and a Bluetooth module. The circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module to be converted into a digital voltage signal, the digital voltage signal is then transmitted out through the Bluetooth module. The wireless sensing device further includes a mobile terminal which is used to receive a digital voltage signal transmitted by the Bluetooth module, and convert the digital voltage signal into the resistance signal and display it.
According to embodiments of the present disclosure, a wireless sensing device includes the aforementioned CFR-PEEK orthopedic implant, and the CFR-PEEK orthopedic implant is used to be implanted into a human body or an animal body. The wireless sensing device further includes an in-vitro probe and a network analyzer. The in-vitro probe releases a first alternating electromagnetic field, after the patterned carbonization layer senses a mechanical signal, a temperature signal or a chemical signal, a resonant frequency of the patterned carbonization layer will change, and the patterned carbonization layer generates an induced current under the first alternating electromagnetic field to generate a second alternating electromagnetic field, the second alternating electromagnetic field causes the first alternating electromagnetic field to change, the in-vitro probe senses a change in the first alternating electromagnetic field and transmits it to the network analyzer, and the network analyzer converts the change of the first alternating electromagnetic field into an alternating current signal and converts the alternating current signal into an offset of a peak value of the resonant frequency and displays the offset, so as to obtain information on the mechanical signal, chemical signal or temperature signal at an orthopedic implant injury in a human or an animal by analysis.
The above and/or additional aspects and advantages of the present disclosure will become obvious and easily understood from the description of embodiments in conjunction with the following drawings. In the drawings:
Embodiments of the present disclosure are described in detail below. It should be noted that the embodiments described below are exemplary and are intended only to explain the present disclosure and cannot be understood as limitations on the present disclosure. If a specific technology or condition is not indicated in an embodiment, technologies or conditions described in the literatures in the art, or product specifications shall be followed. A reagent or an instrument used, in which a manufacturer is not indicated, are conventional products that can be obtained through market purchase.
It is one aspect of the present disclosure to provide a carbon fiber reinforced polyether-ether-ketone (CFR-PEEK) orthopedic implant, referring to
According to the embodiments of the present disclosure, the patterned carbonization layer 20 in the CFR-PEEK orthopedic implant 100 may have different patterns to feed back different signal features. Specifically, according to a specific embodiment of the present disclosure, referring to
According to embodiments of the present disclosure, referring to
It is another aspect of the present disclosure to provide a method for preparing a CFR-PEEK orthopedic implant, including:
S100: providing a CFR-PEEK matrix.
In this step, a CFR-PEEK matrix is provided. The CFR-PEEK is a polyether-ether-ketone composite material with a reinforced carbon fiber, concentrates advantages of a polyether-ether-ketone material and a carbon fiber material, has a light mass, and has excellent mechanical performance, excellent chemical erosion resistance performance and excellent biological compatibility, so that the CFR-PEEK can be used as an orthopedic implant.
S200: performing in-situ carbonization of a surface of the CFR-PEEK matrix.
In this step, a patterned carbonization layer is formed by performing in-situ carbonization of a surface of the CFR-PEEK matrix, so by this simple method, the patterned carbonization layer can be formed on a surface of the CFR-PEEK matrix. The pattered carbonization layer in the CFR-PEEK orthopedic implant can be used to sense a mechanical signal, temperature signal or chemical signal in a body, which is conducive to real-time detection and real-time monitoring of healing of an injured part.
The shapes of the patterned carbonization layer have been described in detail in the preceding text, and are not repeated here.
According to the embodiments of the present disclosure, a specific mode of performing in-situ carbonization of the CFR-PEEK matrix may be laser irradiation. Specifically, laser may be directly irradiated on a surface of the CFR-PEEK, so that a carbonization conductive layer with high conductivity is carbonized on an accurately selected region of the surface of the CFR-PEEK by means of instantaneous high-temperature laser carbonization. The carbonization conductive layer is directly used as an in-situ sensor for sensing a mechanical signal, temperature signal or chemical signal in a body.
According to the embodiments of the present disclosure, laser irradiation may use ultraviolet light, visible light, or infrared light, and may use a pulse width of millisecond, nanosecond, picosecond, or femtosecond, etc., as long as it is capable of carbonizing a required patterned carbonization layer on the surface of the CFR-PEEK. In addition, an energy density of the laser may be changed by changing laser parameters such as an output power, a scanning speed, a repetition rate, defocusing amount of laser, thereby changing the morphology, compositions and resistivity of the patterned carbonization layer. Meanwhile, it is also possible to design a pattern of the carbonization conductive layer (carbonization layer) by designing a laser processing trajectory, to form a sensor having different patterns and applicable for composite signal sensing such as mechanics (pressure, strain, friction, etc.), temperature, chemistry (pH, etc.).
