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Patent US9192517B2

Mazaheri LASIK method for visual enhancement

Abstract

A new and novel method for performing refractive correction on a patient’s eyes is introduced. In one embodiment the method includes (1) performing a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (2) reshaping a corneal stroma of the patient’s dominant eye, where the reshaping includes the making of a lamillar cut in the surface of the dominant eye to create a flap; folding the flap back to reveal the corneal stroma and ablating a portion of the corneal stroma, after which the flap is replaced.

SUMMARY OF THE INVENTION

To address the above-discussed deficiencies of the prior art, the present invention provides, in one aspect, a new and novel method for performing refractive correction on a patient’s eyes. In one embodiment the method includes (1) performing a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (2) reshaping a corneal stroma of the patient’s dominant eye, where the reshaping includes the making of a lamillar cut in the surface of the dominant eye to create a flap; folding the flap back to reveal an interior section of the corneal stroma and ablating a portion of such interior section, after which the flap is replaced.

Thus this new method introduces the MLasik™ procedure for visual correction. The MLasik™ procedure provides several advantages over existing procedures. For example, by performing a flapless visual corrective procedure on the patient’s non-dominant eye, the risk of any medical complication is significantly reduced. The surgeon has the opportunity to determine if the patient has an epithelial or Bowman membrane disease that could cause in-growth, the determination of which could also militate against a more invasive procedure being performed on the dominant eye. The performance of surface ablation correction on the non-dominant eye also eliminates the potential of diffuse lamellar keratitis (DLK). Surface ablation correction also has less potential for eye dryness than does the more invasive procedure of shaping an interior portion of the corneal stroma. In addition, the surgeon can also provide a slight under correction in the non-dominant eye to reduce the chance of an over correction and scaring. On the other hand, the major benefits of shaping the corneal stroma under a folded back flap cut from the cornea are retained with respect to the dominant eye. The patient will be able to see more clearly quickly and patient anxiety is reduced. In addition, the chances of bilateral scaring of the eyes are reduced and the potential of the patient having an adverse steroid reaction. Also, when the corneal stroma is shaped using a flap technique, the surgery can be more easily enhanced if needed.

As those skilled in the pertinent art will understand, there may be an advantage, such as a medical reason, for using the flap technique to correct the dominant eye vision before correcting the non-dominant eye’s vision using a surface ablation technique. The scope of the present invention is intended to include correction being performed on the dominant eye using a flap technique before correcting the non-dominant eye using a surface ablation technique.

In one embodiment, a micro-kerotome or a laser is used to make the lamillar cut in the cornea to form a flap. In another embodiment, the method provides for the surface ablation corrective procedure to result in a slight under correction of the patient’s vision in the non-dominant eye. In still another embodiment, the method provides for the surgeon to determine whether the patient suffers epithelial or Bowman membrane disease.

In yet still another embodiment of the invention, the method is further comprised of making a cut to an epithelium depth of the non-dominant eye to create an epithelium flap. This epithelium flap is then folded back prior to performing the surface ablation corrective procedure after which it is replaced.

Of course those skilled in the pertinent art will understand that ablation of the surface as well as ablation of the corneal stroma will most likely be done with a laser device. An aspect of this embodiment provides for the laser device to be an Excimer laser.

An embodiment of the invention provides for the refractive correction on the patient’s eyes to be for the purpose of correcting myopia or hypermetropia. In another embodiment, the refractive correction on a patient’s eyes is for the purpose of correcting astigmatism.

In still another embodiment, the method provides for enhancement of the refractive correction on the patient’s dominant eye. An aspect of this embodiment provides for the enhancement to be achieved by a further reshaping of the corneal stroma.

A particularly useful embodiment of the invention provides for the performance of refractive correction on a patient’s eyes wherein the procedure calls for (1) determining the patient’s dominant eye and non-dominant eye; (2) using a laser device to perform a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (3) using a laser device to reshape the corneal stroma of the patient’s dominant eye, where the reshaping includes making a lamillar cut in the corneal surface of the dominant eye to create a flap; folding the flap back to reveal the corneal stroma; ablating a portion of the corneal stroma with a laser device; and replacing the flap over the corneal stroma.

