WO2017183190A1

WO2017183190A1 - Sample observation kit and semen sample observation method using sample observation kit

Info

Publication number: WO2017183190A1
Application number: PCT/JP2016/062792
Authority: WO
Inventors: 佐藤　忠男; 善友小堀; 雅信佐藤
Original assignee: 佐藤　忠男
Priority date: 2016-04-22
Filing date: 2016-04-22
Publication date: 2017-10-26
Also published as: JPWO2017183190A1; JP6630897B2

Abstract

Provided is a sample observation kit that makes it possible to observe a semen sample using a simple and inexpensive configuration. A sample observation kit 200 that is disposed in front of a camera lens 311 of a mobile terminal device 300 provided with a digital camera unit 310 and an image display unit 320 and makes it possible to acquire an image of a semen sample S using the digital camera unit 311 and display the image on the image display unit 320 is provided with: a ball lens unit 210 that supports a ball lens 215 and is set on the mobile terminal device 300 such that the ball lens 215 is disposed in front of the camera lens 311; and a sample holding unit 220 that is disposed above the ball lens unit 210 and has, on one surface, a sample holding surface 225a for holding the semen sample S and, on the other surface, a transparent sheet 225 that has a contact surface 225b for coming into contact with the ball lens 215. The ball lens 215 is for magnifying the semen sample S to a prescribed magnification and forming an image of the semen sample S on the digital camera unit 311.

Description

Sample observation kit and semen sample observation method using sample observation kit

The present invention relates to a sample observation kit that makes it possible to easily observe the state of sperm using a smartphone or the like at home, and a semen sample observation method using the sample observation kit.

In recent years, signs of infertility have been found in 15% to 20% of human couples of reproductive age, and about 50% are attributed to men. A male infertility examination by a medical institution is performed by analyzing semen, thereby determining the presence / absence of fertilization ability, strength, and possibility of reproduction.
However, in order to conduct this examination, the test subject is required to go to a medical institution and masturbate and collect semen, so there are many people who feel shame and the cost is high. Many people are hesitant.

Against this background, screening for men's fertility tends to be avoided, and as a result, the opportunity of treatment at a medical institution has been lost, and the problem of infertility between couples due to men has been solved. The problem of losing is also evident. Therefore, in order to solve such a problem, a system (microscope observation apparatus) that enables semen observation by itself has been proposed (for example, Patent Document 1).

The microscope observation apparatus described in Patent Document 1 is a so-called Leewen hook type simple microscope apparatus in which a ball lens is arranged in front of a CCD camera, and can observe a sample (semen) at a magnification of about 5000 times. It is configured to be able to.

JP 2000-275544 A

Using the technique of Patent Document 1, it is possible to easily check the number of sperm and the presence or absence of malformation by itself. However, since the configuration of Patent Document 1 requires a CCD camera and a TV monitor, it is expensive to purchase individually, and a simpler system has been desired.

Moreover, according to the structure of patent document 1, although the sperm in a semen can be observed, there existed a problem that it could not be judged until the presence or absence of the possibility of infertility.
If the state of the spermatozoa (number, concentration) is simply observed by observing the image displayed on the monitor using a mobile terminal device such as a smartphone, in addition to determining the visual field range, Special software (application) is required to quantitatively grasp the number and concentration of sperm reflected in the camera, but such software cannot be shared between mobile terminal devices of different models. The proposal of an apparatus and method that can be observed without using special software has been awaited.
In particular, when visually observing an image displayed on a monitor without using expensive special software, anyone can easily and easily count a small number of sperm, for example, within the range of (0 to 15). There is no conventional example in which normality and abnormality can be determined.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a simple and inexpensive configuration without using special and expensive software for a mobile terminal device, and a mobile terminal. Providing a sample observation kit that can easily observe the possibility of infertility and the presence or absence of infertility from the small number of sperm reflected in the image display section of the device, and for sample observation that can determine the possibility of infertility An object is to provide a method for observing a semen sample using a kit.

In order to solve the above-described problems and achieve the object, the sample observation kit of the present invention is disposed in front of a camera lens of a mobile terminal device including a digital camera unit and an image display unit, and a semen sample is formed by the digital camera unit. For observing a sample and displaying it on an image display unit, which supports a ball lens and is set on a portable terminal device so that the ball lens is arranged in front of a camera lens A ball lens unit, a sample holding unit that has a sample holding surface that holds a semen sample on one side and a transparent sheet that has a contact surface that contacts the ball lens on the other side, and is disposed on the ball lens unit The ball lens is characterized by enlarging a semen sample at a predetermined magnification and forming an image on a digital camera unit.

From another viewpoint, the method for observing a semen sample using the sample observation kit of the present invention supports a ball lens, has a digital camera function, and a front surface of a camera lens of a mobile terminal device having an image display unit. A transparent sheet having a ball lens unit set on the portable terminal device so that the ball lens is disposed on the surface, a sample holding surface for holding the semen sample on one side, and a contact surface on the other side in contact with the ball lens A method for observing a semen sample using a sample observation kit comprising: a step of setting a ball lens unit on a portable terminal device so that the ball lens is disposed in front of a camera lens; and a sample holding surface Setting the transparent sheet to the ball lens unit so that the contact surface of the transparent sheet is in contact with the ball lens while holding the semen sample in Activating the digital camera function of the mobile terminal device to capture the image of the semen sample enlarged by the ball lens and displaying it on the image display unit, and counting the number of sperm in the image displayed on the image display unit And a step of performing.
The number of sperm can be counted visually from the video displayed on the image display unit of the portable terminal device, and expensive special software (application) is unnecessary. In addition, it is possible to determine the presence or absence of infertility simply by visually counting a very small number of sperm (for example, 0 to 15) that can be easily counted by humans.

