A bone repair stent system capable of tumor early warning and non-invasive treatment and a bone repair method

Abstract

This invention discloses a bone repair scaffold system for tumor early warning and non-invasive treatment, comprising a bone repair scaffold, a microenvironment monitoring RFID module, a controlled drug release module, a signal reading system, and a cloud processor. The bone repair scaffold is shaped to fit the wound site and has a porous internal structure. The microenvironment monitoring RFID module is disposed on the internal and external surfaces of the bone repair scaffold. The controlled drug release module includes a microwave induction module and a drug storage unit. An external microwave excitation causes the microwave induction module to heat up, stimulating the thermoresponsive drug storage unit to release the drug. The signal reading system communicates with the microenvironment monitoring RFID module via radio frequency and is interconnected with the cloud processor via the internet. This invention can promote bone repair while rapidly monitoring tumor recurrence, alerting patients to seek medical attention early. Simultaneously, the drug release module enables non-invasive treatment, reducing patient suffering, improving quality of life, and prolonging survival.

Description

Technical Field

[0001] This invention relates to the field of smart medical technology, and to a bone repair scaffold system and bone repair method that can provide tumor early warning and non-invasive treatment. Background Technology

[0002] Irregular bone defects caused by trauma, infection, tumors, and other factors pose a significant challenge in clinical treatment. With advancements in science, technology, and medical concepts, orthopedic transplantation has benefited numerous patients. Current treatment methods primarily include autologous bone grafting, allogeneic bone grafting, and the transplantation of synthetic bone materials. However, the repair effects of these materials after implantation are difficult to monitor in real time, making it impossible to effectively assess the quality of repair. This is especially complex for patients with bone metastases, who simultaneously face the challenges of bone repair and tumor recurrence.

[0003] Breast cancer and prostate cancer are the most common malignant tumors in women and men, respectively, and both have a particularly high tendency to metastasize to bone. Bone metastasis is a common and serious complication of advanced cancer, and both bone metastases and primary bone tumors are important contributing factors to bone defects. Clinically, after a bone tumor or bone metastasis is detected, surgical removal of the tumor from the bone is generally performed, and a bone repair scaffold is implanted at the site of bone erosion to compensate for bone loss and prevent fractures and other physiological problems caused by bone loss. Currently, after surgical removal of metastatic bone tumors and implantation of bone repair scaffolds, regular monitoring of tumor recurrence and bone tissue repair is required using large-scale equipment in hospitals. This places a significant financial burden on patients and consumes limited medical resources. Furthermore, some patients have poor adherence to medical advice and fail to attend regular check-ups as required by their doctors. Moreover, patients with bone metastases often experience tumor recurrence later in life, which leads to further metastasis and bone erosion, causing immense suffering, severely impacting their quality of life, and shortening their survival time. Sometimes, patients only seek medical attention when they experience pain, at which point the tumor has already recurred and metastasized, often missing the optimal treatment window. The combination of these unfavorable factors makes effective postoperative recovery for patients very difficult. Furthermore, a severe recurrence of the tumor increases the patient's financial burden and again consumes the hospital's limited medical resources. In addition, the inability to monitor their recovery can cause patients significant psychological stress.

[0004] Therefore, how to monitor the progress of bone repair after bone repair scaffold implantation in real time, how to monitor or predict tumor bone metastasis and recurrence in a timely manner using simple and effective equipment, and further, how to directly kill tumor cells without surgical intervention, are urgent clinical problems that need to be solved. Solving these problems can greatly improve the postoperative repair effect of bone defects, eliminate the need for clinical follow-up, save public medical resources, and alleviate patients' difficulties in accessing medical care, as well as their psychological and economic burden. More importantly, it can promptly alert cancer patients to the possibility of recurrence and remind them to seek medical attention in the early stages of recurrence. Doctors can then use non-invasive treatment methods to directly kill recurrent tumor cells immediately, avoiding secondary surgery and preventing tumor metastasis. Therefore, this treatment method can significantly improve patients' quality of life and prolong their survival, which has significant clinical implications. Furthermore, the number of such patients worldwide is very large, and this type of monitoring system has a wide applicability, which can create enormous socio-economic value.

[0005] Studies have found that after a bone scaffold is implanted at the site of bone injury, osteoblasts migrate, proliferate, and form bone matrix along the scaffold surface, while repair inside the scaffold lags behind on the surface. This creates differences in the microenvironment signals inside and outside the bone repair scaffold. Therefore, this invention designs a monitoring system based on this characteristic to track the bone repair process by monitoring the differences in the microenvironment inside and outside the bone repair scaffold in real time, providing a reference for clinicians' diagnosis.

