Intraocular pressure compensating and regulating valve

An intraocular pressure compensating and regulating valve installed inside the eye's cornea includes: a valve body having a valve seat at an end; a mobile element connected to the valve seat under normal intraocular pressure conditions inside the eye, the mobile element being configured such that it can be separated from the valve seat when the intraocular pressure exceeds the intraocular pressure limit; and an element to keep the mobile element in contact with the valve seat.

FIELD OF THE DISCLOSURE

The present disclosure refers to devices to use in glaucoma treatment, and specifically to a device to reduce intraocular pressure.

BACKGROUND OF THE DISCLOSURE

Glaucoma is an ocular disorder characterized in that it is a neuropathy in which several mechanisms causing damage and loss of retinal ganglion cells intervene, one of the main factors and to date a controllable factor is that of intraocular pressure, and an objective of the disclosure is to keep the intraocular pressure at a normal level. One of the theories is that cell damage is caused by the elevated intraocular pressure that by means of mechanical action causes compression of the nervous fibers and consequently damage to the optical nerve, which is expected to gradually lead to irreversible damage to ganglion cells, nervous fibers and atrophy of the optical nerve and consequently damage and visual field loss until eyesight is lost completely.

The frontal part of the eye is filled with a clear liquid called aqueous humor, which is primarily produced in the ciliary passages found behind the iris. This liquid exits or is removed from the eye through canals in the frontal part thereof, in an area called the anterior chamber angle, at times simply referred to as “angle.”

A normal eye has been generally considered as having a normally appropriate intraocular pressure of about 10 to about 20 mm Hg, through the circulation inside the aqueous humor of the eye, which is secreted from the ciliary body, goes through the pupil to the anterior chamber of the eyeball, and is filtered outside the eyeball through the trabecular meshwork and the Schlemm's canal. When the aqueous humor excreting passageway is blocked, the aqueous humor cannot leave the eyeball at a suitable speed, the intraocular pressure is increased, the eyeball hardens, and direct damage is produced, subsequently developing atrophy of the optical nerve, which is called glaucoma. A characteristic optical neuropathy is developed, resulting in progressive loss of ganglion cells of the retina, visual field restriction, and finally producing blindness. The advanced stages of the illness are also characterized by significant pain.

Treatment for glaucoma, if started early in the course of the illness, may avoid additional damage and preserve the most of the ocular functions. The object of glaucoma treatment is to reduce the intraocular pressure until reaching a level considered safe particularly for the sight, but which is not so low as to cause an ocular malfunction or retinal complications.

There are diverse and varied techniques for treating intraocular high pressure “deviating” the aqueous humor to adjacent tissues contained inside the eyeball, all beneath the sclera or conjunctiva, this technique being subject to the ability of absorbing each one of the tissues wherein the liquid causing the elevated intraocular pressure is canalized.

Typical ophthalmic implants have a valve mechanism to regulate the aqueous humor flow from the anterior chamber; defects in and/or failure of said valve mechanisms can lead to an excessive loss of aqueous humor from the eyeball and possible hypotony. The implants also tend to be obstructed as time goes by, whether from the interior by the tissue, such as the iris, being inhaled at the entrance, or from the exterior by cell proliferation, for example, by forming scars. Furthermore, typical operation of inserting the implant is complicated, highly traumatic and takes a long time.

U.S. Pat. No. 3,788,327 shows an implant from the state of the art using a valve mechanism for regulating the aqueous humor flow from the eyeball to its exterior.

The deficiency and main drawback of this device is the existence of a gap or cavity between the upper part of its liquid-releasing mechanism and the output hole located in the exterior of the eye that is directly connected to the environment and eyelids; since said cavity is highly inclined to organic and inorganic matter sedimentation that will restrict or impede free movement of the release mechanism and/or will generate an obstruction (clogging) in the aqueous humor exit channel, thus resulting in deficiency of its performance and draining capacity of aqueous humor and increasing the intraocular pressure.

The functioning of this device and draining capacity is unsafe since it is conditioned to free movement in its release mechanism, free fluid conduction and the lack of obstacles in the channel removing the aqueous humor towards the outside of the eye and does not have any mechanism nor measures to impede forming these restrictions and/or obstructions.

Another drawback or deficiency of this device results in its high feasibility of establishing bacterial colonies in the cavity existing between the upper part of its liquid release mechanism and the output hole located outside the eye, since this channel does not have any mechanism or measure to impede the formation and accumulation of bacteria as well as the eye's own secretions.

This device has a high endophtalmitis risk, since clogging the channel existing in the upper part of the release mechanism will cause an aqueous humor blockage in its inside, and thus bacteria will find here a favorable niche for its rapid development and entrance to the inside of the eye.

As previously mentioned, the defects and/or failure in the mechanism and drainage of the valve could lead to increasing the intraocular pressure.

