JP2021053262A - Wearable durometer - Google Patents

Abstract

To provide a wearable durometer that can objectively evaluate hardness of an evaluation object part.SOLUTION: A wearable durometer 10 includes a wearing part 14 capable of being worn in fingers, a sensor part 16 making a hollow tubular shape, an output part for outputting a sound toward the inside of the sensor part 16, and a reflected sound acquisition part for acquiring a reflected sound obtained by the sound outputted from the output part and being hit against an inner wall of the sensor part 16 and reflected. The wearable durometer is configured such that at least a portion of the sensor part 16 is an elastic part 26 capable of being elastically deformed by coming in contact with an evaluation object part, the reflected sound is changed according to an elastic deformation volume of the elastic part 26, and the hardness of the evaluation object part can be detected from the reflected sound. The elastic part 26 extends along an outer surface 14S of the wearing part 14, and is provided by protruding outwardly from the outer surface 14S.SELECTED DRAWING: Figure 1

Description

The present disclosure relates to a wearable hardness tester.

The cervix in pregnant women usually undergoes a histological change similar to an inflammatory response, called ripening, with increased water content and softening as parturition progresses. This also applies to preterm birth, and even in cases of imminent preterm birth, which is a disease in which preterm birth is imminent, cervical ripening tends to progress and the cervical canal tends to soften. Therefore, it is possible to diagnose the condition of imminent preterm birth by evaluating the hardness of the cervix.

As a method for diagnosing the medical condition of such imminent preterm birth, for example, there are pelvic examination by fingers and diagnosis using ultrasonic waves. Here, the ultrasonic diagnosis includes a diagnosis by transvaginal ultrasonography (uterine echo), a diagnosis by estography (see Non-Patent Document 1), and a diagnosis by VTTQ (Virtual Touch Touch Quantification).

Transvaginal ultrasonography diagnoses the condition of preterm labor by examining the length of the cervix and the ostium of the uterus. Estography is a method capable of non-invasively and relatively fractionating the hardness of tissues, and as shown in Non-Patent Document 1, excellent results have been shown in predicting the delivery time of 10 days or more. There is. VTTQ is a method in which a tissue is vibrated by using a shear wave and the hardness of the tissue is evaluated by an absolute value.

Miura H, et al. Stiffness of cervix as a predictor of labor onset using transvaginal elastgraphy. International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) 23rd World Congress in Sydney, Australia. 2013.

In the method for diagnosing the medical condition of imminent preterm birth, the pelvic examination by fingers is a subjective evaluation, is not reproducible, and has an error between examiners. In addition, it is difficult to evaluate the hardness of the cervical canal by diagnosis by transvaginal ultrasonography. Further, in elastography, since the cervical canal is not fixed, the compression at the time of measurement tends to be insufficient, and it is difficult to evaluate the hardness with sufficient accuracy. There is also a problem that there is a certain error between examiners. Further, in the diagnosis by VTTQ, since energy stronger than that of normal ultrasonic waves is given to the tissue, there is a problem that safety for the foetation cannot be ensured and it cannot be used for pregnant women.
The present disclosure has been completed based on the above circumstances, and an object of the present invention is to provide a hardness tester (wearable hardness tester) capable of objectively evaluating the hardness of an evaluation target portion (for example, cervical canal). To do. Although the main object of the present invention is to evaluate the hardness of the cervical canal, the intended use is not limited to the cervical canal and can be applied to the entire body surface of the human body.

In order to solve the above problems, the wearable hardness tester of the present disclosure outputs a sound toward the inside of a mounting portion that can be mounted on a finger, a hollow tubular sensor portion, and the inside of the sensor portion. It includes an output unit and a reflected sound acquisition unit that acquires the reflected sound that is reflected by the sound output from the output unit hitting the inner wall of the sensor unit, and at least a part of the sensor unit comes into contact with the evaluation target unit. As a result, the elastic portion can be elastically deformed, the reflected sound is changed according to the amount of elastic deformation of the elastic portion, and the wearable hardness capable of detecting the hardness of the evaluation target portion from the reflected sound. As a meter, the elastic portion extends along the outer surface of the mounting portion and is provided so as to project outward from the outer surface.

Since the elastic portion in the sensor portion protrudes outward from the outer surface of the mounting portion, for example, the amount of elastic deformation of the elastic portion when the elastic portion presses the evaluation target portion with a constant force is the evaluation target portion. If the hardness of (for example, the cervical canal) is soft, it becomes small, and if the hardness of the evaluation target portion is hard, it becomes large. Therefore, since the reflected sound also changes according to the amount of elastic deformation of the elastic portion, the hardness of the evaluation target portion can be objectively evaluated by observing the reflected sound. Further, since the elastic portion in the sensor portion protrudes outward from the outer surface of the mounting portion, for example, the elastic portion is easily elastically deformed as compared with the configuration in which the elastic portion is embedded in the mounting portion. , The sensitivity of the sensor unit can be improved. Further, the sound output from the output unit (for example, a speaker) may be a sound in an audible frequency band (for example, a sound of 3 [kHz]), and is compared with a conventional method using ultrasonic waves. The hardness of the evaluation target part can be evaluated with low energy sound. As a result, for example, if the evaluation target portion is a tissue of the human body (for example, the cervical canal of a pregnant woman), the load on the human body (including the foetation if the evaluation target portion is the cervical canal) is reduced.

