# Patent

## Title
Eye therapy system

## Abstract

A system for applying therapy to an eye selectively applies coolant to the corneal surface to minimize heat-related damage to the corneal surface during thermokeratoplasty. Embodiments may include an energy source, a conducting element, a coolant supply, and a coolant delivery system. The conducting element is operably connected to the energy source and extends from a proximal end to a distal end. The conducting element directs energy from the energy source to the distal end, which is positionable at the eye. The coolant delivery system is in communication with the coolant supply and is operable to deliver a micro-controlled pulse of coolant to the distal end.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a Continuation of application Ser. No. 12/208,963, now U.S. Pat. No. 8,202,272, titled “Eye Therapy System” and filed Sep. 11, 2008, which is a Continuation-In-Part (CIP) Application of U.S. application Ser. No. 11/898,189, titled “Eye Therapy System” and filed Sep. 10, 2007, which claims the benefit of U.S. Provisional Application No. 60/929,946, titled “Commercialization Of Microwave Thermokeratoplasty” and filed Jul. 19, 2007, the contents of these applications being incorporated herein by reference.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention pertains to the field of keratoplasty and, more particularly, to thermokeratoplasty and the application of coolant to the eye during thermokeratoplasty.
2. Description of Related Art
A variety of eye disorders, such as myopia, keratoconus, and hyperopia, involve abnormal shaping of the cornea. Keratoplasty reshapes the cornea to correct such disorders. For example, with myopia, the shape of the cornea causes the refractive power of an eye to be too great and images to be focused in front of the retina. Flattening aspects of the cornea's shape through keratoplasty decreases the refractive power of an eye with myopia and causes the image to be properly focused at the retina.
Invasive surgical procedures, such as laser-assisted in-situ keratomileusis (LASIK), may be employed to reshape the cornea. However, such surgical procedures typically require a healing period after surgery. Furthermore, such surgical procedures may involve complications, such as dry eye syndrome caused by the severing of corneal nerves.
Thermokeratoplasty, on the other hand, is a noninvasive procedure that may be used to correct the vision of persons who have disorders associated with abnormal shaping of the cornea, such as myopia, keratoconus, and hyperopia. Thermokeratoplasty may be performed by applying electrical energy in the microwave or radio frequency (RF) band. In particular, microwave thermokeratoplasty may employ a near field microwave applicator to apply energy to the cornea and raise the corneal temperature. At about 60° C., the collagen fibers in the cornea shrink. The onset of shrinkage is rapid, and stresses resulting from this shrinkage reshape the corneal surface. Thus, application of heat energy in circular or ring-shaped patterns around the pupil may cause aspects of the cornea to flatten and improve vision in the eye. However, devices for thermokeratoplasty generally apply energy through the corneal surface to heat the underlying collagen fibers. Therefore, the maximum temperature can occur at the corneal surface, resulting in possible heat-related injury and damage to the outer layer, known as the epithelium, at the corneal surface. Moreover, devices for thermokeratoplasty may provide inadequate approaches for controlling the depth of heating below the corneal surface and promoting sufficient heating of the targeted collagen fibers while minimizing the application of heat to areas outside the targeted collagen fibers.
SUMMARY OF THE INVENTION
In view of the foregoing, embodiments of the present invention provide a system that selectively applies coolant to the corneal surface to minimize heat-related damage to the corneal surface during thermokeratoplasty and to determine the depth of heating below the corneal surface.
Accordingly, an embodiment of the present invention includes an energy source, a conducting element, a coolant supply, and at least one coolant delivery element. The conducting element is operably connected to the energy source and extends from a proximal end to a distal end. The conducting element directs energy from the energy source to the distal end, which is positionable at an eye. The coolant delivery elements are in communication with the coolant supply and are operable to deliver a micro-controlled pulse of coolant to the distal end.
Another embodiment includes an electrical energy source, an electrical energy conducting element, a coolant supply, and at least one coolant delivery element. The electrical energy conducting element includes two conductors that are separated by a gap of a selected distance and that extend from a proximal end to a distal end. The electrical conducting element, which is operably connected to the electrical energy source, receives, at the proximal end, electrical energy generated by the electrical energy source and directs the electrical energy to the distal end, which is positionable at an eye. The coolant delivery elements are in communication with the coolant supply and are operable to deliver a micro-controlled pulse of coolant to the distal end.
A particular embodiment includes an electrical energy source and an electrical energy conducting element extending from a proximal end to a distal end. The energy conducting element is operably connected to the electrical energy source at the proximal end and adapted to direct electrical energy to the distal end. The energy conducting element includes an outer conductor extending to the distal end and an inner conductor extending to the distal end and disposed within the outer conductor, where the outer conductor and the inner conductor are separated by a gap. In this embodiment, the inner conductor has an opening at the distal end and a contact area along a periphery of the opening. The contact area is positionable at a surface of an eye, and the electrical energy is applied to the eye according to the contact area. The outer conductor and the inner conductor may be substantially cylindrical at the distal end, and the gap may be a substantially annular gap with a radial thickness of approximately 0.5 mm to approximately 1.5 mm. The contact area may also be a substantially annular surface with a radial thickness in a range of approximately 50 μm to approximately 200 μm. The opening at the distal end may be defined by a hollow portion extending into the inner conductor from the distal end toward the proximal end, and the hollow portion may be defined by a substantially concave surface within the inner conductor. In a further embodiment, the system may further include a coolant supply, and a coolant delivery system in communication with the coolant supply, where the coolant delivery system is operable to deliver a micro-controlled pulse of coolant to the distal end. In this further embodiment, the inner conductor may include at least one coolant delivery opening coupled to the coolant delivery system, where the at least one coolant delivery opening is configured to deliver coolant toward the distal end. The at least one coolant delivery opening may include at least one interior coolant delivery opening configured to deliver coolant through the opening and/or at least one exterior coolant delivery opening configured to deliver coolant outside of the periphery of the inner conductor.
Operation of embodiments according to the present invention may include positioning an electrical energy conducting element at a surface of an eye and applying a selected amount of electrical energy through the electrical energy conducting element to the eye. The energy conducting element extends from a proximal end to a distal end, and the energy conducting element is operably connected to an electrical energy source at the proximal end. The selected amount of electrical energy is applied according to a power parameter and a time parameter that generate structural changes in a localized volume in the eye. The selected amount of electrical energy is deliverable according to a range of power values and a range of corresponding time values. The power parameter may be an upper power value in the range of power values, and the time parameter is a lower time value in the range of time values. The upper power value may be in a range of approximately 300 W to approximately 500 W. The selected amount of electrical energy may be in a range of approximately 2 J to approximately 25 J. The localized volume may be in a range of approximately 0.1 mm3 to approximately 2.0 mm3.
Another operation of embodiments according to present invention may include positioning an energy conducting element to the eye and applying a selected amount of electrical energy through the electrical energy conducting element to the eye according to a power parameter and a time parameter. The energy conducting element, extending from a proximal end to a distal end, is operably connected to an electrical energy source at the proximal end and is configured to deliver electrical energy to generate a structural changes in a eye positioned at the distal end. In this method, the power parameter is greater than a threshold value determining structural changes in a localized volume in the eye, and the time parameter is less than a value of approximately 100 ms. The selected amount of electrical energy may be a range of approximately 2 J to approximately 25 J. The localized volume may have a value of approximately 0.1 mm3 to approximately 2.0 mm3.
Yet another embodiment includes an optical energy source, an optical energy conducting element, a coolant supply, and at least one coolant delivery element. The optical energy conducting element, which is connected to the optical energy source, extends from a proximal end to a distal end and directs optical energy from the optical energy source to the distal end, which is positionable at an eye. The coolant delivery elements are in communication with the coolant supply and are operable to deliver a micro-controlled pulse of coolant to the distal end.
An additional embodiment includes an energy source, a monopole conductor, a coolant supply, and at least one coolant delivery element. The monopole conductor, which is connected to the energy source, extends from a proximal end to a distal end and contacts, at the distal end, an eye of a body, whereby the body acts as a backplane and the conductor delivers energy to the eye. The coolant delivery elements are in communication with the coolant supply and are operable to deliver a micro-controlled pulse of coolant to the distal end.
A further embodiment includes an energy source, a conducting element, a coolant supply, and a vacuum source. The conducting element, which is operably connected to the energy source, extends from a proximal end to a distal end and directs energy from the energy source to the distal end, which is positionable at the eye. The vacuum source is operable to draw the coolant in a micro-controlled pulse from the coolant supply to the distal end, whereby the pulse of coolant is applied to the eye.
In addition to delivering micro-controlled pulses of coolant, some embodiments may deliver pulses of energy. In particular, the embodiments may employ high power energy to generate heat in a targeted region of the eye in a relatively short amount of time. To minimize unwanted diffusion of heat, the duration of the energy pulse may be shorter than the thermal diffusion time in the targeted region of the eye. In an exemplary application: a first pulse of coolant is delivered to reduce the temperature of the corneal surface; a high power pulse of microwave energy is then applied to generate heat within selected areas of collagen fibers in a mid-depth region; and a second pulse of coolant is delivered in sequence to end further heating effect and “set” the corneal changes that are caused by the energy pulse.
Another embodiment includes an energy conducting element and a vacuum ring. The vacuum ring receives the energy conducting element and creates a vacuum connection with an eye and positions the energy conducting element relative to the eye, whereby the energy conducting element directs the energy to the eye. The energy conducting element may be detachably coupled to the vacuum ring.
The embodiments of the present invention may also employ a controller to control the operation of one or more components or sub-systems. In addition, embodiments may employ pressure relief mechanisms to reduce the pressure introduced by the pulses of coolant into a closed environment. Furthermore, embodiments may also employ a readable use indicator, such as a radio frequency identification (RFID) device, that ensures that elements of the system, particularly those that come into contact with the body and bodily fluids, are disposed of after one use.
These and other aspects of the present invention will become more apparent from the following detailed description of the preferred embodiments of the present invention when viewed in conjunction with the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a schematic of an embodiment of the present invention.
FIG. 2 illustrates an embodiment of the present invention employing a microwave energy source.
FIG. 3A illustrates a variation of the embodiment of FIG. 2, which employs a pressure relief valve in place of a vacuum sub-system to reduce pressure created by a pulse of coolant.
FIG. 3B illustrates a variation of the embodiment of FIG. 2, which employs a vent passage in place of a vacuum sub-system to reduce pressure created by a pulse of coolant.
FIG. 4 illustrates an embodiment of the present invention employing an optical energy source.
FIG. 5A illustrates a variation of the embodiment of FIG. 4, which employs a pressure relief valve in place of a vacuum sub-system to reduce pressure created by a pulse of coolant.
FIG. 5B illustrates a variation of the embodiment of FIG. 4, which employs a vent passage in place of a vacuum sub-system to reduce pressure created by a pulse of coolant.
FIG. 6 illustrates an embodiment of the present invention employing a monopole conductor as an energy conducting element.
FIG. 7A illustrates an embodiment of the present invention employing a vacuum ring to position an applicator over an eye surface.
FIG. 7B illustrates the vacuum ring employed in the embodiment of FIG. 7A.
FIG. 8A illustrates another embodiment of the present invention employing a microwave energy source.
FIG. 8B illustrates the inner conductor of the embodiment of FIG. 8A.
FIG. 8C illustrates the thin contact area for the inner conductor of the embodiment of FIG. 8A.
FIG. 8D illustrates the cooling delivery system in the inner conductor of the embodiment of FIG. 8A.
FIG. 8E illustrates the contact between an eye and the thin contact area for the inner conductor of the embodiment of FIG. 8A.
FIG. 8F illustrates an example result of applying the applicator of the embodiment of FIG. 8A to an eye.
FIG. 9A illustrates a graph of change in energy required as a function of increasing power for a constant target lesion size for a set of simulations employing the embodiment of FIG. 8A.
FIG. 9B illustrates a graph of maximum temperature reached as a function of increasing power at a constant energy value for a set of simulations employing the embodiment of FIG. 8A.
FIG. 9C illustrates a graph of lesion volume as a function of increasing power at a constant energy value for a set of simulations employing the embodiment of FIG. 8A.



