The present invention relates to a protective device for ophthalmic laser treatment. Specifically, the present invention relates to a protective device for protecting an eye from direct contact by a reference body disposed between a laser applicator and the eye.
Laser technology has been used in ophthalmic surgery for many years. Significant progress in laser technology has made it possible to also use laser technology for cutting an exterior layer of the cornea, a procedure that used to be performed before by means of a microkeratome using a mechanical blade. For cutting tissue inside the cornea, laser producing ultra-short laser pulses are used, for example pico second lasers producing pulse widths of 1 ps to 10 ps (1 ps=10−12s) or femto second lasers producing pulse widths of typically 1 fs to 1000 fs (1 fs=10−15s). The required high intensities to dissolve tissue are achieved by focusing strongly the laser beam to a few microns. For cutting, it is necessary to place precisely pulses next to each other. For ophthalmic laser surgery to achieve sufficient precision, there needs to be a precise and stable coupling of the laser applicator to the operative area of the patient's eye.
In U.S. Pat. No. 6,730,074, a system is described for accurately guiding a laser focal point along a predetermined path within the stroma of a cornea. The system includes a contact lens used as a reference body for the laser applicator. The contact lens is mounted in a suction ring and pressed gently against the exterior surface of the cornea. Applying a vacuum or a partial vacuum to the suction ring, the contact lens is held against the cornea. For example, the suction ring is fixed to the laser applicator.
In U.S. Pub. No. 2002/0103481, described is a stabilization and applanation device for reconfiguring the cornea of an eye for opthalmic laser surgery. The device includes an applanation lens used as a reference body for the laser applicator. A cone including the lens is connected to the laser applicator. A suction ring is attached to the eye and the cone is coupled to the suction ring. Thereby, the laser applicator is positioned in a defined relationship with the surface of the patient's eye applanated by the lens.
The reference bodies used in the prior art are in direct contact with the cornea of the patient's eye. Consequently, there is a danger of transferring infectious material, such as viruses, from one patient to another patient, if the same reference bodies are re-used without proper sterilization. Harm to the patient's eye may also be caused by abrasion, resulting from sliding movements, or by exposure to materials that are non-biocompatible. Using only disposable devices for contacting directly the patient's eye, as proposed in U.S. Pub. No. 2002/0103481, would help to prevent some of these problems. However, the reference bodies are precision devices and disposing thereof after one-time use causes a significant financial cost, to be covered by the patient or his medical insurance.
There are other risks and dangers to the patient's eye from having reference bodies in direct contact with the patient's eye, which cannot be prevented by limiting usage of reference bodies to one-time use. For example, when the reference body is in direct contact with the patient's eye, there is a risk that the patient's eye is being injured by sharp edges of a broken reference body. Injuries to the patient's eye may also result from decomposition products of the reference body or deformations of the reference body, produced when the laser focal point is moved accidentally or deliberately into the area of the reference body.
It is an object of this invention to provide a protective device for ophthalmic laser treatment, the protective device protecting an eye from direct contact by a reference body disposed between a laser applicator and the eye. Particularly, is an object of this invention to provide a protective device for ophthalmic laser treatment wherein a transparent reference body is disposed between a laser applicator and a patient's eye and wherein the eye is treated by means of a laser, producing ultra-short laser pulses, for example. Particularly, the protective device for ophthalmic laser surgery should prevent the transfer from patient to patient of infectious material attached to reference bodies, without having to limit usage of a reference body to one-time. Moreover, the protective device for ophthalmic laser surgery should prevent injuries to the eye from broken or deformed reference bodies.
According to the present invention, these aims are achieved in particular by the elements of the independent claims. Further advantageous embodiments also follow from the dependent claims and the description.
According to the present invention, the above-mentioned objects are particularly achieved in that a protective device for ophthalmic laser treatment comprises a transparent foil, for protecting an eye from direct contact by a reference body disposed between a laser applicator and the eye. The reference body is also referred to as “contact body” or “applanation body”. For example, the laser is a femto second laser or a pico second laser producing ultra-short laser pulses with typical widths of 1 ps to 10 ps or 1 fs to 1000 fs, respectively. Preferably, the foil is disposable. When the reference body is applied onto the eye, the foil is protecting the eye from direct contact by the reference body. The reference body is coupled removably to the laser applicator or the reference body is fixed permanently to the laser applicator. When the laser is activated, the laser pulses are projected from the laser applicator through the reference body and the foil to dissolve tissue of the eye, particularly corneal tissue. In addition to protecting the eye from direct contact with the reference body, disposing a foil between the reference body and the eye has the advantage that the focal point of the laser cannot only be adjusted to positions within cornea tissue of the eye, but also to positions within the foil to make open cuts in the cornea, without damaging the reference body. Moreover, disposing a foil between the reference body and the eye has the advantage that this makes it possible to choose freely the material used for the reference body.
