CN114145835A - On-line monitoring system for injection, dispersion and solidification process of bone cement at fracture - Google Patents
On-line monitoring system for injection, dispersion and solidification process of bone cement at fracture Download PDFInfo
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- CN114145835A CN114145835A CN202111424066.XA CN202111424066A CN114145835A CN 114145835 A CN114145835 A CN 114145835A CN 202111424066 A CN202111424066 A CN 202111424066A CN 114145835 A CN114145835 A CN 114145835A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B2017/883—Means for indicating hardening of bone cement
Abstract
The invention provides an on-line monitoring system for injection, dispersion and solidification processes of bone cement in a fractured vertebral body in a bone cement vertebral body strengthening operation treatment process, which comprises an imaging device, a monitoring device and a monitoring system, wherein the imaging device is used for acquiring an image of a fracture position; the bone cement injection module is used for injecting bone cement into a specified position; the sensor module comprises a plurality of fiber grating sensors which are implanted and fixed at corresponding positions of the fracture according to the setting scheme and are used for identifying sensor numbers and sensing signals according to wavelength codes; the sensing signal demodulation module is used for receiving signals from the fiber bragg grating sensors and demodulating the signals; the post-processing module is used for determining the fracture line type according to the image and determining the setting scheme of the sensor module; processing the demodulated signal data to obtain temperature, stress and strain information in the processes of bone cement injection, dispersion and solidification, and determining the injection amount and the injection time of a bone cement injection module; the invention can effectively provide ideas and methods for the research of reducing the bone cement leakage.
Description
Technical Field
The invention belongs to the technical field of on-line monitoring of fiber bragg gratings, and particularly relates to an on-line monitoring system for injection, dispersion and solidification processes of bone cement at a fracture.
Background
The statements in this section merely provide background information related to the present disclosure and may not necessarily constitute prior art.
Osteoporosis, a common bone disease in the elderly, is a systemic metabolic bone disease characterized by increased bone fragility and susceptibility to fracture due to low bone mass and damage to the microstructure of bone tissue. Minimally invasive bone cement injection surgery treatment has the advantages of rapid pain relief, vertebral body strengthening, early normal activity recovery of patients and the like, and has remarkable clinical potential in the aspects of increasing the strength and stability of fractured vertebral bodies, so that a bone repair method for treating the osteoporotic vertebral compression fracture with continuous pain by using a bone cement vertebral body strengthening technology (percutaneous vertebroplasty (PVP) and Percutaneous Kyphoplasty (PKP)) is widely concerned.
The percutaneous vertebroplasty is generally called percutaneous puncture vertebroplasty clinically, and is a technology for strengthening a vertebral body by injecting bone cement or artificial bone into a diseased vertebral body, and aims to stabilize the fractured vertebral body; percutaneous kyphoplasty is an improvement and development of percutaneous vertebroplasty, and an expandable bone expansion balloon (kyhpxtm) is used, after percutaneous puncture, the vertebral body is expanded by using the balloon in the vertebral body to reset the vertebral body, and a space is formed in the vertebral body, so that the injection pressure in the bone cement injection process can be reduced, and the aim of resetting the fractured vertebral body is to ensure that the height of the fractured vertebral body is as close to the level before fracture as possible. As a minimally invasive surgery mode, percutaneous vertebroplasty disperses bone cement to the fractured ends and the gaps of trabecular bone, so that the centrum becomes a firm whole again, the biomechanical property of the centrum is remodeled, and the pain caused by micromotion of the fractured ends is avoided. Generally, the strength recovery of the vertebral body can prevent the vertebral body from being further compressed under the action of external force, and the height of the vertebral body and the normal physiological curvature of the spine are maintained; the rigidity recovery can make the centrum more stable, reduce the trabecular bone fine motion, alleviate pain, provide stable environment for fracture healing, finally reach the fracture broken end of stabilizing, resume the biomechanics intensity of centrum, prevent the centrum further to sink, provide the purposes of stabilizing fracture centrum healing microenvironment and effectively alleviating pain, do benefit to the patient and resume normal activity as early as possible, reduce bed complication. However, the research and comparative analysis on the reasonable injection amount (mainly including Percutaneous Vertebroplasty (PVP), Percutaneous Kyphoplasty (PKP), Stenting (SP) and the like) corresponding to different operation modes of bone cement therapy are still insufficient, and no unified standard exists so far.
When the bone cement strengthening technologies such as PVP, PKP and the like are used for treating osteoporotic fracture, bone cement leakage is a common complication, leakage positions are different, and damage is different, for example, epidural and intervertebral foramen leakage can cause neurological symptoms; disc leakage increases the risk of disc degeneration and adjacent vertebral body fractures; venous leakage carries an increased risk of pulmonary embolism, and in severe cases can lead to patient death. Therefore, the leakage of bone cement should be reduced as much as possible during the bone cement treatment process of the fractured vertebral body, and the risk of complications is reduced. Researches find that the bone cement leakage rate increases along with the increase of the integrity damage degree of the vertebral body, and the bone cement leakage probability can be increased due to improper puncture or repeated puncture for many times in the operation, excessive bone cement injection amount, early injection time, excessive injection instantaneous pressure and the like.
Disclosure of Invention
The invention aims to solve the problems and provides an online monitoring system for the injection, dispersion and solidification processes of bone cement at the fracture part.
According to some embodiments, the invention adopts the following technical scheme:
an on-line monitoring system for the injection, dispersion and setting of bone cement at a fracture site, comprising:
the imaging device is used for acquiring an image of the fracture position;
the bone cement injection module is used for injecting bone cement into a specified position;
the sensor module comprises a plurality of fiber grating sensors which are implanted and fixed at corresponding positions of the fracture according to the setting scheme and are used for identifying sensor numbers and sensing signals according to wavelength codes;
the sensing signal demodulation module is used for receiving signals from the fiber bragg grating sensors and demodulating the signals;
the post-processing module is used for determining the fracture line type according to the image and determining the setting scheme of the sensor module; and processing the demodulated signal data to obtain temperature, stress and strain information in the processes of bone cement injection, dispersion and solidification, and determining the injection amount and the injection time of the bone cement injection module.
