DE3904741A1 - Ocular device - Google Patents

Abstract

An ocular device comprises a lens structure 110 capable of being surgically associated with a living cornea 114 to change the optical properties of the eye associated with the living cornea and an effective amount of at least one added component associated with the lens structure and acting to promote at least one of the growth of epithelial cell 112 of the cornea onto the lens structure and the adhesion of the living cornea to the lens structure. <IMAGE>

Description

The invention relates to an eyepiece device or an eye operation during surgery, for example during surgical implantation, in a living cornea can be introduced, or that in one another embodiment is designed so that it in the Be placed near a damaged, living cornea can. In particular, the invention is concerned with such Eyepiece devices or visual aids, in which at least the growth and / or adherence of the living cornea, for example the corneal epithelium, on the eyepiece device is supported after the surgery, whereby corrected a visual impairment or healing one damaged cornea can be supported, and being also a visual defect, such as a refractive error, corri can be greeded.

The cornea has five layers, one of which is outer Layer of epithelial cells, a Bowman membrane immediately behind the cells, the stroma (basic tissue) immediately behind the Bowman membrane, a Descemet membrane immediately bar behind the stroma and the endothelium immediately behind of the Descemet membrane. A number of chirurgi interventions require a corrective lens device tion in or on one or more of these cornea stocks implant parts. In one type of eye surgery intervention, for example, the layer of Epithelial cells removed, and a corrective lens device Tung is placed on the spot and fastened there at the the cells were removed. In another form of a ophthalmic surgery becomes part of the layer the epithelial cells are removed, and then a wedge-shaped Ring part of the Bowman membrane and the one below Stroma removed. An incision is then made from the back  End of the groove obtained radially outwards in a ring zone is provided to form a flap. A correction Lens device is attached in that the wing the lens device below the corneal flap leads and there on the spot, for example by means of Sewing is fixed. In addition, a correction lens device completely arranged within the stroma will. In this surgical procedure, an on cut into the cornea provided for access to the stroma to have, and this also breaks down the stroma disturbs that a lens device is inserted into it.

With all of these surgical procedures, it is extreme desirable, if not necessary, with regard to a long-term viability of such lens pads or implants that the cornea, e.g. the epithelial cells, grow on the lens device and / or on the lenses stick facility. About this growth and this adherence Achieving ability is a considerable challenge which is necessary when using corneal pads and Implants occurs.

One suggestion to overcome this difficulty is seen in it drops of a liquid fibronectin solution the cornea after surgery to add to the growth to support the epithelial cells. This suggestion has however, he is not completely satisfactory grasslands. For example, the drops have to be in very frequently to be instilled in the eye. This is cumbersome and can cause inconvenience. Even with one frequent instillation of the drops, it is extremely difficult that an effective amount of the fibronectin is present. The natural cleaning effect, e.g. the tears of Eyes, causes the fibronectin to be removed.

Another common situation is in it to see that the cornea is enabled, for example in  Sports accidents and other accidents. Since such Be damage can cause great inconvenience and / or adversely affect the eyesight of each pregnant, it is extremely desirable to have this damage to heal as soon as possible.

The invention provides an eyepiece device that is effective the growth and / or adherence of a living Cornea on a lens device and / or healing a damaged, living cornea. In the Application of the device according to the invention is obtained faster and more promising convalescence from eye surgery or damage to the cornea. In particular, these beneficial results come with little or no additional effort, no care or an additional treatment, for example of Sides of the patient. For example, none Drops or other additional materials repeated in the eyes brought in.

In a preferred embodiment according to the invention the eyepiece device has a lens device or a structure based on surgery assigned to a living cornea or preferably to this can be attached, and an effective amount at least one added component, that of the lenses institution is assigned, does little to support the growth of the epithelial cells of the cornea on the Lens device and / or the adherence of the living Cornea on the lens device. The lens device, when attached through surgery is, for example, in the living cornea implanted or applied to this causes a Change in optical properties, e.g. become visual defects corrected the eyes related to the living Cornea stand.  

Under the name "At least support the wax epithelial cells on the lens device and / or the adherence of the living cornea to the lens direction "is to be understood that the existing additional Component is so effective that at least the growth of the epithelial cells over the lens device, which is common is synthetic, and / or the adherence of the corneal cells, e.g. newly formed epithelial cells on the lens device is strengthened and / or supported. Both the growth as well as adherence are extremely desirable to successful surgical interventions for corneal implantation and to be able to carry out implants.