According to the present invention, a sample observation kit capable of observing a semen sample with a simple and inexpensive configuration is realized. Moreover, the observation method of the semen sample using the sample observation kit which can judge the presence or absence of the possibility of infertility is provided.

It is a figure which shows schematic structure of the sample observation kit which concerns on embodiment of this invention. It is a figure explaining the structure of the ball lens unit contained in the sample observation kit which concerns on embodiment of this invention. It is a figure explaining the structure of the sample holding unit contained in the sample observation kit which concerns on embodiment of this invention. It is a flowchart explaining the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention. It is sectional drawing which shows the state which set the sample holding unit of the sample observation kit which concerns on embodiment of this invention on the ball lens unit. It is a block diagram explaining the structure of the portable terminal device with which the kit for sample observation which concerns on embodiment of this invention is attached. It is a figure which shows an example of the enlarged image of the semen sample displayed on the image display part of the portable terminal device with which the kit for sample observation which concerns on embodiment of this invention was attached. It is a graph which shows the correlation of the total sperm number obtained by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm density | concentration measured by the CASA system. It is a graph which shows the correlation of the total sperm number obtained by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm density | concentration measured by the CASA system. It is a graph which shows the correlation of the total sperm number obtained by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm density | concentration measured by the CASA system. It is a graph which shows the correlation with the sperm motility calculated | required by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm motility measured by the CASA system. It is a graph which shows the correlation with the sperm motility calculated | required by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm motility measured by the CASA system. It is a graph which shows the correlation with the sperm motility calculated | required by the observation method of the semen sample using the sample observation kit which concerns on embodiment of this invention, and the sperm motility measured by the CASA system.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. However, unless specifically stated, the components, types, combinations, materials, shapes, relative arrangements, and the like described in this embodiment are not merely intended to limit the scope of the present invention, but are merely illustrative examples. Not too much. In addition, the same code | symbol is attached | subjected to the same or an equivalent part in a figure, and the description is not repeated.

(Configuration of Sample Observation Kit 200)
FIG. 1 is a diagram showing a schematic configuration of a sample observation kit 200 according to an embodiment of the present invention. As shown in FIG. 1, the sample observation kit 200 of the present embodiment is disposed on the front surface of a camera lens 311 of a mobile terminal device 300 including a digital camera unit 310 and an image display unit 320. This is a product that allows an image of the semen sample S to be captured and displayed on the image display unit 320. The sample observation kit 200 includes a ball lens unit 210 that is fixed on the mobile terminal device 300, and a sample holding unit 220 that holds the semen sample S and is disposed on the ball lens unit 210.

(Configuration of Ball Lens Unit 210)
2A and 2B are diagrams for explaining the configuration of the ball lens unit 210 of the present embodiment, FIG. 2A is a plan view, and FIG. 2B is a cross-sectional view taken along line AA in FIG. FIG. 2A and 2B, the ball lens unit 210 includes a main body sheet 211, an iron powder sheet 212, a lens support member 213, a ball lens 215, an adhesive sheet (adhesive part, spacer) 216, and the like. ing.

The main body sheet 211 is a long and thin plate member (for example, a thickness of 0.5 mm) made of a flexible resin or the like. A circular through-hole 211a is formed in a substantially central portion of the main body sheet 211, and a lens support member 213, which will be described later, is inserted into the through-hole 211a and attached to the lower surface of the main body sheet 211 with an annular adhesive tape 214. It has been. A pair of rectangular adhesive sheets 216 made of urethane gel having self-adhesive properties for fixing the ball lens unit 210 to the portable terminal device 300 are fixed to the lower surface of the main body sheet 211. Self-adhesive urethane gel can be freely attached and removed any number of times, and can be installed at the most suitable location according to the model.

The iron powder sheet 212 is substantially the same shape as the main body sheet 211 (for example, a thickness of 0.6 mm), and is a sheet obtained by mixing magnetic powder such as iron powder with rubber, resin, etc. The upper surface of 211 is fixed by an adhesive means such as a double-sided tape. A through hole 212 a communicating with the through hole 211 a is formed in a substantially central portion of the iron powder sheet 212, and the ball lens 215 supported by the lens support member 213 slightly protrudes from the upper surface of the iron powder sheet 212. Are arranged as follows. The iron powder sheet 212 is attracted and fixed to the magnet sheet 222 of the sample holding unit 220 when the sample holding unit 220 is disposed on the ball lens unit 210.
The total thickness (including the protruding length of the ball lens 215) of the main body sheet 211, the iron powder sheet 212, and the adhesive sheet 216 is, for example, about 2.5 to 2.7 mm (average 2.6 mm). By adjusting the thickness of the functioning adhesive sheet 216 and finely adjusting the distance from the camera lens of the mobile terminal device, it is possible to ensure an optimal positional relationship for obtaining an optimal sperm image.
By adjusting the distance between the ball lens 215 and the camera lens on the mobile terminal device side by adjusting the thickness of the adhesive sheet 216 to a predetermined value, for example, 1 mm, the visual field range of the image displayed on the image display unit is adjusted. Can do. As a method of setting a standard for visual field range adjustment on the image display unit, it is possible to obtain a visual field range having an area where a small number that allows easy counting of the number of sperm, for example, a number of sperm within 10 is reflected. Set to.
In the present invention, since an image with an optimal field of view is projected on the image display unit, the number of sperm in a focused state within the range of the field of view may be counted.
The use of the adhesive sheet 216 as a means (spacer) for adjusting the distance between the ball lens 215 and the camera lens on the mobile terminal device side is merely an example. The distance can also be adjusted by setting the thicknesses of the main body sheet 211 and the iron powder sheet 212 to optimum thicknesses corresponding to the models.

