1. Field of the Invention
The invention pertains to the field of keratoplasty and, more particularly, to a systems and methods employing an applicator configured to achieve sufficient contact with an eye to apply 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 according to particular patterns, including, but not limited to, circular or annular patterns, may cause aspects of the cornea to flatten and improve vision in the eye.
In general, the pattern of energy applied to a cornea during thermokeratoplasty depends on the position of the energy applicator relative to the cornea. Thus, to provide reliable application of energy to the cornea, embodiments according to aspects of the present invention position the applicator in uniform and constant contact with the cornea while the applicator provides eye therapy. In this way, the relationship between the applicator and the cornea is more definite and the resulting delivery of energy is more predictable and accurate. The positioning of the applicator provides better electrical and thermal contact. Advantageously, these embodiments also provide a system and method for accurately reproducing sufficient contact between the applicator and the cornea.
An electrical energy applicator in one embodiment extends from a proximal end to a distal end. The energy conducting applicator includes, at the proximal end, a connection to an electrical energy source. The energy conducting applicator directs electrical energy from the electrical energy source to the distal end. The distal end is positionable at a surface of an eye. The energy conducting applicator includes a first conductor and a second conductor separated by a gap. The first conductor has a first contact surface at the distal end, and the second conductor has a second contact surface at the distal end. The first conductor and/or the second conductor has a length that is adjustable by a biasing element. The first contact surface of the first conductor is movable relative to the second contact surface of the second conductor. The first contact surface and the second contact surface are adjustably positionable simultaneously against the surface of the eye to deliver energy to the eye according to a pattern defined by the first contact surface, the second contact surface, and the gap.
In operation, the distal end of the electrical energy applicator is positioned at a surface of an eye, and electrical energy is directed from the electrical energy source to the surface of the eye according to the pattern. For example, the distal end of the electrical energy applicator is positioned by positioning the first contact surface against the eye surface and subsequently moving the second contact surface against the eye surface by compressing the biasing element in the first conductor and reducing the length of the first conductor.
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.
In general, the pattern of energy applied to a cornea during thermokeratoplasty depends on the position of the energy applicator relative to the cornea. Thus, to provide reliable application of energy to the cornea, embodiments according to aspects of the present invention position the applicator in uniform and constant contact with the cornea while the applicator provides eye therapy. In this way, the relationship between the applicator and the cornea is more definite and the resulting delivery of energy is more predictable and accurate. The positioning of the applicator provides better electrical and thermal contact. Advantageously, these embodiments also provide a system and method for accurately reproducing sufficient contact between the applicator and the cornea.
As further illustrated in
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 in part the penetration depth of microwave energy into the cornea 2 according to established microwave field theory. Thus, the energy 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.
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 systems, 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 energy by the applicator 110.
A controller 140 may be employed to selectively apply the energy any number of times according to any predetermined or calculated sequence. In addition, the heat 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 determines the extent of changes that are brought about within the cornea 2. Of course, the system attempts to limit the changes in the cornea 2 to an appropriate amount of shrinkage of collagen fibrils in a selected region and according to a selected pattern. 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 systems 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 500 W to 3 kW and a pulse duration in the range of about 5 milliseconds to about one second.
Referring again to
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 ceramic of high or low permittivity, 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 heating 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
The system of
As further illustrated in
As shown in
In some embodiments, sufficient contact is determined by causing an observable amount of flattening, or applanation, of the cornea. The applanation indicates a constant and uniform pressure against the corneal surface 2A. For example, as illustrated in
Other systems and methods for improving electrical and thermal contact between an energy conducting element and the corneal surface are described in U.S. patent application Ser. No. 12/209,123, filed Sep. 11, 2008, which is a continuation-in-part application of U.S. patent application Ser. No. 12/018,457, filed on Jan. 23, 2008, and U.S. patent Ser. No. 12/617,554, filed on Nov. 12, 2009, which claims priority to U.S. Provisional Patent Application No. 61/113,395, filed Nov. 11, 2008, the contents of these applications being entirely incorporated herein by reference.