Further, a plurality of the sensor units are provided, and the plurality of the sensor units include at least a first sensor unit and a second sensor unit, and are the elastic portions related to the first sensor unit. The elastic portion 1 and the second elastic portion, which is the elastic portion related to the second sensor portion, extend in the same extension direction and are arranged side by side in a direction intersecting the extension direction. The configuration may be offset when viewed from the direction of intersection with.

When the mounting portion comes into contact with the evaluation target portion, if the hardness of the evaluation target portion is soft, the mounting portion easily sinks into the evaluation target portion, so that the contact area between the mounting portion and the evaluation target portion becomes large. On the contrary, if the hardness of the evaluation target portion is hard, the contact area between the mounting portion and the evaluation target portion becomes small. Here, since the first elastic portion and the second elastic portion are arranged so as to be offset from each other when viewed from the direction intersecting the extension direction, for example, the first elastic portion is more than the second elastic portion. When the side is relatively closer to the evaluation target portion, the contact area of the adjacent second elastic portion with the evaluation target portion differs depending on the hardness of the evaluation target portion. For example, when the hardness of the evaluation target portion is soft and the contact area of the second elastic portion with the evaluation target portion is large, the amount of elastic deformation of the second elastic portion is large. On the contrary, if the hardness of the evaluation target portion is hard, the amount of elastic deformation of the second elastic portion becomes small. From this, for example, by looking at the output of the second sensor unit when the output of the first sensor unit reaches a certain value, the output of the evaluation target unit is relatively relative to the output of the first sensor unit. Hardness can be evaluated. For example, when evaluating the difference in hardness between different evaluation target parts, if there is only one sensor unit, the difference in hardness will be seen unless the elastic part is applied to each evaluation target part with a constant force. Cannot be evaluated. However, since the force pressed by the finger varies widely and the output of the sensor unit changes according to the force pressed by the finger, it is difficult to accurately evaluate the difference in hardness between different evaluation target units. On the other hand, when the sensor unit has two configurations, the output of the second sensor unit can be viewed with reference to the output of the first sensor unit, so that even if the pressing force of the finger varies, the output of the first sensor unit By looking at the output of the second sensor unit when the output reaches a certain output, the difference in hardness between different evaluation target units can be accurately evaluated.

Further, the amount of deviation between the first elastic portion and the second elastic portion when viewed from the direction intersecting the extension direction extends over the entire length of the first elastic portion and the second elastic portion. The configuration may be constant.

By making the amount of deviation in the height direction between the first elastic portion and the second elastic portion as seen from the direction intersecting the extension direction of each elastic portion constant over the entire length of each elastic portion, each of them The hardness of the evaluation target portion can be evaluated more accurately as compared with the configuration in which the amount of deviation of the elastic portion in the height direction varies.

Further, the mounting portion may include a spherical portion having a spherical shape, and the first elastic portion and the second elastic portion may be arranged on the outer surface of the spherical portion.

Since the first elastic portion and the second elastic portion are arranged on the spherical portion in the mounting portion, the height of the first elastic portion from the spherical portion and the height of the second elastic portion from the spherical portion. Even when they have the same height, the first elastic portion and the second elastic portion are arranged so as to be offset from each other when viewed from the direction intersecting the extension direction. As a result, the first elastic portion and the second elastic portion can be set to have the same size, and the first sensor portion and the second sensor portion can use the same sensor, so that the sensitivity can be set. Is easy to adjust. For example, when the first elastic portion and the second elastic portion are arranged in a flat surface shape, it is necessary to design the second elastic portion to be smaller than the first elastic portion, and it is necessary to design the second elastic portion to be smaller than the first elastic portion. The adjustment of the sensitivity of is complicated.

Further, the mounting portion is mounted on the tip of the finger, and the spherical portion in the mounting portion has a spherical shape corresponding to the shape of the tip of the finger, and the outer surface of the spherical portion. Has a palm surface located on the palm side, and the first elastic portion and the second elastic portion are arranged along the palm surface, and the first elastic portion and the second elastic portion are arranged along the palm surface. The extension direction of the portion may be the length direction of the finger.

Since the first elastic portion and the second elastic portion are arranged so as to extend in the length direction of the finger along the palm surface of the spherical portion, the palm surface of the spherical portion is in contact with the evaluation target portion. Even if the contact angle between the mounting portion and the evaluation target portion changes, the first elastic portion and the second elastic portion will come into contact with the evaluation target portion as before the change in the contact angle. .. That is, if the extension directions of the first elastic portion and the second elastic portion intersect with the length direction of the finger, the first elasticity increases as the contact angle approaches 90 °. Since the portion and the second elastic portion change in a direction away from the evaluation target portion, the amount of elastic deformation becomes small, and it is assumed that the hardness of the evaluation target portion cannot be evaluated. Therefore, with the above configuration, the hardness of the evaluation target portion can be accurately evaluated regardless of the contact angle of the mounting portion with the evaluation target portion.

Further, the plurality of the sensor units further include a third sensor unit, and the third elastic portion, which is the elastic portion of the third sensor portion, extends in the extending direction and the first elastic portion. And the second elastic portion, the first sensor portion is arranged side by side on the outer surface in a direction intersecting the extension direction, and the first sensor portion includes the second sensor portion and the third sensor. It may be configured to be arranged between the parts.