As an alternative embodiment, a puncture device is further included for establishing a working channel of the bone cement injection module.
As a further limited embodiment, the puncture device includes a puncture needle for removal of the core after the puncture into the vertebral body, leaving the working cannula to form the working channel.
As an alternative embodiment, the bone cement injection module comprises an injection syringe and a connecting pipe, and an injection pipe is connected to the injection end of the injection syringe.
As a further limited embodiment, the infusion tube is introduced into the working cannula through an inner catheter.
As an alternative embodiment, the fiber grating sensor comprises a temperature fiber grating sensor and a strain fiber grating sensor, the fiber grating sensor is provided with a fiber core, a cladding and a coating layer from inside to outside, and a plurality of fiber gratings are arranged on the fiber core at intervals;
the central wavelengths of the fiber gratings are different.
As a further limited embodiment, the fiber grating sensor is arranged in a gap or even a hole formed in a working sleeve or a vertebral body fracture part, and does not change position during the injection of bone cement.
As an alternative embodiment, the fibre-grating sensor is configured to be removed from the mounting position before the injected bone cement has fully cured.
In an alternative embodiment, the imaging device is an X-ray machine or a nuclear resonance elastography device.
As an alternative embodiment, the post-processing module is configured to determine the type of the fracture line based on the image acquired by the imaging device, mainly on the CT sagittal plane, in combination with the coronal plane and the transverse plane;
when the fracture line is in an opening type, determining that the arrangement scheme of the sensor module is that the fiber bragg grating sensor is arranged at the gap of the vertebral body fracture;
when the bone folding line is of an inserting type, the arrangement scheme of the sensor module is determined to be that the fiber bragg grating sensor is arranged in the working channel.
The post-processing module is configured to calculate bone cement strain change data according to the temperature change data of the specific position of the fiber grating of the sensor module and the relation between the central wavelength offset of the strain grating and strain; and determining the proper injection time and injection amount of the bone cement according to the temperature and strain change data so as to control the bone cement injection module.
Compared with the prior art, the invention has the beneficial effects that:
the invention uses the method and the device for the on-line real-time monitoring of the fiber bragg grating, can accurately monitor the temperature and the strain of the bone cement in the whole process, can reasonably improve the existing bone cement formula and the injection process, improves the success rate of the operation and reduces the operation risk.
The invention records the evolution process of temperature and strain along with time in the bone cement hardening process by using the fiber bragg grating temperature sensor and the strain sensor which are embedded into the bone cement, obtains the temperature change data of the specific position of the fiber bragg grating by processing the data collected by the fiber bragg grating unit, and further converts the bone cement strain change data according to the relation between the central wavelength offset and the strain of the strain bragg grating. According to the temperature and strain change data obtained by recording and processing of the sensor and by combining experience, the proper injection time and injection amount of the bone cement are determined, so that more reasonable injection time is obtained, the leakage risk caused by too early injection of the bone cement, too much injection amount and too large injection instantaneous pressure is reduced, the bone cement is prevented from being too large in fluidity, and sufficient time is provided for injection.
In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.
FIG. 1 is a schematic diagram of a monitoring system according to at least one embodiment of the present disclosure;
FIGS. 2(a), (b) are schematic structural diagrams of a fiber grating sensor according to at least one embodiment of the present invention;
FIG. 3 is a first monitoring system layout diagram in accordance with at least one embodiment of the present invention;
FIG. 4 is a diagram of a second monitoring system layout in accordance with at least one embodiment of the present invention;
FIG. 5 is a simplified view of a lumbar vertebral segment of a pig according to at least one embodiment of the present invention;
figure 6 is a simplified illustration of a human lumbar spine in accordance with at least one embodiment of the present invention;
FIGS. 7(a) and (b) are a cone penetration view and a lateral view of a fiber grating sensor embedded in a pig lumbar vertebra segment cone in test example 1 of the present invention;
FIG. 8 is a schematic structural view of a temperature sensor (FBG-T) and a strain sensor (FBG-S) of test example 1 of the present invention;
FIG. 9 is a system configuration diagram of test example 1 of the present invention;
FIG. 10 is a graph showing the results of temperature measurement in test example 1 of the present invention;
FIG. 11 is a diagram of a double-sided vertebral body puncture in which a lumbar vertebral body of a pig in test example 2 of the present invention is embedded in a fiber grating sensor;
FIG. 12 is a system configuration diagram of test example 2 of the present invention;
FIG. 13 is a schematic view of the system configuration of test example 2 of the present invention;
FIG. 14 is a graph showing the results of the system temperature test in test example 2 of the present invention.
Wherein: 101-a computer; 102-fiber grating demodulator; 103-fiber optic lead-in; 104-lumbar puncture simulation patient model; 105-a puncture needle; 106-fiber grating string; arm type 107-C;
201-a computer; 202-fiber grating demodulator; 203-fiber optic pigtail; 204-puncture needle; 205-vertebral body model; arm type 206-C; 207-vertebral body fracture; 208-a strain sensor; 209-temperature sensor;
11-spinous process; 12-superior articular process; 13-transverse process; 14-vertebral body; 15-vertebral arch; 16-foramen vertebralis; 17-the vertebral plate; 18-pedicle of vertebral arch.
