Field of the invention

The invention concerns a device (functions, architecture, material selection) suitable for eye examinations and investigations with similar characteristics, in particular those accompanied by a doctor.

Background of the invention

Devices suitable for eye examination, in particular devices, that are part of a larger system that are applied to the eye, exist.

Appliances, particularly glass pipettes, to extract fluid of the eye, exist.

Sterility is important in a hospital and certainly for eye exams. Sterility is very important for these products in order to analyze as correctly as possible and not to influence the test results.

Devices and appliances must be disinfected before every use/research. It is opted not to recycle the material and to throw away after use.

Summary of the invention

The invention comprises a self-standing device (functions, architecture, selection of materials) for research of tissue of humans and/or animals, corresponding ways of manufacturing and operating methods. The invention is particularly illustrated for eye examinations, but several of the aspects of this example also return in related investigations of (soft) tissue of humans and/or animals.

The invention includes a system (100) for extracting human or animal secretion (by corneal proteins) secreted near (soft) tissue (110) (cornea of the eye) of a (living) human or animal (120), including (1) a 1st subsystem (holder) (140) created for (i) making contact with the tissue (and keep the eyelids open) and (ii) to retain a 2"° subsystem (150); and (2) a second subsystem (blisters) (150) developed to hold by the 1st subsystem; where the first and second subsystem are removably connected to each other, with the second subsystem (150), including a reservoir for containing a liquid; and (3) methods (200) for transporting this fluid to or from the reservoir. Various embodiments of the invention are explained below.

A system (100) to capture human or animal excretion (by corneal proteins) secreted in the proximity of (soft) tissue (110) (cornea) of a (living) human or animal (120), comprising (1) a 1st subsystem (holder) (140) is created to (i) make contact with the tissue (and to keep the eye open), and (ii) to retain a 2 ^nd subsystem (150); and (2) a 2nd subsystem (blister) (150), whereby (i) it is equipped with means for holding fluids (or fluid) (180, 190), and (ii) designed to be held in place by the 1st subsystem; where the 1st and 2nd subsystem are removably connected with each other.

A system as explained above, where the 1st subsystem (140), comprises (1) a first part of a first materia! (160); and (2) a second part (170) of a second material, where the second part is connected to the first part, the first part is created to make contact with the tissue; and the second part is created to hold the 2nd subsystem.

A system as explained above, where the 2nd subsystem (150), comprises (1) a first reservoir for containing a liquid (180); (2) a second reservoir (190) for containing a liquid; and (3) appliances (200) for transporting liquid of the first reservoir to the proximity of the (soft) tissue and transporting the liquid (with or without discharge) to the second reservoir.

A system as explained above, where the first material is selected for of its softness to make contact with the (soft) tissue, particularly the first material being medical grade silicone.

A system as explained above, which the second material selected for its firmness in order to hold the 2nd subsystem, in particular the second material being polypropylene. A system as explained above including the liquid, in particular an aqua solution, Sodium Chloride.

A system as expiained above, a 2nd subsystem, that consists of a third material, is selected for its semi-flexibility, more specifically the third material being low-density polyethylene (LDPE). A system as explained above; where the means to transport the liquid of the first reservoir to the proximity of the (soft) tissue and transporting the liquid (with or without discharge) to the second reservoir includes (1) a first channel (210), developed to transport the liquid of the first reservoir to the proximity of the (soft) tissue; and (2) a second channel (220), developed to transport the fluid (with or without discharge) of the second reservoir; and the first subsystem is created for guidance of the liquid (with or without discharge) to the second channel. A system as expiained above, where the voiume of the first reservoir is smaller than the voiume of the second reservoir. A system as explained above, where the volume and/or diameter of the channels are dimensioned and/or the choice of the third material is selected to transport by an amount of pressure (300), is achieved by a human operator, on (the exterior of) the reservoirs.

