DEVICE FOR THE INTERRUPTION OF THE FLOW OF TEARS

Applicant For:

INC And Eagle's View.

6263 poplaraveAve., 650 suites

memphis, Tennessee 38119

uU.S.A.

Lacrimal fluid control device.

This application associated with the content of the older American patent No 3,949,750 designated "punctum plug-and-Verfahren zur treatingkeratoconjunctivitssicca (in dry-eye) sand ophthalmie normothermic aliments Using Conjugate seed" and the American patents No 4,915,684 designated "Verfahren sand Beheizung zur modulatinglacrimalpunctumcanaliculus-the case of the fluid-flow Callthrough a is associated sand".

This invention relates to a device for the treatment of diseases related with tears. In particular the invention relates to an improved plug for the treatment of tears (punctum) point - and other conditions wherein dry eyes and problems with keraconjunctivitis sicca contact lens wear are enlarged and contracted tears and pathologically points. The use of language and keratitis sicca or "dry eye" keraconjunctivitis sicca or belonging to a number of problems, of which up to visually and pain and discomfort in extreme cases lead to blindness go. The causes of dry eye is aging, disease, inflammatory processes and side effects of prescribed drugs. A widespread fact the inability, maintain a stable preokularen tear film (pTF) is.

In a healthy eye of the pTF is spread by the upper eyelid over the cornea and the conjunctival epithelial and makes the surface of the eye smooth and optically clear. The tear film is composed of three thin, the surface of the eye be coated films. An outer oily film is produced by small glands, and located at the edge of the eyelid meibomdrüsen the hot. This gives a smooth surface and prevents the evaporation of tears outer film tears. A central aqueous film is produced by large tears and purified by the eye wash away of foreign particles and irritating products.

An inner film is of the cup cells in the conjunctiva of mucus produced. This inner film makes it possible the aqueous film-, spread evenly over the surface of the eye and helps to, keeping the eye moist. This causes the adhesion of the mucus produced by inner film tears to the eye.

The pTF is normally by a cooperating interaction of products from the meibomian gland, the tears and the cup cells produced. A dry eye generated when said glands produce less than a sufficient amount or the flow tears or tears to flash evaporating.

In a chronic irritation of the front segment shortages cause tears, has itchy eyes sandige complaints about what, conjunctivitis, metabolic disorders of the cornea and extreme cases, lead to loss of the optics. Patient complaints and problems associated with a partial decrease which often carry the aqueous tear production are facing. A cause of such complaints is the partial atrophy of the tears, as often happens in old patient and some patient found as a result of infection. In a younger patient atrophy can also occur, if this contact lenses with high water content (high-Bridgewater-type contactlenses) carries, due to the need of the front segment to aqueous tears increasing.

The state of the dry eye has been treated in the past with varying degrees of success. A previous practice in the treatment of dry eye has been the application of different types of topical drops and ointments. Some prefer the use of dry eye suffering humidifiers and evaporators, to increase moisture in the surrounding air, which underpin, lacrimal fluid from the eye to reduce evaporation.

The lasting conclusion of the tear point has again proved to be effective method for treating deviations, which are in communication with the trärien, including dry eye, stratum corneum ulcers, conjunctivitis, eyelid inflammation, problems with contact lenses and other external eye diseases. In extreme cases of discomfort and pain, for example as you enter sjörgren syndrome, has the permanent complete tears and the tears (canaliculi) tube by surgical procedures or points by cauterization guided at least in a certain success. The close with thermal means initially made and is carried out for the increasing time dia. therapy cauterizing or of laser devices for medical use. If the loss of pTF through the tear nose gear is blocked, gives the volume of the front segment increased moisture remaining tears.

Each of the above measures is tainted with certain restrictions however. Topical drops and ointments require a regular re-orders. Humidifier and evaporator are relatively bulky and must be connected to an electrical power source and for this reason are not satisfactory in all circumstances, as with outdoor activities. Finally constitute a risk of subsequent surgical or are expensive and/or epiphorakauterisationsmaßnahmen and infection, wherein the destruction of normal tissue must be made via surgical measure undo.

To avoid one or more of the disadvantages mentioned above, an alternative process for temporary or reversible locking a tear point opening have been proposed. Such methods comprise a temporary complete tears of small sticks of gelatin or collagen by insertion into the tube, or the application of temporary plugs from bone cement produced. The blocking effects of these means is either too short or for other reasons unsatisfactory.