The lens support member 213 is a plastic member having a bottomless conical shape, and is inserted into the through hole 211 a and fixed to the main body sheet 211. A circular opening 213 a into which the ball lens 215 is fitted is formed at the apex of the lens support member 213. Further, the end portion of the conical surface of the lens support member 213 extends outward, and an annular fixing portion 213b is formed. When the lens support member 213 is inserted into the through-hole 211a, the fixing portion 213b is brought into contact with the lower surface of the adhesive tape 214 and positioned. In other words, the lens support member 213 is attached to the lower surface of the main body sheet 211 by the annular adhesive tape 214 disposed so as to cover the fixing portion 213b.

The ball lens 215 is a spherical lens made of glass or plastic, and in the present embodiment, a lens having a diameter of about 0.8 mm is used. The ball lens 215 is fixed by an adhesive or the like in a state of being fitted in the opening 213a at the apex of the lens support member 213, and is disposed so as to slightly protrude from the upper surface of the iron powder sheet 212 as described above. Is done. When the sample holding unit 220 is disposed on the ball lens unit 210, the ball lens 215 comes into close contact with the contact surface 225 b of the transparent sheet 225 of the sample holding unit 220. When the ball lens unit 210 is arranged on the mobile terminal device 300, the distance between the mobile terminal device 300 and the ball lens 215 is set to about 2.6 mm. Further, the optical characteristics of the ball lens 215 of the present embodiment are as follows.
(1) Clear viewing distance: 250mm
(2) Effective focal length: 0.45mm
(3) Magnification: 555 times

(Configuration of sample holding unit 220)
3A and 3B are diagrams illustrating the configuration of the sample holding unit 220 according to the present embodiment. FIG. 3A is a plan view, and FIG. 3B is a cross-sectional view taken along line BB in FIG. FIG. As shown in FIGS. 3A and 3B, the sample holding unit 220 includes a magnet sheet 222 and a transparent sheet 225.

The through hole 222a having a diameter of about 8 mm of the magnet sheet 222 forms a sample holding part P for holding the semen sample S. The other end portion (the right end portion in FIG. 3) of the magnet sheet 222 is a grip portion that the user grips when the sample holding unit 220 is disposed on the ball lens unit 210.

The magnet sheet 222 (for example, 0.8 mm in thickness) attracts and fixes the iron powder sheet 212 of the ball lens unit 210 when the sample holding unit 220 is disposed on the ball lens unit 210.

The transparent sheet 225 is, for example, a transparent resin (polyester, polyethylene, PET, vinyl chloride, etc.) film having a thickness of about 0.03 mm, and is fixed to the lower surface of the magnet sheet 222 with an adhesive so as to close the through hole 222a. ing. The transparent sheet 225 is preferably bonded to one surface of the magnet sheet 222 by using a pressure-sensitive adhesive tape in which an adhesive is applied on one side in advance. By using a hydrophilic adhesive, it is possible to improve the familiarity with the dropped semen, and to allow the sperm to adhere to the transparent sheet surface. As a result, an accurate video suitable for counting can be obtained.
The upper surface of the transparent sheet 225 forms a sample holding surface 225a that holds the semen sample S when the semen sample S is dropped through the through hole 222a. The lower surface of the transparent sheet 225 serves as a contact surface 225 b that comes into contact with the ball lens 215 when the sample holding unit 220 is disposed on the ball lens unit 210. The transparent sheet is not necessarily required to be transparent in the strict sense, and it is sufficient that the transparent sheet has a transparency that does not hinder photographing and observation of semen. Therefore, even if the transparency is slightly lowered, there is no problem as long as there is no trouble in photographing and observation.

(Observation Method of Semen Sample S Using Sample Observation Kit 200)
FIG. 4 is a flowchart for explaining an observation method of the semen sample S using the sample observation kit 200 of the present embodiment.

As shown in FIG. 4, when the semen sample S is observed using the sample observation kit 200 of the present embodiment, first, the ball lens 215 is arranged on the front surface of the camera lens 311 of the portable terminal device 300 ( That is, the ball lens unit 210 is set in the portable terminal device 300 (so that the optical axis of the ball lens 215 and the optical axis of the camera lens 311 substantially coincide) (FIG. 4: S101).

Next, about 10 μl of semen sample S is dropped on the sample holding surface 225a of the sample holding unit 220, and the contact surface 225b of the transparent sheet 225 contacts the ball lens 215 in a state where the semen sample S is held on the sample holding surface 225a. Then, the sample holding unit 220 is set on the ball lens unit 210 (FIG. 4: S103).

FIG. 5 is a cross-sectional view showing a state where the sample holding unit 220 is set on the ball lens unit 210. As shown in FIG. 5, when the sample holding unit 220 is set on the ball lens unit 210, the optical axis of the ball lens 215, the optical axis of the camera lens 311, and the optical axis of the image sensor 312 in the mobile terminal device 300 are approximately. Arranged to match.