By using the three sensor parts, when each elastic part comes into contact with the evaluation target part, the wearable hardness tester is in contact with the evaluation target part at a deviation from the vertical direction (more specifically, it is in contact with the evaluation target part). It is possible to detect that the contact is offset to the second elastic portion side or the third elastic portion side with the first elastic portion as a reference). For example, when the second elastic portion and the third elastic portion are arranged in a target with respect to the first elastic portion 26A, the second elastic portion 26B is elastically deformed more than the third elastic portion. If the amount is large, it can be detected that the second elastic portion is in contact with the elastic portion. As a result, for example, by performing a process of correcting the deviation from the outputs of the three sensor units, the hardness of the evaluation target portion can be accurately measured even when the wearable hardness tester is not in contact with the evaluation target portion from the vertical direction. Can be evaluated.

Further, the sound output from the output unit may be configured to be a sound in a frequency band in the audible range.

By setting the sound output from the output unit to sound in the audible frequency band (generally, sound in the frequency band of 20 [Hz] to 20 [kHz]), it is widely used in, for example, medical equipment. Since the energy is lower than that when ultrasonic waves are used, the load applied to the evaluation target portion is reduced.

Further, the mounting portion and the elastic portion may be integrally formed of silicone rubber.

Since the mounting portion and the elastic portion are integrally formed of silicone rubber, which is a soft material, it is possible to prevent the mounting portion or the elastic portion from being damaged when it comes into contact with the evaluation target portion.

According to the present disclosure, it is possible to provide a wearable hardness tester capable of objectively evaluating the hardness of an evaluation target portion.

FIG. 1 is a perspective view of a wearable hardness tester according to an embodiment. FIG. 2 is a plan view of the wearable hardness tester. FIG. 3 is a bottom view of the wearable hardness tester. FIG. 4 is a side view of the wearable hardness tester. FIG. 5 is a cross-sectional view of the wearable hardness tester viewed from the front. FIG. 6 is a diagram illustrating a state in which a wearable hardness tester is used. FIG. 7 is a diagram for explaining the detection principle of the sensor unit. FIG. 8 is a diagram for explaining the detection principle of the sensor unit. FIG. 9 is a diagram for explaining the difference in the contact area of each sensor unit due to the difference in the hardness of the evaluation target portion (FIG. 9 (a) ... When the hardness of the evaluation target portion is hard / FIG. 9 (b) ... Evaluation. When the hardness of the target part is soft). FIG. 10 is a diagram for explaining the difference in the pressure distribution applied to the elastic portion of each sensor portion due to the difference in the hardness of the evaluation target portion (FIG. 10 (a) ... When the hardness of the evaluation target portion is hard / FIG. 10 (Fig. 10). b) ... When the hardness of the evaluation target portion is soft). FIG. 11 shows the output (horizontal axis) of the first sensor unit in the center and the output (horizontal axis) of the second sensor unit and the third sensor unit when the hardness of the sample is 240 [kPA]. It is a graph showing the relationship of output. FIG. 12 shows the output (horizontal axis) of the first sensor unit in the center and the output (horizontal axis) of the second sensor unit and the third sensor unit when the hardness of the sample is 120 [kPA]. It is a graph showing the relationship of output. FIG. 13 is a simplified view of the wearable hardness tester viewed from the front in another embodiment (1), and is a diagram for explaining the number and position of elastic portions.

<Embodiment>
The wearable hardness tester 10 of the present disclosure will be described with reference to FIGS. 1 to 12. The wearable hardness meter 10 of the embodiment is a hardness meter used for evaluating the hardness of the evaluation target portion E (for example, the cervical canal of a pregnant woman) that deforms when pressed, and as shown in FIG. 1, a finger. A mounting unit 14 that can be mounted on the sensor unit 14, a plurality of (three in the embodiment) sensor units 16, a speaker (output unit) 18 provided for each sensor unit 16, and a microphone (reflected sound acquisition unit) 20 ( The speaker 18 and the microphone 20 are configured with (shown only in FIG. 7).

As shown in FIG. 6, the mounting portion 14 has a finger cap shape that can be mounted on the tip of the index finger F, and is made of a soft material (silicone rubber in the embodiment). As shown in FIG. 1, the mounting portion 14 includes a cylindrical portion 14A having a cylindrical shape and a spherical portion 14B forming a hemispherical shape. The spherical portion 14B has a spherical shape corresponding to the shape of the tip portion of the index finger F.

As shown in FIG. 6, the outer surface 14S of the mounting portion 14 is a palm surface 14S1 relatively located on the back side of the hand and a palm surface 14S2 relatively located on the palm side P in a state of being mounted on the index finger F. And, it is divided into. A wall portion 22 is formed so as to project on the palm surface 14S2 side of the cylindrical portion 14A.

As shown in FIGS. 1 to 5, the sensor portion 16 includes a silicone tube portion 24 and an elastic portion 26. The silicone tube portion 24 is a hollow cylindrical silicone tube having openings on both sides, and has flexibility. The length of the silicone tube portion 24 in the embodiment is 290 [mm: milli meter], the outer diameter is 3 [mm], and the inner diameter is 2 [mm].