The foregoing has outlined preferred and alternative features of the present invention so that those skilled in the pertinent art may better understand the detailed description of the invention that follows. Additional features of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the pertinent art should appreciate that they can readily use the disclosed conception and specific embodiment as a basis for designing or modifying other structures for carrying out the same purposes of the present invention. Those skilled in the pertinent art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention.

Patent US9956230

Abstract

A new and novel method for determining post procedural treatment is disclosed herein. In one embodiment, a method for a treating a patient following a surgical procedure on at least one eye comprises determining a depth at which the surgical procedure is to be performed or was performed, and providing instructions for administering medication for a length of time to the at least one eye of the patient, the length of time based at least in part upon the depth.

TECHNICAL FIELD OF THE INVENTION

The present invention is directed, in general, to a surgical procedure and, more particularly, to surgical procedure to improve the visual acuity of a patient.

BACKGROUND OF THE INVENTION

There are a number of types of photorefractive surgical procedures now being used for vision correction. Included among these procedures is LASIK (Laser-Assisted In Situ Keratomileusis). LASIK is a procedure used to permanently change the shape of the cornea with an Excimer laser. A flap is cut in the cornea and folded back revealing the stroma, which is the middlesection of the cornea. Pulses from a computer-controlled Eximer laser are used to ablate or vaporize a portion of the interior of the stroma and reshape the corneal tissue. The flap is then replaced over the reshaped area to conform to the new corneal shape.

Some patients, however, are not suitable candidates for LASIK. Those patients that have extremely thin corneas are better served using a procedure other than LASIK. Advanced surface ablations techniques provide a suitable alternative in such cases. These techniques involve the removal of the very surface layer of the cornea, known as the epithelium, and lasering the exposed corneal bed. This keeps the laser from ablating or vaporizing too deep into the tissue of the cornea and reduces the risk of ectasia, or de-stabilization of the cornea.

Both LASIK and the various surface ablation techniques can be grouped under the general umbrella of laser eye surgery, but each is a little different with respect to their advantages and disadvantages. The great advantage of LASIK over a surface ablation technique, is that, as soon as the flap created during the LASIK procedure is replaced, the cornea begins to heal and will naturally seal itself to the rest of the cornea. This greatly speeds the overall healing process when compared to surface ablation techniques, which leaves the reshaped area generally more exposed or open. With surface ablation, improvement is more gradual and the eye may take a few days or even a month or two to stabilize. In general, most surgeons prefer LASIK except for patients with thin corneas, in which case a surface ablation technique is preferred. Patient satisfaction is another reason surgeons prefer LASIK, because the patient can quickly see clearly and his or her anxiety is significantly reduced.

Several potential problems are inherent in LASIK. The three most common problems are: (1) under correction, where not enough tissue is removed during the procedure; (2) over correction, where too much tissue is removed during the procedure; and (3) wrinkling of the corneal flap, where a small fold or wrinkle occurs during replacement which causes a small blurry area in the patients vision. In most cases each of these problems can be easily corrected with a second surgical procedure. Of course, if the under or over correction is very slight, the surgeon will most likely advise against any attempt to refine the patient’s vision any further. In fact, many recipients of laser eye surgery, although they may never achieve normal vision, view the procedure as a success if they are able to achieve a significant reduction in their corrective-lens prescription.

In addition to the more common surgical type of problems listed above, there is also a potential for certain side effects to occur with respect to LASIK. Such side effects include dryness, blurred vision, halos around lights, increased light sensitivity, diffuse lamellar keratitis, torn flaps, incomplete flaps, and even double vision. There is also a chance that damage or scarring to the cornea can occur with the resultant partial or complete loss of vision.

Accordingly, what is needed in the art to overcome the problems set forth above is a procedure that combines the benefits of LASIK with a surface ablation technique.