Next, the digital camera unit 310 of the portable terminal device 300 is operated to capture an image of the semen sample S enlarged by the ball lens 215 and display it on the image display unit 320 (FIG. 4: S105).

FIG. 6 is a block diagram illustrating the configuration of the mobile terminal device 300. As illustrated in FIG. 6, the mobile terminal device 300 includes a digital camera unit 310, an image display unit 320, a touch panel 330 that receives input operations from a user, a flash memory 340 that stores various application programs, an application A RAM (Random Access Memory) 350 in which a program is expanded, a processor 360 that controls each unit of the mobile terminal device 300, and the like are included.

When the user operates the touch panel 330 to cause the digital camera unit 310 to function, the processor 360 develops and executes an application program stored in the flash memory 340 for controlling the digital camera unit 310 in the RAM 350. Then, the processor 360 controls the camera control circuit 313 to drive the image pickup device 312, takes an image formed on the image pickup device 312 through the camera lens 311 as image data (moving image or still image), and displays an image display unit. To 320.

As described above, in this embodiment, the optical axis of the ball lens 215, the optical axis of the camera lens 311, and the optical axis of the image sensor 312 in the mobile terminal device 300 are substantially the same, and as described above. Since the effective focal length of the ball lens 215 is as short as 0.45 mm (that is, because the focal depth is shallow), the sample facing the contact surface 225b in the region where the ball lens 215 of the contact surface 225b of the transparent sheet 225 is in contact. The semen sample S located near the surface of the holding surface 225a is enlarged by the ball lens 215, and forms an image on the image sensor 312 through the camera lens 311. Therefore, when the digital camera unit 310 is caused to function, an enlarged image of the semen sample S is captured as image data and displayed on the image display unit 320.

FIG. 7 is a diagram illustrating an example of an enlarged image of the semen sample S displayed on the image display unit 320 of the mobile terminal device 300 of the present embodiment. As shown in FIG. 7, in the present embodiment, as a result of being enlarged at a predetermined overall magnification determined by the magnification of the ball lens 215 and the specifications of the digital camera unit 310 (size of the image sensor 312 etc.), it is included in the semen sample S. The image of the sperm is displayed on the image display unit 320.

When an image of sperm contained in the semen sample S is displayed on the image display unit 320, the number of sperm is counted in the image displayed on the image display unit 320 (FIG. 4: S107).
Specifically, in the image displayed on the image display unit 320, the number of live sperm (that is, moving sperm) that are constantly moving and the number of dead sperm (that is, immovable sperm) that have stopped moving are shown. Count and find the sum of them (ie total sperm count). It should be noted that in the determination of the difference between life and death, observation with a moving image is more suitable than observation with a still image. Therefore, after taking a video over a predetermined time, it is possible to discriminate the sperm that are alive at a glance and count the number by reproducing the video as a moving image for an arbitrary time, for example, 1 second.
Further, only the sperm at the in-focus position is counted, and when determining whether or not it is in the focused state, for example, the sperm that is focused on the sperm head is counted. . More specifically, spermatozoa whose head is clearly visible because they are in focus are counted. In the experiment, when it was visually confirmed, any in-focus state could be easily discriminated by anyone, and the discrimination was very easy. For example, it can be said that sperm S1 in FIG. 7 is in a focused state. In the present invention, by carrying out the discrimination and counting method using such an image, it becomes possible to obtain almost the same counting result regardless of skill, experience and knowledge.

In the configuration of the present embodiment, the specifications of the digital camera unit 310 (the size of the image sensor 312 and the like) differ depending on the mobile terminal device 300 to be used, so that the field of view range of the image displayed on the image display unit 320 is different. The total number of sperm in the image displayed on the unit 320 also varies depending on the mobile terminal device 300 to be used. However, the inventors of the present invention, as a result of intensive studies, as described later, the total number of spermatozoa obtained by the observation method of the present invention and a CASA (Computer-Aided Sperm Analysis) system used in general semen tests There is a strong correlation (first correlation) with the sperm concentration measured by, and infertility is possible by setting a predetermined threshold (first predetermined value) according to the mobile terminal device 300 used It was found that the presence or absence of sex can be judged. In addition, between the number of motile spermatozoa obtained by the observation method of the present invention and the total sperm motility, the sperm motility rate (number of motility sperm / total sperm count) and the sperm motility measured by the CASA system It has been found that there is a strong correlation (second correlation), and the possibility of infertility can be determined by setting a predetermined threshold (second predetermined value) according to the mobile terminal device 300 to be used.

Therefore, in the observation method of the present embodiment, it is determined whether the total number of spermatozoa and the motion rate in the image displayed on the image display unit 320 are equal to or greater than a predetermined value, respectively. It is determined that there is a possibility of infertility, and when it is equal to or greater than a predetermined value, it is determined that it is normal (FIG. 4: S109).
The sperm is roughly composed of a substantially round head and a tail that performs a propulsion motion, but in actual observation using the device of the present invention, the whole shape appears as a clear image in the image, There are a mix of what appears only as the head and what appears as an unclear image. Under such circumstances, in this observation, only spermatozoa (sperm S1 in FIG. 7) appearing as a clear image mainly with the head in the focused state were counted.

(Correlation between observation method of semen sample S using sample observation kit 200 and CASA system)
FIGS. 8 to 10 show the results of the first experiment conducted by the inventors of the present invention in order to examine the correlation between the observation method of the present embodiment and the CASA system. FIGS. It is the result of 2 experiment.

