1. Field of the Invention
The invention pertains to the field of medical treatment and, more particularly, to systems and methods for sterilizing a field, particularly on an eye, for a medical treatment, such as LASIK surgery.
2. Description of Related Art
Laser-assisted in-situ keratomileusis (LASIK) is one of a number of surgical procedures for treating various eye disorders. During LASIK surgery, an instrument called a microkeratome is used to cut through the corneal epithelium to form a thin flap. The flap is then peeled back and the underlying cornea tissue is reshaped using an excimer laser so that light traveling through the cornea is properly focused onto the retina.
The epithelium is the cornea's outermost region and one of its functions includes protecting the underlying tissue from exposure to foreign material, such as dust, water, and bacteria. As a result, the protective function of the epithelium is compromised when the microkeratome cuts through the epithelium during LASIK surgery. In general, any incision, injection, or other penetration of the outer protective layer, e.g., epithelium, during an eye treatment, e.g., LASIK surgery, increases the risk of infection.
Embodiments according to aspects of the present invention provide systems and methods for reducing the risk of infection when eye treatments, e.g., LASIK surgery, require incision, injection, or other penetration of the outer protective layer of the eye.
According to an example embodiment, a method for treating an eye includes applying, to an outer protective layer of an area of an eye, one or more initial doses of a cross-linking agent that acts as a photosensitizer. The method also includes delivering, from a light source, one or more initial doses of ultraviolet light to the area of the eye. The cross-linking agent increases absorption of the ultraviolet light by the area of the eye, and the absorption of the ultraviolet light sterilizes the area of the eye before the outer protective layer is penetrated. Additionally, the method includes penetrating the outer protective layer of the eye to provide access to an area below the outer protective layer. Moreover, the method includes applying a treatment to the eye via the access provided by cutting the outer protective layer. In some embodiments, the cross-linking agent is Riboflavin.
According to further embodiments, the method includes delivering, from the light source, one or more additional doses of the ultraviolet light after penetrating the outer protective layer of the eye. The one or more additional doses of the ultraviolet light further sterilize the area of the eye. According to yet further embodiments, the method includes applying, one or more additional doses of the cross-linking agent after penetrating the outer protective layer of the eye. The one or more additional doses of the cross-linking agent increases absorption of the ultraviolet light by the area of the eye, and the absorption of the ultraviolet light further sterilizes the area of the eye
In particular embodiments, the treatment is LASIK surgery. Thus, in some embodiments, penetrating the outer protective layer of the eye includes cutting a thin flap from the outer protective layer of a cornea, and applying the treatment to the eye includes reshaping the cornea with an excimer laser while the thin flap is peeled back.
These and other aspects of the present disclosure will become more apparent from the following detailed description of embodiments of the present disclosure when viewed in conjunction with the accompanying drawings.
According to aspects of the present disclosure, a cross-linking agent is applied to the regions of the cornea treated by LASIK surgery, or other similar eye treatment. According to some embodiments, the cross-linking agent is applied to initiate molecular cross-linking of corneal collagen to stabilize corneal tissue and improve its biomechanical strength when LASIK surgery is employed to make corrections to corneal structure and shape. According to other embodiments, the cross-linking agent is applied to sterilize the field for LASIK surgery and reduce the risk of infection associated with penetration of the outer protective layer, e.g., epithelium, of the eye.
The optical elements 112 may include, for example, one or more mirrors or lenses for directing and focusing the light emitted by the light source 110 to a particular pattern on the cornea 2 suitable for activating the cross-linking agent 130. The light source 110 may be an ultraviolet light source, and the light directed to the cornea 2 through the optical elements 112 activates the cross-linking agent 130. The light source 110 may also alternatively or additionally emit photons with greater or lesser energy levels than ultraviolet light photons. The delivery system 100 also includes a controller 120 for controlling the operation of the optical elements 112 or the applicator 132, or both. By controlling aspects of the operation of the optical elements 112 and the applicator 132, the controller 120 can control the regions of the cornea 2 that receive the cross-linking agent 130 and that are exposed to the light source 110. By controlling the regions of the cornea 2 that receive the cross-linking agent 130 and the light source 110, the controller 120 can control the particular regions of the cornea 2 that are strengthened and stabilized through cross-linking of the corneal collagen fibrils. In an implementation, the cross-linking agent 130 can be applied generally to the eye 1, without regard to a particular region of the cornea 2 requiring strengthening, but the light source 110 can be directed to a particular region of the cornea 2 requiring strengthening, and thereby control the region of the cornea 2 wherein cross-linking is initiated by controlling the regions of the cornea 2 that are exposed to the light source 110.