21-puncture needle; 22-strain sensor (FBG-S); 23-temperature sensor (FBG-T); 24-fracture site; 25-trabecular bone; 26-compact bone; 27-fiber optic pigtail;
31-puncture needle; 32-a temperature sensor; 33-a strain sensor; 34-a vertebral body; 35-fiber optic pigtail;
41-a grating; 42-stainless steel tube; 43-Adhesives
The specific implementation mode is as follows:
the invention is further described with reference to the following figures and examples.
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
The bone cement used by the invention can be an existing formula or an improved formula, the structure of the monitoring system in the invention is not influenced, and the formula of the bone cement is only required to be referred when the post-processing module determines the proper injection time and injection amount of the bone cement according to the temperature and strain data. Moreover, the above process of determining the proper injection timing and injection amount of the bone cement can be determined by pre-test simulation according to the formula of the bone cement, so the system structure and function of the invention are not different according to the formula of the bone cement, and the bone cement with different formulas is still within the protection scope of the invention as long as the monitoring system is consistent with the invention, but the following exemplified bone cement is provided to ensure that the technical personnel in the field can better understand the scheme of the invention.
SpinePlax radiopaque bone cement composition:
each dose of bone cement comprises 20g of powder and 10ml of liquid. 20g of sterile powder contained: 2.3g of polymethyl methacrylate, 11.7g of methyl methacrylate-styrene copolymer-containing benzoyl peroxide (1.5%) and 6.0g of barium sulfate. 10ml of sterile liquid comprises 9.75ml of methyl methacrylate (monomer), 0.25ml of N, N-dimethyl-p-toluidine and 7.5. mu.g of hydroquinone.
Biomet propylene resin bone cement component:
the acrylic bone cement containing zirconia developer consists of two parts of powder and liquid. The powder comprises: methyl methacrylate-methyl acrylate copolymer powder, zirconia powder, benzoyl peroxide; the liquid agent comprises: methyl methacrylate, N dimethylaniline, p-phenylenediamine and a small amount of chlorophyll.
The brushite bone cement comprises the following components:
powder: 250g of dibasic calcium phosphate dihydrate and 72.7g of calcium carbonate (molar ratio 2:1) to give a mixture of β -tricalcium phosphate powder (β -TCP), β -tricalcium phosphate (β -TCP) and monocalcium phosphate; liquid: citric acid, phosphorylated chitosan, gelatin, hydroxypropyl methylcellulose and other solidifying liquids.
26g of powder per sachet contained: 14.2g of methyl acrylate-methyl methacrylate polymer, 11.7g of zirconium dioxide, 0.1g of benzoyl peroxide and a small amount of copper chlorophyll; each ampoule contains 10ml of liquid: 9.2g of methyl methacrylate, 0.2g of N, N-dimethyl-p-toluidine, a small amount of copper chlorophyll and hydroquinone.
The bone cement leakage is caused by physical factors and chemical factors, and the problem of bone cement leakage can be improved by optimizing the physical factors and realizing further clinical treatment (such as low pressure, a balloon, a directional balloon, a Sky vertebral body expander, a percutaneous reticular balloon, the bone cement amount, the bone cement perfusion period, filling materials and the like); the improved chemical factors also have the clinical effect of reducing the leakage of the bone cement, such as a bone cement viscosity temperature difference technology, adjustment of bone cement viscosity, and control of injection time and method (early injection of the bone cement has low viscosity and strong fluidity, and is easy to cause leakage risk), and the temperature difference injection needs to be controlled by heating temperature and time.
The bone cement can be divided into four stages from mixing components to final completion of the polymerization reaction: 1. rarefaction phase, 2 thickening phase, 3 hardening phase, 4 heat generation phase. The thinning stage is that the bone cement is quickly mixed from powder/liquid, and is mixed into a low-viscosity liquid within 20-50s, and then the free radical polymerization is started. And (3) thickening stage: in the chain growth stage, a monomer (methyl methacrylate) free radical formed in the chain initiation stage is continuously combined with a monomer molecule to form a long-chain free radical, the reaction rate is extremely high in the stage, the viscosity of the bone cement is continuously increased and gradually becomes viscous, the reaction lasts for about 3 minutes, the prepared bone cement needs to be quickly injected into a vertebral body in the stage of percutaneous vertebroplasty, and otherwise, the bone cement is difficult to inject into the vertebral body; to assess whether the bone cement can be injected, many physicians perform qualitative probing or testing of the material at this stage. And (3) hardening stage: after about 5-7 min, the bone cement becomes hard and is fixed and does not deform when pressed. A heat generation stage: the heat generation can reach 70 ℃ at most when the polymerization is carried out for 7-12 min, and the tissues can be burnt to some extent.
Therefore, the injection timing and injection amount of the bone cement need to be determined according to the specific strain, temperature, and the like. The invention aims to provide an on-line monitoring system for the injection, dispersion and solidification processes of bone cement at a fracture. As shown in fig. 1, the online monitoring system includes: (1) the imaging device is used for imaging in the operation, and is convenient for accurate positioning; (2) a bone cement injection module for injecting bone cement through puncture; (3) the sensor module is used for implanting one or more fiber bragg grating sensors into the fracture position, fixing the sensors and sensing signals by using wavelength coding; (4) the sensing signal demodulation module is used for receiving the signal from the fiber grating sensor and demodulating the signal; (5) and the post-processing module is used for displaying, processing and storing the data transmitted by the sensing signal demodulation module to obtain the information such as temperature, stress, strain and the like in the processes of bone cement injection, dispersion and solidification.
