WO2010047387A1 - Method for compensating for deterioration in elasticity of sclera of eyeball and spacer used in the method - Google Patents

Method for compensating for deterioration in elasticity of sclera of eyeball and spacer used in the method Download PDF

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Publication number
WO2010047387A1
WO2010047387A1 PCT/JP2009/068270 JP2009068270W WO2010047387A1 WO 2010047387 A1 WO2010047387 A1 WO 2010047387A1 JP 2009068270 W JP2009068270 W JP 2009068270W WO 2010047387 A1 WO2010047387 A1 WO 2010047387A1
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Prior art keywords
eyeball
extensibility
sclera
spacer
corneal
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PCT/JP2009/068270
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French (fr)
Japanese (ja)
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憲次 吉田
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志村 好美
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F9/00825Methods or devices for eye surgery using laser for photodisruption
    • A61F9/00827Refractive correction, e.g. lenticle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F9/00825Methods or devices for eye surgery using laser for photodisruption
    • A61F9/00838Correction of presbyopia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F2009/00861Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00865Sclera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F2009/00861Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00872Cornea

Definitions

  • the present invention relates to a method for complementing the decrease in extensibility of the sclera located between the eyeball adhering portion and the cornea ring portion of the extraocular muscle, and a spacer used in the method.
  • the eye movement is explained by the internal eye muscle adjustment theory, the so-called Helmholtz theory, proposed by Helmholtz, a physiologist and physicist in the 19th century.
  • Helmholtz theory proposed by Helmholtz, a physiologist and physicist in the 19th century.
  • the eye movement is driven by the elastic movement of the ciliary muscle in the eyeball, and its effector is only the lens. And it is an effector.
  • the focus of the crystalline lens is adjusted by changing its thickness and position.
  • Helmholtz theory is not a complete theory because it cannot often explain the eye movement. This is already a well-known fact, but there is still no new theory that can overturn this theory, and Helmholtz theory has been supported to date.
  • presbyopia age-related accommodation weakness
  • wearing a spectacle or contact lens with a convex lens to adjust the focal position (far point) and near vision It has been generally done to improve.
  • the near vision is improved by these methods, the distance vision will be disturbed. Therefore, at present, a multifocal lens or a progressive focus lens is transplanted into the eye and referred to as presbyopia recovery treatment for convenience.
  • the present inventor in the process of examining and treating patients for many years as an ophthalmologist, said, “Only the ciliary muscles that the eyeball's accommodation movement is actively operated are proposed by Helmholtz theory. In other words, it is done by changing the shape of the whole eyeball flexibly. " In addition to the extraocular muscles directly attached to the eyeball, the shape of the entire eyeball changes due to coordinated movements of the eyelids, eyelid fist muscles, facial muscles such as the ocular muscles and the frontal muscles, and further contains the eyeballs We obtained the knowledge that the soft tissue behind the eyeball in the eye socket and the eye socket is also indispensable for the eye movement.
  • FIG. 15 is a schematic diagram showing the eyeball and its peripheral part when the external eye muscle is in a relaxed state
  • FIG. 16 is a schematic diagram showing the eyeball and its peripheral part when the external eye muscle contracts.
  • the internal pressure of the soft tissue 8 that has been compressed increases, and the eyeball bottom 4 is pushed back evenly with a pressure P1 having the same magnitude as the internal pressure.
  • the drag force P2 generated in the eyeball 1 becomes a force P3 for extending the sclera 5 and the cornea 6 positioned in front of the extraocular muscle adhesion portion 3 of the eyeball 1 toward the front.
  • the eyeball axis extends.
  • the extraocular muscle adhering part 3 works as an action point, and therefore the sclera 5 part from the extraocular muscle adhering part 3 to the corneal ring part 7 is most strongly extended (indicated by an arrow E in FIG. 16).
  • the portion of the sclera 5 to which the extraocular muscles 2 are attached is the thinnest, and is originally a site with excellent extensibility.
  • the present inventor has found that not only the expansion and contraction movement of the ciliary muscle (inner eye muscle) but also the extension of the eyeball axis due to the extension of the sclera 5 has a great influence on the adjustment movement of the eyeball. Therefore, hereinafter, the sclera is also referred to as a regulatory sclera in the present specification.
  • symbol 6 in a figure shows an optic nerve, 9 shows a cornea, respectively.
  • the extensibility of the regulatory sclera 5 depends on its thickness and the moisture content of the collagen tissue constituting it. This decrease in the moisture content of the collagen tissue leads to the hardening of the tissue, leading to a decrease in the extensibility of the regulatory sclera 5.
  • the moisture content of the collagen constituting the regulatory sclera 5 tends to decrease with aging, similar to that of the skin. Therefore, the extensibility of the regulatory sclera 5 decreases with age, and as a result, the ability to adjust the eyeball is reduced.
  • the present inventor has discovered that a decrease in the ability to adjust the eyeball by such a series of mechanisms leads to the development of presbyopia.
  • the present inventor has proposed a constant-depth corneal ring-shaped incision device for the treatment of presbyopia based on the above theory (see Patent Document 1).
  • Patent Document 1 in order to prevent the incision formed in the cornea from being repaired by re-adhesion and adhesion and to maintain the incision, an indwelling ring inserted into the incision was proposed (Patent Document). 2).
  • the desired constant depth annulus incision is formed in the corneal region near the corneal limbus using the constant depth corneal annulus incision instrument, this incision becomes a new extension site to replace the regulatory sclera 5, and as a result
  • the decrease in the extensibility of the regulatory sclera 5 due to aging is complemented.
  • the intracorneal indwelling ring is inserted into the incision, adhesion and adhesion of the incision are prevented, so that the function of the incision is maintained, and the above complementation can be continued. As a result, the ability to adjust the eyeball is restored and presbyopia is healed.
  • the suction ring having the suction means is fixed to the cornea and the adjustment sclera with suction pressure.
  • the patient had discomfort during the procedure.
  • the revolver equipped with the blade is rotated by hand, so that an incision is formed at a predetermined position of the cornea with the blade. Therefore, adjustment of the position and posture of the blade and the amount of protrusion of the blade that determines the depth of the incision Adjustment was cumbersome.
  • the incision was formed with a blade, the cross-sectional shape of the incision was limited to a straight line. For this reason, unless the incision is formed to a very deep part of the cornea, the function of the incision as described above cannot be fully exhibited.
  • the indwelling ring When using the indwelling ring, since the cross-sectional shape of the incision formed by the incision instrument is limited to a straight line as described above, the incision is formed to a considerably deeper position. Otherwise, the intracorneal indwelling ring will be pushed out of the cornea from the incision. However, forming an incision deep in the cornea often involves a risk of excision (separation) of the cornea itself.
  • the Bowman's membrane which is the corneal constituent tissue, is incised, and the function of the Bowman's membrane, particularly the traction force Since the resistance to resistance is impaired, a highly plastic site appears on the cornea along the incision.
  • the shape of the cornea is sharpened more strongly in the periphery of the cornea than in the incision, while the curvature of the cornea does not change in the center of the cornea than in the incision or is flattened and close. In other words, hyperregulation occurs as a result.
  • forming a corneal flap with a laser in LASIK surgery so that it does not cross with the incision formed with the incision instrument means that the center of the incision by the incision instrument (the center of the circle drawn by the incision) and the corneal flap It was actually impossible because it was extremely difficult to match the center without any difference.
  • the present invention provides a method for complementing the decrease in scleral extensibility and a spacer used in the method, which can be performed safely without burdening the patient. It is an object.
  • the method for complementing the decrease in sclera extensibility of the eye according to the invention of claim 1 is characterized by creating a highly flexible region between the corneal periphery and the corneal limbus.
  • An eyeball sclera extensibility reduction complementing method is a method of creating a highly flexible region between the cornea peripheral part and the cornea ring part, thereby providing an eyeball adhering part and a cornea ring part of the extraocular muscle.
  • the sclera extensibility reduction complementing method according to each of the above inventions may further include a step of inserting a spacer into the incision wound surface or the excision layer, respectively.
  • the scleral extensibility reduction complementing method according to the first aspect of the present invention may further include a step of inserting a spacer into the first incision wound surface.
  • the scleral extensibility reduction complementing method according to the invention of claim 2 may further include a step of inserting a spacer into the first ablation layer.
  • the above spacers are preferably ring-shaped or arc-shaped.
  • a material that is harmless to the living body is selected.
  • a synthetic resin that is harmless to a living body such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected.
  • PMMA polymethyl methacrylate
  • Au gold
  • Pt platinum
  • the spacer When the spacer is ring-shaped or arc-shaped, the spacer is inserted not in the incision along the thickness direction of the cornea as in the prior art, but in the first incision surface (or the first excision layer) along the radial direction of the cornea. Even if it tries to move into the second incisional wound surface (or second excision layer) along the thickness direction of the cornea from that position, it is caught at the lower end of the second incisional wound surface (or second excision layer). Therefore, since the spacer always stays in the first incisional wound surface (or the first excision layer) along the radial direction of the cornea, there is no possibility of slipping out of the cornea.
  • a plurality of chip-like spacers having anchor portions that enter the first incision wound surface are further provided in the second incision wound surface.
  • the process of inserting over may be included.
  • chip-like spacers having anchor portions that enter the first ablation layer are further provided in a plurality of locations in the second ablation layer. May include a step of inserting.
  • the number of chip-shaped spacers inserted is arbitrary, but 4 to 8 is preferable.
  • the insertion interval of a spacer becomes equal intervals along a 2nd incisional wound surface or a 2nd excision layer. For example, when the number of inserted spacers is four, the interval is 90 °, and when the number is eight, the interval is 45 °.