In the first experiment shown in FIGS. 8 to 10, using the semen sample provided from 50 volunteers, the total number of sperm (number of motor sperm + number of immobile sperm) was determined by the observation method of this embodiment. And the sperm concentration was determined by a laboratory-based CASA system.
In the second experiment shown in FIG. 11 to FIG. 13, using the semen sample provided from 50 volunteers, the number of motile sperm and the total number of sperm obtained by the observation method of this embodiment are used. The motility rate (number of motility sperm ÷ total sperm count) was determined, and the sperm motility rate was determined by a laboratory-based CASA system.
Note that when the total number of sperm (number of moving sperm + number of immobile spermatozoa) is determined by the observation method of the present embodiment, Apple's iPhone (registered trademark) 6S and Apple's iPhone (registered trademark) are used as the mobile terminal device 300. ) 5S and LG Electronics Optimus (registered trademark) Exceed 2 are used, and in the image displayed on the image display unit 320, a focused sperm that can clearly see the shape of the head (head and Only those whose tails contained clear sperm) were counted visually.

FIG. 8 shows the relationship between the total sperm count counted by the observation method of this embodiment and the sperm concentration measured by the CASA system when using Apple's iPhone (registered trademark) 6S as the mobile terminal device 300. It is a graph to show. FIG. 9 shows the relationship between the total sperm count counted by the observation method of this embodiment and the sperm concentration measured by the CASA system when an Apple iPhone (registered trademark) 5S is used as the mobile terminal device 300. It is a graph to show. FIG. 10 shows the total sperm count counted by the observation method of the present embodiment and the sperm concentration measured by the CASA system when Optimus (registered trademark) Exceed 2 manufactured by LG Electronics is used as the mobile terminal device 300. It is a graph which shows the relationship. 8 to 10, the vertical axis represents the number of sperm (n / FOV (Field Of View)) counted by the observation method of the present embodiment, and the horizontal axis represents the sperm concentration (× X) measured by the CASA system. 10 ⁶ / ml). Note that each straight line in FIGS. 8 to 10 is a regression line obtained from each data.

FIG. 11 shows the sperm motility rate (number of motility sperm ÷ total number of sperm) determined by the observation method of this embodiment and the CASA system when iPhone (registered trademark) 6S manufactured by Apple is used as the mobile terminal device 300. It is a graph which shows the relationship with the exercise rate of the sperm measured by (1). FIG. 12 shows the sperm motility rate (number of motility sperm / total number of sperm) determined by the observation method of this embodiment and the CASA system when using Apple (registered trademark) 5S manufactured by Apple as the mobile terminal device 300. It is a graph which shows the relationship with the exercise rate of the sperm measured by (1). FIG. 13 shows the sperm motility rate obtained by the observation method of the present embodiment when the Optimus (registered trademark) Exceed 2 manufactured by LG Electronics is used as the portable terminal device 300 (number of motility sperm / total number of sperm). ) And the sperm motility measured by the CASA system. 11 to 13, the vertical axis represents the sperm motility rate (%) obtained by the observation method of the present embodiment, and the horizontal axis represents the sperm motility rate (%) measured by the CASA system. Yes. Each straight line in FIGS. 11 to 13 is a regression line obtained from each data.

(Consideration of the first experiment result)
As shown in FIG. 8, when iPhone (registered trademark) 6S manufactured by Apple Inc. is used as the mobile terminal device 300, the total number of sperm (number of motor sperm + immobility) counted by the semen sample S observation method of the present embodiment. The number of spermatozoa was found to have a strong correlation (significance probability p <0.001) with the sperm concentration measured by the CASA system. Further, from FIG. 8, if the total number of spermatozoa displayed on the image display unit 320 is more than 8, the reference value of sperm concentration (15 million / sound) announced by WHO (World Health Organization) in 2010 ml). That is, it is determined whether or not the total number of spermatozoa displayed on the image display unit 320 is more than 8, and if it is 8 or less, it is determined that there is a possibility of infertility, and the number is more than 8 It was found that it can be judged normal. In addition, when such a test | inspection was performed, it turned out that a sensitivity is 87.5% and a specificity is 90.9%.

As shown in FIG. 9, when iPhone (registered trademark) 5S manufactured by Apple is used as the mobile terminal device 300, the total number of sperm (number of motor sperm + immobility) counted by the semen sample S observation method of the present embodiment. The number of spermatozoa was found to have a strong correlation (significance probability p <0.001) with the sperm concentration measured by the CASA system. Further, from FIG. 9, if the total number of spermatozoa displayed on the image display unit 320 is more than five, the sperm concentration reference value (15 million / ml or more) announced by WHO in 2010 is satisfied. I understand that. That is, it is determined whether the total number of sperm displayed on the image display unit 320 is more than 5, and if it is 5 or less, it is determined that there is a possibility of infertility. It was found that it can be judged normal. In addition, when such a test | inspection was performed, it turned out that a sensitivity is 90.9% and a specificity is 88.2%.