SUMMARY OF THE INVENTION

To address the above-discussed deficiencies of the prior art, the present invention provides, in one aspect, a new and novel method for performing refractive correction on a patient’s eyes. In one embodiment the method includes (1) performing a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (2) reshaping a corneal stroma of the patient’s dominant eye, where the reshaping includes the making of a lamillar cut in the surface of the dominant eye to create a flap; folding the flap back to reveal an interior section of the corneal stroma and ablating a portion of such interior section, after which the flap is replaced.

Thus this new method introduces the MLasik™ procedure for visual correction. The MLasik™ procedure provides several advantages over existing procedures. For example, by performing a flapless visual corrective procedure on the patient’s non-dominant eye, the risk of any medical complication is significantly reduced. The surgeon has the opportunity to determine if the patient has an epithelial or Bowman membrane disease that could cause in-growth, the determination of which could also militate against a more invasive procedure being performed on the dominant eye. The performance of surface ablation correction on the non-dominant eye also eliminates the potential of diffuse lamellar keratitis (DLK). Surface ablation correction also has less potential for eye dryness than does the more invasive procedure of shaping an interior portion of the corneal stroma. In addition, the surgeon can also provide a slight under correction in the non-dominant eye to reduce the chance of an over correction and scaring. On the other hand, the major benefits of shaping the corneal stroma under a folded back flap cut from the cornea are retained with respect to the dominant eye. The patient will be able to see more clearly quickly and patient anxiety is reduced. In addition, the chances of bilateral scaring of the eyes are reduced and the potential of the patient having an adverse steroid reaction. Also, when the corneal stroma is shaped using a flap technique, the surgery can be more easily enhanced if needed.

As those skilled in the pertinent art will understand, there may be an advantage, such as a medical reason, for using the flap technique to correct the dominant eye vision before correcting the non-dominant eye’s vision using a surface ablation technique. The scope of the present invention is intended to include correction being performed on the dominant eye using a flap technique before correcting the non-dominant eye using a surface ablation technique.

In one embodiment, a micro-kerotome or a laser is used to make the lamillar cut in the cornea to form a flap. In another embodiment, the method provides for the surface ablation corrective procedure to result in a slight under correction of the patient’s vision in the non-dominant eye. In still another embodiment, the method provides for the surgeon to determine whether the patient suffers epithelial or Bowman membrane disease.

In yet still another embodiment of the invention, the method is further comprised of making a cut to an epithelium depth of the non-dominant eye to create an epithelium flap. This epithelium flap is then folded back prior to performing the surface ablation corrective procedure after which it is replaced.

Of course those skilled in the pertinent art will understand that ablation of the surface as well as ablation of the corneal stroma will most likely be done with a laser device. An aspect of this embodiment provides for the laser device to be an Excimer laser.

An embodiment of the invention provides for the refractive correction on the patient’s eyes to be for the purpose of correcting myopia or hypermetropia. In another embodiment, the refractive correction on a patient’s eyes is for the purpose of correcting astigmatism.

In still another embodiment, the method provides for enhancement of the refractive correction on the patient’s dominant eye. An aspect of this embodiment provides for the enhancement to be achieved by a further reshaping of the corneal stroma.

A particularly useful embodiment of the invention provides for the performance of refractive correction on a patient’s eyes wherein the procedure calls for (1) determining the patient’s dominant eye and non-dominant eye; (2) using a laser device to perform a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (3) using a laser device to reshape the corneal stroma of the patient’s dominant eye, where the reshaping includes making a lamillar cut in the corneal surface of the dominant eye to create a flap; folding the flap back to reveal the corneal stroma; ablating a portion of the corneal stroma with a laser device; and replacing the flap over the corneal stroma.

The foregoing has outlined preferred and alternative features of the present invention so that those skilled in the pertinent art may better understand the detailed description of the invention that follows. Additional features of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the pertinent art should appreciate that they can readily use the disclosed conception and specific embodiment as a basis for designing or modifying other structures for carrying out the same purposes of the present invention. Those skilled in the pertinent art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention.

