CN101198282A - Device for separating the epithelial layer from the surface of the cornea of eye - Google Patents

Abstract

A method of processing an eye of a patient for a corrective procedure including providing a separator having an edge, penetrating an epithelial layer of the eye of the patient with the edge. Moving the separator relative the eye of the patient. Separating at least a portion of the epithelial layer as the separator moves, wherein the at least a portion of the separated epithelial layer is rolled during the separating.

Description

Be used for from the equipment of the surface isolation epithelial layer of cornea

The reference of early stage submit applications

According to 35U.S.C. § 119 (e), the applicant requires U.S. Provisional Patent Application No.60/599, August 6 2004 applying date of 368 is as priority, it is above-mentioned that to apply for the aforementioned date submitted, and its full content is incorporated into this with for referencial use, present patent application is the U.S. Patent application No.10/971 that submitted on October 22nd, 2004 in addition, 727 part continuation application, it is the U.S. Patent application No.10/098 that submitted on March 12nd, 2002,167 part continuation application, it is the U.S. Patent application No.09/911 that submits to July 23 calendar year 2001,356 part continuation application, and the full content of each above-mentioned application is incorporated into this with for referencial use.

Background

LASIK (laser in situ keratomileusis) is a kind of dependent operation technique of people to glasses or contact lens that be used to reduce.Use excimer laser, LASIK forever changes the shape of cornea (clear covering of eyes front).The equipment that is known as microkeratome is used for cutting the flap of cornea.End at this flap stays hinge.Flap is folded back to expose substrate (mid portion of cornea).A part and flap from the pulse of computer controlled laser vaporization substrate are put back to original position.Importantly the scalpel that uses in LASIK operating period is sharp, otherwise the quality and the healing time of operation are undesirable.Scalpel is sharp in addition is in order to produce the reproducible flap of making peace.Figure 20 is the diagram that shows the perspective view of known blade 2000, and described blade can be used for the cutting that the LASIK operation relates to.

Some complication relevant with the use of microkeratome are arranged.Common complication comprises and produces irregular flap, half flap for example, buttonhole, or full cup (total cup).These complication are represented the irregular otch of cornea, and it is a kind of situation that can forever reduce visual performance.

Alternatively, the curvature that can be used to proofread and correct cornea than a kind of technology PRK (photorefractive keratectomy) of the more Zao development of LASIK.The doctor scrapes off the shallow top layer of cornea, for example epithelium in PRK.After removing shallow top layer, laser therapy is applied to the exposed surface of cornea.

Yet the defective of PRK is the healing stage of glasses and typically continues a week, and is more much longer than the healing stage of LASIK.And the patient is subjected to certain pain between healing stage.What typically disposable contact lens was used to cover cornea in PRK is reduced postoperative pain by area for treatment and help.

In another technology LASEK (laser epithelium keratomileusis), epithelial layer can be preserved separated epithelial layer from the surface isolation of cornea is feasible in one way.At first, epithelium is handled with part with alcoholic solution and is made its inactivation.In case determine the accurate zone of treatment, surface and permission that several Diluted Alcohol solution is applied to cornea contact several seconds with epithelium.Wash out this Diluted Alcohol solution then from the surface of eyes.The function of Diluted Alcohol solution is to loosen epithelial layer (50 microns) and allow it to be stripped from as flap in epithelium layer by hand-held scraper, the cornea below exposing thus.LASEK is a kind of operation that is difficult to carry out, and reason is that it needs skilled doctor to produce flap with a few minutes, avoids damaging cornea simultaneously.Because the doctor is executable operations manually, therefore the shape of the flap that produces between different operating can change.The LASEK process can not obscured with LASIK, and in fact LASIK uses the microkeratome apparatus to produce epithelium and the forward flap of the matrix organization of measuring Anywhere between the 130-180 micron.Thereby LASEK has avoided some complication of aforesaid LASIK, for example produces the irregular otch of irregular flap and cornea.Should be noted that so irregular otch can forever reduce visual performance, reason is that cornea is can quickly-healing and regenerated permanent tissue.

In LASEK, only epithelial layer is put back in the mode that is similar to LASIK, but only is made up of epithelium, and does not have corneal stroma.In case epithelial cell is placed to the next door, laser is applied to the surface of cornea in the mode identical with reality among the PRK.In case finish laser therapy, epithelial layer is put back to original position.Because epithelial layer also is not adhered to cornea, thus soft-contact lens be similar to be placed on the epithelial layer among the PRK and eyes on as sticking patch.Be placed on the area for treatment and can be by the epithelial cell of Diluted Alcohol solution part inactivation as the promotion thing of the new epithelium healing in below.Ethanol inactivation epithelium was similar to incrustation and comes off from eyes in 5-10 days.These inactivation epithelial cells do not become the new surface of eyes, but are used simply as protective agent except contact lens to promote the comfortable and healing of new below epithelium.The alcohol treatment of epithelium causes epithelial a large amount of damage, and this fact can cause the epithelium disk unavailable, and reason is that the globality/stability reduction of epithelium and/or durability and the adhesiveness on cornea reduce.Under our situation, it does not need the doctor to have a lot of experiences, in seconds produce flap automatically, and it is more importantly many.We use contact lens as sticking patch in epi-LASIK.

Our flap has more repeatability than LASEK, easier execution and producing in the shorter time.And we do not use ethanol, and well-known ethanol is deleterious for epithelium.

Thereby, needing a kind of automatic corneal epithelium separator, it is by substantially intactly or as a whole mechanically rather than by using chemicals-especially inactivation chemicals separation epithelial layer overcomes the above problems.In addition, need a kind of operation technique, it easily reproduces between the patient and can carry out with a small amount of technology at short notice.In addition, by having benefit not puncturing basically or do not carry out such separation under the situation of cutting angle membrane matrix basically.

Summary of the invention

Plant equipment is separated from the corneal stroma of patient's eye and is gone up leather material, simultaneously cutting angle membrane matrix and compare the damage that causes separated epithelium to be subjected to LASEK much smaller not basically.In separation after the cortex, on eyes, carry out medical care precess-for example use laser and help to proofread and correct defective in the cornea.Epithelial layer be put back into exposed cornea on to reduce recovery of vision phase and postoperative pain thereafter.

A first aspect of the present invention relates to a kind of piece-rate system, it comprises with respect to the horizontal plane with last plane surface and lower plane surface from the angle orientation of approximately-20 spending about 30 degree scopes, wherein go up a plane surface and lower plane surface angle separated from one another, this angular range is spent to about 90 more than 0 degree.Between last plane surface and the lower plane surface root face edge is arranged, wherein described at least root face edge comprises that a kind of structure is to separate the part of the epithelial layer of eyes from eye's cornea substrate, simultaneously do not damage the described part of epithelial layer basically, and can the cutting angle membrane matrix.

A second aspect of the present invention relates to a kind of separator that is used for the separated part of mobile eyes, it comprises upper surface with curved shape and with respect to the lower plane surface of upper surface with an angle orientation, wherein upper surface and lower plane surface limit the edge betwixt, and described edge has a kind of structure to remove the part of eyes.

A third aspect of the present invention is related to a kind of method that correct operation is handled patient's eyes, and it comprises provides the separator with edge, with described edge puncture the patient eyes epithelial layer and move separator with respect to patient's eyes.Described method further comprises at least a portion of separating described epithelial layer when separator moves, and wherein described at least a portion of separated epithelial layer is rolled between separation period.

A fourth aspect of the present invention is related to a kind of method that correct operation is handled patient's eyes, it comprises that the eye's cornea with respect to the patient moves separator and separates the epithelial layer that interrelates with cornea, wherein separated epithelial layer limits hinge on cornea, thereby the free end of epithelial layer pivots with near the eyebrow that is positioned at the patient around hinge.

A fifth aspect of the present invention is related to a kind of method that correct operation is handled patient's eyes, and it comprises that the described eye's cornea with respect to the patient moves separator and controls the distance that separator moves automatically.

A sixth aspect of the present invention relates to a kind of separator, and it comprises that upper surface and integral body are connected to the forward edge of upper surface and are positioned at the back at described edge and the back open and flat device (post-applanator) under the upper surface.

A seventh aspect of the present invention is related to a kind of method that correct operation is handled patient's eyes, and it comprises from the part of patient's eyes and separates epithelial layer with the part that exposes the eye's cornea substrate with in the described part of the open and flat cornea substrate of after separating.

The advantage that one or more above aspects provide is to have reduced the recovery of vision phase and/or the postoperative pain that interrelate with following operation, comprise remove epithelial layer, a part wherein or comprise the part epithelial layer but do not comprise substrate substantial portion (and can comprise the part of basement membrane, also can comprise the part of bowman's lamina) other " sticking patch? "

Description of drawings

Figure 1A is the diagram of the side view of demonstration eyes and the epithelium separation equipment that has the separator that is positioned at primary importance according to preferred implementation.

Figure 1B is the side view of the embodiment of the separator that uses of the epithelium separation equipment with Figure 1A.

Fig. 1 C is top view, the perspective diagram of the embodiment of the separator bearing that uses of the epithelium separation equipment with Figure 1A.

Fig. 2 is the diagram of the top view of demonstration eyes and the separator that is positioned at primary importance according to preferred implementation.

Fig. 3 is the diagram of the side view of demonstration eyes and the separator that is positioned at the second position according to preferred implementation.

Fig. 4 is the diagram of the top view of demonstration eyes and the separator that is positioned at the second position according to preferred implementation.

Fig. 5 is the diagram of the side view of demonstration eyes and the separator that is positioned at the 3rd position according to preferred implementation.

Fig. 6 is the diagram of the top view of demonstration eyes and the separator that is positioned at the 3rd position according to preferred implementation.

Fig. 7 is the diagram of the side view of demonstration eyes and the separator that is positioned at the 4th position according to preferred implementation.

Fig. 8 is the diagram of the top view of demonstration eyes and the separator that is positioned at the 4th position according to preferred implementation.

Fig. 9 is the diagram of top view that shows eyes and be positioned at the separator of the 5th position according to preferred implementation, separates littler disk thereby form with higher position, edge at the open and flat device than Fig. 1-8 with the edge at the described separator withdrawal of epithelium after separating and open and flat device.

Figure 10 is the diagram of the top view of the removed eyes of display separation device.

Figure 11 shows with the laser execution to melt the diagram of the top view of eyes afterwards.

Figure 12 is the diagram of the top view of eyes after the demonstration epithelium is put back on the eyes.

Figure 13 shows that epithelium stretches the diagram of the top view of eyes in place smoothly.

Figure 14 is the diagram that shows the eyes and the side view of the epithelium separation equipment that comprises rotary drum.

Figure 15 is the diagram that shows the eyes and the front view of the epithelium separation equipment that comprises rotary drum.

Figure 16 is the diagram that shows the eyes and the top view of the epithelium separation equipment that comprises rotary drum.

Figure 17 is the diagram that shows according to the drum of an embodiment.

Figure 18 is the diagram that shows according to the drum of another embodiment.

Figure 19 is the diagram of expression from the side view of the separator of eye's cornea surface removal epithelial layer.

Figure 20 is the diagram that shows the perspective view of known insert.

Figure 21 is the diagram of demonstration according to the side view of the leading edge of the separator of an embodiment.

Figure 22 is the diagram of demonstration according to the side view of the leading edge of the separator of another embodiment.

Figure 23 is the diagram of demonstration according to the side view of the leading edge of the separator of another embodiment.

Figure 24 A has shown the top perspective view according to second embodiment of epithelium separation equipment of the present invention.

Figure 24 B has shown the bottom perspective view of the epithelium separation equipment of Figure 24 A.

Figure 25 is the side view of the embodiment of the separator that uses of the epithelium separation equipment with Figure 24 A-B.

Figure 26 has shown the perspective view of the embodiment of the preventer that the epithelium separation equipment with Figure 1A-B and 24A-B uses.

Figure 27 has shown the top perspective view of the epithelium separation equipment of Figure 24 when the embodiment that utilizes at the open and flat device of primary importance.

Figure 28 has shown the top perspective view of the epithelium separation equipment of Figure 24 when the open and flat device of the Figure 27 that utilizes in the second position.