Preferably, the protective device further comprises means for disposing the foil between the reference body and the eye. The means for disposing the foil facilitate the handling of the foil as well as the placement and/or positioning of the foil.
In an embodiment, the means for disposing the foil include a carrier frame and the foil is attached to the carrier frame. For example, the carrier frame and the foil are made in one piece. A carrier frame makes it easier for a user to handle the foil and to place the foil. The carrier frame also makes it possible to package and unpackage easily the foil with or from a protective packaging that keeps the foil sterile.
In a preferred embodiment, the means for disposing the foil further include a suction ring designed for attachment to the eye around an operative area. The suction ring is designed to receive the foil such that the operative area is covered by the foil in a state of the suction ring being attached to the eye. For example, the foil is attached to the suction ring such that the operative area is covered by the foil in a state of the suction ring being attached to the eye. Preferably, however, the suction ring is designed to receive the carrier frame such that the operative area is covered by the foil in a state of the suction ring being attached to the eye. For example, the carrier frame and/or the suction ring are provided with coupling means for removably coupling the carrier frame to the suction ring. In an alternative embodiment, the carrier frame (and/or to the reference body or the laser applicator) is provided with coupling means for removably coupling the carrier frame to the reference body or the laser applicator, the laser applicator having the reference body attached thereto. Preferably, the suction ring is provided with coupling means for removably coupling the suction ring to the reference body or the laser applicator, the laser applicator having the reference body attached thereto, such that the foil is interposed between the eye and the reference body in the state of the suction ring being attached to the eye.
In a preferred embodiment, the suction ring and the foil form a vacuum chamber in the state of the suction ring being attached to the eye. In an embodiment, the suction ring has a first opening closed off by the foil, the suction ring has a second opening closed off by the eye, in the state of the suction ring being attached to the eye, and the operative area is in contact with the foil in the state of the suction ring being attached to the eye. In a further embodiment, the first opening is confined by a protrusion of the suction ring extending to an interior of the suction ring and the first opening is closed off by the foil placed on the protrusion. For example, the protrusion has a slanted edge for contacting the eye in the state of the suction ring being attached to the eye.
In a further preferred embodiment, the means for disposing the foil are configured to position the foil such that there is a gap between the foil and the reference body, in a state prior to the reference body being applied to the eye, and such that, in a process of the reference body being applied to the eye, a contact region of the foil, that comes into contact with the reference body, is interposed between the reference body and the eye, and fluid (e.g. air) which is located in the area between the contact region and the reference body is forced out of the latter area. Depending on the embodiment, the gap between the foil and the reference body is defined by the design of the carrier frame and/or the suction ring, keeping the foil at a distance from the reference body. With increasing applanation of the eye by the reference body, the contact region of the foil that comes into contact with the reference body increases in size from a first point of contact. As a result, inclusions of fluid, e.g. air, between the contact region and the reference body are forced out in the increasingly enlarging contact region, extending out from the initial point of contact, so that no fluid (air) pockets remain. The forcing of fluid (air) out of the area between the contact region and the reference body has the advantage that the transmission of laser pulses from the laser applicator through the reference body and the foil into the eye is not influenced negatively by inclusions of fluid (air), i.e. the laser pulses are not refracted or diffused by inclusions of fluid (air). In the process of the foil being disposed between the reference body and the eye, the gap between the foil and the reference body prevents the foil from being damaged when the foil is moved relative to the reference body while in contact with the reference body. For example, scratching of the foil is prevented when a translatory or rotary motion is applied to the foil, e.g. through a bayonet coupling used for attaching the carrier frame and/or the suction ring with the foil to the laser applicator.
In an embodiment, the foil is adhesive on at least one side such that the foil attaches removably to the reference body at least in a contact region of the foil in a state of the foil being interposed between the reference body and the eye. Particularly, in combination with the embodiment that supports forcing out of air located in the area between the contact region and the reference body, an adhesive foil makes possible a stable fixation of the foil to the reference body without inclusions of air.
In various alternative or complementing embodiments, the foil has a specified area of non-transparency to thereby limit an operative area of the eye, the foil has a refraction index corresponding to the refraction index of the tissue of the eye and/or the refraction index of the reference body, the foil has surface structures on an interior surface of the foil contacting the eye to thereby conduct fluids from and to an exterior surface of the eye being contacted by the foil, the foil has elastic coating on an interior surface of the foil contacting the eye to thereby even out uneven areas of an exterior surface of the eye being contacted by the foil, the foil has perforations to make possible the exchange of fluids between an interior surface of the foil contacting the eye and an exterior surface of the foil contacting the reference body, the foil is made of polyvinyl chloride, polyethylene or polypropylene, the foil is made of medical grade plastic, and/or the foil is selected with a specified thickness to determine an operative depth.