In the process of treating the continuously painful osteoporotic vertebral body compression fracture by using a bone cement strengthening technology, a series of complications can be induced by overhigh curing temperature, bone cement leakage and the like after the bone cement is injected into the vertebral body, and serious patients can die, so the method is particularly important for monitoring the temperature and the strain in the processes of injecting and curing the bone cement, and the changes of the temperature, the strain and the like in the process can be accurately monitored by using a fiber grating sensor. The fiber grating temperature sensor can monitor the evolution law of the temperature of the bone cement, has good accuracy and reliability, is only influenced by the temperature, can more accurately and conveniently obtain the actual temperature evolution and fluctuation of materials compared with the traditional temperature monitoring equipment, and the temperature detected by the fiber grating temperature sensor can be regarded as the actual temperature of the bone cement. The fiber bragg grating temperature sensor can monitor the temperature of bone cement in the processes of injection and dispersion at a fracture part, the temperature change of the bone cement caused by monomer polymerization in the bone cement and the highest temperature of a heat production stage in real time, and monitor the comprehensive strain change of expansion with heat and contraction with cold and chemical shrinkage strain of the bone cement from mixing to finally finishing the polymerization reaction. When the viscosity of the bone cement is low, the bonding strength between the bone cement and the fiber grating strain sensor is weak, and the strain of the bone cement can not be effectively transferred to the fiber grating strain sensor; as the viscosity of the bone cement increases, the bonding strength between the bone cement and the fiber grating strain sensor gradually increases, and the strain change caused by temperature and the strain change caused by chemical shrinkage can be effectively transmitted to the fiber grating strain sensor. The fiber grating strain sensor reacts to the strain caused by the temperature in the whole process, so that the detection result of the fiber grating strain sensor can be combined with the detection result of the fiber grating temperature sensor to calculate and obtain the pure chemical shrinkage strain quantity.
In the invention, the selected fiber grating sensor structure is as shown in fig. 2(a) and (b), a fiber core, a cladding and a coating layer are arranged from inside to outside, and a plurality of fiber gratings are arranged on the fiber core at intervals;
the central wavelengths of the fiber gratings are different.
According to the invention, different fiber bragg grating fixing modes are determined according to the difference between the fracture degree and the fracture line type, so that two arrangement modes of the monitoring system are obtained. The fiber bragg grating coated by the bone cement is ensured, the proper injection amount and injection time of the bone cement are determined by monitoring the temperature and strain of the bone cement in the injection, dispersion and curing processes of the bone cement at the fracture part in real time, and the leakage of the bone cement is reduced.
Through the imaging examination, the CT sagittal plane of the fractured vertebral body is taken as a main observation plane, and the types of fracture lines are divided into two types by combining a coronal plane and a transverse plane: an insertion type and an open type. After vertebral fracture, a high-density compact zone in which bone trabeculae are embedded into each other is defined as an embedded fracture line; the low-density bright lines, which are shown by fracture and separation of trabecular bone and cortical bone of the vertebral body after vertebral body fracture, are defined as open fracture lines. There are three degrees of vertebral fracture: i degree: a mild fracture, within which the anterior border of the vertebra is reduced in height 1/3 as compared to the same or adjacent vertebra; II degree: a moderate fracture having a reduced anterior border height 1/3-2/3 compared to the same or an adjacent vertebra; and III degree: a severe fracture, with the height of the anterior border of the vertebra reduced by more than 2/3 compared to the same or adjacent vertebrae. The degree of osteoporosis and the state of compression of the vertebral body can be observed through preoperative examination (such as QCT, DXA, MRE, and the like), and then different arrangement modes can be selected.
First, for the vertebral fracture with the fracture degree I degree of the vertebral body and the fracture line type of the open type, the monitoring system is shown in fig. 3 and comprises a puncture needle 204, a C-shaped arm 206, a strain sensor 208, a temperature sensor 209, a fiber grating demodulator 202 and a computer 201. The data of the strain sensor 208 and the temperature sensor 209 are demodulated by the fiber grating demodulator 202 and then sent to the computer 201. The whole puncture process is carried out under the perspective of an X-ray machine or a C-shaped arm 206, and the detailed description of the monitoring system layout process is carried out by taking a lumbar vertebral body model as an example in the section, namely, a fiber grating sensor is inserted into a gap of vertebral body fracture, then an optical fiber lead is led out from a trabecula bone through a cortical bone, and a PVP bilateral puncture method is used. The change of temperature and strain is obtained by measuring the shift amount of the central wavelength of the fiber grating reflected light during the bone cement injection process. In the whole process, the fact that the bone cement coats the fiber bragg grating is ensured, the puncture needle slowly penetrates into the vertebral body along the direction of the vertebral pedicle by selecting a proper angle, the needle point is ensured to be rightly close to the central line of the vertebral body, and the needle point is not contacted with the fiber bragg grating sensor. When the bone cement is in a wire drawing state, the bone cement is pushed into the vertebral body, the pushing is stopped after the vertebral body back wall is filled, and at the moment, the bone cement completely covers the fiber bragg grating sensor. The selected fiber grating can also be a fiber grating string, namely, a plurality of gratings are written on the same optical fiber, and a plurality of fiber gratings with different central wavelengths are arranged on the same optical fiber; because of the difference of the central wavelength, each fiber grating does not influence each other when working, can measure a plurality of physical parameters, is suitable for multi-point test, can improve the stability and the reliability of the system, and simplifies the whole sensing system at the same time. When in detection, a wide-spectrum light source with a certain bandwidth is emitted into the fiber grating coated by the bone cement, the light meeting the conditions is reflected back under the wavelength selectivity effect, and the reflected wavelength is measured by a demodulation device. When the temperature or the strain of the bone cement is measured by using the fiber bragg grating, the grating pitch of the fiber bragg grating can be changed, so that the wavelength of a reflected wave is changed, the reflection center wavelength of the fiber bragg grating depends on the grating period and the effective refractive index of a fiber core, the effective refractive index of the fiber bragg grating and the grating period can be changed due to the change of the temperature and the strain, so that the light wave with the specific wavelength reflected by the fiber bragg grating is shifted, the wavelength change can be detected by the demodulating device, the external temperature or the load change can be deduced, and the temperature and the strain in the bone cement injection process can be monitored.