The optical elements 112 can be used to focus the light emitted by the light source 110 to a particular focal plane within the cornea 2, such as a focal plane that includes the mid-depth region 2B. In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110, and may include one or more heat sinks for absorbing light emitted by the light source 110. The optical elements 112 may further include filters for partially blocking wavelengths of light emitted by the light source 110 and for advantageously selecting particular wavelengths of light to be directed to the cornea 2 for activating the cross-linking agent 130. The controller 120 can also be adapted to control the light source 110 by, for example, toggling a power switch of the light source 110.
In an implementation, the controller 120 may include hardware and/or software elements, and may be a computer. The controller 120 may include a processor, a memory storage, a microcontroller, digital logic elements, software running on a computer processor, or any combination thereof. In an alternative implementation of the delivery system 100 shown in
Other aspects of devices and approaches for applying a cross-linking agent to the cornea and delivering light to activate the applied cross-linking agent are described in U.S. patent application Ser. No. 13/051,699, filed Mar. 18, 2011, the contents of which are incorporated entirely herein by reference.
Referring to
As the example embodiment 200B of
The cross-linking agent 130 may be applied to the corneal tissue in an ophthalmic solution, e.g., from an eye dropper. In some cases, the cross-linking agent 130 is effectively applied to the corneal tissue after removal of the overlying epithelium. However, in other cases, the cross-linking agent 130 is effectively applied in a solution that transitions across the epithelium into the underlying corneal tissue, i.e., without removal of the epithelium. For example, a transepithelial solution may combine Riboflavin with approximately 0.1% benzalkonium chloride (BAC) in distilled water. Alternatively, the transepithelial solution may include other salt mixtures, such as a solution containing approximately 0.4% sodium chloride (NaCl) and approximately 0.02% BAC. Additionally, the transepithelial solution may contain methyl cellulose, dextran, or the like to provide a desired viscosity that allows the solution to remain on the eye for a determined soak time.
The amount of time required to achieve the desired cross-linking can be controlled by adjusting the parameters for delivery and activation of the cross-linking agent. In an example implementation, the time can be reduced from minutes to seconds. While some configurations may apply the initiating element (e.g., from the light source 110) at a flux dose of 5 J/cm2, aspects of the present disclosure allow larger doses of the initiating element, e.g., multiples of 5 J/cm2, to be applied to reduce the time required to achieve the desired cross-linking. Highly accelerated cross-linking is particularly possible with the devices and approaches described in detail in U.S. application Ser. No. 13/051,699, filed Mar. 18, 2011, referenced above.
To decrease the treatment time, and advantageously generate stronger cross-linking within the cornea 2, the initiating element (e.g., the light source 110) may be applied with a power between 30 mW and 1 W. The total dose of energy absorbed in the cornea 2 can be described as an effective dose, which is an amount of energy absorbed through a region of the corneal surface 2A. For example the effective dose for a region of the cornea 2 can be, for example, 5 J/cm2, or as high as 20 J/cm2 or 30 J/cm2. The effective dose delivering the energy flux just described can be delivered from a single application of energy, or from repeated applications of energy. In an example implementation where repeated applications of energy are employed to deliver an effective dose to a region of the cornea 2, each subsequent application of energy can be identical, or can be different according to information provided by a feedback system.
Although LASIK surgery may initially achieve desired reshaping of the cornea 2, the desired effects of reshaping the cornea 2 may be mitigated or reversed at least partially if the collagen fibrils within the cornea 2 continue to change after the desired reshaping has been achieved. Indeed, complications may result from further changes to the cornea 2 after treatment. For example, a complication known as post-LASIK ectasia may occur due to the permanent thinning and weakening of the cornea 2 caused by LASIK surgery. In post-LASIK ectasia, the cornea 2 experiences progressive steepening (bulging).
Therefore, aspects of the present disclosure preserve the desired corneal structure and shape that result from LASIK surgery. In particular, embodiments provide approaches for initiating molecular cross-linking of the corneal collagen to stabilize the corneal tissue and improve its biomechanical strength and stiffness after the desired shape change has been achieved. In addition, embodiments may provide devices and approaches for monitoring cross-linking in the corneal collagen and the resulting changes in biomechanical strength to provide a feedback to a system for inducing cross-linking in corneal tissue. Such devices and approaches are described in detail in U.S. application Ser. No. 13/051,699, filed Mar. 18, 2011, referenced above.
