ES2556615T3 - Device for ocular alignment and coupling of eye structures - Google Patents

Abstract

A system (100) for defining a reference axis (18) of an eye (10) of a patient in an external coordinate system, characterized in that it comprises: (a) a light source (108) for directing a beam of coherent or focused light on a reflective surface (16) associated with the patient's eye, (b) an imaging system (102) for recording an image of a limbus (26) of the patient's eye and an image formed by a reflection of the light beam from the cornea (12) of the patient's eye, and (c) a processor operatively connected to the imaging system (102) for (i) from the image of the limbus (26), determine the center (30) of the patient's eye blade (10) in the external coordinate system, and (ii) from the reflection image, determine when the position of the reflection is coincident with the center (30) of the limbo, in which position an axis (18) normal to the cornea (12) in the corneal center defines the reference axis.

Description

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DESCRIPTION

Device for ocular alignment and coupling of eye structures Field of the invention

The invention relates to systems for aligning the eye of a subject. More specifically, the invention relates to providing an image formation system to determine the objective eye.

Background of the invention

The exact alignment of a subject's eye is important in a number of situations. For example, when certain types of eye measurements are taken, it is critical to know that the eye is in a particular reference position. When measuring the cornea of a patient's eye before a therapeutic treatment, it may be important to repeat these measures after the treatment to determine how much, if any, the treatment has affected the measures. In order to achieve this, one has to make sure that the alignment of the eye is in the same position each time the particular measurements are made. Otherwise, the difference in the data before and after the treatment may be due to a change in the alignment of the eye rather than the treatment.

In addition to those situations in which one needs to ensure that the eye is aligned in the same position for two or more measurements, there are situations in which the alignment of the eye is convenient for diagnostic measures of the functioning of the eye. There are situations in which a human subject can simply be requested to look at a particular object. In this way, the human can affirm that he or she is currently looking at a light source, which in this way provides a "subjective" eye alignment information. However, there are situations in which a physician or researcher wanted an "objective" eye alignment information that would indicate the orientation of the eye and, as far as possible, indicate what the eye is seeing.

For example, children who are too young cannot be relied upon to be fixed on such a particular object for measurements, such as refractive measures that are very convenient to ensure that "in focus" images are being received when the child's brain is Learning to interpret images. Similarly, adults undergoing extensive eye exams may become tired or undergo other coercion and failure to maintain a reliable fixation. A patient who undergoes a therapeutic process such as an eye laser removal operation may not be able to maintain the desired eye orientation for a prolonged treatment time due to anesthesia applied, fatigue, or distraction due to the procedure. . In addition, a research animal normally cannot be trained to remain fixed during eye measurements.

In each of the previous cases, the failure or inability of the subject to maintain the fixation of the eye on an object can produce measures or treatments of the eye that are clearly wrong. Therefore, there are situations in which absolute alignment data of the eye is necessary (i.e., the eye is aligned in a certain way) and situations in which the comparative alignment data of the eye (i.e., the eye is in the same alignment as when the previous alignments were taken) are necessary and one cannot rely on a subject to maintain the alignment.

A high level of precision is often required when performing surgery or other treatment on a part of the body that is subject to involuntary movement. Typically a problem is the alignment of a patient's eye. The eye is predisposed to sudden jerks, which are involuntary, rapid movements of small magnitude. A patient can voluntarily shift his gaze during surgery, and also, the stability of the eye position is affected by the patient's heartbeat and other psychological factors. In addition, it is still discussed with respect to the appropriate reference axis of alignment of the eye for treatment, such as for laser refractive surgery.

In typical laser ophthalmic systems for treatment of defects or conditions, an ocular tracker component of the system is used to track the movement of the eye during surgery, and to interrupt the administration of therapeutic treatment when the scan cannot be maintained. Often, the surgeon will manually apply an eye tracker when it appears to be properly aligned. This subjective technique is prone to errors that can lead to off-center excisions and other impediments to satisfactory vision correction. Various eye tracking technologies are commercially available. In some embodiments of the present invention described below it is convenient to apply an eye tracker when it is locked on the desired reference point in the eye.

Various types of visual axis detection devices have been proposed. For example, some visual axis detection devices are based on the patient's gaze. Japanese Patent Publication 1-274736, for example, describes a device that projects parallel light beams towards an observer's eyeball from a light source and determines a visual axis using an image reflected from a cornea, this it is, an image reflected in the cornea, or image of Purkinje, and the position of formation of the image of a pupil.

US 6,257,722 describes that light is reflected from a patient's eye to generate a captured image of the pupil. The captured image is divided into areas, with predetermined pixel numbers, and is

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analyzed to determine the situation of the center of the pupil. The reflected light only provides the image that is used to determine the center of the pupil. The non-coherent or focused beam of light is provided as a basis for comparison with the situation of the pupil center.

Thus, it is necessary for greater reliability and precision in the alignment of the eye, particularly when referring to methods of treating the eye such as ophthalmic laser surgery.

general

The invention is defined in the appended claims. Therefore, preferably the invention provides a system for determining or measuring the objective alignment of the eye in an external coordinate system to define a reference axis of an eye of a subject. It is another object of the invention to provide an alignment system of a reference axis of the eye objectively determined in a selected relationship with a therapeutic axis of an ophthalmic therapeutic apparatus and / or a diagnostic axis of an ophthalmic diagnostic apparatus.

Preferably the invention can be used in a method and an eye tracking system to monitor the movement of a patient's eye during an ophthalmic procedure, wherein the eye tracker system is automatically applied after determining the objective alignment of the eye in a system of external coordinates

Preferably the invention can be used in a method and a system to plan an ophthalmic treatment procedure based, at least in part, on an objective alignment of the eye in an external coordinate system to define a reference axis of an eye to be be treated. The invention can be used in an ophthalmic treatment method and system, wherein a therapeutic energy component is controlled in one or more operational aspects based on the determination of the objective alignment of the eye in an external coordinate system.

Preferably the invention finds application in an ophthalmic treatment method and system, wherein a therapeutic energy component is located and / or stabilized with respect to a reference axis of an eye to be treated, defined by the objective alignment of the eye. in an external coordinate system. It is also another object of the invention to provide an ophthalmic treatment system, wherein an objectively determined reference axis of an eye to be treated is placed and / or stabilized with respect to a therapeutic energy component.

Preferably the invention provides an ophthalmic treatment system, wherein a therapeutic energy component is controlled in one or more operational aspects based on the determination of the objective alignment of the eye in an external coordinate system.

In a main aspect the invention provides a system for defining a reference axis of a patient's eye in an external coordinate system, characterized in that it comprises: (a) a light source for directing a coherent or focused beam of light on a reflective surface associated with the patient's eye, (b) an imaging system to record an image of a limbo of the patient's eye and an image formed by a reflection of the beam of light from a cornea of the patient's eye , and (c) a processor operatively connected to the imaging system to (i) from the image of the limbus, determine the limbo center of the patient's eye in the external coordinate system, and (ii) from The image of the reflection, determine when the position of the reflection coincides with the center of the limbus, in which position a normal axis to the cornea in the corneal center defines the reference axis.

In an embodiment that has aspects of the invention, a method has been provided to determine when the position of a subject's eye is aligned with a reference axis in an external coordinate system, wherein the method comprises determining the positions of the limbus ( the generally circular limit of the sclera / cornea) of the subject's eye in the external coordinate system, and from these positions, determine the center of the limbus in the external coordinate system. The method further comprises determining the position of an image of a beam of light reflected from the patient's eye (for example, the cornea), and determining that the subject's eye is aligned with the reference axis when the determined position of the reflection It is coincident with the determined center of the limbus.

In embodiments of this method the determinations of the center of the limbus and the corneal reflection can be carried out with the patient's head stabilized in a headrest, and can be performed by an image formation system arranged in the external coordinate system. For example, the method may include registering an image of the subject's limbus by an optical detector, fitting the image of the limbus into a circle, and determining the position of the center of the circle with respect to the external coordinate system.

In some embodiments of this method the reflection from the patient's eye is a first image of Purkinje formed by the reflection of a coherent beam of light or focused outside the anterior surface of the cornea. For example, the optical axis of the coherent or focused beam of light can be aligned with the reference axis.

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Some embodiments of this method include generating an eye alignment signal when the subject's eye position is aligned with an external coordinate reference axis. As an example, a signal can be generated after a determination that the position of the corneal reflection is coincident with the center of the limbus. The method may include the use of this signal as an element of a procedure, such as the use of an eye alignment signal to attach an eye positioning and stabilization device to the subject's eye; and / or the use of an alignment signal to activate a therapeutic beam directed along a path that has a known relationship with the external coordinate reference system. In some embodiments, the method is used to treat macular degeneration, for example where the therapeutic beam includes one or more low energy collimated X-ray beams, which are directed along a path that intersects the reference axis in a selected area of the subject's eye, for example, at an angle of intersection between about 10 to about 45 degrees.

In some embodiments, the reference axis may define a geometric axis of the patient's eye, and the method may include calculating the distance between the cornea and the retina along this axis.

In some embodiments, the method can be applied to determine the position of the intersection of the reference axis with the patient's retina in relation to a structure of interest in the retina. Additional steps may include determining the position of an image formed by a beam of light reflected from the retina of the patient's eye. For example, a beam of light used to obtain a reflection of the anterior eye, such as a first Purkinje image, can also be used to illuminate the retina, to obtain a retinal reflection image, such as when a first Purkinje image is coinciding with the center of the limbus image and thus the retinal reflection image is aligned with the reference axis. In addition, a second beam of coherent or focused light can be passed through the pupil of the subject's eye to be reflected outside a structure of interest in the retina, and the position of the reflection image of the second beam outside the structure. of interest can be determined in the external coordinate system, in relation to the reference axis.

In yet another embodiment having aspects of the invention, a method is provided for defining a reference axis of a patient's eye in an external coordinate system, wherein the method comprises determining the positions of the patient's eye blade in the system. of external coordinates, and from these positions, determine the center of the limbus in the external coordinate system. The method further comprises determining the position of an image of a beam of light reflected from the cornea of the patient's eye, and adjusting the position of the eye until the position of the reflection is coincident with the center of the limbus, in whose position an axis Normal to the cornea in the corneal center defines the patient's axis of reference.

In some embodiments, the reference axis defined by the method extends from the cornea to a position in the retina that is a maximum distance from the cornea. The method may also include superimposing the patient's reference axis on a three-dimensional model of the eye by aligning the patient's reference axis with a model reference axis. In some embodiments, the method may be applied to direct a diagnostic or therapeutic procedure in the eye, the method also includes the placement of a beam of a diagnostic or therapeutic device in a selected position and angle with respect to the reference axis of the patient.

Some embodiments of this method include the generation of an eye alignment signal when the patient's eye position is aligned with an external coordinate reference axis. The method may include the use of this signal to attach an eye positioning and stabilization device to the subject's eye. Alternatively or additionally, the method may include the use of the eye alignment signal to activate a therapeutic beam directed along a path that has a known relationship with the external coordinate reference system. In some embodiments, the method is used to treat macular degeneration, for example where the therapeutic beam is a low energy collimated X-ray beam, and the therapeutic beam is directed along a path that intersects the reference axis in a macular area of the eye of the patient subject, and with an angle between approximately 10-45 degrees with respect to the reference axis.

In some embodiments, the method may be applied to determine the position of the intersection of the reference axis with the patient's retina relative to a structure of interest in the retina, which includes determining the position of an image formed by a beam of light. reflected from the retina of the patient's eye when a corneal reflection of the light beam is coincident with the center of the limbus. In addition, a second beam of coherent or focused light can be passed through the pupil of the subject's eye to be reflected outside a structure of interest in the retina, and the position of the reflection image outside the structure of interest can be determined in the external coordinate system.

In yet another embodiment that has aspects of the invention, a system for defining a reference axis of an eye of the subject is arranged in an external coordinate system, wherein the system comprises (a) a head support to support the the patient's head, (b) a light source to illuminate the sclera / cornea (limbus) limit of the patient's eye, (c) a light source to direct a coherent beam of light or focused on the cornea of the eye of the patient, (d) an imaging system to record an image of the patient's limbus and an image formed by the reflection of the beam of light consistent or focused from the cornea of the patient's eye, and (e) a processor operatively connected to the imaging system for (i) from the image of the sclera / corneal limit determine the center of the patient's eye blade in the system of

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external coordinates, and (ii) from the reflection image of the coherent or focused beam of light outside the cornea, determine when the position of the reflection image is coincident with the center of the image of the limbus, in which position a normal axis to the cornea in the corneal center defines the reference axis.

In some embodiments of the system the light source for illuminating the limbus is effective for illuminating the entire eye, and the light source for directing a coherent or focused beam of light on the cornea is a coherent beam of light. In some embodiments of the system the image formation system includes a CCD photodetector. In some embodiments of the system the processor operates to fit the image of the limbus into a circle and find the center of the circle. In addition, the processor can operate to determine, at each position of the patient's eye, if the center of the patient's eye blade is the same as the position of the reflection image from the cornea. In some embodiments of the system the processor may operate to generate a signal when the position of the reflection image is coincident with the center of the image of the limbus. In addition, the processor can operate to generate positioning signals to place a diagnostic or therapeutic device in a selected position and angle with respect to the reference axis.

In some embodiments, the system also operates to record the reflections of a coherent or focused beam of light outside the surface of the retina, where the processor also operates to (iii) determine the position of an image formed by the reflection of the beam of light outside the retina, when the position of the reflection image outside the cornea is coincident with the center of the limbo image, (iv) determine the position of an image formed by the reflection of another coherent or focused beam of light outside a structure of interest selected in the retina, and (v) determine the position of the image of the reflection of the other beam outside the structure of interest in the external coordinate system, in relation to the position of the image of the image reflection outside the retina along the reference axis.

In yet another embodiment having aspects of the invention, a method of placing the patient's eye in alignment with a reference axis in an external coordinate system is provided, which comprises (a) placing an eyeglass on a patient's eye, (b) center the frog with respect to the sclerotic / corneal limit of the patient's eye, (c) stabilize the ocular grenade over the eye by applying a negative pressure between the frog and the eye, (d) move the ocular grind, and so both the patient's eye, until the eyepiece is aligned with the reference axis, so as to place the patient's eye in alignment with the reference axis. The eyecup may have a peripheral ring sized to be contained within or substantially coincident with the sclera / corneal limit of the patient's eye, and the step (b) may include adjusting the position of the frog until the peripheral ring and the sclera limit / cornea are aligned coaxially.