The bare fiber grating has the advantages of light weight, small volume, corrosion resistance and the like, but the bare fiber grating is small in diameter, fine and fragile, and is easy to break and inactivate due to large pressure when bone cement is injected, so that the bare fiber grating needs to be packaged when the fiber grating is fixed on a fractured vertebral body, the gap formed at the fractured position of the vertebral body is small, the gap difficulty of embedding the substrate-packaged fiber grating sensor into the fractured position is large, the thin neck tube protection type is adopted, the bare fiber grating is fixed on the central axis position of the thin neck tube, the periphery of the bare fiber grating sensor is fixed and protected by colloids such as epoxy resin and the like, and the sensors under different use conditions have different requirements on the performance of the adhesive, so the fiber grating sensor adhesive for monitoring the bone cement has good performances such as biological compatibility, corrosion resistance and the like. The fiber grating is fixed in a gap or even a hole formed at the fracture of the vertebral body, so that the processes of injection, solidification and the like of bone cement can be accurately and stably monitored, the fiber grating can be directly embedded into a crack of the fracture of the vertebral body, the fixing mode has no influence or little influence on the distribution characteristics of various physical fields such as a temperature field, a stress field and the like of a measured environment, and the sensor can be ensured not to move due to the change of pressure in the vertebral body caused by the injection of the bone cement. The lead of the fiber grating sensor is led out from the hole at the fracture part and led out from the cancellous bone area through the cortical bone, and the fiber lead of the sensor needs to be protected, so that the interruption of fiber transmission signals is avoided.
Fiber grating fixed position of the monitoring system: the fiber grating sensor is inserted into the gap of the vertebral body fracture, and then the fiber lead is led out from the trabecular bone through cortical bone, and the fiber grating sensor adopts a temperature sensor and a strain sensor.
Bone cement injection module: the PVP bone cement injection needle is used to inject bone cement into the fractured vertebral body. The working process of the bone cement injection module comprises the following steps: the thoracolumbar puncture adopts pedicle of vertebral arch approach, determines puncture point after disinfection, enters collapsed centrum through pedicle of vertebral arch with puncture needle under the perspective of C-shaped arm or X-ray machine, takes out the needle core, completes the establishment of working channel, puts the centrum drill into the working channel, observes under X-ray, after drilling to the required depth, takes out the centrum drill; opening a packaging bag of the bone cement, blending the bone cement according to a proportion, wherein the setting time of the bone cement reaches 18min, the working time is about from 8min to 14min, the total time is 6 min, the injection time is sufficient, the bone cement is slowly poured into a needle cylinder through a funnel when the bone cement is in a porridge shape, a connecting pipe is connected with the needle cylinder and is tightly screwed, the front end of the needle cylinder is kept upward, a push rod is rotated to push the bone cement to the front end port of the connecting pipe, and air is exhausted; slowly rotate the push rod, observe the state of extruding connecting pipe front end bone cement, in order to prevent the unexpected seepage of bone cement, when bone cement must arrive the tooth paste form, just can be with connecting pipe front end and filling tube firm in connection, the filling tube pours into the centrum suitable position into through working channel, under the X ray supervision, slowly pour into bone cement into, begin to disperse to the centrum department that sinks after bone cement pours into, the bone cement pouring into is monitored to fiber grating sensor this moment, the temperature in dispersion stage, can be according to actual conditions control bone cement's injection volume, fiber grating sensor can monitor the temperature that bone cement pours into complete process, the strain that chemical shrinkage and expend with heat and contract with cold arouses, treat before bone cement solidifies completely, extract fiber grating sensor, withdraw from the working sleeve with the filling tube after bone cement solidifies completely, it can to extract the working sleeve.
Of course, the specific parameters in the above process are only examples, and may be modified according to the fracture degree or the formula of the bone cement, and the like, and are not limited to the above parameters.
And secondly, for vertebral body fracture with the vertebral body fracture degree of I degree, the vertebral body compression degree of small and the fracture line type of insertion type. The monitoring system is shown in fig. 4. The whole puncture process is carried out under the perspective of an X-ray machine or a C-shaped arm, a lumbar puncture simulation patient model is selected and used, a PVP bilateral puncture method is used, a fiber grating sensor is implanted and fixed in a working channel established by a puncture needle at one side of a centrum through a vertebral pedicle, and bone cement is injected into the other side of the centrum through an injection pipe along the established working channel. The change of temperature and strain is obtained by measuring the shift amount of the central wavelength of the fiber grating reflected light during the bone cement injection process.
