Referring to the drawings which form a part of this disclosure:
As seen in
To begin, the refractive error in the eye is measured using wavefront technology, as is known to one of ordinary skill in the art. A more complete description of wavefront technology is disclosed in U.S. Pat. No. 6,086,204 to Magnate, the entire content of which is incorporated herein by reference. The refractive error measurements are used to determine the appropriate shape of lens or contact 20 to best correct the error in the patient's cornea. Preferably, the lens 20 is manufactured or shaped prior to the use of the wavefront technology and is stored in a sterilized manner until that specific lens shape or size is needed. However, the information received during the measurements from the wavefront technology can be used to form the lens using a cryolathe, or any other desired system or machine.
Preferably, a flap or portion 18 can be formed in the surface 24 of the cornea 12, as seen in
The flap is moved or pivoted about portion 28 using any device known in the art, such as a spatula or microforceps or any other device, to expose the first and second corneal surfaces 22 and 26, respectively. The flap preferably exposes a portion of the corneal surface that intersects the main optical axis 30 and allows uninhibited access thereto.
Lens or shield 20 can then be positioned adjacent and overlying the surface 22 of the cornea, as seen in
Lens 20 is preferably any metal that can absorb heat and transmit and distribute heat throughout the lens in a uniform or substantially uniform manner. However, the lens does not necessarily need to be metal and can be any synthetic or semi-synthetic material, such as plastic or any polymer or any material that has pigmentation that would allow the lens to absorb the heat from the laser and transmit and distribute the heat uniformly throughout the lens.
Additionally, lens 20 is substantially circular and has a first or inner side or surface 32 and a second or outer side or surface 34 and preferably has a substantially concave shape. The lens preferably has a predetermined shaped, or more specifically, the first surface 32 preferably has a predetermined shape that would be the proper shape of the surface 26 of the cornea plus the flap 18 to focus light onto the retina. In other words, if the interior of the cornea were the shape of the interior surface of the lens the patient would be able to have 20/20 vision or better.
Once the reshaping device is positioned immediately adjacent the exposed surface 26 of the cornea 12, a heating device is applied or administered to the reshaping device 20, which in turn transfers the heat to the surface of the cornea. Preferably, as seen in
The laser beam preferably heats the lens so that the inner surface of the reshaping device is about or below 60° Celsius (140° F.), which in turn heats the corneal surface 26 (preferably the stroma) to about the same temperature, thereby softening the cornea. The reshaping device inner surface temperature is constantly controlled or measured, preferably using multiple thermocouples 40 on the inner surface of the reshaping device. The thermocouples are linked to a computer control system (not shown) using any method known in the art, such as direct electrical connection or wires or a wireless system. The computer control system monitors the temperature and controls the laser to change the temperature of the reshaping device. The computer can maintain a precise constant temperature, increase temperature or decrease temperature as desired, and at any rate desired. This computer control system, along with the thermocouples ensure an adequate and precise temperature, since heating the cornea above 60° Celsius can cause coagulation of the cornea.
By heating the corneal stroma to about or below 60° C., the molecules of the cornea are loosened, and the cornea changes from a substantially solid substance to a gelatinous substance or gel-like substance. However, the corneal temperature is maintained at or below 60° C., and therefore, protein denaturization does not occur as with conventional thermal coagulation. Since the heated portion of the cornea is now flowable, the cornea reforms and is molded to take the shape of the inner surface 32 of the reshaping device, thereby forming the cornea into the reformed, corrected shape in an effort to provide the patient with 20/20 vision. The cornea is then cooled by applying cool or cold water, by applying air or by simply removing the heated reshaping device or the heat from the reshaping device and using the ambient air temperature. As the cornea cools, it is held by the reshaping device 20 to the preferred shape, which becomes its new permanent shape once the cornea is completely cooled and changes from its gel-like consistency to its original substantially solid consistency, as shown in
The flap 18 is then replaced so that it covers or lies over the first surface 26 of the cornea 12 in a relaxed state, as seen in
A reshaping lens can be applied to the external surface of the cornea, if necessary, after the flap has been replaced to maintain the proper corneal curvature or the eye can be left to heal with no additional reshaping lens being used.
Furthermore, at the end of the method, if desired, topical agents, such as an anti-inflammatory, antibiotics and/or an antiprolifrative agent, such as mitomycin or thiotepa, at very low concentrations can be used over the ablated area to prevent subsequent haze formation. The mitomycin concentration is preferably about 0.005-0.05% and more preferably about 0.02%. A short-term bandage contact lens may also be used to protect the cornea.