DETAILED DESCRIPTION
Referring to FIG. 1, an embodiment of the present invention is schematically illustrated. In particular, FIG. 1 shows an applicator 10 operably connected to an energy source 20. The applicator 10 includes an energy conducting element 11, which extends from the proximal end 10A to the distal end 10B of the applicator 10. The applicator 10 may be connected to the energy source 20 at the proximal end 10A. Operation of the energy source 20 causes energy to be conducted through the energy conducting element 20 and heat to be generated at the distal end 10B. As such, the applicator 10 may be employed to apply heat to a cornea 2 of an eye 1 that is positioned at or near the distal end 10B. In particular, the heat is applied to selected areas of collagen fibers in a mid-depth region 2B of the cornea 2 to shrink the collagen fibers according to a predetermined pattern and reshape the cornea 2, thereby improving vision through the eye 1.
As further illustrated in FIG. 1, the applicator 10 includes at least one coolant delivery element 12 in fluid communication with a coolant supply, or reservoir, 13. The outer surface 10C of the applicator 10 may define a substantially enclosed assembly, especially when the distal end 10B is placed in contact with the corneal surface 2A. As shown in FIG. 1, this enclosed assembly may house the energy conducting element 11, the coolant delivery element 12, and the coolant supply 13. Although the coolant supply 13 in FIG. 1 is positioned within the applicator 10, the coolant supply 13 may be external to the applicator 10 in other embodiments. Moreover, although FIG. 1 shows one coolant delivery element 12, some embodiments may employ more than one coolant delivery element 12 and/or more than one coolant supply 13.
The coolant delivery element 12 delivers a coolant, or cryogen, from the coolant supply 13 to the distal end 10B of the applicator 10. As such, the applicator 10 may be employed to apply coolant to selectively cool the surface 2A of the cornea 2 positioned at the distal end 10B. The delivery of coolant from the coolant delivery element 12 toward the corneal surface 2A, in sequence with the application of heat to the cornea 2, permits the corneal temperature to be increased to cause appropriate shrinkage of the collagen fibers in the targeted mid-depth region 2B and reshape the cornea 2, while also minimizing injury to the outer layer 2A, i.e. the epithelium, of the cornea 2.
A controller 40, as also shown in FIG. 1, may be operably connected to the energy source 20 and/or the coolant delivery element 12. The controller 40 may be employed to control the delivery of energy from the energy source 20 to the applicator 10, thereby determining the magnitude and timing of heat delivered to the cornea 2 positioned at the distal end 10B. In addition, the controller 40 may be employed to determine the amount and timing of coolant delivered from the coolant delivery element 12 toward the corneal surface 2A at the distal end 10B. As described further below, the controller 40 may be employed to selectively apply the heat and the coolant any number of times according to a predetermined or calculated sequence. For instance, the coolant may be applied to the corneal surface 2A before, during, or after the application of heat to the cornea 2, or any combination thereof.
In some embodiments, the coolant delivery element 12 may employ a delivery nozzle 12A and a solenoid valve. The delivery nozzle 12A has an opening 12B directed at the distal end 10B. As is known, a solenoid valve is an electromechanical valve for use with liquid or gas controlled by applying or stopping an electrical current through a coil of wire, thus changing the state of the valve. As such, the controller 40 may electronically control the actuation of the solenoid valve to deliver the coolant through the delivery nozzle 12A to the corneal surface 2A. However, other embodiments may employ other types of actuators or alternative techniques for delivering coolant through the delivery nozzle 12A in place of a solenoid valve.
During operation of the embodiment of FIG. 1, the controller 40 may be used to actuate the application of micro-controlled pulses of coolant to the corneal surface 2A before the application of heat to the cornea 2. A pulse, or a spurt, of coolant is applied to the corneal surface 2A for a predetermined short period of time so that the cooling remains generally localized at the corneal surface 2A while the temperature of deeper corneal collagen fibers 2B remains substantially unchanged. Preferably, the pulse is on the order of tens of milliseconds and is less than 100 milliseconds. The delivery of the coolant to the corneal surface is controlled by the controller 40 and may be less than 1 millisecond. Furthermore, the time between the application of the coolant and the application of the heat is also controlled by the controller 40 and may also be less than 1 millisecond. The coolant pulse generally covers an area of the corneal surface 2A that corresponds with the application of heat to the cornea 2. The shape, size and disposition of the cooled region may be varied according to the application.
Advantageously, localized delivery of coolant to the corneal surface 2A before the application of heat to the cornea 2 minimizes the resulting temperature at the corneal surface 2A when the heat is applied, thereby minimizing any heat-induced injury to the corneal surface 2A. In other words, the coolant reduces the temperature of the corneal surface 2A, so that the maximum surface temperature achieved at the corneal surface 2A during or immediately after heat exposure is also reduced by a similar magnitude when compared to a case where no coolant is applied prior to heat exposure. Without the application of coolant, the temperature at the corneal surface 2A rises during or immediately after heat exposure with persistent surface heating resulting from a slow dissipation of heat trapped near the surface-air interface.
Although temperatures observed at the corneal surface 2A immediately after heat exposure are lowered by the application of coolant before exposure, a delayed thermal wave may arrive at the corneal surface 2A after exposure as the heat generated in the corneal areas 2B below the surface 2A diffuses toward the cooled surface 2A. The heat transfer from the corneal surface 2A to the surrounding air is likely to be insignificant, because air is an excellent thermal insulator. With no cooling after the application of heat, heat diffusing away from the areas 2B beneath the corneal surface 2A builds up near the corneal surface 2A and produces an elevated surface temperature that may persist after the application of heat. Although the heat that builds up near the corneal surface 2A may eventually dissipate through thermal diffusion and cooling via blood perfusion, such dissipation may take several seconds. More immediate removal of this heat by additional application of coolant minimizes the chances for heat-related injury to the corneal surface 2A. Thus, embodiments of the present invention may employ not only a pulse of coolant immediately prior to heat exposure, but also one or more pulses of coolant thereafter. Accordingly, in further operation of the embodiment of FIG. 1, the controller 40 may also be used to apply micro-controlled pulses of coolant during or after the applicator 10 applies heat to the cornea 2, or any combination thereof. This application of coolant rapidly removes heat which diffuses from the mid-depth corneal region 2B to the corneal surface 2A.
When the coolant delivery element 12 delivers the pulse of coolant to the corneal surface 2A, the coolant on the corneal surface 2A draws heat from the surface 2A, causing the coolant to evaporate. In general, coolant applied to the surface 2A creates a heat sink at the surface 2A, resulting in the removal of heat before, during, and after the application of heat to the cornea 2. The heat sink persists for as long as the liquid cryogen remains on the surface 2A. The heat sink can rapidly remove the trapped heat at the surface 2A without cooling the collagen fibers in the region 2B. A factor in drawing heat out of the cornea 2 is the temperature gradient that is established near the surface 2A. The steeper the gradient, the faster a given quantity of heat is withdrawn. Thus, the application of the coolant attempts to produce a large surface temperature drop as quickly as possible.
Because the cooled surface 2A provides a heat sink, the amount and duration of coolant applied to the corneal surface 2A affects the amount of heat that passes into and remains in the region underlying the corneal surface 2A. Thus, controlling the amount and duration of the cooling provides a way to control the depth of corneal heating, promoting sufficient heating of targeted collagen fibers in the mid-depth region 2B while minimizing the application of heat to regions outside the targeted collagen fibers.
In general, dynamic cooling of the corneal surface 2A may be optimized by controlling: (1) the duration of the cooling pulse(s); (2) the duty cycle of multiple pulses; (3) the quantity of coolant deposited on the corneal surface 2A so that the effect of evaporative cooling can be maximized; and (4) timing of dynamic cooling relative to heat application. For example, a single pulse timing may include applying a 80 ms heat pulse and a 40 ms cooling pulse at the beginning, middle, or end of the heating pulse. In another example, multiple cooling pulses may be applied according to a pattern of 10 ms ON and 10 ms OFF, with four of these pulses giving a total of 40 ms of cooling, but timed differently.
In some embodiments, the coolant may be the cryogen tetrafluoroethane, C2H2F4, which has a boiling point of about −26.5° C. and which is an environmentally compatible, nontoxic, nonflammable freon substitute. The cryogenic pulse released from the coolant delivery element 12 may include droplets of the cryogen cooled by evaporation as well as mist formed by adiabatic expansion of vapor.
In general, the coolant may be selected so that it provides one or more of the following: (1) sufficient adhesion to maintain good surface contact with the corneal surface 2A; (2) a high thermal conductivity so the corneal surface 2A may be cooled very rapidly prior to heat application; (3) a low boiling point to establish a large temperature gradient at the surface; (4) a high latent heat of vaporization to sustain evaporative cooling of the conical surface 2A; and (5) no adverse health or environmental effects. Although the use of tetrafluoroethane may satisfy the criteria above, it is understood that embodiments of the present invention are not limited to a particular cryogen and that other coolants, such as liquid nitrogen, argon, or the like, may be employed to achieve similar results. For instance, in some embodiments, other liquid coolants with a boiling temperature of below approximately body temperature, 37° C., may be employed. Furthermore, the coolant does not have to be a liquid, but in some embodiments, may have a gas form. As such, the pulse of coolant may be a pulse of cooling gas. For example, the coolant may be nitrogen (N2) gas or carbon dioxide (CO2) gas.
Referring now to the cross-sectional view illustrated in FIG. 2, an embodiment of the present invention employs an applicator 110. The applicator 110 includes an electrical energy conducting element 111, a micro-controlled coolant delivery system 112, as well as a coolant supply 113.
The electrical energy conducting element 111 is operably connected to an electrical energy source 120, for example, via conventional conducting cables. The electrical energy conducting element 111 extends from a proximal end 110A to a distal end 110B of the applicator 110. The electrical energy conducting element 111 conducts electrical energy from the source 120 to the distal end 110B to apply heat energy to a cornea 2, which is positioned at the distal end 110B. In particular, the electrical energy source 120 may include a microwave oscillator for generating microwave energy. For example, the oscillator may operate at a microwave frequency range of 400 MHz to 3000 MHz, and more specifically at a frequency of around 915 or around 2450 MHz which has been safely used in other applications. As used herein, the term “microwave” corresponds to a frequency range from about 10 MHz to about 10 GHz.