As shown in FIG. 10, when Optimus (registered trademark) Exceed 2 manufactured by LG Electronics is used as the mobile terminal device 300, the total number of sperm (the number of motility sperm) counted by the semen sample S observation method of the present embodiment. + Number of immobile spermatozoa) was found to have a strong correlation (significance probability p <0.001) with the sperm concentration measured with the CASA system. Further, from FIG. 10, if the total number of spermatozoa displayed on the image display unit 320 is more than five, the sperm concentration reference value (15 million / ml or more) announced by WHO in 2010 is satisfied. I understand that. That is, it is determined whether the total number of sperm displayed on the image display unit 320 is more than 5, and if it is 5 or less, it is determined that there is a possibility of infertility. It was found that it can be judged normal. In addition, when such a test | inspection was performed, it turned out that a sensitivity is 75.0% and a specificity is 87.8%.

As described above, the total number of spermatozoa counted by the method for observing the semen sample S of the present embodiment has a strong correlation with the sperm concentration measured by the CASA system, and has a predetermined threshold according to the mobile terminal device 300 to be used. (That is, regardless of the type of smartphone), it is possible to determine whether or not there is a possibility of infertility. Moreover, since this test | inspection method has a high sensitivity and specificity, it turns out that it fully functions as a screening test for infertility. Moreover, the observation method of the semen sample S of this embodiment counts the number of sperm by visual observation, and does not require special application software, and can count accurately.

(Consideration of the second experiment result)
As shown in FIG. 11, when iPhone (registered trademark) 6S manufactured by Apple Inc. is used as the portable terminal device 300, the sperm motility rate (number of motility sperm / total number) determined by the method for observing the semen sample S of the present embodiment. The sperm count) was found to have a strong correlation (significance probability p <0.001) with the sperm motility measured by the CASA system. Further, from FIG. 11, if the sperm motility obtained by the method of observing the semen sample S of the present embodiment is greater than 50%, the reference value of the total sperm motility published by WHO in 2010 (40% It can be seen that the above is satisfied. That is, it is determined whether or not the sperm motility rate obtained by the observation method of the semen sample S of the present embodiment is greater than 50%, and if it is 50% or less, it is determined that there is a possibility of infertility, It turned out that it can be judged that it is normal when it is larger than 50%.

As shown in FIG. 12, when iPhone (registered trademark) 5S manufactured by Apple Inc. is used as the mobile terminal device 300, the sperm motility rate (number of motility sperm / total number) determined by the method for observing the semen sample S of this embodiment. The sperm count) was found to have a strong correlation (significance probability p <0.001) with the sperm motility measured by the CASA system. Also, from FIG. 12, if the sperm motility determined by the method of observing the semen sample S of this embodiment is greater than 55%, the reference value of the total sperm motility rate published by WHO in 2010 (40% It can be seen that the above is satisfied. That is, it is determined whether or not the sperm motility rate obtained by the method for observing the semen sample S of the present embodiment is greater than 55%, and if it is 55% or less, it is determined that there is a possibility of infertility, It was found that it can be judged normal when it is greater than 55%.

As shown in FIG. 13, when Optimus (registered trademark) Exceed 2 manufactured by LG Electronics is used as the portable terminal device 300, the sperm motility rate (number of motility sperm obtained by the semen sample S observation method of the present embodiment is used. ÷ total sperm count) was found to have a strong correlation (significance probability p <0.001) with the sperm motility measured by the CASA system. Further, from FIG. 13, if the sperm motility obtained by the method of observing the semen sample S of the present embodiment is greater than 55%, the reference value of the total sperm motility published by WHO in 2010 (40% It can be seen that the above is satisfied. That is, it is determined whether or not the sperm motility rate obtained by the method for observing the semen sample S of the present embodiment is greater than 55%, and if it is 55% or less, it is determined that there is a possibility of infertility, It was found that it can be judged normal when it is greater than 55%.

As described above, the sperm motility rate (number of motility sperm ÷ total sperm count) determined by the method for observing the semen sample S of this embodiment is strongly correlated with the sperm motility rate measured by the CASA system, By setting a predetermined threshold according to the mobile terminal device 300 to be used (that is, regardless of the smartphone model), it is possible to determine the possibility of infertility.

The above is the description of the embodiment of the present invention. However, the present invention is not limited to the configuration of the above embodiment, and various modifications are possible within the scope of the technical idea. For example, in the present embodiment, the ball lens 215 having a diameter of about 0.8 mm is used. However, any ball lens having a magnification capable of accurately counting the number of sperm may be used, and a ball lens having a different diameter may be applied. It is also possible to apply other optical systems.

In the observation method of the present embodiment, the total sperm count and the motion rate in the image displayed on the image display unit 320 are determined to be equal to or greater than a predetermined value. Alternatively, it may be determined whether one of the exercise rates is equal to or greater than a predetermined value, and thereby whether there is a possibility of infertility.

(Summary of configuration, action and effect of the present invention)
A sample observation kit 200 according to the present invention is disposed on the front surface of a camera lens 311 of a mobile terminal device 300 including a digital camera unit 310 and an image display unit 320, and takes an image of the semen sample S by the digital camera unit 310. The sample observation kit 200 that can be displayed on the image display unit 320, which supports the ball lens 215 and is disposed on the front surface of the camera lens 311 on the portable terminal device 300. A ball lens unit 210 that is set on the surface, a sample holding surface 225a that holds the semen sample S on one side, and a transparent sheet 225 that has a contact surface 225b that contacts the ball lens 215 on the other side. 210, a sample holding unit 220, and the ball lens 215 includes Expanding the semen sample S at a predetermined magnification, characterized in that it forms an image on a digital camera unit 310.
Further, the visual field range of the sperm sample displayed enlarged on the image display unit is set so that the number of sperm in the visual field range has a predetermined correlation with the sperm concentration measured by the CASA system, Alternatively, the sperm motion rate within the visual field range is set to have a predetermined correlation with the sperm motion rate measured by the CASA system.
According to such a configuration, an enlarged image of the semen sample S can be easily obtained using the digital camera unit 310 of the mobile terminal device 300. That is, the sample observation kit 200 capable of observing the semen sample S with a simple and inexpensive configuration is realized.
That is, without using special expensive software for the mobile terminal device, a relatively small number (which is easy to visually count) reflected in the image display unit of the mobile terminal device with a simple and inexpensive configuration. Providing a sample observation kit that allows easy observation of the possibility of infertility from the number of sperm, and a method for observing semen samples using a sample observation kit that can determine the possibility of infertility can do.
The number of spermatozoa that can be easily visually counted is, for example, a range of 0 to 15, but if the density (number) of spermatozoa within the visual field range is low enough not to cause a problem in relation to the visual field range, it is 16 It may be more than one.