As described previously, during LASIK surgery, an instrument called a microkeratome is used to cut through the corneal epithelium to form a thin flap. The flap is then peeled back and the underlying cornea tissue is reshaped using an excimer laser so that light traveling through the cornea is properly focused onto the retina. In one embodiment, the outer surface of the cornea, e.g., in the area of the flap, is treated with a cross-linking agent, e.g., Riboflavin, after the flap is put back in place. The cross-linking agent is then activated with an initiating element. Activation of the cross-linking agent, for example, may be triggered thermally by the application of microwaves or light to corresponding areas of the cornea. Cross-linking occurs in the area of application. Although the cross-linking agent is applied to the outer surface of the cornea, i.e., the epithelium, it has been shown that cross-linking agents can chemically transition across the outer surface into the underlying corneal tissue, i.e., the stroma. Thus, in some embodiments, the cross-linking agent may be delivered to the underlying corneal tissue by applying the cross-linking agent topically to the outer surface of the cornea. Moreover, in further embodiments, the outer surface may be treated to promote the transition of the cross-linking agent therethrough.
In another embodiment, after the flap is peeled back, inner surfaces of the cornea are exposed for the application of a cross-linking agent. In particular, the inner surface of the flap as well as the underlying corneal tissue are exposed. Therefore, the inner surface of the flap and/or the underlying corneal tissue are treated with a cross-linking agent. In other words, the cross-linking agent may be applied to (i) the inner surface of the flap only, (ii) the underlying corneal tissue only, or (iii) both the inner surface of the flap and the underlying corneal tissue. The cross-linking agent is then activated with an initiating element. Again, activation of the cross-linking agent may be triggered thermally by the application of microwaves or light. Although the initiating element may be applied before the flap is put back, the initiating element additionally or alternatively may be applied to the treated areas after the flap is put back in place. In this case, the initiating element can be delivered through the outer surface of the cornea.
According to yet another embodiment, the inner surface of the flap and/or the underlying corneal tissue are treated with a cross-linking agent after the flap is peeled back. The cross-linking agent is then activated with an initiating element. As in the previous embodiment, the cross-linking agent may be applied to (i) the inner surface of the flap only, (ii) the underlying corneal tissue only, or (iii) both the inner surface of the flap and the underlying corneal tissue. In addition, the outer surface of the cornea, e.g., in the area of the flap, is treated with a cross-linking agent after the flap is put back in place. The cross-linking agent is then activated in step with an initiating element. Again, activation of the cross-linking agent may be triggered thermally by the application of microwaves or light. In a variation of this embodiment, the cross-linking agent may be activated with an initiating element according to a single act, rather than two separate acts. Thus, the initiating element may be delivered in the single act after the flap is put back in place.
Accordingly, a cross-linking agent may be applied and activated in different regions at different points during LASIK treatment. For example, the cross-linking agent may be applied to any combination of the outer surface of the cornea, the inner surface of the flap, and the exposed underlying corneal tissue. Moreover, specially tailored concentrations of cross-linking agent may be applied in combination with varying levels of initiating element to these regions to achieve the appropriate amount of stability and strength in the cornea.
In an example embodiment, Riboflavin may be applied as the cross-linking agent 1202 to the corneal tissue. In addition, a photoactivating light, such as ultraviolet (UV) light, may be applied as an initiating element 1204 to initiate cross-linking in the corneal areas treated with Riboflavin. To achieve optimal results, an appropriate amount of Riboflavin is applied to the targeted regions of the cornea and an appropriate amount of UV light is applied to match the application of Riboflavin. In some cases, damage to the eye may result if too much Riboflavin and UV light reach the endothelium. This may occur, in particular, if too much time passes between the application of the Riboflavin in act 1230 and the application of the UV light in act 1240. The passage of time allows the Riboflavin to diffuse more deeply into the corneal tissue to the endothelium, and the UV light may reach the Riboflavin at the endothelium.