[0006] During normal metabolism, the body's acid-base balance is maintained, with a pH range of 7.35-7.45 and an average of 7.41, indicating a slightly alkaline state. This buffering mechanism typically consists of a weak acid and its corresponding strong base salt, such as H₂CO₃ / NaH₂PO₄ / Na₂HPO₄. In healthy individuals, the body's pH generally remains stable. Clinically, if the body's pH remains below 7.3 for an extended period, it can lead to an acidic constitution, resulting in a sub-healthy state and potentially triggering various diseases. Studies by Hanahan and Weinberg et al. have found that gene mutations and disruption of cellular homeostasis can cause cancer. The extracellular environment resulting from these changes, which differs from that of normal tissues, is called the tumor microenvironment (TME), and it influences tumor progression and metastasis. The tumor microenvironment caused by altered tumor cell metabolism has an acidic pH of approximately 6.5-6.8, characterized by abnormal cell-cell interactions and homeostasis disruption. In this state, tumor cells preferentially utilize glycolysis over oxidative phosphorylation as the primary means of energy release; this effect is known as anaerobic glycolysis. This metabolic pathway leads to an approximately 10-fold increase in lactate load in the extracellular environment. +Ion diffusion transports to the intercellular matrix, and the low density of blood vessels in tumor tissue makes it difficult for acidic metabolic products to be excreted via the bloodstream, leading to local accumulation. For example, metastatic breast cancer cells in bone release large amounts of lactic acid. Lactic acid is a key energy source for osteoclasts; osteopic tumor cells can release lactic acid to promote osteoclast differentiation and metabolic reprogramming, allowing tumor cells to invade metastatic lesions. Therefore, tumor recurrence can cause changes in the pH of the microenvironment surrounding the tumor.

[0007] This invention utilizes the difference in pH between the tumor microenvironment (6.5-6.8) and normal tissue (7.35-7.45) to design a material coupled with an RFID tag that can monitor changes in the pH of the bone microenvironment in real time. The data is then fed back to an external signal reading system via radio frequency signals. This system can promote bone repair while rapidly monitoring tumor recurrence, alerting patients to seek medical attention early. Simultaneously, the drug delivery module enables non-invasive treatment, reducing patient suffering, improving quality of life, and prolonging survival. Summary of the Invention

[0008] To address the problems of existing technologies, this invention aims to monitor the differences in the internal and external microenvironments of the bone repair scaffold in real time to track the bone repair process. Simultaneously, it monitors microenvironmental changes during bone metastasis repair in real time to monitor tumor recurrence, providing timely early warnings to patients and facilitating optimal treatment timing. Furthermore, through a built-in microwave-sensing drug delivery module, non-invasive drug delivery can intervene in tumor development, alleviating patient suffering. This invention interconnects the bone repair scaffold with a cloud processor, enabling remote smart healthcare without leaving home, providing personalized treatment plans for each patient.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A bone repair scaffold system for tumor early warning and non-invasive treatment includes a bone repair scaffold, a microenvironment monitoring RFID module, a controlled drug release module, a signal reading system, and a cloud processor. Research has found that the tumor microenvironment, caused by metabolic changes in tumor cells, is acidic at pH, a characteristic feature of abnormal cell-cell interactions and homeostasis disruption. The cancer microenvironment is known to be slightly acidic, with a glutathione (GSH) concentration of approximately 10 mmol / L. -1 The concentration of glutathione (GSH) in normal tissues is approximately 3 mmol / L. -1Therefore, monitoring local pH levels can serve as a potential application for tumor early warning. The microenvironment monitoring RFID module detects the pH in the bone repair scaffold's microenvironment at regular intervals. The detected signals are transmitted to a signal reading system via RFID tags and then fed back to a cloud processor, enabling real-time online monitoring of the microenvironment. When the cloud processor analyzes abnormalities in the microenvironment, it sends information such as pH mutations, tumor recurrence predictions, and timely medical advice to the patient's mobile client. Doctors can also analyze historical microenvironment information to predict bone repair progress and tumor recurrence, and can use the cloud processor to remotely administer drug delivery therapy or remote microwave hyperthermia. This system can detect early-stage recurring tumors, and after recurrence, the frequency of drug release can be selected based on pH mutations after drug release. After the drug in the microcapsule has been released, the microwave heating module can continue to use microwave hyperthermia to further kill tumor cells.