A system as explained above, adjusted to capture human or animal secretion near (soft) tissue (cornea) of a living human or animal can be performed by using a predefined maximum amount of liquid, in particular, the diameter of the first channel is designed to produce one or more droplets (130) of a suitable voiume near (soft) tissue (cornea).

A system as explained above, adapted so the position of the system near (soft) tissue (cornea) of a human or animal can be carried out by a certain pressure (310), performed by a human operator, on (the exterior) of the 1st subsystem, in particular the 2nd part of the first subsystem.

The (2nd) subsystem (blister) suitable for application in the system as mentioned above, for capturing human or animal secretion produced near (soft) tissue (cornea) of a living human or animal, comprising (1) a first reservoir for holding a liquid; (2) a second reservoir for holding a liquid and (3) means to transport the liquid of the first reservoir to the proximity of the (soft) tissue and to transport the liquid (with or without discharge) to the second reservoir.

The above subsystem consisting of a third material, selected for its semi-flexibility, more particularly the third material being low-density polyethylene (LDPE).

The above subsystem; where the means to transport the liquid of the first reservoir to the proximity of the (soft) tissue and transporting the liquid (with or without discharge) to the second reservoir, comprises (1) an adapted first channel to transport the liquid of the first called reservoir to the proximity of the (soft) tissue; and (2) a second channel, designed for transporting the liquid (with or without discharge) to the second reservoir.

The above subsystem, where the volume and/or diameter of the channels are dimensioned and/or the choice of the third material was made to make the transportation possible by an amount of pressure, achieved by a human operator, on (the mantle/exterior) of the reservoirs. The above subsystem, which captures human or animai secretion near (soft) tissue (cornea) of a human or animai can be achieved by using a predefined maximum amount of fluid, in particular, the diameter of the first channel is designed, to incorporate one or more drops of the right volume near (soft) tissue (cornea).

The (1st) subsystem (holder) suitable for use in the described system comprises (1) a first part of a first material; and (2) a second part of a second material, where the second part is connected to the first part, where the first part is created for contacting the tissue; and because of its softness for touching (soft) tissue, in particular the first material being medical grade silicone.

The previous mentioned subsystem, where the second materia! is selected on its firmness to hold a subsystem, in particular the second material being polypropylene.

The subsystem, adapted by positioning the system near (soft) tissue (cornea) of a human or animal can be achieved by an amount of pressure, performed by a human operator, on (the mantle/exterior) of the subsystem, in particular the second part of the first subsystem.

Brief description of the figures

Figure 1 shows the context in which the invented device is used.

Figure 2 shows the placement of the invented device on the eye.

Figure 3 shows a schematic overview of the invention.

Figure 4 shows a schematic picture of the parts of the device.

Figure 5 shows a part (blister) for a particular embodiment.

Figure 6 shows a part (holder) for a particular embodiment.

Figure 7 shows a picture of the integration of the components above.

Figure 8 shows a different view on this integration.

Figure 9 shows the application and extraction of the fluid from the eye.

Figure 10 shows a different picture of this integration.

Figure 11 shows a different picture of this integration.

Detailed description

The invention comprises a device; suitable for an eye exam, applied to the eye, with attention to the sterility, more particularly suited to drip the liquid on the eye and to extract the liquid from the eye. The device is designed with the aim to guarantee the sterility and if possible a partial reuse.

The invention comprises a device; suitable for an eye exam, that is applied to the eye, particularly suited to drip a liquid (e.g. a combination of sodium chloride (0,09g in 10ml) and (sterilized) water in the eye and to extract liquid from the eye, more suitable for the extraction of proteins of the cornea of the eye. The combination of a sodium chloride solution and the corneal proteins are collected/extracted in the product itself. The device supports the application of liquid on the cornea, e.g. by ' spraying ' and/or drip, in particular to drip onto the eye. In a sitting position of the patient, the liquid will move itself from the surface of the cornea to a lower point and is collected by the product. The liquid will be absorbed by means of pressure and release the pressure on the reservoir. The device or product provides absorption of the liquid in the product itself, what is a great added value for the transportation to the laboratory.