As further illustrated in FIG. 2, the electrical energy conducting element 111 may include two microwave conductors 111A and 111B, which extend from the proximal end 110A to the distal end 110B of the applicator 110. In particular, the conductor 111A may be a substantially cylindrical outer conductor, while the conductor 111B may be a substantially cylindrical inner conductor that extends through an inner passage extending through the conductor 111A. With the inner passage, the conductor 111A has a substantially tubular shape. The inner and the outer conductors 111A and 111B may be formed, for example, of aluminum, stainless steel, brass, copper, other metals, coated metals, metal-coated plastic, or any other suitable conductive material.
With the concentric arrangement of conductors 111A and 111B, a substantially annular gap 111C of a selected distance is defined between the conductors 111A and 111B. The annular gap 111C extends from the proximal end 110A to the distal end 110B. A dielectric material 111D may be used in portions of the annular gap 111C to separate the conductors 111A and 111B. The distance of the annular gap 111C between conductors 111A and 111B determines the penetration depth of microwave energy into the cornea 2 according to established microwave field theory. Thus, the microwave conducting element 111 receives, at the proximal end 110A, the electrical energy generated by the electrical energy source 120, and directs microwave energy to the distal end 111B, where the cornea 2 is positioned.
The outer diameter of the inner conductor 111B is preferably larger than the pupil. In general, the outer diameter of the inner conductor 111B may be selected to achieve an appropriate change in corneal shape, i.e. keratometry, induced by the exposure to microwave energy. Meanwhile, the inner diameter of the outer conductor 111A may be selected to achieve a desired gap between the conductors 111A and 111B. For example, the outer diameter of the inner conductor 111B ranges from about 2 mm to about 10 mm while the inner diameter of the outer conductor 111A ranges from about 2.1 mm to about 12 mm. In some embodiments, the annular gap 111C may be sufficiently small, e.g., in a range of about 0.1 mm to about 2.0 mm, to minimize exposure of the endothelial layer of the cornea (posterior surface) to elevated temperatures during the application of heat by the applicator 110.
As shown in FIG. 2, the micro-controlled coolant delivery system 112 as well as the coolant supply 113 may be positioned within the annular gap 111C. Although FIG. 2 may illustrate one coolant delivery system 112, the applicator 110 may include a plurality of coolant delivery systems 112 arranged circumferentially within the annular gap 111C. The coolant supply 113 may be an annular container that fits within the annular gap 111C, with the coolant delivery element 112 having a nozzle structure 112A extending downwardly from the coolant supply 113 and an opening 112B directed toward the distal end 110B.
The micro-controlled coolant delivery system 112, which is in fluid communication with the coolant supply 113, may operate in a manner similar to the coolant delivery system 12 in FIG. 1. In other words, pulses of coolant, or cryogen, from the coolant supply 113 are preferably applied to the corneal surface 2A before, during, and after energy is applied to the cornea 2 with the electrical energy source 120 and the electrical energy conducting element 111.
As described previously, the controller 140 may be employed to selectively apply the heat and the coolant pulses any number of times according to any predetermined or calculated sequence. In addition, the heat and the pulses of coolant may be applied for any length of time. Furthermore, the magnitude of heat being applied may also be varied. Adjusting such parameters for the application of heat and pulses of coolant determines the extent of changes that are brought about within the cornea 2. Of course, as discussed, embodiments of the present invention attempt to limit the changes in the cornea 2 to an appropriate amount of shrinkage of selected collagen fibers. When employing microwave energy to generate heat in the cornea 2, for example with the applicator 110, the microwave energy may be applied with low power (of the order of 40 W) and in long pulse lengths (of the order of one second). However, other embodiments may apply the microwave energy in short pulses. In particular, it may be advantageous to apply the microwave energy with durations that are shorter than the thermal diffusion time in the cornea. For example, the microwave energy may be applied in pulses having a higher power in the range of 300 W to 3 kW and a pulse duration in the range of about 10 milliseconds to about one second. Thus, when applying the coolant pulses before and after the application of heat as discussed previously: a first pulse of coolant is delivered to reduce the temperature of the corneal surface 2A; a high power pulse of microwave energy is then applied to generate heat within selected areas of collagen fibers in a mid-depth region 2B; and a second pulse of coolant is delivered in sequence to end further heating effect and “set” the corneal changes that are caused by the energy pulse. The application of energy pulses and coolant pulses in this manner advantageously reduces the amount to heat diffusion that occurs and minimizes the unwanted impact of heating and resulting healing processes on other eye structures, such as the corneal endothelium. Moreover, this technique promotes more permanent and stable change of the shape of the cornea 2 produced by the heat. Although the application of high powered energy in short pulses has been described with respect to the delivery of microwave energy, a similar technique may be applied with other types of energy, such as optical energy or electrical energy with radio frequency (RF) wavelengths described further below.
Referring again to FIG. 2, at least a portion of each of the conductors 111A and 111B may be covered with an electrical insulator to minimize the concentration of electrical current in the area of contact between the corneal surface 2A and the conductors 111A and 111B. In some embodiments, the conductors 111A and 111B, or at least a portion thereof, may be coated with a material that can function both as an electrical insulator as well as a thermal conductor. A dielectric layer 110D may be employed along the distal end 111B of the applicator 110 to protect the cornea 2 from electrical conduction current that would otherwise flow into the cornea 2 via conductors 111A and 111B. Such current flow may cause unwanted temperature effects in the cornea 2 and interfere with achieving a maximum temperature within the collagen fibers in the mid-depth region 2B of the cornea 2. Accordingly, the dielectric layer 110D is positioned between the conductors 111A and 111B and the cornea 2. The dielectric layer 110D may be sufficiently thin to minimize interference with microwave emissions and thick enough to prevent superficial deposition of electrical energy by flow of conduction current. For example, the dielectric layer 110D may be a biocompatible material, such as Teflon, deposited to a thickness of about 50 μm. In general, an interposing layer, such as the dielectric layer 110D, may be employed between the conductors 111A and 111B and the cornea 2 as long as the interposing layer does not substantially interfere with the strength and penetration of the microwave radiation field in the cornea 2 and does not prevent sufficient penetration of the microwave field and generation of a desired heating pattern in the cornea 2. The dielectric material may be elastic, such as polyurethane and silastic, or nonelastic, such as Teflon and polyimides. The dielectric material may have a fixed dielectric constant or varying dielectric constant by mixing materials or doping the sheet, the variable dielectric being spatially distributed so that it may affect the microwave hearing pattern in a customized way. The thermal conductivity of the material may have fixed thermal properties (thermal conductivity or specific heat), or may also vary spatially, through mixing of materials or doping, and thus provide a means to alter the heating pattern in a prescribed manner. Another approach for spatially changing the heating pattern is to make the dielectric sheet material of variable thickness. The thicker region will heat less than the thinner region and provides a further means of spatial distribution of microwave heating.
During operation, the distal end 110B of the applicator 110 as shown in FIG. 2 is positioned on or near the corneal surface 2A. Preferably, the applicator 110 makes direct contact with the corneal surface 2A. In particular, such direct contact positions the conductors 111A and 111B at the corneal surface 2A (or substantially near the corneal surface 2A if there is a thin interposing layer between the conductors 111A and 111B and the corneal surface 2A). Accordingly, direct contact helps ensure that the pattern of microwave heating in the corneal tissue has substantially the same shape and dimension as the gap 111C between the two microwave conductors 111A and 111B. An annulus is a preferred heating pattern because the inner diameter of the heated annulus can be selected to be sufficiently large so as to avoid heating the central cornea overlying the pupil.
The advantages of direct contact between the applicator 110 and the corneal surface 2A may be reduced by the presence of a layer of fluid coolant which may exist therebetween. Rather than creating an annular heating pattern with dimensions equal to that of the gap between the conductors 111A and 111B, the presence of such a fluid layer may cause a less desirable circle-shaped microwave heating pattern in the cornea 2 with a diameter less than that of the inner conductor 111B. Therefore, embodiments of the present invention do not require a flow of coolant or a cooling layer to exist over the corneal surface 2A during the application of energy to the cornea 2. In particular, the short pulses from the coolant delivery element 112 may apply a coolant that evaporates from the corneal surface before the application of the microwave energy and thus does not create a fluid layer that would interfere with the desired microwave pattern.
Embodiments may employ a vacuum passageway 114 operably connected to a vacuum source 130. The vacuum passageway 114 may have an opening 114A that is positioned near the corneal surface 2A and opens to the interior of the applicator 110. The vacuum source 130 may be used to draw any coolant, or unwanted fluid layer, from the corneal surface 2A before the microwave energy is applied to the cornea 2. In this case, the vacuum source 130 also draws the fluid to a waste receptacle (not shown).
The application of coolant and the subsequent evaporation of coolant may cause the pressure to increase within the applicator 110. In particular, the applicator 110 may have an outer surface 110C that may define a substantially enclosed assembly, especially when the distal end 110B is placed in contact with the corneal surface 2A. As shown in FIG. 2, the substantially enclosed assembly contains the electrical conducting element 111, the coolant delivery element 112, the coolant supply 113, as well as the vacuum passageway 114. The pressure is more likely to increase within such an enclosed assembly. As the applicator 110 may be in contact with the corneal surface 2A, the resulting pressure may act against the corneal surface 2A. Therefore, to minimize the effects of this pressure on the corneal surface 2A, embodiments may employ a pressure relief mechanism for removing excess pressure that may occur in the applicator 110.