Figure 29 has shown the bottom perspective view of the epithelium separation equipment of Figure 24 when utilizing the open and flat device of Figure 27.

Figure 30 is the diagram of demonstration according to the side view of the separator of another embodiment.

Figure 31 A is the diagram of demonstration according to the side view of the separator of another embodiment.

Figure 31 B is the enlarged side view of a part of the leading edge of the separator shown in Figure 31 A.

Figure 31 C is the enlarged side view of a part of leading edge of another embodiment of separator.

Figure 31 D is the enlarged side view of a part of leading edge of another embodiment of separator.

Figure 31 E has schematically shown the separation process of using the separator of Figure 31 D, and wherein the zoomed-in view of the beginning of separation process and final stage also is shown.

Figure 32 A is the diagram of demonstration according to the side view of the separator of another embodiment.

Figure 32 B is the side view part of the separator shown in Figure 32 A, and wherein added size is shown.

Figure 33 is the diagram of perspective view of another embodiment of display separation device, and described separator adopts the form of line.

Figure 34 has shown the perspective view that is used to regulate the machine of separator according to an embodiment.

Figure 35 A has shown the front view of the machine of the Figure 34 that comprises separator.

Figure 35 B has schematically shown the side view of the machine of the Figure 34 that comprises separator.

Figure 36 has shown the side view of an embodiment of the separation equipment with two rotary drums.

Figure 37 has shown the top view of the separation equipment of Figure 36.

The specific embodiment

As the part of the process of the vision that is used to improve eyes 12, epithelium separation equipment 12 (as shown in Fig. 1-9) separates epithelial layer that is positioned in the cornea substrate 18 or at least a portion that goes up leather material 16.As it is defined to run through present patent application, cornea substrate 18 as shown in Figure 19 comprises corneal stroma 1910 at least and can comprise following one or more: basement membrane 1,900 1) bowman's lamina 1908 and 2), it will be described in present patent application subsequently in more detail.Therefore, be positioned on the corneal stroma or can carry out the various separation processes of describing about the present invention here not at described eyes the time when bowman's lamina and/or basement membrane when bowman's lamina and/or basement membrane.Under normal circumstances, separation occurs between two main stor(e)ies of basement membrane.For example (latter event LASEK) or during a kind of operation of describing about the present invention, typically takes place here in PRK for example when eyes before have been subjected to surface ablation operation.Similarly, and to small part (and also be because this reason owing to separate and can occur in different joints, although do not want to be attached to a kind of theory, because believing separation usually occurs between two main stor(e)ies of basement membrane as described below), when the application mentions isolating epithelium or epithelial layer or material, mean that bowman's lamina and/or basal lamina material can be connected to the there equally.

For example proofread and correct to carry out laser ablation although typically be used to prepare eyes, separation equipment 12 also can be used for other operation techniques, and for example lens insert.In ablation operation, the part of epithelial layer 16 is removed, and reason is that it has covered the eyes 10 gauged zones of needs and the doctor needs unhinderedly near this position.

The thickness of the separating part of epithelial layer 16 is preferably corresponding to the full-thickness of layer 16.Make separating part have more minimal thickness although may adjust separation equipment 12, this is not ideal for laser ablation operation yet, and reason is that the thin layer of epithelial layer 16 will still be stayed on the cornea and with needs and be removed to carry out laser ablation.In case correctly be adjusted, separation equipment 12 can be removed whole epithelial layer 16 during once passing cornea, and this will be described in this patent application subsequently.

Above-mentioned and the following separation process of describing about the present invention provides the several advantages that are better than LASIK and LASEK.For example, (for example LASEK) compares with the prior art of utilizing ethanol, and equipment 12 can not cause epithelial a large amount of losses of separating part in separation skin the time.Fully from corneal stroma under the removed situation, epithelial cell loses usually less than 5-10% at epithelial layer 16, and this has guaranteed that layer 16 can survive.So the low epithelial cell loss that equipment 12 is realized after being put back in the cornea substrate 18 has realized the epithelial layer 16 that more can survive.After carrying out laser ablation and being put back into epithelial layer 16 on corneal stroma or the bowman's lamina, compare the healing that this epithelial layer that more can survive 16 can improve eyes 10 with LASEK.

Compare with LASIK, the present invention does not remove any a large amount of corneal stroma material (not removing ideally) from cornea substrate 18.When being retained in when comparing in the LASIK operation with host material, as the LASEK sharp cutter, the present invention fails incision and remove the corneal stroma material and cause corneal stroma more mechanical intact.

Similarly, compare, fail to cut and remove the corneal stroma material and also have the irregular littler risk of the optics of generation with the LASIK operation.Compare with operation described here, the microkeratome that is used for LASIK is removed the flap comprise large stretch of corneal stroma, and described large stretch of corneal stroma is " permanent " tissue more, and is taken back to after melting on the flap of eyes 10.If microkeratome takes out to be different from and realizes melting/amount of the required corneal stroma of correct operation, then the patient has to be with forever and should damage lives or stand further correct operation (for example corneal transplantation).Thereby in sum, compare with the situation when at same eye cutting LASIK flap, before laser ablation, corneal stroma structurally more mechanical intact and after layer 16 is removed in operation of the present invention its optical property be not subjected to appreciable impact.

Another advantage of the present invention is that the error result that uses the present invention to cause does not have fearful in other operation methods (for example LASIK).As discussed previously, if LASIK operating period improperly corneal substrate have an operation, may cause permanent impaired vision or may need further operation.Just do not have serious problems if when use is of the present invention, occurred some problem by comparison in the separation at epithelial flap; On the contrary, the doctor can abandon flap and it simply and will grow once more in general a couple of days.

Other advantage of the present invention comprises the simplification of operation, the speed of operation and the fact that needs training of doctors still less than other technologies.

For example the separation equipment 12 ' shown in Figure 14-18 and Figure 35-36, some embodiments of 2700 comprise further advantages by additional keeper (for example drum 42 or thin film 2740).These keep epithelial layer 16 not destroy epithelial layer 16 simultaneously then and up to needs it are put back in the cornea substrate 18 from the separating part or the whole isolating epithelial layer 16 of the epithelial layer 16 of separator 14 reception disks 34 forms.Should be noted that in some embodiments keeper is also deposited part or all of separated epithelial layer 16 of disk 34 forms (although other shapes of separated epithelial layer also are possible) for example with hydrate matter and/or instrumentality quality guarantee.

Figure 1A has shown patient's eyes 10 and epithelium separation equipment 12.Epithelium separation equipment 12 comprises separator 14, this separator comprise separate bearing 28 with by the blunt edge 102 or the line that separate bearing 28 supports.Separator 14 structurally is designed such that when the edge of blunt edge 102 or line or the initial contact tissue layer of other isolating constructions (for example epithelial layer 16), with as suitable power and/or 6000Hz-15 for example, when the suitable vibration of 000Hz is applied to separator, separator 14 can separate (for example by promote) one or more organized layers (for example layer 16) and leave corneal stroma 1910, do not puncture simultaneously/entrance angle membrane matrix 1910 in.Should be noted that blunt edge 102 initially along the direction P side-to-side vibrations shown in Figure 1A and 2, amplitude range is 0.5mm-2mm, and more preferably 0.8mm-1.6mm or 1.25mm-1.6mm most preferably are 1.25mm.Also may be along the vibration of the direction M shown in Fig. 2 blunt edge 102.In either case, vibration blunt edge 102 makes its puncture epithelial layer 16 up to its contact cornea substrate 18 along direction X translation simultaneously.[the cornea substrate comprises basement membrane as previously defined], blunt edge 102 continued its side-to-side vibrationss and along the translational motion of direction X in this, made blunt edge 102 push layer 16 in the above described manner.Should be noted that it is that blunt edge 102 and separator 14 have the planar result of generation incision between two kinds of materials of different engineering propertiess (being epithelial layer 16 and cornea substrate 18) that epithelial layer 16 separates from cornea substrate 18.Cut the plane and may be located in 1) between epithelial layer 16 and the basement membrane 1900,2) in the basement membrane 1900,3) between basement membrane 1900 and the bowman's lamina 1908 and 4) between bowman's lamina 1908 and the corneal stroma 1910.Be not attached to a particular theory, it is believed that edge 102 carries out the separation of a part that comprises the fibriilar cornea substrate 18 of solid gum and apply distributed force at described point, thereby push epithelial layer 16 open from corneal stroma 1910.Should be noted that cutting the common major part in plane occurs in the basement membrane.

How understand about blunt edge 102 in this is helpful with epithelial layer 16 interactional several notions.At first, as run through defined in this application, thereby generate compression and shearing force to cause physical object along separating by cutting surperficial defined path on physical object by apply sharp-pointed orientation force on the cutting surface of cutting device, the action of cutting will be defined as physical object is separated into the action of two parts.The puncture of this and previously mentioned blunt edge 102 forms contrast, and wherein such puncture causes layer 16 to separate along the path that blunt edge 102 is limited.The ability that should be noted that edge cuts is relevant with the stress that the interaction in its surface by the edge and zone to be cut produces on zone to be cut.Because stress is inversely proportional to the surface area that applies power, therefore enlarges the area that contacts with corneal stroma 1910 and will reduce stress.Enlarged-area will prevent that the edge is cut fully, so the edge will be restricted to " blunt " or " stubbed " as defining among the application.For example, " sharp " edge 2002 of the prior art shown in Figure 20 can be converted to " blunt " or " stubbed " edge 102 by the machine 2500 that is applied to edge 2002 shown in Figure 33-34 and describe subsequently.Especially, thus machine 2500 at any one time the different piece of crooked initial edge form circular blunt edge.Figure 23 provided the example of this bending and shown circular blunt/sharp edges 2100 not " the area size greater than plate 15 ' " the area at tip.

Prevent that another probability of cutting from being to reduce the power that is applied to corneal stroma 1910.On general significance very, suppose that active force is into the vertical component of the power F that the plate 15 of angle θ orientation transmits, then active force has the size of Fsin θ.Thereby, select angle θ enough little (for example zero degree) will make the size of active force be reduced to such degree so that prevent cutting.In this case, plate 15 can have the rectangular lateral cross section, and wherein the flat base of plate 15 lies in that anterior corneal surface (θ=0 °) is gone up and the vertical side push layer 16 of far-end.Although the turning is " sharp " under base portion and the lateral crossing right angle that is limited, it does not become the angle is that any cutting force is applied to corneal stroma 1910.Thereby the turning is " blunt " or " stubbed " about the ability of its cutting angle membrane matrix 1910 effectively under the right angle.Should be noted that last angle is not the key factor of plate 15.Key is whether can overcome the resistance that separates that pressure that eyes produce and epithelial layer 16 produce by the power that plate 15 applies.When plate 15 overcame those power, edge 102 can separate epithelial layer 16 with effective and efficient manner and not relate to the cutting of corneal stroma 1910.Be not attached to any one theory, it is believed that the performed separation of the present invention relates to destruction with different confinement element or the power that are tied each other with entity integral body.This destruction causes different entities no longer to be connected to each other, and keeps the character and the integrity of different entities simultaneously.

Use above the analysis, if plate 15 has trapezoidal lateral cross section, its base portion lies on the anterior corneal surface and power is applied to the plate that is parallel to base portion, and the Cheng Jiao turning between the side of base portion and plate will be counted as " blunt " or " stubbed " aspect the cutting effectiveness.

During the previously mentioned pushing course that separation equipment 12 is carried out, separator 14 for example promotes epithelial layer 16 by blunt edge 102 at so-called engagement edge 19, and described engagement edge is the edge of the current layer 16 that contacts with edge 102.As shown in Figure 1A, 4,6,8 and 9, engagement edge 19 can be linear in shape.Blunt edge 102 promotes engagement edges 19 towards the outer rim 45 of tissue, and described outer rim limits the part of the external boundary that does not separate epithelial layer 16 and relatively is positioned with engagement edge as shown in Figure 1A, 4,6,8 and 9.As shown in Figure 19, blunt edge 102 forces engagement edge 19 to rise, from corneal stroma 1910 separate and when separator during along direction X translation the part along the top of plate 15 move.Should be noted that the stayed surface of the top of previously mentioned plate 15 as separated epithelial layer 16.Pushing course makes that blunt edge 102 can not entrance angle membrane matrix 1910 and after pushing course is finished, and compares with its original state, and organized layer is complete basically.Owing to do not use ethanol or other inactivation chemicals, during process of the present invention, be damaged epithelial quantity typically less than the epithelial quantity that is damaged that is subjected to the LASEK operation.