Unlike the outer conductor 111A shown in
The variable section 212C has a length that can vary along the longitudinal axis 210C. For example, the variable section 212C may be adjustably compressed to reduce its length. As the proximal section 212A and the distal section 212B are connected to opposing ends of the variable section 212C, the distal end 212B (and corresponding contact surface 211G) can move relative to the proximal end 212A. This relative movement results in a change in the length of the variable section 212C. Any change in the length of the variable section 212C also corresponds to a change in length of the outer conductor 211A. Thus, when opposing compressive forces are applied against the proximal section 212A and the distal section 212B along the longitudinal axis 210C, the variable section 212C may be compressed and the length of the outer conductor 211A may be reduced.
As shown in
However, as also described previously, the variable section 212C allows the distal section 212B to move relative to the proximal section 212A. In fact, the variable section 212C generally allows the distal section 212B to move relative to the rest of the energy conducting element 211, including the inner conductor 211B. As a result, the configuration of the energy conducting element 211 is not fixed and can be changed to allow both the inner conductor 211B and the outer conductor 211A to achieve sufficient contact with the cornea 2. In effect, the degree to which the inner conductor 211B is recessed within the outer conductor 211A is adjustable to achieve the appropriate geometry for the energy conducting electrode 211.
As
Furthermore, even though the distal section 212B may move relative to the inner conductor 211B, the desired contact between the contact surface 211G and the cornea 2 is maintained, so that both contact surfaces 211G and 211H achieve sufficient contact once the inner conductor 211B is moved the necessary distance against the cornea 2. In particular, the variable section 212C may provide a bias against a change in length, so that contact between the cornea 2 and the contact surface 211G must be maintained to provide the necessary force against the distal section 212B to keep the variable section 212C compressed. For example, as shown in
In some embodiments, a sensor system may be coupled to the outer conductor 211A and/or the inner conductor 211B to monitor the force being applied against the eye. The signal from the sensor system may indicate that the desired contact has been achieved or may provide an alert when excessive contact force is applied to the eye.
In other embodiments, the amount of contact between the energy conducting element 211 and the eye may be determined by measuring the effect of sending low level pulses of microwaves from the energy source through the energy conducting element 211. These low level pulses, also known as “sounding pulses,” have a lower power than pulses employed for treatment. When the outer conductor 211A and the inner conductor 211B are only in contact with air at the distal end 210B and are not in contact with an eye, the electrical impedance is generally very high. This impedance may be calculated by sending sounding pulses through the outer conductor 211A and the inner conductor 211B. The sounding pulses also cause power to be reflected within the energy conducting element 211, and this reflected power has a higher value when the outer conductor 211A and the inner conductor 211B are not in contact with tissue. As the energy conducting element 211 comes into contact with tissue, the impedance changes and the reflected power decreases. Thus, the change in contact between the energy conducting electrode 211 and the eye may be dynamically monitored by measuring changes in the impedance or reflected power. An example of a system that monitors contact by measuring reflected power in an energy conducting electrode is described in U.S. patent Ser. No. 12/617,554, filed on Nov. 12, 2009, which claims priority to U.S. Provisional Patent Application No. 61/113,395, filed on Nov. 11, 2008, the contents of these applications being entirely incorporated herein by reference.
In sum, the
In general, however, the embodiment of
Although the embodiments described herein may apply energy to the cornea according to an annular pattern defined by an applicator such as the applicators 110 and 210, the pattern in other embodiments is not limited to a particular shape. Indeed, energy may be applied to the cornea in non-annular patterns. Examples of the non-annular shapes by which energy may be applied to the cornea are described in U.S. patent Ser. No. 12/113,672, filed on May 1, 2008, the contents of which are entirely incorporated herein by reference.
Furthermore, the controller 140 described above may be a programmable processing device that executes software, or stored instructions, and that may be operably connected to the other 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.
Although the application of the embodiments described herein may be described with respect to the cornea, it is understood that aspects of the present invention may be applied to other features of the eye or anatomy.
While the present invention has been described in connection with a number of exemplary embodiments, and implementations, the present inventions are not so limited, but rather cover various modifications, and equivalent arrangements.
This application claims priority to U.S. Provisional Application No. 61/165,998, filed Apr. 2, 2009, the contents of which are incorporated entirely herein by reference.
Number | Date | Country | |
---|---|---|---|
61165998 | Apr 2009 | US |