As shown in FIG. 1, the elastic portion 26 is integrally formed with the mounting portion 14 by silicone rubber. The elastic portion 26 has a hollow semi-cylindrical shape, projects outward from the palm surface 14S2 side of the spherical portion 14B, and is curved along the palm surface 14S2. Here, as shown in FIG. 6, the extension direction of the elastic portion 26 is the same as the length direction D1 of the index finger F. As shown in FIG. 5, the outer diameter of the elastic portion 26 is OD, and the inner diameter is ID. Here, the outer diameter OD is 5 [mm], and the inner diameter ID is 3 [mm]. Further, the cavity length inside the elastic portion 26 is set to 14.5 [mm]. As shown in FIG. 6, the elastic portion 26 is a portion that comes into contact with the evaluation target portion E, and when the elastic portion 26 presses the evaluation target portion E, the evaluation target portion E is elastically deformed and the elastic portion 26 is elastic. It elastically deforms inward due to the repulsive force of the deformed evaluation target portion E.

As shown in FIG. 1, one end of the elastic portion 26 is closed by the wall portion 22, and the other end is open. One end of the silicone tube portion 24 is arranged along the instep surface 14S1 of the mounting portion 14 and is connected to the opening on the other side of the elastic portion 26. As shown in FIG. 8, the inside of the silicone tube portion 24 and the inside of the elastic portion 26 communicate with each other.

As shown in FIG. 7, the speaker 18 and the microphone 20 are provided near the opening on the other side of the sensor unit 16. The speaker 18 is a device that outputs sound, and the microphone 20 is a device that inputs sound. Here, the opening on the other side of the sensor unit 16 is an input unit 17 into which the sound output from the speaker 18 is input.

A waveform generating unit 30 that generates a waveform having a constant frequency is connected to the speaker 18, and a sound having a constant frequency generated by the waveform generating unit 30 is output from the speaker 18. More specifically, the waveform generation unit 30 constantly generates a sine wave of 3.12 [kHz: kilo Hertz], and the sine wave signal generated by the waveform generation unit 30 is amplified by the amplifier 32. A sine wave sound of 3.12 [kHz] is constantly output from the speaker 18. Here, the sound of 3 [kHz] is generally a sound in the audible range that can be heard by the human ear. The audible range generally refers to a frequency band of 20 [Hz] to 20 [kHz].

The sound (IW shown in FIG. 7) input from the input unit 17 travels in the cylinder of the sensor unit 16 toward the wall unit 22 side. Further, the input sound IW hits the inner wall 28 of the wall portion 22 and the sensor portion 16 and is reflected to become reflected sounds (RW1 and RW2 shown in FIG. 7).

The reflected sound proceeds toward the input unit 17 side. Here, the reflected sound RW1 in FIG. 7 is a sound that hits the wall portion 22 and is reflected. Further, the reflected sound RW2 is a sound reflected by hitting the inner wall 28 of the elastically deformed portion when the elastic portion 26 is elastically deformed at a position of a distance XP from the wall portion 22. The synthetic sound RW3 is a sound obtained by synthesizing the input sound IW, the reflected sound RW1, and the reflected sound RW2.

The microphone 20 acquires the synthetic sound RW3. At this time, each parameter of the sensor unit 16 (length of the silicone tube portion 24, length of the elastic portion 26, etc.) and so as to increase the amplitude of the synthetic sound RW3 as the elastic deformation amount DFA of the elastic portion 26 increases. The frequency of the sound is adjusted. Thereby, the elastic deformation amount of the elastic portion 26 can be obtained from the amplitude information of the synthetic sound RW3 acquired by the microphone 20, for example, the value of PP (Peak to Peak) of the synthetic sound RW3. The synthetic sound RW3 acquired by the microphone 20 is analog-to-digital converted by the A / D converter 34, and the data processing unit 36 (for example, a personal computer or the like) performs a process of calculating the PP value of the synthetic sound RW3. It is said.

As shown in FIG. 1, each elastic portion 26 of the three sensor portions 16 extends in the same extending direction along the palm surface 14S2 and intersects the extending direction of each elastic portion 26 (shown in FIG. 5). They are arranged side by side in the left-right direction). As shown in FIG. 5, the distance between the adjacent elastic portions 26 is L. Here, the distance L is 5 [mm].

As shown in FIG. 5, the elastic portion 26 located at the center when viewed from the front is referred to as a first elastic portion 26A, and the sensor portion 16 pertaining to the first elastic portion 26A is referred to as a sensor portion 16A. Further, the elastic portion 26 located on the right side when viewed from the front is referred to as a second elastic portion 26B, and the sensor portion 16 over the second elastic portion 26B is referred to as a sensor portion 16B. Further, the elastic portion 26 located on the left side when viewed from the front is referred to as a third elastic portion 26C, and the sensor portion 16 pertaining to the third elastic portion 26C is referred to as a sensor portion 16C.

As shown in FIG. 5, the palm surface 14S2 connected to the elastic portions 26A, 26B, and 26C has a spherical shape. Therefore, the central first elastic portion 26A, the second elastic portions 26B on both sides, and the third elastic portion 26C are arranged so as to be offset in the vertical direction shown in the drawing. Here, the amount of deviation between the first elastic portion 26A and the second elastic portion 26B is DA1, and the amount of deviation between the first elastic portion 26A and the second elastic portion 26C is DA2. To.

The second elastic portion 26B and the third elastic portion 26C are arranged symmetrically with respect to the first elastic portion 26A, and are provided at the same positions in the vertical direction shown in FIG. Therefore, the deviation amount DA1 and the deviation amount DA2 are the same value.