When pushing course finishes,, separator 14 still is attached to cornea substrate 18 than short distance organized layer to remove whole organized layer or to have moved thereby having moved enough distances.Under latter event, the separated part of epithelial layer 16 is connected to the remainder of epithelial layer 16 by the hinge H as shown in Fig. 9-11.As shown in Fig. 9 and 10, hinge is linear and is positioned at the solstics, moved with respect to its initial position along cornea at described solstics blunt edge 102 before beginning to separate.Should be noted that the decline for separated epithelial layer 16 still is connected to those situations of hinge H, the size that decline typically has is: along the maximum gauge of about 8.5mm-10mm of the orientation measurement that is parallel to the line that is limited by hinge HG and along with the maximum gauge of about 9mm of the vertical orientation measurement of direction that is parallel to the line that is limited by hinge H.

Under the situation of the separator shown in Figure 1B 14, separator comprises the separator bearing 28 of rectangular block A form.Should be noted that separator bearing 28 can be by many rigidity and sterilizable material (for example metal and plastics) manufacturing.Under the situation of plastics, material can be transparent, thereby the user can see the part of the eyes 10 under separator bearing 28.

Rectangular block A makes it can not be out of shape basically during separation process by the material manufacture with enough hardness.The example of acceptable material can be PMMA (polymethyl methacrylate), ceramic or known surgical instruments metal.Rectangular block A has the height of about 3mm, approximately length and the width range from about 2mm to 6mm of 12mm.The basal surface 47 of rectangular block A has the width w from about 2mm to the 6mm scope and is parallel to the length of about 12mm of leading edge 41 measurements.Should be noted that the bottom of rectangular block A is polished and/or scribble such as the such material of parylene so that reduce friction between bottom and the eyes.Certainly other shapes and the orientation of basal surface 47 and piece A are possible under the situation that does not break away from spirit of the present invention.For example, thus the bottom that might redesign piece A piece A can not contact cornea substrate 18.

As shown in Figure 1B, separator 14 also comprises the surface plate 15 in the one-tenth angle groove 17 that forms among the piece A (referring to Fig. 1 C) that is located at separator bearing 28.Groove preferably size is determined to be and has the height/thickness that corresponds essentially to plate 15 and the height/thickness h and the width of width, thereby restraining plate 15 moves along being parallel to the planar direction that comprises groove 17.If plate 15 is ideal along the motion of direction P (referring to Figure 1A and 2), then the width of groove can enlarge desired amount.

Should be noted that plate 15 can be by many substantially rigids and sterilizable material manufacturing, for example polymer, metal and plastics.Plate 15 is designed to light as much as possible, has simultaneously to avoid the character of vibrating and can promote epithelial layer 16 during separation process.The example of suitable material is PMMA, and wherein plate can have the quality of about 0.5g under these circumstances.Should be noted that plate 15 can be polished and/or scribble friction and reduce material (for example parylene) so that reduce friction between plate 15 and the eyes.

The thickness range that plate 15 has is about 100-400 μ m, more preferably 200-300 μ m, more preferably 250 μ m.Plate has the width of about 10mm.The thickness that the blunt edge 102 of plate 15 has can be from half varied in thickness of the individual cells of epithelial layer 16 to layer 16 gross thickness.Also might have thickness greater than the gross thickness of layer 16.More preferably, the blunt edge 102 of plate 15 has the thickness between two to three cellular layer thickness.15 one-tenth angle θ of plate extend, and described angle θ scope is 0 °-90 °, and more preferably 10 °-60 °, most preferably 20 °-40 °.Far-end at plate 15, blunt/sharp edges 102 is not formed when being designed so that proper some power that is subjected to explained later with vibration, and it will contact one or more organized layers to be removed, for example epithelial layer 16, do not thrust the corneal stroma 1910 that is positioned under the organized layer simultaneously.In other words, between the operating period of equipment 12, do not cut or excise such tissue to thrust corneal stroma 1910 in the operating period of epithelium separation equipment 12 thereby edge 102 is enough sharp.Thereby blunt edge 102 contrasts with before forming directly about the leading edge 2002 of the described blade 2000 of Figure 20, if because edge 2002 be sharp and be used for from corneal stroma 1910 stratum disjunctums 16 then may have the risk of cutting angle membrane matrix 1910.Should be noted that blunt edge 102 be after initial penetration will is by layer 16 with the part of the far-end of the plate 15 that during separation process subsequently, contacts with epithelial layer 16.Blunt edge 102 also comprises the adjacent part of the plate 15 that contacts with cornea substrate 18 with non-cutting mode.Thereby, plate 15 limits edges, and this edge all is blunt with respect to epithelial layer 16 (because it moving/basically can damaged layer 16 during separation process) and corneal stroma 1910 (owing to substrate can not damaged in the surface of the plate 15 of contact angle membrane matrix 1910 during separation process).

As shown in Figure 1A, separator bearing 28 and basal surface 35 initially are placed away from patient's eyes.As shown in Figure 1A-B and 2, the separator bearing 28 of separator 14 integrally with at the very blunt far-end 33 of very round (to avoid puncture or incised layer 16 during moving at it) in shape is connected by the throat area B, and described far-end is used as open and flat device and has triangular cross section.(certainly, other shapes of far-end 33 are possible).

Separator bearing 28 and basal surface 35 be along direction X translation, thereby basal surface 35 initially contacts with the outer surface of eyes in the inside position of the outer peripheral edges of as shown in Figure 3 epithelial layer 16.At such period of contact, far-end 33 and the basal surface 35 as open and flat device compresses the outer surface of epithelial layers 16 and the appropriate section of the cornea substrate 18 below it together.Such compression cause layer 16 from blunt edge 102 to far-end 33 41 relatively flats of leading edge at least, as shown in Fig. 3,5 and 7.Thereby the basal surface 35 of far-end 33 is as open and flat device.

The basal surface 35 that should be noted that far-end 33 needs polished as far as possible smoothly to reduce the probability of layers 16 structural intergrity during along the top translation of layer 16 when surface 35.In addition, near planar base surface 35 is in the expection angle that helps between separation period between maintenance edge 102 and the cornea.Basal surface 35 can scribble the friction reduce material (for example parylene) in case reduce the surface 35 and eyes between rub.Far-end 33 reduces need be by any open and flat device in back or piece A applied pressure.Should be noted that can carry out open and flat in each described embodiment here and/or the back open and flat or neither be performed.

The basal surface 35 of far-end 33 be basic horizontal so that with basal surface 47 levels (although can have small angle) and be enhanced and, make the basal surface 35 of far-end 33 at first contact the outermost layer cell (referring to Figure 19) of epithelial layer 16 with respect to blunt edge 102 skew.Basal surface 35 can have many shapes and be parallel to edge 102 extension and the width of scope from 1mm to 10mm with having.Especially, blunt edge 102 is approximately the distance, d of 300 μ m and the also segment distance of vertical shift scope from about 240 μ m to 300 μ m under basal surface 35 from the trailing edge laterally offset of basal surface 35.Should be noted that laterally offset is the not function of sharpness of edge.For example, edge 102 is more not sharp, and laterally offset d is big more.Originally laterally offset d is wide more, and edge 102 is pressed against on epithelium/cornea more.If so to such an extent as to original edge 102 very blunt it usually can not initial penetration will epithelial layer 16 when the beginning of process, then offset d can increase with increase pressure, thereby allows edge 102 puncture epithelial layers 16.Similarly, if making, the dullness at edge 102 only need light pressure to be applied to edge 102 to allow its puncture epithelial layer 16 then offset d can reduce.

As shown in fig. 1, separation equipment 12 comprises by the annular ring 20 that can sterilize and rigid material (metal that for example comprises titanium) is made.Ring 20 is supported on and is connected on the shell 21, and described shell limits goes up circular open 23 and end circular open 25.Upper shed 23 has the corresponding diameter of internal diameter with ring 20.Bottom opening 25 is limited by outer wall 27, and wherein bottom opening has the diameter of scope from 16mm to 21mm.The bottom bend of outer wall 27 is with the outer radius of the curvature of the part of coupling eyes 10.In alternative, outer wall 27 can tilt rather than be crooked, and this depends on the diameter of outer wall 27.Shell 21 be by can sterilizing and rigid material (for example being used to encircle 20 material) is made, and has the height that need be fitted on the eyes, therefore based on the diameter of wall 27 be used for the average anatomical data of eyes.As shown in Figure 1A and 2, the bottom of outer wall 27 is placed on the outer surface of eyes 10, thereby the top surface 31 of shell 21 is parallel to the limbus of corneae of eyes 10.The bottom of outer wall 27 and top surface 31 can tilt slightly the better adaptive of some individual eyes to be provided and to avoid allowing the bottom of outer wall 27 be cut into cornea substrate 18.Therefore, the ring 20 of epithelium separation equipment 12 is positioned on the eyes 10, and its plane also is arranged essentially parallel to the limbus of corneae of eyes 10.As shown in Figure 2, ring 20 limit diameter ranges from about inner periphery of 10 to about 12mm 22 and diameter range from about 13 to about 16mm and comprise the excircle 24 of groove 26 (among Figure 15 the most as seen).Groove 26 sizes are determined to be the diameter of being wider than inner periphery 22, and this diameter is called as internal diameter thereafter.Being formed at open component 37 among the rectangular block A of separator bearing 28 is fitted snugly in the groove 26 and slides therein to carry separator 14 on the linear mobile route of determining.Similarly groove/open component structure is used for the epithelium separation equipment 400 of Figure 24 A-B and 25.

As shown in Figure 1A-B, separator bearing 28 and plate 15 are connected to sports equipment, for example 1) edge 102 is applied the vibratory equipment 30 of linear and oscillating movement, or 2) linear motion devices.Under the situation of vibratory equipment 30, equipment 30 is along line generative power on plate 15 of the power F that is positioned at a plane, and extend with the planes overlapping ground that extends along the length of groove 17 and plate 15 on described plane, thereby plate 15 moves in groove 17 smoothly.The separator 14 that power F preferably causes by vibratory equipment 30 generates along the translational motion of direction X.

Vibratory equipment 30 is preferably along the direction P oscillating plate 15 shown in Figure 1A, simultaneously along direction X translation plates 15.For such vibration, groove to the width of piece A can be widened desired amount and vibratory equipment 30 and be changed and make that plate 15 can be along direction P free vibration (this knows for a person skilled in the art easily).From 0.5mm to 2mm, more preferably 0.8mm to 1.6mm, most preferably is 1.25mm to 1.6mm or 1.25mm along the amplitude range of frequency range from about 10Hz to about 10KHz and this vibration of the vibration of direction P.This vibration helps to allow edge 102 from corneal stroma 1910 stratum disjunctums 16.Should be noted that replacement direction P or vibrate except direction P can be along direction M.

Electromagnetism on the plate 15 or piezoelectric forces can provide vibration, and perhaps outside rotation or vibration string line can provide vibration.For example, an end of axle can be connected to motor, and described motor makes axle around the axis rotation that is parallel to axle self.The string of a musical instrument is connected to the other end of axle and is rotated in one way by rotating shaft, and described mode is used in the microkeratome that the RefractiveTechnologies in joslyn hi-voltage city company limited is sold with trade mark FlapMaker.

In another embodiment, two separate motors are arranged in vibratory equipment 30.That is to say that vibratory equipment 30 is connected to separator bearing 28 comprises the separator bearing 28 of far-end 33 and blunt end 102 with generation constant point-to-point speed independently by first motor; Towards the center constant speed scope of eyes 10 from about 0.8 to 3mm/s, preferably from about 1.2 to 2mm/s, most preferably about 1.5 or 1.6mm/s.Second motor of the end of the most close plate 15 is connected to plate 15 to vibrate it along direction M.Therefore, when first motor during along direction X translation, the plate 15 of second motor and connection (with the whole bearing 14 that is connected to plate 15) is along direction X translation.Certainly, separation equipment can be used for translation ground mobile support saddle 28 rather than vibratory equipment 30.