In an embodiment, the device has one or more of the following system functions and associated components:

The cup will keep the eyelids open and collect the added liquid

A drop system of neutral fluid (sodium chloride) on the eye

A refill system of the container

Extracting system to collect a mix of sodium chloride and substances of the cornea

Transportable samples for the laboratory

A drop system for laboratory usage

In an embodiment, the device has one or more of the following specifications:

1. HOLDING THE EYELIDS OPEN

The material must be flexible to avoid injuries. The thickness of the edge of the cup is preferably maximum 2 mm and has rounded edges. The eyelids should sufficiently in order to ensure optimal exposure of the cornea. The cup has to be suitable for children from 6 years, adults and seniors. alpositioning of the cup between the eyelids must has to be avoided at all times. The cup must fit around the cornea of the patient and between the eyelids. The dimensions are shown below:

AVERAGE DIMENSIONS OF TH E CORN EA

Vertical: 10.40 mm

Horizontal: 11.25 mm AVERAG E DIM ENSIONS OF TH E EYELI DS

Length : 27 mm

Height: 9 mm 2. COLLECTING

The patient should be in a sitting position whereas the iiquid spreads across the corneal surface. The diameter of the cu p may be max 1 mm bigger than the diameter of the cornea. The cup should be fitted on to the eyeball in order to avoid leakage. The cup must have the correct labels of sterilization and disposability. If the cup is disposable, then it has to be collected at the chemical waste. If the cup will be reused, it must be sterilized with an excellent d isinfectant or a professional sterilization mach ine.

3, APPLYING

Only the Iiquid sodium chloride can be applied on the cornea. A maximum of 100 microliters (2 drops) of Sodium Chloride is applied on the surface of the cornea. The Iiqu id should be applied on top of the cornea in order to improve the dispersion of the iiquid.

4, EXTRACTING

A minimum of 50 microliters should be extracted from the eye. The extracted Iiquid should be collected in a DNA and RNA free container. The extracting system can't contact the surface of the eye.

5, SAVING/CONTAINING

The extracted Iiquid is collected in a container. The volume of the container is minimum 50 micro liter and maximum 150 microliter. The container must be free of human DNA and RNA. The container should, if possible, be placed within the product and should be removable. The container must withstand freezing temperatures (-80 °C). The container should be re-opened by the laboratory.

6, TRANSPORTING

The extracted iiqu id should be transported by the pick-up service of the lab. The sample must be kept cool during transport. The risk of infection during transport must be excluded from the sample.

7, OTHER SPECIFICATIONS

The fingers of the doctor should not touch the cornea wh ile placing and removing the product/cup. The components, which make contact with the patient, must be disinfected. The product is suitable for left- and right-handed users. Only doctors and assistants are allowed to use this product.

The product is suitable for 90-percentile range of adults' hands (18-65 years). The product should weight minimum lOg and maximum of lOOg. The product must apply and extract liquid on and of the cornea. The product has to mention the composition of the liquid, the expiration date, the name of the manufacturer, the CE label and model number.

Product architectures:

In an embodiment, the device contains the following product architecture. The device has an external container filled with sodium chloride. Depending of the choice of disposal or disinfecting the cup, the cup will be fixed on the product or will be replaceable. The cup is placed between the upper and lower eyelids and the sodium chloride is released on the surface of the cornea. The device will then extract the mix (Sodium Chloride and corneal proteins) and store them in the container. This container is ejected from the device and sent to the lab.

In an alternate embodiment, the device has the following product architecture. The sodium chloride will be added in the device. The sodium chloride is stored in a fixed container of the device. The cup is then placed on the product and between the eyelids. The product releases 2 drops of sodium chloride on the eye. The cup will finally extract the liquid that is present on the eye. The cup is sent to the lab.

In another alternate embodiment, the sodium chloride will be dripped by external ampoules, which are used nowadays. As follows, the empty container will be placed in the product. The cup, which is fixed to the product or replaceable, is placed between the eyelids. Then the liquid is extracted of the eye and collected in the container. The container can be removed from the product and sent to the lab.

