Patent Application
20240058212
This application claims priority to and the benefit of Korean Patent Application No. 10-2022-0102106, filed on Aug. 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.
The disclosure relates to a method for predicting safety and effectiveness of a massage device, and more particularly, to a method for predicting safety and effectiveness of a spinal thermal device.
Spinal thermal devices are widely used to alleviate acute or chronic pain generated in muscles and nerve tissues of spinal region caused by continuing to work in an inappropriate posture for a long time or by habituation of these postures, and to move along a body part for the purpose of improving the blood circulation of the body or relieve instantaneous muscle stiffness, and to improve blood flow by applying heat stimulation to the site of pain.
Aspects of the disclosure provide a method for predicting safety and effectiveness of a spinal thermal device, which can optimize an effect of improving blood flow provided to a targeted region using the spinal thermal device.
The disclosure is not limited to the above-described tasks, and other tasks not described herein will be clearly understood by those skilled in the art from the following description.
According to an aspect of the disclosure, there is provided a method of predicting safety and effectiveness of a spinal thermal device, the method including: a step of generating three-dimensional structure data of a user's body; a step of generating three-dimensional structure data of the spinal thermal device; a step of setting a set value of the spinal thermal device; a step of calculating a thermal conduction and a temperature change of the user's body due to heat applied in a process of pressurizing the user's body as the spinal thermal device operates as the set value; a step of converting the temperature change value of the user's body into a blood circulation value; and a step of visualizing the blood circulation value of the user's body.
In this case, the calculating of the thermal conduction and the temperature change of the user's body due to heat applied in a process of pressurizing the user's body may include: visualizing the thermal conduction and the temperature change value of the user's body.
In this case, the calculating the thermal conduction and the temperature change due to a warming effect during the user's body pressurization may be: calculating a temperature change of a portion corresponding to a depth of 3 cm from a skin surface of the user during a process of pressurizing the user's body while a ceramic of the spinal thermal device rises along a height direction.
In this case, the calculating the thermal conduction and the temperature change of the user's body may be: calculating the thermal conduction and the temperature change through Equation 1 below:
In this case, the calculating through the Equation 1 may further include: calculating a convective heat loss from boundaries of the user's body to external environment through Equation 2 below:
q
0
=h(Tamb−T) (2)
In this case, the converting the temperature change value of the user's body into the blood circulation value may be: converting the temperature change value of the user's body into a blood circulation value through Equation 3 below:
F(ΔT)=F0(Fmax−Fo)e−(aΔT+b) (3)
In this case, the setting the set value of the spinal thermal device may be: setting a ceramic temperature, a ceramic height, and a heating element temperature.
In this case, the method may further include: after the visualizing of the blood circulation value of the user's body, deriving a set value for obtaining an optimal temperature or an optimal blood circulation value of the user's body within a range of a set ceramic temperature, a ceramic height, and a heating element temperature.
In this case, the deriving the set value for obtaining an optimal temperature or an optimal blood circulation value of the user's body may be: deriving the set value for obtaining the optimal temperature or the optimal blood circulation value for each user's body type according to a change in structure according to the user's body type.
In this case, the converting the temperature change value of the user's body into the blood circulation value may further include: correcting the temperature change value of the user's body by reflecting blood circulation data for each user's body position.
In this case, the correcting the temperature change value of the user's body may further include: analyzing a laser received from the blood of the user.
In this case, the three-dimensional structure data of the user's body may be three-dimensional structure data classified into skin, subcutaneous fat, soft tissue, muscles, vertebrae, intervertebral disc, epidural fat, cerebrospinal fluid, and spinal cord.
According to the above configuration, the method for predicting the safety and effectiveness of the spinal thermal device according to the embodiment of the disclosure generates three-dimensional structure data of the user's body and three-dimensional structure data of the spinal thermal device, calculates thermal conduction and temperature change of the user's body due to the heat while the spinal thermal device operates according to the set value, and then converts the thermal conduction and temperature change into a blood circulation value, thereby optimizing the effect of improving the blood flow provided to the targeted region, through this the safety and effectiveness of the spine thermal device can be predicted.