To be power F be applied to layers 16 by edge 102 along the longitudinal length of plate 15 and groove 17 for the vibration and the net effect of translational motion.Ideally, the horizontal component of the power F of the upward force of the pressure generation in the vertical component of the power F of the generation counteracting eyes and generation is offset the horizontal frictional force that epithelial layer 16 is generated.The horizontal component of power F and the counteracting of frictional force cause separator to move with constant speed.

Remain on the eyes 10 in order for example during vibration and translation, to encircle 20, be drained by the peripheral groove 32 on the side that is positioned at eyes 10 thereby shell 21 and ring 20 are fitted snugly into the air that forms in sealing and the inner chamber 39 on the eyes 10.Thereby the air that suction can be applied in peripheral groove 32 chambeies 39 is drained to guarantee the ring 20 stable eyes 10 that are installed to.Pressure below atmospheric pressure scope in the evacuation chamber 39 is from 300mmHg to 700mmHg.

Fig. 3 and 4 shows eyes 10 respectively and is positioned at the side-looking of separator 14 of the second position and the diagram of top view with respect to eyes.This second position is represented eyes 10 and edge 102 and 33 both initial moment that contact of far-end.In this position, plate 15 and edge 102 initially move to allow edge 102 pierce through epithelial layer 16 along direction X along direction P vibration and separator bearing 28.As discussed previously, when separator 14 moves with contact during eyes 10, the part of epithelial layer 16 and its corresponding corneal stroma 18 are down flattened by the open and flat device that the edge 41 and the basal surface 35 of far-end 33 limited.Simultaneously, blunt edge 102 beginning push layer 16.This promotion causes layer 16 center towards eyes to be pushed.

Cross moving of cornea in order to adapt to previously mentioned separator 14, separator bearing 28 can have open component, the open component 37 of Figure 15 for example, and described open component engagement is formed at the corresponding cunette groove in the ring 20, for example groove 26 of Figure 15.Separator bearing 28 is connected to equipment 30, makes bearing 28 be free to slide in groove 26 thereby vibratory equipment 30 promotes separator bearing 28.Thereby plate 15 and edge 33 pass through vibratory equipment 30 translations along direction M.

Fig. 5 and 6 shows eyes 10 and the side-looking of separator 14 and the diagram of top view that is positioned at the 3rd position.When separator 14 when cornea 10 moves, the blunt edge 102 of separator 14 separates epithelial layers 16 and does not puncture or cut cornea 18.The edge 41 of far-end 33 and basal surface 35 continue the part of open and flat epithelial layer 16.During cornea substrate 18 under basal surface 47 contact is positioned at the separated part of epithelial layer, provide further open and flat.When separator 14 crossed cornea, the open and flat fact of progressively being carried out by basal surface 47 owing to more basal surface 47 contact cornea substrates 18 increased, and epithelial layer 16 separates from cornea.In application this progressively increases and is considered to cause intraocular pressure progressively to increase.This increase of intraocular pressure has effect for complete isolating realization, because the increase of intraocular pressure can compensate different angular dependences (referring to Figure 31 E) between separator and the free cornea in isolating beginning and when finishing.Be not subject to any particular theory, the pressure that it is believed that increase is pressed against cornea on the edge and prevents near the eyes end that when separation process finishes separator from extending through epithelial layer 16, and it is terminal relative that described end and separation process begin to locate.

More specifically, Figure 19 is the diagram of the enlarged side view of display plate 15 and the blunt edge 102 of removing epithelial layer 16 from the corneal stroma 1910 of eyes 10 thereof.Epithelial layer 16 is made up of epithelial cell 1902.Epithelial layer 16 covers basement membrane 1900.Basement membrane 1900 is formed by epithelium basal cell 1922 (epithelial cell in the base portion/bottom of epithelial layer 16).When epithelium basal cell 1922 growths, basement membrane 1900 is also grown.Basement membrane 1900 is formed by the dense plates 1904 of about 50nm thickness and lower floor's lamella lucida 1906 of about 25nm thickness.Dense plates 1906 covers bowman's lamina 1908.Epithelial layer 16 anchors to bowman's lamina 1908 by the composite web with interactional anchoring fiber of the collagen fiber of dense plates 1904 and bowman's lamina 1908 (VII Collagen Type VI) and anchoring speckle (VI Collagen Type VI).Bowman's lamina 1908 cone of coverage membrane matrixs 1910.

Epithelial layer 16 is had the layer of 5-6 epithelial cell 1902 by stratification.Epithelial layer 16 typically thickness is approximately the 50-60 micron.Adjacent epithelial cell 1902 is kept together by desmosome 1912.Epithelial cell 1902 remains to lower floor's basement membrane 1900 by hemi desmosome 1914 and anchoring filament.The basal surface of epithelial layer 16 comprises many microvilluss and little pleat, i.e. ridge, its glycocalyx and precorneal tear film interact and help it stable.New epithelial cell 1902 is derived from the mitosis activity in 1900 layers of the basement membranes.Newly epithelial cell 1902 shallow tables ground and the existing cell of dislocation centripetally.

As mentioned above, plate 15 comprises that blunt leading edge 102 is to promote epithelial cell 1902 when plate 15 and blunt edge 102 are mobile under epithelial layer 16.Plate 16 preferably promotes epithelial cell 1902 and can not apply to destroy the power that iuntercellular connects (for example desmosome 1912).Therefore, plate 15 can become to separate en bloc epithelial layer 16 and cutting angle membrane matrix 1910 not basically, thereby it can be moved back into and rely on structural its prime area, keeps in case the laser ablation process is finished described prime area, and this will be described below.Should be noted that and have been found that the point that separates epithelial layer 16 usually appears at the boundary between dense plates 1904 and the lamella lucida 1906.In other cases, basement membrane 1900 and/or can still be connected to the separated part of epithelial layer 16 from some fragments of bowman's lamina 1908 or part.Under situation further, thickness can be removed less than the part of the epithelial layer of the gross thickness of epithelial layer.Yet it is unfavorable that such part as discussed previously is removed in carrying out the present invention.Plate 15 preferably promotes two to three bottoms of epithelial cell 1902, and described bottom may comprise most of shear strength of epithelial layer 16.

Fig. 7 and 8 shows eyes 10 and the side-looking of separator 14 and the diagram of top view that is positioned at the 4th position.In one embodiment, the mobile of separator 14 is controlled, thereby forms the border circular areas of separated epithelial layer 16, and described zone and limbus of corneae or pupil are concentric, and (pupil is not usually at the center of cornea; In many eyes, can exist eccentric a little).Separator 14 and blunt edge 102 thereof mobile is arranged to make blunt edge 102 to stop in desired location, for example just before forming circular layer 16.Thisly stop at the part of separated layer 16 and also produce the twisting zone between the part of cornea substrate 18 isolating layers 16.In this stage, the separated part of layer 16 has " D " shape, and wherein the straight portion of " D " is more much smaller than the height of " D " certainly.For example, during the final stage that progressively moves shown in Fig. 1-8, separator 14 stopped to move with the moment of blunt edge 102 before will separating disk fully, thereby formed the D shape epithelium disk 34 be connected to as shown in Figure 8 at the hinge at the edge 36 that is positioned at layer 16 of the left part of eyes.In another embodiment, epithelium disk 34 is for example as described below fully from corneal stroma 1910 separately.Should be noted that D shape epithelium disk 34 or distinct disk can be shaped to form the capsule bag of admitting lens.

Should be noted that above removal process can be closed with the handheld wiper knife tackle of lifting/manipulation layer 16 carries out.Hand-held scraper is similar to formerly the hand-held scraper that LASEK operating period of describing uses.In addition, whole removal process is mechanical, and reason is there is not chemicals, and (for example ethanol) is used for interacting with epithelial layer 16 and loosening epithelial layer 16.Should be noted that several salt water droplets can be applied to separation equipment and make salt water droplet and edge 102 and eyes interact, thereby layer can not adhere to surface 2204 during separation process.The salt water droplet will never and epithelial layer 16 interact to loosen the connection between epithelial layer 16 and the cornea substrate 18.

Fig. 9 is the diagram that shows the eyes 10 and the top view of the separator 14 that is positioned at retracted position after forming epithelium disk 34.In this embodiment of separator 14, open and flat device and blunt edge 102 are formed at the position higher than the open and flat device of Fig. 1-8 and blunt edge 102 with respect to the surface 31 of Figure 1A.Thereby open and flat device and blunt edge 14 are along the plane contact eyes on the summit that is positioned at more close eyes.Thereby, the cross-sectional area of the eyes that higher plane is transversal on area less than those cross-sectional areas that form by the plane of lower position more.Thereby epithelium disk 36 littler when open and flat device and edge are formed at high position more is separated.Should be noted that and separate the diameter that diameter represents to peel off the part of epithelial cornea substrate 18.Thereby, in the above example that provides, separate diameter and equal with cornea substrate 18 with by the diameter of blunt edge 102 along the corresponding cardinal principle border circular areas of planar intersection point that moving direction limited.

After separator 14 withdrawals, close to the suction of peripheral groove 32 and from eyes 10 and remove epithelium separation equipment 12.Also with reference to Figure 10, after removing epithelium separation equipment 12, expose dark epithelium and form zone 38, described zone corresponds essentially to the shape and the size in the zone that separator 14 contacts with edge 33 during moving.At epithelial layer this point from the surface isolation of cornea, the doctor can carry out operation on exposed region.For example the doctor can arrive zone 38 with the laser ablation pooled applications according to laser manufacturer.

Figure 11 shown dark epithelium form carry out laser ablation on the zone 38 after the top view of eyes of Figure 10.Laser ablation forms radiation areas 40 on eyes 10.With reference to Figure 12, thereafter, epithelium disk 34 is taken back on the remainder of cornea substrate 18 of eyes 10 to help agglutination.Should be noted that and put back to the known scraper execution that epithelium disk 34 can be generally used for handling the LASIK flap by use.Scraper also can be used for promoting and/or handling epithelial layer 16 during separation process.With reference to Figure 13, in case be put back on the remainder of cornea substrate 18, epithelium disk 34 is preferred by being stretched in place smoothly such as the so known surgical instruments of mechanical hand, scraper, tweezers or sponge.It is in place that macroscopical globality of epithelium disk 34 allows epithelium disk 34 easily to be handled.Because epithelial layer also is not adhered to cornea, therefore with PRK in the same soft-contact lens be placed on the epithelial layer and eyes on to be used as sticking patch.Compare with the situation when melting of eyes as among the PRK 10 partly allowed exposure, the epithelium disk of putting back to 34 allows more painless recovery, and reason is that the NE of eyes 10 is covered by epithelium disk 34.When the stylish epithelial cell of cell death of epithelium disk 34 is being grown under the epithelium disk of putting back to 34.Separated epithelium disk 34 was typically replaced by new cell in about 3-6 days fully.

Figure 21 is the side view that shows an embodiment of the leading edge 2100 that can use with plate 15 '.Plate 15 ' structurally is similar to the plate 15 of Fig. 1-9, and difference is its use leading edge 2100.Plate 15 ' is supported by separator bearing 28, thereby plate 15 ' and separator bearing 28 limit another embodiment of separator to replace the separator 14 of Fig. 1.Plate 15 ' with before moved by vibratory equipment 30 about the described plate 15 similar modes of Fig. 1-9.During the removal of epithelial layer 16, surface, the baseplane of plate 15 ' 3000 corneas contiguous and that be parallel under basement membrane 1900 are positioned, and flat leading edge 2100 contact layers 16.Can use such orientation to avoid cutting angle membrane matrix 1910.Therefore, plane leading edge 2100, top surface 3002 and basal surface 3000 can be counted as limiting blunt edge about epithelial layer 16 and substrate together, because do not have essence damage and substrate to be without damage when epithelial layer 16 moves during the moving of basal surface 3000 and leading edge 2100.Basal surface 3000 is as open and flat device when leading edge 2100 moves with removal/stratum disjunctum 16 a part of.Top surface 3002 can be positioned on the described stayed surface at separated epithelial layer 16 during the separation process as stayed surface.The leading edge 2100 of separator 14 should not have such width w, to such an extent as to it will increase the chance that edge 2100 penetrates epithelial layer 16 to this width too greatly.Leading edge 2100 preferably includes the width w of from 5 to 25 microns of scopes, and more preferably about 15 microns width w is although it can be greater than 50 microns.Should be noted that the embodiment of Figure 21 is better than the embodiment of Figure 22, reason is the end that does not need the rounding separator.