Alternative product architecture, the product and the cup are placed on the eye. The cup can be fixed on the product or removable from the product. Sodium chloride is then added to the eye by the existing ampoules. The product will absorb the mix (sodium chloride and corneal proteins) and after the product is removed between the eyelids, stored in an external container.

Alternative product architecture without product, the cup is placed between the upper and the lower eyelid. The sodium chloride is dripped on the eye through separate existing ampoules. After the sodium chloride has absorbed the enzymes and other substances that are present on the cornea, the cup wili extract this liquid. The cup is in this case the container. This cup/container is then sent to the iab.

Alternative product architecture without product. The difference embodies the liquid and the container. The sodium chloride is already present in the cup, the cup acts as a container. As the first product architecture, the cup is placed between the eyelids. The sodium chloride is released on the eye. After the liquid is mixed with the enzymes on the cornea, the cup extracts and stores the liquid. The cup is also the container for the liquid. In a preferred embodiment, the product is disposable by the end user, the laboratory or GP. The content of the product releases 100 microliters and extracts the same 100 microliters + enzymes. The product consisting of LSR is disposed after single use at the chemical waste.

KEEPING OPEN OR SPREAD OF EYELIDS

In an embodiment, the product is handled with a spinning movement. The product is placed on the eye in the horizontal position. A rotating movement of 90° will spread the eyelids. The product is suitable for left and right-handed users. The patient can affect the positioning of the product by flashing with the eyelids. The cornea is isolated.

In an alternate embodiment, the product is positioned by using a pinch movement. The doctor places the product between the fingers. By pressing the top and bottom of the product, the round shape of the product deforms to an oval shape making it possible to be placed on the eye. By releasing the pressure, the oval jumps back in its original round shape and pushes the eyelids open. The patient can't affect the positioning of the product by flashing with the eyelids. Left-and right- handed users can use the product.

APLLYI G (preferably 2} DROPS OF SOIDU CH LORIDE ON THE CORNEA The administration of the sodium chloride can be done by two methods. The first technique is ' spraying ' and the second technique is 'dripping'. The ' spray ' of the sodium chloride on the eye of the patient can happen on a patient in a sitting position or in a laying position. The liquid can only be released by pressing on the reservoir in which the sodium chloride is stored. The small nozzle spreads the liquid over the entire cornea and is collected at the lower base of the cornea. The second technique is to drip. The patient is positioned on his/her back or sitting straight up with his/her head bent backwards. This iast position is not accessible for older people and is therefore rejected. The droplet is released by pressing slightly on the reservoir. The drop is released on the top of the cornea and flows over the cornea to the edge. This technique is already used when administering eye drops and everyone can apply this method. The ergonomics of the patient will be improved, by switching the position from laying to sitting. It will benefit the patient, but also the doctor has a better overview of his actions. The patient feels more comfortable as he/she can see the preparations performed by the doctor. The sodium chloride is (in sitting position) dripped on the upper side of the cornea, instead of dripping the sodium chloride at the top of the cornea (in laying position). A specific embodiment is described in the following description.

The system consists two parts, the blister in which sodium chloride is stored and the holder that is placed on the eye and acts as a frame for the blister. The blister contains 2 reservoirs: the first reservoir stores the sodium chloride. The second reservoir will absorb the liquid. The first reservoir has a smaller cavity than the second reservoir. This has two reasons. The product is placed horizontally on the eye with the sodium chloride at the top. By a horizontal positioning of the product, the liquid is squeezed out easier (smaller volume). The second cavity is bigger and has the advantage that it can take up more volume. The pipette is preferably made of LDPE and is formed by the extrusion blow molding.

The holder has the purpose to position the reservoir, spread the eyelids and to absorb the liquid. The holder is made of different materials. A soft material (medical grade silicone) which makes contact with the cornea and the eyelids. And a sturdy/flexible material (for example, polypropylene ("PP")) that holds the reservoir in place. The holder is produced by injection molding. These materials have to withstand sterilization with gamma radiation. This can occur after the production of the parts.