By reforming the cornea into the desired shape in this manner, a highly effective surgical method is formed that allows perfect or near perfect vision correction without the need to ablate any of the cornea or causing a gray to white response in the cornea of the eye.
As shown in
This method for correcting hyperopic conditions is substantially similar to the method for correcting myopic conditions. Thus, the entire method described above for correcting myopic error of the cornea applies to the correction of hyperopic error, except for the exact configuration of the reshaping device.
As shown in
This method is similar to those described above; however, the temperature of the cornea is increased using the thermocouple plate instead of a laser. As seen in
Although, the method is shown in
Furthermore, since this method is substantially similar to the methods described above, the description of those methods and references numerals used therein, excluding the specific lens and heating element, apply to this method.
As shown in
The method of
Although, the method shown in
Furthermore, since this method is substantially similar to the methods described above, the description of those methods along with the reference numerals used therein, excluding the specific reshaping device and heating element, apply to this method.
As seen in
As described above and seen in
As seen in
It is noted that the method of
Additionally, this method of
Although, the method shown in
Furthermore, since this method is substantially similar to the methods described above, the description of those methods along with the reference numerals used therein applies to this method.
First, as described above the refractive error in the eye is measured using wavefront technology, as is known to one of ordinary skill in the art or any other suitable method. The refractive error measurements are used to determine the appropriate shape of lens or contact 504 to best correct the error in the patient's cornea 12. Preferably, the lens or reshaping device 504 is manufactured or shaped prior to the use of the wavefront technology and is stored in a sterilized manner until that specific lens shape or size is needed. However, the information received during the measurements from the wavefront technology can be used to form the lens using a cryolathe, laser, or any other desired system, method or machine.
Preferably lens 504 is preferably clear and formed any organic, synthetic or semi-synthetic material or combination thereof, such as plastic or any polymer or any material that has pigmentation that would allow laser light to pass therethough such that laser light could heat the cornea as described herein. Lens 504 has a first surface 520 and a second surface 522. The second surface preferably is adapted to be positioned adjacent a surface of the cornea and has a predetermined curvature that will change the curvature of the cornea to correct refractive error. However, the lens does not necessarily need to be formed in this manner and can be opaque and/or formed in any manner described above or in any manner suitable for changing the curvature of the cornea.
As shown in
Laser 500 is preferably an ultra short pulse laser, such as a femto, pico, or attosecond laser; but may be any light emitting device suitable for creating cavities 502. The ultrashort pulse laser 500 is positioned in front of the eye and focuses the laser beam in the cornea 12 at the desired depth for creating multiple cavities. Ultra short pulse lasers are desired since they are capable of ablating or vaporizing corneal tissue beneath the surface of the cornea without disrupting, damaging or affecting the surface of the cornea. Additionally, ultra short pulse lasers are high precision lasers that require less energy than conventional lasers to cut tissue and do not create “shock waves” that can damage surrounding structures. Cuts or ablation performed using ultra short pulse lasers can have very high surface quality with accuracy better than 10 microns, resulting in more precise cuts than those made with mechanical devices or other lasers. This type of accuracy results in less risks and complications than the procedures using other lasers or mechanical devices. However, it is noted that the cavities 502 can be formed by any manner or device desired.
As shown in
As shown in
Once the photosensitizer is applied and allowed to spread through or penetrate to the corneal stroma, lens or reshaping device 504 is positioned immediately adjacent the external corneal surface, as shown in
As shown in
Additionally, it is noted that the laser can heat the reshaping device, which in turn heats the cornea, or the cornea can be heated in any manner described herein.
By heating the corneal stroma to about or below 60° C., the molecules of the cornea are loosened, and the cornea is softened, in a manner substantially similar to that described above. However, the corneal temperature is maintained at or below 60° C., and therefore, protein denaturization does not occur as with conventional thermal coagulation. Since the heated portion of the cornea is now softened, the cornea reforms and is molded to take the shape of the inner surface of reshaping device 504, thereby forming the cornea into the reformed, corrected shape in an effort to provide the patient with 20/20 vision. The cornea is then cooled by applying cool or cold water, by applying air, by letting the reshaping device 504 cool through time or by simply removing the heated reshaping device or the heat from the reshaping device and using the ambient air temperature.