  • the chip-shaped spacer includes a flaky main body portion inserted into the second incision wound surface or the second excision layer, and the first spacer protruding from one end or both sides from the lower end of the main body portion. What provided the anchor part which penetrates in an incisional wound surface or a 1st excision layer is preferable.
  • the anchor portion enters the first incision wound surface (first excision layer) and functions as an anchor, so that the spacer remains stably in the second incision wound surface (second excision layer). There is no risk that the spacer will come out of the cornea.
  • a material that is harmless to a living body is selected as in the case of the ring-shaped or arc-shaped spacer.
  • a synthetic resin that is harmless to a living body such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected.
  • the tip-shaped spacer as described above is easier to insert into the incisional wound surface (excision layer) than the above-described ring-shaped or arc-shaped spacer, and the treatment time can be further shortened.
  • a granular material or powder of gold (Au) or platinum (Pt) is also suitable.
  • the corneal opacity can be effectively reduced or suppressed after the operation.
  • the incision wound surface (or excision layer) along the radial direction of the cornea and the incision wound surface (or excision layer) along the thickness direction of the cornea are adjacent to each other in the vicinity of the corneal ring portion. Since it is formed, it is possible to obtain greater extensibility at the formation site than when the conventional incision is formed. That is, it is possible to create a part having higher flexibility than the conventional part between the corneal peripheral part and the corneal ring part.
  • the same femtosecond laser as that used to form the incised wound surface is used in a series of treatments, so there is no risk of both crossing and short-term myopia. And correction of hyperopia.
  • the phrase “parallel to the corneal surface” means a direction along the radial direction of the cornea, and does not mean to be strictly parallel to the corneal surface. Therefore, the first incisional wound surface and the first excision layer each include a case where the inclined surface is slightly inclined with respect to the surface of the cornea.
  • an incisional wound surface having a desired cross-sectional shape can be formed without imposing a burden on the patient, and a region having higher flexibility than the conventional one can be created between the corneal peripheral part and the corneal ring part.
  • the extensibility of the sclera can be complemented, the ability to adjust the eyeball can be restored more effectively. It can also correct myopia and astigmatism.
  • FIG. 2 shows the other example of the positional relationship of a 1st incision wound surface and a 2nd incision wound surface. It is a figure corresponding to FIG. 2 which shows the positional relationship of a 2nd incision wound surface and a corneal flap. It is a figure corresponding to FIG. 2 which shows the state which inserted the spacer in the 1st incision wound surface.
  • FIG. 2 shows a perspective view which shows one Embodiment of a spacer.
  • FIG. 2 shows the front view which shows other embodiment of a spacer.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface.
  • FIG. 11 shows the state which inserted the spacer shown in FIG. 7 in the 2nd in
  • FIG. 1 is a schematic view of the cornea as viewed from the front
  • FIG. 2 is a schematic view showing an end surface taken along line II-II in FIG.
  • the method for complementing the decrease in sclera extensibility of the eyeball according to the present invention creates a highly flexible portion between the cornea peripheral part and the corneal ring part 7 to thereby provide the eyeball attachment part 3 and the corneal ring part 7 of the extraocular muscle 2. It is a method of complementing the decrease in the extensibility of the regulatory sclera 5 positioned between the two. That is, in the method according to the present invention, the step of forming a ring-shaped first incisional face 10 parallel to the corneal surface 92 in the corneal substantial layer 91 in the vicinity of the corneal ring portion 7, and the first incisional wound face 10 to the corneal surface 92. Forming the second incisional wound surface 20 that reaches the point, and each of these steps is performed by a femtosecond laser.
  • the laser beam emitted from the laser irradiation means is stored in advance in the memory of the femtosecond laser device, with the spot in the corneal substantial layer 91.
  • the light is guided so as to reach the depth of one incisional wound surface 10, and the laser light spot is scanned by any of the following methods. That is, scanning is performed in a ring shape along the corneal ring portion 7 while performing amplitude scanning with the width of the first incision wound surface 10 stored in advance in the memory of the femtosecond laser apparatus.
  • scanning may be started from the inner peripheral side of the cornea 9 or may be started from the outer peripheral side (corneal ring portion 7 side).
  • scanning is performed in a ring shape and a spiral shape along the corneal ring portion 7 within the range of the width of the first incision wound surface previously stored in the memory.
  • scanning may be started from the inner peripheral side of the cornea 9 or may be started from the outer peripheral side (corneal ring portion 7 side).
  • the depth of the first incision surface 10 is selected from the range of 100 to 900 ⁇ m from the corneal surface 92, and preferably 400 to 600 ⁇ m.
  • the width W of the first incision wound surface 10 is preferably 500 ⁇ m or more for the purpose of correcting myopia and astigmatism, and 1000 ⁇ m or more for the purpose of presbyopia correction, glaucoma, macular degeneration, keratoconus and the like.
  • the first incision wound surface 10 is not limited to the ring shape as described above, but may be an arc shape. Which form is selected, and how long is the arc shape? This may be determined as appropriate in consideration of the entire eyeball and the state of the cornea.
  • a laser beam spot emitted from the laser irradiation means is directed from the first incisional wound surface 10 toward the corneal surface 92 or from the corneal surface. Scan along the first incision wound surface 10 in the direction toward the one incision wound surface. As a result, the second incisional wound surface 20 is connected to the first incisional wound surface 10 at the lower end thereof.
  • the second incision wound surface 20 is connected to the first incision wound surface 10 at a substantially central portion in the width direction, and these two incision wound surfaces 10 and 20 form an “inverted T shape”.
  • the treatment subject when the treatment subject is an elderly person, there may be a white and cloudy part in the periphery of the cornea (specially called the elderly ring). 2
  • the incisional wound surface 20 should be separated from the corneal ring portion 7. Therefore, as shown in FIG. 3, the second incision wound surface 20 is connected to the first incision wound surface 10 at its inner peripheral end (inner peripheral edge on the center side of the cornea 9) or at a position closer to the inner peripheral end. Is good.
  • the distance of the second incision wound surface 20 from the corneal ring portion 7 is preferably 0.1 to 2.0 mm, more preferably 0.5 to 1.0 mm.
  • the 1st incision wound surface 10 and the 2nd incision wound surface 20 are good also as an excision layer instead of these, respectively.
  • a certain region of tissue may be excised along the first incision wound surface 10 and the second incision wound surface 20.
  • the corneal flap 60 is formed in the inner region of the second incision wound surface 20.
  • the corneal flap 60 may be before or after the first incision wound surface 10 and the second incision wound surface 20 are formed.
  • a flat ring-shaped spacer 50 may be inserted into the first incision wound surface 10 as shown in FIG.
  • the material of the spacer 50 is preferably gold or platinum. Further, the thickness can better compensate for the decrease in extensibility of the adjusting sclera 5 as the thickness increases, but a thickness of about 50 ⁇ m is preferable.
  • the spacer may be gold or platinum particles or powder. A metal having a low ionization tendency and low toxicity can also be used as the spacer material.
  • the spacer is not limited to the ring shape as described above, and may be a chip-like spacer 52 as shown in FIGS.
  • the spacer 52 includes a flaky body portion 521 inserted into the second incision wound surface 20 and an anchor portion 522 that protrudes from the lower end of the body portion 521 to both sides and enters the first incision wound surface 10. As shown in FIG. 7, it has an arrow shape facing downward.
  • the anchor portion 522 is formed in a wedge shape so that it can be easily inserted into the second incision wound surface 20.
  • the spacer 52 thus configured is inserted into the second incision wound surface 20 over a plurality of locations as indicated by a circle A in FIG.
  • eight spacers 52 are inserted at intervals of 45 °.
  • the number of spacers 52 is not limited to eight, and may be four to seven. Also in this case, it is preferable that the insertion interval of the spacers 52 is equal.
  • the anchor portion 522 enters the first incision wound surface 10 and functions as an anchor. Therefore, the spacer 52 stays stably in the second incision wound surface 20, and the spacer 52 comes out of the cornea. There is no fear.
  • the second incision wound surface 20 actually intersects the first incision wound surface 10 in relation to the treatment accuracy, and the lower end 22 of the second incision wound surface 20 is slightly slightly in the first incision wound surface 10. It is formed so as to protrude downward.
  • the shape of the anchor portion 522 is a so-called wedge shape as shown in FIG. 7, the tip of the anchor portion 522 bites into the lower end 22 of the second incision wound surface 20 as shown in FIG.
  • the anchor portion 522 is not displaced in the direction along the first incisional wound surface 10, and the spacer 52 is not inclined in the second incisional wound surface 20.
  • the anchor portion 522 does not necessarily protrude from the lower end of the main body portion 521 on both sides, and may protrude only one side from the lower end of the main body portion 521 as shown in FIG.
  • FIG. 14 shows a case where the spacer 52 shown in FIG. 13 is used.
  • a material that is harmless to the living body is selected.
  • a synthetic resin that is harmless to a living body such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected.
  • the insertion work into the incision wound surface is easier than the above-described ring-shaped or arc-shaped spacer 50, and the treatment time is further shortened. be able to.
  • the present invention can be applied not only to the treatment of presbyopia, but also to myopia and astigmatism, and particularly to irregular irregular astigmatism that has not been treated before.
  • the present invention enables myopia and astigmatism correction surgery without impairing the thickness of the cornea, so that it is possible to treat myopia and astigmatism even in an eyeball with a thin cornea thickness.
  • the effect of reducing intraocular pressure is also obtained, it is effective for the treatment of glaucoma.