The specific layout process of the monitoring system is as follows: injecting bone cement by using PVP (polyvinyl pyrrolidone) punctured at two sides, implanting a fiber bragg grating sensor in a working channel established by a puncture needle at one side of a vertebral body through a vertebral pedicle and fixing, wherein the fiber bragg grating sensor adopts a temperature sensor and a strain sensor, and a lead can be led out from the working channel and is connected to a fiber bragg grating demodulator; the bone cement is injected through the pedicle of vertebral arch on the other side of the vertebral body, and the steps are as follows: the conventional disinfection drape is used for symmetrically displaying vertebral pedicles on two sides under back-front perspective, selecting 1-2mm of outer edge of vertebral pedicle projected on body surface as a puncture point, firstly puncturing the vertebral pedicle on one side of a vertebral body, using a puncture needle to enter the collapsed vertebral body through the vertebral pedicle, taking out a needle core to complete the establishment of a working channel, sending a fiber grating sensor into the vertebral body through the working channel, packaging a protective layer outside the sensor, changing the length of a grid area of the sensor extending into the vertebral body by changing the length of the sensor extending into the vertebral body, fixing the sensor and the working channel, enabling the sensor not to change the position in the bone cement injection process, and monitoring the temperature of the bone cement in the vertebral body by the fiber grating sensor at the moment. Puncturing through the vertebral pedicle at the other side of the vertebral body, adjusting the direction of the puncture needle to be consistent with the central line of the pathological vertebral body as much as possible under side perspective, and when the head end of the puncture needle reaches the rear edge of the vertebral body, displaying that the puncture needle just crosses the inner edge of the vertebral pedicle in a positive perspective manner, which is an ideal puncturing state, continuously inserting the needle to the junction of 1/3 in front of the vertebral body under side perspective, and then, the head end of the puncture needle is positioned in the center of the vertebral body in a positive visual perspective manner; opening a packaging bag of the bone cement, blending the bone cement according to a proportion, slowly pouring the bone cement into the needle cylinder when the bone cement is in a porridge shape, connecting the connecting pipe with the needle cylinder, screwing the connecting pipe tightly, keeping the front end of the needle cylinder upward, rotating the push rod to push the bone cement to a front port of the connecting pipe, and exhausting air; slowly rotating the push rod to observe the state of the bone cement extruded out of the front end of the connecting pipe, in order to prevent the bone cement from accidentally leaking, when the bone cement must reach the dental paste, firmly connecting the front end of the connecting pipe with the injection pipe, slowly injecting the bone cement under lateral perspective, when the environment in the vertebral body changes, immediately monitoring the change by the fiber grating sensor, coating the fiber grating sensor after the bone cement is injected, then starting to disperse to the collapsed vertebral body, at the moment, monitoring the temperature in the vertebral body and the strain change caused by chemical shrinkage and thermal expansion and cold shrinkage during the process of injecting and dispersing the bone cement by the fiber grating sensor, stopping injecting when the bone cement is observed to diffuse close to the back wall of the vertebral body or leak to the outside of the vertebral body, pulling out the fiber grating sensor before the bone cement is completely cured, slowly rotating the inner catheter until the inner catheter is completely separated from the injection pipe, and withdrawing the injection pipe from the working sleeve after the bone cement is completely cured, and (5) pulling out the working sleeve.
Similarly, the specific parameters in the above process are only examples, and may be modified according to the fracture degree or the formulation of the bone cement, and the parameters are not limited to the above parameters.
The important points to be explained are:
fiber grating type: the invention does not limit the length of the grating region of the fiber grating; preferably selecting a fiber grating string;
direct physical quantity of on-line monitoring of fiber bragg grating: temperature, axial strain of fiber grating; the physical process of the on-line monitoring of the fiber bragg grating is as follows: the temperature of the bone cement in the process of injecting and dispersing at the fracture part, the temperature change of the bone cement caused by monomer polymerization in the bone cement, and the comprehensive strain change of thermal expansion and cold contraction strain and chemical contraction strain of the bone cement in the curing process.
The fiber bragg grating online real-time monitoring method and the fiber bragg grating online real-time monitoring device based on the processes of injection, dispersion and solidification of bone cement at the fracture part can be combined with a numerical simulation technology of bone cement bone repair forming, the rationality and accuracy of a mathematical model of bone repair forming are checked by using data such as temperature, strain and the like obtained by fiber bragg grating real-time online monitoring, and meanwhile, the optimal design of the position of the fiber bragg grating implanted into a vertebral body is carried out by using a numerical simulation result, so that the sensitivity and the reliability of the fiber bragg grating online real-time monitoring method of the bone cement injection, dispersion and solidification processes at the fracture part are improved.
The working process of the monitoring system and the verification of the effectiveness of the monitoring system are explained in detail by the following test examples.
Test example 1: selecting a vertebral body of the experimental animal close to the vertebral body of the human body. As shown in fig. 5 and fig. 6, the shape, weight and structure of the spine of the pig are similar to those of the vertebral body of the human, the spine of the thoracolumbar section of the pig is similar to that of the vertebral column of the human, and has the structures of the superior zygapophysis joint, the transverse process, the spinous process, the vertebral lamina, the vertebral pedicle, the vertebral body and the like, so the spine of the pig is selected as a specimen for in vitro experiments, the bone mass of the spine of the pig is reduced by using a decalcification method, a low bone mass model is verified by imaging, histology and biomechanics, and the vertebral body is damaged by using a material testing machine so as to prepare the fracture model of the spine of the pig with low bone mass.
A first monitoring system layout scheme is that as shown in figures 7(a), (b) and 8, fiber gratings are fixed at gaps and even holes formed at fracture positions through optimizing trabeculae and gaps thereof, fiber grating sensors are inserted into fracture cracks, the fiber grating sensors adopt temperature sensors and strain sensors, configured German Heley bone cement is injected into a vertebral body by PVP under radiation irradiation of a GE OEC 8800C-type arm X-ray machine, the fiber gratings are coated by the bone cement, a puncture needle is slowly punctured into the vertebral body along the direction of a vertebral pedicle by selecting a proper angle, the fact that the needle point is right close to the central line of the vertebral body and is not contacted with the fiber grating sensors is ensured, and an inner core is taken out after the needle point reaches the puncture position. When the bone cement is in a wire drawing state, the bone cement is pushed into the vertebral body, the pushing is stopped after the vertebral body back wall is filled, and at the moment, the bone cement completely covers the fiber bragg grating sensor. The selected fiber grating can also be a fiber grating string, namely, a plurality of gratings are engraved on the same optical fiber, and a plurality of fiber gratings with different central wavelengths are arranged on the same optical fiber; because of the difference of the central wavelength, each fiber grating does not influence each other when working, can measure a plurality of physical parameters, is suitable for multi-point test, can improve the stability and the reliability of the system, and simplifies the whole sensing system at the same time.