Patent US9192517B2

TECHNICAL FIELD OF THE INVENTION

The present invention is directed, in general, to a surgical procedure and, more particularly, to surgical procedure to improve the visual acuity of a patient.

BACKGROUND OF THE INVENTION

There are a number of types of photorefractive surgical procedures now being used for vision correction. Included among these procedures is LASIK (Laser-Assisted In Situ Keratomileusis). LASIK is a procedure used to permanently change the shape of the cornea with an Excimer laser. A flap is cut in the cornea and folded back revealing the stroma, which is the middlesection of the cornea. Pulses from a computer-controlled Eximer laser are used to ablate or vaporize a portion of the interior of the stroma and reshape the corneal tissue. The flap is then replaced over the reshaped area to conform to the new corneal shape.

Some patients, however, are not suitable candidates for LASIK. Those patients that have extremely thin corneas are better served using a procedure other than LASIK. Advanced surface ablations techniques provide a suitable alternative in such cases. These techniques involve the removal of the very surface layer of the cornea, known as the epithelium, and lasering the exposed corneal bed. This keeps the laser from ablating or vaporizing too deep into the tissue of the cornea and reduces the risk of ectasia, or de-stabilization of the cornea.

Both LASIK and the various surface ablation techniques can be grouped under the general umbrella of laser eye surgery, but each is a little different with respect to their advantages and disadvantages. The great advantage of LASIK over a surface ablation technique, is that, as soon as the flap created during the LASIK procedure is replaced, the cornea begins to heal and will naturally seal itself to the rest of the cornea. This greatly speeds the overall healing process when compared to surface ablation techniques, which leaves the reshaped area generally more exposed or open. With surface ablation, improvement is more gradual and the eye may take a few days or even a month or two to stabilize. In general, most surgeons prefer LASIK except for patients with thin corneas, in which case a surface ablation technique is preferred. Patient satisfaction is another reason surgeons prefer LASIK, because the patient can quickly see clearly and his or her anxiety is significantly reduced.

Several potential problems are inherent in LASIK. The three most common problems are: (1) under correction, where not enough tissue is removed during the procedure; (2) over correction, where too much tissue is removed during the procedure; and (3) wrinkling of the corneal flap, where a small fold or wrinkle occurs during replacement which causes a small blurry area in the patients vision. In most cases each of these problems can be easily corrected with a second surgical procedure. Of course, if the under or over correction is very slight, the surgeon will most likely advise against any attempt to refine the patient’s vision any further. In fact, many recipients of laser eye surgery, although they may never achieve normal vision, view the procedure as a success if they are able to achieve a significant reduction in their corrective-lens prescription.

In addition to the more common surgical type of problems listed above, there is also a potential for certain side effects to occur with respect to LASIK. Such side effects include dryness, blurred vision, halos around lights, increased light sensitivity, diffuse lamellar keratitis, torn flaps, incomplete flaps, and even double vision. There is also a chance that damage or scarring to the cornea can occur with the resultant partial or complete loss of vision.

Accordingly, what is needed in the art to overcome the problems set forth above is a procedure that combines the benefits of LASIK with a surface ablation technique.

SUMMARY OF THE INVENTION

To address the above-discussed deficiencies of the prior art, the present invention provides, in one aspect, a new and novel method for performing refractive correction on a patient’s eyes. In one embodiment the method includes (1) performing a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (2) reshaping a corneal stroma of the patient’s dominant eye, where the reshaping includes the making of a lamillar cut in the surface of the dominant eye to create a flap; folding the flap back to reveal an interior section of the corneal stroma and ablating a portion of such interior section, after which the flap is replaced.