  • the tension of the extraocular muscles can be released, it is also effective in treating senile macular degeneration, retinitis pigmentosa, keratoconus, and cataract prevention.

Abstract

 A first incision surface (10) and a second incision surface (20) are formed using a femtosecond laser. The first incision surface (10) has a circular shape or an arc shape, and is parallel to the corneal surface (92) in the cornea parenchyma layer (91) near the corneoscleral limbus (7). The second incision surface (20) extends from the first incision surface (10) to the corneal surface (92). Therefore, a region having high flexibility is produced between the corneal peripheral part and the corneoscleral limbus (7), and deterioration in the elasticity of the sclera (5) disposed between the corneoscleral limbus (7) and the ocular attachment part (3) of an extraocular muscle (2) is compensated.

Description

眼球の強膜伸展性低下補完方法及びその方法に使用されるスペーサComplementing method for decreasing the sclera extensibility of eyeball and spacer used in the method
 本発明は、外眼筋の眼球付着部と角膜輪部との間に位置する強膜の伸展性の低下を補完する方法及びその方法に使用されるスペーサに関する。 The present invention relates to a method for complementing the decrease in extensibility of the sclera located between the eyeball adhering portion and the cornea ring portion of the extraocular muscle, and a spacer used in the method.
 眼球の調節運動については、19世紀に生理学者であり物理学者でもあるドイツ人ヘルムホルツが提唱した内眼筋調節説、いわゆるヘルムホルツ理論により説明がされている。この理論を簡潔に説明すると、「眼球の調節運動は眼球内に存在する毛様体筋の伸縮運動をその唯一の原動力にしており、その効果器は唯一水晶体のみである。そして効果器である水晶体は、その厚みや位置を変化させることにより焦点の調整を行っている。」ということである。ところが、ヘルムホルツ理論は、これだけでは眼球の調節運動について説明できないことも多いことから、完全な理論ではない。このことはすでに周知の事実となっているが、いまだにこの理論を覆し得る新しい理論が登場していないこともあり、ヘルムホルツ理論は現在に至るまで支持されている。 The eye movement is explained by the internal eye muscle adjustment theory, the so-called Helmholtz theory, proposed by Helmholtz, a physiologist and physicist in the 19th century. To explain this theory briefly, “The eye movement is driven by the elastic movement of the ciliary muscle in the eyeball, and its effector is only the lens. And it is an effector. The focus of the crystalline lens is adjusted by changing its thickness and position. " However, the Helmholtz theory is not a complete theory because it cannot often explain the eye movement. This is already a well-known fact, but there is still no new theory that can overturn this theory, and Helmholtz theory has been supported to date.
 ところで、一般的には老眼、専門的には加齢性調節衰弱と呼ばれる現象を、ヘルムホルツ理論に従ってみてみると、加齢により毛様体筋(内眼筋)の伸縮運動能力が衰えた結果、効果器である水晶体に対して十分な影響力を与えることができなくなり、このため、眼の調節機能の低下が起こり、遠方に焦点位置(遠点)を調整した場合、近方を見ることが困難になる、ということになる。 By the way, when we look at the phenomenon called generalized presbyopia, technically weakening of age-related regulation according to Helmholtz theory, as a result of the aging, the ability to stretch and contract the ciliary muscle (inner eye muscle) decreased. It is not possible to give sufficient influence to the lens, which is an effector, and this causes a drop in the eye's accommodation function, and when the focal position (far point) is adjusted far away, it is possible to see near. It will be difficult.
 このような加齢性調節衰弱(以下、老眼という。)が生じた場合、これまでは凸レンズを用いた眼鏡やコンタクトレンズを装着することで、焦点位置(遠点)を調整して近方視力を改善することが一般的に行なわれてきた。しかし、これらの方法により近方視力を改善すると、今度は遠方視力に支障が出てくることになる。そこで現在では多重焦点レンズや累進焦点レンズを眼内に移植して、便宜上の老眼回復治療と称している。 When such age-related accommodation weakness (hereinafter referred to as presbyopia) occurs, until now, wearing a spectacle or contact lens with a convex lens to adjust the focal position (far point) and near vision It has been generally done to improve. However, if the near vision is improved by these methods, the distance vision will be disturbed. Therefore, at present, a multifocal lens or a progressive focus lens is transplanted into the eye and referred to as presbyopia recovery treatment for convenience.
 しかし、本質的な意味での老眼の回復とは、眼の調節能力を回復することである。そのための根本的な解決法としては、ヘルムホルツ理論に従うと、衰えた毛様体筋(内眼筋)の機能を回復させる方法が求められる。ところが、加齢現象の一環として現れてくる毛様体筋の機能回復や眼の調節能力の回復はこれまで不可能と考えられてきた。 However, the recovery of presbyopia in the essential sense is to restore the eye's ability to adjust. As a fundamental solution for this, according to Helmholtz theory, a method for recovering the function of the ciliary muscle (inner eye muscle) that has declined is required. However, it has been considered impossible to restore the function of the ciliary muscle and the ability to adjust the eye, which appear as part of the aging phenomenon.
 そのような状況下で、本発明者は、眼科医として長年にわたり患者を診察、治療してきた過程において、「眼球の調節運動は、ヘルムホルツ理論が提唱する毛様体筋だけが能動的に動作すること、で行われるのではなく、眼球全体がしなやかにその形状を変化させることにより行なわれる」と推論した。そして、眼球に直接付着する外眼筋をはじめとして、眼瞼、眼瞼拳筋、表情筋である眼輪筋や前頭筋等の協調運動によって眼球全体の形状変化が起き、さらに、眼球を収めている眼窩や眼窩内で眼球後方にある軟部組織も眼球の調節運動になくてはならない存在である、といった知見を得た。 Under such circumstances, the present inventor, in the process of examining and treating patients for many years as an ophthalmologist, said, “Only the ciliary muscles that the eyeball's accommodation movement is actively operated are proposed by Helmholtz theory. In other words, it is done by changing the shape of the whole eyeball flexibly. " In addition to the extraocular muscles directly attached to the eyeball, the shape of the entire eyeball changes due to coordinated movements of the eyelids, eyelid fist muscles, facial muscles such as the ocular muscles and the frontal muscles, and further contains the eyeballs We obtained the knowledge that the soft tissue behind the eyeball in the eye socket and the eye socket is also indispensable for the eye movement.
 これを図面を参照してより詳細に説明すると次のようになる。 This will be explained in more detail with reference to the drawings as follows.
 図15は、外眼筋が弛緩状態にあるときの眼球及びその周辺部を示す模式図、図16は、外眼筋が収縮したときの眼球及びその周辺部を示す模式図である。 FIG. 15 is a schematic diagram showing the eyeball and its peripheral part when the external eye muscle is in a relaxed state, and FIG. 16 is a schematic diagram showing the eyeball and its peripheral part when the external eye muscle contracts.
 近方を見るとき(近方調節時)には、毛様体筋(内眼筋)が収縮し調節運動をするだけでなく、眼球1に付着した全ての外眼筋2(外眼筋2のもう一方の端は眼窩を形成する骨に腱を介して付着している。)がバランスを保ちながら収縮する(図15に示す状態から図16に示す状態となる。図16において矢符Cで示す。)。このとき眼球1は外眼筋2の眼球付着部3を作用点として眼窩後方へ向け牽引される。これによって、眼球1と接触して眼窩後方に存在している視神経や軟部組織8は、眼球底4から圧迫を受ける。圧迫を受けた軟部組織8はその内圧が高まり、その内圧と同じ大きさの圧力P1で均等に眼球底4を押し返す。それにより眼球1に生じた抗力P2は眼球1の外眼筋付着部3より前方に位置する強膜5と角膜6を前方に向け伸展させる力P3となる。その結果、眼球軸が伸びる。このとき外眼筋付着部3が作用点として働くため、外眼筋付着部3から角膜輪部7までの強膜5部分が最も強く伸展されることになる(図16において矢符Eで示す。)。ところで解剖学的に見ると、外眼筋2が付着している強膜5の部分は最も薄く構成されており、もともと伸展性が優れた部位である。本発明者は毛様体筋(内眼筋)の伸縮運動だけではなく、この強膜5の伸展による眼球軸の伸びも、眼球の調節運動に大きな影響を与えることを見出した。そこで、以下、本明細書においては強膜を調節強膜とも称する。なお、図中の符号6は視神経を、9は角膜をそれぞれ示す。 When looking near (when adjusting near), not only the ciliary muscle (inner eye muscle) contracts and adjusts, but also all extraocular muscles 2 (outer eye muscle 2) attached to the eyeball 1. The other end is attached to the bone forming the orbit via a tendon) but contracts while maintaining balance (from the state shown in FIG. 15 to the state shown in FIG. 16. In FIG. 16, the arrow C) Indicated by). At this time, the eyeball 1 is pulled toward the rear of the orbit with the eyeball attachment portion 3 of the external eye muscle 2 as the action point. As a result, the optic nerve and soft tissue 8 existing in the rear of the eye socket in contact with the eyeball 1 are pressed from the eyeball bottom 4. The internal pressure of the soft tissue 8 that has been compressed increases, and the eyeball bottom 4 is pushed back evenly with a pressure P1 having the same magnitude as the internal pressure. Thereby, the drag force P2 generated in the eyeball 1 becomes a force P3 for extending the sclera 5 and the cornea 6 positioned in front of the extraocular muscle adhesion portion 3 of the eyeball 1 toward the front. As a result, the eyeball axis extends. At this time, the extraocular muscle adhering part 3 works as an action point, and therefore the sclera 5 part from the extraocular muscle adhering part 3 to the corneal ring part 7 is most strongly extended (indicated by an arrow E in FIG. 16). .) By the way, anatomically, the portion of the sclera 5 to which the extraocular muscles 2 are attached is the thinnest, and is originally a site with excellent extensibility. The present inventor has found that not only the expansion and contraction movement of the ciliary muscle (inner eye muscle) but also the extension of the eyeball axis due to the extension of the sclera 5 has a great influence on the adjustment movement of the eyeball. Therefore, hereinafter, the sclera is also referred to as a regulatory sclera in the present specification. In addition, the code | symbol 6 in a figure shows an optic nerve, 9 shows a cornea, respectively.