Figure 22 be show can with plate 15 " side view of second embodiment of the leading edge 2100 ' used.Plate 15 " structurally be similar to the plate 15 of Fig. 1-9, difference is the part that its uses leading edge 2100 ' to separate epithelial layer.Plate 15 " support by separator bearing 28, thereby plate 15 " and separator bearing 28 limit the separator 14 of another embodiment of separators with replacement Fig. 1.Plate 15 " with before moved by vibratory equipment 30 about the described plate 15 similar modes of Fig. 1-9.During the removal of epithelial layer 16, plate 15 " surface, baseplane 3000 ' cornea contiguous and that be roughly parallel under basement membrane 1900 be positioned and leading edge 2100 ' contact layer 16.Therefore, leading edge 2100 ', top surface 3002 ' and basal surface 3000 ' can be counted as limiting blunt edge about epithelial layer 16 and substrate together, because do not have essence damage and substrate to be without damage when epithelial layer 16 moves during the moving of basal surface 3000 ' and leading edge 2100 '.Leading edge 2100 ' be the circle and non-flat.Leading edge 2100 ' has the leading edge 2100 similar width w with Figure 21.Leading edge 2100 ' has such radius of curvature r, and this radius of curvature has scope from 1 micron to 20 microns or the value of the only about half of thickness at edge 2100 '.

When leading edge 2100 ' moves when removing layer 16 basal surface 3000 ' as the open and flat device in back.Should be noted that the term that is used for present embodiment and other embodiments described here " the open and flat device in back " and " back is open and flat " about a kind of situation, in this case separator comprise open and flat after edge separation epithelial layer 16 surface of the remainder of the corneal stroma 18 of existence.The open and flat device in this back provides several advantages.For example, the open and flat device in back is presented as single part, and therefore comparing it with many parts assembly has unconspicuous tolerance aspect eye location.Second advantage is that the open and flat device in back contacts with the remainder rather than the epithelium of cornea substrate 18, so guaranteed the constant relationship between the remainder of edge 2100 ' and cornea substrate 18.This second advantage is former, and not experience in the eyes of operative treatment be significant.Especially, between the patient variation of epithelial layer thickness greater than the variation of the cornea size of same patient.This variation of epithelial thickness can cause influencing the localized preceding open and flat device at edge 2100 ', and then open and flat device will be to the almost not influence of location at edge 2100 '.Said process provides with embodiment can be with the easily multiple safe separating process of consistent mode.

Should be noted that plane surface 3000 ' can become the angle to be similar to the mode shown in Figure 1A.In the smooth orientation of Figure 22 or become in the angular range, by plate 15 " power that applies can overcome the resistance that separates that pressure that eyes produce and epithelial layer 16 produce.

Figure 23 be show can with plate 15 " ' leading edge 2100 used " and the diagram of side view of the 3rd embodiment.Plate 15 " ' structurally be similar to the plate 15 of Fig. 1-9, difference is that its uses leading edge 2100 ".Plate 15 ' " support by separator bearing 28, thereby plate 15 " ' and separator bearing 28 limit the separator 14 of another embodiment of separators with replacement Fig. 1.Plate 15 ' " with before moved by vibratory equipment 30 about the described plate 15 similar modes of Fig. 1-9.During the removal of epithelial layer 16, plate 15 ' " surface, baseplane 3000 " cornea contiguous and that be parallel under basement membrane 1900 is positioned, and leading edge 2100 " contact layer 16.Can use such orientation to avoid cutting angle membrane matrix 1910.Therefore, leading edge 2100 " and basal surface 3000 " can be counted as together limiting blunt edge about epithelial layer 16 and substrate because at basal surface 3000 " and leading edge 2100 " move during epithelial layer 16 do not have essence to damage when moving and substrate is without damage.Leading edge 2100 " for example the leading edge 2002 by the blade 2000 shown in crooked Figure 20 be configured.Leading edge 2100 " preferably include the diameter of about 5-25 micron, the perhaps about radius of 2-13 micron, and more preferably comprise 15 microns diameter.When leading edge 2100 " move when removing layer 16 basal surface 3000 " as the open and flat device in back.Top surface 3002 " as stayed surface, can be positioned on the described stayed surface at separated epithelial layer 16 during the separation process.Should be noted that leading edge can become the angle with respect to corneal stroma with basal surface.

Figure 24 A-B and 25 has shown second embodiment of epithelium separation equipment 4000.Epithelium separation equipment 4000 comprises the shell of being made by rigid material (for example metal) 4002.Shell 4002 limits the whole each other track that connects 4004 and drives coupling 4006.Track 4004 is limited by plane surface 4008 and two vertical sidewalls 4010 and 4012, and the distance of described vertical sidewall each interval is approximately 12mm to 16mm, and more preferably 13mm most preferably is 14mm to 15mm.The circular open 4014 that has the diameter of about 11mm at an end of track 4004 is formed in the surface 4008.On the end on surface 4008, forming diameter is the annulus 4011 of 19mm, and this annulus is placed in the middle around opening 4014.Sleeve 4011 is by with surperficial 4008 identical materials manufacturings and integrally be attached thereto.Have seven arc-shaped protrusions 4016 as shown in Figure 23 B in sleeve 4001, described projection is extended from the bottom on surface 4008.Projection 4016 length are identical, be spaced apart to equal angles each other and around opening 4014 placed in the middle.Each projection 4016 has the inclination free end, thereby described inclination free end is bent the outer curvature radius of coupling eyes 10 parts when the contact cornea.Projection 4016 is carried out following function: 1) keep conjunctiva in place and 2) vacuum equably distributes in the circumference of sleeve 4011.Conjunctiva is the tissue that is similar to thin film, and it covers eyes in the part that sleeve 4011 connects.Conjunctiva can become flexible sometimes in some way, so conjunctiva raises when applying vacuum in sleeve 4011.It can arrive suction ports (manage 4034 there and enter the suction ring) and stop up it if it raises in the suction ring.Vacuum will ring distributes and entire equipment will be unstable on eyes around aspirating unevenly under described situation.

Equipment 4000 comprises the separator 4018 as shown in Figure 24-25.Other separators can be used in the equipment 4000 to replace separator 4018.For example, the separator 14 of Fig. 1-9, Figure 21-23 comprises plate 15 ', 15 " and 15 " ' separator bearing 28 and the separator 14 ' and 14 of Figure 30-31 " can be used in the equipment 4000.As shown in Figure 25, separator 4018 is included in the blunt leading edge 2100 of the end formation of plane surface 2200 and 2210 " '.Plane surface 2200 separates certain number of degrees each other angulately with 2202, and this number of degrees scope is the 0-90 degree, preferred 10-60 degree, preferably approximately 10-30 degree.Surface, baseplane 2202 with respect to planar bottom surface 2210 with 20-60 degree scope, preferably approximately 26 the degree be directed (width along moving direction is approximately 300 μ m) and have the length d of about 1.5mm.Leading edge 2100 ' " push layer 16, and basal surface 2210 flattens eyes as open and flat device and when separator 14 moves.Because leading edge 2100 " and surface 2200,2202 and 2210 significantly do not destroy epithelial layer 16 and during separation process, can not damage or cut substrate, so leading edge 2100 " ', surface 2210 and surperficial 2200 and 2202 can jointly be counted as blunt edge to small part.In addition, surface 2200 can be as stayed surface to be used for supporting separated epithelial layer during separation process.

Separator 4018 is positioned in the metallic retainer 4020, and described keeper comprises: the 1) planar support surface 4022,2 of sliding on surface 4008) U-shaped sidewall 4024 and 3) top surface 4026 can pivot.Stayed surface 4022 comprises the parallel bottom side open component of the open component 37 that is similar to Figure 15, and described open component engages the corresponding cunette groove that is formed at the groove that is similar to Figure 15 26 in the sidewall 4010,4012.When top surface 4026 is pivoted to open position, separator 4018 slides in the chamber that is limited by keeper 4020, thereby rectangular recess 4027 is snugly engaged by the rectangle open component (not shown) on the top that is formed at surface 4022 and the leading edge of separator 4018 extends to outside the keeper 4020.In case be properly oriented, top surface 4026 is pivoted to the closed position, and wherein top surface 4026 is positioned on the top surface of separator 4018 just.Then, in case screw 4028 separators 4018 of fastening top surface 4026 are held in place, described screw thread is engaged on the opening that the main body that is arranged in the keeper 4020 of closing under the top surface 4026 forms.The action that is threaded like this causes the top surface of the basal surface engagement separator 4018 on surface 4026, therefore separator 4018 is trapped in the keeper 4020.

Separator 4018 is designed to contact and removes epithelial layer 16 and do not make otch at the cornea tissue that is arranged under the epithelium.Separator 4018 is removed epithelial layer 16 on the corneal stroma 1910 that is positioned at eyes 10 to be similar to before about the separator 14 described modes of Fig. 1-9.The operating period of epithelium separation equipment 4000 separator 4018 enough not sharp with the excision cornea tissue.

As shown in Figure 24 A, separator 4018 is connected to vibratory equipment 4030 by bar 4032, and an end of described bar is connected to the rear portion of keeper 4020.The other end of bar 4032 passes to be formed at and drives the opening in the coupling 4006 and directly be connected to vibratory equipment 4030.The other end limit stop of bar 4032, this stop limits bar 4032 can be with respect to the distance of coupling 4006 translations.When block engaged the part of the driving coupling 4006 that limits opening, the leading edge of separator 4018 was just passed through the opening of the end 4034 of the most close equipment 4000.Vibratory equipment 4030 is generation power on the separator 4018 that is parallel to surface 4008.

In operation, sleeve 4011 and projection 4016 are placed on the outer surface of eyes 10 forming sealing, thereby surface 4008 is parallel to the limbus of corneae of eyes 10.In order for example during vibrating sleeve 4011 to be remained on the eyes 10, the air in the inner chamber is drained by the outlet 4034 on the side that is positioned at eyes 10.Suction can be employed by exporting 4034, thereby the air in the chamber 39 is drained to guarantee that sleeve 4011 stably is installed to eyes 10.

Should be noted that the equipment of having described the equipment that is similar to 4000 in U.S. Patent Application Publication No.2005/0055041A1, the full content of this application is incorporated into this with for referencial use.

Should be noted that known applications suction can cause tissue (for example conjunctival tissue) thereby block and export 4034 from the eyes displacement.In order to overcome this problem, use C shape preventer 5000 as shown in Figure 26.Preventer 5000 is made by elastomeric material (for example can sterilize metal or duroplasts), and the diameter that has is a bit larger tham the internal diameter of sleeve 4011.Thereby when preventer 5000 was placed on the intracavity that is limited by sleeve 4011, the bottom 5002 of preventer 5000 sealed to produce with the bottom of the mode coupling spool 4011 of spring-like.The top 5004 of preventer is being annular in shape and is inwardly concaving slightly with respect to the outside of bottom 5002.Top 5004 has several rectangular apertures 5006 of formation, and described rectangular aperture limits a plurality of arc preventers 5008.When preventer 5000 was inserted in the sleeve 4010, one of preventer 5008 was positioned in the front of outlet 4034.In operation, preventer 5000 allows to carry out suction by the passage that is limited by recessed top 5004, sleeve 4011 and opening 5006.Tissue is tackled/stopped to preventer 5008 before tissue stops up outlet 4034.Should be noted that preventer 5000 can be in a similar fashion uses with the equipment of Fig. 1.