Thus this new method introduces the MLasik™ procedure for visual correction. The MLasik™ procedure provides several advantages over existing procedures. For example, by performing a flapless visual corrective procedure on the patient’s non-dominant eye, the risk of any medical complication is significantly reduced. The surgeon has the opportunity to determine if the patient has an epithelial or Bowman membrane disease that could cause in-growth, the determination of which could also militate against a more invasive procedure being performed on the dominant eye. The performance of surface ablation correction on the non-dominant eye also eliminates the potential of diffuse lamellar keratitis (DLK). Surface ablation correction also has less potential for eye dryness than does the more invasive procedure of shaping an interior portion of the corneal stroma. In addition, the surgeon can also provide a slight under correction in the non-dominant eye to reduce the chance of an over correction and scaring. On the other hand, the major benefits of shaping the corneal stroma under a folded back flap cut from the cornea are retained with respect to the dominant eye. The patient will be able to see more clearly quickly and patient anxiety is reduced. In addition, the chances of bilateral scaring of the eyes are reduced and the potential of the patient having an adverse steroid reaction. Also, when the corneal stroma is shaped using a flap technique, the surgery can be more easily enhanced if needed.

As those skilled in the pertinent art will understand, there may be an advantage, such as a medical reason, for using the flap technique to correct the dominant eye vision before correcting the non-dominant eye’s vision using a surface ablation technique. The scope of the present invention is intended to include correction being performed on the dominant eye using a flap technique before correcting the non-dominant eye using a surface ablation technique.

In one embodiment, a micro-kerotome or a laser is used to make the lamillar cut in the cornea to form a flap. In another embodiment, the method provides for the surface ablation corrective procedure to result in a slight under correction of the patient’s vision in the non-dominant eye. In still another embodiment, the method provides for the surgeon to determine whether the patient suffers epithelial or Bowman membrane disease.

In yet still another embodiment of the invention, the method is further comprised of making a cut to an epithelium depth of the non-dominant eye to create an epithelium flap. This epithelium flap is then folded back prior to performing the surface ablation corrective procedure after which it is replaced.

Of course those skilled in the pertinent art will understand that ablation of the surface as well as ablation of the corneal stroma will most likely be done with a laser device. An aspect of this embodiment provides for the laser device to be an Excimer laser.

An embodiment of the invention provides for the refractive correction on the patient’s eyes to be for the purpose of correcting myopia or hypermetropia. In another embodiment, the refractive correction on a patient’s eyes is for the purpose of correcting astigmatism.

In still another embodiment, the method provides for enhancement of the refractive correction on the patient’s dominant eye. An aspect of this embodiment provides for the enhancement to be achieved by a further reshaping of the corneal stroma.

A particularly useful embodiment of the invention provides for the performance of refractive correction on a patient’s eyes wherein the procedure calls for (1) determining the patient’s dominant eye and non-dominant eye; (2) using a laser device to perform a surface ablation corrective procedure on a corneal surface of the patient’s non-dominant eye; and (3) using a laser device to reshape the corneal stroma of the patient’s dominant eye, where the reshaping includes making a lamillar cut in the corneal surface of the dominant eye to create a flap; folding the flap back to reveal the corneal stroma; ablating a portion of the corneal stroma with a laser device; and replacing the flap over the corneal stroma.

The foregoing has outlined preferred and alternative features of the present invention so that those skilled in the pertinent art may better understand the detailed description of the invention that follows. Additional features of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the pertinent art should appreciate that they can readily use the disclosed conception and specific embodiment as a basis for designing or modifying other structures for carrying out the same purposes of the present invention. Those skilled in the pertinent art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention.

Patent US6034292A

Eye closure appliance

Abstract

Maza-Strips are designed to protect the cornea in patients at high risk for dry cornea and lack of blinking reflex problems. Maza-Strips work by creating a natural closure of the eye lids without the use of any invasive maneuvers. They are used as pairs; one for the upper lid, and one for the lower lid. Each piece is composed of a curvo-linear solid structure material that rests on each lid conforming to the curvature of the lids. Plastic family compounds, metals, or any combination of plastic and metals can be used to make Maza-Strips. Maza-Strips are secured in place with a strong skin adhesive that is coated on the concave side (skin side) of the Maza-Strip. After placing the Maza-Strips on the lids, by using a string or combination of strings that pass though the elevated anchorage loops of Maza-Strips, the two lids are pulled and brought together to close the eye with out getting caught in the lashes or rubbing against the cornea.