Thus, according to aspects of the present invention further illustrated in
Moreover, the power and duration are also based on the distance that the cross-linking agent and the UV light can travel though the cornea before reaching the endothelium. This distance generally corresponds with the thickness of the cornea. Therefore, in act 1236, the corneal thickness c is determined. By determining the diffusion distance d of the cross-linking agent and determining the thickness c of the cornea, the appropriate power P and duration T2 can be determined in act 1238. The embodiments can apply the UV light to the cross-linking agent in the cornea in act 1240 while preventing damage to the endothelium.
When the cross-linking agent is applied and activated while the corneal flap remains peeled back during LASIK surgery, the amount of corneal tissue through which the cross-linking agent and the UV light can travel decreases. The risk of damage to the endothelium may be greater during LASIK surgery. Thus, to ensure that the UV light does not reach the endothelium, act 1236 may determine an “effective” thickness c by adjusting for the fact that the corneal flap is peeled back. For example, peeling back the flap may reduce the effective thickness of the cornea to 120 μm, and embodiments may apply the UV light according to a power P and duration T2 that delivers the UV light to a depth of 100 μm.
Referring to
Referring to
While embodiments above apply Riboflavin in combination with LASIK surgery to stabilize and strengthen the corneal tissue, aspects of these embodiments may also be employed to apply Riboflavin to reduce the risk of infection when the outer protective layer of the eye is compromised during LASIK surgery. The Riboflavin acts as a photosensitizer that increases the absorption of UV light. The resulting absorption of UV light can induce DNA and RNA lesions, and as a result, is effective in killing viruses, bacteria, and other pathogens in the field.
Referring to
LASIK surgery is a particular invasive treatment that compromises the outer protective layer of the eye. Referring to the example embodiments of
Referring to
Referring to
Referring to
The present disclosure includes systems having controllers for providing various functionality to process information and determine results based on inputs. Generally, the controllers (such as the controller 120 or 950) may be implemented as a combination of hardware and software elements. The hardware aspects may include combinations of operatively coupled hardware components including microprocessors, logical circuitry, communication/networking ports, digital filters, memory, or logical circuitry. The controller may be adapted to perform operations specified by a computer-executable code, which may be stored on a computer readable medium.
As described above, the controller 120 or 950 may be a programmable processing device, such as an external conventional computer or an on-board field programmable gate array (FPGA) or digital signal processor (DSP), that executes software, or stored instructions. In general, physical processors and/or machines employed by embodiments of the present disclosure for any processing or evaluation may include one or more networked or non-networked general purpose computer systems, microprocessors, field programmable gate arrays (FPGA's), digital signal processors (DSP's), micro-controllers, and the like, programmed according to the teachings of the exemplary embodiments of the present disclosure, 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(s) used for monitoring, etc., 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 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 disclosure 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 disclosure for performing all or a portion (if processing is distributed) of the processing performed in implementations. Computer code devices of the exemplary embodiments of the present disclosure 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 disclosure 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 the present disclosure has been described in connection with a number of exemplary embodiments, and implementations, the present disclosure is not so limited, but rather cover various modifications, and equivalent arrangements.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/051,699, filed Mar. 18, 2011, which claims priority to U.S. Provisional Application No. 61/315,840, filed Mar. 19, 2010; U.S. Provisional Application No. 61/319,111, filed Mar. 30, 2010; U.S. Provisional Application No. 61/326,527, filed Apr. 21, 2010; U.S. Provisional Application No. 61/328,138, filed Apr. 26, 2010; U.S. Provisional Application No. 61/377,024, filed Aug. 25, 2010; U.S. Provisional Application No. 61/388,963, filed Oct. 1, 2010; U.S. Provisional Application No. 61/409,103, filed Nov. 1, 2010; and U.S. Provisional Application No. 61/423,375, filed Dec. 15, 2010, the contents of these applications being incorporated entirely herein by reference. This application also claims the benefit of, and priority to, U.S. Provisional Patent Application No. 61/484,572, filed May 10, 2011, the contents of which are incorporated entirely herein by reference.
Number | Date | Country | |
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61315840 | Mar 2010 | US | |
61319111 | Mar 2010 | US | |
61326527 | Apr 2010 | US | |
61328138 | Apr 2010 | US | |
61377024 | Aug 2010 | US | |
61388963 | Oct 2010 | US | |
61409103 | Nov 2010 | US | |
61423375 | Dec 2010 | US | |
61484572 | May 2011 | US |
Number | Date | Country | |
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Parent | 13051699 | Mar 2011 | US |
Child | 13468760 | US |