As shown in FIG. 4, when the elastic portion 26 is viewed from the side which is the direction intersecting the extension direction of each elastic portion 26, the amount of deviation DA1 between the first elastic portion 26A and the second elastic portion 26B Is the same amount of deviation over the entire length of each elastic portion 26A and 26B. Although not shown, the deviation amount DA2 between the first elastic portion 26A and the third elastic portion 26C is also the same deviation amount over the entire length of each elastic portion 26A, 26C.

Next, an example of a method for evaluating the hardness of the evaluation target portion E in the wearable hardness tester 10 will be described. As shown in FIG. 6, when evaluating the hardness of the evaluation target portion E, the mounting portion 14 mounted on the index finger F of the user (for example, an obstetrician / gynecologist) is evaluated from the palm surface 14S2 side of the spherical portion 14B. Make contact with the target part E slightly strongly. As a result, the evaluation target portion E is pressed and elastically deformed, and the spherical portion 14B in the mounting portion 14 is sunk into the evaluation target portion E. At this time, as shown in FIG. 9, when the hardness of the evaluation target portion E is soft (see FIG. 9B), it is compared with the case where the hardness of the evaluation target portion E is hard (see FIG. 9A). , You will be deeply absorbed. Therefore, the contact range between the wearable hardness tester 10 and the evaluation target portion E is larger in the contact range CR2 when the hardness is soft than in the contact range CR1 when the hardness is hard. Further, when the repulsive force of the evaluation target portion E is applied to the palm surface 14S2 of the mounting portion 14, each elastic portion 26A, 26B, 26C receives pressure from the evaluation target portion E and elastically deforms inward.

As shown in FIG. 10, the pressure received from the evaluation target portion E by the central first elastic portion 26A is higher in the pressure PDA1 when the hardness of the evaluation target portion E is hard (in the case of FIG. 10A). When the hardness of the evaluation target portion E is soft (in the case of FIG. 10B), the pressure is higher than the pressure PDA2. Therefore, the amount of elastic deformation of the first elastic portion 26A is larger when the hardness of the evaluation target portion E is harder than when it is soft.

On the other hand, the pressures received by the second elastic portions 26B and the third elastic portions 26C on both sides from the evaluation target portion E are the pressure PDB1 and the pressure when the hardness of the evaluation target portion E is hard (in the case of FIG. 10A). The pressure PDB2 and the pressure PDC2 are larger than the PDC1 when the hardness of the evaluation target portion E is soft (in the case of FIG. 10B). Therefore, the amount of elastic deformation of the second elastic portion 26B and the third elastic portion 26C is larger when the hardness of the evaluation target portion E is softer than when it is hard.

11 and 12 show the test results obtained by acquiring the outputs of the sensor units 16A, 16B, and 16C when the wearable hardness tester 10 presses a sample having a constant hardness. According to these test results, when the sample is pressed with the same force, the output of the second sensor unit 16B and the third sensor unit 16C is larger when the sample hardness is softer than when the sample hardness is harder. It shows that it becomes.

FIG. 11 shows the output (horizontal axis) of the first sensor unit 16A and the second sensor unit when the hardness of the sample is hard (specifically, when the hardness of the sample is 240 [kPA: kilo Pascal]). It is a graph which shows the relationship with the output (vertical axis) of 16B and the third sensor part 16C. Further, FIG. 12 shows the output (horizontal axis) of the first sensor unit 16A and the second sensor unit 16B when the hardness of the sample is soft (specifically, when the hardness of the sample is 120 [kPA]). It is a graph which shows the relationship with the output (vertical axis) of the 3rd sensor part 16C. Here, the units of the horizontal axis and the vertical axis of each graph are [N: Newton], which is a unit of force, and are converted from the PP values of the amplitudes of the synthesized sounds in the sensor units 16A, 16B, and 16C. It is what was sought. Further, when acquiring the outputs of the sensor units 16A, 16B, and 16C, the spherical portion 14B is attached to the sample so that the forces received from the samples of the second elastic portion 26B and the third elastic portion 26C are the same. On the other hand, the sample is pressed from the vertical direction.

In each graph, "side1" represents the second sensor unit 16B, and "side2" represents the third sensor unit 16C. Further, the respective angles of 30 °, 60 °, and 80 ° in each graph represent the contact angles α (see FIG. 6) when the spherical portion 14B contacts the evaluation target portion E. Here, "°", which is a unit of angle, represents an angle by the degree method and is synonymous with [deg: degree].

From the graph of the test results, the output values of the second sensor unit 16B and the third sensor unit 16C are higher when the sample hardness in FIG. 12 is softer than when the sample hardness in FIG. 13 is harder. It turns out that it is large as a whole.

From the graphs of the test results of FIGS. 11 and 12, it can be seen that almost the same output results are obtained even if the contact angle α is changed. Therefore, it is possible to evaluate the hardness of the evaluation target portion E even if the contact angle α is changed. This is because the elastic portions 26A, 26B, and 26C are formed so as to extend along the palm surface 14S2 of the spherical portion 14B in the same extension direction as the length direction D1 of the index finger F, so that the contact angle α changes. Even so, the elastic portions 26A, 26B, and 26C come into contact with the evaluation target portion E. When the contact angle α is 80 °, the output tends to be small as a whole and the S / N (Signal / Noise) ratio is lowered. Therefore, an angle in the range of 30 ° to 60 ° is practically used. Be done.