In case equipment 4000 is positioned on the eyes, vibratory equipment 4030 was operated to provide translational motion and vibration to separator 4018 about vibratory equipment 30 described modes to be similar to before.In addition, epithelial layer 16 before is removed about the described mode of the equipment of Fig. 3-8 and does not cut cornea 18 to be similar to.Should be noted that the open and flat of cornea 10 carried out separately by separator 4018, might be open and flat by utilizing open and flat device 6000 of metal and open and flat device 4018 to carry out with serial mode, the open and flat device of described metal is connected to and is placed on the front of keeper 4020 as shown in Figure 27-29.Therefore, in operation cornea is at first open and flat by open and flat device 6000, and separated then device 4018 backs are open and flat, simultaneously the part of layer 16 with aforementioned manner separated/remove.

Should be noted that formerly and in described subsequently all embodiments, still can realize the separation of epithelial layer 16 and open and flat before or after not using.

Open and flat device 6000 has along the width of about 2mm of direction X measurement.As shown in Figure 29, the bottom of open and flat device 6000 is by rounding and polishing.As shown in Figure 27 and 28, open and flat device 6000 has the shape of " H " and has crooked vertical component 6002, thereby the end of part 6002 fits in the cunette groove of previously mentioned sidewall 4010,4012 and slides therein.The open component 6004 that should be noted that stayed surface 4022 extends towards part 6002, thereby when metallic retainer 4020 moved forward, open component engaged vertical component 6002 and promotes open and flat device 6000 equally.Yet when stayed surface 4022 was withdrawn in opposite direction, open and flat device 6000 did not move, and did not therefore withdraw.

In operation, cornea is at first open and flat by open and flat device 6000, and separated then device 4018 backs are open and flat, and layer 16 is removed in previous described mode simultaneously.Open and flat device flattens eyes before blunt edge arrives eyes.Should be noted that thereby open and flat device 6000 can be suitable for operating to be similar to above-mentioned mode with the equipment use shown in Fig. 1.As discussed previously, so back open and flat advantage that provides be compare with many parts assembly do not have remarkable tolerance and to edge 2100 " almost not influence of location.

After layer 16 was removed, separator 4018 was contracted to be similar to the mode shown in Fig. 9.After separator 4018 was contracted, suction is closed and epithelium separation equipment 4000 is removed from eyes 10.After epithelium separation equipment 4000 was removed, for example the dark epithelium shown in Figure 10 formed the zone and 38 is exposed, and described zone is corresponding to the shape and the size in the zone of separator 4018 contacts during moving.

Then, carry out the laser ablation of exposed region on eyes 10, to form radiation areas 40 as shown in Figure 11.With reference to Figure 12, thereafter, epithelium disk 34 is taken back on the remainder of cornea substrate 18 of eyes 10 to help agglutination.With reference to Figure 13, in case be put back on the remainder of cornea substrate 18, epithelium disk 34 is preferably stretched in place smoothly.Should be noted that to use before and remove disk 34 about the described equipment of Figure 14-18.

Figure 30 has shown the side view of second embodiment of the separator 4018 ' of the separator 4018 (referring to Figure 25) in the epithelium separation equipment 4000 that can replace Figure 24 A-B.Especially, separator 4018 ' may slide in the chamber that is limited by keeper 4020, thereby rectangular recess 4027 is snugly meshed by the rectangle open component (not shown) on the top that is formed at surface 4022 and the leading edge 2100 ' of separator 4018 ' stretches out.Also can predict separator 4018 ' and can replace the separator 14 and the far-end 33 of the epithelium equipment 12 of Fig. 1-9.The blunt leading edge 2100 ' of separator 4018 ' forms by rounding and at the end of plane surface 2200 ' and 2202 ', and described plane surface separates certain number of degrees each other angulately, and this number of degrees scope is the 0-90 degree, preferred 10-60 degree, most preferably about 10-30 degree.Surface, baseplane 2202 ' is directed and has the length d of about 1.5mm with respect to the top surface 31 of shell 21 with 20-60 degree scope, preferred 26 degree.Leading edge 2100 ' push layer 16, and basal surface 2202 ' flattens eyes as open and flat device and when separator 14 moves.Because leading edge 2100 ' and surface 2200 ' and 2202 ' are not significantly destroyed epithelial layer 16 and can not damage or cut substrate so leading edge 2100 ' during separation processes " and surperficial 2200 ' and 2202 ' can jointly be counted as blunt edge to small part.In addition, surface 2200 ' can be as stayed surface to be used for supporting separated epithelial layer during separation process.

Figure 31 A-B has shown the separator 4018 of the separator 4018 (referring to Figure 25) in the epithelium separation equipment 4000 that can replace Figure 24 A-B " the side view of the 3rd embodiment.Especially, separator 4018 " slide in the chamber that is limited by keeper 4020, thereby rectangular recess 4027 is snugly meshed by the rectangle open component (not shown) on the top that is formed at surface 4022 and the leading edge 2100 of separator 4018 " stretch out.Also can predict separator 4018 " can replace the separator 14 of the epithelium equipment 12 of Fig. 1-9.At the U.S. Provisional Patent Application No.60/599 of on August 6th, 2004 application, described embodiment is disclosed in 368, the full content of above-mentioned application is incorporated into this with for referencial use.Separator 4018 " blunt leading edge 2100 " form at the end of plane surface 2204 and 2206, described plane surface separates certain number of degrees each other angulately, this number of degrees scope is the 0-90 degree, more preferably 30-60 degree, most preferably about 40 degree.Basal surface 2206 have scope be 0-0.4mm, preferably approximately 0.3mm or 0.15mm length b and as shown in Figure 1A, be parallel to surface 31 and be directed.Should be noted that if the b size reduces, then be applied to the pressure size increase of eyes by surface 2206.Basal surface 2206 with respect to become angle basal surface 220820-40 degree, preferably approximately 26 degree are directed, basal surface 2208 has the length c of about 1.2mm.Leading edge 2100 " push layer 16, and basal surface 2206 flattens eyes as open and flat device and when separator 14 moves.Should be noted that being used for comparing basal surface 2206 when open and flat with blunt edge when Figure 25 and 30 separator strengthens open and flat.Should be noted that into angle basal surface 2206 and allow surface 2206 to apply correct pressure to eyes, allow the correct orientation at edge and reduce cornea and surface 2206 between amount of friction.Because leading edge 2100 " and surface 2204,2206 and 2208 significantly do not destroy epithelial layer 16 and during separation process, can not damage or cut substrate, so leading edge 2100 ", surface 2206 and surperficial 2204 and 2208 can jointly be counted as blunt edge to small part.In addition, surface 2204 can be as stayed surface to be used for supporting separated epithelial layer during separation process.

In Figure 31 C, shown separator 4018 " far-end of ' modification; comprising surface 2204,2206 and 2208 separator 4018 " ' is by separator 4018 " " replace, described separator 4018 " " be similar to separator 4018 " ', difference is that its far-end material has trapezoidal lateral cross section shape.Should be noted that separator 4018 can make its edge rounding.Described material comprise limit leading edge 2100 " ' surface 2204 ', 2206 ' and 2208 '.Surface 2206 ' the length b ' that has is about 0-400 μ m, is preferably 50 μ m-350 μ m, more preferably 150 or 300 μ m.Because leading edge 2100 ' " and surface 2204 ', 2206 ' and 2208 ' significantly do not destroy epithelial layer 16 and during separation process, can not damage or cut substrate, so leading edge 2100 " ', surface 2206 ' with surperficial 2204 ' can jointly be counted as blunt edge to small part.In addition, surface 2204 ' can be as stayed surface to be used for supporting separated epithelial layer during separation process.

Figure 31 D has shown as separator 4018 " " the modification of separator 4018.Separator 4018 " " comprise limit leading edge 2100 " " surface 2204 ", 2206 " and 2208 ".Surperficial 2206 " the length b that has " be about 0-400 μ m, be preferably 50 μ m-350 μ m, more preferably 150 or 300 μ m.Because leading edge 2100 " " and surface 2204 ", 2206 " and 2208 " significantly do not destroy epithelial layer 16 and during separation process, can not damage or cut substrate, so leading edge 2100 " ", surperficial 2206 " and surperficial 2204 " can jointly be counted as blunt edge to small part.In addition, surface 2204 " can be as stayed surface to be used for during separation process, supporting separated epithelial layer.Top surface 2204 " with respect to basal surface 2206 " be directed with angle Ф, described angle is approximately the 0-90 degree, is preferably the 30-60 degree, most preferably is 40 degree.Top surface 2206 " level relatively, for example with respect to separator 4018 " " separator bearing 28 ' be directed with angle θ, described angle is approximately-the 20-30 degree, is preferably-the 10-10 degree, most preferably is 0 degree.Become angle basal surface 2208 " be directed with angle γ with respect to level, described angle is approximately the 0-40 degree.Again, because leading edge 2100 " " and surface 2204 ", 2206 " and 2208 " significantly do not destroy epithelial layer 16 and during separation process, can not damage or cut substrate, so leading edge 2100 " ", surperficial 2206 " and surperficial 2204 " can jointly be counted as blunt edge to small part.In addition, surface 2204 " can be as stayed surface to be used for during separation process, supporting separated epithelial layer.

Figure 31 E shown along T move separator 4018,4018 ', 4018 when crossing eyes 10 ", 4018 " ' and 4018 " " and their leading edges 2100,2100 ', 2100 separately ", 2100 " ', 2100 " ".Separator 4018,4018 ', 4018 ", 4018 " ' and 4018 " " can be from the starting position 3110 move to terminal position 3120, and return once more.When they move, separator 4018,4018 ', 4018 ", 4018 " ' with 4018 " " can separate epithelial layer 16 from the cornea of eyes 10.Separator 4018,4018 ', 4018 ", 4018 " ' and 4018 " " surface 2206,2206 ' can be as open and flat or flatten the surface of eyes 10.When separator 4018,4018 ', 4018 ", 4018 ' " and 4018 " " 3110 pressure that are applied to eyes 10 when moving to terminal position 3120 can increase from the starting position, reason is when separator 4018,4018 ', 4018 ", 4018 " ' and 4018 " " more parts of eyes 10 are driven plain when arriving terminal position 3120 rather than starting position 3110.When separator 4018,4018 ', 4018 ", 4018 " ' and 4018 " " during the terminal position 3120 that arrive to move, hinge 3130 can keep, the part 3140 that is removed of epithelial layer 16 is connected with the part 3150 that still is attached to eyes 10 there.The length b on surface 2206 can change according to expection thickness or the robustness that hinge 3130 keeps.Less but not bigger length b can make and be removed part 3140 and minimize from the division of attachment portion 3150, thereby can keep thicker hinge 3130.

Should be noted that the leading edge 2100,2100 ', 2100 of Figure 25 and 30-31 ", 2100 " ' and 2100 " " but the separator 4018,4018 ', 4018 from making respectively by many rigidity and pasteurization material (for example metal and plastics) ", 4018 " ' and 4018 " " form.Certainly other materials is possible.Two reticules that connect between the surface can be passivated by separator is placed in the container that comprises bead, thereby wherein rolling of bead of container rotation reduces the acutance of reticule.Separator 4018,4018 ', 4018 ", 4018 ' " with 4018 " " with they leading edges 2100,2100 ', 2100 separately ", 2100 " ' with 2100 " " can integrally separate epithelial layer 16 basically and not cut cornea, thereby it can be moved back into and rely on structural its prime area, described prime area keeps after the laser ablation process is finished, and this will be described below.In case should be noted that finishing laser ablation process bowman's lamina 1908 can be removed, this will be described below.