 調節強膜5の伸展性は、その厚みと、それを構成しているコラーゲン組織の含水率とに左右される。このコラーゲン組織の含水率の低下は、組織の硬化につながり、調節強膜5の伸展性の低下を招くことになる。調節強膜5を構成しているコラーゲンの含水率は、皮膚のそれと同様に加齢とともに低下する傾向がある。そのため調節強膜5の伸展性は加齢とともに低下し、結果的に眼球の調節能力の低下を招くことになる。本発明者は、このような一連のメカニズムによる眼球の調節能力の低下が、老眼の発生につながっていることを発見した。 The extensibility of the regulatory sclera 5 depends on its thickness and the moisture content of the collagen tissue constituting it. This decrease in the moisture content of the collagen tissue leads to the hardening of the tissue, leading to a decrease in the extensibility of the regulatory sclera 5. The moisture content of the collagen constituting the regulatory sclera 5 tends to decrease with aging, similar to that of the skin. Therefore, the extensibility of the regulatory sclera 5 decreases with age, and as a result, the ability to adjust the eyeball is reduced. The present inventor has discovered that a decrease in the ability to adjust the eyeball by such a series of mechanisms leads to the development of presbyopia.
 本発明者の上述の理論によれば、加齢による調節強膜の伸展性の低下を補完するような処置を施せば、眼球の調節能力が回復し、老眼を治癒させることが可能になる。そこで本発明者は、上記理論を背景にして老眼治療を目的とした定深度角膜輪状切開器具を提案した(特許文献1参照)。また、その切開器具により角膜に形成される切開創が再接着や癒着により修復されてしまうのを防ぎ、切開創を維持させるために、切開創に挿入する角膜内留置リングを提案した(特許文献2参照)。 According to the above-mentioned theory of the present inventor, when a treatment that complements the decrease in extensibility of the regulatory sclera due to aging is performed, the ability to adjust the eyeball is restored, and presbyopia can be cured. Therefore, the present inventor has proposed a constant-depth corneal ring-shaped incision device for the treatment of presbyopia based on the above theory (see Patent Document 1). In addition, in order to prevent the incision formed in the cornea from being repaired by re-adhesion and adhesion and to maintain the incision, an indwelling ring inserted into the incision was proposed (Patent Document). 2).
 上記定深度角膜輪状切開器具を使用して、角膜輪部近傍の角膜部位に所望の定深度輪状切開創を形成すれば、この切開創が調節強膜5に代わる新たな伸展部位となり、その結果、加齢による調節強膜5の伸展性の低下が補完されることになる。また、上記角膜内留置リングを上記切開創内に挿入すれば、切開創の接着や癒着が防止されるので切開創の機能が維持されることになり、上記補完を継続させることができる。その結果、眼球の調節能力が回復し、老眼が治癒される。 If the desired constant depth annulus incision is formed in the corneal region near the corneal limbus using the constant depth corneal annulus incision instrument, this incision becomes a new extension site to replace the regulatory sclera 5, and as a result The decrease in the extensibility of the regulatory sclera 5 due to aging is complemented. Further, if the intracorneal indwelling ring is inserted into the incision, adhesion and adhesion of the incision are prevented, so that the function of the incision is maintained, and the above complementation can be continued. As a result, the ability to adjust the eyeball is restored and presbyopia is healed.
特開2007-130334号公報JP 2007-130334 A 特開2007-151768号公報JP 2007-151768 A
 しかしながら、上記の切開器具にあっては、吸引手段を有するサクション・リングを角膜及び調節強膜に吸引圧で固定するため、眼球への装着に際して患者に少なからず恐怖心を抱かせてしまったり、施術中患者に不快感を与えてしまっていた。 However, in the above-mentioned incision device, the suction ring having the suction means is fixed to the cornea and the adjustment sclera with suction pressure. The patient had discomfort during the procedure.
 また、ブレードが装着されたレボルバーを手で回転させ、これによってブレードで角膜の所定箇所に切開創を形成するため、ブレードの位置及び姿勢の調整や、切開創の深度を決するブレードの突出量の調整が煩瑣であった。 In addition, the revolver equipped with the blade is rotated by hand, so that an incision is formed at a predetermined position of the cornea with the blade. Therefore, adjustment of the position and posture of the blade and the amount of protrusion of the blade that determines the depth of the incision Adjustment was cumbersome.
 さらに、角膜の直径は個人差が大きいため、直径が異なる複数のサクション・リングを用意する必要があった。 Furthermore, since the cornea diameter varies greatly among individuals, it was necessary to prepare a plurality of suction rings with different diameters.
 また、切開創の形成をブレードにより行うため、切開創の断面形状が直線に限定されていた。このため、切開創を角膜のかなり深いところまで形成しなければ、前述したような切開創の機能を十分に発揮させることができなかった。 Also, since the incision was formed with a blade, the cross-sectional shape of the incision was limited to a straight line. For this reason, unless the incision is formed to a very deep part of the cornea, the function of the incision as described above cannot be fully exhibited.
 そしてなによりも、切開創の形成が手動によることになるため、高い切開精度を得るにはそれ相応の熟練度が要求されるものであった。特に、切開創が形成されていくのにしたがって角膜輪部付近が動き易くなっていくため、ブレードが角膜内に所定の深さよりも深く入り込んでしまいがちとなる。このため、定深度の切開創を形成するのはほぼ不可能であった。 And above all, since the formation of the incision is manual, a high level of skill is required to obtain high incision accuracy. In particular, as the incision is formed, the vicinity of the corneal ring becomes easier to move, so that the blade tends to enter deeper than a predetermined depth into the cornea. For this reason, it was almost impossible to form a constant depth incision.
 また、上記角膜内留置リングを使用する場合は、上記切開器具で形成される切開創の断面形状が上述したように直線に限定されていることから、かなり深いところまで切開創を形成しておかないと角膜内留置リングが切開創から角膜外へ押し出されてしまうことになる。ところが、角膜内の深いところまで切開創を形成することは、往々にして角膜自体の切除(切離)といった危険を伴うものであった。 When using the indwelling ring, since the cross-sectional shape of the incision formed by the incision instrument is limited to a straight line as described above, the incision is formed to a considerably deeper position. Otherwise, the intracorneal indwelling ring will be pushed out of the cornea from the incision. However, forming an incision deep in the cornea often involves a risk of excision (separation) of the cornea itself.
 さらに、上記の切開器具、又は切開器具と角膜内留置リングの両方を使用して老眼の治療を行うと、角膜構成組織であるボーマン膜が切開されることにより、ボーマン膜が有する機能、特に牽引力に対する抵抗力が損なわれるため、可塑性の大きな部位が切開創に沿って角膜上に出現する。その結果、近方調節時に、切開創よりも角膜周辺部において角膜の形状に強い急峻化が起こる一方、切開創よりも角膜中心部においては角膜の曲率に変化が起きないかむしろ平坦化して近方調節が阻害されるといったことが起き、結果的に遠視化が起こる。したがって、上記治療により近視も矯正されることになるが、その矯正度合いは、元から強度の近視であった患者には不十分なこともある。そのため、さらなる近視の矯正手術を行ったりする場合がある。また、逆に元から遠視であった看者は、治療後さらに遠視が進むため、遠視の矯正手術を行ったりする必要がある。その場合、近年、近視や遠視の治療に広く行われるようになったLASIK手術を採用することが考えられる。しかし、上記切開器具で形成した切開創と交錯しないように、LASIK手術でレーザにより角膜フラップを形成することは、上記切開器具による切開創の中心(切開創が描く円の中心)と角膜フラップの中心とを寸分違わず合致させることなど極めて困難であることから、実際には不可能であった。 Further, when presbyopia is treated using the above incision instrument, or both the incision instrument and the indwelling ring, the Bowman's membrane, which is the corneal constituent tissue, is incised, and the function of the Bowman's membrane, particularly the traction force Since the resistance to resistance is impaired, a highly plastic site appears on the cornea along the incision. As a result, during the near-field adjustment, the shape of the cornea is sharpened more strongly in the periphery of the cornea than in the incision, while the curvature of the cornea does not change in the center of the cornea than in the incision or is flattened and close. In other words, hyperregulation occurs as a result. Therefore, although the above treatment corrects myopia, the degree of correction may not be sufficient for patients who have had high myopia. Therefore, there are cases where further corrective surgery for myopia is performed. On the other hand, a viewer who has been hyperopic from the beginning is required to perform corrective surgery for hyperopia because hyperopia further proceeds after treatment. In that case, it is conceivable to adopt the LASIK surgery that has been widely used for the treatment of myopia and hyperopia in recent years. However, forming a corneal flap with a laser in LASIK surgery so that it does not cross with the incision formed with the incision instrument means that the center of the incision by the incision instrument (the center of the circle drawn by the incision) and the corneal flap It was actually impossible because it was extremely difficult to match the center without any difference.