Mild to moderate dry eye problems raised previously have been addressed by the introduction of a tear point advantageously plug, which advantageously effected in a reversible conclusion of the tear point, as disclosed in the aforementioned freeman and from US Patent Nos 3,949,750 claimed. The disclosure of this patent, from the same inventors as the present invention, and is taken as represented in full length whether explicitly here, reference.

A lower and/or upper tear point with plugs from conclusion of silicones for medical application according to freeman has proven to be highly useful in the case of a number of patients, who suffer with dry eye conditions, .

It has been found however, that a plug of the conventional type is in some circumstances sometimes tears point unintentionally expelled or removed, neatly in the corner of his eye when the patient. Accordingly it would be highly desirable, to facilitate retaining capacity and the functional structure of a point of a patient's eye point plug within the tears tears and simultaneously the advantages of reversible blocking the tear fluid flow from the eye.

The problems, have been indicated in the notification should, not be abeschließend listed, but are a selection of many problems, which may isolate, that the effectiveness of the previous methods and apparatuses, to prevent the flow of tear fluid by a tear point opening and a tube connected thereto, is reduced. The described above but should be sufficient, in order to show, that previously existing devices for treating a valuable improvement give rise to PTF loss.

It is therefore a general object of the invention, a new and improved device for control of the tears to flow available, which blocks the drain tube of the support points by the tears and lacrimal fluid.

It is another goal of the invention, a new apparatus for alleviating the PTF loss symptoms to create, the tears in the eye of the patient complete points without surgically.

It is another task of the invention, to increase the storage of pTF in patients with pathologically expanded or contracted tears dots with a device, which can be removed easily and reversibly mounted, .

It is another task of the invention, to create a new lacrimal fluid control device, which works in a manner, that the random and undesired expulsion of the device from a patient's lacrimal point opening is minimized.

It is another goal of the invention, to create a new lacrimal fluid control device, which works in a manner, that the physiognomy of a substrate being advantageously used lacrimal point opening, to amplify the securing the apparatus.

It is another task of the invention, creating a device for lacrimal fluid control, wherein a protected device is secured in a small recess with a head part keep the tear point opening of the carrier.

A preferred embodiment of the invention, which intends, to solve at least some of the preceding tasks, comprises a lacrimal fluid control device, to block the flow of tear fluid away from the surface of the eye of a wearer by a tear point opening and into a related tears tube.

The lacrimal fluid control device includes a tip portion, and a head portion comprising a generally inverted truncated cone, which usually comprises a enlarged cap. The tip is able, to simplify the mounting of the device at least partially through the lacrimal fluid control point opening of the support and the enlarged head portion or cap tears prevents flushing the lacrimal fluid control device in full manner by the tears point opening and into a vertical portion of a related tube usually tears.

A shank portion is between the tip portion and the head portion and is held in total mounted along its outer periphery by a effectively from existing fibroelastischem tissue of the patient, by the tears point annulus formed opening. The shaft portion has a diameter at the head portion in the subsequent part, which is less than the diameter of the subsequent part tip. This ratio of the dimensions of the lateral forces cause a resultant force vector fibroelastic tissue encircling lacrimal point opening to the shank portion, a direction toward the tip of the device towards the lacrimal fluid control having. This resultant force facilitates securing the apparatus for closing the lacrimal fluid control with said head portion within a slight recess opening within the tears point fixed, which leads to the opening point tears.

In a preferred embodiment of the invention the shaft portion is curved to conform to an associated tear point opening. In still another preferred embodiment a plurality of annular recesses or projections are incorporated into the surface of the shank portion having circles.

Further tasks and advantages of the present invention from the following detailed description of the preferred embodiments are in connection with the accompanying drawings clearly. In this show:

Figure 1: a scenic representation, the anatomy of a human eye including a lowermost point representing tears opening, which opens to a tear tube, that is; connected to a bag and finally with the nasal passage of a human tears

Figure 2: a detailed, partially cut side view of a circular area indicated in Figure 1, which is a device for lacrimal fluid control according to the present invention, in a position in which the flow of a lacrimal pTF is blocked in tube, wherein a tip portion and a head portion by a tear point ring extends within a substantially conical recess is mounted near the opening of the tear point. A shaft portion with outwardly extended side surfaces is supported by the tears point opening and forces from the tissue of the tears shall point ring, which holds; tears in use point plug at position

Figure 3: two sheet, a side view of a embodiment of the lacrimal fluid control device in question, comprising; a shank portion outwardly sloping side surfaces with note

Figure 4: one sheet, as shown in Figure 3 a plan view of a control device shown tear liquid; again note

Figure 5: a side view of a variation of the control apparatus shown in Figure 3 tear liquid;

Figure 6: a variation represented in Figure 5 as a lacrimal fluid control device, wherein the truncated cone segment having outwardly curved or concave sidewall surfaces is formed.