Figure 32 A-B is the separator 4018 that shows the separator 4018 (referring to Figure 25) in the epithelium separation equipment 4000 can replace Figure 24 A-B " " " the diagram of side view of the 4th embodiment.Separator 4018 " " " can replace such as other separators of separator 12 (Fig. 1-9) with such as Figure 14-16 Figure 19, Figure 21-25, Figure 27-31, other separators of the separator shown in Figure 33 and Figure 36-37.Especially, top surface 2204 " ' bend to the plough or the general shape of semicolumn.The surface has the shape of cross section that mates camber line or curve in fact.Camber line can mate a round part, and described radius of a circle R is approximately 0.3mm-2mm, and more preferably 0.5-1.5mm most preferably is 0.8-1.4mm.Curved shape can mate and be different from circular shape, for example ellipse, parabola, hyperbola or other cone shapes.Curved shape also can comprise other shapes, loaarithmic curve shape for example, a kind of curve of curvature gradual change, Archimedian screw (referring to http://mathworld.wolfram.com/ArchimedesSpiral.html) for example, or by the combination of all aforementioned curves of three rank batten multinomials associatings.Curve shown in Figure 32 A-B can be protruding, thereby layer is to roll with the opposite way that separator was taken place of Figure 32 A-B.In addition, above-mentioned camber line can by be used for horizontal V-arrangement for example＞two plane surfaces replace.The acute angle scope that limits between two plane surfaces is the 5-170 degree.From the distance in the cross point of separation edge to two plane surface is that scope is 15 microns distances to 4mm.And, can predict a plurality of steps that can use the mode with common bending to rise.Curve starts from leading edge 2100 " " ' and continue to push up into angle surface 3200 up to arrival.When with curved surface 2204 " ' tangent line and stayed surface 28 " and between angle θ be approximately 90 and push up into angle surface 3200 beginnings when spending.In one embodiment, from the distance h of the horizontal plane 3204 of the center to face 2206 of curve 3202 less than about radius R.Can realize that distance h is to produce positive incisal plane T 3204 the about 40 angle ω that spend with respect to the horizontal plane.Positive incisal plane T is in leading edge 2100 " " tangent line of ' curved surface 2204 " '.For any given radius of curvature, height h can change, thereby angle ω excursion is the 0-90 degree, and more preferably the 15-60 degree most preferably is the 30-40 degree.

When epithelial layer curved surface 2204 when eyes 10 separate " ' can be used to roll described layer.Crooked top surface 2204 " ' length can change, make that having enough curvature is rolled onto epithelial layer on himself.When edge 2100 " " ' when clashing into eyes 10, edge 2100 " " ' the puncture epithelium, and the corneal stroma that do not puncture.When edge 2100 " " ' move when crossing eyes 10, at least a portion that covers the epithelium of eyes 10 is removed.Epithelial layer is the part of removed epithelium.Epithelial layer comprises one or more cellular layers of epithelium.Epithelial layer can be removed or still be attached to eyes 10 from eyes 10 fully, for example at the twisting end.When separator 4018 " " ' when withdrawal, rolled-up epithelial layer will remain on the position that was pushed last time, and not can with separator 4018 " " ' back move.Rolled-up epithelial layer can be favourable, and reason is that the doctor does not need further to operate epithelial layer before for example with laser ablation eyes 10.If epithelial layer is not rolled-up, the doctor may be before melting shifts epithelial layer onto the next door.Preferably, do not use and edge 2100 " " described open and flat device may be untied rolled-up epithelial layer during ' at interval open and flat device, when separator 4018 " " ' withdrawal.Edge 2100 " " ' can carry out open and flat.And, can use and stay edge 2100 " " ' mobile end and not can with edge 2100 " " ' the open and flat device that moves.Separator (for example separator 15 ', 15 ", 15 " ', 4018,4018 ', 4018 ", 4018 " ', 4018 " " and 2400 (Figure 21,22,23,25,30,31A-D and 33)) can be suitable for comprising general plow-shape.Although should be noted that the blunt edge of above example,, then also can use sharp edges if the cutting function that for example is used for the LASIK process will be carried out in the edge about just being used.

Edge 2100 " " ' and other leading edges 2100,2100 ', 2100 ", 2100 " ', 2100 " " can carry out texture processing so that edge 2100,2100 ', 2100 ", 2100 " ', 2100 " ", 2100 " " ' coarse.The texture processing operation can be controlled so that rough grain and/or ripple to be provided to the edge.A kind of possible operation is in polishing and carries out controlled polishing to polish the surface but process wavy line before not exclusively removing ripple.Can use other patterns and/or random grain, for example the ripples pattern.Too shinny surface may not have as so as one man removes epithelial layer 16 with the surface that comprises at least some roughenings.Rough grain can be used for other separators, Fig. 1-9 for example, Figure 14-16, Figure 19, Figure 21-25, Figure 27-31, the separator of the embodiment of Figure 33 and Figure 36-37.

Figure 33 shows can be used to replace separator 14,4018,4018 ', 4018 according to preferred implementation " and 4018 " ' the perspective view of line 2400.Line 2400 comprises ellipse or circular cross sectional shape substantially.Line 2400 comprises that width is approximately the leading edge 3002 of 5-25 micron.Line 2400 is preferably by enough solid to promote the material manufacture of epithelium under situation about not rupturing.Typical wire material comprises titanium and alloy thereof, tungsten and alloy thereof, steel alloy and carbon fiber.Two ends 3004 of line 2400 and 3006 preferably are connected to the yoke 3008 that connects with vibratory equipment 14.Keep tensioning in the yoke 3008 online 2400, thereby it keeps straight relatively when leading edge 3002 promotes epithelial layer 16.

Should be noted that in all embodiments of the separator shown in Fig. 1-33 separator and the vibratory equipment that interrelates are positioned such that they move separator (referring to Fig. 2) towards patient's bridge of the nose B.Should move causes epithelial flap to be positioned on the bridge of the nose.If the patient blinks then such location can cause the damage to flap.

As alternative, separator and vibratory equipment can revolve and turn 90 degrees, thereby separator moves towards patient's eyebrow.In this case, epithelial flap will be positioned in the more vantage point on patient's the eyebrow E (referring to Fig. 2).The vibratory equipment of Fig. 1-33 can contact patient's cheekbone, and cheekbone may stop loop mapping on eyes.This can be corrected by making suction encircle darker or reseting meter vibratory equipment contained structure, thereby it has avoided buccal.

Should be noted that in all embodiments of the separator shown in Figure 133 vibratory equipment can be changed to be subjected to closed-loop control system 7000 controls.Such control system will be designed to control the distance that separator moves along direction X.Control system can be controlled mobile device by shut-down mechanism, and for example vibrator 30.Such shut-down mechanism can be an Electronic Control, and it is electrically connected to mobile device and sends signal to mobile device to guarantee that separator can not be moved beyond preset distance.Shut-down mechanism also can be presented as block, and this block is arranged in the path of mobile separator, and when the separator contact blocks, stops separator further to move, thereby prevent that separator from passing through described preset distance.In addition, control system 7000 will be controlled the speed of separator along direction X, thereby speed is constant during whole separation process, even in the time of separator contacting substrate and epithelial layer.Control system 7000 also will be controlled along the frequency of the vibration of direction M or P, thereby frequency is constant during whole separation process, even in the time of separator contacting substrate and epithelial layer.

Figure 14 is the diagram that shows the eyes 10 and the side view of an embodiment of the epithelium separation equipment 12 ' that comprises rotary drum 42.Equipment 12 ' has made up the structure of epithelium separation equipment 12 of Fig. 1-9 and the bulging structure that will be described below basically.Especially, equipment 12 ' comprises U-shaped yoke 51, the drum 42 that described yoke supports therebetween by axle 53.Axle 53 can be supported by the two legs of the yoke 51 that is similar to bicycle quick, is perhaps supported by the only one leg that is similar to paint roller.For going barrel 42, epithelium separation equipment 12 ' can comprise swing pinion 44.Gear 44 also can be used for providing motion to the separator bearing 28 ' that is similar to the separator bearing 28 shown in Figure 1B.Separator 28 ' structurally is similar to the separator 28 of Fig. 1, and difference is that it comprises yoke 51.

Also with reference to Figure 15 and 16, it is respectively the forward sight and the top view of epithelium separation equipment 12 ', and swing pinion 44 can be placed on the both sides of separator bearing 28 ' of separator 14 ' symmetrically.Vibratory equipment 30 can provide the rotation of gear 44 and gear 44 for example to move on the rack rails at the track that is parallel to groove 26 extensions.In addition, drum 42 is as shown in Figure 14 open and flat device.The second open and flat device that is similar to the open and flat device 6000 of Figure 27-29 can be used for equipment 12 ' with before drum 42 and in series be positioned with it.

Since the typical thickness of epithelium disk 34 comprise about 50 microns to preserve epithelium disk 34, separated epithelium disk 34 is rolled on the drum 42.Drum 42 can comprise from the length of about diameter range of 3 to about 9mm and about 12mm.Also with reference to Figure 17, in one embodiment, in order to keep the integrity of epithelium disk 34, drum 42 can be coated with hydration and/or regulate substrate.Although layer 16 can be attached to drum 42 under the situation of not using substrate, substrate can provide layer the 16 controlled drum 42 that is attached to.Hydration and/or adjusting substrate for example can comprise the HEMA contact lens, tissue culturing medium, silicones and biocompatible hydrogels.Hydration and/or adjusting substrate can be removed from drum after epithelium disk 34 is attached to bulging going up.Thereafter, epithelium disk 34 can be removed and be put back on the anterior corneal surface 16, as mentioned above from drum 46.

Figure 18 has shown another embodiment of drum 42 ' of the drum 42 of the equipment 12 ' that can replace Figure 14-17.Drum 42 ' comprises perforate 46 and is connected to the adapter 48 of suction source (not shown).By the perforate 46 that application of suction is arrived drum 42, epithelium disk 34 can be rolled onto on the drum 42.Thereafter, epithelium disk 34 can be removed and be put back on the anterior corneal surface 16, as mentioned above from drum 46.

Figure 36 has shown the side view of an embodiment that is used to separate and preserves the equipment 2700 of epithelial layer 16, and described epithelial layer has for example used that Figure 21-23 promote/is separated with 4000 by the separation equipment 12 of Fig. 1-9 and 24-25 with the blunt edge shown in the 30-31.Equipment 2700 comprises main body 2705, the first drums 2720 and second drum 2730 and is with 2730 with what first drum 2720 was connected to second drum 2730.Equipment 2700 holds substrate, and for example thin film 2740.When epithelial layer 16 thin film 2740 when eyes 10 are removed is used for preserving basically epithelial layer 16.Thin film 2740 can remain to drum 2710 with bar or clip 2750.Alternatively, thin film 2740 can be used to connect drum 2720 and 2730, is not with 2730 so do not need to use.

Figure 37 has shown how the top view of equipment 2710 and equipment 2700 use with clip 2750.In one embodiment, thin film 2740 is rolled onto on the drum 2710 and (also referring to Figure 35) under the clip 2750.First drum 2710 rotates when second drum 2720 rotates, because they are by being with 2730 to connect.Thin film 2740 is installed in to be with on 2730 and to move when first drum 2710 and second drum 2720 move.Thin film 2740 preferably removably is attached to by adhesion and is with 2730.Two drums 2710 and 2720 use allow less drum 2720 very near Fig. 1-9, and therefore the running of the separator of 21-23 and 30-31 can be used as open and flat device.In addition, be large enough to hold whole removed epithelial layer 16 with 2730 size.

Thin film 2740 comprises outer surface 2760.Outer surface 2760 is configured to be attached to epithelial layer 16, thereby provides mechanical stability for epithelial layer 16 when eyes 10 separate when epithelial layer 16.Thin film 2740 comprises natural or synthetic polymer.Typical polymer comprises HEMA (poly--2 hydroxyls-ethyl-methacrylate).Thin film 2740 comprises from about 20 to about 100 microns thickness.If thin film 2740 has the shape of film tape, the diameter of separated epithelial layer 16 preferably is longer than and is wider than to length of thin film 2740 (a) and width (b).

Thin film 2740 preferably by hydration so that epithelial layer 16 is attached to thin film 2740.The hydration level control of thin film 2740 adheres to thin film 2740.Hydration thin film 2740 also helps to stop the crack to be formed in the removed epithelial layer 16, and helps to avoid removed epithelial layer 16 to be torn or shrink.In one embodiment, drying is for example carried out with sponge or with compressed air stream in the surface of epithelial layer 16.Thin film 2740 be placed into epithelial layer 16 on thereafter.Epithelial layer 16 is owing to the difference of hydration level between epithelial layer and the thin film is attached to dry film 2740.Thereafter, separator 14 is used for separating epithelial layer 16 from cornea substrate 18.Thin film 2740 and the epithelial layer 16 that adheres to thereof are rolled onto on first and second drums 2710,2720.