In addition to the functions of the vacuum passageway 114 discussed previously, the vacuum passageway 114 with opening 114A may also act as a pressure relief mechanism for the applicator 110. As such, the pressure in the applicator 110 may be lowered by activating the vacuum source 130. Alternatively, as shown in FIG. 3A, the applicator 110 may include any type of pressure relief valve 118 that opens up the interior of the applicator 110 to the environment external to the applicator 110 when the pressure in the applicator 110 rises to a certain level. As another alternative shown in FIG. 3B, the applicator 110 may simply employ a vent passage 119 that places the interior of the applicator 110 in communication with the environment external to the applicator 110, in which case the pressure interior will generally be in equilibrium with the external area.
As FIG. 2 further illustrates, the vacuum passageway 114 also passes through the dielectric material 110D and has an opening 114B at the distal end 110B. While the opening 114A opens to the interior of the applicator 110, the opening 114B opens to the corneal surface 2A which is positioned at the distal end 110B. With the opening 114B positioned at the corneal surface 2A, the vacuum passageway 114 with the vacuum source 140 helps the applicator 110 to maintain a fixed position relative to cornea 2 during treatment. The vacuum source 130 may apply a controlled amount of suction to the corneal surface 2A to ensure that the applicator surface at the distal end 110B has a firm and even contact with the cornea 2.
Referring to FIG. 8A, an alternative embodiment employs an applicator 510, which includes an electrical energy conducting element 511, a micro-controlled coolant delivery system 512, as well as a coolant supply 513. Except where indicated otherwise, the applicator 510 may be similar in many respects to the applicator 110. In general, the electrical energy conducting element 510 extends from a proximal end 510A to a distal end 510B of the applicator 510. The electrical energy conducting element 511 is operably connected to an electrical energy source 520 at the proximal end 510A and conducts electrical energy to the distal end 510B to apply energy, for example, to a cornea 2 of an eye 1. For example, the electrical energy source 520 may include a microwave oscillator for generating microwave energy.
As shown in FIG. 8A, the electrical energy conducting element 511 includes electrodes 511A and 511B, which extend from the proximal end 510A to the distal end 510B of the applicator 510. In particular, the electrode 511A is an outer conductor with an inner passage, while the electrode 511B is an inner conductor that extends through the inner passage of the conductor 511A. The inner and the outer conductors 511A and 511B may be formed, for example, of aluminum, stainless steel, brass, copper, other metals, coated metals, metal-coated plastic, or any other suitable conductive material.
The outer conductor 511A and the inner conductor 511B may be substantially cylindrical at least at the distal end 510B. As such, the outer conductor 511A and the inner conductor 511B may be concentrically arranged. With this concentric arrangement, a substantially annular gap 511C of a selected distance may be defined between the conductors 511A and 511B. The distance, or radial thickness, of the annular gap 511C between conductors 511A and 511B determines the penetration depth of microwave energy into the cornea 2 according to established microwave field theory. Thus, the energy conducting element 511 receives, at the proximal end 510A, the electrical energy generated by the electrical energy source 520, and directs microwave energy to the distal end 511B, where the cornea 2 is positioned.
The outer diameter of the inner conductor 511B is preferably larger than the pupil. In general, the outer diameter of the inner conductor 511B may be selected to achieve an appropriate change in corneal shape, i.e. keratometry, induced by the exposure to microwave energy. Meanwhile, the inner diameter of the outer conductor 511A may be selected to achieve a desired gap between the conductors 511A and 511B. For example, the outer diameter of the inner conductor 511B may range from approximately 2 mm to approximately 10 mm while the inner diameter of the outer conductor 111A ranges from approximately 2.1 mm to approximately 12 mm. In some embodiments, the annular gap 511C may be range from approximately 0.1 mm to approximately 2.0 mm, or preferably approximately 0.5 mm to approximately 1.5 mm.
As shown further in FIG. 8A, the distal end 510B of the inner conductor 511B includes a thin contact area 511E. In particular, the contact area 511E may be a thin annular surface that is disposed along the periphery of a substantially circular opening 51111 at the distal end 510B. In some embodiments, the contact area 511E may have a radial thickness of approximately 50 μm to approximately 200 μm. The inner electrode 511B is shown in greater detail in FIGS. 8B-D. FIG. 8B illustrates a perspective view of the inner electrode 511B, while FIG. 8C shows a closer view of the contact area 511E. The circular opening 511H is defined by a hollow portion 511G that extends into the inner conductor 511B from the distal end 510B. The hollow portion 511G is defined, in turn, by a concave, substantially semi-spherical surface 5111 within the inner conductor 511B. When the inner conductor 511B is applied to an eye, the interior surface 5111 is shaped so that only the thin contact area 511E contacts the corneal surface 2A. Similar to embodiments discussed previously, a dielectric layer may be employed along the contact area 511E.
As illustrated in FIG. 8A, the energy conducting element 511 may include at least one vent 519 that helps to control the pressure within the hollow portion 511G. For example, an interior vent 519 may connect the hollow portion 511G to the gap 511C between the inner electrode and the outer electrode, and an exterior vent may connect the gap 511C to an exterior area outside the energy conducting element 511.
FIG. 8E illustrates the thin contact area 511E positioned at the corneal surface 2A of an eye 1. In addition, FIG. 8F shows a ring 3 that corresponds to the uniform shrinkage of corneal fibers resulting from the application of energy via the thin contact area 511E (with a radial thickness of approximately 200 μm) to the corneal surface 2A. As shown in FIG. 8F, employing a thin contact area 511E produces a well-defined contact area with the corneal surface 2A, leading to uniform circular contact. In particular, the narrow contact between the inner electrode 511B and the corneal surface 2A results in a very localized microwave contact area and power deposition region. Moreover, the small thermal mass corresponding to the inner electrode 511B enables more controlled cooling. Although the contact area 511E shown in FIGS. 8A-D may be substantially annular, it is contemplated that other embodiments may employ contact areas of other shapes, such as an ellipse, that deliver energy to the cornea 2 according to a well-defined pattern.
As further illustrated in FIGS. 8B-C, the inner conductor 511B may include openings, or ports, 512C, D, E for delivering coolant from the coolant source 513 to the eye 1 positioned at the distal end 510B. The openings 512C, D are disposed within the hollow portion 511G, while the openings 512E are disposed along an exterior surface 511J of the inner conductor 511B. Accordingly, as shown in FIG. 8A, the openings 512C, D deliver coolant to the eye 1 from the interior of the inner conductor 511B, and the openings 512E deliver coolant to the eye 1 from the gap 511C, outside the inner conductor 511B.
Any number of openings 512C, D, E may be sized and arranged according to any configuration that achieves a predetermined delivery of coolant to the eye 1. In the example of FIGS. 8B-C, the plurality of openings 512E are equally spaced around the inner conductor 511B, while the plurality of openings 512C, D are arranged in two concentric circles. In particular, the openings 512C are equally spaced in a larger circle disposed along the surface 5111, while the openings 512D are equally spaced in a smaller circle along the angled surface of an interior structure 511K. The interior structure 511K, which is generally frustoconical, is disposed centrally within the hollow portion 511G. Positioning the smaller openings 512D on its angled surface allows the coolant to be delivered at a particular angle to the eye 1. FIGS. 8B-C also illustrate that openings 512C, D, E may have varying sizes to deliver a predetermined amount of coolant from each opening.
FIG. 8D shows the coolant delivery system 512 within the inner conductor 511B. In particular, coolant channels 512A, B are operably connected to the coolant source 513 and direct coolant through the openings 512C, D, E. A central channel 512A extends centrally through the inner conductor 511B to the distal end 510B, and additional channels 512B branch out to the openings 512C, D, E. The branching channels 512B may be angled with respect to the interior surface 5111, the interior structure 511K, and the exterior surface 511J so that the coolant passes through the openings 512C, D, E at selected angles toward the eye 1.
As described previously, a controller 540, as shown in FIG. 8A, may be operably connected to the energy source 520 and/or the coolant delivery system 512. The controller 540 may be employed to control the delivery of energy from the energy source 520 to the applicator 510, thereby determining the magnitude and timing of energy delivered to the cornea 2 positioned at the distal end 510B. In addition, the controller 540 may be employed to determine the amount and timing of coolant delivered from the coolant delivery element 512 toward the eye 1 at the distal end 510B. In particular, the controller 540 may be employed to selectively apply the energy and the coolant any number of times according to a predetermined or calculated sequence. For instance, the coolant may be applied to the corneal surface 2A before, during, and/or after the application of heat to the cornea 2.
During operation of the applicator 510, the electrical energy conducting element 511 is positioned at a corneal surface 2A of an eye 1. A selected amount of electrical energy is delivered through the thin contact area 511E to the cornea 2 according to a power parameter and a time parameter. The power parameter and the time parameter generate structural changes in a localized volume in the eye.
Numerical modeling with a commercially available package (e.g., from COMSOL, Inc.) was performed in an eye model to compare a range of energy settings (power×time) and the resulting lesion, defined as the region of corneal shrinkage. The lesion is defined as the region in the eye that attains a temperature of 65° C. due to the power and time applied with an energy conducting element 511 having a thin contact area 511E. In these simulations, the annular thickness of the thin contact area 511E was approximately 100 μm while the gap 511C between the electrodes was approximately 1.25 mm. A membrane of polyurethane with a thickness of 35 μm was also placed between the thin contact area 511E and the corneal surface. The initial temperature for the cornea, aqueous layer, lens and both the outer conductor 511A and the inner conductor 511B was set to 20° C.
In a first set of simulations, the application of the energy conducting element 511 was compared for different power settings while maintaining substantially the same lesion size. Specifically, energy was varied by changing the pulse time, and power was varied from 100 W to 500 W in increments of 100 W, while the volume of the lesion size remained substantially constant (with temperature remaining substantially constant at 65° C.).
Results of Simulations Varying Energy and Power while Keeping Lesion Size Constant