The device of the present disclosure does not depend on the capacity of absorption of any tissue to remove the aqueous humor without obstructions between its spindle and the outside. Also, its implant process is the least traumatic possible, typically requiring only ambulatory or out-patient surgery, the device or valve of the disclosure being based on its design simplicity and components. The present valve comprises an interior part or chassis and a stem that is displaced outside in the corneal surface (over the epithelium), the valve stem is subject to a tension caused by a compression spring or the repulsion between two permanent magnets, this spring or the magnetic repulsion are calibrated to a given tension (about 10 to about 20 mm Hg), and when the eyeball reaches the tension value greater than the spring or the repulsion, it achieves displacement of the stem outside the cornea, such that the aqueous humor causing the elevated intraocular pressure can be drained outside the eye. Once the pressure is regulated, the stem returns to its initial position tightly closing the valve and thus avoiding any entrance of foreign objects, such as dust, microorganisms, etc., into the eye.

There are very clear and precise advantages between the device of the present disclosure and the devices from the state of the art. These include:Regulating pressure is always constant, and the aqueous humor flow is free of obstacles.The smooth exterior upper surface of the device allows cleaning and constant lubrication through the natural movement of the eyelids impeding formation of sediments and bacteria build-up.The lack of interior and exterior cavities impedes the formation of sediments and bacteria build-up.The drainage mechanism is always free and lacks movement restrictions; thus its functioning does not have conditions.This type of configuration allows a laminar flow of the aqueous humor through the device walls to achieve a sweeping effect and thus avoid adherence of bacterial strains.

The present disclosure provides an intraocular pressure compensating and regulating valve installed on the cornea of an eye, comprising: a valve body having a valve seat on one end; a mobile element in contact with the valve seat under normal intraocular pressure conditions in the eye; the mobile element is configured such that it can be separated from the valve seat when the intraocular pressure exceeds an intraocular pressure limit; and an element is provided to keep the mobile element in contact with the valve seat. The valve body has an exterior part with fastening elements to retain the valve to the cornea, and the intraocular pressure limit is from about 10 to about 20 mm Hg.

In a first embodiment, the element to keep the mobile element in contact with the valve seat is a spring placed on an interior part of the valve body, and the mobile element is a stem comprising a tubular body with an internal canal therein, the stem having on its upper part perforations for allowing the aqueous humor exit the valve.

In a second embodiment, the element to keep the mobile element in contact with the valve seat is constituted by two permanent magnets with the same polarity placed on an interior part of the valve part, and the mobile element is a stem comprising a tubular body with an internal canal therein, the stem having on its upper part perforations for allowing the aqueous humor exit the valve.

In a third embodiment, the mobile element is a stem comprising a tubular body with an internal canal therein, and the element for keeping the mobile element in contact with the valve seat is constituted by two springs placed in contact with one valve body end opposite the end where the valve seat is and a ring located in the stem, the stem having on its upper part perforations for allowing the aqueous humor exit the valve.

In a fourth embodiment, the element to keep the mobile element in contact with the valve seat is a spring having a first end and a second end, the spring is located in an interior part of the valve body, and the mobile element is a pad having on its lower part a hoop to fasten a first end of the spring; and the second end of the spring is attached to a fastening element located on the inside part of the valve body.

DETAILED DESCRIPTION

With reference toFIG. 1, an eye10is shown indicating the eyeball11, the optical nerve12and the cornea13in which the intraocular pressure compensating and regulating valve14is implanted. Said valve14allows release of aqueous humor outside the eye, when the threshold pressure is exceeded to which the valve14is calibrated.

A first embodiment of the intraocular pressure compensating and regulating valve100is illustrated inFIGS. 2 and 3, and comprises a valve body or sheath110, a stem120and a spring130. The valve body110has a hollow tubular body111and a flange112in a tubular body111end. The stem120comprises a tubular body121with an internal canal122having in one of its ends, a conical part123resting on a seat113, which is also conical at the location where the flange112is located in the valve body110. The tubular body121of the stem120, beneath the conical part123, has radial perforations124in communication with the internal canal122of the tubular body111of the stem120.

The valve body110includes the spring130in the internal part of the hollow tubular body111, to keep the stem120pressured such that the conical part123is seated on seat113of the valve body110. The hollow tubular body111includes fastening elements114to retain and fasten the valve100to the cornea. The spring130is tightened to the stem120and the other one of the ends of the spring is not tightened to the stem but there is a separation with the stem120from about 5 to about 10 microns, such that the stem120can be displaced outside the valve body110.

Under normal conditions of intraocular pressure (10-20 mm Hg), valve100remains closed and there is no aqueous humor flow outside. However, when the intraocular pressure exceeds the limit to which the spring130is calibrated, the stem120is displaced defeating the spring's130strength and thus the conical part123of the stem120is separated from the seat113of the valve body110allowing the aqueous humor to flow through the internal canal122and the radial perforations124of the stem120expelling the aqueous humor. Once the pressure is regulated, stem120returns to its initial position tightly closing valve100and thus avoiding any entrance of foreign objects to the eye (dust, microorganisms, etc.).