It should be understood that the effects of the disclosure are not limited to the above-described effects, and include all effects that can be inferred from the configuration of the disclosure described in the detailed description or claims of the disclosure.
Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily carry out the present disclosure. The present disclosure may be embodied in various different forms and is not limited to the embodiments described herein. In order to clearly describe the present disclosure, parts not related to the description are omitted in the drawings, and the same or similar components are denoted by the same reference numerals throughout the specification.
The words and terms used in the specification and the claims are not interpreted as limited to ordinary or dictionary meanings, but should be interpreted as meanings and concepts corresponding to technical aspects of the present disclosure according to principles capable of defining terms and concepts by the inventor in order to describe the disclosure in the best way.
In order to provide an optimal thermal effect using a spinal thermal device, quantitative information on how much a temperature of a ceramic required to improve blood flow of a targeted region (e.g., a specified muscle group) is needed.
However, spinal heating devices according to one example technology do not consider the targeted region, heat the ceramic at the temperature selected by the user, and then perform the thermal massage, so the blood flow improvement effect of the targeted region is not constant, and if the temperature of the ceramic is excessively increased to enhance the effect of improving blood flow, there is a risk that the user may get burned.
Therefore, there is a need to develop a technology capable of optimizing the effect of improving blood flow provided through the spinal thermal device.
As shown in
At this time, the computer may include a notebook, a laptop, a tablet PC, a slate PC, and the like equipped with a web browser (WEB Browser), and the computer may comprise a controller for performing each of the above steps, an input unit for inputting a user command, and an output unit for showing a resultant to the user.
The controller may include a processor, a ROM in which a control program is stored, and a RAM that stores an input signal or data or is used as a storage area corresponding to various operations to be performed.
Also, a graphic processing board including a processor, a RAM, or a ROM may be included in a separate circuit board electrically connected to the controller. The processor, the RAM, and the ROM may be connected to each other through an internal bus.
Also, the controller may be used as a term referring to a component including the processor, the RAM, and the ROM. Also, the controller may be used as a term referring to a component including the processor, the RAM, the ROM, and the processing board.
The input unit receives a predetermined instruction or command from a user for controlling the computer. For example, the input unit may include a user interface such as a keyboard, a mouse, a trackball, a time gain compensation (TGC) control knob, a lateral gain compensation (LGC) control knob, or a paddle.
The output unit may display a resultant on one or more display areas. The user may check the visualized result through the display area.
In this case, data related to the user's body may be pre-held user's body data, and may be computed tomography (CT) or magnetic resonance imaging (MRI) data. Also, the user's body data may be three-dimensional structure data classified into skin, subcutaneous fat, soft tissue, muscles, vertebrae, intervertebral disc, epidural fat, cerebrospinal fluid, and spinal cord. When the user's body data is modeled and simulated as described above, the effect of improving blood flow provided to a target site may be optimized, and thus safety and effectiveness of the spinal thermal device may be predicted.
A T2-weighted MRI of a healthy male adult (BMI: 25 kg/m2, age: 42 years) was performed by using a 3 T Siemens MAGNETOM Prisma scanner equipped with a CP Spine array coil (Siemens Healthineers, PA, USA), and
Based on image intensity, the MRI was segmented into nine tissue masks: skin, subcutaneous fat, soft tissue, muscles, intervertebral disc, vertebrae, epidural fat, cerebrospinal fluid, and spinal cord. Manual tissue segmentation was carried out by first thresholding the images, followed by morphological filtering such as flood fill, dilation, and erosion, performed in Simpleware ScanIP (Synopsys Inc., CA, USA). To ensure tissue continuity and improve segmentation accuracy, the data was extensively visualized and compared with the anatomy of the subject's spine while performing manual adjustments to the tissue masks. Thicknesses of the tissues comprising the imaged region were measured as: (skin) 1.1 mm, (subcutaneous fat) 13 mm, (muscle) 42 mm, (soft tissue) 2.8 mm, (epidural fat) 2.2 mm, (CSF) 2.9 mm, and (spinal cord) 1.9 mm. Thus, the muscle (e.g., the presumed target of thermal massage) occupied a region approximately 1.5-5.5 cm from the surface.