Preferably, as the cornea cools, it is held by the reshaping device 504 to the preferred shape, which becomes its new permanent shape once the cornea is completely cooled and changes to its original substantially solid consistency, as shown in
Preferably, the reshaping device 504 is transparent as described above, thus allowing the patient to see while the reshaping device is still on the external surface of the eye. In other words, as the cornea cools, the reshaping device 504 acts as a contact lens.
It is noted that reshaping device does not necessarily need to be applied to the external surface of the cornea and can the positioned directly on the Bowman's layer, directly on the corneal stroma or any other suitable portion of the cornea. This positioning can be achieved by forming a flap that would expose the desired portion of the internal structure of the cornea. As described herein the flap can be a Lasik type flap (i.e., attached to the cornea at the periphery—see.
In another embodiment, device 600 (
Such application of the device 600 encourages absorption of deposits which plug the out flow of the aqueous fluid. The heat damages (or kills) certain cells and encourages regeneration of the cells (i.e., re-population), while simultaneously causing other cells to become more active, thereby facilitating removal of debris. The device preferably heats the corneal stroma to above body temperature and below about 60° C., and preferably to between about 45° C.-50° C.; however, the stroma can be heated to any suitable temperature. As with the embodiments described above, the temperature can be controlled using thermocouples and/or a suitable computer control system or in any other suitable manner.
The device 600 can be substantially circular, substantially semicircular, substantially ring shaped, arcuate or any other suitable configuration that would facilitate or achieve the desired outcome. Device 600 can be between about 10 mm to about 14 mm in diameter; but can be any suitable size. Preferably, the device has a first surface 602 and a second surface 604. The first surface is generally arcuate and has a radius of curvature of about the same curvature as the external surface of the eye; however, the device can have any suitable configuration. The first surface is preferably positioned on the external surface of the cornea at or near the desired area. The device can be heated using any desired means, such as electrically, with lasers and/or water or any suitable means or any combination of the herein described means or any other suitable means.
Once the device is heated, the eye can be monitored for any suitable duration to determine if any blockage in the Schlem's canal and/or the trabecular meshwork has been reduced or relieved. If desired, the procedure can be repeated one or multiple times or until the desired result is achieved.
Furthermore, a laser can be used to heat the appropriate portion of the eye. For example, a laser can be used to ablate or heat the meshwork, thus enhancing the outflow of vitreous fluid. The laser can be used alone to heat/ablate portions of the eye (e.g., the meshwork) or in combination with any other device or method described herein. The addition of the laser to the system allows the light to penetrate deeper into the cornea (or other portion of the eye) while controlling the temperature at the application site. The laser can be applied simultaneously from outside (through the conjunctiva and or sclera) or in a non-coagulative form to the Schlem's canal (at the junction of the cornea and sclera) in treatment of glaucoma.
The device 600 can also be used to treat small choroidal tumors, melanoma and/or Retinoblastoma, among other things. In this embodiment, the device is positioned adjacent (or in any suitable location) the choroidal tumors, melanoma and/or Retinoblastoma and heat is applied. The heat is preferably controlled to be below 60 degree Celsius to prevent coagulation of the tissue while achieving destruction of the tumor cells which are more sensitive to heat application than normal cells; however, the heat can be within any suitable range including any temperature above body temperature and at or below the temperature at which coagulation occurs. Preferably the temperature to which the device (and thus the temperature of the specific area of the eye) is heated is closely controlled or monitored using computers and/or any other means, as described above, or by any suitable means or device.
The heat to treat small choroidal tumors, melanoma and/or Retinoblastoma, among other things, is applied alone through device 600 or in conjunction with a laser. The laser can be any suitable laser, including a laser within the visible spectrum or any other suitable wavelength. Furthermore, the device can be used with an ultrasonic device or radio frequency probe or any other suitable device.
Additionally, the device 600 can have any suitable diameter to eliminate or treat any size tumor. For example, the device can be substantially circular with a diameter of about 2-3 mm to treat smaller tumors or the device can be 3-7 mm to eliminate or treat larger tumors. However, it is noted that the device can be any configuration and/or size disclosed above or any other suitable size and/or configuration.