[0011] In the bone repair scaffold system for tumor early warning and non-invasive treatment proposed in this invention, the bone repair scaffold is shaped to fit the wound site; the bone repair scaffold has a porous internal structure; a microenvironment monitoring RFID module is disposed on the internal and / or external surface of the bone repair scaffold; the drug controllable release module includes a microwave induction module and a drug storage unit; by applying an external microwave to excite the microwave induction module to heat up, the thermoresponsive drug storage unit is stimulated to release the drug; the signal reading system communicates with the microenvironment monitoring RFID module via radio frequency; the signal reading system is interconnected with a cloud processor via the Internet.

[0012] Preferably, the bone repair scaffold obtains wound shape information through methods including: bone X-ray, computed tomography, and magnetic resonance imaging; the wound shape information is 3D printed to obtain a specific shape adapted to the wound site.

[0013] Preferably, the pores of the porous structure are infiltrated or not infiltrated with growth factors adapted to bone cell growth and angiogenesis; the porosity and pore size can be adjusted as needed to meet specific cell growth environments.

[0014] Preferably, the microenvironment monitoring RFID module includes: a pH value detection unit and an RFID tag; the RFID tag is a chipless radio frequency tag, which is embedded inside the bone repair scaffold and / or attached to the outer surface of the bone repair scaffold.

[0015] Preferably, the cloud processor collects the microenvironment signal inside the bone repair scaffold through the signal reading system; the cloud processor sends instructions to the signal reading system to control the signal reading system to emit microwaves to excite the microwave sensing module and remotely control drug release.

[0016] Preferably, the microenvironment monitoring module and RFID tag used in this invention are coupled, and the RFID tag circuitry is printed using a pH-responsive material. When the pH of the environment in which the tag is located changes, it causes a change in the conductivity of the RFID circuitry, which in turn affects the resonant reactance and capacitance values, ultimately leading to a shift in the characteristic frequency and intensity of radio frequency reflection. By detecting the shift in the characteristic frequency and intensity of the RFID tag's reflection, changes in the microenvironment can be detected non-contactly. The pH detection unit is a passive module; the RFID tag uses a pH-responsive antenna, or a pH-responsive film as the RFID load, to detect pH changes; the frequency range used for communication between the RFID tag and external systems is 860-960MHz.

[0017] Preferably, the RFID tag can also store the patient's identification number to prevent information confusion.

[0018] Preferably, the controlled drug release module includes a drug storage unit (release unit) and a microwave induction module. The drug storage unit (release unit) is a temperature-responsive polymer capsule. The microwave induction module uses a microwave-responsive polymer material or polymer-encapsulated saline as the heating material; the microwave induction module uses a microwave frequency range of 300-3000MHz and a wavelength range of 1mm-100cm; when microwave irradiation is applied to the bone repair scaffold site in vitro, the microwave-responsive polymer membrane is heated and conducts heat to the temperature-responsive polymer capsule, increasing the capsule wall permeability and thus releasing the drug; when microwave irradiation stops, the temperature decreases, the capsule wall permeability decreases, and drug release is interrupted. This method can reduce postoperative damage to patients and alleviate their economic burden.

[0019] Preferably, the signal reading system can emit microwaves to excite the microwave sensing module.

[0020] Preferably, the RFID tag is embedded inside the bone repair scaffold and adhered to its outer surface using common methods such as 3D printing or embossing. By comparing the differences between the signals from the inner and outer tags, the bone repair process and quality can be analyzed.

[0021] Preferably, the cloud processor communicates with the bone repair scaffold without contact via a signal reading system, collecting real-time data on the bone repair scaffold's microenvironment. The cloud processor can record and analyze the collected data, allowing medical professionals to interpret the repair process or predict the likelihood of tumor recurrence based on neural network models. Patients can access the cloud processor via an app or WeChat mini-program to stay informed about their repair progress and assess the possibility of tumor recurrence.

[0022] Preferably, the cloud processor can be accessed remotely via the Internet to provide registration services to patients and doctors.

[0023] Based on the above system, this invention also proposes a bone repair method with tumor early warning and non-invasive treatment, the method comprising the following steps:

[0024] Step 1: Implant a bone repair scaffold at the bone defect site after surgical removal of a bone tumor in patients with trauma, infection, bone metastasis, or bone tumors.

