CN101119689A - Intracorneal lens placement method and apparatus - Google Patents

Abstract

A corneal-pocket keratome having a support and blade assembly and in which the support has a guide on a forward portion in front of the blade and spaced precisely from the blade to control entry of the blade into the cornea to precisely position the pocket in the cornea that is cut by the blade. A lens is placed in the pocket.

Description

The method and apparatus of intracorneal lens placement

The present invention is the U.S. Patent application No.09/132 that subjects to approval that submitted on August 12nd, 1998, the continuation of 987 part, and it is incorporated herein for your guidance.

Cross-index

The present invention is the U.S. Patent application No.10/618 that submitted on July 11st, 2003, the continuation of 279 part, the U.S. Patent application No.09/586 that this application was submitted to as on June 2nd, 2000,273, the division of present United States Patent (USP) 6,599,305, this application is again the U.S. Patent application No.09/132 that submitted on August 12nd, 1998,987, the continuation of the part of present United States Patent (USP) 6,083,236.The present invention still is the U.S. Patent application No.10/668 of JIUYUE in 2003 submission on the 23rd, the continuation of 882 part, the U.S. Patent application No.09/521 that this application was submitted to as on March 7th, 2000,010, the continuation of the part of present United States Patent (USP) 6,623,497, this application is again the U.S. Patent application No.09/132 that submitted on August 12nd, 1998,987, the continuation of the part of present United States Patent (USP) 6,083,236.The content of aforementioned each application and patent is incorporated herein for your guidance.

Technical field

The invention belongs to the general field of external coat, more specifically, belong to the surgical method and the equipment of the corneal transplantation that is used for optical lens.

Background technology

Developed multiple eye surgery method, corrected such as visual sensitivity defectives such as myopia or hypermetropias.In the many decades, developed multiple keratome in the past, this equipment is used to carry out corneal ablation to allow to touch cornea inside, can use the surgical operation shaping with the defective of for good and all correcting defects of vision then.

With reference to Fig. 1 and 2 a, typically existing resection operation will be from the flap 6 of eyeball 4 isolated corneas (and epithelium) tissue 2.The skin of cornea and epithelial cell separately and be lifted away from internal layer 12 to expose cornea 2 and make it only attached with flap 6.The internal layer 12 of the cornea 2 that exposes is self regulation to a certain degree, and perhaps its shape can be by changing such as laser ablation or follow-up further surgical procedure such as excision, to take off the profile layer of cornea tissue.When surgical procedures finished, flap 6 was taken back on the interior cornea tissue 12 usually, with the tissue in the protection recovery from illness.

Yet most this surgical operation shapings are irreversible, cause the patient to produce the not normal certain danger of vision for good and all.Known optional form is to prepare an opening with surgical operation in the not normal eye's cornea of vision, and lens are inserted within it, and this operation is difficult to accurately carry out.And the lens that can be used for this vision correction are not because a variety of causes is entirely satisfactory, comprise place the back from the trend of position skew, weaken the gas diffusion of passing cornea, blocked up or can not correct presbyopia and astigmatism.

Therefore, need a kind of method and apparatus, it is used for correcting visual abnormality by the suitable correcting lens of the surgical graft in eye's cornea, make these lens to place reliably and will keep correct positioning and orientation, so that can carry out reversible rectification visual abnormality widely.

Summary of the invention

The present invention satisfies above-mentioned needs by the method and apparatus that a kind of intracorneal lens placement is provided.Particularly suitable lens are implanted in the corneal pocket, and this corneal pocket is accurately formed by the equipment of generation and this capsule bag that is shaped, to accept lens and its lens are remained in the cornea.Yet in typical correction surgical, shown in Fig. 2 a, lift the whole flap of cornea, carry out further surgical operation correction to allow corneal.In vision correction according to the present invention, do not lift cornea flap, but the capsule bag is formed in the cornea tissue, shown in Fig. 2 b.Anterior corneal surface is remained intact, so that recovery from illness, and prevent that the lens that inserted from moving or lose.

For with lens with accurately expected and repeatably mode be positioned in the eye's cornea, help the expection orientation and the location of these lens of maintenance and eyes are fully recovered from surgical operation, the invention provides a kind of corneal pocket keratome, in cornea, to form the capsule bag of accurate dimension; With lens, closely cooperate between lens and corneal pocket, to form with special characteristics.These two parts can be realized in a plurality of different embodiments.In addition, the corneal pocket keratome has several subassemblies, and each subassembly can be realized in many ways.

The formed corneal pocket of the size and dimension of lens and corneal pocket keratome coupling, and required focus correction is provided in being placed into cornea tissue the time.Lens allow sufficient gas diffusion and make eye inner tissue can carry out suitable Oxygenation.In a preferred embodiment, lens peculiarity is formed on interference fit between lens and the cornea tissue in the edge of corneal pocket, to help to keep the position and the orientation of lens.Except accurate cooperation, this maintenance characteristic of lens can comprise a kind of material, and it expands when the back combines with water in being placed into cornea, and perhaps the radius of lens changes, to form circumferential ridge.Therefore these lens can have focal length radially asymmetrical and/or that axially change, outside common compensate for myopia or hypermetropia, also have the effect of complementary astigmatism or presbyopia.In some applications, can lens thickness can be reduced satisfactorily by adopting Fresnel (Fresnel) intracorneal lens.