Furthermore, the device 600 can be used alone or in a combined system for treatment of Age Related Macular Degeneration (ARMD). As with several of the embodiments described above, it is preferable not to increase the corneal tissue temperature above 59 degrees Celsius (or more preferably to above 50 degrees Celsius); however, the cornea can be heated to any suitable temperature between about body temperature and about 60 degrees Celsius. Preferably the temperature that the macula is heated to is closely controlled or monitored using computers and/or any other means, as described above or by any suitable device or means.
Additionally, device 600 can be used simultaneously or substantially simultaneously with a device that also applies heat through electricity, ultrasound, radio frequency wave or a laser in visible or infrared light or heated water. The application time of the heat is generally between about 5 seconds to about 600 seconds, but can be 1000 seconds or more. The spot size is preferably between about 0.1 to about 10 mm or larger, but can be any suitable spot size. The diameter of device 6—when treating ARMD is preferably between about 10 to about 15 mm and is preferably substantially ring shaped; however, the instrument can have any suitable shape or configuration and be any suitable size.
Furthermore, if desired the above method can be used to heat the macular simply using a device that applies heat through electricity, ultrasound, radio frequency wave or a laser in visible or infrared light or heated water without device 600 to treat ARND.
Additionally, any of the above described methods and/or devices can be used to encouraging the penetration of a drug applied to an adjacent tissue. For example, the drug (or any other substance) can be applied topically to the cornea of the eye or in any suitable or desired area of the body. Examples of substances that can be applied are photosensetizers, antimetabolites, anti-cancer, ant-inflammatory, antibiotics, macrolides, antiprostoglandins etc. It is noted that the present method is not limited to these substances and any suitable substance can be used to treat the appropriate portion of the body or to benefit the human body or facilitate healing thereof.
In another embodiment of the present invention, a system is configured to use a device to apply controlled heat substantially simultaneously or simultaneously with a drug or medicinal substance on or in a desired portion of a patient or animal. For example, a medicinal substance and controlled heat can be applied on the skin, on or in the nose, on or in the mouth, on the mucosa, on or in any tissue, outside or inside the eyelid, on the cornea, conjunctiva or sclera or any other suitable portion of the patient.
Preferably, the system includes a device that is configured to be positioned adjacent a desired external portion of a patient, a heating element or means, a computer control system and a medicinal substance delivery system; however, the system does not need to include each of or only these elements.
The device can be positioned adjacent or immediately covering an appropriate portion of the body or be positioned in any other suitable manner. The device is preferably formed from a suitable material that would allow efficient heat absorption and transfer. For example, the device can be made from metal or from any suitable synthetic or semi-synthetic material, such as plastic or any polymer or any material that would allow the device to absorb the heat and transmit and distribute the heat uniformly throughout the device or from any suitable materials described above. The device can be applied in or on any suitable location. For example, the device can be applied on the eyelid, on the sclera, on the skin or any other place on a patients' body. The device can be any device described herein, have any suitable configuration, or can have any suitable heating device or element. Preferably, the device is sized and configured for a specific local application. For example, the devices described above can have concaved surfaces for placement on the external surface of the cornea.
The heating element or means can be any suitable device for heating the device. The heating means can be coupled to the device, implanted in the device, be an integral part of the device or be located in a position relative to the device. For example, the heating means can be an electrical circuit or current supplied to a circuit or system on or in the device, a system or component imbedded or integral with the device or the heating means can be an external system configured to transfer heat to the device. The heating means is preferably in electrical connection and/or communication with the computer control system, but can be activated in any suitable manner. However, as stated above, the heating means can be any suitable device and can heat the device in any suitable manner. For example, the heating means can use radiation, light, ultrasound, or electrical current, alone or in any suitable combination.
Preferably, the heat application is controlled in any of the suitable manners described above, which facilitates penetration of medication or medicinal substance (or other substance) in the eye (or other suitable location), including the surrounding tissue.
The computer control system is preferably electrically coupled to the device and the heating means and is used to monitor and control the temperature of the device. The computer control system preferably is capable of precisely calculating or monitoring the temperature of the portion of the body and controls the temperature thereof to achieve favorable results. However, it is noted that the computer control system can be any suitable system and does not necessarily need to be coupled to each or either of these devices and can be coupled to one or none and monitor the system wirelessly or in any other manner.