Regarding the generation of the three-dimensional structure data of the spinal thermal device 10, the tissue masks generated by the segmentation process were utilized to construct a finite element model (FEM) of the lumbar back. To this end, FEM consisting of more than 3.38 million tetrahedral elements was generated using Simpleware Scan IP software running tetrahedral voxel-based meshing algorithm. The resulting model was then integrated with separate domains that captured the position, orientation, and geometry of a thermal massage device. For example, the spinal thermal device 10 may model the characteristics of a CGM MB-1901 massage bed (CERAGEM Co. Ltd., Cheonan, Korea). The massage bed has two types of heat sources. The bed surface provides a diffuse layer of heat and four ceramics 11 that make direct contact with the body to provide more punctate and intense thermal stimulation. The spinal thermal device 10 includes four ceramics 11 arranged as the vertices of a rectangle. A width direction Y distance (a) between the ceramics 11 is 56 mm, and a length direction X distance between top and bottom ceramics 11 is 32 mm. Specifically, in Solidworks (Dassault Systems, MA, USA), the cross-section of the ceramics 11 was modeled by having a width (c) of 65 mm for the four ceramics 11, a diameter of the circular ends (d) of 45 mm, and a spacing (e) between the two circular ends is 30 mm, and the components were imported into Simpleware ScanIP for positioning and meshing.
The spinal thermal device 10 may include a driving unit 12 for adjusting the position of the ceramics 11 in the length direction X, and a support unit 13 for supporting the ceramics 11. The support unit 13 may include a first support member 13a for supporting the ceramics 11 disposed on one side of the length direction X and a second support member 13b for supporting the ceramics 11 disposed on the other side of the length direction X.
After generating the three-dimensional structure data of the spinal thermal device 10 as described above, the set value of the spinal thermal device 10 is set. The set value may be a temperature of the ceramics 11 according to the thermal massage mode selected by the user, a height of the ceramics 11, a temperature of the heating element, and the like.
Thereafter, as the set value, as the spinal thermal device 10 operates, the thermal conduction and temperature change of the user's body due to heat applied in a process of pressing of the user's body are calculated. In this case, the thermal conduction and temperature change of the skin, muscle, vertebrae, intervertebral disc of the user may be calculated.
After generating the 3D structure data of the spinal thermal device 10, the resulting model was imported into COMSOL Multiphysics 5.5 (COMSOL Inc., MA, USA), and then the Pennes' bio-heat transfer equation for governing heating during the thermal was solved as shown in Equation 1 below. Through this, the thermal conduction and temperature change of the user's body may be calculated.
At this time, ρ is tissue density (units of kg/m3), c is specific heat capacity (J kg−1 K−1), T is temperature (K), t denotes time (s), k is thermal conductivity (W m−1 K−1), ρb is density of blood (kg m−3), cb is specific heat capacity of blood (J kg−1 K−1), wb is perfusion rate of blood (1/s), Tb is blood temperature (K), Qm is rate of metabolic heat generation (W/m3). The solution is carried out under steady state conditions.
That is, the thermal conduction and temperature change due to heat applied while pressing the user's body are calculated, and it is possible to check whether there is safety when the presses and heating are applied to the user's body.