In yet another embodiment that has aspects of the invention, an image-guided eye treatment system is provided, comprising (a) a head support to support a patient's head, (b) an eye piece adapted to be placed in the patient's eye, and stabilized in the eye by the application of a negative pressure between the eye's eye and the eye when the line is approximately centered with respect to the sclera / corneal limit of the patient's eye, (c) a camera to record an image of the eye gland in the patient's eye, (d) a line alignment assembly to detect the alignment between the eye gland, with it stabilized in a patient's eye, and a reference axis of external coordinates, (e) an external arm pivotally attached to the eye's eye to keep the eye in a position where the eye's eye is aligned with the external coordinate reference axis, (e) a processor operatively connected to the camera and a set of gma-alignment to (i) determine from the image of the eye line and the sclera / cornea limit any variation from the true centering of the eye line in the patient's eye, (ii) if determine a variation from the true centering, construct a coordinate transformation between the real and centered positions of the eyeglass, (iii) with the eyebrow moved to and maintained in its aligned position, and if necessary by applying the transformation of coordinates, which determines the position of the eye with respect to the coordinate reference axis, (iv) from the determination in step (iii) determine a treatment axis or axes along which a therapeutic beam will be directed towards an objective area of the eye, and (f) a display monitor operatively connected to the processor to display to the user an image of the patient's eye and the attached eye line, information on the extent of the alignment between the eye line and the reference beam, and a virtual image of the treatment axis or axis.

In some embodiments the processor may include stored background images and operates to superimpose those images on the image of the patient's eye displayed on the monitor, which allows the user to see the areas of intersection of the axes of the therapeutic beam and the background.

These and other objects and features of the invention will be more fully appreciated by reading the following detailed description of the invention in conjunction with the accompanying figures.

Brief description of the figures

The figures and associated descriptions are provided to illustrate embodiments of the description and not to limit the scope of the description. Through the figures the reference numbers are reused to indicate a correspondence between the referenced elements. The figures are in a simplified form and are not necessarily at an exact scale. In reference to this description, for convenience and

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clarification only, the directional terms such as top, bottom, left, right, up, down, over, under, under, back, front are used with respect to the accompanying figures. Such directional terms should not be construed as limiting the scope of the invention in any way.

The particular figures can be briefly summarized as follows:

Figure 1 illustrates a schematic side view of an anterior portion of an eye in association with an embodiment of an alignment system having aspects of the invention.

Figure 2 is a drawing of a coalition detection signal as an example indicative of a coincident reflection of the first Purkinje reflex and the center of the limbus.

Figures 3A and 3B illustrate exemplary ophthalmic treatment systems that have aspects of the invention, including a treatment device that is placed and / or controlled by an eye placement / stabilization device.

Figures 3C and 3D illustrate an exemplary ophthalmic treatment system for an X-ray retina treatment, wherein Figure 3C is a cross-sectional view of an eye taken along the geometric axis in a plane horizontal, and Figure 3D is a detailed front view of an eye seen aligned with an axis of the reference system.

Figures 4A-B and 5A-B illustrate the placement of the eye by way of example and / or stabilization devices that have aspects of the invention.

Figures 6A-C illustrate schematic side views of an anterior portion of an eye in three orientations with respect to an embodiment of an alignment system having aspects of the invention, which represent a method that uses a sizing of the blade to define the reference axis

Figure 7 is a diagram of an exemplary method having aspects of the invention, showing a sequence of successive data processing steps used to identify the limbic limit and the limbic center.

Figures 8A-B illustrate a defined reference axis in an embodiment of an alignment system having aspects of the invention, oriented so that the center of reflection of the light collimated from the retina coincides with the center of the limbus.

Figures 9A-B illustrate an embodiment of an alignment system generally similar to that of Figures 8A-B, in which the center of reflection of the light collimated from the retina is now outside the center or outside the axis with respect to the center of limbo

Figure 10 represents an embodiment of an alignment system having aspects of the invention, which includes beam splitters to superimpose the reflection of a laser beacon aligned with a reference axis on the image obtained from the retina of a subject by A camera in the background.

Figures 11A-B show a couple of background images obtained with the system as in Figure 10, where Figure 11A represents an image in which the focus of the laser beacon and the reflection of the laser beacon are aligned with the center of the limbus, and Figure 11A represents an image in which the beacon is not aligned with the center of the limbus.

Figures 12A-B represent a compendium of the methodology system that has aspects of the invention, adapted to be used to administer radiation therapy to a patient's macula, where Figure 12A is a diagram of the treatment system. Figure 12B shows a background image of the subject's retina.

Figures 13A-C represent x-ray therapy beams that travel through an eye to a center or target of the therapy, where Figure 13A shows in cross section the angular arrangement of the beams, Figure 13B represents a retinal image in which the center of radiation therapy is centered around the treatment axis, and Figure 13B represents a retinal image in which the center of radiation therapy is coincident with the macula and not with the axis of treatment.

Figure 14 is a diagram of an exemplary method that has aspects of the invention, showing a sequence of successive steps used to obtain the relationship between the center of the limbus, the optical axis, and the relative position of a beam. that travels through limbo.

Figure 15 is a diagram of an exemplary system that has aspects of the invention, configured to administer a photoextirpative eye surgery.

Figures 16A-F represent alternative species that have aspects of the invention of a "separation" after fitting that can be used with eye placement and / or stabilization devices as shown in Figures 4A-B and 5A -B.

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Figures 17A-17D represent various embodiments of eye bras that have aspects of the invention that have alternative configurations of a contact member.

Figures 18A (1) -18B (2) represent embodiments of eye bras that have aspects of the invention that have alternative configurations of a contact member.

Detailed description of the invention

Reference will now be made in detail to the described embodiments of the invention, examples of which are illustrated in the accompanying figures.

I. Definitions

Unless stated otherwise, all the technical and scientific terms used here have the same meaning as they have for an expert in the art of the present invention. It is to be understood that this invention is not limited to the methodology and protocols described, since they may vary.

As used here, "accommodation" refers to the ability to change the focus of distant objects to nearby objects, whose capacity may tend to decrease with age.

The term "choroid" refers to the highly vascular layer of the eye under the sclera.

As used here, "ciliary muscle" refers to a muscular ring of a tissue located below the sclera and attached to the lens by means of zonules.

As used here, "conjunctiva" refers to the thin, transparent tissue that covers the outer side of the sclera. In some embodiments of the invention reference is made to one or more devices or systems of the invention in contact with the outer structures of the eye, such as the sclera. In these embodiments it is to be understood that the device or systems of the invention may be in contact with the named structure, or they may be in contact with the conjunctiva that covers the structure.

As used here, "cornea" refers to the transparent, avascular tissue that is continuous with the opaque sclerotica and the semitransparent conjunctiva, and covered by a tear film, or corneal epithelium, on its anterior surface and bathed by an aqueous humor on its back surface.

As used here, "limbo" refers to the limit in which the cornea meets the sclera.

As used here, "retina" refers to the layer of light-sensitive tissue that lines the inner back of the eye

and sends visual impulses through the optic nerve to the brain.

As used herein, "eye disease" refers to an eye disease that includes, but is not limited to tumors, ocular degeneration, retinopathies, retinitis, retinal vasculopathies, diabetic retinopathies, Bruch's membrane diseases and the like.

As used herein, the term "reduce an eye disease" also encompasses the treatment and relief of eye disease.

As used here, "sclera" refers to the outer support structure, or "white," of the eye.

As used here, the term "subject" refers to a man or animal that has an eye.

As used here, "vitreous body" refers to the colorless transparent jelly that fills the eye after the lens and

which is enclosed by a hialoid membrane.

As used herein, "zonules" refers to a circular set of radially directed collagen fibers that are attached at their ends to the lens and at the outer ends of the ciliary muscle.

As used here, the term "presbyopia" refers to the inability of the eye to precisely focus on nearby objects. Presbyopia is associated with advanced age and is typically the cause of a decrease in accommodation. The introduction of the treatment, for example laser removal, in accordance with any of the implementations described here, preferably increases or facilitates an increase in accommodation, which mitigates the effects of presbyopia.

The term "radiodynamic therapy" refers to the combination of collimated X-rays with a concomitantly administered systemic therapy.

The term "radiodynamic agents" is understood to have its ordinary and simple meaning, which includes, without limitation, agents that respond to radiation such as X-rays, and agents that sensitize a tissue for the purposes of radiation.

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The term "photodynamic therapy" refers to a therapeutic or diagnostic method that involves the use of a photoreactive agent and radiation of sufficient intensity and wavelength to activate the photoreactive agent. Then, the activated photoreactive agent, through the emission of ene, exerts a therapeutic effect or facilitates the diagnosis by detecting the emitted energy.

The term "photodynamic agents" is understood to have its simple and ordinary meaning that includes, without limitation, the agents that react to light and the agents that sensitize a tissue against the effects of light.

"Radiation," as used herein, is understood to have its ordinary meaning that includes, without limitation; at least any photon-based electromagnetic radiation that covers the range from gamma radiation to radio waves and includes X-ray, ultraviolet, visible, infrared, microwave, and radio waves. Therefore, planned and directed radiation therapy can be applied to an eye with energies at any of these wavelength ranges.

"Radiotherapy," as used here, and is understood to have its ordinary meaning, which includes, without limitation, at least any type of chemical therapy that treats a disease by releasing energy through electromagnetic radiation. Radiation X generally refers to photons with wavelengths below about 10 nm to about 0.01 nm. Gamma rays refer to electromagnetic waves with wavelengths below approximately 0.01 nm. Ultraviolet radiation refers to photons with wavelengths from about 10 nm to about 400 nm. Visible radiation refers to photons with wavelengths from approximately 400 nm to approximately 700 nm. Photons with wavelengths above 700 nm are generally in the areas of infrared radiation. Within the X-ray regime of electromagnetic radiation, low-energy X-rays can be referred to as orthovoltage. While the exact photon energies included within the definition of orthovoltage go, for the present description, orthovoltage refers to at least some X-ray photons with energies from about 20 keV to about 500 keV.

As used herein, "treatment" refers to any way in which one or more of the symptoms of a disease or disorder are improved or otherwise beneficially altered. Treatment also encompasses any therapeutic use of the present systems.

The diagnoses can also be made with any type of energy source or treatment described here and can be referred to as "radiation diagnoses."

As used here, the term "global coordinate system" or "external coordinate system" refers to a physical world of a machine or space. The global coordinate system is generally a system that refers to a machine, such as a computer or any other operating device, to the physical world or to the space that is used by the machine. The global coordinate system can be used, for example, to move a machine, the components of a machine, or other elements from a first position to a second position. The global coordinate system can also be used, for example, to identify the location of a first element with respect to a second element.

"Kerma", as used herein, refers to the energy released (or absorbed) by volume of air when the air is reached with an X-ray beam. Kerma's unit of measure is Gy. The air-kerma rate is the Kerma (in Gy) absorbed in the air per unit of time. Similarly, the "kerma tissue" rate is the radiation absorbed into the tissue per unit of time. Kerma is generally insensitive to the wavelength of radiation, since it incorporates all wavelengths in its joule reading.

As used herein, the term "radiation dose" is understood to include, without limitation, the energy absorbed per unit of tissue mass. An example of a measurement of the radiation dose is Gray, which is equal to 1 July per kilogram, which is also equal to 100 rad. Or for example, as used here in some embodiments, a radiation dose may be the amount of radiation, or energy absorbed per unit of tissue mass, that is received or administered for a certain period of time. For example, a radiation dose may be the amount of energy absorbed per unit of tissue mass during a process, session, or treatment procedure.

As used herein, the term "trajectory" is understood to include, without limitation, a path, orientation, angle, or general direction of travel. For example, as used here in some embodiments, the path of a beam of light may include the actual or planned path of the beam of light. In some embodiments the trajectory of a light beam can be determined by an orientation of a light source emitting the light beam, and the path can, in some embodiments, be measured, such as by an angle, or determined with respect to to a reference, such as an axis or a plane.

As used herein, the term "geometric axis" refers to an axis that is the axis of symmetry of the eye in the anterior to posterior direction. This axis extends from the center of the cornea through the center of the posterior pole of the eye and is the axis on which the eye can be rotated around with a rotational symmetry. The geometric axis is an axis purely related to the ocular anatoirffa and can be determined in any eye, even in a blind patient.

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As used here, the term "optical axis" of the axis is taken to be generally synonymous with the term "geometric axis."

As used here, the term "visual axis" is the axis that crosses the center of the lens to reach the center of the fovea. It is typically determined when the subject looks directly at an object, the axis that intersects an area above the fovea. The visual axis is to some extent determined by the specific visual function of the patient, it can be affected by the pathology of the eye and the adaptive behavior of the patient, and in some patients it can be difficult to determine.

As used here, the term "reference axis" refers to an axis that relates to an ocular anatoirna of the subject with respect to an external coordinate system, that is, an external coordinate system to the eye, such as a coordinate system. defined by an ophthalmological or diagnostic treatment device (in some cases a reference axis can be referred to here as an "axis of interest"). In the embodiments described here in particular detail, the reference axis is generally, or accurately approximates and represents, the geometric axis of the eye as referenced in an external coordinate system.

However, alternative reference axes can be defined, and it should be understood that many aspects of the invention can be applied usefully, without departing from the invention, to systems and methods in which the axis of interest is different from the geometric axis. For example, in certain embodiments that have aspects of the invention the "axis of interest" may be the visual axis. Alternative embodiments may define an eye reference system with respect to several other observable and / or measurable structures or properties of the eye. Regardless of whether the axis of the eye is defined by a reference axis, it may be aligned with respect to an external coordinate system, and may serve as a reference axis for anatomical structures of the eye that may be of interest in diagnosis or treatment, such as a retinal macula that shows a macular degeneration.

As used here, the term "aligned with" means arranged in a line or so to be coincident or parallel. In particular, a position of the patient's eye is aligned with a reference axis in an external coordinate system when the geometric axis of the eye is coincident with the reference axis.

The term "placed with respect to" is understood to include, without limitation, that it has a fixed angular relationship between zero and 180 degrees. For example, as used here, two beams of light or X-ray beams are located relative to each other if they are collinear, are oriented relative to each other at a fixed angle, or have another fixed relationship. In some embodiments, the angle between the aligned light beams or X-ray beams can range from about zero degrees to about 360 degrees, and can include about 90 degrees, about 180 degrees, and about 270 degrees.

"Beam axis" or "device axis", as used herein, is understood to include, without limitation, a characteristic directional axis of a treatment or diagnostic device, for example, a propagation axis of a light beam collimated or focused and / or a collimated x-ray beam emitted by a device for treatment or diagnosis. In such embodiments, a beam axis may be the axis of an orthovoltage collimated X-ray beam emitted by an X-ray device and used to treat a target tissue in an organ, such as an eye. Such an embodiment can also emit a collimated or focused laser beam that is collinear with the x-ray beam, for example, and also aligned with the beam axis.

"Treatment axis", as used herein, is understood to include, without limitation, an axis of an anatomical organ or structure in relation to a treatment device. For example, in some embodiments the axis of treatment of the organ is related, such as by an angle, with a characteristic axis of the treatment device (for example, the axis of the beam of a treatment device that emits a beam). In some embodiments the intersection of the treatment axis and the device axis is used to define the objective for the radiotherapy beam.