 そこで、上記課題を解決するために、本発明は、患者に負担をかけることなく安全に実施し得る、強膜の伸展性の低下を補完する方法及びその方法に使用されるスペーサを提供することを目的としている。 Therefore, in order to solve the above-mentioned problems, the present invention provides a method for complementing the decrease in scleral extensibility and a spacer used in the method, which can be performed safely without burdening the patient. It is an object.
 上記の目的を達成するため、請求項1の発明に係る眼球の強膜伸展性低下補完方法は、角膜周辺部から角膜輪部の間に柔軟性の高い部位を作成することにより外眼筋の眼球付着部と角膜輪部との間に位置する強膜の伸展性の低下を補完する方法であって、角膜輪部の近傍における角膜実質層内に角膜表面と平行な輪状又は円弧状の第1切開創面を形成する工程と、この第1切開創面から角膜表面にまで達する第2切開創面を形成する工程と、を含み、前記各工程をフェムト秒レーザにより行うものである。 In order to achieve the above object, the method for complementing the decrease in sclera extensibility of the eye according to the invention of claim 1 is characterized by creating a highly flexible region between the corneal periphery and the corneal limbus. A method of complementing the decrease in extensibility of the sclera located between the eyeball adhering portion and the corneal limbus, wherein the corneal stroma in the vicinity of the corneal limbus has a ring-like or arc-like shape parallel to the corneal surface. Including a step of forming one incisional wound surface and a step of forming a second incisional wound surface reaching from the first incisional wound surface to the corneal surface, and each of the steps is performed by a femtosecond laser.
 請求項2の発明に係る眼球の強膜伸展性低下補完方法は、角膜周辺部から角膜輪部の間に柔軟性の高い部位を作成することにより外眼筋の眼球付着部と角膜輪部との間に位置する強膜の伸展性の低下を補完する方法であって、角膜輪部の近傍における角膜実質層内に角膜表面と平行な輪状又は円弧状の第1切除層を形成する工程と、この第1切除層から角膜表面にまで達する第2切除層を形成する工程と、を含み、前記各工程をフェムト秒レーザにより行うものである。 An eyeball sclera extensibility reduction complementing method according to a second aspect of the present invention is a method of creating a highly flexible region between the cornea peripheral part and the cornea ring part, thereby providing an eyeball adhering part and a cornea ring part of the extraocular muscle. A method of complementing the decrease in extensibility of the sclera located between the corneal limbus and forming a ring-shaped or arc-shaped first excision layer parallel to the corneal surface in the corneal stroma in the vicinity of the corneal limbus; And a step of forming a second ablation layer reaching from the first ablation layer to the corneal surface, and each step is performed by a femtosecond laser.
 上記の各発明に係る強膜伸展性低下補完方法にあっては、それぞれ切開創面又は切除層内にスペーサを挿入する工程をさらに含んでもよい。 The sclera extensibility reduction complementing method according to each of the above inventions may further include a step of inserting a spacer into the incision wound surface or the excision layer, respectively.
 すなわち、上記請求項1の発明に係る強膜伸展性低下補完方法においては、さらに、前記第1切開創面内にスペーサを挿入する工程を含んでもよい。 That is, the scleral extensibility reduction complementing method according to the first aspect of the present invention may further include a step of inserting a spacer into the first incision wound surface.
 上記請求項2の発明に係る強膜伸展性低下補完方法においては、さらに、前記第1切除層内にスペーサを挿入する工程を含んでもよい。 The scleral extensibility reduction complementing method according to the invention of claim 2 may further include a step of inserting a spacer into the first ablation layer.
 上記の各スペーサとしては、輪状又は弧状のものが好ましい。その場合、材質は生体に無害なものが選択される。例えば、コンタクトレンズの材料として用いられているポリメチルメタアクリレート(PMMA)をはじめとする生体に無害な合成樹脂、あるいは、金(Au)又は白金(Pt)が選択される。スペーサの形態としては偏平であることが好適である。 The above spacers are preferably ring-shaped or arc-shaped. In this case, a material that is harmless to the living body is selected. For example, a synthetic resin that is harmless to a living body, such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected. The spacer is preferably flat.
 スペーサは、輪状又は弧状である場合、従来のような角膜の厚み方向に沿う切開創ではなく、角膜の半径方向に沿う第1切開創面(又は第1切除層)に挿入されるため、スペーサはその位置から角膜の厚み方向に沿う第2切開創面(又は第2切除層)内に移動しようとしても、第2切開創面(又は第2切除層)の下端で引っ掛かってしまう。したがって、スペーサは、角膜の半径方向に沿う第1切開創面(又は第1切除層)の中に常時留まるので、角膜から抜け出てしまう虞がない。 When the spacer is ring-shaped or arc-shaped, the spacer is inserted not in the incision along the thickness direction of the cornea as in the prior art, but in the first incision surface (or the first excision layer) along the radial direction of the cornea. Even if it tries to move into the second incisional wound surface (or second excision layer) along the thickness direction of the cornea from that position, it is caught at the lower end of the second incisional wound surface (or second excision layer). Therefore, since the spacer always stays in the first incisional wound surface (or the first excision layer) along the radial direction of the cornea, there is no possibility of slipping out of the cornea.
 また、上記請求項1の発明に係る強膜伸展性低下補完方法においては、さらに、前記第1切開創面内に入り込むアンカー部を備えたチップ状のスペーサを、前記第2切開創面内に複数箇所に亘って挿入する工程を含んでいてもよい。 In the scleral extensibility reduction complementing method according to the first aspect of the present invention, a plurality of chip-like spacers having anchor portions that enter the first incision wound surface are further provided in the second incision wound surface. The process of inserting over may be included.
 上記請求項2の発明に係る強膜伸展性低下補完方法においては、さらに、前記第1切除層内に入り込むアンカー部を備えたチップ状のスペーサを、前記第2切除層内に複数箇所に亘って挿入する工程を含んでいてもよい。 In the scleral extensibility reduction complementing method according to the second aspect of the present invention, chip-like spacers having anchor portions that enter the first ablation layer are further provided in a plurality of locations in the second ablation layer. May include a step of inserting.
 ここで、上記チップ状のスペーサの挿入個数は任意であるが、4~8個が好ましい。また、スペーサの挿入間隔は、第2切開創面又は第2切除層に沿って等間隔となるのが好ましい。例えば、スペーサの挿入個数が4個の場合は90°の間隔で、8個の場合は45°の間隔で、という具合になる。 Here, the number of chip-shaped spacers inserted is arbitrary, but 4 to 8 is preferable. Moreover, it is preferable that the insertion interval of a spacer becomes equal intervals along a 2nd incisional wound surface or a 2nd excision layer. For example, when the number of inserted spacers is four, the interval is 90 °, and when the number is eight, the interval is 45 °.
 上記チップ状のスペーサとしては、前記第2切開創面又は第2切除層内に挿入される薄片状の本体部と、この本体部の下端から一側方又は両側方に突出された、前記第1切開創面又は第1切除層内に入り込むアンカー部とを備えたものが好ましい。 The chip-shaped spacer includes a flaky main body portion inserted into the second incision wound surface or the second excision layer, and the first spacer protruding from one end or both sides from the lower end of the main body portion. What provided the anchor part which penetrates in an incisional wound surface or a 1st excision layer is preferable.
 このような形態を有するスペーサは、アンカー部が第1切開創面(第1切除層)内に入り込んでまさしくアンカーとして機能するので、第2切開創面(第2切除層)内に安定して留り、角膜からスペーサが抜け出てしまう虞がない。 In the spacer having such a configuration, the anchor portion enters the first incision wound surface (first excision layer) and functions as an anchor, so that the spacer remains stably in the second incision wound surface (second excision layer). There is no risk that the spacer will come out of the cornea.
 このスペーサも、前記の輪状又は弧状のスペーサと同様、材質は生体に無害なものが選択される。例えば、コンタクトレンズの材料として用いられているポリメチルメタアクリレート(PMMA)をはじめとする生体に無害な合成樹脂、あるいは、金(Au)又は白金(Pt)が選択される。 As for the spacer, a material that is harmless to a living body is selected as in the case of the ring-shaped or arc-shaped spacer. For example, a synthetic resin that is harmless to a living body, such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected.
 上記のようなチップ状のスペーサにあっては、前記した輪状又は弧状のスペーサに比べて切開創面(切除層)内への挿入作業が容易であり、施術時間をより短縮することができる。 The tip-shaped spacer as described above is easier to insert into the incisional wound surface (excision layer) than the above-described ring-shaped or arc-shaped spacer, and the treatment time can be further shortened.
 さらに、スペーサとしては、金(Au)又は白金(Pt)の粒状物又は粉末も適している。 Further, as the spacer, a granular material or powder of gold (Au) or platinum (Pt) is also suitable.
 スペーサの材料として金又は白金を用いた場合、術後において角膜の混濁を効果的に軽減又は抑止することができる。 When gold or platinum is used as the spacer material, the corneal opacity can be effectively reduced or suppressed after the operation.
 本発明にあっては、角膜輪部の近傍に角膜の半径方向に沿う切開創面(又は切除層)と、角膜の厚み方向に沿う切開創面(又は切除層)の2つが相互に連続した状態で形成されることになるから、この形成部位において、前記従来の切開創を形成する場合よりも大きな伸展性を得ることができる。つまり、角膜周辺部から角膜輪部の間に、柔軟性が従来よりも高い部位を作成することができる。 In the present invention, the incision wound surface (or excision layer) along the radial direction of the cornea and the incision wound surface (or excision layer) along the thickness direction of the cornea are adjacent to each other in the vicinity of the corneal ring portion. Since it is formed, it is possible to obtain greater extensibility at the formation site than when the conventional incision is formed. That is, it is possible to create a part having higher flexibility than the conventional part between the corneal peripheral part and the corneal ring part.