In the sample observation kit 200 according to the present invention, at least one of the ball lens unit 210 and the sample holding unit 220 has a magnetic part (iron powder sheet 212) or a magnet part (magnet sheet 222) that adsorbs the other. It is characterized by having.
With such a configuration, the ball lens unit 210 and the sample holding unit 220 can be easily aligned.

The sample observation kit 200 according to the present invention has a surface where the magnetic body part (iron powder sheet 212) or the magnet part (magnet sheet 222) faces the sample holding unit 220 of the ball lens unit 210, and the sample holding unit 220. It is formed on a surface facing the ball lens unit 210.

In the sample observation kit 200 according to the present invention, the ball lens unit 210 is detachably fixed to the mobile terminal device 300 on the surface facing the mobile terminal device 300 (adhesive sheet 216). It is characterized by having.
According to such a configuration, the ball lens unit 210 can be easily fixed on the mobile terminal device 300. Also, by adjusting the thickness of the adhesive part according to the model of the mobile terminal device, the visual field range of the image projected on the image display unit by finely adjusting the distance between the ball lens and the camera lens on the mobile terminal device side Can be set to an optimum value. The visual field range (magnification) is set so as to include a small number of sperm that are easy to count for humans. For example, if the total number of sperm in the visual field range exceeds 5, it is not infertile (normal). Thus, even an amateur can easily make a determination.

The sample observation kit 200 according to the present invention is characterized in that the ball lens 215 protrudes from the surface of the ball lens unit 210 facing the sample holding unit 220.
According to such a configuration, when the sample holding unit 220 is disposed on the ball lens unit 210, the contact surface 225 b of the transparent sheet 225 reliably contacts the ball lens 215.

The sample observation kit 200 according to the present invention digitally analyzes the semen sample S near the surface of the sample holding surface 225a facing the contact surface 225b in the region where the ball lens 215 is in contact with the ball lens 215 of the contact surface 225b. An image is formed on the camera unit 310.

In the sample observation kit 200 according to the present invention, the sample holding unit 220 has a transparent sheet 225 on the surface facing the ball lens unit 210, and an opening (penetration) formed so that the sample holding surface 225a is exposed. It is characterized by having holes 222a).
In the sample observation kit 200 according to the present invention, the visual field range of the semen sample displayed on the image display unit in an enlarged manner is set to a visual field range in which the number of spermatozoa within 15 is reflected. May be.
The visual field range (magnification) is set so as to include a small number of sperm that can be easily counted by a general human without medical knowledge, and the numerical value is, for example, 15 or less.
In addition, by arranging a template having a predetermined opening area and opening shape on the surface of the image display portion so that an image can be viewed from the opening portion, the viewing range is set by the opening portion. It is also possible. According to this, the number of sperm in the opening is adjusted without finely adjusting the distance between the ball lens and the camera lens on the mobile terminal device side and adjusting the visual field range of the image projected on the image display unit to an optimum one. It is possible to determine the presence or absence of infertility simply by counting.

The method of observing the semen sample S using the sample observation kit 200 according to the present invention includes a portable terminal device 300 that supports the ball lens 215 and includes a digital camera function (digital camera unit 310) and an image display unit 320. The ball lens unit 210 set in the portable terminal device 300 so that the ball lens 215 is disposed on the front surface of the camera lens 311, and the sample holding surface 225 a for holding the semen sample S are provided on one side and the ball lens on the other side. The semen sample S is observed using the sample observation kit 200 provided with a transparent sheet 225 having a contact surface 225b in contact with 215, and the ball lens 215 is arranged on the front surface of the camera lens 311. The step of setting the ball lens unit 210 to the portable terminal device 300 (S101) and the sample storage Setting the transparent sheet 225 to the ball lens unit 210 so that the contact surface 225b of the transparent sheet 225 contacts the ball lens 215 with the semen sample S held on the surface 225a (S103); The digital camera function (digital camera unit 310) is operated to capture an image of the semen sample S enlarged by the ball lens 215 and display it on the image display unit 320 (S105), and the image displayed on the image display unit 320 And a step of counting the number of sperm (S107).
According to such a configuration, it is possible to accurately count the number of sperm by visual observation using the mobile terminal device 300 such as a smartphone.

The method for observing the semen sample S using the sample observation kit 200 according to the present invention determines whether or not the number of sperm is equal to or greater than a predetermined number, and if there is less than the predetermined number, there is a possibility of infertility. It is further characterized in that it further includes a step (S109) of determining that it is normal and determining that it is normal when it is equal to or greater than a predetermined number.
According to such a configuration, a screening test for infertility can be easily performed.