As used herein, the term "treatment session" is understood to include, without limitation, a single or a plurality of therapeutic treatment administrations of a target tissue, for example, a heat therapy and / or a radiation therapy. For example, in some embodiments a treatment session may include a single administration of X-ray beams to the eye. In some embodiments a treatment session may include a plurality of administrations of X-ray beams and laser radiation to the subject's eye. In some embodiments a treatment session is limited to, for example, a single visit of a patient to a treatment clinic, and in some embodiments a treatment session may be extended to a plurality of a patient's visits to the treatment. In some embodiments a treatment session may include a single radiotherapy administration procedure, and in some embodiments a treatment session may include a plurality of procedures that follow different protocols for each procedure. In some embodiments a treatment session may be limited to approximately one day, and in some embodiments a treatment session may be approximately 2 days, approximately 3 days, approximately 5 days, approximately 1 week, approximately 10 days, approximately 2 weeks, approximately 3 weeks, approximately 1 month, approximately 6 weeks, approximately 2 months, approximately 3 months, approximately 6 months, approximately 1 year, or longer.

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As used herein, the term "treatment period" is understood to include, without limitation, any of a single or a plurality of radiotherapy administrations or a related therapeutic treatment of the tissue, and may include a single or a plurality of sessions of treatment.

As used herein, the term "orders of magnitude" is understood to include, without limitation, a class of scale or magnitude of any quantity, where each class contains values of a relationship related to the class that precedes it. For example, in some embodiments, the relationship that relates each class may be 10. In these embodiments an order of magnitude is a magnitude based on a multiple of 10, two orders of magnitude are based on two multiples of 10, or 100, three Orders of magnitude are based on three multiples of 10, 1,000.

The "laser" energy is composed of photons of different energies ranging from short wavelengths, such as ultraviolet radiation, to long wavelengths, such as infrared radiation. Laser refers more to the mechanism of administration than to the specific wavelength of radiation. The laser light is considered "coherent" because the photons move in phase with each other and with little divergence. The laser light is also collimated because it travels with slight divergence as it advances in space. The light can be collimated without being coherent (in phase) and without being a laser; for example, the lenses can be used to collimate a light other than X-rays. X-ray light is typically collimated with the use of collimators that are not lenses, the penumbra defines the degree of collimation successfully. Laser pointers are typically visualization tools, while higher lasers with higher flow are used for therapeutic applications. In some embodiments of the systems and methods described herein, opticians, such as lenses or mirrors, may be used, and in some embodiments no optical elements are involved, although collimators can be used.

The two cameras of the eye are the anterior and posterior chambers. The anterior chamber includes, among other things, the lens, the conjunctiva, the cornea, the sclera, the trabecular apparatus, the ciliary bodies, the muscles, and processes, and the iris. The posterior chamber includes, among other structures, the humor, the retina, and the optic nerve.

By "eye diseases", as used in this description, it is understood to have its ordinary meaning, which includes, without limitation, at least the diseases of the anterior eye (eg, glaucoma, presbyopia, cataracts, dry eye, conjunctivitis) as well as diseases of the posterior eye (for example, retinopathies, age-related macular degeneration, diabetic macular degeneration, and choroidal melanoma).

Druze are hyaline deposits in Bruch's membrane under the retina. Deposits are due to, or at least are markers of inflammatory processes. They are present in a large percentage of patients over 70 years. Although the cause is unknown, drusen are associated with markers of the place where inflammation is occurring and where neovascularization has a high chance of occurring in the future; These are the areas of the so-called "vulnerable retina." Therefore, it is beneficial to apply a radiation that reduces inflammation in the area, according to some embodiments of the invention.

As used here, Purkinje is a term used to indicate an image reflected outside a surface of the eye. For example, the first Purkinje refers to the reflection outside the anterior surface of the cornea and the second Purkinje refers to the reflection outside the posterior surface of the cornea.

II. System and method of alignment of the eye

One aspect of the invention is directed to systems for objectively and accurately identifying and aligning a reference axis of a patient's eye. In the embodiments described in particular detail the reference axis is, or exactly approximates or represents the geometric axis of the eye, and therefore, the terms "geometric axis" and "reference axis" will be used interchangeably frequently. In these embodiments the geometric axis of the eye is identified and aligned with reference to an external coordinate system.

In another aspect of the invention the aligned eye can then be placed in relation to the axis of the beam or axis of the device of a diagnostic or therapeutic component whose position is referenced with respect to the common external coordinate system, such as a laser of the former of a refractive vision correction surgery system, an orthovoltage x-ray treatment system, or the like. Typically, the external coordinate system will be a three-dimensional coordinate system for purposes of alignment of the eye, regardless of the particular degrees of freedom of movement that can be incorporated into the structure of a particular associated diagnosis or therapeutic device.

Aspects of the invention will find utility in both laboratory research and in clinical applications. The advantages of the present invention are numerous. Exemplary advantages of the systems and methods described below include:

(i) provide objective information on the alignment of the eye that allows an alignment of the eye with

with respect to an external point or line, such as an axis of the instrument or device, or to provide information on the alignment of the eye indicating when the present alignment of the eye is the same as the anterior alignment of the eye;

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(ii) provide eye alignment data that can be used in combination with other diagnostic and therapeutic instruments;

(iii) allow eye alignment data to be provided without requiring instrumentation, such as an eye gma, that could block or prevent the use of diagnostic and / or therapeutic devices that could advantageously use an eye alignment information to improve its diagnostic and / or therapeutic operations; Y

(iv) allow one to bring the eye of a subject to a particular desired alignment, while the subject is under general anesthesia or otherwise unable to cooperate to bring his eye to a particular alignment, for example with Using a gma of the eye, a subject's eye can be brought to a predetermined alignment.

With reference now to the figures, and more particularly to Figure 1, a schematic side view of an anterior portion of an eye 10 is shown in association with a block diagram of an alignment system 100 having aspects of the invention. The system and method in this embodiment of the invention are based on the detection of the coalition of the first Purkinje reflection from the eye 10 of the subject with the center of the blade 30 of the eye of the subject. When the eye 10 is properly illuminated by a light source, four Purkinje reflections can be detected but the first (anterior cornea) is typically the brightest.

Next, the elements of the eye 10 necessary to understand the present invention will be briefly described. The cornea 12 of the eye 10 is characterized by an anterior surface 16 and a posterior surface 14 that are concentric with each other. The remaining portion of the eye 10 shown in Figure 1 is the iris 24 extending outward from the posterior surface 14 of the cornea 12. The intersection circle between the iris 24 and the inner surface 14 is a reference point known as the limbus, the position indicated by the reference number 26. The limbus 26 of an eye is visible from the outside and is easily represented by images.

In embodiments that have aspects of the invention, a reference axis may be defined by the coalition of the first, second, third, or fourth reflection of Purkinje with the center of the limbus. The first Purkinje reflex is defined as the virtual image formed by the light reflected from the anterior surface 16 of the cornea 12. The second Purkinje reflex is an image of the input light formed by the reflection from the posterior corneal surface 14. Light that is not reflected from the anterior corneal surface 16 or the posterior corneal surface 14 propagates through the cornea and aqueous humor, and through the lens of the eye on the retina. The third Purkinje reflection is a virtual image formed by the input light 14 reflected from the front surface of the lens, while the fourth Purkinje image is formed by the light reflected from the rear surface of the lens at its interface with The humor vftreo. See, for example, P.N. Cornsweet and H.D. Crane, J. Opt. Soc. Am. 63, 921 (1973) for a more detailed discussion of the formation of Purkinje images.

Alternatively, the axis is defined by a Purkinje from an optional surface 34 located above the eye 10 such as any of the contact surfaces of the eye in priority applications. Similarly, in Figure 1, a reflection from the corneal cover 34 can be called a "first Purkinje reflex." See, for example, the discussion that follows with respect to the embodiment shown in Figures 5A-5B, in which the term "first Purkinje reflex" is used to describe a reflection from an anterior surface of an element of the device ( contact member 520) which in operation is arranged on the surface of the cornea (this may be a transparent member or may include a mirror surface to improve reflection) and acts in certain aspects as a substitute for the anterior corneal surface 16 .

In the embodiments described in particular detail, the geometric reference axis is identified and determined by the coalition of the center of the limbus 26 and a first Purkinje reflex. That is, the reference axis 18 in Figure 1 is coincident with the center of the blade 26 and the plane 28 normal to the cornea 12 where the plane 28 meets the anterior portion 16 of the cornea at point 32, which is substantially in the center of the cornea of the eye. This reference axis is, or accurately approximates and represents, the geometric axis of the eye, and therefore, the term "geometric axis" can be used interchangeably with "reference axis" in this example.

Figure 1 shows a block diagram of a system 100 for performing a method that has aspects of the invention. In the illustrated embodiment, the system 100 includes a camera 102 located to form an image of the eye 10 along the geometric axis 18. The camera 102 provides video image data of the eye 10 on a display monitor 104. Attached to the display monitor 104 is an image generator 106, such as a personal computer programmed with a commercially available computer-aided software, capable of generating and superimposing geometric images on the image of the eye 10 that appears on the display monitor 104 In operation, the image generator 106 superimposes an image on the image of the eye 10 on the display monitor 104. The superimposed image is typically a geometric shape sized and positioned to match an anatomical reference point that appears in the image of the image. eye 10. The selected anatomical reference point should be one that remains unchanged in size, shape and position in relation to n to eye 10.

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A preferred anatomical reference point is limbo 26, which is generally circular. Therefore, as a first step, the image generator 106 can be operated to place an image of a circle on the image of the blade 26. The image generator 106 comprises a processor and can place the center 30 of the blade 26 by use of the processor within the system. Next, the first 32 Purkinje reflex is identified. The light from the light source 108 travels along the path 35, enters the eye 10 through the cornea 12 and is directed by the lens to the retina. A portion of the light is reflected at point 32 outside the anterior surface of the cornea 16 (or optionally, the anterior surface of the cover 34), which identifies the first Purkinje reflex. The alignment of the center 30 of the limbus with the first Purkinje reflection 32 defines and allows the exact location of the geometric axis 18. The generation of these image coordinates is well understood in the fields of computer graphics and in the design assisted by computer. Thus, an embodiment of the invention includes an image collection system 102 for generating an alignment along the geometric axis 18 from the information captured in two different but interrelated places in an eye 10 of the subject. In a preferred embodiment, the alignment is generated from a combined image of the limbic center 30 and the corneal reflex at location 32. Alternatively, in another embodiment, the surface 34 of the cover provides a reflective surface for a Purkinje image 38.

The limbic center 30 and Purkinje reflex 32 of the anterior cornea are ocular features that are both independent and strongly coupled. They are independent because they are extracted from different biological structures; they are strongly coupled because there is generally a close geometric relationship between the limbic center 30 and the reflex 32 of the anterior cornea that comes from the vertex of the curvature of the cornea. Specifically, the position and orientation of the eye can be determined simultaneously when these two ocular features are aligned together. The strong coupling between the limbic center and the ocular features of the anterior corneal reflex not only facilitates the simultaneous capture of both, but also allows these characteristics to be cross-referenced or combined in a common feature space that maintains the geometric relationship between the two. .

As noted above, an image collection system 102 generates an image 106 of these features capturing an image of the anterior corneal reflex, which captures an image of the limbic limit, processes these images, and correlates the spatial distribution of the limbic center and the anterior corneal reflex to provide a combined image limbic center / Purkinje reflex, or lens cover center / Purkinje reflex center. The image collection system 102 includes, or is attached to, one or more light sources 108 such as one or some LEDs that direct the light towards the surface of the eye 10. The camera system 102 preferably includes an optics that includes at least one partially reflective mirror that directs the light to the eye 10 and that passes the reflected light from the eye 10 towards an image capture device 102. The optics also includes in one embodiment a system of lenses with one or more lenses so that the light coming from the light source 108 is directed from the anterior corneal surface 32, where the light reflected from the anterior corneal surface 32 represents a Purkinje's first reflection. The lens system also directs the light coming from the light source 108 to reflect the light coming from the iris 24, the light reflected from the outer iris representing the limbic limit.

In one embodiment the light reflected by the anterior cornea at point 32 and the light reflected by iris 24 are simultaneously captured by an image capture device 102, such as a digital image capture device, and are displayed on the monitor. of display 104 to capture and generate a combined image of a limbic limit in a first Purkinje reflex that can be used to determine ocular alignment. In one embodiment, the image capture device 102 is formed by two cameras that respectively capture an image of a first Purkinje reflection 32 and an image of an iris 24 and the sclera 17 that determines the limbic limit at the same time or near the weather. In this embodiment, a limbic limit representing at least a portion of the captured iris and a first Purkinje reflex that represents at least a portion of the anterior corneal reflex are generated where the limbic center and the first Purkinje reflex are correlated. These correlated images can be combined together to form an image or can be linked so that they can be analyzed either as an image or as two separate images. In the various embodiments of the present invention the combined limbic center and the information of the first Purkinje reflex provides a geometric axis 18 that can be used to determine eye alignment, treatment and / or diagnostic references.

The objective alignment of the eye can be determined by placing the subject's eye 10 in relation to the image capture device 102 to allow imaging of the subject's eye. The imaging device obtains data from the patient's eye while the subject's face is located approximately vertically above and secured by an articulated headrest so that the subject's eyes look substantially forward, in the direction of the capture device 102 images. In certain embodiments the image capture device is adjustable, for example, by using a joystick. The joystick can be tilted horizontally, vertically, or at the same time horizontally and vertically, on a fixed base, in order to adjust the place and / or the image displayed on the display monitor 104 by the image forming module 400 .

A beam of light 35 is applied to the eye 10 of the subject. The image capture device 102 detects a portion of the beam 35 after crashing into the eye 10 of the subject and generates, based on the detected portion of the beam,

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an image of the limbus of a portion of the limbo of the subject's eye and / or a first Purkinje reflex of the subject's eye, which can be displayed on the visualization monitor l04. By observing the positions of the image of the limbus and the first Purkinje reflex, the alignment of the objective and reproducible eye can be determined. A concentric coalition of the first Purkinje reflex of the subject's eye and the limbo center of the subject's eye establishes the alignment of an ocular geometric axis 18 with the system 100.

In some embodiments of the invention, the system 100 also includes a controller for controlling the time in which the image capture device 102 captures respectively images of the cornea and the limbus and couples the digital representations thereof to the controller for analysis. The controller preferably includes a microprocessor and associated memory. The microprocessor can analyze the images of the cornea and limbus captured to generate a respective first Purkinje reflex and a limbo center that are combined or linked together as described below. Alternatively, the microprocessor can store the captured and correlated images for transmission through a communication interface to a remote computer for analysis and to generate the respective center of the limbus, the first Purkinje reflex and a combined or linked ocular information. In this embodiment, before transmitting the data representing the captured images, the microprocessor determines if the captured images are sufficient to provide alignment data, ie data used to align the eye. If it is decided that the image of the corneal reflex is sufficient, the microprocessor controls the image capture device 102 to capture an image of the iris almost simultaneously with the captured corneal image that was determined to be sufficient to provide data for the alignment of the eye. As used herein, the term simultaneously refers to being at the same time or next in time, for example, within approximately 0.5 seconds, so that the images captured from the retina and iris are correlated.