Figure 7: another embodiment of the present tears control device, wherein the outer side surface of the shank portion is bent from the head to the tip adjacent to the head portion and the radius of the curvature is greater than the radius adjacent the tip portion arranged curvature arranged;

Figure 8: another embodiment of the present device for lacrimal fluid control the side surface of the shank portion is curved and wherein the radius of curvature is greater than the radius of the tip portion on the subsequent to the head portion of the subsequent curvature control device.

Detailed discussion of the new and useful prior, non-biodegradable lacrimal fluid control device, the discharge from the eye by lacrimal fluid surface point opening and in communication therewith for blocking in tears tears tube, it can be useful, the connection of the invention with reference to Figure 1 to discuss briefly. In particular 10 including an outer surface of the cornea of an eye anatomy is represented 12, which is lubricated by a thin, the surface of the eye pTF be coated. As noted earlier, this thin film consists of three layers:

a outer film, an average aqueous film and an inner film of oily slime.

The lacrimal fluid produced by glands on the eyelid edge pTF or, as the meibomian gland, small glands, are distributed over the conjunctiva and greater tear gland, which large tears called gland. If a human is the pTFblinzelt, distributed over the surface of the eye and is optically clear. Without a sufficiently good visibility would be pTF, not possible and a patient can feel symptoms such as cutting, burning, an inclination for scraping, tough mucus and excessive confusion by smoke.

Tears, which lubricate the eye, are produced continuously, wherein an excess pTF is removed from the ocular surface by an upper and a lower opening (not-shown) tears point 14. Once the pTF is over the opening point has passed through the tears starts to move, through a channel or passageway, which is known as a tear tube (canaliculus), away. Of the canaliculus excess flows from the lacrimal fluid, tears and finally into the nasal cavity in a bag.

Point is the proximal port of the lacrimal tears tube, which leads from the inner or central edge of eyelid to the lacrimal sac. Normally there are two openings for each eye tears point, a and a in the lower central region in the central upper eyelid the eyelid. It is an opening, which is oval usually round, or shaped gap-like and its size varies sometimes, but normally has a diameter of about 1 millimeter under a normal adult. The tears point by a slightly larger opening 14 is initiated opening, which has a certain similarity with a horn and which passes downwardly and is close, if you divesunterlid down into and above into the upper eyelid, a major part of the tube is achieved before tears, which is called the ampulla. The vertical portion of the tube extends substantially horizontally and then makes a curve tears to the lacrimal sac.

The proximal end of the tube is tears, as previously discussed, often referred point with annular tears. Although the tear point and the anatomy in the surroundings thereof about the impression of a sphincter or power in to be surrounded by a right sphincter appears, this tissue is best described as an elastic, collagen-like material, which has the form of a sphincter or point annular tears. If the tear point is extended, this fibroelastische stretches the material. If enlargement is terminated, it has sufficient recovery, contract again, wherein the neck of the tears the tear point opening on the previous point or size will, unless it was made or the elastic fibers are torn off a overstretch. The tears are like a total point openings and cause sphincter muscle forces, reinforcing the proximal canaliculusöffnung and tears as if they were active muscles point. The forces, generated here, drawn together in this area in a generally horizontal direction.

It is a first task of the present invention, advantageously exploit the forces of tears point as an elastic ring tissue, adapting them for a lacrimal fluid control device and cooperate therewith, for retaining the device in a more advantageous position, such that the discharge of the surface of the eye of the user is blocked by the pTF.

