Patent Application
20210109012
The present invention relates to apparatus for the inspection of a sample. More particularly, the invention relates to novel apparatus adapted to perform optical analyses of specimens located on a slide. Still more particularly, the invention relates to the use of the novel device for performing a variety of tests, such as fertility tests.
Many different tests require the optical inspection of a specimen, typically place on a transparent slide, to determine a parameter relevant to the specific test undertaken. Illustrative examples of such tests include blood, urine and saliva tests. Another important test is the fertility test to be undertaken by inspecting a variety of sperm parameters. According to the WHO, the following are some of the lowest limits for parameters relevant to the present invention:
Semen volume (ml) 1.5 (1.4 to 1.7)
Total sperm count (10{circumflex over ( )}6) 39 (33 to 46)
Sperm concentration (10{circumflex over ( )}6/ml) 15 (12 to 16)
Total motility (percent) 40 (38 to 42)
Progressive motility (percent) 32 (31 to 34)
Vitality (percent) 58 (55 to 63)
Other parameters can also be indicative of a fertility problem. Motile sperm concentration (MSC) is an important parameter in assessing whether a fertility problem may exist in a male subject. Detailed MSC analysis can be performed in a laboratory environment and involves expensive and time-consuming procedures. Accordingly, it is desirable to provide a qualitative assessment of MSC, which can be performed at home or at the clinic and can be used for screening purposes. It has been found, according to published statistics and based on the WHO fifth edition for the reference values for semen parameters, that if the sample count is less than 6 M/ml (million per milliliter) this may be indicative of a male fertility problem and requires medical attention. Accordingly, apparatus used for sperm counting must include optical and imaging elements suitable for this level of detection. MSC will be referred to herein as the illustrative test, it being understood that the invention is not limited to any specific test, and that any test requiring optical image acquisition can be performed according to the invention, by providing test-specific parameters such as magnification.
Although devices have been proposed for performing various home tests (the term “home” is used herein to indicate test that can be carried out outside a specialized laboratory, by a nonspecialized individual, such as the subject of the tests, but of course can be performed in any location), for instance by utilizing the camera of a mobile phone, the need still remains for a simple apparatus that delivers consistent results without being influenced by the nature or quality of other devices (such as, for instance, the aforementioned mobile phone.) It is therefore an object of the present invention to provide apparatus that overcomes the disadvantages of prior art devices.
It is a further object of the invention to provide apparatus for performing a variety of tests, without the need of employing highly specialized, complex to use and expensive apparatus.
It is another object of the invention to provide apparatus for the qualitative assessment of fertility of semen, which is simple to operate and which is not influenced by environmental conditions.
Other objects and advantages of the invention will become apparent as the description proceeds.
The present invention is directed to apparatus for performing optical testing of a sample. In the description to follow the above will be exemplified by referring to a qualitative assessment of motile sperm concentration of semen, although everything described with respect to this illustrative example applies mutatis mutandis also to other tests. The device according to the invention is characterized by comprising a receptacle for accepting a specimen slide, at least one illumination element, an optical lens, and image acquisition apparatus, all having fixed positioned relationships relative to said receptacle. The fixed position of the elements of the apparatus of the invention are critical to the invention, as will become apparent from the description to follow.
According to one embodiment of the invention, the receptacle is accessed via a slot provided in the outer wall surrounding the apparatus. In a further embodiment of the invention, positioning elements are provided within the receptacle, which are adapted to position the specimen slide in a desired position relative to the optical lens. The positioning elements may comprise both bottom and top positioning elements. In one embodiment of the invention the optical lens is provided in said top positioning element. The at least one illumination element is located below the specimen slide receptacle, to illuminate the specimen images of which are acquired by the image acquisition apparatus.
The apparatus of the invention needs power to operate, and in one embodiment of the invention it comprises a battery suitable to power it. In another embodiment of the invention a power port is provided, which is adapted to supply power to the apparatus from an external source. In a further embodiment of the invention the power port is a USB port.
According to one embodiment of the invention the apparatus comprises circuitry suitable to generate data from the acquired images. In one embodiment of the invention, image processing or other data processing processes are not performed within the apparatus and digital data and/or raw images are transferred to external data processing apparatus for analysis. The external data processing apparatus can comprise any suitable circuitry, and in some embodiments of the invention it is selected from a desktop computer, a laptop computer, a smart phone, a tablet, or the like. However, in some embodiments, image processing circuitry can be provided, to perform at least some processing of the acquired images.
Data can be transferred to processing apparatus or to display means wirelessly, for instance via Bluetooth or Wi-Fi, or via physical connection, for instance via a USB connection. When raw images are transferred to an external device, image processing software is provided in said external device, which is suitable to perform the required analysis of said image, for instance, a qualitative assessment of MSC of semen.
According to another embodiment of the invention the sample assessment (e.g., the qualitative assessment of MSC of semen) is performed in the apparatus, and the apparatus further comprises reporting elements adapted to display a result of the analysis to the user. Said reporting elements may for instance include a display, or one or more lights (e.g., green light for a successful result—i.e. sufficient count—and a red light for an unsuccessful one). In another embodiment of the invention the reporting element is the display or other output means of an external device.
In the drawings:
The apparatus of the invention generates data representative of the sample tested, e.g., MSC. The data so obtained—or the results derived therefrom—needs to be displayed to the user. Said data can be transferred to an external device, such as a PC, smart phone, tablet or the like, via wireless link, e.g. Bluetooth or Wi-Fi, but additionally or alternatively wired connection can also be provided. This is shown in the embodiment of
In order to acquire images to be analyzed, a camera assembly 504 is provided, which according to the invention is again positioned at a fixed distance from the specimen slide, thus obtaining a system with constant focus and consistent performance.
The apparatus may be powered by a battery (not shown), or in some embodiments power can be supplied via USB port 401 or through a dedicate power inlet (not shown). Cover 104 is provided on this embodiment to allow access to the top portion of the device, but may not exist in other embodiments.
Any suitable specimen slide can be employed for the purpose of the invention, which will be easily recognized by skilled persons and, therefore, are not discussed herein in detail, for the sake of brevity. An illustrative example of a suitable slide is that sold by MES Global, Los Angeles, Calif., under the name Vision Fixed Coverslip Slides (Item Number: A-CA-01082-00), but any other suitable slide can be used, and the most appropriate slide will be selected by the skilled person for the specific test intended.
The casing and chassis can be made of any material, and according to one embodiment of the invention they are molded from plastic material such as ABS. Lens 502 can of course be made of any suitable optical material, but according to one embodiment of the invention it is a ball lens with a ×100 optical magnification, images acquired by which can of course be further digitally processed. An illustrative suitable material for this lens is BK7 polished glass. The software used to operate the various components of the apparatus can be easily devised by the skilled person and, therefore, it is not described herein in detail for the sake of brevity. Similarly, the procedure for preparing the test sample slide and for performing the analysis are within the scope of the man of the art and can be, for instance as described in US Patent Publication 2016/0290916 of the same applicant hereof.
All the above description of preferred embodiments has been provided for the purpose of illustration and is not intended to limit the invention in any way, except as provided for in the claims. Many different alternative arrangements to those shown in the figures can be provided. For instance, the chassis and casing may have different shape, the slide receptacle can be differently positioned and, as a result, the positioning of the lens, camera and LED may be different, and many other modifications can be made without exceeding the scope of the invention.