Signal generation after optical alignment

In one embodiment of the invention the microprocessor controls one or more of the cameras in the image capture device 102 to capture a corneal image and / or an image of the iris, and generate an alignment signal indicating that an eye is properly aligned. with the system An appropriate alignment is when an axis intersects the eye at least two predetermined features in the eye, for example, the center of the limbus and the first Purkinje reflex. The alignment signal may be generated by a switch or the like that is manually operated by a physician when it is decided that the subject's eye is aligned when viewed on the display monitor 104. Alternatively, the system can automatically detect when the eye is in sufficient alignment with the system.

A signal is generated only when the path 35 of the beam of the light beam reflected from a measuring surface 32 is co-aligned with the center of the blade 30 or center of the surface 34 of the roof. In order to achieve the coalition, the image capture device 102, in cooperation with the image generator 106, recognizes the reflection of the probe beam 35 from the anterior corneal surface corresponding to the first Purkinje reflex, and the center of the limbo. As shown in graph 700 in Figure 2, the coalition signal 710 is essentially zero until the coincident reflection of the first Purkinje reflex and the center of the limbus are detected 720. At point 730 the geometric axis is aligned with the system, and according to the invention, the signal can be used to initiate a subsequent event. Or certainly, in alignment, the signal is defined and then if there is no signal, this in itself is a sign that the device is out of alignment.

In one embodiment, an alignment signal drives an eye tracking device to monitor eye movement during a diagnostic or therapeutic procedure or other desired function. In a conventional eye tracker system, the patient can be asked to look at a source of illumination while a visible laser beam coinciding with an axis of the therapeutic beam is directed over the patient's cornea. Based on the surgeon's observation of the visible laser beam in relation to the corneal position, the surgeon will manually apply the eye tracker using their best judgment on the corneal position. Advantageously, according to the invention, the eye tracker can now be started automatically and more precisely since the alignment signal will only be generated when the patient's geometric axis is properly aligned.

In certain embodiments the eye tracking system is configured to track the movement of the patient, such as an eye movement, for use by the system. The eye tracking system can calculate a three-dimensional image of the patient's eye through physician input, and can include real-time tracking of the patient's eye movement. The eye tracking system obtains data that becomes a factor in determining treatment planning for various medical conditions related to the eye. For example, the eye tracking system can create an image of the posterior area of the patient's eye by using the data it obtains. In certain embodiments, the data may be transferred through communication by cable or other means, such as a wireless medium, to a treatment or diagnostic device. In certain embodiments, a processing module coupled to the treatment or diagnostic device can process data on the patient's eye and present an image of the patient's eye on a coupled display monitor. In certain embodiments, the coupled display monitor may present a real-time image of the patient's eye, which includes eye movement.

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In another embodiment, the alignment signal is used to reversibly apply an eye placement and / or stabilization device to the subject's eye, the eye placement and / or stabilization device is in cooperative application with the system. An exemplary eye placement and / or stabilization device is described in detail below, and is illustrated in Figures 4A-5B.

Rangefinder

In another embodiment of the invention the system includes a proximity detector (103 in Figure 1) in the form of a telemeter (camera) or transducer such as an ultrasound transducer to determine when an eye is at a predetermined distance from the system. The proximity detector is preferably located adjacent to the image capture device 102. The proximity detector is operated in a transmission and reception mode. The distance between a system reference point (for example a collinear selected point with the path 35) and the subject's eye (for example, the corneal surface 16) can be determined by the microprocessor or a specialized integrated circuit coupled to the detector. proximity. The microprocessor or integrated circuit calculates the distance between the eye and the system to determine the proximity of the eye to the system.

In one embodiment, the microprocessor or integrated circuit compares the determined distance between the eye and the system with a value of the predetermined distance stored in memory, a register or the like, accessible by the microprocessor or integrated circuit. When the microprocessor determines from the exit of the proximity detector that the individual is at a predetermined or correct distance, the microprocessor signals the image capture device 102 to capture an image of an area of the blade 26. Simultaneously, the microprocessor can signaling the image capture device 102 to capture an image of the cornea 12. In one embodiment, the microprocessor first controls the image capture device 102 to capture an image of the cornea that is immediately analyzed by the microprocessor to determine if the Purkinje's first reflex captured is sufficient to provide the alignment information discussed above. When a first sufficient Purkinje image has been detected, the microprocessor signals the image capture device 102 to capture an image of the blade 26. In this embodiment the microprocessor analyzes the image captured from the cornea for sufficient time for the The microprocessor can signal the image capture device to capture an image of the limbus sufficiently close in time to the image captured from the cornea so that the images are correlated and can be considered captured simultaneously.

It should be borne in mind that in addition to using in the operation of the alignment system as described above, the proximity detector can be configured to monitor the distance of the eye over any selected period of time, for example after alignment of the reference axis of the eye (for example, axis 18) by the alignment system, during the treatment or diagnostic operation (for example, input for feedback of controls, safety interlocks and the like).

Coupling of the alignment system to a treatment system

In some embodiments of the invention the alignment of the system is directly or indirectly coupled to a treatment or diagnostic device. The alignment method is used in combination with a treatment device to treat a wide variety of medical conditions related to the eye. As discussed in more detail below, once the reference axis is defined, it can be geometrically linked to the anatomical structures of the eye that may be of interest in the treatment of structures or diseases, for example places of the tissue on the retina such as the macula affected by macular degeneration. Similarly, the reference axis may be linked to other areas of treatment of the eye, such as areas of the retina such as the fovea, the macula, a pathological lesion such as a tumor, a growth of the blood vessels, a membrane, a telectasia, and an edematous zone, and the like.

For example, the system can be used alone or in combination with other treatments to treat macular degeneration, diabetic retinopathy, inflammatory retinopathies, infectious retinopathies, tumors in, around, or near the eye, glaucoma, refractive disorders. , cataracts, post-surgical inflammation of any of the structures of the eye (for example, trabeculoplasty, trabeculectoirna, intraocular lenses, drainage tubes for glaucoma, corneal transplants, infections, idiopathic inflammatory disorders, etc.), tyranny, dry eye, and other eye diseases or other medical conditions related to the eye. The treatment system is preferably a radiotherapy system that also includes controls to define the maximum energy of the beam (for example, between about 30 keV to about 150 keV), the beam angles, the eye geometries, and the controls to turn off the device when the patient and / or the eye move out of place.

The radiotherapy treatment system includes, in some embodiments, a radiation source, a system to control and move the source to a coordinate in a three-dimensional space, an image formation system, and an interface for a healthcare professional Enter treatment parameters. Specifically, some embodiments of the radiotherapy system include a radiation therapy module or subsystem that includes the radiation source and the power supply to operate the source, an electromotive control module or subsystem that operates to control the power of the source asf such as the directionality of the source, a coupling module that links the source and control to the eye, and a subsystem of image formation. In

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Some embodiments of these modules are linked to an interface for a health professional and form the basis of the treatment planning system. In another embodiment described below the treatment system is a photoextirparative laser surgical system.

Figures 3A and 3B illustrate two examples of embodiments that have aspects of the invention, in which the alignment system is coupled to a treatment system (for example, a radiotherapy device, an excision laser, or the like) and configured to provide an operational control and / or monitoring functionality of the treatment system functionality, such as position control, orientation control, timing control, power enable-disable, and the like. In the examples shown the alignment system is coupled to a treatment system, wherein the image generator 306 is coupled to a placement device 310 used to place an ophthalmic treatment device (312 and 314 in Figures 3A and 3B, respectively), for example, an excision laser or a radiotherapy device.

In Figures 3A, the position of the geometric axis 18, properly positioned by the alignment system, can be used by placing the device 310 to direct the ophthalmic treatment device 312 to an objective tissue 318, which may or may not be located at along the axis 18. In this example the objective 318 is positioned outside the axis with respect to the geometric axis 18, as will be discussed later.

In Figure 3B the position of the geometric axis 18, properly positioned by the alignment system, can be used by the positioning device 310 to "center" the ophthalmic treatment device 314 on the geometric axis 18 of the eye, for example, in where as a treatment objective it is centered on the geometric axis, as will be discussed later.

In these embodiments of the invention the position of the eye and the treatment device are known at all times, and the angles of entry of the therapeutic or diagnostic beam can therefore be performed. For example, the geometric axis of the eye can be determined and defined as the reference axis of the system. A treatment axis can be defined with respect to the reference axis, and then the treatment device can be placed at a known angle and / or travel distance of the reference axis. For treatment objectives that are on the reference axis, the treatment axis can be defined as the reference axis. Depending on the area that has to be treated, the treatment device can be readjusted; For example, an arm of a robot can move the treatment device to a position to send a therapeutic beam to a place above or in the eye.

Returning to the embodiment illustrated in Figure 3A, a schematic view of an alignment and treatment embodiment is shown, including a cross-sectional view of a portion of the eye taken along the geometric axis. The system 300 includes an image capture device 302 positioned to form an image of the eye 10 along the geometric axis 18. The image capture device 302 provides data data of the image of the eye 10 to a display monitor 304 Attached to the display monitor 304 is an image generator 306, such as a commercially available personal computer with a commercially available computer-assisted design software capable of generating and superimposing geometric images on the image of the eye 10 that appears in the display monitor 304. In operation, the image generator 106 superimposes an image on the image of the eye 10 on the display monitor 304. The superimposed image is typically a geometric shape sized and positioned to match an anatomical reference point that appears in the image of eye 10. The selected anatomical reference point should be one that remains a without changing size, shape and position in relation to the eye 10.

A preferred anatomical reference point is limbo 26, which is generally circular. Therefore, as a first step, the image generator 306 can be operated to place an image of a circle on the image of the blade 26. The image generator 306 can then place the center 30 of the blade 26. Next, the Purkinje's first reflex 32 is identified. The light from the light source 308 travels along the path 35, enters the eye 10 through the cornea 12 and is directed by the lens to the retina. A portion of the light is reflected at point 32 outside the anterior surface of the cornea 16, which identifies the first Purkinje reflex. The alignment of the center 30 of the blade with the first Purkinje reflex 32 defines and allows the exact positioning of the geometric axis 18 as a reference axis with respect to the external coordinate system.

With the position of the geometric axis 18 properly positioned, the geometric axis 18 becomes a reference axis, and can therefore be used by placing the device 310 to direct the ophthalmic treatment device 312 towards the eye in a predetermined orientation with respect to to the geometric axis 18 such as a therapeutic beam, such as a collimated electromagnetic radiation beam 311, can be directed to a predetermined coordinate of the eye 10 to enter the surface of the body (point 324 on the superficial sclera 17) and propagate to collide on a selected target tissue 318.

Note that Figure 3A is a flat illustration of the three-dimensional anatoirna of the eye, and in general the axis 311 of the device 312 does not need to intersect the reference axis 18 (i.e., axes 18 and 311 may, but not need, be within a plane). In general, the axis 311 of the beam may have a selected orientation with respect to the reference axis 18, such as a selected angle "0" and offset "d" with

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with respect to axis 18. The device 312 can in fact form an angle to intersect any anterior-posterior line within the eye.

Once the reference axis 18 has been identified, the treatment can be performed by a device oriented with respect to the axis 18, for example in which a treatment objective is along the axis 18 (see the description referring to Figure 3B) . Alternatively, a different axis 19 may be defined with respect to axis 18, for example by a distance shift "d", so that axis 19 intersects the treatment target 318 positioned outside the axis with respect to axis 18. The axis 19 can be called the “treatment” axis. Based on a simple geometry, the device 312 can now be positioned so that the axis 311 of the beam intersects the treatment axis 19 in the target fabric 318. The axis 18 can be used to define one or more correlated axes in the system of external coordinates, and to define one or more additional intersection points with respect to beam 311. It must be taken into account for treatment objectives that are on the reference axis 18, that the displacement "d" can be approximately zero, and that for a treatment administered through or in the cornea, the angle "0" may approach zero.

Figures 3C-3D illustrate an example of an embodiment in which the alignment system is coupled to a treatment system adapted for orthovoltage X-ray treatment of an area of the retina that generally includes the macula. Figure 3C is a cross-sectional view of an eye taken along the geometric axis in a horizontal plane, shown in association with the alignment-treatment system 300. Figure 3D is a detailed front view of an eye seen aligned with axis 18 (temporal to the right, nasal to the left).

As shown in Figure 3D, although a single axis 311 of the beam can be used, a plurality of beam axes can be defined in which two or more treatment beams are directed to collide on the target 318 stereotactically. The treatment axis 19 can be chosen to intersect a target 318 selected within the eye, and used as a reference to orient two or more treatment beams directed to collide on the target 318 stereotactically. In the example of Figure 3D, the treatment axis 19 is chosen to intersect a selected target 318 within the eye, and is used as a reference to orient three projected treatment beams along three different axes 311a, 311b and 311c , the axes of the beams are defined so that each one hits the target 318 from a different direction.

Several beams can be projected simultaneously or sequentially with intervening nodes of non-treatment, if desired. Likewise, several beams can be arranged by means of several treatment devices located separately. However, a preferred embodiment employs a single treatment device 312 (for example, a collimated orthovoltage X-ray source), which is sequentially repositioned again by placing the device 310 to administer a sequential dose treatment along each one of the axes of the beam, such as axes 311a, 311b and 311c.

The axes of the beams each have a respective different point of entry on the surface of the body (324a, 324b and 324c respectively) and each follows a different tissue path to objective 318. Similarly, each beam follows a different tissue path for any spread beyond objective 318. In this way, the dose of the treatment beam that penetrates the tissue away from objective 318 can be minimized with respect to the dose received in objective 318.

The axis 311 of the beam (or several beams, each with axes 311a-c) can be selected to follow a tissue path that avoids vulnerable structures or tissues that are far from the target 318 to minimize the dose received by such tissues. For example, in the treatment of the macula for macular degeneration, axes 311a-c can be selected to administer a selected dose of treatment with the beam (for example, a selected dose of absorbed X-ray energy) to a target 318 at or near the retina 340, centered on the macula 342 while minimizing the radiation absorbed by the optic nerve 350, the lens, and the like.

In the example shown, the three axes 311a, 311b and 311c of the beams are defined so that the axes directed towards the back of the eye enter the body on the surface of the anterior sclera 17 at points 324a, 324b and 324c , each entry point at a selected distance beyond the limb 26. Such orientation of the beam can prevent or minimize absorption by the lens and other structures within the eye, by appropriate selection of the beam paths.