TABLE 1








Max
Area
Volume
% Deviation


Pow-

Ener-
temp
of
of
in volume


er/
Time/
gy/
Reached/
ROI >
ROI >
compared to


W
ms
J
C.
65 C./m2
65 C./m3
minimum





















500
10.2
5.1
111.2
1.60E−08
2.48E−10
1.8%


400
13
5.2
106.6
1.59E−08
2.46E−10
1.2%


300
17.9
5.37
100.58
1.57E−08
2.43E−10
0.0%


200
29
5.8
93.1
1.59E−08
2.46E−10
1.2%


100
75
7.5
82.5
1.58E−08
2.45E−10
0.7%









The results of the first set of simulations are provided in TABLE 1. TABLE 1 shows the range of power values and the range of time values required to achieve the constant target lesion size. At higher powers, less energy was required for the same lesion size. For example, when the power applied was 100 W, the power was applied for 75 ms to produce 7.5 J and to achieve the target lesion. When power was increased to 500 W, however, the power was applied for only 10.2 ms to produce 5.1 J and achieve the target lesion. FIG. 9A also provides a graph of change in energy as a function of increasing power for a constant target lesion size. Accordingly, as power increases, the energy requirements decrease for the same tissue effect, i.e., a constant lesion size at 65° C.
A second set of simulations was also performed by calculating the lesion size while keeping the energy level constant at 5 J and varying the power. Time and power were adjusted at each power level to maintain 5 J. FIG. 9B shows the maximum temperature reached as a function of increasing power for the second set of simulations, while FIG. 9C shows lesion volume as a function of increasing power. As shown by FIG. 9B, the maximum temperature increased as the power increased. As shown in FIG. 9B, the rate of change at low powers (between 100 W and 200 W) was greater than the rate at higher powers (200 W and 500 W). In particular, the maximum temperature increased by a factor of 1.23 times when doubling power from 100 W to 200 W, and by a factor of 1.17 times when doubling power from 200 W to 400 W. Correspondingly, as shown by FIG. 9C, the lesion volume (defined as the region that achieved or exceeded 65° C.) increased as the power increased. Similar to the graph of FIG. 9B, the rate of change at low power (between 100 W and 200 W) was higher than the rate at higher power (200 W and 500 W). In particular, the volume increased by a factor of 2.9 times when doubling power from 100 W to 200 W, and by a factor of 1.22 times when doubling power from 200 W to 400 W.
Accordingly, the selected amount of electrical energy is deliverable according to a range of power values and a range of corresponding time values. To produce a selected lesion volume in a cornea, the range of power values must exceed a particular threshold power value and the range of time values be less than a particular threshold time value. Although a large amount of energy may be delivered to the cornea by applying a low power value over a longer period of time, the desired lesion may not be sufficiently generated in the corneal tissue with such parameters. Indeed, as described above, a selected lesion volume may be produced by applying less energy with a higher power. Thus, during operation of the applicator 511, the power parameter may be an upper power value in the range of power values, while the corresponding time parameter is a lower time value in the range of time values. In particular, the upper power value may range from approximately 300 W to approximately 500 W, while the lower time value may range from approximately 4 ms to approximately 80 ms. Correspondingly, the selected amount of energy applied to the eye 1 may range from approximately 2 J to approximately 25 J. Moreover, the localized volume may from approximately 0.1 mm3 to approximately 2.0 mm3. Although power parameters and time parameters for applying energy to an eye may be discussed with reference to the embodiment of FIG. 8A, it is understood that power parameters and time parameters may be determined in a similar manner for other embodiments.
Referring now to the cross-sectional view illustrated in FIG. 4, another embodiment of the present invention employs an applicator 210, which includes an optical energy conducting element 211, a micro-controlled coolant delivery system 212, as well as a coolant supply 213.
The optical energy conducting element 211 is operably connected to an optical energy source 220, for example, via conventional optical fiber. The optical energy source 220 may include a laser, a light emitting diode, intense pulsed light (IPL), or the like. The optical energy conducting element 211 extends to the distal end 210B from the proximal end 210A, where it is operably connected with the optical source 220. The optical energy conducting element includes an optical fiber 211A. Thus, the optical fiber 211A receives optical energy from the optical energy source 220 at the proximal end 210A and directs the optical energy to the distal end 210B, where the cornea 2 of an eye 1 is positioned. A controller 240 may be operably connected to the optical energy source 220 to control the delivery, e.g. timing, of the optical energy to the optical conducting element 211. The optical energy conducting element 211 irradiates the cornea 2 with the optical energy and generates heat for appropriately shrinking collagen fibers in the mid-depth region 2B of the cornea 2. As also illustrated in FIG. 4, the optical conducting element may optionally include an optical focus element 212B, such as a lens, to focus the optical energy and to determine the pattern of irradiation for the cornea 2.
As FIG. 4 illustrates, the coolant delivery system 212 may be positioned adjacent to the optical energy conducting element 211. The coolant delivery system 212, which is in fluid communication with the coolant supply 213, delivers micro-controlled pulses of coolant, or cryogen, from the coolant supply 213 to the corneal surface 2A. Such pulses of coolant may be applied before and/or after energy is applied to the cornea 2 with the optical energy source 220 and the optical energy conducting element 211.
FIG. 4 further illustrates another technique for delivering pulses of coolant to the corneal surface 2A. In particular, the pulse of coolant may be drawn from the coolant delivery element 212 by creating an area of low pressure at or near the distal end 210B, where the corneal surface 2A is positioned. As shown in FIG. 4, the applicator 210 may have a vacuum passageway 214, such as a tube structure, which is connected to the vacuum source 230. The vacuum passageway 214 has an opening 214A which is positioned at or near the distal end 210B to create the area of low pressure. To enhance the applicator's ability to create this low pressure area, the applicator 210, as illustrated in FIG. 4, may include a contact element 215 that defines a small enclosure in which the area of low pressure can be created.
In particular, FIG. 4 shows that the applicator 210 includes a contact element 215 at the distal end 210B which makes contact with the corneal surface 2A. The contact element 215 has a housing 215A with a cavity 215B. The housing 215A has an opening 215C at the distal end 210B of the applicator 210, so that the cavity 215B is exposed to the distal end 210B. As such, the contact element 215 forms an enclosure over the cornea 2 when it is positioned over the cornea 2. As shown further in FIG. 4, the nozzle structure 212A of the coolant delivery element 212 is received by the contact element 215 and the opening 212B opens to the cavity 215B. In some embodiments, the coolant delivery system 212 simply places the coolant supply in communication with the contact element 215 via structure 212A. While one coolant delivery element 212 is illustrated in FIG. 4, it is understood that more than one coolant delivery element 212 may be employed by the applicator 210. The vacuum passageway 214 is also received by the contact element, where the opening 214A opens to the cavity 215B. Accordingly, when the contact element 215 is positioned over the corneal surface 2A to form an enclosure, the vacuum source 240 may be operated to create a near vacuum or low pressure in the cavity 215B, which in turn draws the coolant through the nozzle structure 212A toward the corneal surface 2A positioned at the opening 215C. The controller 240 may be operably connected to control the vacuum source 240 to cause micro-controlled pulses of coolant to be drawn from the coolant delivery element 212.
Of course, it is understood that in other embodiments, the contact element 215 may be employed with a coolant delivery element 212 that employs a solenoid valve, or other actuator, and does not require the vacuum source 230. As such, the controller 140 may electronically control the solenoid valve, or other actuator, to deliver the coolant to the corneal surface 2A.
The application of coolant to the corneal surface 2A and the subsequent evaporation of coolant may cause the pressure to increase within the cavity 215A of the contact element 215. As the contact element 215 is positioned against the corneal surface 2A, the resulting pressure may act against the corneal surface 2A. Therefore, to minimize the effects of this pressure on the corneal surface 2A, embodiments may employ a pressure relief mechanism for removing excess pressure that may occur in the applicator 210.