 また、角膜フラップを形成する場合は、上記切開創面を形成するのと同じフェムト秒レーザを使用し一連の施術で行うことになるので、両者が交錯してしまう虞がないとともに、短時間に近視や遠視の矯正も行うことができる。 In addition, when forming a corneal flap, the same femtosecond laser as that used to form the incised wound surface is used in a series of treatments, so there is no risk of both crossing and short-term myopia. And correction of hyperopia.
 なお、本発明において、角膜表面と平行とは、角膜の半径方向に沿う方向を意味するものであり、厳密に角膜表面と平行であることのみを意味するものではない。したがって、第1切開創面及び第1切除層は、それぞれ角膜の表面に対して僅かながら角度をもった傾斜面である場合を含む。 In the present invention, the phrase “parallel to the corneal surface” means a direction along the radial direction of the cornea, and does not mean to be strictly parallel to the corneal surface. Therefore, the first incisional wound surface and the first excision layer each include a case where the inclined surface is slightly inclined with respect to the surface of the cornea.
 本発明によれば、患者に負担をかけずに所望の断面形状を有する切開創面を形成することができ、角膜周辺部から角膜輪部の間に柔軟性が従来よりも高い部位を作成することができる。これにより、強膜の伸展性を補完することができるので、より効果的に眼球の調節能力を回復させることができる。また近視や乱視の矯正を行うこともできる。 According to the present invention, an incisional wound surface having a desired cross-sectional shape can be formed without imposing a burden on the patient, and a region having higher flexibility than the conventional one can be created between the corneal peripheral part and the corneal ring part. Can do. Thereby, since the extensibility of the sclera can be complemented, the ability to adjust the eyeball can be restored more effectively. It can also correct myopia and astigmatism.
角膜を正面からみた模式図である。It is the schematic diagram which looked at the cornea from the front. 図1におけるII-II線に沿う端面を示す模式図である。It is a schematic diagram which shows the end surface which follows the II-II line | wire in FIG. 第1切開創面と第2切開創面との位置関係の他の例を示す、図2に対応する図である。It is a figure corresponding to FIG. 2 which shows the other example of the positional relationship of a 1st incision wound surface and a 2nd incision wound surface. 第2切開創面と角膜フラップとの位置関係を示す、図2に対応する図である。It is a figure corresponding to FIG. 2 which shows the positional relationship of a 2nd incision wound surface and a corneal flap. 第1切開創面内にスペーサを挿入した状態を示す、図2に対応する図である。It is a figure corresponding to FIG. 2 which shows the state which inserted the spacer in the 1st incision wound surface. スペーサの一実施形態を示す斜視図である。It is a perspective view which shows one Embodiment of a spacer. スペーサの他の実施形態を示す正面図である。It is a front view which shows other embodiment of a spacer. 図7に示すスペーサの平面図である。It is a top view of the spacer shown in FIG. 図7に示すスペーサの側面図である。It is a side view of the spacer shown in FIG. 図7に示すスペーサの配設例の一例を示す、角膜を正面から見た模式図である。It is the schematic diagram which looked at the cornea from the front which shows an example of arrangement | positioning of the spacer shown in FIG. 図10におけるXI-XI線に沿う端面を示す模式図である。It is a schematic diagram which shows the end surface which follows the XI-XI line in FIG. 第2切開創面内に図7に示すスペーサを挿入した状態を示す、図11に対応する図である。It is a figure corresponding to FIG. 11 which shows the state which inserted the spacer shown in FIG. 7 in the 2nd incisional wound surface. スペーサのさらに他の実施形態を示す正面図である。It is a front view which shows other embodiment of a spacer. 第2切開創面内に図13に示すスペーサを挿入した状態を示す、図11に対応する図である。It is a figure corresponding to Drawing 11 showing the state where the spacer shown in Drawing 13 was inserted in the 2nd incisional wound surface. 外眼筋が弛緩状態にあるときの眼球及びその周辺部を示す模式図である。It is a schematic diagram which shows the eyeball and its peripheral part when the extraocular muscle is in a relaxed state. 外眼筋が収縮したときの眼球及びその周辺部を示す模式図である。It is a schematic diagram which shows the eyeball and its peripheral part when an extraocular muscle contracts.
 以下、本発明を実施するための最良の形態について、図面を参照しながら説明する。 Hereinafter, the best mode for carrying out the present invention will be described with reference to the drawings.
 図1は、角膜を正面からみた模式図、図2は、図1におけるII-II線に沿う端面を示す模式図である。 FIG. 1 is a schematic view of the cornea as viewed from the front, and FIG. 2 is a schematic view showing an end surface taken along line II-II in FIG.
 本発明に係る眼球の強膜伸展性低下補完方法は、角膜周辺部から角膜輪部7の間に柔軟性の高い部位を作成することにより外眼筋2の眼球付着部3と角膜輪部7との間に位置する調節強膜5の伸展性の低下を補完する方法である。すなわち、本発明による方法は、角膜輪部7の近傍における角膜実質層91内に角膜表面92と平行な輪状の第1切開創面10を形成する工程と、この第1切開創面10から角膜表面92にまで達する第2切開創面20を形成する工程と、を含み、これら各工程をフェムト秒レーザにより行うものである。 The method for complementing the decrease in sclera extensibility of the eyeball according to the present invention creates a highly flexible portion between the cornea peripheral part and the corneal ring part 7 to thereby provide the eyeball attachment part 3 and the corneal ring part 7 of the extraocular muscle 2. It is a method of complementing the decrease in the extensibility of the regulatory sclera 5 positioned between the two. That is, in the method according to the present invention, the step of forming a ring-shaped first incisional face 10 parallel to the corneal surface 92 in the corneal substantial layer 91 in the vicinity of the corneal ring portion 7, and the first incisional wound face 10 to the corneal surface 92. Forming the second incisional wound surface 20 that reaches the point, and each of these steps is performed by a femtosecond laser.
 フェムト秒レーザにより第1切開創面10を形成するには、レーザ照射手段から出射されるレーザ光を、そのスポットが角膜実質層91内において、フェムト秒レーザ装置のメモリに予め記憶させておいた第1切開創面10の深度に達するように導光するとともに、レーザ光のスポットを次のいずれかの方法で走査させる。すなわち、フェムト秒レーザ装置のメモリに予め記憶させておいた第1切開創面10の幅で振幅走査させながら角膜輪部7に沿って輪状に走査させる。又は、メモリに予め記憶させておいた第1切開創面10の幅の範囲内で、角膜輪部7に沿って輪状に且つ複数回に亘り同心円状に走査させる。この場合、角膜9の内周側から走査を開始しても外周側(角膜輪部7側)から走査を開始してもよい。或いは、メモリに予め記憶させておいた第1切開創面の幅の範囲内で、角膜輪部7に沿って輪状に且つ螺旋状に走査させる。この場合も、角膜9の内周側から走査を開始しても外周側(角膜輪部7側)から走査を開始してもよい。 In order to form the first incisional wound surface 10 by the femtosecond laser, the laser beam emitted from the laser irradiation means is stored in advance in the memory of the femtosecond laser device, with the spot in the corneal substantial layer 91. The light is guided so as to reach the depth of one incisional wound surface 10, and the laser light spot is scanned by any of the following methods. That is, scanning is performed in a ring shape along the corneal ring portion 7 while performing amplitude scanning with the width of the first incision wound surface 10 stored in advance in the memory of the femtosecond laser apparatus. Or within the range of the width | variety of the 1st incision wound surface 10 memorize | stored previously in memory, it scans in a concentric form over a corneal ring part 7 in a ring shape and several times. In this case, scanning may be started from the inner peripheral side of the cornea 9 or may be started from the outer peripheral side (corneal ring portion 7 side). Alternatively, scanning is performed in a ring shape and a spiral shape along the corneal ring portion 7 within the range of the width of the first incision wound surface previously stored in the memory. Also in this case, scanning may be started from the inner peripheral side of the cornea 9 or may be started from the outer peripheral side (corneal ring portion 7 side).
 第1切開創面10の深さは、角膜表面92から100~900μmの範囲から選択され、好ましくは400~600μmである。また第1切開創面10の幅Wは、近視・乱視矯正を目的とする場合は500μm以上、老眼矯正や緑内障、黄斑変性症、円錐角膜等の治療を目的とする場合は1000μm以上が好ましい。 The depth of the first incision surface 10 is selected from the range of 100 to 900 μm from the corneal surface 92, and preferably 400 to 600 μm. The width W of the first incision wound surface 10 is preferably 500 μm or more for the purpose of correcting myopia and astigmatism, and 1000 μm or more for the purpose of presbyopia correction, glaucoma, macular degeneration, keratoconus and the like.
 なお、第1切開創面10は、上記したような輪状に限らず、円弧状であってもよく、そのいずれの形態を選択するか、また円弧状とする場合はその長さをどの程度とするかについては、眼球全体及び角膜の状態などを勘案して適宜決定すればよい。 The first incision wound surface 10 is not limited to the ring shape as described above, but may be an arc shape. Which form is selected, and how long is the arc shape? This may be determined as appropriate in consideration of the entire eyeball and the state of the cornea.