The lens device is preferably operated by surgery intervention, for example by sewing and the like attached to the living cornea, and the additional Component is effective to the adherence of the living Support cornea on the lens device. According to the The corneal cells themselves act in such a way that that they example the lens device on the spot then hold wisely when the threads have been pulled or become loose have dissolved.

The additional component can be, for example, the lenses installation by attaching, fixing, depositing and equal on or near the outer surface of the lenses institution can be assigned. However, it is preferred that the additional component in the lens device is located, in particular substantially uniformly in the lens device is distributed. In a preferred one Embodiment in which the eyepiece device looks like this is placed through surgery the cornea, for example by means of a surgical implant in the cornea is the additional one Component preferably does not deteriorate substantially ternd and not washable or not extractable from the lens device in the state of use, i.e.,  if this is inserted into the patient's eye. At a particularly advantageous embodiment is the additional component chemically ge to the lens device bound, in particular covalently bound to them. One of the like covalent bond acts so that the additional Component associated with the lens device hold, and that the amount of additional component, which is lost in use, as low as possible is.

In another preferred embodiment according to the Invention, an eyepiece device has a lens device device or a structure which is nearby, e.g. attached directly to a damaged, living cornea can be, and that at least one additional component the lens device for example by fixing or Attach, deposit, or a combination thereof, or the like is assigned. This additional component can time from the connection with the lens device dependent, preferably at least in about 12 hours, especially in a range from 2 days to 20 days or more are released to heal the damaged to support living cornea. With this out In the embodiment according to the invention, the eyepiece device can be considered as a contact lens that essentially is placed directly on the cornea. This possible ability to provide an additional component on a damaged, living cornea is much cheaper than the frequent additional instillation of drops in the Eyes. For example, the release of the additional Component of the lens device more effective control be lated so that a usable amount of the additional Component is essentially constantly present to the To aid corneal healing. Nor is it he required, repeated in the damaged eye and constantly Instilling drops, a procedure that is often around is understandable and leads to inconvenience.  

In this embodiment, the additional component on or near the outer surface of the lens device be provided. To be a more even, time-dependent Achieve release of the additional component it prefers the additional component to be internal half of the lens device. Preferably the additional component physically of the lens device, i.e. not chemically bound, assigned to it if it is the embodiment referred to as "contact lens" acts according to the invention. It is important that that too additional component from the lens device via a Period is released. As previously stated does the chemical bond, e.g. the covalent bond, the additional component to the lens device frequently so that this release essentially does not occur but it has been shown that this release in the embodiment referred to as "contact lens" according to the invention proved to be extremely useful Has.

The lens device with the be as "contact lens" embodiment may or may not be such be designed so that the optical properties change, so that, for example, vision defects of the eye are corrected, that has the damaged living cornea. A main function the lens device in this embodiment is Provision of a substrate by means of which the usable, time-dependent release of the additional component is achieved. Another purpose of the lenses facility is that the damaged, living cornea ge protects.

Any suitable additional component can be used in the present invention may be used provided that it fulfills the functions described above and no substantial or unacceptable disadvantage Influences on the eye or the patient to be treated  Has. Under the term "additional component" is one Component or are components to be understood that the have the function described herein and not so far in lens devices of the type described herein hold or in connection with these to use came. Among the additional components that the Invention are useful are the different wax Factors and adherence factors to mention growth and adherence of the corneal cells of the type described herein. With an off the additional component is a protein. Useful additional components include those that are selected from the group consisting of fibronectin, collagen cell attachment protein, anti-gelatin factor, cold-insoluble Lich globulin, chondronectin, laminin, epidermal Growth factor (EGF), mussel-like protein, derivatives of in each case the substances and mixtures mentioned above includes. Fibronectin, derivatives of fibronectin, EGF, Deri EGF and mixtures thereof can be used in particular use particularly advantageous.

The lens device or the lens structure can be made of any suitable material or material provided that the so produced Lens assembly works in the manner described herein and no significant impairment or harm Effects on the eye or the patient being treated Has. The lens structure should be permeable to water and nourishing be permeable to material so that the lens structure is not in inefficiently the flow of nutrients to the cornea Limited epithelium. Although the lens device out a material that occurs in nature, are preferably synthetic materials, in particular synthetic polymeric materials used. In addition can both physical and chemical mixtures or combinations of natural products and synthetic ones Materials are used in the lens devices.  