In addition to providing a way to initiate micro-controlled pulses of coolant, the vacuum passageway 214 may also act as a pressure relief mechanism for the applicator 210. As such, the pressure in the applicator 210 may be lowered by activating the vacuum source 230. Alternatively, as shown in FIG. 5A, the applicator 210 may include any type of pressure relief valve 218 that opens up the interior of the applicator 210 to the environment external to the applicator 210 when the pressure in the applicator 210 rises to a certain level. As another alternative shown in FIG. 5B, the applicator 210 may simply employ a vent passage 219 that places the interior of the applicator 210 in communication with the environment external to the applicator 210, in which case the interior pressure will generally be in equilibrium with the external area. Of course, as there is no vacuum source shown in the embodiments of FIGS. 5A and 5B, the coolant delivery element 212 requires another element such as a solenoid valve, or other actuator, to deliver the pulses of coolant.
As further shown in FIG. 4, the contact element 215 also receives the optical conducting element 211, so that the applicator 210 can deliver the optical energy from the optical energy source 220 to the cornea 2 at the distal end 210B. FIG. 4 shows that the optical focus element 211B is connected to the contact element 215.
Advantageously, the contact element 215 may act as an additional heat sink for drawing heat from the corneal surface 2A, as the contact element 215 is in direct contact with the corneal surface 2A. In particular, the contact element may be formed from a heat conducting material, such as a metal. In general, other heat sinks, such as metal applicator walls 410C, may be employed with embodiments of the present invention to provide further heat transfer from the corneal surface 2A.
As FIG. 4 further illustrates, the vacuum passageway 214 also has an opening 214B at the distal end 210B. While the opening 214A opens to the cavity 215B of the contact element 215, the opening 214B opens to the corneal surface 2A which is positioned at the distal end 110B. With the opening 214B positioned at the corneal surface 2A, the vacuum passageway 214 with the vacuum source 240 helps the applicator 210 to maintain a fixed position relative to cornea 2 during treatment. The vacuum source 230 may apply a controlled amount of suction via opening 214B to the corneal surface 2A to ensure that applicator surface at the distal end 210B has a firm and even contact with the cornea 2.
Referring now to the cross-sectional view illustrated in FIG. 6, another embodiment of the present invention is illustrated. In particular, the embodiment of FIG. 6 illustrates an applicator 310 which employs a monopole conducting element 311 for conducting energy to the cornea 2.
The monopole conducting element 311 is operably connected to an electrical energy source 320, which may provide a radio frequency (RF) electrical energy. The monopole 311 extends to the distal end 310B from the proximal end 310A, where it is operably connected with the electrical energy source 320. The monopole conducting element 311 may have a needle-like shape at the distal end 310B, which is designed to contact or penetrate the cornea 2. When the applicator is positioned to place the monopole 311 into contact with the eye 1, the body in contact with the applicator 310 acts as a backplane to complete the circuit. Accordingly, the monopole 311 may receive the electrical energy generated at the electrical energy source 320 and conduct electrical energy to the cornea 2 of an eye 1. As a result, heat is generated within the cornea 2 to shrink selected collagen fibers in the mid-depth region 2B of the cornea 2 and to reshape the cornea 2. A controller 340 may be operably connected to the electrical energy source 320 to control the delivery, e.g. timing, of the electrical energy to the monopole 311.
Other aspects of the embodiment of FIG. 6 are similar to the embodiments described previously. In particular, as FIG. 6 illustrates, the applicator 310 also employs a micro-controlled coolant delivery system 312 as well as a coolant supply 313. The micro-controlled coolant delivery system 312 is positioned adjacent to the monopole 311. The coolant delivery element 312 may employ a nozzle structure 312A with an opening 312B directed at the distal end 310B. A solenoid valve, or other actuator, may be employed to create the pulses of coolant. The controller 340 may electronically control the solenoid valve, or other actuator, to deliver the coolant to the corneal surface 2A. As such, the micro-controlled coolant delivery system 312, which is in fluid communication with the coolant supply 313, operates in a manner similar to the coolant delivery system 12 in FIG. 1. In other words, pulses of coolant, or cryogen, from the coolant supply 313 are preferably applied to the corneal surface 2A before, during, or after the energy is applied to the cornea 2, or any combination thereof.
As also shown in FIG. 6, the applicator 320 may include a vacuum passageway 314 with an opening 314A positioned at or near the distal end 310B. The vacuum passageway 314 is operably connected to a vacuum source 330, which may be controlled by the controller 340. Similar to other embodiments described previously, the vacuum source 340 and the vacuum passageway 314 may be operated to relieve pressure created by the delivery of coolant from the coolant delivery element 312. Alternatively, a pressure relief valve or a vent passage may be employed to act as the pressure relief element, in a manner similar to embodiments described previously.
In addition, as further shown in FIG. 6, the vacuum passageway 314 may also have an opening 314B that opens to the corneal surface 2A which is positioned at the distal end 310B. With the opening 314B positioned at the corneal surface 2A, the vacuum passageway 314 with the vacuum source 340 creates suction between the applicator 110 and the corneal surface 2A to maintain the applicator 310 in a fixed position relative to cornea 2 during treatment.
In general, any arrangement of vacuum openings operably connected to a vacuum source may be employed to keep embodiments of the present invention in position over the corneal surface during treatment. For example, FIG. 7A shows an applicator 410 which is positioned over the cornea 2 with a vacuum ring 417. Like the applicators described above, the applicator 410 includes an energy conducting element 411, such as those discussed previously, which extends from the proximal end 410A to the distal end 410B of the applicator 410. The energy conducting element 411 is operably connected to an energy source 420 at the proximal end 410A. Operation of the energy source 420 causes energy to be conducted through the energy conducting element 420 and heat to be generated at the distal end 410B. As such, the vacuum ring 417 positions the distal end 410B of the applicator 410 over the cornea 2 to enable the energy conducting element 411 to generate heat at the cornea 2. In particular, the heat is applied to targeted collagen fibers in a mid-depth region 2B of the cornea 2, thereby shrinking the collagen fibers and reshaping the cornea 2 to improve vision through the eye 1.
As shown further in FIGS. 7A and 7B, the vacuum ring 417 has a substantially annular structure and receives the energy conducting element 411 coaxially through a ring passage 417A. The vacuum ring 417 creates a vacuum connection with the corneal surface 2A to fix the energy conducting element 411 to the corneal surface 2A. The vacuum ring 417 may include an interior channel 417C which is operably connected to the vacuum source 430 via connection port 417B. The vacuum ring 417 may also include a plurality of openings 417D which open the interior channel 417B to the corneal surface 2A. Therefore, when the openings 417D are positioned in contact with the corneal surface 2A and the vacuum source 430 is activated to create a near vacuum or low pressure within the interior channel 417C, the openings 417D operate to suction the vacuum ring 417 and the applicator 410 to the corneal surface 2A. In this case, the vacuum source 430 may be a syringe or similar device.
In some embodiments, the energy conducting element 411 and the vacuum ring 417 may be separate components which may be detachably coupled to each other. Thus, as shown in FIG. 7A, a separate energy conducting element 411 may be slidingly received by the vacuum ring 417 into the coaxial position. Any coupling technique, such as a mechanical attachment, may be employed to keep the energy conducting element 411 stably positioned within the vacuum ring 417. The vacuum ring 417 may be positioned on the corneal surface 2A before it receives the energy conducting element 411, or alternatively, the electrical conducting element 411 may be combined with the vacuum ring 417 before the combination is positioned on the corneal surface 2A.
In alternative embodiments, the energy conducting element 411 and the vacuum ring 417 may be non-detachably fixed to each other.
Other aspects of the embodiment of FIG. 7 are similar to the embodiments described previously. In particular, as FIG. 7 illustrates, the applicator 410 also employs a micro-controlled coolant delivery system 412 as well as a coolant supply 413. The coolant delivery element 412 may employ a nozzle structure 412A with an opening 412B directed at the distal end 410B. A solenoid valve, or other actuator, may be employed to create the pulses of coolant. The controller 440 may electronically control the solenoid valve, or other actuator, to deliver the coolant to the corneal surface 2A. As such, the micro-controlled coolant delivery system 412, which is in fluid communication with the coolant supply 413, operates in a manner similar to the coolant delivery system 12 in FIG. 1. In other words, pulses of coolant, or cryogen, from the coolant supply 413 are preferably applied to the corneal surface 2A before and after the energy is applied to the cornea 2.