The system is divided into a test area and an analysis device, as shown in fig. 9, in the test area, a fiber bragg grating sensor is inserted into a gap or a hole at a fracture part, a proper amount of bone cement is injected into a vertebral body by using PVP (polyvinyl pyrrolidone), the condition that the bone cement coats the fiber bragg grating sensor is ensured, the evolution process of the temperature and strain along with time in the hardening process of the bone cement is recorded, the analysis device comprises a demodulator containing a broadband light source and a computer provided with analysis software, the broadband light source arranged in the demodulator emits light into a fiber, the light is totally reflected on a fiber core and is transmitted forwards, and the light meeting the specific wavelength can be reflected and returned to the demodulator at the position of the fiber bragg grating area. After the bone cement is injected into a vertebral body, the bone cement gradually hardens and changes in volume to drive a grid region of the strain sensor to change axially, so that the period of the grid region changes, the wavelength of light reflected back to the demodulator changes, the demodulator converts the change of the optical signal into a digital signal, and the online monitoring and recording of the test result are realized through analysis software of a computer.
The pig vertebral body is placed in a water bath kettle with the temperature of 37 ℃, a device with the first setting scheme is adopted for carrying out subsequent experiments, and a temperature curve obtained by testing of the fiber grating sensor is shown in figure 10.
Placing the grid area part of the fiber bragg grating sensor into a pig cone, displaying a reflection spectrogram in a current state on a computer-related detection software interface, and placing the cone in a 37 ℃ water bath (simulating the temperature of a human body) in advance, so that the temperature monitored by the sensor is 37 ℃ when bone cement is not injected; slowly injecting bone cement which is mixed well in advance and is in a wire drawing shape into the vertebral body at the 8 th minute; at the 10 th minute, the bone cement in the vertebral body enters the agglomeration stage, at the moment, the viscosity is gradually increased, and the temperature is increased; after which the cement begins to set, the temperature rises sharply and reaches a maximum. Before the bone cement is completely solidified, the injection pipe is pulled out in advance to ensure that no bone cement is injected, and then the temperature of the bone cement is slowly reduced until the temperature is the same as that of the vertebral body. Because the experiment is an in-vitro experiment, the fiber grating sensor is not pulled out after being placed in the vertebral body in the whole process, so that a more comprehensive and more detailed temperature test result is obtained.
Test example 2: the method comprises the steps of selecting a vertebral body of an experimental animal close to a human vertebral body, selecting a pig vertebral body as a specimen of an in-vitro experiment, reducing the bone mass of the pig vertebral body by using a decalcification method, verifying a low bone mass model by imaging, histology and biomechanics, and using a material testing machine to destroy the vertebral body so as to prepare the pig vertebral body compression fracture model with low bone mass.
A second monitoring system layout mode is adopted, as shown in figure 11, configured German Heley bone cement is injected into a vertebral body by PVP under the radiation irradiation of a GE OEC 8800C-type arm X-ray machine, a fiber bragg grating sensor is introduced into a working channel at one side and fixed, a lead wire can be led out from the working channel, an optical fiber grid-free area in the working channel and an optical fiber grid area in the vertebral body are arranged, the fiber bragg grating sensor adopts a temperature sensor and a strain sensor, the bone cement is injected from the working channel at the other side, and the fact that the fiber bragg grating is coated after the bone cement is injected and dispersed is ensured. And selecting a proper angle to slowly penetrate the puncture needle into the vertebral body along the direction of the vertebral pedicle at the other side, ensuring that the needle point is rightly close to the central line of the vertebral body, and taking out the inner core after the needle point reaches the puncture position. When bone cement is in a wire drawing state, the bone cement is pushed into a vertebral body, the bone cement is firstly dispersed to be coated with the fiber bragg grating, then the angle of the puncture needle is properly adjusted, so that the bone cement can be better dispersed, the bone cement is injected and stopped after filling the back wall of the vertebral body, the selected fiber bragg grating can be a fiber bragg grating string, namely, a plurality of gratings are engraved on the same optical fiber and implanted into a working channel, so that a plurality of physical parameters can be measured, the system is suitable for multi-point testing, and the stability and the reliability of the system can be improved; two fiber bragg gratings which are respectively a temperature sensor and a strain sensor can also be introduced at the same time, and two fiber bragg grating leads penetrate through the working channel and are placed into the vertebral body to monitor the changes of the temperature and the strain in the vertebral body after the bone cement is injected.
The device is divided into a test area and an analysis device, wherein fig. 13 is a structural diagram of the system, corresponds to fig. 12, a PVP (polyvinyl pyrrolidone) bilateral puncture method is used in the test area (namely a cone part), one side of the cone forms a working channel for fixing a fiber grating sensor through puncture, bone cement is injected into the cone along the established working channel by using an injection pipe at the other side of the cone to coat the fiber grating sensor, the temperature and the time evolution process of the cement in the hardening process are recorded, the analysis device comprises a demodulator containing a broadband light source and a computer provided with analysis software, broadband light arranged in the demodulator enters an optical fiber, the light is totally reflected and forwards transmitted in a fiber core, and the light meeting specific wavelength is subjected to Bragg reflection at the position of the fiber grating area and then returns to the demodulator. After the bone cement is injected into a vertebral body, the bone cement gradually hardens and changes in volume to drive an optical fiber grating area of the strain sensor to change in the axial direction, so that the grating area period changes, the optical wavelength reflected back to the demodulator changes, the demodulator converts the change of the optical signal into a digital signal, and the online monitoring and recording of the test result are realized through the analysis software of the computer.
The pig vertebral body is placed in a water bath kettle with the temperature of 37 ℃, a monitoring system of the second scheme is adopted for subsequent experiments, and the result obtained by the test of the fiber grating temperature sensor is shown in figure 14.