A large number of polymeric materials have been proposed for use with the lens devices. Synthetic polymeric materials useful in the present invention include homopolymers and copolymers of mono- and diolefins, blends of these polymers, polystyrene, copolymers of styrene and α- methyl styrene, graft copolymers of styrene, halogen-containing vinyl polymers, polymers of unsaturated α , β- acids and derivatives thereof, polymers of unsaturated alcohols and amines, homopolymers and copolymers of epoxides, poly acetals, polyalkylene oxides, polyphenyl oxides, polyurethanes and polyureas, polycarbonates, polysulfones, poly amides and copolyamides, polyesters, crosslinked polymers, of aldehydes plus phenols are derived from urea or melamine, alkyd resins, unsaturated polyester resins, silicones, hydrogel-forming polymers and the like.

The lens device of the eyepiece device is preferably made of polymers derived from unsaturated α , β- acids and derivatives thereof, poly urethanes, silicone and hydrogel-forming polymers. Hydrogel-forming polymers are particularly useful because they have excellent permeability properties.

Covalently attach the additional component to the lenses direction, it may be necessary that either the additional component and / or the lens device or both can be derivatized. That or those provided Derivatives depend, for example, on the particular one Lens material that is used, as well as from each because special, additionally used component. At a particularly expedient embodiment responds of the parts comprising the material of the lens device and the additional component with a difunctional Component. One of the functional groups of the difunktio component reacts with and is covalent to Lens construction material or the additional component ge  bound, and the other functional group represents the comprehensive covalent bond with the other part the material of the lens device or the additional Component available.

Any suitable difunctional component can be used provided that it has the ability a covalent bond with both the material of each because of the lens device as well as the one used additional component. Of course it should difunctional component no adverse effects on the eyepiece device or its use. Examples of difunctional components with ge know materials in the lens device and the additional components can be used include Aldehydes such as glutaraldehyde and the like and imides such as Carbodiimide.

The difunctional component can be made with the lens material and the additional component in separate reaction steps or in a single reaction step react to all existing reactive substances.

In another embodiment, the covalent bin of the lens material and the additional component be supported or induced by this Materials or components rays, such as gamma rays, suspends, or that one carries out a plasma treatment.

Further details, features and advantages of the invention emerge from the description below of before preferred embodiments with reference to the attached drawing. It shows:

Fig. 1 is an enlarged axial sectional view of an ocular device according to the invention, which is mounted on a cornea,

Fig. 2 is an enlarged axial sectional view of another ocular device according to the invention, which is mounted on a cornea,

Fig. 3 is an enlarged axial sectional view to illustrate an eyepiece device according to the invention, which is inserted into the stroma of a cornea, and

Fig. 4 is an enlarged axial sectional view showing an eyepiece device according to the invention, which is in contact with a cornea.

In the figures of the drawing, the same or similar Provide parts with the same reference numerals.

With reference to FIG. 1, an eyepiece device in the form of a corneal rest, generally designated 110 , is provided and attached (sewn) on the Bowman membrane 111 of a living cornea 114 . The cornea 114 also comprises an epithelial cell layer 112 , a stroma 113 , a restriction membrane 115 and the endothelium 117 . A corneal pad 110 , which is designed to correct one or more visual difficulties caused by defects in the cornea 114 or due to one or more parts of the eye, is brought into place by providing a desired one Area of the epithelial cell layer 112 is exposed or removed, the corneal pad 110 is placed on this exposed area and the corneal pad 110 is attached in place to the Bowman membrane 111 by sewing. The pad 110 is arranged with respect to the cornea 114 as shown in FIG. 1, so that the cornea pad 110 is coaxial with the optical axis of the eye.

When the surgical procedure is complete, the epithelial cell layer 112 should grow on the corneal pad 110 , anchor it or make it adhere.

Corneal pad 110 is made of a water-permeable, optically transparent polymeric material, such as poly (hydroxyethyl) methacrylate, which is biocompatible and suitable for use with corneal inserts and pads. Fibronectin or a derivative of fibronectin is covalently bound to the polymeric material of the corneal pad 110 . This fibronectin or fibronectin derivative is essentially uniformly distributed in the polymeric material and amounts to approximately 1% by weight of the corneal layer 110 .

After the corneal pad 110 is attached to the Bowman membrane 111 , the fibronectin or its derivative acts in the corneal pad 110 to stimulate the growth of the epithelial cell layer 112 on the corneal pad 110 and supports the adhesion of the epithelial cell layer 112 to the corneal pad 110 . In the final state, the layer 112 grows completely over the corneal pad 110 and is firmly connected to the corneal pad 110 . The timing within which this occurs is significantly shorter when using such a corneal pad 110 than with a pad that does not contain fibronectin or a comparable substance.