If the Figures and in particular the Figures 2 - 4 are now seen, a preferred embodiment of the present invention is perceived, lacrimal fluid control device 20 is shown wherein a, with a tip portion 22, which is composed of a generally inverted truncated cone and a head part which has a generally enlarged cap 24. A shank portion or segment 26 connects the tip 22 with the head 24. The shaft portion 26 is formed in the embodiment shown in Figures 2 - 4 in the form of a generally elongated truncated cone, small diameter connected at one end with said head portion 24 and 28 connected at one end with a base portion of the tip 30 larger diameter 22. The diameter of the narrow end 28 of the truncated cone has a value smaller than the diameter 32 near the head 24 and thereby an edge portion 34 at the bottom of the head is modeled. Similarly the diameter of the tip 22 at its lowermost portion 36 is greater than the diameter of said shank portion at its base is represented thereby 30th, as shown in Figure 3, the transition between the shaft and the tip 27 26 formed on a peripheral edge.

The circularly symmetric nature of the lacrimal fluid control device 20, as discussed in connection with Figure 3 is, represented in Figure 4 in plan view, this view can be found in turn sheet 1st note, that the outer diameter of the head 24 is substantially greater than the diameter of 40 42 narrow end of the truncated cone comprising the shaft 26. Similarly is shown, that the diameter of the base of the truncated cone forming the shaft 44 30 36 40 is less than the diameter of the base of the tip 22, so that in both cases, as mentioned before, a peripheral edge 34 and 38 is designed to tip or head, where they adjoin the shaft 26.

Figure 2 now in particular when, as shown on sheet 1, is seen, shows the lacrimal fluid control apparatus of the present invention in a retracted position by a tear point opening 50. This will be noted, that the head 24 of the device fits into a funnel-shaped recess 20 lacrimal fluid control 52, which connects directly to the tear point opening 50. The tip 22 of the lacrimal fluid control device is inserted through the opening 50 and is positioned in the substantially vertical tear point portion of the connecting tube tears.

The tissue of the tear point 54 located around the shank portion fibroelastische ring 26 of the device 20 in a lacrimal fluid control contracting and works together with the peripheral projecting edge manner advantageously 38, which connects directly to the tip,, to secure the control device in a preferred working position. In this context attention is requested for Figure 3 to turn, to note the sheet 2 of Figures, where forces in a vector diagram represent the normal f1, on the lateral surface of the shaft of the force transmitted fibroelastic material. Normal forces can in two substantially horizontally directed vector components of f1 f2, relative to the shaft 26, equal and opposite size and niederwärts f3 directed vectors, as illustrated in Figure 3, shall be distributed. The niederwärts directed vectors f3 never make a resulting net force is and thereby owing to the outer walls of the shank portion 26 which surrounds the outwardly extending tissue exerted downwardly on the device by lacrimal fluid control.

Accordingly, as shown in Figure 2 the fibroelastische facilitates the material, the fixing of the lacrimal fluid control device 20 in an advantageous position of the head in the flat funnel 24 operating position with a recess 52 and 50 closely adjacent the tear point opening.

5 when the character is now seen, another embodiment of the present invention is seen, wherein a lacrimal fluid control device 60 with a tip portion 62, a head portion and a connecting shaft 64 66 is shown. The tip 62 and the head portion 64 and the head portion are substantially identical with the tip portion 22 of the embodiment of the invention according to Figure 3 64. It will be apparent however, that the outer configuration of the connecting shaft portion 66 has substantially the shape of a truncated cone in turn, wherein the large diameter of the shank portion 66 at 68 is identical to the diameter of the base of the truncated cone representing the tip 62 70 representing truncated cone.

In the embodiment discussed in connection with Figure 5, not by the connecting zone exists between shaft and tip edge formed, as shown in Figure 3 embodiment wherein the zone 38. Despite the absence of a fixing zone 38 the lacrimal fluid control device is represented 60, as shown in Figure 5 in a working position within a tear point to securely retain opening through the niederwärts directed, by the fibroelastische material of the tear point vectors formed ring forces, as discussed in connection with the Figure 3 is.

6 when the character is now seen, still another embodiment of the present invention is observed, wherein a device 100 having a tip section 102 lacrimal fluid control and a head portion 104 is shown. The tip is connected by a connecting shaft 106 with the head. The shaft 106 has a cylindrical upper portion and a lower portion in the general configuration of a truncated cone 108 110. The outer configuration of the side walls of the truncated cone 110 are different, because they are outwardly curved and concave. The diameter of the base of the truncated cone 110 is as great as the diameter of the base 112 of the tip 102 114 forming truncated cone.