In a second embodiment, such as is illustrated inFIGS. 4 and 5, the intraocular pressure compensating and regulating valve200comprises one valve body210or sheath, a stem220and two circular magnets (230and231). The valve body210has a hollow tubular body211and a flange212at a tubular body211end. The stem220comprises a tubular body221with an internal canal222having on one of its ends, a conical part223resting upon a seat213, which is also conical in the part wherein the flange212is located in the valve body210. The stem220tubular body, beneath the conical part223, has radial perforations224in communication with the internal canal222of the tubular body221of the stem220.

The valve body210includes the first circular permanent magnet230placed on the internal part of the hollow tubular body211at the end where the flange212of the valve body210is located. The second circular permanent magnet231is placed on stem220at the other end level of the valve body210, such that magnets (230and231) are separated by a distance. The polarity of the first magnet is equal to that of the second magnet in order to obtain a repulsion strength between the magnets, and thus to keep the conical part223resting on seat213of the valve body210. The hollow tubular body211includes fastening elements214to retain and attach the valve200to the cornea. The second magnet231is tightened to stem220and the first magnet230is not tightened to the stem but there is a separation with the stem220from about 5 to about 10 microns, such that stem220can be displaced outside the valve body210.

When the intraocular pressure exceeds the limit to which the repulsion strength is calibrated (e.g., about 10 to about 20 mm Kg), the stem220is displaced defeating the repulsion strength and thus the conical part223of stem220is separated from the seat213of the valve body210allowing the aqueous humor to flow through the internal canal222at the radial perforations224of stem220expelling the aqueous humor. Once the pressure is regulated, stem220returns to its initial position tightly closing valve200and thus avoiding entrance of foreign objects such as dust, microorganisms, etc. to the eye.

A third embodiment of the intraocular pressure compensating and regulating valve300is illustrated inFIGS. 6 and 7, and comprises a valve body310, a stem320and elastic laminates or springs330and331. The valve body310has a hollow tubular body311and a flange312in a tubular body311end. The stem320comprises a tubular body321with an internal canal322having in one of its ends, a conical part323resting on a seat313, which is also conical in the part where the flange312is found in the valve body310. The tubular body321of the stem320, beneath the conical part323, has radial perforations324in communication with the internal canal322of the tubular body321of the stem320.

Between the valve body310in the end opposite flange312and a ring or disk325located on stem320there is a spring330to keep the stem320pressured, such that the conical part323is seated on seat313of the valve body310. The hollow tubular body311includes fastening elements314to retain and attach the valve300to the cornea. Between the hollow tubular body311of the valve body310and stem320, there is a separation from about 0.5 microns to about 3 microns, such that the stem320can be displaced outside the valve body310.

Under normal conditions of intraocular pressure (about 10 to about 20 mm Hg), valve300remains closed and there is no aqueous humor flow outside. However, when the intraocular pressure exceeds the limit to which the spring330is calibrated, the stem320is displaced defeating the strength of spring330, resulting in the conical part323of the stem320becoming separated from the seat313of the valve body310, allowing the aqueous humor to flow through the internal canal322and the radial perforations324of the stem320expelling the aqueous humor. Once the pressure is regulated, stem320returns to its initial position tightly closing valve300and thus avoiding any entrance of foreign objects such as dust, microorganisms, etc. to the eye.

A fourth embodiment, such as is illustrated inFIGS. 8 and 9, of the intraocular pressure compensating and regulating valve400comprises a main body410, a magnetic head420, spring430. The main body410is tubular body with an internal canal411and a spring fastening element412in a flange413. The main body410includes a fastening element414to retain and attach valve400to the cornea.

The magnetic head420comprises a conical part421resting upon seat415also conical on an end of the main body410. One rear part of the magnetic head420includes a hoop423wherein the first end431of the spring430is attached, and a second end432of spring430is attached to the fastening element412. The spring is located inside the internal canal411of the main body410.

Under normal conditions of intraocular pressure about 10 to about 20 mm Hg), valve400remains closed and there is no aqueous humor flow outside. However, when the intraocular pressure exceeds the limit to which the spring430is calibrated, the magnetic head420is displaced defeating the strength of spring430and thus forming a separation between the magnetic head420and seat415of the main body410allowing the aqueous humor to flow through the internal canal411and thus the separation formed expels the aqueous humor. Once the pressure is regulated, the magnetic head returns to its initial position tightly closing the valve and thus avoiding any entrance of foreign objects such as dust, microorganisms, etc. to the eye.

The present disclosure has been described and illustrated in multiple embodiments; however, modifications can be made, for example, geometrical modifications of the valve's parts can be made, thus comprised within the scope of the following claims.