The embodiments described herein may all employ sensors to measure physical variables of the eye. For example, in one embodiment, FIG. 1 depicts a plurality of sensors 16 which are discretely positioned at and about the distal end 10B of the applicator 10. The sensors may be operably connected to the controller 40 (not shown) to allow the data to be stored and/or communicated to operators. As a further example, the embodiment of FIGS. 7A and 7B employs an arrangement of sensors 416 on the vacuum ring 417 as the vacuum ring 417 makes direct contact with the corneal surface 2A. In other embodiments, sensors may be more broadly incorporated into a surface at the distal end of the applicator, such as the dielectric layer 110D in FIG. 2. Typically, the sensors are placed in contact with the cornea and provide measurements for various areas of the cornea. In general, the sensors may include devices that are formed as parts of the applicator and/or external devices that are separate from the applicator. The sensors may be microelectronic devices, including, but not limited to, infrared detectors that measure temperature, thin film or microelectronic thermal transducers, mechanical transducers such as a piezoresistive or piezoelectric devices, or force-sensitive quartz resonators that quantify corneal elongation or internal pressure.
In general, the sensors may provide information that is used to prepare the systems before treatment, provide feedback during treatment to ensure proper application of treatment, and/or measure the results of the treatment.
The cornea and eye have one or more variable physical properties that may be affected by the application of energy and the resulting increase in temperature. The sensors may directly or indirectly measure these physical variables and provide a sensor signal to processing circuitry, such as the controllers 40, 140, 240, and 340 described above. The controller may analyze the measurements to determine if and when the treatment has achieved the desired effects. Processing circuitry may also generate a stop signal that terminates treatment when a specified physical variable achieves a predetermined value or falls within a predetermined range. In some embodiments, to avoid thermal damage to the corneal epithelium, and the endothelium, program instructions for the controller may include a safety mechanism that generates a stop signal when the application of heat energy exceeds certain parameters, e.g. time limits.
The embodiments described herein may also include disposable and replaceable components, or elements, to minimize cross-contamination and to facilitate preparation for procedures. In particular, components that are likely to come into contact with the patient's tissue and bodily fluids are preferably discarded after a single use on the patient to minimize cross-contamination. Thus, embodiments may employ one or more use indicators which indicate whether a component of the system has been previously used. If it is determined from a use indicator that a component has been previously used, the entire system may be prevented from further operation so that the component cannot be reused and must be replaced.
For example, in the embodiment of FIG. 1, a use indicator 50 is employed to record usage data which may be read to determine whether the applicator 10 has already been used. In particular, the use indicator 50 may be a radio frequency identification (RFID) device, or similar data storage device, which contains usage data. The controller 40 may read and write usage data to the RFID 50. For example, if the applicator 10 has not yet been used, an indicator field in the RFID device 50 may contain a null value. Before the controller 40 delivers energy from the energy source 20 to the energy conducting element 11, it reads the field in the RFID device 50. If the field contains a null value, this indicates to the controller 40 that the applicator 10 has not been used previously and that further operation of the applicator 10 is permitted. At this point, the controller 40 writes a value to the field in the RFID device 50 to indicate that the applicator 10 has been used. When a controller 40 later reads the field in the RFID device 50, the non-null value indicates to the controller 40 that the applicator 10 has been used previously, and the controller will not permit further operation of the applicator 10. Of course, the usage data written to the RFID device 50 may contain any characters or values, or combination thereof, to indicate whether the component has been previously used.
In another example, where the applicator 410 and the vacuum ring 417 in the embodiment of FIG. 7A are separate components, use indicators 450A and 450B may be employed respectively to indicate whether the application 410 or the vacuum ring 417 has been used previously. Similar to the use indicator 50 described previously, the use indicators 450A and 450B may be RFID devices which the controller 440 may access remotely to read or write usage data. Before permitting operation of the applicator 410, the controller 40 reads the use indicators 450A and 450B. If the controller 440 determines from the use indicators 450A and 450B that the applicator 410 and/or the vacuum ring 417 have already been used, the controller 440 does not proceed and does not permit further operation of the applicator 410. When the applicator 410 and the vacuum ring 417 are used, the controller 440 writes usage data to both use indicators 450A and 450B indicating that the two components have been used.
In operation, a physician or other operator manually accesses a device, such as a computer keyboard, that interfaces with a controller, such as the controllers 40, 149, 240, and 340. The interface enables the operator to set up and/or initiate treatment. The system may request input, such as a predetermined amount of diopter correction that is required for a particular patient, baseline measurements of physical variables, astigmatism measurements, parameters for energy conduction to the cornea, timing and sequence information for the application of heat energy and pulses of coolant, and/or target values for physical variables that will be modified by treatment. The controller accepts program instructions that may access user input data or program selections from the interface and causes the system to implement a selected vision correction treatment.
In general, the controller may be a programmable processing device that executes software, or stored instructions, and that may be operably connected to the devices described above. In general, physical processors and/or machines employed by embodiments of the present invention for any processing or evaluation may include one or more networked or non-networked general purpose computer systems, microprocessors, field programmable gate arrays (FPGAs), digital signal processors (DSPs), micro-controllers, and the like, programmed according to the teachings of the exemplary embodiments of the present invention, as is appreciated by those skilled in the computer and software arts. The physical processors and/or machines may be externally networked with the image capture device, or may be integrated to reside within the image capture device. Appropriate software can be readily prepared by programmers of ordinary skill based on the teachings of the exemplary embodiments, as is appreciated by those skilled in the software art. In addition, the devices and subsystems of the exemplary embodiments can be implemented by the preparation of application-specific integrated circuits (ASICs) or by interconnecting an appropriate network of conventional component circuits, as is appreciated by those skilled in the electrical art(s). Thus, the exemplary embodiments are not limited to any specific combination of hardware circuitry and/or software.
Stored on any one or on a combination of computer readable media, the exemplary embodiments of the present invention may include software for controlling the devices and subsystems of the exemplary embodiments, for driving the devices and subsystems of the exemplary embodiments, for enabling the devices and subsystems of the exemplary embodiments to interact with a human user, and the like. Such software can include, but is not limited to, device drivers, firmware, operating systems, development tools, applications software, and the like. Such computer readable media further can include the computer program product of an embodiment of the present inventions for performing all or a portion (if processing is distributed) of the processing performed in implementing the inventions. Computer code devices of the exemplary embodiments of the present inventions can include any suitable interpretable or executable code mechanism, including but not limited to scripts, interpretable programs, dynamic link libraries (DLLs), Java classes and applets, complete executable programs, and the like. Moreover, parts of the processing of the exemplary embodiments of the present inventions can be distributed for better performance, reliability, cost, and the like.
Common forms of computer-readable media may include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other suitable magnetic medium, a CD-ROM, CDRW, DVD, any other suitable optical medium, punch cards, paper tape, optical mark sheets, any other suitable physical medium with patterns of holes or other optically recognizable indicia, a RAM, a PROM, an EPROM, a FLASH-EPROM, any other suitable memory chip or cartridge, a carrier wave or any other suitable medium from which a computer can read.
While various embodiments in accordance with the present invention have been shown and described, it is understood that the invention is not limited thereto. The present invention may be changed, modified and further applied by those skilled in the art. Therefore, this invention is not limited to the detail shown and described previously, but also includes all such changes and modifications.