The positioning device 310 may favor robotic control with any selected degrees of freedom and may have corresponding feedback sensors to allow accurate treatment control by a processor and / or a manual operator. See, for example, systems with a high degree of freedom from robotic surgical control such as those used in the CyberKnife® robotic radiosurgery system (Accuray, Inc. Sunnyvale, CA) and the highly invasive Da Vinci® surgical system (Intuitive Surgical, Inc., Sunnyvale, CA). Such systems can favor a high degree of operational reach and flexibility. It should be borne in mind that in the most general case the treatment axis 19 does not need to be parallel to the reference axis 18, and the objective 318 can be located relative to axis 18 by other analytical methods that do not include a defined treatment axis. separately. On the other hand, a real or at least conceptual danger of robotized systems of a high degree of freedom that employ an energy beam treatment is the large possible number of

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beam paths (for example, after a failure of the control system), and the associated risk issues, regulatory complexity, and the high costs of modifying the installation and the place of the end user.

The important safety and regulatory / validation advantages, as well as the compactness and cost reduction, can be provided by the configuration of the placement device 310 to have reduced degrees of freedom and simplified control and / or software support devices. Particularly when a treatment system is optimized for a particular range of treatment procedures (for example, treatment objectives at or near the retina), a finite number of degrees of rotational or translational freedom (for example, electric actuators mounted on a rail or a pivot) can provide the desired range of selectable beam paths to deliver a medically optimal dose to the treatment target.

As illustrated in Figure 3D, one or more axes (311a, 311b and 311c) of the beams are defined so that each axis is within a conical conceptual surface and so that each beam intersects the cone vertex. The cone can be defined as having the conical axis 19 the treatment axis 19 with the vertex disposed in the objective 318. In this example the treatment axis 19 is defined parallel to the reference axis 18, which has x and defined displacements in a perpendicular plane by "dx" and "dy" respectively (for a treatment objective intersected by the reference axis, the displacements are zero). Once the treatment axis 19, the base 34, the angle of the vertex ("0" in Figure 3C), and the rotational positions of the axes 311a-c with respect to the axis 19, can be adjusted to provide the intersection of the beam at approximately the target 318 as well as to arrange the entry points 324a-c located in a desired position of the body surface.

As shown in Figure 3C, in an example of a treatment of macular degeneration with orthovoltage x-rays, the displacements dx and dy are selected to define a treatment axis 19 centered on the macula, angle 0 is selected to provide the intersection of the beams 311a-c on the macular surface, and the base 34 is selected to arrange the entry points 324a-c of the surface in an area of the lower anterior sclera beyond the limit of the limbus 26. In this example A source of an X-ray beam can be placed by placing the device 310 to project a collimated beam from a distance from the selected X-ray source to form a beam having a characteristic width at the "w" entrance of the tissue. It should be noted that although a treatment beam can be projected through an eyelid or other tissue close to the eye, the eyelids (in this case the lower eyelid) can be conveniently folded to expose an additional area of the anterior sclera 17 .

In the example shown in Figures 3C-3D, objective 318 is approximately fovea 344. As shown in Figure 3C, the collimated X-ray beam 311 of orthovoltage at the entrance to the sclera has an effective width of the beam of We (for example, defined by a limit in the isodosis of 90%). The beam 311 extends as it propagates through the eye to have an effective width of the Wt beam, which covers an area surrounding the target that constitutes the treatment zone, which in this case corresponds to the macula.

In the example shown, for each axis 311a-c of the beam a rotational angle O can be selected to define a different propagation path for the beam (for example, a path that avoids vulnerable structures such as the optic nerve 350 and that is sufficiently different from other treatment beams to reduce the dose to collateral tissue). It should be taken into account that when the treatment axis 19 is displaced from the axis 18 of geometric reference, the points 324a-c will tend to be at different distances from the blade 26, and the combination outside the base 34 and the rotational angle O for the nearest beam it can be selected to ensure a desired minimum corneal clearance "c" for beam entry (324a in Figure 3B).

The positioning device 310 may conveniently have actuators that facilitate 5 degrees of freedom of movement for the treatment device 312, such as providing an xyz adjustment relative to the patient's eye, and the rotation of angles 0 and O to direct each of you make them 311a-c to objective 318 along a different path. See, for example, the limited placement system for an X-ray source and collimator, described and shown with respect to Figures 12E-F of US Patent Application for Joint Invention / Property No. 12 / 100,398, entitled " Orthopedic radio-surgery ”presented on April 9, 2008 by Gertner et al.

A person with ordinary experience in the art will appreciate that for a specialized device optimized for a particular range of treatments, less degrees of freedom can be provided, such as when certain of the described parameters can be reasonably set. It should be taken into account in this regard that an eye positioning and / or stabilization device, as shown in Figures 4-5, may include actuators (or use the patient's manual movement) sufficient to change the position and orientation of the treated eye 10, to replace the degrees of freedom of the placement device 310 with respect to the treatment device 312. Thus, the patient and / or the eye can be moved in one or more parameters with respect to the device 312, until it has been determined that the treatment path 311 is correctly directed towards the objective 318 (which can be confirmed by the system of alignment).

In some embodiments, one or more systems of additional image formation cameras may be included. In the example shown in Figure 3A, the camera 322 is configured to be placed by the positioning device 310, and directed to obtain an image of the area of intersection of the therapeutic beam 311 with a

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exposed body surface, such as an exposed area of the sclerotic surface of the eye. Additionally, a reference light beam may be arranged to illuminate and / or mark the area of intersection. For example, the device 312 may incorporate a laser pointer beacon along a path coinciding with the therapeutic beam 311 (for example, directed by a coiled mirror), to indicate the intersection of the beam 311 on a surface of the eye ( for example, for visual or automated confirmation of beam alignment 311, or the like). Alternatively, a reference light beam that is not directed along a path coinciding with the therapeutic beam 311 can be arranged, for example, configured to be directed by placing the device 310 on a path that intersects the surface in the area ( see Figure 2C and the related description of US Joint Ownership Application No. 11 / 873,386 filed on October 16, 2007).

In the embodiment depicted in Figure 3B, the system 350 includes a camera 302 positioned to form an image of the eye 10 along the geometric or reference axis 18. The camera 302 provides video image data of the eye 10 to a display monitor 304. Attached to the display monitor 304 is an image generator 306, such as a personal computer programmed with a commercially available computer-aided design software, capable of generating and superimposing geometric images on the image of the eye 10 that appears on the display monitor 304. In operation, the image generator 306 superimposes an image on the image of the eye 10 on the display monitor 304. The superimposed image It is typically a geometric shape sized and positioned to coincide with an anatomical reference point that appears in the image of the eye 10. The selected anatomical reference point should be one that remains unchanged in size, shape and position relative to the eye 10.

A preferred anatomical reference point is limbo 26, which is circular. Therefore, as a first step, the image generator 306 can be operated to place an image of a circle on the image of the blade 26. The image generator 306 can then place the center 30 of the blade 26. Next, the image is identified. Purkinje's first reflex 32. The light coming from the light source 308 travels along the path 35, enters the eye 10 through the cornea 12 and is directed by the lens towards the retina. A portion of the light is reflected at point 32 outside the anterior surface of the cornea 16, which identifies the first Purkinje reflex. The alignment of the center 30 of the blade with the first Purkinje reflex 32 defines and allows the exact location of the geometric axis 18. With the position of the geometric axis 18 properly positioned, the geometric axis 18 becomes a reference axis, and of this mode can be used to position the device 310 to direct the ophthalmic treatment device 314 towards the eye and co-aligned with the geometric axis 18 so that a therapeutic beam, such as a beam of an excision laser 316 can be directed to a coordinate preset of eye 10, such as point 32 on cornea 12 of eye 10.

The treatment device 314, in one embodiment of the invention, is used for the treatment of macular degeneration of the eye through the use of radiotherapy. For example, in some embodiments systems and methods for radiotherapy use on selected portions of the retina are described to prevent or reduce retinal neovascularization. Some embodiments described herein also refer to systems and methods for treating glaucoma or controlling wound healing through the use of radiotherapy. For example, embodiments of systems and methods for use of radiotherapy on a tissue in the anterior chamber following glaucoma surgery, such as trabeculoplasty, trabeculotoirna, canaloplasty, and laser iridotoirna, are described to reduce the possibility of postoperative complications. Other embodiments describe systems and methods for using radiotherapy to treat drusen, inflammatory deposits in the retina that are believed to lead to vision loss in macular degeneration. Localized treatment of drusen and surrounding inflammation may impede the progression of dry and / or wet AMD.

In some embodiments, laser therapy is applied to drusen in combination (adjuvant therapy) with a colocalized X-ray radiation for substantially the same place where the laser is incident on the retina; The laser can create a localized heating effect that can facilitate radiation treatment, or the laser can remove an area, or laser point, while radiation can prevent subsequent scarring around the area. Such combination therapy can improve the effectiveness of each therapy individually. Similarly, adjuvant therapies may include x-ray radiation therapy in combination with one or more drugs or other medicines or chemicals that improve radiation therapy. In some embodiments, X-ray therapy is combined with invasive surgery such as vitrectoirna, cataract removal, trabeculoplasty, trabeculectoirna, laser photocoagulation, and other surgeries.

Reversible coupling of an eye device in the eye after alignment

With reference now to Figures 4A-4B, after identification of the geometric axis 18, as described in detail above, an eye device, for example eye device 400 described in the provisional US application for joint ownership number 61 / 020.655 , filed on January 11, 2008, entitled "System and Method for the Placement and Stabilization of an Eye", can be placed on, and aligned with the eye 10. After placement and alignment, the eye device 400 can be used for several methods, which include:

(i) stabilize the eye in a controllable way,

(ii) physically manipulate the position of the eye,

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(iii) limit eye movement during treatment,

(iv) provide a positional reference in relation to the external coordinates of the eye surface and its internal anatoirna,

(v) provide fiduciaries related to the eye,

(vi) maintain corneal lubrication during treatment, and

(vii) provide a mechanism for aligning a treatment device and continuously signaling the proper alignment or misalignment.

Figures 4A-4B schematically illustrate an up-down view of the eye device 400 that is reversibly and controllable coupled to the cornea 12 and / or the limbus 24 of the eye 10, in association with the alignment system 100. It is necessary to have note that the ocular device 400 (and other embodiments of the ocular device having aspects of the invention) can be used usefully independent of alignment systems, such as system 100. The ocular device may be supported by a mounting (not shown). ) coupled to the positioning arm 480 to keep the eye in a first position to provide stability to the eye while the eye is being treated. The assembly can be configured to manually and / or robotically adjust the position of the device 400 and the eye 10. The eye device 400 includes a contact member 420 that makes contact with the eye 10. The contact member 420 can be placed on the eye in a variety of positions, and therefore is useful in a wide variety of eye treatment procedures.

As illustrated below in Figure 4B, the eye contact member 420 includes a curved structure that is generally centered on the axis 18 and makes contact with portions of the anterior surface of the eye 10. As will be seen later with reference to Figure 5A, the eyeglass can provide a normal outer reflective surface ae intersected by the central axis of the eye contact member, which allows alignment of the eye by using a reflection from this reflective surface as a Purkinje reflection , that is, as a substitute for Purkinje's first reflection outside the anterior surface of the cornea.

In some embodiments the contact member 420 makes contact with all or a portion of the corneal surface 16, and in some embodiments the contact member 420 makes contact with portions of the surface of the sclera 17 (represented by dotted lines) arranged adjacent to blade 26 while covering all or a portion of the corneal surface 16. For example, in one embodiment the contact member 420 with the eye has a profile configured so that the periphery 437 of the contact member 420 is in contact with the sclera 17 adjacent to the blade 26, and configured so that the central portion of the contact member 420 substantially covers the cornea, but is not in direct physical contact with at least one central portion of the cornea.

In another alternative embodiment, the contact member 420 may be sized and configured so that in operation it covers a mayona of the corneal surface, while leaving all or a portion of the limbus 26 visible beyond the edge 437 of the contact member 420. In this embodiment a camera of an alignment system (see, for example, Figures 1 and 6) may be arranged to obtain and process images of the blade while the contact member 420 is in contact with the cornea 12. For example, a Camera, such as camera 102 or another camera may be arranged, configured to make possible an alignment system to confirm the placement and stability of the contact member 420 by the spatial relationship of the member 420 with the blade 26.

The contact member 420 with the eye can be held against the eye 10 by a selected pushing force, for example, mechanically applied by means of the positioning arm 480. In addition, or alternatively, a vacuum suction can be used to create a attraction between the member 420 and the surface of the eye 10. The eye support illustrated in Figures 4A-4B includes a vacuum port 410 that functions as a passage of air and / or fluid and can be adapted to be coupled to a source vacuum through vacuum tube 275. In the embodiment illustrated in Figures 4A-4B, vacuum port 410 is positioned by means of the eye contact member 420 so that an air communication space is formed or fluid through the eye contact member 420 to allow air trapped between the eye contact member 420 and the anterior surface of the cornea 12 of the eye 10 to be removed, thereby reversibly applying the same Bro 420 of contact with the eye with the anterior surface of the eye in the area of the cornea 12. The pressure of the vacuum can be adjusted for patient comfort, and in relation to the pushing force and the geometry of the cup. For example, a vacuum pressure of approximately 25 mmHg or less has been found to be suitable for providing stability to the eye in an embodiment that has aspects of the invention. When the eye device is seated on and coupled with the eye 10, the mirror 430 is aligned so that it is substantially parallel to the plane 28 (normal to the cornea 12 on the axis 18 coinciding with the center of the blade 26). In this way the mirror 430 becomes an additional alignment tool to perform an alignment procedure in the eye 10 of a subject. Alignment methods having aspects of the invention may include identifying a reflection of the beam 35 (light source 108) from the mirror 430, and aligning the reflection with respect to an anatomical reference point such as the center of the blade 26. Such methods may be employed in addition to, or instead of, the alignment methods based on a first Purkinje reflex from the surface 16 of the cornea 12 as described above with respect to Figure 1.

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It should be borne in mind that all or a portion of the contact member 420 may comprise a transparent material to allow an operator (and / or a system camera) to visualize the relative position of the eye structures such as the blade 26 when the contact member 420 is brought into contact with eye 10, and while member 420 remains in contact.

An exemplary method for performing an alignment procedure after placement of the eye device 400 on the subject's eye 10 includes supporting the subject's head in a position set in an external coordinate system, determining the position and orientation of the eye. according to any of the methods described above, which connect an effective eye contact device 400 to the front of the eye 10 to stabilize the position of the eye in relation to the contact device 400, and then determine the position and orientation of the eye contact device in the external coordinate system, in order to determine the position and orientation of the patient's eye in the external coordinate system. The eye 10 can thereafter be moved or positioned as desired, while maintaining contact between the eye 10 and the contact member 420, and while monitoring the movement or position of the contact device 400 in the system of external coordinates. For example, after joining the eye 10 to the eye contact device 400, the method may include moving the eye contact device 400 to place the device 400 in a selected orientation in the external coordinate system, such as adjusting the angular position of the contact member 420 with respect to the subject's head. You can then determine the position of the eye device in the external coordinate system with the same placed in the selected orientation.