[0025] Step 2: The microenvironment monitoring RFID module monitors the changes in the microenvironment of the remediation site in real time, and communicates with the outside world through the RFID tag, feeding back the microenvironment information to the cloud processor through the signal reading system;

[0026] Step 3: The cloud processor monitors the bone repair process in real time and detects abnormalities in the microenvironment signals caused by tumor recurrence during the bone repair process. When abnormal signals are detected, the cloud processor will send an early warning signal to the client device held by the patient. The cloud processor can also use algorithms to analyze historical microenvironment data to predict the possibility of tumor recurrence and provide treatment suggestions to the patient.

[0027] Step 4: The doctor remotely controls the drug release module to release tumor treatment drugs for non-invasive treatment.

[0028] Compared with the prior art, the present invention has the following advantages:

[0029] This invention can monitor changes in the internal microenvironment of the bone repair scaffold in real time, enabling monitoring of the bone repair process. Simultaneously, the cloud platform can rely on accumulated historical data and a neural network model to predict the likelihood of tumor recurrence, allowing for timely assessment of bone tumor recurrence and facilitating early treatment and intervention. Therefore, it eliminates the need for large-scale equipment, enabling patients to monitor their health at home, significantly reducing the strain on limited medical resources and alleviating the financial burden on patients.

[0030] This invention enables real-time reporting of microenvironment data to a cloud processor and microwave-controlled drug release via contactless communication. This eliminates the need for patients to undergo secondary surgery. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a diagram of the overall system architecture of the present invention.

[0033] Figure 2 This is a structural diagram of the bone repair scaffold of the present invention. Detailed Implementation

[0034] The invention will be further described in detail below with reference to the specific embodiments and accompanying drawings. Except for the contents specifically mentioned below, the processes, conditions, and experimental methods for implementing the invention are all common knowledge and general knowledge in the art, and the invention does not have any particular limitations.

[0035] This invention discloses a bone repair scaffold system for tumor early warning and non-invasive treatment, comprising a bone repair scaffold, a microenvironment monitoring RFID module, a controlled drug release module, a signal reading system, and a cloud processor. After trauma, infection, bone metastasis, or surgical removal of a bone tumor, a bone repair scaffold is implanted at the bone defect site. During bone repair, the microenvironment monitoring RFID module monitors changes in the microenvironment at the repair site in real time and communicates externally via RFID tags, feeding the microenvironment information back to the cloud processor through the signal reading system. The cloud processor can detect the bone repair progress in real time, and when tumor recurrence occurs during bone repair, causing abnormalities in the microenvironment signal, the cloud processor will send an early warning signal to the mobile client held by the patient who received the scaffold, reminding them to seek medical attention promptly. Doctors can remotely control the controlled drug release module to release tumor treatment drugs for non-invasive treatment. This system can promote bone repair while rapidly monitoring tumor recurrence, reminding patients to seek medical attention early. Simultaneously, the built-in drug release module can also achieve non-invasive treatment, reducing patient suffering, improving quality of life, and prolonging survival.

[0036] Example 1

[0037] In this embodiment, as Figures 1-2 As shown, a 3D printer was used to print an RFID tag 2-2 with polyaniline wires on a cross-linked chitosan film. Then, a chitosan scaffold was printed on both sides of the RFID tag to obtain a bone repair scaffold 2-1. Finally, an identical RFID tag 2-3 was printed on the surface of the bone repair scaffold. A polyarginine membrane 2-4 was filled with PEG-NIPAAm microcapsules 2-5 containing anticancer drugs and adhered to the outer surface of the bone repair scaffold. A UHF radio frequency reader 1-4 was used as the signal reader, providing a network port for interconnection with the cloud processor 1-5. The signal reader uploaded microenvironmental information, including the patient's ID, to the cloud processor database. Patients can access the cloud processor through a mini-program and app to view microenvironmental data and understand the bone repair process. More importantly, the cloud processor can rely on historical curves of the microenvironment and trend prediction curves provided by a neural network model to predict the probability of tumor occurrence and remind patients to seek medical attention promptly by sending SMS or app messages to the patient's mobile client 1-6.