The physical and thermal properties of the user's body tissue were assigned according to the values listed in Table 1 below (the thermal properties of the tissue and source comprising the computational model to estimate the temperature gradient during the thermal massage).
indicates data missing or illegible when filed
In order to solve the bio-thermal equation (Equation 1), it is assumed that the temperature at external boundaries of the user's body was fixed to core body temperature (37° C.), and the absence of convective gradients across all internal tissue boundaries. The convective heat loss from the model boundary (user's body boundary) to the environment was modeled as shown in Equation 2 below.
q
0
=h(Tamb−T) (2)
At this time, q0 (units of W m−2) is convective heat flux, h=5 W m−2 K is heat transfer coefficient for the tissues comprising the model (e.g., user's body), Tamb is ambient temperature (e.g., 25° C.). Initial temperature of the tissues is set to 37° C. Temperature of the ceramic is fixed within a simulation to a value ranging from 45 to 65° C. External boundary of a skin in contact with a bed surface, corresponding to a heating mat, is assigned a temperature of 40° C.
A non-linear model for mapping in situ tissue temperature to the resulting blood flow was developed in order to estimate magnitude and distribution of the blood flow produced during the thermal massage. This model was guided by simultaneous empirical measurement of the temperature and blood flow in the user's leg during heat stress as conducted by Chiesa and colleagues. The general form of the model developed here is as follows and through this, the temperature change value of the user's body can be converted into the blood circulation value:
F(ΔT)=Fo+(Fmax−Fo)e−(aΔT+b) (3)
At this time, where Fo is blood flow (L/min), ΔT is change in temperature at the site of vessel (° C.), Fo is blood flow in absence of exogenous heating, Fmax is maximum achievable blood flow due to physical limitations of cardiovascular system, and the free model parameters a and b are estimated by fitting the model (e.g., user's body) to empirical measurements reported by Chiesa and colleagues.
Namely, the following (T, F) pairs of measurements were reported. Here, T was taken to be the temperature in the muscle of the leg (e.g., the deepest measurement taken and the one closest to the site of the vessel) and F was taken to be the empirical blood flow in the central femoral artery (CFA): (34.9° C., 0.31 L/min), (36.2° C., 0.53 L/min), (37.0° C., 0.86 L/min), (37.6° C., 1.24 L/min), and (38.3° C., 1.22 L/min).
From these empirical measurements, the values Fo=0.31 L/min and Fmax=1.22 L/min were assigned to the baseline and maximum blood flow, respectively. The conventional least-squares fitting was then performed employing the Matlab (Mathworks, MA, USA) function Isqcurvefit. As shown in
As shown in
The spatial distribution of temperature at the sagittal slice of the portion where the pair of ceramics 11 contacts with the temperature set to 65° C. is as shown in
The temperature immediately anterior to the centroid of the ceramics 11 was analyzed as a function of depth to quantify the effect of tissue depth on the ceramics 11 temperature. As shown in
Next, the effect of passive heating on tissue laterally displaced along the width direction Y at the portion in contact with the ceramics 11 was considered.
The temperature was analyzed across the full lateral extent of the back to better characterize the effect of the thermal massage on the tissue temperature, but at fixed depth of the user's body was 2 cm (
A vertical position in the height direction Z matching the pair of ceramics 11 arranged along the width direction Y was considered. The resulting temperature profile confirmed the local action of the ceramics 11, as the temperature fell to near mean body temperatures at the midline (37.9° C. at a depth of 2 cm as shown in
As shown in the blue solid line of
As shown in the green solid line of
In order to predict the magnitude of increased blood flow during thermal massage, a simple non-linear model of the relationship between in situ tissue temperature and blood flow was developed. The model was based on concurrent empirical measurements of temperature and blood flow in the user's leg during heat stress, where flow was found to non-linearly increase from a baseline value of 0.31 L/min to a maximum value of 1.22 L/min. The tissue temperature value computationally derived employing the resulting sigmoid model was as shown in
When the ceramics 11 temperature is 65° C., the spatial distribution of predicted blood flow is shown in
As shown in blue solid line of
As shown in
At this time, the step of calculating the thermal conduction and the temperature change due to the thermal effect when the user's body is pressed (Step 400) may include a step of visualizing the thermal conduction and the temperature change value of the user's body. The user's body may be any one or more parts of the user's body, such as the calculated skin, muscle, vertebrae, intervertebral disc.