Placing the grid area part of the fiber bragg grating sensor into a pig cone, displaying a reflection spectrogram in a current state on a computer-related detection software interface, and placing the cone in a 37 ℃ water bath (simulating the temperature of a human body) in advance, so that the temperature monitored by the sensor is 37 ℃ when bone cement is not injected; slowly injecting bone cement which is mixed well in advance and is in a wire drawing shape into the vertebral body at the 8 th minute; at the 10 th minute, the bone cement in the vertebral body enters the agglomeration stage, at the moment, the viscosity is gradually increased, and the temperature is increased; after which the cement begins to set, the temperature rises sharply and reaches a maximum. Before the bone cement is completely solidified, the injection pipe is pulled out in advance to ensure that no bone cement is injected, and then the temperature of the bone cement is slowly reduced until the temperature is the same as that of the vertebral body. Because the experiment is an in-vitro experiment, the fiber grating sensor is not pulled out after being placed in the vertebral body in the whole process, so that a more comprehensive and more detailed temperature test result is obtained. Because blood circulation exists in a human body, heat transfer includes two modes of heat conduction and convection, the dosage of the bone cement in each experiment is different from the clinical dosage of the bone cement, and the heat transfer condition of surrounding substances is difficult to simulate, the actual temperature distribution condition of the bone cement in the vertebral body in the human body in the PVP operation can not be completely simulated by in-vitro experimental data.
According to the fiber bragg grating online real-time monitoring method and the fiber bragg grating online real-time monitoring device, the fiber bragg grating temperature sensor and the strain sensor which are embedded into bone cement record the evolution process of temperature and strain along with time in the hardening process of the bone cement, the temperature change data of the specific position of the fiber bragg grating are obtained by processing the data collected by the fiber bragg grating unit, and the bone cement strain change data are further converted according to the relation between the central wavelength offset and the strain of the strain bragg grating. According to the temperature and strain change data obtained by recording and processing the sensors and combining clinical experience, the proper injection time and injection amount of the bone cement are determined, the leakage risk in the bone cement injection process is reduced, the bone cement injection process is ensured not to have obvious fluidity, and sufficient time is ensured for injection. Although the bone cement is widely applied to orthopedics department, has the advantages of low cost, stable property, easiness in shaping and the like, the bone cement also has the defects of poor mechanical property, burning of healthy tissues due to heat release of polymerization and the like. In recent years, research on the improvement of the performance of bone cement has been conducted, and the ratio of solid to liquid of bone cement is adjusted to increase the compressive strength of bone cement, lower the maximum temperature of the setting process, and shorten the dough time and the setting time. The method and the device for on-line real-time monitoring by using the fiber bragg grating can accurately monitor the temperature and the strain of the bone cement in the whole process, can reasonably improve the existing bone cement formula and the injection process, improve the success rate of the operation and reduce the operation risk.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like which do not require creative efforts of those skilled in the art within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims (10)
1. An online monitoring system for the injection, dispersion and solidification process of bone cement at a fracture part is characterized in that: the method comprises the following steps:
the imaging device is used for acquiring an image of the fracture position;
the bone cement injection module is used for injecting bone cement into a specified position;
the sensor module comprises a plurality of fiber grating sensors which are implanted and fixed at corresponding positions of the fracture according to the setting scheme and are used for identifying sensor numbers and sensing signals according to wavelength codes;
the sensing signal demodulation module is used for receiving signals from the fiber bragg grating sensors and demodulating the signals;
the post-processing module is used for determining the fracture line type according to the image and determining the setting scheme of the sensor module; and processing the demodulated signal data to obtain temperature, stress and strain information in the processes of bone cement injection, dispersion and solidification, and determining the injection amount and the injection time of the bone cement injection module.
2. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 1, wherein: the bone cement injection device further comprises a puncture device, and the puncture device is used for establishing a working channel of the bone cement injection module.
3. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 2, wherein: the puncture device comprises a puncture needle, wherein the puncture needle is used for taking out a needle core after the puncture enters a vertebral body, and a working sleeve is reserved to form a working channel.
4. An on-line monitoring system for the injection, dispersion and solidification of bone cement at a fracture as claimed in claim 1 or 3, wherein: the bone cement injection module comprises an injection needle cylinder and a connecting pipe, and the injection end of the injection needle cylinder is connected with an injection pipe.
5. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 4, wherein: the injection tube is introduced into the working sleeve through an inner catheter.
6. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 1, wherein: the fiber bragg grating sensors comprise a temperature fiber bragg grating sensor and a strain fiber bragg grating sensor, fiber cores, cladding layers and coating layers are distributed on the fiber bragg grating sensors from inside to outside, and a plurality of fiber bragg gratings are arranged on the fiber cores at intervals;
the central wavelengths of the fiber gratings are different.
7. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 6, wherein: the fiber grating sensor is arranged in a gap or even a hole formed in a working sleeve or a vertebral fracture part, and does not change position in the bone cement injection process.
8. An on-line monitoring system for the injection, dispersion and solidification of bone cement at a fracture as claimed in claim 1 or 6, wherein: the fiber grating sensor is configured to be removed from the installed position before the injected bone cement is fully cured.
9. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 1, wherein: the post-processing module is configured to determine the type of a fracture line by taking a fracture CT sagittal plane as a main observation plane and combining a coronal plane and a transverse plane according to an image acquired by the imaging equipment;
when the fracture line is in an opening type, determining that the arrangement scheme of the sensor module is that the fiber bragg grating sensor is arranged at the gap of the vertebral body fracture;
when the bone folding line is of an inserting type, the arrangement scheme of the sensor module is determined to be that the fiber bragg grating sensor is arranged in the working channel.
10. The system for on-line monitoring of the injection, dispersion and setting of bone cement at a fracture as claimed in claim 1, wherein: the post-processing module is configured to calculate bone cement strain change data according to the temperature change data of the specific position of the fiber grating of the sensor module and the relation between the central wavelength offset of the strain grating and strain; and determining the proper injection time and injection amount of the bone cement according to the temperature and strain change data so as to control the bone cement injection module.
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