Of course, the fibronectin or derivative thereof, which is covalently bound in the corneal pad 110 , can be replaced in whole or in part by one or more additional components which act in such a way that the growth of the epithelial cell layer 112 on the corneal pad 110 is stimulated and / or that Adhesion or the anchoring of the epithelial layer 112 on the corneal layer 110 is supported.

Referring to FIG. 2, an eyepiece device in the form of an alternative embodiment of a corneal pad or epikeratophakia lenticule, indicated generally at 210 , is attached (sewn) to the Bowman membrane 211 of a living cornea 214 . Each element of cornea 214 in FIG. 2, which is also shown as an element of cornea 114 in FIG. 1, has a reference number that is enlarged by 100 compared to the same element in FIG. 1. Corneal support 210 has circular optics 216 and an annular wing 218 that surrounds the optics. The pad 210 is arranged with respect to the cornea 214 corresponding to FIG. 2 such that the optics 216 is coaxial with the optical axis of the eye and the annular wing 218 is received in a circular, worn zone 220 . This zone 220 is obtained by removing part of the epithelial cell layer 212 and the Bowman membrane 211 . An expedient device and a procedure for carrying out this exposure / ablation are described in the US patent application Serial No. assigned to the same applicant. 1 02 344 of September 29, 1987, which is hereby incorporated by reference into its content.

Corneal overlay 210, and particularly optics 216, is designed to correct one or more difficulties caused by defects in cornea 214 or any other component of the eye.

When the surgical procedure for setting the cornea completed pad 210 at the predetermined position corresponding to FIG. 2, the epithelial cell layer 212 should grow to the Corneaauflage 210 and pad 210 on the cornea to be anchored or adhered.

Corneal overlay 210 is made from essentially the same material as corneal overlay 110 .

After the Corneaauflage is attached to the cornea 214 as shown in FIG. 2 210, the fibronectin or derivative works thereof in the Corneaauflage 210 for stimulating the growth of the epithelial cell layer 212 located at the Corneaauf 210 and supports the adhesion of the epithelial cell layer 212 on the Corneaauflage 210 . In the final state, the layer 212 has grown completely over the corneal pad 210 and the corneal pad 210 is firmly anchored. This is achieved much faster when using the corneal pad 210 than with a pad that contains no fibronectin or a comparable substance.

As other additional components / cell layer with respect to the support of the wax tums of the epithelial cell layer 212 on the Corneaauflage 210 and or the adhesion or anchoring of the epithelium 212 are effective on the Corneaauflage 210, are used in the Corneaauflage 210 in Corneaauflage 110 the fibronectin or derivative thereof being replaced in whole or in part.

With reference to FIG. 3, there is an eyepiece device in the form of a lens located in the interior of the organ tissue, which is designated as a whole by 310 , in the stroma 313 of the living cornea 314 . Each element of cornea 314 in FIG. 3, which is also shown as an element of cornea 114 in FIG. 1, has a reference number that is 200 times larger than the same element in FIG. 1. The lens 310 is coaxial with the optical axis of the eye and it is inserted into the stroma 313 and anchored there with the aid of conventional surgical procedures. The lens 310 is designed to correct one or more visual problems caused by defects in the cornea 314 or one or more parts of the eye.

The lens 310 is made from essentially the same material as the corneal pad 110 .

After the lens 310 is implanted into the stroma 313 of FIG. 3 by surgery, the fibronectin or derivative thereof acts in the lens 310 to aid in the adherence of the stroma 313 tissue to the lens 310 . Finally, the stroma 313 is firmly anchored to the lens 310 . The period of time during which this occurs is significantly shorter when using the lens 310 than with a lens located inside the organ tissue, which contains no fibronectin or a comparable substance.

Other additional components that are effective to aid in the adhesion or anchoring of stroma 313 and lens 310 can be used in lens 310 , which replace, in whole or in part, the fibronectin or derivative thereof.

Referring to FIG. 4 is an ocular device in the form of a contact lens, which is generally indicated at 410, provided on the epithelial cell layer 412 of a living cornea 414th A thin film of natural lubricant or moisture (not shown) may be provided between contact lens 410 and layer 412 .

In addition to the epithelial cell layer 412, the living cornea 414 also includes the Bowman membrane 411 and the stroma 413 , the Descemet membrane 415 and the endothelium 417 .