In total, 3 to 4 components are produced. The packaging not included.

First of all components is the blister which will be produced with the technique "Form, Fill and Seal ' by extrusion blow molding. This technique is widely used in the food industry but also in the medical field in which instruments should be packed sterile. The blister is simultaneously formed, the sodium chloride is sprayed in the blister and the blister is hermetically sealed. This production method is used in the packaging of eye drops.

The second component is the holder, which is produced by injection molding, in addition, the silicone ring is produced, also with the injection molding technique, whereby the holder is placed as an insert. The ring is formed around the holder so they share a single component.

By merging these two components, the number of acts and assemblies are minimized. The material selection of silicone is dictated by the functions of the product. The component that makes contact with the eye surface should have soft and flexible characteristics and may not cause harmful injuries. The material must withstand the sterilization methods, micro-organisms and freezing temperatures (-80 ° c). The blister is manufactured from LDPE with the following specifications: transparent, semi flexible, produced by blow molding, no presence of harmful substances, withstands freezing temperatures and it has to be inexpensive.

Injection molding is used for the PP part (the holder) that withstands freezing temperatures, radiation and micro-organisms and it has to be inexpensive.

STERILITY DURING AN D AFTER PRODUCTION

There are two methods to produce a sterile product. The first is to produce the product in a sterile environment. The second method is sterilizing the produced products by means of a sterilization machine.

A sterile product is produced in a sterile environment, the so-called ' clean rooms ', but also the equipment and other facilities must comply with the quality requirements.

During the production process there must be paid attention to infection controll. Infections can be caused by people, the environment, machines, other materials and other areas.

An infection can develop easily because micro-organisms can spread by contact, but also through the air.

Sterility is an important feature because the product is directly placed onto the eye. if the product is not sterile, it can cause severe infections.

APPLYING THE SYSTEM

In brief, the invention comprises a sample collector, which absorbs corneal proteins. The purpose of these samples is to get an impression of the health of the eye.

In an embodiment, the system contains 2 parts. The holder consists of a silicone ring (makes contact with the corneal surface) and the container (contains two cavities, one with sodium chloride). The smallest reservoir contains lOOmicroliter sodium chloride and is positioned at the top of the cornea (and under the upper eyelid).

The holder and blister are conserved in its package. The holder is fixed in the screw cap of the package. The package is opened and the doctor needs to disinfect his hands. The blister is taken from the holder and the closures are removed from the blister. The presence of the closures ensure the product to be hermetically sealed against micro-organisms. The final step in the preparation is to position the blister in the holder and to push it down.

It is important that the smallest reservoir of the blister is placed on top of the holder where the text ' UP ' is provided. This is only possible by the different sizes of slits, made in the lower ring. The blister is in place as the blister slides smoothly into the holder (slits) and when the 'click' ^' sound is produced, the product is ready for use.

The product (holder + blister) is taken from its package and placed on the eye.

The patient sits up on the exam table (or chair) and the doctor stands in front of the patient. The doctor holds the product with one hand and the other hand presses down the holder. This will deform the ring into an oval.

The 'oval' ring is placed between the eyelids and the pressure on the holder is released. The eyelids are spread open, the ring makes contact with the eye and seals the cornea. The blister is positioned between thumb and finger (index and middle finger) of the other hand and both reservoirs are pinched down together. Pressure on the blister: the sodium chloride is released by the upper reservoir and runs across the cornea surface, from top to bottom. At the same time, the air is blown out from the lower reservoir and is ready to suck in the air again. By releasing the pressure on the blister: the lower (biggest) reservoir will absorb the sodium chloride and corneal enzymes, which have collected at the bottom of the ring

To remove the product from the eye, the holder is pressed again (ring deforms into an oval) and the product can be taken away.

The product is stored in its package and placed in a cold environment until the laboratory will collect the samples.