An example of a method of evaluating the hardness from the output values of the sensor units 16A, 16B, and 16C will be described. For example, the evaluation of the hardness of the evaluation target unit E is performed by looking at the output values of the second sensor unit 16B and the third sensor unit 16C with reference to the output value of the first sensor unit 16A. More specifically, the data processing unit 36 outputs the output of the second sensor unit 16B when the output of the reference first sensor unit 16A reaches a certain value (for example, 1.2 [N]). The value and the output value of the third sensor unit 16C are obtained, and the hardness of the evaluation target unit E is calculated from the output value of the second sensor unit 16B and the output value of the third sensor unit 16C.

At this time, if there is a difference between the output value of the second sensor unit 16B and the output value of the third sensor unit 16C, the wearable hardness tester 10 comes into contact with the evaluation target unit E at a deviation from the vertical direction. You can see that. Therefore, when there is such a deviation, the data processing unit 36 performs a process of correcting the deviation amount, and performs a process of calculating the hardness from the output values of the corrected sensor units 16A, 16B, and 16C. From the above, the hardness of the evaluation target portion E can be evaluated accurately and objectively.

Next, the effect of this embodiment will be described. According to the present embodiment, since the elastic portion 26 in the sensor portion 16 projects outward from the outer surface 14S of the mounting portion 14, for example, the elastic portion 26 presses the evaluation target portion E with a constant force. In this case, the amount of elastic deformation of the elastic portion 26 decreases when the hardness of the evaluation target portion E (for example, the cervical canal) is soft, and increases when the hardness of the evaluation target portion E is hard. Therefore, since the reflected sound also changes according to the amount of elastic deformation of the elastic portion 26, the hardness of the evaluation target portion E can be objectively evaluated by observing the reflected sound. Further, since the elastic portion 26 in the sensor portion 16 projects outward from the outer surface 14S of the mounting portion 14, for example, the elastic portion 26 has a structure in which the elastic portion is embedded in the mounting portion. Since it is easily elastically deformed, the sensitivity of the sensor unit 16 can be improved. Further, the sound output from the output unit (for example, the speaker 18) may be a sound in an audible frequency band (for example, a sound of 3 [kHz]), as compared with the conventional method using ultrasonic waves. , The hardness of the evaluation target portion E can be evaluated by the sound of low energy. As a result, for example, if the evaluation target portion E is a tissue of the human body (for example, the cervix of a pregnant woman), the load on the human body (and the foetation) is reduced.

Further, when the mounting portion 14 comes into contact with the evaluation target portion E, if the hardness of the evaluation target portion E is soft, the mounting portion 14 easily sinks into the evaluation target portion E, so that the mounting portion 14 and the evaluation target portion E come into contact with each other. The area will be large. On the contrary, if the hardness of the evaluation target portion E is hard, the contact area between the mounting portion 14 and the evaluation target portion E becomes small. Here, since the first elastic portion 26A and the second elastic portion 26B are arranged so as to be offset from each other when viewed from the direction intersecting the extension direction, for example, the first elastic portion 26B is more than the second elastic portion 26B. When the elastic portion 26A is relatively closer to the evaluation target portion E, the contact area of the adjacent second elastic portion 26B with the evaluation target portion E differs depending on the hardness of the evaluation target portion E. For example, when the hardness of the evaluation target portion E is soft and the contact area of the second elastic portion 26B with the evaluation target portion E is large, the amount of elastic deformation of the second elastic portion 26B becomes large. On the contrary, if the hardness of the evaluation target portion E is hard, the amount of elastic deformation of the second elastic portion 26B becomes small. From this, for example, by looking at the output of the second sensor unit 16B when the output of the first sensor unit 16A reaches a certain value, it is relatively evaluated with reference to the output of the first sensor unit 16A. The hardness of the target portion E can be evaluated. For example, when evaluating the difference in hardness between different evaluation target parts E, if there is only one sensor unit, the difference in hardness must be applied to each evaluation target part with a constant force. Cannot be evaluated. However, since the force pushed by the finger varies widely and the output of the sensor unit changes according to the force pushed by the finger, it is difficult to accurately evaluate the difference in hardness between different evaluation target parts E. On the other hand, when the sensor unit 16 has two configurations, the output of the second sensor unit 16B can be seen with reference to the output of the first sensor unit 16A. By looking at the output of the second sensor unit 16B when the output of the sensor unit 16A reaches a certain output, the difference in hardness between different evaluation target units E can be accurately evaluated.

Further, the amount of deviation in the height direction between the first elastic portion 26A and the second elastic portion 26B as viewed from the direction intersecting the extension direction of each elastic portion 26 is constant over the entire length of each elastic portion 26. By doing so, the hardness of the evaluation target portion can be detected more accurately as compared with the configuration in which the amount of deviation of each elastic portion in the height direction varies.