Field of Invention

Human cornea is composed of three main layers; the inner endothelial layer, the middle stromal layer, and the external layer (1). The external or the outer layer, which is in contact with air, has to be kept moist at all times (2). Humans blink constantly through out the day to keep the cornea moist, therefor loss of eye lid function can be devastating and ultimately cause loss of vision (3).

The external layers of the cornea which are composed of 5-7 epithelial cell layers, upon dryness and loss of normal blinking reflex, loose their normal form and start separating from the surface. As this process continues the cornea gets eroded and painful. Epithelial defects form on the surface of the cornea and it becomes prone to infection and ulcers (4,5). If not treated promptly this can even ultimately lead to perforation of the cornea. Even though aggressive medical treatment can reverse the process, still corneal scarring and decreased vision can be a the end result.

Patients with sever head injury or loss of innervation to orbicularis muscle are susceptible to corneal related morbidity (2,3,4). Patients on ventilators are also at high risk for corneal problems due to poor eye lid closure (6). Currently, preventive measures include frequent eye ointments and drops to keep the surface of the eye moisten (4,6), however with limited success in patient with long standing loss of blinking reflex and poor eye lid closure. when, conservative therapy fails, a surgical procure known as tarsorrhaphy is performed by some surgeons. In this procedure the eye lids are sutured closed to preserve the cornea (7,8).

The present invention provides a means (referred to as “Maza-Strips” that preserve the cornea from drying damage by keeping the eye closed without the need for a surgical procedure. Maza-Strips are as effective as suturing the eyes closed, because they also induce the same physiologic function, however they are non surgical and do not involve any invasive maneuvers. They also have the advantage of allowing to open the eyes by simply removing the strings and later putting them back on. This is important for checking the pupils in a patient that might need frequent pupillary exams secondary to head trauma (9).

SUMMARY OF INVENTION

The eye closure appliances according to the present invention (“Maza-Strips”) are designed to protect the cornea in patients at high risk for corneal dryness and lack of blinking related problems. Maza-Strips work by creating a natural closure of the eye lids without the use of any invasive maneuvers. Currently, there are no practical and cost efficient ways to save the eyes that lack lid function. Most hospitals put expensive ointments around the clock in these eyes to keep it moist, however it is not only very difficult for the nurses, it is also not successful in many cases. Many patient get ulcers that require long term treatment and compromised vision or loss of the eye, inadition to the cost of multiple visits or consults from the eye surgeons. Some of these patients after recovery from the hospital end up having corneal transplants or permanent surgical closure of the eye lids.

When the human eye is kept open for more than a few minutes, that is if the blinking is stopped, the corneal epithelium will start to separate and brake down. This is the initial process to corneal ulcers, and it is very common in all comatose patient; patients after lid surgery, stroke, severed facial nerve, bells palsy, senile loss of eye lid structure, Parkinson’ disease, and corneal de-innervation are just a few more groups that are at high risk for corneal problems.

Maza-Strips are used as pairs; one for the upper lid, and one for the lower lid (FIGS. 1,2,3,4). Each piece is composed of a material that rests on each lid conforming to the curvature of the lids. Plastic family compounds, metals, or any combination of plastic and metals can be used to make Maza-Strips.

Maza-Strips are secured in place with a strong skin adhesive that is coated in the concave side of the Maza-Strip. On the convex side it has two or more anchorage loops as seen in FIGS. 1&2.

After placing the Maza-Strips on the lids, by using a string or combination of strings or rubber band that courses through the anchorage loops, the two lids are pulled together, in order to close the eye lids as demonstrated in FIGS. 3&4.

The two lids are brought together by different mechanisms.

1) The pulling force created by a string or rubber band between the opposite Maza-Strips.

2) The upper lid because of the lid expansion caused by the width of the Maza-Strip, when placed on the upper lid, is placed downward.

3) The lower lid has less motion, so, when the string or rubber banned is placed, the vector force will exert some force away from the globe anteriorly. This will slightly lift the upper lid from the cornea to enhance a better closure and less strain on the globe.