[0038] Example 2

[0039] In this embodiment, a 3D printer is used to print RFID tags with polyaniline wires on a cross-linked chitosan film. Allogeneic bone is etched using a laser, and the tags are placed into the etched channels. Chitosan hydrogel is used to seal the channels and adhere the tags, resulting in a bone repair scaffold containing RFID tags. The same RFID tags are then printed on the surface of the bone repair scaffold using the same 3D printer. PEG-NIPAAm microcapsules containing anticancer drugs are used to fill the polyarginine membrane and adhere it to the outer surface of the bone repair scaffold. A UHF radio frequency reader is used, providing a network port for interconnection with the cloud processor. The reader uploads microenvironmental information, including the patient's ID, to the cloud processor database. Patients can access the cloud processor via a mini-program and app to view microenvironmental data and understand the bone repair process. More importantly, the platform can rely on historical curves of the microenvironment and trend prediction curves provided by a neural network model to predict the probability of tumor occurrence, reminding patients to seek medical attention promptly by sending SMS or app messages to their mobile clients.

[0040] Example 3

[0041] In this embodiment, a 3D printer is used to print RFID tags with polyaniline wires on a cross-linked chitosan film. These tags are then placed in a bone scaffold mold to obtain a bone repair scaffold containing the RFID tags. The same RFID tags are then printed on the surface of the bone repair scaffold using the same 3D printer. A polyarginine membrane is filled with PEG-NIPAAm microcapsules containing anticancer drugs and adhered to the outer surface of the bone repair scaffold. A UHF radio frequency reader is used, providing a network port for interconnection with the cloud processor. The reader uploads microenvironmental information, including the patient's ID, to the cloud processor database. Patients can access the cloud processor via a mini-program and app to view microenvironmental data and understand the bone repair process. More importantly, the platform can record a large number of historical curves of the microenvironment, and through trend prediction curves provided by a neural network model, it can predict the probability of tumor occurrence and remind patients to seek medical attention promptly by sending SMS or app messages to their mobile clients.

[0042] The scope of protection of this invention is not limited to the above embodiments. Any variations and advantages that can be conceived by those skilled in the art without departing from the spirit and scope of the inventive concept are included in this invention and are protected by the appended claims.

Claims

1. A bone repair scaffold system capable of tumor early warning and non-invasive treatment, characterized in that, include: Bone repair scaffold, microenvironment monitoring RFID module, controlled drug release module, signal reading system, and cloud processor; among them, The bone repair scaffold is made into a specific shape adapted to the wound site according to the wound shape; the bone repair scaffold has a porous internal structure; The microenvironment monitoring RFID module is disposed inside and / or on the outer surface of the bone repair scaffold; the microenvironment monitoring RFID module includes: a pH value detection unit and an RFID tag; the RFID tag is a chipless radio frequency tag, which is embedded inside the bone repair scaffold and / or attached to the outer surface of the bone repair scaffold; the pH value detection unit is a passive module used to detect pH changes; the RFID tag uses a pH-responsive antenna, or uses a pH-responsive film as the RFID load; the frequency range used for external communication between the RFID tag and the external environment is 860-960MHz; The controlled drug release module includes a microwave induction module and a drug storage unit. An external microwave is applied to the microwave induction module to generate heat, stimulating the thermoresponsive drug storage unit to release the drug. The microwave induction module uses a microwave frequency range of 300-3000MHz and a wavelength range of 1mm-100cm. The microwave induction module uses a microwave-inducing polymer material as the heating element. The drug storage unit is a thermoresponsive polymer microcapsule; an external microwave generates heat through the microwave-inducing polymer material, stimulating the microcapsule to release the drug. The signal reading system communicates with the microenvironment monitoring RFID module via radio frequency; the signal reading system can emit microwaves to excite the microwave sensing module; The signal reading system is interconnected with a cloud processor via the Internet; the cloud processor collects the internal microenvironment signals of the bone repair scaffold through the signal reading system; the cloud processor sends instructions to the signal reading system to control the signal reading system to emit microwaves to excite the microwave sensing module and remotely control drug release.

2. The bone repair scaffold system for tumor early warning and non-invasive treatment according to claim 1, characterized in that, The bone repair scaffold obtains wound shape information through methods including bone X-rays, computed tomography scans, and magnetic resonance imaging; the wound shape information is then 3D printed to obtain a specific shape adapted to the wound site.

3. The bone repair scaffold system for tumor early warning and non-invasive treatment according to claim 1, characterized in that, The porous structure may or may not be infiltrated with growth factors adapted to bone cell growth and angiogenesis.

4. The bone repair scaffold system for tumor early warning and non-invasive treatment according to claim 1, characterized in that, The cloud processor provides registration services to patients and doctors via remote internet access.

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