Further, since the first elastic portion 26A and the second elastic portion 26B are arranged on the spherical portion 14B of the mounting portion 14, the height of the first elastic portion 26A from the spherical portion 14B and the second elasticity Even when the height of the portion 26B from the spherical portion 14B is the same, the first elastic portion 26A and the second elastic portion 26B are arranged so as to be offset from each other when viewed from the direction intersecting the extension direction. The Rukoto. As a result, the first elastic portion 26A and the second elastic portion 26B can be set to have the same size, and the first sensor portion 16A and the second sensor portion 16B can use the same sensor. Therefore, the sensitivity can be easily adjusted. For example, when the first elastic portion and the second elastic portion are arranged in a flat surface shape, it is necessary to design the second elastic portion to be smaller than the first elastic portion, and it is necessary to design the second elastic portion to be smaller than the first elastic portion. The adjustment of the sensitivity of is complicated.

Further, since the first elastic portion 26A and the second elastic portion 26B are arranged so as to extend along the palm surface 14S2 of the spherical portion 14B in the finger length direction D1, the palm surface 14S2 of the spherical portion 14B The first elastic portion 26A and the second elastic portion 26B still have a contact angle α even if the contact angle α between the mounting portion 14 and the evaluation target portion E changes in a state where the first elastic portion 26A and the second elastic portion 26B are in contact with the evaluation target portion E. It comes into contact with the evaluation target portion E as before the change of. That is, if the extension directions of the first elastic portion and the second elastic portion intersect with the finger length direction D1, the first elastic portion α becomes closer to 90 °. Since the elastic portion and the second elastic portion of the above change in a direction away from the evaluation target portion E, it is assumed that the amount of elastic deformation becomes small and the hardness of the evaluation target portion E cannot be evaluated. Therefore, with the above configuration, the hardness of the evaluation target portion E can be accurately evaluated regardless of the contact angle α of the mounting portion 14 with the evaluation target portion E.

Further, by using the three sensor units 16A, 16B, 16C, when the respective elastic parts 26A, 26B, 26C come into contact with the evaluation target part E, the wearable hardness tester 10 is in the direction perpendicular to the evaluation target part R. (More specifically, the contact is deviated from the second elastic portion 26B side or the third elastic portion 26C side with reference to the first elastic portion 26A). Can be detected. For example, when the second elastic portion and the third elastic portion are arranged in a target with respect to the first elastic portion 26A, the second elastic portion 26B is elastically deformed more than the third elastic portion. If the amount is large, it can be detected that the second elastic portion is in contact with the elastic portion. As a result, for example, by performing a process of correcting the deviation from the outputs of the three sensor units 16A, 16B, and 16C, the wearable hardness tester 10 is accurate even when it is not in contact with the evaluation target unit E from the vertical direction. The hardness of the evaluation target portion E can be evaluated.

Further, by setting the sound output from the speaker 18 to the sound in the audible frequency band (generally, the sound in the frequency band of 20 [Hz] to 20 [kHz]), it is widely used in medical equipment, for example. Since the energy is lower than that in the case of using the ultrasonic wave to be evaluated, the load applied to the evaluation target portion E can be reduced.

Further, since the mounting portion 14 and the elastic portion 26 are integrally formed of silicone rubber which is a soft material, when the mounting portion 14 or the elastic portion 26 comes into contact with the evaluation target portion, the evaluation target portion is damaged. Can be suppressed.

<Other Embodiments>
The present disclosure is not limited to the embodiments described by the above description and drawings, and for example, the following embodiments are also included in the technical scope of the present disclosure.

(1) In the above embodiment, the wearable hardness tester 10 has three sensor units 16, but the present invention is not limited to this. For example, as shown in the wearable hardness tester 110 of FIG. 13A, it is composed of only the first sensor unit 116A and the second sensor unit 116B, which is the configuration excluding the third sensor unit 16C in the above embodiment. It may be configured. In the figure, the silicone tube portions of the sensor portions 116A and 116B are not shown, and only the elastic portions 126A and 126B are shown.
Further, as shown in the wearable hardness tester 210 of FIG. 13B, the first elastic portion 226A of the first sensor portion 216A is arranged so as to be offset to the left side of the drawing from the central axis CL of the mounting portion 214 when viewed from the front. It may be configured to be used. Even in this case, the first sensor unit 216A and the second sensor unit 216B are displaced by the amount of displacement DA1A in the vertical direction shown in the drawing.

(2) In the above embodiment, the mounting portion 14 and the elastic portion 26 are integrally formed, but the present invention is not limited to this. For example, the mounting portion and the elastic portion may be formed separately, and the elastic portion may be adhered to the mounting portion.

(3) In the above embodiment, the silicone tube portion 24 is configured to be a cylindrical tube, but the present invention is not limited to this. For example, the silicone tube portion may have a square tubular shape.

(4) In the above embodiment, the mounting portion 14 and the elastic portion 26 are formed of silicone rubber, but the present invention is not limited to this. For example, it may be configured to be formed of another flexible resin (for example, EVA (Ethylene Vinyl Acate) resin).

(5) In the above embodiment, the sound output from the speaker 18 is configured to be a sine wave of 3.12 [kHz], but the present invention is not limited to this, and the frequency and waveform of the sound are determined by the sensor unit. It is appropriately changed according to the shape, length, etc. When the frequency of sound is increased, the wavelength is shortened, so that it is generally necessary to adjust the overall length of the sensor unit to be shortened.

(6) In the above embodiment, the output of the sensor unit 16 is configured to be obtained from the amplitude information of the synthesized sound (more specifically, the P-P value of the amplitude), but the output is not limited to this. For example, the output of the sensor unit may be configured to be obtained from the phase information of the input sound and the reflected sound.