The contact lens 410 is made of water-permeable, optically transparent poly (hydroxyethyl) methacrylate, which is biocompatible and suitable for use with contact lenses. Fibronectin is physically mixed with and essentially uniformly distributed in the polymeric material, which is of the order of about 1% by weight of the contact lens 410 . The contact lens 410 may or may not be designed to correct one or more visual difficulties caused by defects in the cornea 414 or one or more parts of the eye. It is important that the fibro nectin in contact lens 410 be released from contact lens 410 for a period of time to promote healing of cornea 414 .

The epithelial cell layer 412 of the cornea 414 is damaged as a result of an accident and healing is required. Contact lens 410 is provided near the damaged portion of layer 412 . The fibronectin is released from the contact lens 410 over a period of time and supports the necessary healing of the layer 412 . Applying fibronectin to the damaged layer 412 in this manner has significant advantages over using drops of solution containing fibronectin. With the contact lens 410 , fibronectin is continuously fed to the layer 412 . In the case of drops, however, this is supplied intermittently. The gradual release of the fibronectin from the contact lens 410 also enables more effective monitoring of the dosage of the fibronectin and therefore this growth factor can be used more effectively. If appropriate, the fibronectin can be enclosed in microcapsules in the contact lens 410 in order to be able to better control the temporal release of the fibronectin.

Of course, the fibronectin in contact lens 410 may be replaced in whole or in part by one or more additional components that act to promote healing of epithelial cell layer 412 .

Although the invention is based on preferred Exemplary embodiments and embodiments explained has been, of course, numerous changes and Modifications possible, which the specialist in case of need will meet without leaving the inventive concept.

In summary, the invention provides an eyepiece device which has a lens device which has the capability  speed that she has a surgical procedure a living cornea can be assigned to the to change the optical properties of the eye, which in the Are related to the living cornea. An effective same amount of at least one additional component, which is assigned to the lens device acts in such a way that at least the growth of the epithelial cells of the cornea stimulated on the lens device and the liability of the living cornea supported on the lens device becomes.

Claims (8)

1. eyepiece device, characterized by a lens device ( 110 , 210 , 310 , 410 ) which can be assigned to a living cornea ( 114 , 214 , 314 , 414 ) by means of a surgical intervention in order to determine the optical properties of the living cornea ( 114 , 214 , 314 , 414 ) and an effective amount of at least one additional component which is covalently bound to the lens device ( 110 , 210 , 310 , 410 ) and acts in such a way that at least the growth of the epithelial cells ( 112 , 212 , 312 , 412 ) of the cornea ( 114 , 214 , 314 , 414 ) on the lens device ( 110 , 210 , 310 , 410 ) and / or the adhesion of the living cornea ( 114 , 214 , 314 , 414 ) to the lens device ( 110 , 210 , 310 , 410 ) is supported. 2. Eyepiece device according to claim 1, characterized in that the lens device ( 110 , 210 , 310 , 410 ) on the living cornea ( 114 , 214 , 314 , 414 ) is attached, and that the additional component to promote the liability of living cornea ( 114 , 214 , 314 , 414 ) acts on the lens device ( 110 , 210 , 310 , 410 ). 3. Eyepiece device according to claim 1 or 2, characterized in that the additional com component covalently bound to the lens device ( 110 , 210 , 310 , 410 ) on or in the vicinity of the outer surface of the Linsenein direction ( 110 , 210 , 310 , 410 ) is. 4. eyepiece device according to claim 1 or 2, characterized in that the additional com component is provided substantially uniformly in the Linsenein direction ( 110 , 210 , 310 , 41 ). 5. eyepiece device according to one of claims 1 to 4, characterized in that the lenses device has a synthetic polymeric material, that is permeable to water. 6. eyepiece device according to claim 5, characterized ge indicates that the synthetic polymer Material is a hydrogel-forming polymer. 7. eyepiece device according to one of claims 1 to 6, characterized in that the to casual component is selected from the group consisting of Fibronectin, collagen cell attachment protein, anti gelatin factor, biologically active polypeptides, in the cold insoluble globulin, chrondronectin, laminin, epithelium growth factor, mussel-like protein, derivatives thereof and Mixtures thereof include. 8. eyepiece device according to one of claims 1 to 6, characterized in that the additional  component is selected from the group, the Fibro nectin, derivatives of fibronectin, epithelial growth factor, Epithelial growth factor derivatives and mixtures here of includes.