In a related embodiment, with the ocular device 400 now placed over the eye, a therapeutic device may be used to provide a therapeutic treatment to the subject's eye. In this embodiment, a source of a collimated electromagnetic beam, such as an X-ray beam, is positioned so that when driven, it is directed along a selected vision line in a selected coordinate in the external coordinate system. corresponding to a selected target area in the subject's eye.

Figures 17A-17D represent embodiments of eye supports 400 (ad) that have aspects of the invention, similar in many ways to those shown in Figures 4A-B and Figures 16, which have alternative configurations of the contact member 420 In each figure the support 400 of the eye is shown superimposed on a front schematic view of a portion of an eye 10 having the iris 24 contiguous to the area of the sclera 17, the junction of which defines the limbus 26. In each The eye 10 is shown aligned with the reference axis 18 placed in the center of the blade 26. In each figure the support post 422 is shown centered on the axis 420, although it does not need to be centered.

Figure 17A depicts an embodiment in which the contact member 420 is sized to have a margin that can be placed on the surface of the eye to leave all or most of the limit 26 of the limbus uncovered. This configuration facilitates a visual confirmation of the placement of the member 420. This configuration also facilitates the use of automated methods of pattern recognition / limit detection, for example, by using images captured by camera 102, or another camera arranged for capture images of limbo. For example, the proximity detector 103 in Figure 1 may in certain embodiments include a camera with a telemeter, which can also be used to determine the position of the blade 26 with respect to the contact member 420.

Figure 17B depicts an embodiment in which the contact member 420 is sized to cover all or a portion of the blade 26. In certain embodiments the comparatively large contact member or cup 420 provides great stability of the eye control for a given combination. of pushing force and / or vacuum pressure, and can provide an outline that avoids direct contact with the center of the cornea. It should be borne in mind that the member 420 may comprise a transparent material that allows viewing of the covered portion of the blade 26.

Figure 17C represents an embodiment in which the contact member 420 is configured to be asymmetric with respect to the blade 26, and in operation it can be placed off-center with respect to the limbic center (see axis 18).

Figure 17D depicts an embodiment in which the contact member 420 is configured to include one or more lobes 440, the lobes extend beyond limbo 26, cover areas of the sclera adjacent to one or more zones 324 of the beam entry of treatment. In the embodiment shown, the lobes surround portions of a pattern of three inlet zones of the treatment beam arranged radially similar to those shown in Figure 3D. For example, in an eye support for use in an orthovoltage X-ray treatment system, the lobes may comprise a material selected to absorb X-rays, for example to reduce the dose absorbed by the eye lens. In this example, a large portion of the blade 26 is exposed in portions of the surface of the eye not close to the treatment beams, and one or more fiduciaries 450 may be arranged to facilitate eye tracking devices. In an alternative embodiment (not shown) the lobes can completely surround the zones 324 of the beam entry.

Figure 5A depicts a configuration of an eye support 500, which is generally similar to eye support 400 shown in Figures 4A-B, but in which post 522 is offset from the central portion of the

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60

contact member - 520 cup of the sclera lens. In particular, the displacement from the central axis of the eye gma, indicated at 523, is sufficient to allow a beam of light directed along this axis to be reflected outside the central area of the eye gma, not obstructed by a positioning arm 522 and a positioning arm 580. This allows the outer surface of the eye gma, normal to and intersecting axis 523, to provide a reflection point for a beam directed to the center of the eye, which thus produces a Purkinje reflection that corresponds to the first Purkinje reflection from the anterior surface of the cornea, when the eye gma is centered on the patient's eye. As in the embodiments of Figures 4A-B, an optional forging source 575 is also provided in this embodiment to provide a suction application of the cup 520 with the eye 10. All or a portion of the contact member 520 may comprise a transparent material, for example a clear polymer such as PMMA (methacrylate polymethyl) to allow an operator to see the relative position of eye structures such as blade 26 and iris 24 when the contact member or cup 520 is carried to make contact with the eye 10.

Additionally, the transparency allows the transmission of light to and from the surface and inside of the eye through the cup 520 while in contact with the eye 10, to make it possible to observe the internal structures of the eye through the cornea, such as the retina. The imaging camera 102 is also arranged in this embodiment. A feature of this embodiment is that the imaging camera 102 can visualize an eye structure such as the bottom directly through the cup 520 while a therapy is being performed. A background image can be obtained through the clear portion of the sclera cup 520 without the post on the way. The Purkinje of the contact portion 520 and its center align with the Purkinje of the cornea, and the alignment position 523 of the contact portion 520 can be used as a substitute for what the alignment will be if the Purkinje of the cornea was used for alignment 18.

Figures 18A-18B represent embodiments of supports 500 (ab) of the eye that have aspects of the invention, very similar with respect to those shown in Figures 5A-B and 16, which have alternative configurations of the contact member 520. For each figure, the eye support 500 is shown superimposed on a schematic view of a portion of an eye 10 having the iris 24 adjacent to the area of the sclera 17, the junction of which defines the limbus 26. Each figure includes a front view (1) and a cross-sectional view (2) taken along the line (2) - (2) in the view (1).

Figure 18A depicts an embodiment in which the contact member 520 is configured to include a window area 595 comprising a transparent material that allows visualization of the interior of the eye through the central cornea while the support 500a of the eye is in contact with the eye 10 (or the entire contact member 520 may comprise a transparent material). The window 595 can also be configured to facilitate the visualization or capture of an image for the reflection of a collimated or coherent beam of light from the exterior surface of the window 595, as described in the alignment methods here. The vacuum port 510 is configured to apply a suction force that adheres the support 500a from the eye to the eye 10. It should be taken into account that any space between the window 595 and the upper outer surface 16 corneal can be filled with a solution or an ophthalmic gel, which can be composed to reduce the refractive effects between the window 595 and the cornea. The support post 522 can be arranged to mount on the offset contact member 520 with respect to the window 595 so as not to obstruct the visualization through the window. In this example, the contact member 520 is sized and shaped to leave all or a large portion of the blade 26 uncovered.

Figure 18B represents an embodiment in which the eye support 500b is configured in an arrangement generally similar to the eye support 500a of Figure 18A, but in which a central opening 597 is arranged so that the central surface 16 of the Cornea is exposed. The contact member 520 is configured in an annular ring shape that surrounds all or a portion of the limit opening 597. Alternatively, the member 520 may not be fully closed around the periphery of the opening 597, for example having a flat "C" shape rather than an "O". In the example shown, an annular groove 512 is recessed below the surface (eye contact surface) of the member 520 to facilitate the distribution of the vacuum pressure from the communication vacuum port 510 around the peripheral contact area of the member 520. The embodiment shown allows a first Purkinje reflection to be conveniently captured or visualized from the outer corneal surface 16 while the eye support 500b is in operative contact with the eye 10, which facilitates the realization of the alignment methods described here.

Figures 16A to 16B represent alternative species that have aspects of the intervention of an appropriate "separation" post that can be used with the eye positioning and / or stabilization devices as shown in Figures 4A-B and 5A-B. It is advantageous to have a stabilization device 400 as shown in Figures 4A-B (or 500 as in Figures 5A-B) in which the eye or cup contact member 420 (520) can remain attached to the eye 10 in the event that a patient voluntarily or involuntarily removes it from the alignment system 100 after the contact member is engaged in the eye, or if the operator decides to unapply the positioning arm 480 (580) at some point in A patient procedure. For example, a patient may sneeze or startle during the course of a procedure, which causes the patient to move involuntarily.

Each of Figures 16A to 16F represents a portion of contact member 420 (520) of a system 400 (500) for positioning / stabilizing an eye mounted on a multi-piece post 422 (522) comprising a portion

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proximal 422a (522a) of the post coupled to the contact member and a distal portion 422b (522b) of the post coupled to the eye stabilization device, the proximal and distal portions of the post are configured to be applied between them releasably. Each of Figures 16A-16F includes pairs of paired views, in which the view (1) shows the proximal and distal portions 422a-422b applied, and the view (2) shows the proximal and distal portions 422a-422b unapplied in an exploded view.

Each of the species in Figures 16A-16F may also include a tubena and a ford source as described above. In some embodiments, the ford pipe 475 (575) can be mounted and connected to remain attached to the contact member 420 with the eye when the portions 422a, b of the post are unapplied. For example, in one embodiment the tubena and the ford fountain may be mounted on the patient's clothing (such as a neck) to remain with the patient in case the patient moves away from the general system 100. Similarly, each of The species of Figures 16A-16F can be employed with a pushing force applied by the positioning arm (480 in Figures 4A-B) as described above.

It should be understood that the mechanism illustrated in Figures 16A-16F is by way of example, and variations will be apparent to one skilled in the art without departing from the invention. For example, the configurations of the distal and proximal portions of the post can generally be reversed. Likewise, the devices may include sensors configured for the processors of the signal control system after application or de-application of portions 422a, b.

Figure 16A shows a device 400 in which the distal and the proximal are profiled to provide a socket 422a and a post 422b in which the application only transmits a significant compression force, but transmits little or no traction force perpendicular to the eye (for example, it is held in position by a pushing force), while it resists lateral force. The distal-proximal portions can be allowed to rotate axially, or axial torsion can be provided, if desired, by a keyed arrangement on the sides or bottom of the socket (not shown).

Figure 16B shows a device 400 in which the distal and proximal portions 422a, b are generally similar to those of Figure 16A, but in which the socket and posts are profiled to provide a slight "quick fit" effect where One portion grabs the other after the de-application. One or both portions 422a, b may comprise an elastic material, and notches may be incorporated into portions of the socket or post to increase flexibility.

Figure 16C shows a device 400 in which the distal and proximal portions 422a, b include a magnetic coupling, for example when a permanent magnet or an electromagnet and / or ferromagnetic material is incorporated into one or both of the portions 422a, b for create a predefined force of attraction between the distal and proximal portions applied.

Figure 16D shows a device 400 in which the distal and proximal portions are generally similar to that of Figure 16C, which additionally or alternatively includes an adhesive material that releasably joins portions 422a, b together, for example in the form of an adhesive tape or "post-it" products.

Figure 16E shows a device 400 in which the distal and proximal portions 422a, b are generally similar to that of Figure 16A, but in which the socket and posts are deeply applied to apply a lateral force at a selected distance above from the surface of the eye contact member.

Figure 16F illustrates the adaptation of any of the species of Figures 16A-E to a "side post" device 500, in which the structure 522a-522b of the post is positioned sufficiently outside the axis to provide a central portion 595 not obstructed, which can be transparent (a window for the transmission of light) to make possible certain methods that have aspects of the invention as described herein.

Alignment through limbo sizing

In another embodiment of the invention the alignment system uses the dimensioning of the blade to define the geometric axis. In this embodiment, as illustrated in Figures 6A-C, a schematic side view of a portion of an eye 10 is shown. The alignment system in this embodiment of the invention is based on the detection of the maximum area of the blade 26 of the eye 10 of the subject. The cornea 12 of the eye 10 is characterized by an anterior surface 16 and a posterior surface 14 that are concentric with each other, and the iris 24 extends outwardly towards the posterior surface 14 of the cornea 12. The intersection circle between the iris 24 and the inner surface 14 is an anatomical reference point known as the limbus 26. Images of the limbus of an eye can be easily formed.

As discussed above, an "axis of interest" identified as a reference axis for embodiments of an eye alignment method that have aspects of the invention can be advantageously, but not necessarily, the optical axis or the geometric axis of the eye. The geometric axis 18 in Figures 6A-C can be determined to be aligned with the external coordinate system 100 when the axis 18 is coincident with the center of the blade 26 when the area circumscribed by the limit of the blade is positioned to achieve its area maximum apparent with respect to camera 102. In the illustrated embodiment, camera 102 is positioned to form

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images of the eye 10 along the direction 600. The light from the light source 108 travels along the path 35, enters the eye 10 through the cornea l2 and is directed by the lens towards the retina . The camera 102 provides video image data of the eye 10 to the display monitor 104. Attached to the display monitor 104 is an image generator 106. In operation, the image generator 106 generates an image of the blade 26 and displays it on the display monitor 104. Therefore, in a first step the image generator 106 can be operated to generate a first image of the blade 26 when the eye It is in a first position, as shown in Figure 6A. The image generator 106 may then place the limit of the blade 26.

Next, the first area defined by the limit of the limbus is determined. As shown, Figure 6A represents the eye 10 placed in an angle so that the area 610 defined by the limit of the limbus is less than the maximum. The camera 102, or preferably the eye 10, is then placed in a second position and the image generator 106 is operated to generate a second image of the blade 26, as shown in Figure 6B. The image generator 106 can then place the limit of the blade 26. Next, the second area 611 defined by the limit of the blade is determined. As shown, Figure 6B represents the eye 10 forming an angle so that the area 610 defined by the limit of the limbus is less than the maximum. This process is repeated until the maximum area defined by the limit of the limbus is identified, as illustrated in Figure 6C, in which the address 600 is co-aligned with the reference axis 18. The detection of the maximum area 612 of the limbus 26 indicates that the eye is in alignment with the system, and the reference axis 18 is defined.

Limit Limit Identification

As noted above, the limbic limit is determined in the described alignment methods. The determination of the limbic limit, and the limbic center, can be performed in several ways. An exemplary method for determining the center of the limbus is illustrated diagrammatically in Figure 7, which shows the sequence 700 of the successive data processing steps to identify the limbic limit and the limbic center. The input image 710 represents high resolution image data of the eye that is applied. The first step 720 of data processing is to average and reduce the input image 710. This can be done by convolving the data defining the input image 710 with a low-pass Gaussian filter that serves to spatially average and therefore reduce the high frequency noise As spatial averaging introduces a redundancy in the spatial domain, the filtered image is then subsampled without any loss of additional information. The subsampled image serves as the basis for subsequent processing with the advantage that its smaller dimensions and lower resolution lead to lower calculation demands with respect to the original, full-size image input 710.

The following data processing steps involved in the location of the limit of the limbus, and the center of the limbus, include the sequential location of the various components of the limbic limit. Consequently, step 730 places the limbic (or outer) limit 732 of the iris. The location step can be performed in two sub-steps. The first sub-step includes an edge detection operation that is adjusted to the expected configuration of high contrast image locations. This adjustment is based on the generic properties of the limit interest component (for example, the orientation) as well as the specific limitations that are provided by the previously isolated limit components. The second sub-step includes a plan in which the detected edge pixels vote to exemplify particular values for a parameterized model of the limit interest component.

In more detail, for the limbic limit 732 of step 730, the image is filtered with an edge detector based on the gradient that is adjusted in orientation to favor near verticality. Thus, even with the eyelids closed, the left and right portions of the limbus are clearly visible and oriented near the vertical when the head is in a right position. The limbic limit is modeled as a parameterized circle by its two coordinate centers, xc and yc, and its radius, r. The edge pixels detected are thinned and then arranged in a histrogram in a three-dimensional space (xc, yc, r) according to the allowed values (xc, yc, r) for a given image location (x, y). The point (xc, yc, r) with the maximum number of votes is taken to represent the limbic limit. Finally, with the limbic limit 732 isolated, the final processing step 740 includes the location of center 750 of the limbus.