(7) In the above embodiment, the sensor portion 16 is configured to include the silicone tube portion 24 and the elastic portion 26, and the elastic portion 26 is configured to be at least a part of the sensor portion 16. It is not limited to this. For example, the entire sensor unit may be an elastic portion.

(8) In the above embodiment, the mounting portion 14 has a finger cap shape that covers the tip end portion of the index finger F, but the present invention is not limited to this. For example, a part of the mounting portion may be open, and a part of the tip portion of the index finger may be exposed to the outside. With such a configuration, a part of the tip of the index finger can come into contact with the evaluation target part, and the evaluation by the wearable hardness tester and the subjective evaluation by the finger touching the evaluation target part can be performed. Both evaluations can be performed at the same time.

(9) In the above embodiment, the first sensor unit 16A and the second sensor unit 16B are arranged so as to be offset by the amount of deviation DA1 in the height direction, and the first sensor unit 16A and the second sensor unit 16B are arranged. The sensor unit 16C of No. 3 is arranged so as to be offset by the deviation amount DA2, which is the same deviation amount as the deviation amount DA1 in the height direction, but the present invention is not limited to this. For example, the deviation amount DA1 and the deviation amount DA2 may be different from each other.

(10) In the above embodiment, the elastic portions 26A, 26B, and 26C are set to have the same outer diameter and inner diameter, and are adjusted so that the easiness of elastic deformation becomes the same, for example. The outer diameter and inner diameter of each elastic portion may be different for each elastic portion, and the ease of elastic deformation may be different for each elastic portion.

(11) The wearable hardness tester 10 of the embodiment is used for evaluating the hardness of the cervical canal of a pregnant woman, but the wearable hardness tester 10 is not limited to this as long as it is a part to be evaluated for softness. For example, a wearable hardness tester 10 may be used to evaluate the hardness of tissues of a living body other than the cervix.

10, 110, 210: Wearable hardness tester 14, 214: Mounting part 14A: Cylindrical part 14B: Spherical part 14S: Outer surface 14S1: Instep surface 14S2: Palm surface 16: Sensor part 16A, 116A, 216A: First sensor part 16B, 116B, 216B: Second sensor unit 16C, 116C, 216C: Third sensor unit 17: Input unit 18: Speaker (output unit)
20: Microphone (reflected sound acquisition unit)
22: Wall part 24: Silicone tube part 26: Elastic parts 26A, 126A, 226A: First elastic parts 26B, 126B, 226B: Second elastic parts 26C, 126C, 226C: Third elastic parts 28: Inner wall 30 : Waveform generator 32: Amplifier 34: A / D converter 36: Data processing unit E: Evaluation target unit F: Index finger (finger)
P: Palm side α: Contact angle

Claims (8)

A mounting part that can be worn on a finger and
A hollow tubular sensor unit and
An output unit that outputs sound toward the inside of the sensor unit,
A reflected sound acquisition unit that acquires the reflected sound that the sound output from the output unit hits the inner wall of the sensor unit and is reflected is provided.
At least a part of the sensor part is an elastic part that can be elastically deformed by coming into contact with the evaluation target part.
The reflected sound is changed according to the amount of elastic deformation of the elastic portion, and the wearable hardness meter capable of detecting the hardness of the evaluation target portion from the reflected sound.
A wearable hardness tester that extends along the outer surface of the mounting portion and projects outward from the outer surface. A plurality of the sensor units are provided, and the plurality of the sensor units include at least a first sensor unit and a second sensor unit.
The first elastic portion, which is the elastic portion of the first sensor portion, and the second elastic portion, which is the elastic portion of the second sensor portion, extend in the same extending direction and extend in the same extending direction. The wearable hardness tester according to claim 1, which is arranged side by side in a direction intersecting with, and is arranged so as to be offset from the direction intersecting the extension direction. The amount of deviation between the first elastic portion and the second elastic portion as viewed from the direction intersecting the extension direction is constant over the entire length of the first elastic portion and the second elastic portion. The wearable hardness tester according to claim 2. The mounting portion includes a spherical portion forming a spherical shape.
The wearable hardness tester according to claim 2 or 3, wherein the first elastic portion and the second elastic portion are arranged on the outer surface of the spherical portion. The mounting portion is mounted on the tip of the finger, and is mounted on the tip of the finger.
The spherical portion in the mounting portion has a spherical shape corresponding to the shape of the tip portion of the finger.
The outer surface of the spherical portion includes a palm surface located on the palm side.
The first elastic portion and the second elastic portion are arranged along the palm surface.
The wearable hardness tester according to claim 4, wherein the extension direction of the first elastic portion and the second elastic portion is the length direction of the finger. The plurality of sensor units further include a third sensor unit.
The third elastic portion, which is the elastic portion of the third sensor portion, extends in the extending direction, and together with the first elastic portion and the second elastic portion, in a direction intersecting the extending direction. Arranged side by side on the outer surface,
The wearable hardness tester according to any one of claims 2 to 5, wherein the first sensor unit is arranged between the second sensor unit and the third sensor unit. The wearable hardness tester according to any one of claims 1 to 6, wherein the sound output from the output unit is a sound in an audible frequency band. The wearable hardness tester according to any one of claims 1 to 7, wherein the mounting portion and the elastic portion are integrally formed of silicone rubber.

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