The present invention will be explained in more detail, by way of example, with reference to the drawings in which:
a shows a schematic cross section of the cornea of a patient's eye wherein a suction ring, having a transparent foil fixed thereon, is attached to the eye.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye wherein a suction ring, having a transparent foil placed therein, is attached to the eye.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye wherein a transparent foil is placed directly onto the eye and a suction ring, attached to the eye, stabilizes the position of the foil relative to the eye.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye wherein a suction ring, having a transparent foil placed therein, is attached to the eye, and wherein a reference body is held in the suction ring such that the transparent foil is interposed between the reference body and the eye
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye, having a suction ring attached thereto, and a laser applicator with a reference body covered by a transparent foil attached to the laser applicator.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye, having a suction ring attached thereto, and a laser applicator, having a reference body with a transparent foil fixed thereon.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye and of a suction ring, having a transparent foil fixed thereon, coupled to the laser applicator.
b shows the schematic cross section of the cornea of
a shows a schematic cross section of the cornea of a patient's eye and of a suction ring, having a transparent foil placed thereon, coupled to the laser applicator.
b shows the schematic cross section of the cornea of
c shows the schematic cross section of the cornea of
The reference numeral 1 refers to a patient's eye and the reference numeral 11 refers to the cornea of the eye 1.
The reference numeral 4 refers to a laser applicator. Preferably, the laser applicator 4 is configured to project pulsed and focused laser beams having ultra-short laser pulses. For example, the laser applicator 4 is configured to project pulse widths of 1 ps to 10 ps (pico second laser) or pulse widths of typically 1 fs to 1000 fs (femto second laser). The laser is preferably integrated in the laser applicator 4. However, it is also possible to have the laser external to the laser applicator 4, coupled through optical links, e.g. fibers. As is illustrated in
As is illustrated in
The reference numeral 6 refers to a suction ring, which is held in place on the patient's eye 1 by means of a vacuum or a partial vacuum generated by a vacuum pump (not illustrated). The suction ring 6 and the laser applicator 4 (or the applicator end piece 2, respectively) are configured for removably interconnecting with each other, to thereby stabilize the position of the pulsed laser beam relative to the patient's eye. In
The reference numeral 5 refers to a foil, which is transparent at least in some areas so that a pulsed laser beam can be projected through the foil 5 in those areas. The foil 5 is flexible and has a thickness of less than one millimeter. For embodiments where the foil 5 adheres flexibly to the reference body 3, the thickness of the foil 5 is preferably not thicker than 200 μm. For embodiments where the foil 5 is rather stiff and does not need to adhere flexibly to the reference body 3, the thickness of the foil 5 can be thicker than 200 μm. Preferably, the foil 5 is provided in different defined thickness so that a specific foil 5, interposed between reference body 3 and the eye 1, can be selected to adjust the position of the focal point of the pulsed laser beam to thereby determine the operative depth. Preferably, the foil 5 is made from medical grade plastic and has a refraction index corresponding to the refraction index of the tissue of the eye 1 and/or the refraction index of the reference body 3. For example, the foil is made of polyvinyl chloride, polyethylene or polypropylene. In an embodiment, the foil is provided with perforations to make possible the exchange of fluids between the interior surface of the foil 5 contacting the eye 1 and the exterior surface of the foil 5 contacting the reference body 3. In a further embodiment, the foil 5 is provided with surface structures on the interior surface to make it possible to conduct fluids from and to the exterior surface of the eye 1 being contacted by the foil 5. In a further embodiment, the foil 5 is provided with an elastic coating on the interior surface of the foil 5 contacting the eye 1 to make it possible to even out uneven areas, for example scars, of the exterior surface of the eye 1. In yet a further embodiment, the foil 5 has at least one adhesive side for attaching the foil 5 to the reference body 3.
As is illustrated schematically in
In the following paragraphs, different embodiments of a protective device for ophthalmic surgery, each device having at least a sterile foil 5, and of disposing the foil 5 between the reference body 3 and an operative area of the eye 1 are described with reference to
In the embodiment illustrated in
In the embodiment illustrated in
In the embodiment illustrated in
In the embodiment illustrated in
In the embodiment illustrated in
In the embodiment illustrated in
In the embodiment illustrated in
In the preferred embodiment, illustrated in
When the laser is activated for surgical treatment of the patient's eye 1, the laser pulses are projected from the laser applicator 4 through the reference body 3 and the foil 5. For example, if the focal point Fa of the pulsed laser beam 7a is located at a position within the cornea 11, as illustrated in
It must be pointed out that the configurations of the suction ring 6, the foil 5, the laser applicator 4, and the reference body 3 are illustrated schematically only and that alternative configurations of these components are possible without deviating from the scope of the invention. Particularly, one skilled in the art will understand that specific configurations and features of the protective device illustrated and described with reference to
Number | Date | Country | |
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Parent | 11000883 | Dec 2004 | US |
Child | 12081011 | US | |
Parent | PCT/CH2005/000578 | Oct 2005 | US |
Child | 11000883 | US |