According to some embodiments of the present disclosure, ultraviolet nanosecond laser may be adopted for laser irradiation, an output power of a laser may be 5 W-10 W, for example may be 5 W, 6 W, 7 W, 8 W, 9 W, 10 W, etc., a repetition frequency may be 40 kHz-100 kHz, for example may be 40 kHz, 50 kHz, 60 kHz, 70 kHz, 80 kHz, 90 kHz, 100 kHz, etc., and a scanning speed may be 20-110 mm/s, for example may be 20 mm/s, 30 mm/s, 40 mm/s, 50 mm/s, 60 mm/s, 70 mm/s, 80 mm/s, 90 mm/s, 100 mm/s, 110 mm/s, etc., and a defocusing amount may be 2-10 mm, for example may be 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, etc. Thus, an energy density of irradiating on the surface of the CFR-PEEK matrix may be greater than 0.83 J/mm2, thereby forming the carbonization layer on the surface of the CFR-PEEK matrix.
It is still another aspect of the present disclosure to provide a wireless sensing device, referring to
According to some embodiments of the present disclosure, referring to
According to some embodiments of the present disclosure, referring to
The in-vitro probe 300 releases a first alternating electromagnetic field; after the patterned carbonization layer 20 senses a mechanical signal, a temperature signal or a chemical signal, a resonant frequency of the patterned carbonization layer 20 will change, and the patterned carbonization layer 20 generates an induced current under the first alternating electromagnetic field to generate a second alternating electromagnetic field, the second alternating electromagnetic field will cause the first alternating electromagnetic field to change; the in-vitro probe 300 senses a change in the first alternating electromagnetic field and transmits it to the network analyzer 400; the network analyzer 400 converts the change of the first alternating electromagnetic field into an alternating current signal, and converts the alternating current signal into an offset of a peak value of the resonant frequency and displays the offset, so as to obtain change information on the mechanical signal, chemical signal or temperature signal at an orthopedic implant injury in a human or an animal by analysis.
The solution of the present disclosure is described via the following specific embodiment.
Ultraviolet nanosecond laser is used to irradiate a surface of a CFR-PEEK (CFR-PEEK) matrix, the ultraviolet nanosecond laser used has a wavelength of 355 nm and a pulse width of 25 ns, and a laser used has an output power of 5.5 W, a repetition rate of 40 kHz, a scanning speed of 60 mm/s, and a defocusing amount of 2 mm, so that a patterned carbonization layer is formed on the surface of the CFR-PEEK matrix to obtain a CFR-PEEK orthopedic implant.
A three-point bending text is carried out on the CFR-PEEK orthopedic implant, and the text result is shown
Through the above experiment, it can be known that the patterned carbonization layer in the CFR-PEEK orthopedic implant can better feed back a mechanical signal, this orthopedic implant can be used in a human or animal body, and can be used in conjunction with an in-vitro probe or an in-vivo peripheral circuit to achieve real-time detection and real-time monitoring of the healing of an injured part.
In the present disclosure, the healing of the injury refers to healing of an injury at a fracture part. During a gradual healing process of the injured part, the bending strain sensed by the patterned carbonization layer will gradually decrease. Under normal circumstances, when the healing is successful, the bending strain sensed by the patterned carbonization layer will be about 2%, at this moment, a corresponding resistance change in
In the description of the present Specification, description of reference terms “one embodiment”, “another embodiment”, “a further embodiment”, “a specific embodiment”, “another specific embodiment”, “a further specific embodiment” and “some embodiments”, etc. means that a specific feature, structure, material or characteristic described in conjunction with this example is included in at least one example of the present disclosure. In the present Specification, schematic representations of the above terms are not necessary to aim at the same examples. And, the described specific feature, structure, material or characteristic may be combined in a suitable manner in any one or more examples. In addition, without contradicting each other, persons skilled in the art may incorporate and combine different examples described in the present Specification as well as the features of different examples. In addition, it should be noted that in the present Specification, the terms “first” and “second” are used for the descriptive purpose only and cannot be understood as indicating or implying relative importance or as implicitly indicating the number of the indicated technical features.
Although examples of the present disclosure have been shown and described above, it can be understood that the above examples cannot be understood as limitations on the present disclosure, persons skilled in the art may change, amend, replace or modify the above examples within the scope of the present disclosure.
Number | Date | Country | Kind |
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202111618690.3 | Dec 2021 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2022/130564 | 11/8/2022 | WO |