 次に、フェムト秒レーザにより第2切開創面20を形成するには、レーザ照射手段から出射されるレーザ光のスポットを、第1切開創面10から角膜表面92に向かう方向に、或いは角膜表面から第1切開創面に向かう方向に、第1切開創面10に沿って走査させる。これによって、第2切開創面20はその下端において第1切開創面10と接続することとなる。ここで、図1では、第2切開創面20は第1切開創面10とその幅方向の略中央部において接続され、これら2つの切開創面10,20で「逆T字状」を構成しているが、施術対象者が老人の場合は、角膜周辺部に白く混濁した部位(専門的にこれを老人環と呼ぶ。)が存在することがあり、その場合、レーザ光が透過しにくいため、第2切開創面20は角膜輪部7から離れている方がよい。したがって、図3に示すように、第2切開創面20は第1切開創面10とその内周端(角膜9の中心側の内周縁)で接続、又は内周端寄りの位置で接続されるのがよい。また、第2切開創面20の角膜輪部7からの距離は、0.1~2.0mmがよく、より好ましくは0.5~1.0mmである。 Next, in order to form the second incisional wound surface 20 by the femtosecond laser, a laser beam spot emitted from the laser irradiation means is directed from the first incisional wound surface 10 toward the corneal surface 92 or from the corneal surface. Scan along the first incision wound surface 10 in the direction toward the one incision wound surface. As a result, the second incisional wound surface 20 is connected to the first incisional wound surface 10 at the lower end thereof. Here, in FIG. 1, the second incision wound surface 20 is connected to the first incision wound surface 10 at a substantially central portion in the width direction, and these two incision wound surfaces 10 and 20 form an “inverted T shape”. However, when the treatment subject is an elderly person, there may be a white and cloudy part in the periphery of the cornea (specially called the elderly ring). 2 The incisional wound surface 20 should be separated from the corneal ring portion 7. Therefore, as shown in FIG. 3, the second incision wound surface 20 is connected to the first incision wound surface 10 at its inner peripheral end (inner peripheral edge on the center side of the cornea 9) or at a position closer to the inner peripheral end. Is good. The distance of the second incision wound surface 20 from the corneal ring portion 7 is preferably 0.1 to 2.0 mm, more preferably 0.5 to 1.0 mm.
 なお、第1切開創面10及び第2切開創面20は、それぞれこれらに代えて切除層としてもよい。つまり、第1切開創面10及び第2切開創面20に沿って一定領域の組織を切除してもよい。 In addition, the 1st incision wound surface 10 and the 2nd incision wound surface 20 are good also as an excision layer instead of these, respectively. In other words, a certain region of tissue may be excised along the first incision wound surface 10 and the second incision wound surface 20.
 また、LASIK手術により近視矯正や遠視矯正も併せて行う場合は、図1に示すように、上記第1切開創面10及び第2切開創面20を形成するのに使用するフェムト秒レーザ装置を使用して、第2切開創面20の内側領域に、角膜フラップ60を形成する。なお、この角膜フラップ60は、第1切開創面10及び第2切開創面20を形成する前でも後でもよい。また、角膜フラップ60の円周状の外縁と第2切開創面20とは、図4に示すように、一致させてもよい。 When performing myopia correction or hyperopia correction by LASIK surgery, use a femtosecond laser device used to form the first incision wound surface 10 and the second incision wound surface 20, as shown in FIG. Thus, the corneal flap 60 is formed in the inner region of the second incision wound surface 20. The corneal flap 60 may be before or after the first incision wound surface 10 and the second incision wound surface 20 are formed. Moreover, you may make the circumferential outer edge of the corneal flap 60 and the 2nd incisional wound surface 20 correspond, as shown in FIG.
 図1に示す例において、第1切開創面10内に、図5に示すように、偏平なリング状のスペーサ50(図6参照)を挿入してもよい。このスペーサ50の材質としては、金又は白金が好ましい。また、厚みは、厚さが増すにしたがって、調節強膜5の伸展性の低下をよりよく補完することができるが、50μm程度の厚みが好ましい。また、スペーサはこのような偏平なリング状のもの以外に、金又は白金の粒状物又は粉末であってもよい。なお、イオン化傾向が小さく毒性が低い金属もスペーサの材料として採用し得る。 In the example shown in FIG. 1, a flat ring-shaped spacer 50 (see FIG. 6) may be inserted into the first incision wound surface 10 as shown in FIG. The material of the spacer 50 is preferably gold or platinum. Further, the thickness can better compensate for the decrease in extensibility of the adjusting sclera 5 as the thickness increases, but a thickness of about 50 μm is preferable. In addition to the flat ring-shaped spacer, the spacer may be gold or platinum particles or powder. A metal having a low ionization tendency and low toxicity can also be used as the spacer material.
 スペーサは、上記したようなリング状のものに限らず、図7~図9に示すようなチップ状のスペーサ52でもよい。 The spacer is not limited to the ring shape as described above, and may be a chip-like spacer 52 as shown in FIGS.
 このスペーサ52は、第2切開創面20内に挿入される薄片状の本体部521と、この本体部521の下端から両側方に突出された、第1切開創面10内に入り込むアンカー部522とを備えており、図7に示すように、正面視下向き矢印状を呈するものである。 The spacer 52 includes a flaky body portion 521 inserted into the second incision wound surface 20 and an anchor portion 522 that protrudes from the lower end of the body portion 521 to both sides and enters the first incision wound surface 10. As shown in FIG. 7, it has an arrow shape facing downward.
 この例では、アンカー部522は楔状に形成されており、第2切開創面20内への挿入が容易に行えるように図られている。 In this example, the anchor portion 522 is formed in a wedge shape so that it can be easily inserted into the second incision wound surface 20.
 このようになるスペーサ52は、第2切開創面20内に、図10において丸印Aで示すに示すように、複数箇所に亘って挿入される。図10に示す例では、8個のスペーサ52が45°の間隔で挿入されることになる。なお、スペーサ52の個数は8個に限らず、4個~7個でもよい。その場合もスペーサ52の挿入間隔は等間隔とするのが好ましい。 The spacer 52 thus configured is inserted into the second incision wound surface 20 over a plurality of locations as indicated by a circle A in FIG. In the example shown in FIG. 10, eight spacers 52 are inserted at intervals of 45 °. The number of spacers 52 is not limited to eight, and may be four to seven. Also in this case, it is preferable that the insertion interval of the spacers 52 is equal.
 このような形態を有するスペーサ52は、アンカー部522が第1切開創面10内に入り込んでまさしくアンカーとして機能するので、第2切開創面20内に安定して留り、角膜からスペーサ52が抜け出てしまう虞がない。また、第2切開創面20は、図11に示すように、実際には施術精度の関係で、第1切開創面10と交差し、第2切開創面20の下端22が僅かに第1切開創面10の下方に突出するように形成される。このような場合、アンカー部522の形状が、図7に示すような、いわゆる楔状であると、図12に示すように、アンカー部522の先端が第2切開創面20の下端22に食い込むため、アンカー部522が第1切開創面10に沿う方向にずれることがなくなり、スペーサ52が第2切開創面20内で傾くようなことがない。 In the spacer 52 having such a configuration, the anchor portion 522 enters the first incision wound surface 10 and functions as an anchor. Therefore, the spacer 52 stays stably in the second incision wound surface 20, and the spacer 52 comes out of the cornea. There is no fear. In addition, as shown in FIG. 11, the second incision wound surface 20 actually intersects the first incision wound surface 10 in relation to the treatment accuracy, and the lower end 22 of the second incision wound surface 20 is slightly slightly in the first incision wound surface 10. It is formed so as to protrude downward. In such a case, if the shape of the anchor portion 522 is a so-called wedge shape as shown in FIG. 7, the tip of the anchor portion 522 bites into the lower end 22 of the second incision wound surface 20 as shown in FIG. The anchor portion 522 is not displaced in the direction along the first incisional wound surface 10, and the spacer 52 is not inclined in the second incisional wound surface 20.
 なお、アンカー部522は、本体部521の下端から必ずしも両側方に突出している必要はなく、図13に示すように、本体部521の下端から一側方にのみ突出していてもよい。図14は、図13に示すスペーサ52を使用した場合を示す。 Note that the anchor portion 522 does not necessarily protrude from the lower end of the main body portion 521 on both sides, and may protrude only one side from the lower end of the main body portion 521 as shown in FIG. FIG. 14 shows a case where the spacer 52 shown in FIG. 13 is used.
 上記のスペーサ52も、前記の輪状又は弧状のスペーサ50と同様、材質は生体に無害なものが選択される。例えば、コンタクトレンズの材料として用いられているポリメチルメタアクリレート(PMMA)をはじめとする生体に無害な合成樹脂、あるいは、金(Au)又は白金(Pt)が選択される。 As for the spacer 52, as in the case of the ring-shaped or arc-shaped spacer 50, a material that is harmless to the living body is selected. For example, a synthetic resin that is harmless to a living body, such as polymethyl methacrylate (PMMA) used as a material for contact lenses, or gold (Au) or platinum (Pt) is selected.
 上記のようなチップ状のスペーサ52にあっては、前記した輪状又は弧状のスペーサ50に比べて切開創面(第2切開創面20)内への挿入作業が容易であり、施術時間をより短縮することができる。 In the chip-shaped spacer 52 as described above, the insertion work into the incision wound surface (second incision wound surface 20) is easier than the above-described ring-shaped or arc-shaped spacer 50, and the treatment time is further shortened. be able to.