The combination of heat and medicinal substance application will enhance penetration of the medicinal substance inside the tissue. The heat can be precisely controlled using any type of temperature sensors (e.g., theremocouples) and the computer control system. Preferably the temperature is controlled within a range plus or minus about ten degrees Celsius of body temperature. For example, the temperature can be controlled to about 25 degrees Celsius to about 45 degrees Celsius or any suitable range or temperature therein. More preferably, the temperature can be controlled to about 35 degrees Celsius to about 41 degrees Celsius or any suitable range or temperature therein; however, the temperature can be heated to any suitable specific temperature or range of temperatures.
Preferably the medicinal substance is applied topically; however, it can be administered in any suitable manner. The amount and rate at which the substance is administered may be computer controlled or done manually. The medicinal substance can be any suitable compound. For example, the drugs or medicinal substances can be antibiotics, anti-fungals, antivirals, anti-cancers, anti-inflammatories, anti-prostaglandins, steroids, hormones, growth factors NGF, GGF, any desired enzyme, Anti-VEGF, Anti-PDGF, VEGF, Anti-glaucoma and siRNA, nano particles, Antibodies, macrolides, and/or all hydrophilic or lipophilic compounds.
The device can also be implanted into the body and externally heated using a suitable device. For example, the device can be heated using a remote control system or other device capable of penetrating the appropriate portion of the body. The device can be configured with an internal heating element (or any type of heating means described above) that is activated externally (e.g., via an external wireless signal) or the device can absorb heat that is transferred thereto via an external source (e.g., via a laser, radiation or any other suitable source).
The device can be surgically implanted or injected or positioned within the patient in any other suitable manner. For example, the device can be positioned in the eye as a corneal inlay (e.i., inserted between layers of cornea (e.g., under a corneal flap or in a corneal pocket)), an intraocular lens, or positioned in any other manner in the eye or in any other suitable portion of a patients' body. When inserted between layers of the cornea (or otherwise in a patient's body), the inlay can be heated by directed contact with a heating element (e.g., probes or wires inserted through the cornea) or remotely (e.g., a laser). If desired, a flap can be formed (or reformed) to allow access to the device for heating purposes.
As with the externally applied device described above, the implanted device is preferably formed from a suitable material that would allow efficient heat absorption and transfer. For example, the device can be made from metal or from any suitable synthetic or semi-synthetic material, such as plastic or any polymer or any material that would allow the device to absorb the heat from the laser and transmit and distribute the heat uniformly throughout the device or from any suitable materials described above. Furthermore, when inserted in the eye, the inlay or device is formed from suitable transparent materials and can have refractive powers or the ability to alter the refractive power or the eye, as described above.
Additionally, if desired the implanted device can be combined with slow release drug delivery system. Such a combined system would be useful for delivery of pain medication or other medications to desired area inside the body, among other uses. Suitable drugs could be administered through drops, ointment, slow release, microspheres, nano-particles, compacted nano-particles, viral factor, and any other suitable or desired drugs.
Preferably, as described above, a computer control system monitors and controls the temperature of the overall system to precisely control the temperature at the site within the body, and the description of the externally positioned device is applicable to the implanted device. Furthermore, if desired, the computer control system can control the release of the drug.
Any of the herein described embodiments can be used with any combination of the other embodiments. For example, applying heat to encourage drug penetration and/or relieving internal pressure in the eye can occur simultaneously or substantially simultaneously as the embodiments describing reshaping of the cornea.
While various advantageous embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.
This application is a continuation-in-part of U.S. patent application Ser. No. 09/986,141, filed Nov. 7, 2001, entitled “Method of Reshaping the Cornea by Controlled Thermal Delivery”, and U.S. patent application Ser. No. 11/070,659 filed Mar. 2, 2005, entitled “Device and Method for Reshaping the Cornea”, the entire contents of both of which are incorporated herein by reference. This application is related to U.S. patent application Ser. No. 11/446,065, filed Jun. 1, 2006 and entitled “Device and Method for Reshaping the Cornea”, and U.S. patent application Ser. No. 11/558,788, filed Nov. 10, 2006 and entitled “Method of Treating the Eye using Controlled Heat Delivery,” the entire contents of both of which are incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
Parent | 09986141 | Nov 2001 | US |
Child | 11562268 | US | |
Parent | 11070659 | Mar 2005 | US |
Child | 09986141 | US | |
Parent | 11446065 | Jun 2006 | US |
Child | 11070659 | US | |
Parent | 11558788 | Nov 2006 | US |
Child | 11446065 | US |