The approach described above to identify the center of the limbus can be generalized in several ways. For example, representations of images other than those oriented by the detection of the border based on the gradient can be used to improve the limits of the iris. Second, alternative iris parameter settings can be used. Finally, the iris boundary location can be performed without the initial steps of averaging and spatial subsampling.

Definition of the retinal target area after ocular alignment

As described above with respect to Figures 1-5, a first Purkinje reflex (or an equivalent reflection from the member covering the cornea, such as the contact member 420 or 520 with the eye) can be correlated and aligned in relation to the center of the blade 26 to define a reference axis 18. The center of the blade can be detected manually or automatically as described with respect to Figures 6-7. In addition, the axis

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Reference can be aligned with the external coordinate system of an eye placement / stabilization system and / or eye treatment system.

An embodiment of the method that has aspects of the invention includes aligning the eye with the coordinate system and defining the reference axis, and identifying an area of the target tissue of treatment in relation to the intersection of the reference axis with a portion of the eye, for example the retina. With the eye aligned as described above, and the reference axis defined and correlated with an external coordinate system, an area of the target treatment tissue within the eye can be identified and located within the external coordinate system.

In a subsequent embodiment of the method having aspects of the invention, after placing an objective tissue of the treatment with respect to the defined ocular reference axis with respect to a treatment system, the treatment device is placed in relation to this reference axis for administering a desired treatment to the target tissue (for example, a retinal target zone at or near the macula).

Figure 8A depicts a cross section of an eye 10 of the subject on a sagittal axis (ZY) to include an anterior corneal surface 16, a posterior corneal surface 14, a lens 20, and a retinal surface 50, in association with system 800 System 800 includes a collimated light source 35 that illuminates a surface 16 of the cornea and its focal point 15, as shown. It should be taken into account in this aspect that the positioning and stabilization devices that have aspects of the invention, and described with respect to Figures 5A-B, facilitate that a contact member with the transparent eye or cup 520, which allows a path of light transmission to and from the external and / or internal structures of the eye 10, while the eye is stabilized or positioned. Although the focal point is represented in front of the lens 20, the focal point can focus behind the lens and closer to the retina 50 so depending on the power (dioptres) of the cornea 12 and / or the lens 20. The axis 18 is the prolongation of the path 35 of the collimated light source through the anterior-posterior axis of an eye and towards the retina 50. While the collimated light source moves through or near the center of the lens, the collimated beam It will not be largely refracted. This is important in the treatment of radiotherapy because the radiation travels in a straight line through the eye.

The device 102 includes an image forming device such as a background camera or an optical coherence tomography (OCT) machine. The principles of the OCT are familiar to those skilled in the art and for the purpose of the present invention encompass the reflectometna of optical coherence and other forms of optical interferometna. Additional imaging devices contemplated by the present invention include CT Scan, MRI, ultrasound A- or B-, a combination of these, or other ophthalmic imaging devices such as a tracking ophthalmoscope laser.

A video image 104 of a front view (X-Y) of the eye 10 in the configuration shown in Figure 8A is shown in Figure 8B. Point 55 represents the focal point 15 seen on an image-forming monitor 104 by using an image-forming device 102 that can detect the wavelength of light from the collimated light source 108. The limit 42 It is a pupil in Figure 8B. Zone 30 is a circle, whose center coincides with the center of the blade 26. The collimated light source 108 may be positioned on the XY axis so that the center of its reflection 55 coincides with the center 30 of the blade 26. They can be easily form images of the limb of one eye; to the extent that images of the blade 26 can be formed with the same camera as the reflection of the collimated light source 12, both centers can be aligned on the X-Y axis. With such alignment, the intersection of the reference axis 18 with the retina can be determined.

In some embodiments a treatment axis may be defined displaced from the reference axis 18. The treatment axis may be parallel to the reference axis, selected so that the objective is its intersection with the retina. The treatment beams can then be placed with respect to the treatment axis, for example, at selected rotation angles with respect to the treatment axis.

In certain cases, axis 18 coincides with an area near the macula on the retina 50. See Figure 11 for more detail. This point can be called the center of the posterior pole of the eye.

Figure 9A depicts an example in which the center of the collimated light bulb 55 in the X-Y plane, represented on the video monitor 104, is not coincident with the center of the circle 30 (the center of the blade 26). Figure 9B represents the case that corresponds when viewed in the anterior-posterior axis (YZ) of the eye, in association with the alignment system 900. The focal point 14 is now outside the center or outside the axis as shown in the Figure 9A in front view. The beam 35 from the light source 108 extends through the eye towards the retina and is represented in Figure 9B as axis 25. The axis 25 is different from the reference axis 18 in the Y-Z plane; axis 25 is an axis in which a collimated beam of light will be refracted and its position on the bottom will be affected by refraction. The axis 18 is the axis in this figure representing a Y-Z axis that is aligned towards a point near the macula (see Figure 11 for more detail).

Figure 10 represents a configuration of a device used to achieve the results in Figures 8A-9B. An eye 10 is represented in Figure 10 in a Y-Z plane and the cornea 12 of the eye is represented on the front surface. A background image (see Figure 11) can be obtained simultaneously by the background camera 1010. The laser beacon 1015 projects from the laser source 1030 towards the retina and can be aligned

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with the reference axis 18 aligning it with the center of the blade and aligning it simultaneously with its focal point 15, represented by its reflection in a camera 102 of ordinary image formation. The beam splitter 1020 allows the deflection of the laser beacon 1015 so that it can be transmitted through the reference axis of the eye 10. The infrared light coming from the bottom camera 1010 can pass through the beam splitter 1020. so that background images can be formed simultaneously with the laser beacon 1015 in the background image through the background camera 1010. The beam splitter 1020 can at least partially reflect the incident white light so that the camera 102 can Form images of the eye. The beam splitter 1022 reflects the beam 1015 of the laser beacon and also at least partially transmits the white light so that it can form images of the front of the eye in the X-Y plane; that is, the plane in the front of the eye. The system also includes an X-Y position device that makes it possible for the laser beacon 1015 to be moved to different positions along the X-Y axis in the front of the eye. A position sensing element (PSD) can also be included in the path of the laser beacon or by using an additional beam splitter to detect the movement or stability of the beacon over time. The image forming software integrated with, or linked to, the camera 102 may allow the stability of the eye 10 to also be quantified over time.

Figure 11A depicts an image 1105 of the background obtained with the system of Figure 10 when the focus of the laser beacon and the entry point of the laser beacon are aligned in the center of the blade. The projection of the laser beacon at the bottom 1105 is the point of intersection of the reference axis with the retina 1130, and in this embodiment it coincides with the approximate center of the optical or geometric axis of the eye. For reference, the optical disk 1110 and the macula / fovea 1120, or center of visual acuity, is shown and fixed with a small displacement "d" of the reference axis represented by the beacon 1130. Figure 11B depicts an illustration of the eye shown in Figure 12B in which the beacon 1130 is not aligned with the center of the blade.

Figure 12A represents a compendium of the methodology adapted to be used in a system to administer a radiation therapy to a patient's macula. The alignment system 1200 is used to obtain a background image shown in Figure 12B. A three-dimensional OCT, or other instrument that can measure distances quantitatively on the retina, obtains the 1210 image to quantify the distances between the optic nerve and the fovea. The image of the three-dimensional OCT 1210 can be correlated and recorded with respect to the background image shown in Figures 11A-B. Such registration allows the background image with the laser beacon on the reference axis to be graduated for actual distances 1230 (a, b, c in Figure 12B). The measurement 1220 of the axial length makes it possible for the 3D OCT or the 2D OCT to be graduated for the actual distances because these instruments depend on the axial length to determine the quantitative measurements of these parameters. Once the measurements are complete 1230, the limbus and cornea of the eye are matched to the macula both in the XY plane and in the Z plane. The focus of the laser beacon at a depth in the eye and its relation to sclerotics and limbus can be used in combination with a metric on the background to administer radiation therapy.

Figure 13A depicts a beam 1310 of X-ray therapy that travels through an eye 1300 with an angle 1320. These beams 1310 of X-rays are referenced at angles 1320 with the axis 1330. Depending on the treatment tissue of which in question, the axis 1330 may be the optical axis, the geometric axis, or another axis defined as the treatment axis.

In Figure 13B the center 1365 of the radiation therapy is centered with respect to the geometric or optical axis 1360. With the physical metric determined as discussed above with reference to Figures 12A-B, the relationship between the center of the limbo, the geometric or optical axis relative to the center of the limbus, and the macula.

Figure 13C represents the center 1375 of the radiation therapy coinciding with the macula 1370 and not with the geometric or optical axis 1360. In this radiotherapy planning system the laser focus through the cornea in combination with the centering of the The laser pointer over the center of the limbus makes a virtual or alternate reference possible, for the position of the macula, and therefore, allows the angles of the radiotherapy beams to be triangulated with respect to the macula without visualization. The system can also be used to calibrate a lens or other eye contact device that a patient can wear for the administration of radiotherapy. In another embodiment, an injury to the retina or a deposit of drusen can be matched to the front of the eye.

Figure 14 depicts a method 1475 for using the system of the present description to obtain the relationship between the center of the limbus, the optical axis of the eye, and the position of a beam that travels through the limbus in relation to these positions when A patient is fixed on an object. With this data the relationship between the optical axis and the visual axis can be determined for an individual patient. The first step in the method is to form an image of the focal point 1470 of the laser beacon, align the focus of the laser beacon with the center of the limbo 1472, and observe with the camera 1474 for background image formation, as He has described before. From this alignment with the optical / geometric axis, the treatment center can be maintained in this position or 1476 can be moved a distance towards the fovea or the center of an injury, which defines a separate treatment axis.

Photoextirpative eye surgery system

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The use of the alignment method discussed above is, in one embodiment of the invention, applied to a photoextirpative eye surgery. This embodiment of the invention of the eye surgery system is schematically shown in Figure 15. System 1500 may represent a photoextirpative eye surgery system to reshape a patient's cornea represented by the anterior corneal surface 1512. The system may include a component 1510 of the OCT that emits a probe beam 1514 that passes through the divider. 1520 beam and propagates into the eye 1502. The beam is perforated to preferably limit the diameter of the probe beam. This is advantageous since it limits the probe beam to track over a small lateral dimension that results in a faster detection of the OCT signal. The probe beam is aligned with the reference axis of the eye by a coalition of the center 1560 of the blade 1565 and the first Purkinje reflex 850 discussed in detail above. The system may also include a component 1530 of the therapeutic laser that emits a therapeutic beam having a beam propagation axis shown in 1532. The probe beam 1514 of the OCT component 1510 is co-aligned and coincides with the axis 1532 of the therapeutic beam. on the corneal surface. The location of the axis 1532 of the axis of the therapeutic beam on the corneal surface during the therapeutic procedure is controlled by the eye tracker 1540 in a manner well known to those skilled in the art. That is, the movement of the eye due to a voluntary and involuntary movement is monitored in real time to coordinate the removal of the cornea with the therapeutic beam.

The eye tracker 1540 includes at least one image capture device such as a camera to at least track the eye in real time. The imaging device can detect the position of the eye and relate the direction of the laser system with the position of the eye. An optional display monitor directed towards the laser system operator may represent the position of the laser device in real time in some embodiments. In some embodiments, the image acquisition device detects the position of the eye and a digital scanning software is used to track the position of the eye. It is believed that the eye remains within a predetermined position, or treatment field, that may correspond to the edges of the limbus. When the eye deflects beyond a threshold of movement, a signal can be sent to the laser device. The threshold of movement includes a degree or measure in which the eye is able to move and remain within the treatment parameters without turning off the laser device. In some embodiments the movement threshold can be measured in radians, degrees, millimeters, etc. The laser source is turned off when the eye is out of position beyond the threshold of movement, and the laser source is turned on when the eye is within the threshold of movement. In some methods of setting the threshold of movement, a treatment professional delimits the edges of the limbus, and the software that plans the treatment then records the edges of the limbus. If the eye blade is separated from the boundary of the bounded edge, a signal is sent to the laser device to turn it off.

Radiotherapy system

In another embodiment of the invention the alignment system is used to define an ocular axis of interest that intersects the retina in a retinal target area near the macula, and combined with a therapeutic treatment plan in which a radiotherapy device is aligned with a needle placed at least partially through the sclera and even inside the eye glass. A light line, or pointer, can be placed on or coupled with the needle to illuminate the retina with a collimated light source. The needle and light beam can be stabilized within the sclera so that the collimated light source is stable in the area of the retinal target. The radiotherapy device can then be aligned with the needle to deliver radiation in a straight line along the needle and along the path of the light line and towards the desired retinal target area. With this treatment plan, small areas of the retina can be targeted more precisely.

The radiotherapy system used in combination with the alignment methods described above can be configured to administer anywhere from about 1 Gy to about 40 Gy during a treatment period, or from about 10 Gy to about 20 Gy during a treatment period. , to areas of the eye that include, but are not limited to, the retina, the sclera, the macula, the optic nerve, the capsular bag of the lens or artificial lens, the ciliary muscles, the lens, the cornea, the Schlemm canal, the choroid, and the conjunctiva. In some embodiments, the system may be configured to administer from about 15 Gy to about 25 Gy during a treatment period. In some embodiments the system 10 is capable of administering an x-ray therapy in any fractionation plan (for example, about 1 Gy per day, approximately 5 Gy per day, approximately 10 Gy per month, or approximately 25 Gy per year), since the treatment planning system can retain in memory and remember what areas have been treated based on the unique anatomical features and disease of the patient. These features and previous treatments are stored in the treatment database for future reference.

The system can also administer energies of different photons depending on the degree of the disease or the area of the eye being treated. For example, the X-ray generating tube can deliver photons with photon energies ranging from about 20 keV to about 40 keV, up to about 60 keV, or up to about 100 keV. It may be convenient to use photons with photon energies ranging from about 20 keV to about 50 keV for structures in the anterior part of the eye because the photons with these photon energies will penetrate less. It may be convenient to use photons with photon energies ranging from about 60 keV to about 100 keV or greater for structures in the back of the eye for greater retinal penetration. In some embodiments the

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X-ray generating tube can emit photons with photon energies from about 10 keV to about 500 keV, from about 25 keV to about 100 keV, from about 25 keV to about 150 keV, from about 40 keV to about 100 keV, or any combination of intervals described above or here. In some embodiments, the photon energy selection may be based on diagnostic calculations, which may include an eye model created from anatomical data taken from the actual eye of the patient to be treated. The treating medical professional can choose the beam energies based on the disease and then set the machine to the desired energy level. In some embodiments, the system may receive an input energy from the medical professional in relation to the type of disease, and the energy level may be preset, which may also be subject to modification by the medical professional.