 本発明は、老眼の治療に適用できるのは勿論のこと、近視や乱視、とくにこれまで治療法のなかった強度の不整乱視にも応用できる。本発明は既存のLASIK手術とは異なり、角膜の厚みを損なうことなく近視、乱視矯正手術を可能にするため、角膜厚の薄い眼球に於いても近視や乱視治療を可能とすることができる。また、眼圧を低下させる効果も得られることから、緑内障の治療にも有効である。また、外眼筋の緊張を解くことができるため、老人性黄斑変性症の治療や、網膜色素変性症、円錐角膜の治療、白内障の予防にも有効である。 The present invention can be applied not only to the treatment of presbyopia, but also to myopia and astigmatism, and particularly to irregular irregular astigmatism that has not been treated before. Unlike the existing LASIK surgery, the present invention enables myopia and astigmatism correction surgery without impairing the thickness of the cornea, so that it is possible to treat myopia and astigmatism even in an eyeball with a thin cornea thickness. Moreover, since the effect of reducing intraocular pressure is also obtained, it is effective for the treatment of glaucoma. In addition, since the tension of the extraocular muscles can be released, it is also effective in treating senile macular degeneration, retinitis pigmentosa, keratoconus, and cataract prevention.
1   眼球
2   外眼筋
3   外眼筋の眼球付着部
4   眼球底
5   強膜(調節強膜)
6   視神経
7   角膜輪部
8   軟部組織
9   角膜
10  第1切開創面
20  第2切開創面
50  スペーサ
52  スペーサ
 521 本体部
 522 アンカー部
60  角膜フラップ
DESCRIPTION OF SYMBOLS 1 Eyeball 2 Extraocular muscle 3 Extraocular muscle eye adhesion part 4 Eyeball bottom 5 Sclera (regulatory sclera)
6 Optic Nerve 7 Corneal Annulus 8 Soft Tissue 9 Cornea 10 First Incision Wound 20 Second Incision Wound 50 Spacer 52 Spacer 521 Main Body 522 Anchor 60 60 Corneal Flap

Claims (18)

  1.  角膜周辺部から角膜輪部の間に柔軟性の高い部位を作成することにより外眼筋の眼球付着部と角膜輪部との間に位置する強膜の伸展性の低下を補完する方法であって、
     角膜輪部の近傍における角膜実質層内に角膜表面と平行な輪状又は円弧状の第1切開創面を形成する工程と、
     この第1切開創面から角膜表面にまで達する第2切開創面を形成する工程と、
    を含み、
     前記各工程をフェムト秒レーザにより行う眼球の強膜伸展性低下補完方法。
    It is a method that compensates for the decrease in extensibility of the sclera located between the eyeball adhering part of the extraocular muscles and the corneal ring by creating a highly flexible region between the cornea peripheral part and the corneal ring part. And
    Forming a ring-shaped or arc-shaped first incisional face parallel to the corneal surface in the corneal stroma in the vicinity of the corneal limbus;
    Forming a second incision wound surface extending from the first incision wound surface to the corneal surface;
    Including
    A method for complementing the decrease in scleral extensibility of the eyeball, wherein each of the steps is performed with a femtosecond laser.
  2.  角膜周辺部から角膜輪部の間に柔軟性の高い部位を作成することにより外眼筋の眼球付着部と角膜輪部との間に位置する強膜の伸展性の低下を補完する方法であって、
     角膜輪部の近傍における角膜実質層内に角膜表面と平行な輪状又は円弧状の第1切除層を形成する工程と、
     この第1切除層から角膜表面にまで達する第2切除層を形成する工程と、
    を含み、
     前記各工程をフェムト秒レーザにより行う眼球の強膜伸展性低下補完方法。
    It is a method that compensates for the decrease in extensibility of the sclera located between the eyeball adhering part of the extraocular muscles and the corneal ring by creating a highly flexible region between the cornea peripheral part and the corneal ring part. And
    Forming a ring-shaped or arc-shaped first excision layer parallel to the corneal surface in the corneal stroma in the vicinity of the corneal limbus;
    Forming a second ablation layer reaching the corneal surface from the first ablation layer;
    Including
    A method for complementing the decrease in scleral extensibility of the eyeball, wherein each of the steps is performed with a femtosecond laser.
  3.  請求項1に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第2切開創面の内側にフェムト秒レーザにより角膜フラップを形成する工程を含む眼球の眼球強膜伸展性低下補完方法。
    In the method for supplementing decrease in scleral extensibility of the eyeball according to claim 1,
    The method further comprises a step of forming a corneal flap with a femtosecond laser on the inner side of the second incisional wound surface, and a method for complementing the reduction in eyeball sclera extensibility.
  4.  請求項2に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第2切除層の内側にフェムト秒レーザにより角膜フラップを形成する工程を含む眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 2,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of forming a corneal flap with a femtosecond laser inside the said 2nd excision layer.
  5.  請求項1又は3に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第1切開創面内にスペーサを挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the eyeball sclera extensibility reduction complementation method according to claim 1 or 3,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of inserting a spacer in the said 1st incision wound surface.
  6.  請求項2又は4に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第1切除層内にスペーサを挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 2 or 4,
    Furthermore, the sclera extensibility fall complementation method of the eyeball including the process of inserting a spacer in the said 1st excision layer.
  7.  請求項1又は3に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第1切開創面内に入り込むアンカー部を備えたチップ状のスペーサを、前記第2切開創面内に複数箇所に亘って挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the eyeball sclera extensibility reduction complementation method according to claim 1 or 3,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of inserting the chip-shaped spacer provided with the anchor part which penetrates in the said 1st incision wound surface in two or more places in the said 2nd incision wound surface.
  8.  請求項2又は4に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第1切除層内に入り込むアンカー部を備えたチップ状のスペーサを、前記第2切除層内に複数箇所に亘って挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 2 or 4,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of inserting the chip-shaped spacer provided with the anchor part which penetrates in the said 1st excision layer over two or more places in the said 2nd excision layer.
  9.  請求項5又は6に記載の眼球の強膜伸展性低下補完方法において、
     前記スペーサとして、輪状又は弧状のスペーサを用いる眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 5 or 6,
    A method for supplementing a decrease in scleral extensibility of an eyeball using a ring-shaped or arc-shaped spacer as the spacer.
  10.  請求項7から9のいずれか一つに記載の眼球の強膜伸展性低下補完方法において、
     前記スペーサは、合成樹脂、金又は白金を材料とするものである眼球の強膜伸展性低下補完方法。
    In the eyeball sclera extensibility reduction complementation method according to any one of claims 7 to 9,
    The spacer is made of synthetic resin, gold or platinum as a material, and is a supplementary method for supplementing the decrease in scleral extensibility of the eyeball.
  11.  請求項5又は6に記載の眼球の強膜伸展性低下補完方法において、
     前記スペーサとして、金又は白金の粒状物又は粉末を用いる眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 5 or 6,
    A method for complementing the decrease in scleral extensibility of the eyeball using a granular material or powder of gold or platinum as the spacer.
  12.  請求項1又は3に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第2切開創面内に、スペーサとして金又は白金の粒状物又は粉末を挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the eyeball sclera extensibility reduction complementation method according to claim 1 or 3,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of inserting the granule or powder of gold or platinum as a spacer in the said 2nd incisional wound surface.
  13.  請求項2又は4に記載の眼球の強膜伸展性低下補完方法において、
     さらに、前記第2切除層内に、スペーサとして金又は白金の粒状物又は粉末を挿入する工程を含む眼球の強膜伸展性低下補完方法。
    In the sclera extensibility reduction complementation method of the eyeball according to claim 2 or 4,
    Furthermore, the sclera extensibility fall complementation method of an eyeball including the process of inserting the granule or powder of gold or platinum as a spacer in the said 2nd excision layer.
  14.  請求項5又は6に記載の眼球の強膜伸展性低下補完方法に使用されるスペーサであって、
     前記第1切開創面又は前記第1切除層内に挿入される輪状又は弧状のスペーサ。
    A spacer used in the method for complementing the decrease in sclera extensibility of the eyeball according to claim 5 or 6,
    A ring-shaped or arc-shaped spacer inserted into the first incision wound surface or the first excision layer.
  15.  請求項14に記載のスペーサにおいて、
     そのスペーサは偏平に形成されてなるスペーサ。
    The spacer according to claim 14,
    The spacer is a flat spacer.
  16.  請求項7に記載の眼球の強膜伸展性低下補完方法に使用されるチップ状のスペーサであって、
     前記第2切開創面内に挿入される薄片状の本体部と、
     この本体部の下端から一側方又は両側方に突出された、前記第1切開創面内に入り込むアンカー部と
     を備えたスペーサ。
    A chip-like spacer used in the method for complementing the decrease in sclera extensibility of the eye according to claim 7,
    A flaky body inserted into the second incision wound surface;
    A spacer provided with an anchor portion protruding into one side or both sides from the lower end of the main body portion and entering the first incision wound surface.
  17.  請求項8に記載の眼球の強膜伸展性低下補完方法に使用されるチップ状のスペーサであって、
     前記第2切除層内に挿入される薄片状の本体部と、
     この本体部の下端から一側方又は両側方に突出された、前記第1切除層内に入り込むアンカー部と
     を備えたスペーサ。
    A chip-like spacer used in the sclera extensibility reduction complementation method of the eyeball according to claim 8,
    A flaky body inserted into the second ablation layer;
    A spacer provided with an anchor portion that protrudes from the lower end of the main body portion to one side or both sides and enters the first cut layer.
  18.  請求項14から17のいずれか一つに記載のスペーサにおいて、
     そのスペーサは、合成樹脂、金又は白金を材料とするスペーサ。
     
    The spacer according to any one of claims 14 to 17,
    The spacer is a spacer made of synthetic resin, gold or platinum.
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JP2014512878A (en) * 2011-02-15 2014-05-29 ウェイブライト ゲーエムベーハー Apparatus and method for incising cornea of human eye with focused pulsed laser radiation
KR101529962B1 (en) * 2011-02-15 2015-06-18 웨이브라이트 게엠베하 Device and process for machining the cornea of a human eye with focused pulsed laser radiation

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