With reference to Figure 7, there is a further embodiment of the present invention related to a device for lacrimal fluid control. In this embodiment a control device 120 122 comprises a tip portion and a head portion 124, which are substantially identical to the embodiment shown in Figure 3 the tip 22 and the head part 24 in Figures 5 and 6 and further illustrated embodiments. The shaft portion 126 of the embodiment shown in Figure 7 but is different by its configuration and comprises a bent curvature of the side walls. An uppermost section 128 of the shank portion 126 is configured with a longitudinal side wall curvature, with a radius of curvature, which is relatively long and thereby the uppermost segment in its configuration is substantially cylindrical. A lowermost segment of 130 of the shank portion has a smaller radius of curvature compared to the uppermost segment of and conclude with a base portion 132, which has a diameter, the diameter of the base portion 134 as big as the tip 132.

Figure 8 shows a further embodiment of the present invention, wherein a device for lacrimal fluid control having a tip section and a head portion 144 142 140 is shown. The tip portion 142 is connected to the head via a intermediate shaft portion 146. The shape of the tip 142 is substantially identical to the shape of the tip in all embodiments of the invention and comprises a substantially inverted preceding is capable of truncated cone, to facilitate the introduction of a lacrimal fluid control device by the user tears open at a point.

The head portion of the embodiment shown in Figure 8 has compared to the head portions of the preceding embodiments and a rather narrow formation including a curved dome. The shaft portion 146 142 144 which connects the head and tip, is composed of two main segments. An uppermost segment of an inverted truncated cone with a curved side wall 148 is curved configuration and a lowermost segment of 150 of the connecting shaft portion 146 is also composed of a substantially curved tapered portion with curved side walls. The radius of curvature of the upper segment is smaller than the radius of curvature of the lower segment 148 150, shown in Figure 9.

The side walls of the shaft portion 146 are further provided with a plurality of peripheral rings 152, which are configured in a series of four successive annular depressions in a preferred embodiment. Alternatively the annular depressions may constitute projections around the shaft.

The lacrimal fluid control devices described earlier may be manufactured from a plurality of biologically inert materials, such as polytetrafluoroethylene (Teflon-), hydroxyethyl methacrylate (polyHEMA), polymethyl methacrylate (PMMA is) and various compositions of silicones for medical use etc, .

Wherein each of the previously described, specific embodiments is an axial tube made from head to tip and this takes a similar size tip of an introduction tool during its use ausgebildte 162 on, see Figure 1 on the insertion tool allows a clinician 1st sheet, a lacrimal fluid control device receive, on the tip of the insertion tool 162 and then transporting it using the tool and a transport cover the lacrimal fluid control device by the tears point opening and into operation or to use position -, as represented in Figure 2. This process is detailed in the above-described patents cited American 4,915,684 No. The disclosure in this document is hereby expressly referred as if fully represented.

In the description of the various embodiments of the device for effective and reversible blockade of lacrimal fluid control of tears from the surface of an eye by a tears draining point opening and a related tears tube, the expert will see several advantages, whereby the present invention differs from the known state of the art specifically so far.

One essential advantage of the present invention is the formation of a shaft portion and a head portion of a device between a tip of said lacrimal fluid, wherein the diameter of the head is less than the diameter of the shaft adjacent the shaft and said intermediate side walls adjacent to the tip when viewed from the head to the tip of the outwardly expanding control device. This gives the outwardly curved sidewall fibroelastic, the tears tissue encircling opening a way point, as a result a downward force on the lacrimal fluid control device exert such plug in a safe operating position and retain the tear point, as represented in Figure 2.

In the preferred embodiments the conical side surfaces are curved and in one embodiment the radius of curvature is greatest immediately adjacent the head portion and in another embodiment with a lesser height of the head is on the head adjacent the radius of the curvature smaller than that, which is adjacent to the tip of the control device.

In Figures 3 - 8 in each of the various embodiments can be formed for retaining rings represented outdoor, the lacrimal fluid control holding the device in its use position to strengthen, unwanted removal by the user to a minimum is what.

In the description of the invention is on the preferred embodiments referred. With the disclosure of the present invention known to the expert, can causing, omissions, modifications, substitutions and/or further changes, which are described in the following claims within the scope of protection of the invention, detecting.