In addition, the step of calculating the thermal conduction and the temperature change due to the thermal effect when the user's body is pressed (Step 400) may be a step of calculating the temperature change of a portion corresponding to a depth of 3 cm from the surface of the user's skin while the ceramics 11 of the spine thermal device 10 rises along the height direction Z and pressurizes the user's body. That is, since the portion corresponding to the depth of 3 cm from the skin surface is located with the user's spine and the muscle surrounding the spine (e.g., erector spinae muscle), blood circulation (blood flow improvement) of the portion may be maximized, and safety may be secured by checking in advance whether there is a burn risk for the user in a situation where the blood circulation of the portion corresponding to the depth of 3 cm is maximized.
In this case, the step of setting of the set value of the spinal thermal device 10 may be a step of setting the temperature of the ceramics 11, the ceramic height, and the heating element temperature, and may be changed according to the thermal massage mode selected by the user.
Meanwhile, after the step of visualizing the blood circulation value of the user's body (Step 600), the method may further include deriving the set value for obtaining an optimal temperature or an optimal blood circulation value of the user's body within a range of the ceramics 11 temperature, the ceramics 11 height, and the heating element temperature. That is, by visualizing the blood circulation value of the user's body, the set value is derived so that an optimal temperature or optimal blood circulation value suitable for the user can be obtained.
At this time, the step of deriving the set value for obtaining an optimal temperature or an optimal blood circulation value of the user's body may be a step of deriving the set value for obtaining the optimal temperature or the optimal blood circulation value for each user's body type according to a change in structure according to the user's body type. In other words, since thermal conduction and temperature changes vary depending on the BMI value, and at the same time, whether there is a risk of getting burned or not, it may be necessary to derive the optimal temperature and blood circulation value according to the BMI value, and when the optimum temperature and the blood circulation value are reflected in the spinal thermal device 10, optimal thermal massage for various users is possible, and precautions can be conveyed so that the user can avoid burns during the thermal massage process.
In this case, the step of converting the temperature change value of the user's body into the blood circulation value (Step 500) further comprises correcting the temperature change value of the user's body by reflecting blood circulation data for each user's body position. For example, the blood circulation data for each user's body position may be obtained through a laser Doppler imaging technique, and when the temperature change value of the user's body is corrected in this manner, a blood flow distribution may be more accurately derived, and thus it is possible to derive a set value of the spine thermal device 10 suitable for the user.
In addition, the step of correcting the temperature change value of the user's body of the user further comprises analyzing a laser received from the blood of the user, and for example, it may be configured to analyze the laser received from the user's blood by utilizing the above-described laser Doppler imaging technology, and correct the temperature change value of the user's body by reflecting the analysis result.
As described above, in the method for predicting the safety and effectiveness of the spinal thermal device according to an embodiment of the present disclosure, a blood flow improvement effect provided to a target site is optimized by generating three-dimensional structure data of the user's body and three-dimensional structure data of the spinal thermal device 10, calculating the thermal conduction and the temperature change of the user's body due to heat during the operation of the spinal thermal device 10 according to the set value, and then converting the calculated thermal conduction and the temperature change to the blood circulation value, and thus the safety and effectiveness of the spinal thermal device may be predicted.
Logical blocks, modules or units described in connection with embodiments disclosed herein can be implemented or performed by a computing device having at least one processor, at least one memory and at least one communication interface. The elements of a method, process, or algorithm described in connection with embodiments disclosed herein can be embodied directly in hardware, in a software module executed by at least one processor, or in a combination of the two. Computer-executable instructions for implementing a method, process, or algorithm described in connection with embodiments disclosed herein can be stored in a non-transitory computer readable storage medium.
Although the present disclosure has been described above, the spirit of the present disclosure is not limited by the embodiments presented in the specification, and those skilled in the art who understand the spirit of the present disclosure may easily propose other embodiments by adding, modifying, deleting, adding, etc., elements within the same spirit, but the spirit of the present disclosure is also given.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10-2022-0102106 | Aug 2022 | KR | national |