Treatment methods

Thus, the alignment devices and methods described above are useful in combination with numerous treatment devices and compositions for treating a wide variety of eye conditions of a subject. The sources of treatment energy, such as electromagnetic devices that emit energy, can be used to carry out corneal and / or non-corneal manipulations. According to the architectures and techniques of some embodiments of the invention, the source or sources (when used in combination) can be activated to direct energy over and / or parts of the eye, such as the conjunctiva and the sclera to treat conditions such such as presbyopia, where energy affects at least one property of the eye and results in an improvement of an property of the eye.

In some embodiments of the invention, focus disorders such as nearsightedness and farsightedness are treated. Nearsightedness or lack of near vision refers to a refractive vision abnormality in which distant objects appear blurred as a result of the light rays entering the eye being brought to focus in front of the retina. Hypermetropha, or lack of distant vision, on the other hand, refers to a refractive vision abnormality in which nearby objects appear out of focus or blurry as a result of the rays of light entering the eye being brought to focus behind of the retina

In addition to nearsightedness and farsightedness, presbyopia is typically associated with a person's lack of ability to focus over short distances and tends to develop and advance with age. With respect to this advance, it is believed that the presbyopia advances as the eye progressively loses its ability to accommodate or focus precisely on near vision with the increase of a person's age. Therefore, the state of presbyopia generally means a universal decrease in the amplitude of accommodation of the affected person.

Nearsightedness and farsightedness can be treated surgically by using techniques that include corneal interventions, such as reforming a curvature of the surface of the cornea located within the area of the limbus, and non-corneal manipulations, such as altering the properties of the sclera. (which is located outside the area of the limbus), the ciliary muscle, the zonules, or the lens. An example of the above treatments includes the removal of the surface of the cornea itself to form a multifocal arrangement (for example, distance vision in one eye and reading vision in another eye according to a treatment plan called monovision ) that facilitates a patient's view of nearby and distant objects. An example of post-treatment includes introducing recesses in portions of the sclera to increase accommodation. Non-corneal interventions typically include temporarily removing or pulling back the conjunctiva of the subject, through the use of forceps and scissors and / or one or more scalpels, cautery, plasma, and laser methods, followed by actual non-corneal manipulations (for example, formation of notches in the sclera). After making the notches, the conjunctiva is then sutured again in its position.

Electromagnetic energy devices may include, for example, lasers that emit a wide range of wavelengths, such as lasers that have wavelengths ranging, for example, from about 0.2 microns to about 3.1 microns . The exemplary laser beam sizes can range from 0.005 mm to approximately 1.0 mm, or 2.0 mm. The laser energy values by way of example by pulse values range from about 0.1 mJ to about 50 mJ depending on, for example, the duration of the pulse and the size of the laser beam point. The laser pulse widths can range from about 150 nanoseconds to about 1,000 microseconds. The areas to be treated can be previously screened with a vascular laser or long pulse Er, Cr: YSGG, or long pulse Er, Cr: YAG, to minimize bleeding.

In one embodiment of the invention, radiation therapy is administered. Radiation therapy is particularly useful for treating macular degeneration. Macular degeneration is a state in which the light-sensitive cells of the macula, a part near the center of the retina of the human eye, malfunction and slowly stop working. Macular degeneration is the main cause of loss of central vision in people over fifty years of age. The clinical and histological tests indicate that macular degeneration is partly caused by or results from an inflammatory process that ultimately causes the destruction of the retina. The inflammatory process can cause direct destruction of the retina or destruction through the formation of neovascular membranes that lose fluid and blood in the retina, which quickly produces scars.

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Radiation therapy can be used in combination with other therapies for the eye. Radiation therapy can be used to limit the side effects of other treatments or it can work synergistically with other therapies. For example, radiotherapy can be applied to laser burns in the retina or to implants or surgery in the anterior area of the eye. Radiation therapy can be combined with one or more pharmaceutical treatments, and / or photodynamic treatments or agents. For example, radiation therapy can be used in conjunction with an anti-VEGF treatment, VEGF receptors, steroids, anti-inflammatory compounds, DNA binding molecules, oxygen radical formation therapies, oxygen transporting molecules, porphyrin molecules / therapies, gadolinium , particle-based formulations, oncological chemotherapies, heat therapies, ultrasound therapies, and laser therapies.

In some embodiments the radiosensitizers and / or radioprotectors may be combined with a treatment to decrease or increase the effects of radiotherapy, as discussed in Thomas et al., Radiation Modifiers: Overview and future research of the treatment, Hematol. Oncol. Clin. N. Am. 20 (2006) 119139; Senan et al., Design of radiation tests combined with angiogenic therapy, Oncologist 12 (2007) 465477. Some embodiments include radiotherapy with the following radiosensitizers and / or treatments: 5- fluorouracil, fluorinated pyrimidine antimetabolite, anti-S cytoxin phase, triphosphate 5 -fluorouridine, monophosphate 2- deoxyfluorouridine (Fd-UMP), and capecitabine triphosphate 2-deoxyfluorouridine, analogs of platinum such as cisplatin and carboplatin, fluoropyrimidine, gemcitabine, antimetabolites, taxanes, docetaxyl, inhibitors of cycloinin inhibitors, topoisin inhibitors, topoisin inhibitors, topoisin inhibitors, topoisin inhibitors, topoisin inhibitors; Oxygenase-2, hypoxic cell radiosensitizers, antiangiogenic therapy, bevacizumab, recombinant monoclonal antibodies, ras mediation and epidermal growth factor receptor, tumor necrosis factor vector, Egr-RNF adenoviral vector (Ad5.Egr-TNF), and hyperthermia. In some embodiments the embodiments include radiation therapy with the following radioprotectors and / or treatments: amifostine, sucralfate, cytoprotective thiol, vitamins and antioxidants, vitamin C, tocopherol-monoglucoside, pentoxifylline, alpha-tocopherol, beta-carotene, and pilocarpine.

Anti-angiogenic agents (AAs) are aimed at inhibiting the growth of new blood vessels. Bevacizumab is a humanized monoclonal antibody that acts by binding and neutralizing VEGF, which is a binder with a central role in the indication of pathways that control the development of blood vessels. The findings suggest that anti-VEGF therapy has a direct antivascular effect on human tissues. In contrast, small molecule kinase inhibitors (TKIs) prevent the activation of VEGFRs, which thus inhibit the downstream indication pathways rather than joining VEFG directly. Vascular damaging agents (VDAs) cause a rapid stop of the established vasculature, leading to a death of secondary tissue. The destabilizing agents-microtubules, which include combrestastatins and ZD6126, and medications related to 5,6-dimethylxantenone-4-acetic acid (DMXAA) are two main groups of VDAs. Mixed inhibitors, which include agents such as EGFR inhibitors or neutralizing agents and anti-cancer cytotoxic agents, can also be used.

Thus, the system of the present invention can be used in some embodiments to provide a radiotherapy treatment. A treatment axis that provides a reference on which application of the radiation beams are applied can be coupled to or aligned with an axis of the radiotherapy system, on which an X-ray source can be placed, for example being rotated. The X-ray source can rotate around the axis of the radiotherapy device system, around which the X-ray source can be rotated. The X-ray source can rotate around the system axis with or independent of an image formation subsystem and its corresponding axis. With the axis of treatment aligned with the axis of the system, and with the coupling device applied by the eye, the trajectories of the radiation beams can be determined to direct the radiation beams to be coincident with the objective tissue of the subject's eye. The defined space of the treatment axis, the system axis, the location of the coupling device, and the location of the X-ray source provides a confined coordinate frame that can be used, for example, to direct the orientation and administration of the radiation beams.

In one embodiment of the invention, radiodynamic therapy is administered. The radio dynamic agents can be administered either systematically or on the road; Next, radiation therapy is directly aimed at the area in the eye to be treated, as described above. The targeted area can be precisely located by using the device of the invention and / or in combination with an eye model, and then radiation can be applied precisely to that area. In radio dynamic therapy, bundles of sizes of approximately 1 mm or less can be used to treat eye disorders if the target is drusen, for example. In other examples, the beam size is less than about 6 mm.

It has also been contemplated that the system of the present invention can be used to treat a variety of types of eye cancer. Cancer treatments are described below by way of example. Intraocular melanoma begins from pigment cells called melanocytes, which are found in the part of the eye known as the uvea. The uvea includes the iris, which forms the colored part of the eye; the ciliary body, which helps to change the shape of the lens inside the eye so that it can focus; and the choroid, which is a very deep layer of the eye. Although uncommon, uveal melanoma is the most common primary tumor of the eye in adults; Approximately 1,200 people are diagnosed with this disease each year in the United States. Factors associated with the development of this disease include light skin color, environmental exposure and a genetic predisposition. If the melanoma begins in the iris, it may appear as a dark spot in the eye. However, if it starts in the ciliary body or choroid, the symptoms may appear as vision problems, if

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perhaps. In these cases the disease is usually detected during a routine examination. The chances of recovery and response to treatment depend on the location of the melanoma and if it has spread. Melanomas of the posterior uveal tract (cancers that arise from the ciliary body or choroid - the deepest parts of the eye) are typically more malignant, with a five-year mortality rate of 30% when the tumor has spread to areas outside the eye. Melanomas of the anterior uveal tract (those that arise from the iris) have a mortality rate of 2% to 3% in five years. Thus, in one embodiment of the invention, intraocular melanoma is treated by the use of the system of the invention.

Normal treatment of intraocular melanoma includes surgical removal of the eye, or enucleation. Due to the effect of this procedure on the appearance of a patient, the possible diagnostic uncertainties and the possibility of the cancer spreading, alternative treatments have been introduced. These treatments include radiation with radioactive plaques, laser photocoagulation, transpupillary thermotherapy and cryotherapy. A therapy with a beam of protons has also been contemplated that has the ability to accurately target target tumors without causing serious damage to the healthy tissue surrounding the eye.

Choroidal metastasis occurs when the cancer spreads to the choroidal layer of the eye from another primary place, such as the chest. In these situations, the purpose of the treatment is to improve the patient's quality of life while preserving vision and avoiding eye removal. Chemotherapy, radiation therapy with an external beam, and proton therapy in combination with the system described above are contemplated by the present invention for the treatment of choroidal metastases so that the therapeutic treatment allows the preservation of the eye, get a high probability of local control, and help prevent vision loss and pain.

Retinoblastoma is a rare childhood cancer. It begins in the retina, and accounts for approximately 3% of cancers in children under 15 years - approximately 4 cases per million. The most normal is that it occurs before the age of two years, with 95% of retinoblastomas diagnosed before the age of five years. The tumor can affect one eye (approximately 75% of cases), or both eyes (25% of cases). More than 90% of retinoblastomas are cured that do not extend beyond the eye. Retinoblastoma is sometimes caused by an inherited genetic mutation; when it occurs in both eyes, it is always the result of a genetic mutation. The treatment of retinoblastoma according to the present invention contemplates a multidisciplinary approach, and involves treating cancer as well as preserving vision. If the tumor is especially large, or if there is little chance of maintaining normal vision, surgery can be considered. Other options include cryotherapy, photocoagulation, chemotherapy, and radiation therapy. External beam radiation therapy with protons has been used in selected cases to control tumors. Proton therapy in combination with the system of the invention is also contemplated by the present invention.

Choroidal hemangiomas are benign vascular tumors that are usually well contained, and can cause a decrease in visual abilities. The treatment of choroidal hemangiomas is designed to reduce the collection of fluid under the retina and decrease the size of the tumor. Normal treatment involves laser photocoagulation, which successfully reattaches the retina, although it cannot always completely destroy the tumor. In recent years, radioactive plaque treatment and proton beam radiation treatments have been used. Proton beam therapy shares the ability to accurately target the tumor of radioactive plaques, and is therefore contemplated for use with the system of the present invention.

In addition to the methods of cancer treatment described above, the invention also contemplates the alignment and manipulation of the eye to separate critical structures from the treatment axis to administer therapeutic amounts of radiation to tumors outside, but near, the eye. Thus, in one embodiment of the invention the system is used to position the eye for the treatment of extraocular states. In one embodiment of the invention the device described above is used in combination with other therapies for the eye. For example, one or more therapy treatments such as cryotherapy, photocoagulation, chemotherapy, and radiation therapy may be used in combination with the system of the present invention to provide a therapeutic treatment of the eye.

From the above you can see how the objects and features of the invention are achieved. While certain aspects and embodiments of the description have been described, they have been presented by way of example only, and are not intended to limit the scope of the description.

Claims (10)

5 10 fifteen twenty 25 30 35 40 1. A system (100) for defining a reference axis (18) of an eye (10) of a patient in an external coordinate system, characterized in that it comprises: (a) a light source (108) for directing a coherent or focused beam of light on a reflective surface (16) associated with the patient's eye, (b) an imaging system (102) for recording an image of a limbus (26) of the patient's eye and an image formed by a reflection of the light beam from the cornea (12) of the patient's eye, and (c) a processor operatively connected to the imaging system (102) for (i) from the image of the limbus (26), determine the center (30) of the patient's limbus (10) in the external coordinate system, and (ii) from the reflection image, determine when the position of the reflection is coincident with the center (30) of the limbus, in which position an axis (18) normal to the cornea (12) in the corneal center defines The reference axis. 2. The system (100) of claim 1, wherein the system further includes a headrest configured to stabilize a patient's head. 3. The system (100) of claim 1 or claim 2, wherein the light source (108) of (a) is a coherent beam of light. 4. The system (100) of claim 1 or claim 2, wherein the light source (108) of (a) is a focused beam of light. 5. The system (100) of any preceding claim, wherein the processor is configured to generate a signal when the match condition in step (ii) is met. 6. The system (100) of claim 5, wherein the processor is configured to generate positioning signals to place a diagnostic or therapeutic device in a selected position and at an angle to the reference axis (18). 7. The system (100) of any preceding claim, wherein said image forming system (102) includes a CCD photodetector. 8. The system (100) of claim 7, which further comprises an image processor and wherein the processor is configured, in step (i), to fit the limbo image (26) into a circle, and find the center of the circle. 9. The system (100) of claim 7, which further comprises a second image processor and wherein the processor is configured, in step (ii), to determine at each position of the eye of the patient's eye, whether the center (30) of the limbus (26) is the same as the position of the reflection image from the cornea (12). 10. The system (100) of claim 7, wherein the image formation system (102) is configured to record the reflections of a beam outside the surface of the retina (340), and the processor is configured to (iii) determine the position of an image formed by the reflection of the light beam in (c) outside the retina (340) of the patient's eye (10), when the position of the reflection image position outside the cornea is coincident with the center of the image of the limbus (26), (iv) determine the position of an image formed by the reflection of a second beam of light outside a structure of interest (342) selected in the retina (340), and (v) determine the position of the reflection image of the second beam outside the structure of interest in the external coordinate system, in relation to the position of the reflection image outside the retina along the reference axis (18; 35).