## Claims

1. A system for applying therapy to an eye, the system comprising:
an energy source;
a conducting element operably connected to the energy source and extending from a proximal end of the conducting element to a distal end of the conducting element, the conducting element adapted to direct energy from the energy source to the distal end;
a coolant supply;
at least one coolant delivery element in communication with the coolant supply; and
a sheet of dielectric material covering the distal end to provide a bottom surface of a substantially enclosed assembly that includes at least the conducting element and the coolant delivery system, the coolant delivery element being adapted to deliver a micro-controlled pulse of coolant to the dielectric material.

2. The system according to claim 1, wherein the conducting element includes an outer conductor and an inner conductor, the outer conductor and the inner conductor being separated by a gap.

3. The system of claim 2, wherein the inner conductor includes at least one coolant delivery opening coupled to the coolant delivery system, the at least one coolant delivery opening configured to deliver coolant toward the distal end.

4. The system of claim 3, wherein the at least one coolant delivery opening comprises a plurality of coolant delivery openings equally spaced around an exterior surface of the inner conductor.

5. The system of claim 3, wherein the at least one coolant delivery opening comprises a plurality of coolant delivery openings arranged in at least two concentric circles on the inner conductor.

6. The system of claim 3, wherein the inner conductor includes a frustoconical interior structure disposed centrally within a hollow portion.

7. The system of claim 6, wherein the inner conductor further includes at least one channel coupling the at least one coolant delivery opening to the coolant delivery system.

8. The system of claim 7, wherein the at least one channel and the at least one coolant opening are disposed on an angled surface of the frustoconical structure.

9. The system of claim 2, wherein the coolant delivery system is disposed in the gap between the outer conductor and the inner conductor.

10. The system according to claim 1, further comprising a vacuum source and at least one vacuum channel connected to the vacuum source, the at least one vacuum channel having an opening positioned at the distal end.

11. The system according to claim 10, wherein the vacuum channel opening is adapted to engage the eye and position the distal end relative to a feature of the eye.

12. The system according to claim 10, wherein the vacuum channel opening is adapted to draw away the coolant delivered by the at least one coolant delivery element.

13. The system according to claim 1, further comprising a vacuum source coupled to at least one vacuum channel, the at least one vacuum channel having an opening positioned at the distal end and the vacuum source being operable to lower the pressure at the distal end.

14. The system according to claim 1, wherein the sheet of dielectric material has a varying dielectric constant.

15. The system according to claim 1, wherein the sheet of dielectric material has a variable thickness.

16. A system for applying therapy to an eye, the system comprising:
an energy source;
a conducting element operably connected to the energy source and extending from a proximal end of the conducting element to a distal end of the conducting element, the conducting element adapted to direct energy from the energy source to the distal end, the conducting element including an outer conductor and an inner conductor, the outer conductor being separated from the inner conductor by a gap;
a coolant supply;
at least one coolant delivery element in communication with the coolant supply;
a sheet of dielectric material covering the distal end to provide a bottom surface of a substantially enclosed assembly that includes at least the conducting element and the coolant delivery system, the coolant delivery element being adapted to deliver a micro-controlled pulse of coolant to the dielectric material, at least one of a distal end of the outer conductor and a distal end of the inner conductor being in direct contact with the sheet of dielectric material; and
a controller communicatively coupled to the energy source and the at least one coolant delivery element, the controller operable to control delivery of energy from the energy source to the conducting element, the controller further operable to control delivery of the coolant from the at least one coolant delivery element to the dielectric material.

17. The system according to claim 16, wherein the controller is configured to cause the at least one coolant delivery element to deliver a pulse of coolant to the dielectric material to evaporatively cooling the eye.

18. The system according to claim 16, wherein the controller is configured to determine the amount and timing of coolant delivered from the at least one coolant delivery element.

19. The system according to claim 16, wherein the inner conductor has an outer diameter of approximately 2 mm to approximately 10 mm and an inner diameter of approximately 2.1 mm to approximately 12 mm.

20. The system according to claim 16, wherein the inner conductor includes a hollow portion defined by a concave, substantially semi-spherical surface within the inner conductor, the inner conductor further includes at least one vent configured to control the pressure within the hollow portion.