In the method of observing the semen sample S using the sample observation kit 200 according to the present invention, the number of sperm has a predetermined correlation with the sperm concentration obtained by measuring the semen sample S with the CASA system, and the predetermined number is It is determined based on the correlation.

The semen sample S observation method using the sample observation kit 200 according to the present invention is characterized in that the predetermined number is determined based on the model of the portable terminal device 300.
According to such a configuration, various models can be selected as the mobile terminal device 300.

In the method of observing the semen sample S using the sample observation kit 200 according to the present invention, the number of sperm is the sum of the number of motile spermatozoa and the number of immobile spermatozoa. And determining whether or not the exercise rate is equal to or greater than a second predetermined value. If the exercise rate is less than the second predetermined value, it is determined that there is a possibility of infertility. In some cases, the method further includes a step of determining normality.
According to such a configuration, a screening test for infertility can be easily performed.

In the method for observing the semen sample S using the sample observation kit 200 according to the present invention, the motility rate has a second correlation with the motility rate obtained by measuring the semen sample with the CASA system, and the second predetermined The value is determined based on the second correlation.

The method for observing the semen sample S using the sample observation kit 200 according to the present invention is characterized in that the second predetermined value is determined based on the model of the mobile terminal device 300.
According to such a configuration, various models can be selected as the mobile terminal device 300.

It should be noted that the embodiments disclosed this time are examples in all respects and are not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the description above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

200 Sample observation kit, 210 ball lens unit, 211 main body sheet, 211a through hole, 212 iron powder sheet, 212a through hole, 213 lens support member, 213a opening, 213b fixing part, 214 adhesive tape, 215 ball lens, 216 Adhesive sheet (adhesive part), 220 sample holding unit, 222 magnet sheet, 222a through hole, 225 transparent sheet, 225a sample holding surface, 225b contact surface, 300 mobile terminal device, 310 digital camera unit, 311 camera lens, 312 image sensor 313, camera control unit, 320, image display unit, 330 touch panel, 340 flash memory, 350 RAM, 360 processor

Claims

For observing a sample, which is arranged in front of a camera lens of a mobile terminal device including a digital camera unit and an image display unit, and which allows the digital camera unit to capture an image of a semen sample and display it on the image display unit A kit,
A ball lens unit that supports the ball lens and is set on the portable terminal device such that the ball lens is disposed on the front surface of the camera lens;
A sample holding unit having a sample holding surface for holding the semen sample on one side and a transparent sheet having a contact surface in contact with the ball lens on the other side, and disposed on the ball lens unit;
With
The ball lens enlarges the semen sample at a predetermined magnification, forms an image on the digital camera unit,
The visual field range of the sperm sample displayed on the image display unit is enlarged, and the sperm number within the visual field range has a predetermined correlation with the sperm concentration measured by a CASA (Computer-Aided Sperm Analysis) system. Or a sample observation kit characterized in that the sperm motility in the visual field range is set to have a predetermined correlation with the sperm motility measured by the CASA system. .
A ball lens unit that is set on the mobile terminal device so that the ball lens is disposed on the front surface of the camera lens of the mobile terminal device that supports the ball lens and has a digital camera function and an image display unit, and a semen sample A semen sample observation method using a sample observation kit comprising a sample holding surface for holding a transparent sheet having a contact surface that contacts the ball lens on the other surface,
Setting the ball lens unit on the portable terminal device such that the ball lens is disposed in front of the camera lens;
Setting the transparent sheet on the ball lens unit so that the contact surface of the transparent sheet is in contact with the ball lens in a state where a semen sample is held on the sample holding surface;
Taking the image of the semen sample enlarged by the ball lens by operating the digital camera function of the mobile terminal device, and displaying the image on the image display unit;
Counting the number of sperm in the image displayed on the image display unit;
A method for observing a semen sample using a sample observation kit comprising:
It is determined whether or not the number of spermatozoa is equal to or greater than a first predetermined value, and when it is less than the first predetermined value, it is determined that there is a possibility of infertility, and is equal to or greater than the first predetermined value. 3. The method for observing a semen sample using the sample observation kit according to claim 2, further comprising a step of judging that the sample is normal when
The number of sperm has a first correlation with the sperm concentration of the semen sample measured by a CASA (Computer-Aided Sperm Analysis) system,
The semen sample observation method using the sample observation kit according to claim 3, wherein the first predetermined value is determined based on the first correlation.
The method for observing a semen sample using the sample observation kit according to claim 3 or 4, wherein the first predetermined value is determined based on a model of the mobile terminal device.
The number of sperm is the sum of the number of motile sperm and the number of immobile sperm,
The rate of movement is obtained from the number of motile spermatozoa with respect to the number of spermatozoa, and it is determined whether or not the rate of movement is equal to or greater than a second predetermined value. 6. The sample observation according to any one of claims 3 to 5, further comprising a step of determining that it is normal and determining that it is normal when it is equal to or greater than the second predetermined value. Of semen samples using the kit for the semen.
The motility rate has a second correlation with the motility rate obtained by measuring the semen sample with a CASA (Computer-Aided Sperm Analysis) system,
The semen sample observation method using the sample observation kit according to claim 6, wherein the second predetermined value is determined based on the second correlation.
The semen sample observation method using the sample observation kit according to claim 6 or 7, wherein the second predetermined value is determined based on a model of the portable terminal device.