Should be understood that the band of thin film 2740 might not need to comprise coating with equipment 2700 application and described band.And thin film 2740 can be employed before or after removing epithelial layer 16, and can manually use rather than use equipment 2700.

Thin film 2740 can comprise other shapes, for example the shape of disk.A kind of mode that epithelial layer 16 is attached to disk (for example contact lens) is to separate epithelial layer 16 and epithelial layer 16 is moved on to the next door from eyes 10.Epithelial layer 16 is level and smooth and with sponge, compressed air or both dryings with sponge then.Removed epithelial layer 16 be placed into thin film 2740 on thereafter.Epithelial layer 16 and thin film 2740 for example carry out drying with compressed air then.After about 30 seconds of drying, epithelial layer 16 is attached on the thin film 2740 and can be more easily handled reducing to damage under the situation of risk.

After epithelial layer 16 was attached to thin film 2740, laser was to be similar to the surface that before is applied to cornea about the described mode of PRK.In case laser therapy is finished, thus dry anterior corneal surface and thin film 2740 is placed on the eyes 10 epithelial layer is put back into basically its home position on eyes 10.Then, water droplet is applied to the front surface of thin film 2740.The water of using spreads in thin film, causes the film side of thin film and contiguous epithelial layer 16 to be soaked.In this stage, thin film 2740 is raised and leaves epithelial layer 16 and epithelial layer 16 is attached on the eyes 10.

Figure 34 shown be used to regulate separator 14,4018,4018 ', 4018 " the perspective view of an embodiment of typical machine 2500.Machine 2500 is by having the sword separator to change over to comprise general curved edge (for example the separator shown in image pattern 23,25 and the 30-31 14,4018,4018 ', 4018 " leading edge) to regulate separator 14,4018,4018 ', 4018 with sharp ".

Figure 35 A has shown that front view and Figure 35 B have schematically shown the side view of machine 2500 and separator 14,4018.With reference to Figure 34 and 35, machine 2500 comprises motor 2510, rotating cylinder 2520, counterweight 2530, or other modes of blade/ separator 14,4018 of interrelating of the leading edge 2100 and 2100 ' of maintenance and Figure 21 and 22, and blade/separator keeper 2540.The shell 2544 of motor 2510 and cylinder 2520 is positioned on the platform 2546.The separator that interrelates with the leading edge 2100 or 2100 ' of Figure 21-22 is for example kept by clip respectively.In each case, leading edge 2100,2100 ' is arranged essentially parallel to the rotation axis of cylinder 2520.As shown in Figure 35 B, the plane B of blade and the plane P that the edge limited by the axis of cylinder 2520 and blade form the angle φ of 0-20 degree.Motor 2510 is by being with 2550 to be connected to cylinder 2520 with rotating cylinder 2520.In another embodiment, motor 2510 is directly connected to cylinder 2520 with rotating cylinder.

Cylinder 2520 comprises helix 2560.Helix 2560 and cylinder 2520 are made by steel.This helix 2560 is as the spiral protrusion of rotary drum.The pitch that this spiral protrusion has equals the length of the leading edge of separator/blade.Spiral causes at any given instantaneous a bit (contact point between leading edge and the helix) of only regulating the leading edge of separator/blade.When helix 2560 rotated with drum 2520, contact point moved along the length of leading edge, but regulated quantity equals the total length of leading edge.The duration of runs of the amount of counterweight 2530 and cylinder 2520 and rotating cycle change the shape and the width of the leading edge 2100 of related separator.For example, increasing counterweight 2530 will cause more crooked.In one embodiment, by on separator, being used for cylinder 2520 and regulating preferred separator in about 45 seconds with the speed operation cylinder of .7 (0. 7) circle/second with the masterpiece of 20mN.The leading edge that forms is corresponding to the leading edge 2100 shown in Figure 31 A ".

Although the various embodiments of above reference have been described the present invention, should be understood that and to carry out many variations and modification without departing from the scope of the invention.For example, all surface of contact eyes or the separator embodiment that contacts with separated epithelial layer is level and smooth, so they can not cut epithelial layer or corneal stroma.So the specific descriptions of front wish to be understood that current preferred implementation of the present invention for example, and be not to be construed as qualification of the present invention.The following claim that only comprises all equivalence replacements wants to limit scope of the present invention.

Claims (46)

1. piece-rate system, it comprises:

Last plane surface; With

With respect to the horizontal plane with from approximately-20 spending the lower plane surface of angle orientation of about 30 degree scopes, wherein said plane surface and the described lower plane surface angle separated from one another that goes up, this angular range is from spending about 90 degree greater than 0;

Blunt edge on described between plane surface and the described lower plane surface;

Wherein described at least blunt edge comprises the part of a kind of structure to separate the epithelial layer of eyes from eye's cornea substrate, does not damage the described part of described epithelial layer basically simultaneously, and can the cutting angle membrane matrix.

2. piece-rate system according to claim 1, described corneal stroma can not be cut in wherein said upward plane surface and described lower plane surface.

3. piece-rate system according to claim 1 further comprises the 3rd plane surface that is attached to described lower plane surface.

4. piece-rate system according to claim 3, wherein said the 3rd plane surface with respect to described lower plane surface with from about 20 spend about 40 the degree scopes the angle orientation.

5. piece-rate system according to claim 3, wherein said lower plane surface comprise that about 30 microns are arrived about 300 microns length.

6. piece-rate system according to claim 1 further comprises open and flat device.

7. piece-rate system according to claim 6, wherein said open and flat device and described edge are one.

8. piece-rate system according to claim 1, wherein said blunt edge comprises rough grain.

9. piece-rate system according to claim 1 further comprises the track of the described edge of restriction along path movement.

10. handle a kind of method of eyes for correct operation, it comprises:

Move a separator with respect to cornea, wherein said separator comprises:

Last plane surface; With

With respect to the horizontal plane with from approximately-20 spending the lower plane surface of angle orientation of about 30 degree scopes, wherein said plane surface and the described lower plane surface angle separated from one another that goes up, this angular range is from spending about 90 degree greater than 0;

Wherein said upward plane surface and described lower plane surface limit blunt edge betwixt, and described blunt edge comprises that partly a kind of structure is to separate the part of the epithelial layer of eyes from the corneal stroma of described eye's cornea, basically do not damage simultaneously the described part of described epithelial layer, and wherein said blunt edge can not cut described corneal stroma.

11. method according to claim 10, wherein during described moving, described blunt edge is removed the described part and the open and flat described cornea of flat surface while of described epithelial layer from described cornea.

12. method according to claim 11 further comprises described removed epithelial layer is put back on the described cornea.

13. method according to claim 11 was wherein carried out described open and flat before the described part of described epithelial layer is removed thereon.

14. method according to claim 11 has wherein been carried out on the zone of removed described cornea described open and flat in the described part of described epithelial layer.

15. method according to claim 11, wherein said blunt edge comprises rough grain.

16. method according to claim 11, wherein said lower plane surface comprise that about 30 microns are arrived about 300 microns length.

17. a separator that is used for the separated part of mobile eyes, it comprises:

Upper surface with curved shape;

With respect to the lower plane surface of described upper surface with an angle orientation, wherein said upper surface and described lower plane surface limit the edge betwixt, and the structure that described edge has makes it to remove the part of eyes.

18. separator according to claim 17, wherein said edge comprises that a kind of epithelial layer that separates described eyes from described eye's cornea substrate does not damage simultaneously the structure of described epithelial layer basically, and wherein said blunt leading edge can not be cut described corneal stroma.

19. separator according to claim 17, wherein said upper surface and described lower surface all can not cut described corneal stroma.

20. separator according to claim 17, wherein said edge comprises rough grain.

21. separator according to claim 20, wherein said rough grain comprises wave molding.

23. separator according to claim 18, wherein said camber line coupling radius is approximately the part of the circle of 0.5mm-3mm.

24. separator according to claim 23, wherein said camber line coupling radius is approximately the part of the circle of 1.7mm.

25. separator according to claim 23, wherein from the center of described circle to a planar distance of described lower plane surface level size less than described radius.

26. separator according to claim 25 wherein is determined to be to the described planar described distance with described lower plane surface level from the described center of described circle and makes a positive incisal plane have the value of spending about 90 degree scopes from about 15 with respect to the angle of described horizontal plane.

27. separator according to claim 26, wherein said positive incisal plane have the value of about 40 degree with respect to the described angle of described horizontal plane.

28. handle a kind of method of patient's eyes for correct operation, it comprises:

Separator with edge is provided;

With puncture described patient's the epithelial layer of described eyes of described edge;

Described eyes with respect to described patient move described separator; With

At least a portion of separating described epithelial layer when described separator moves, described at least a portion of wherein said separated epithelial layer is rolled-up between described separation period.

29. method according to claim 28, wherein when described separator was contracted away from described separated epithelial layer, described separated epithelial layer was held in place.

30. method according to claim 28 is not wherein carried out open and flat when described leading edge is separated.

31. method according to claim 28, wherein said separated epithelial layer keeps being attached to described eyes by at least one end.

32. handle a kind of method of patient's eyes for correct operation, it comprises:

Described eye's cornea with respect to described patient moves a separator;

Separate the epithelial layer that interrelates with described cornea, wherein said separated epithelial layer limits hinge on described cornea, thereby the free end of described epithelial layer pivots with near the eyebrow that is positioned at described patient around described hinge.

33. handle a kind of method of patient's eyes for correct operation, it comprises:

Described eye's cornea with respect to described patient moves a separator; With

Automatically control the distance that described separator moves.

34. method according to claim 33, further comprise the described separator of automatic control along the speed of described displacement during described method, always to keep constant.

35. method according to claim 33, wherein said separator vibrates along second rectilinear direction, described method further comprise automatic control along the frequency of the described vibration of described second rectilinear direction during described method, always to keep constant.

36. method according to claim 34, wherein said separator vibrates along second rectilinear direction, and described method comprises that further the frequency of the described vibration along second rectilinear direction of automatic control is always to keep constant during described method.

37. a piece-rate system, it comprises:

Upper surface; With

Integral body is connected to the forward edge of described upper surface;

Be positioned at the back at described edge and the back open and flat device under the described upper surface.

38. according to the described piece-rate system of claim 37, wherein said edge is blunt;

Wherein described at least blunt edge comprises the part of a kind of structure to separate the epithelial layer of eyes from described eye's cornea substrate, does not damage the described part of described epithelial layer basically simultaneously, and can not cut described corneal stroma.

39. according to the described piece-rate system of claim 37, the open and flat device in wherein said back is flat.

40. according to the described piece-rate system of claim 37, wherein said open and flat device in back and edge are one.

41. according to the described piece-rate system of claim 39, wherein said open and flat device in back and edge are one.

42. handle a kind of method of patient's eyes for correct operation, it comprises:

Separate epithelial layer to expose the part of described eye's cornea substrate from the part of described patient's described eyes; With

Described part in the open and flat described cornea substrate of described after separating.

43. a separator that is used for the separated part of mobile eyes, it comprises:

Upper surface, it has two plane surfaces that intersect each other;

Become the lower plane surface of an angular orientation with respect to described upper surface, wherein said upper surface and described lower plane surface limit an edge betwixt, and described edge has a kind of structure to remove the part of eyes.

44. according to the described separator of claim 43, wherein said two plane surfaces form horizontal V-arrangement.

45. a control system, it comprises:

Be connected to the separator of mobile device, described mobile device is along the described separator of path movement; With

Be used to prevent the shut-down mechanism of described separator by preset distance.

46. according to the described control system of claim 45, wherein said shut-down mechanism is along the localized block in described path.

47. according to the described control system of claim 45, wherein said shut-down mechanism is electrically connected to described mobile device and sends signal to prevent that described separator is by described preset distance to described mobile device.

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