The corneal pocket keratome preferably includes: the surgical operation unit, it has the cutting head element that is installed on the keratome driven unit, also has control unit and pedal.In the forming process of intracorneal capsule bag, the cutting head element touches patient's eyes closely, perhaps is placed on eye and goes up or form otch.Control unit provides power and vacuum, to control the operation unit according to the setting of being imported by user and according to the instruction that pedal produces.The operation unit preferably manual and on patient's eyes, locate easily.

Preferred operation unit can comprise four different elements.Wherein three contact eyes " cutting head " elements in the cornea surgical procedures: locating ring assembly, cornea supporting component and corneal pocket blade assembly.Preferably, in these three cutting head elements each is extended from quaternary part keratome driven unit, this quaternary part is with respect to other two cutting head element drives corneal pocket blade assemblies, makes interference between the parts of corneal pocket keratome and friction minimum or do not have fully near the surgical operation place.It is further preferred that tool free just takes off each in these three cutting head elements easily and is substituted into the quaternary part easily is on the driven unit, so the surgeon can guarantee aseptic by replacing the cutting head element simply.Replace and conveniently also make the surgeon can easily select dissimilar according to the needs of concrete operation and cutting head element size.

Patient's eyes remain on a position by positioning equipment, and this positioning equipment is attached to the locating ring of keratome driven unit typically.This locating ring provides vacuum, and it is with in the eyes inhaled loop, so that outstanding this ring that passes of cornea.Then, in majority was used, this outstanding cornea compressed the cornea supporting component, and this cornea supporting component also is attached on the keratome driven unit.The corneal pocket blade assembly is attached to the drive member of keratome driven unit, so that the corneal pocket blade of assembly is positioned near the cornea supporting component.According to the guiding from the operator, the keratome driver element makes the corneal pocket blade have compound motion by drive member, drives blade and is advanced forward in the cornea, and blade is laterally swung.

Blade preferably moves in cutting planes, and cutting planes is with respect to anterior corneal surface and controlled.This anterior corneal surface is arranged to usually against the cornea supporting component.Cutting planes can be controlled by guiding piece with respect to the accurate location of anterior corneal surface, and this guiding piece is supported and moved with it by the corneal pocket blade assembly, and directly touches cornea.Alternatively, cutting planes can remain on known distance with the cornea supporting component.This distance can be by the guide portion branch control of corneal pocket blade assembly, and it is interfered with this cornea supporting component in cutting process.During use, this interference guiding piece can contact cornea or can be positioned to avoid this contact.Cutting planes to the distance of cornea support member can also pass through between cornea stayed surface, keratome driven unit and the corneal pocket blade assembly mechanical connection and directly control.Thereby by with respect to the reference plane of cornea supporting component and the Cutting Control plane can form profile in the cornea supporting component, this profile changes into the variation of the degree of depth of the capsule bag of anterior corneal surface below, thereby controls the shape of formed capsule bag.

In some applications, ideally, save the cornea supporting component and realize the present invention, only stay locating ring and finally touch patient's eye's cornea capsule bag blade assembly.At this moment, locating ring is static with respect to patient's eyes, and the corneal pocket blade is driven with respect to it simultaneously.Thereby in the embodiment that saves the cornea supporting component, the thickness of otch is preferably controlled by guiding piece, and this guiding piece is the part of corneal pocket blade assembly, and directly touches the anterior corneal surface tissue.

The characteristic of some embodiments of the present invention is pivotable cornea supporting components, when this supporting component is kept by locating ring at eyes, can swing open, and the surgical operation equipment is being disturbed under the minimum situation indagation and is treating eyes allowing.

Keep in order to allow to insert lens and to be convenient to it, the corneal pocket keratome preferably in anterior corneal surface tissue foundation have the capsule bag of opening, laterally measure from cut-out direction, this aperture efficiency is held lens, and the maximum lateral width of the capsule bag of wide part is narrower.This amplitude that increases the teeter that is applied on the corneal pocket blade in a preferred embodiment when further moving in the cornea tissue at blade realizes.

Description of drawings

Fig. 1 is the cross-sectional view of eyes.

Fig. 2 a shows the cornea that lifts the epithelial tissue flap in the prior art.

Fig. 2 b shows the cornea that is formed with the capsule bag below epithelial tissue.

Fig. 3 shows and is used for surgical operation of the present invention unit, and wherein the cutting head element is on driven unit.

Fig. 4 shows control unit, and it is connected to surgical operation unit and pedal.

Fig. 5 shows front portion, surgical operation unit, wherein cutting head element and its disengaging.

Fig. 6 a shows eyeball and is kept and rest against pressure plate (applanator) boots by locating ring, and blade is supported by the blade fork of preparing the cutting corneal pocket.

Fig. 6 b and Fig. 6 a are similar, have the guiding piece of this pressing plate of contact except this blade.

Fig. 6 c shows blade assembly, and wherein guiding piece contacts the face side of this pressing plate.

Fig. 6 d shows blade assembly and guiding piece, and it cuts corneal pocket without pressing plate.

Fig. 7 is the vertical view by blade in the eye's cornea capsule bag of locating ring maintenance.

Fig. 8 a shows in detail the embodiment of the corneal pocket blade that has guiding piece.

Fig. 8 b shows the sectional view of Fig. 8 a.

Fig. 8 c shows in detail the blade that only has circumferential cross section that has guiding piece.

Fig. 8 d is the sectional view of Fig. 8 c.

Fig. 8 e shows in detail the blade on the blade fork assembly that has pressing plate front guiding piece.

Fig. 8 f is the sectional view of Fig. 8 e.

Fig. 8 g is the sectional view of the blade of no guiding piece.

Fig. 9 a shows the pressing plate that extends and upwards outwards swing from locating ring.

Fig. 9 b shows the identical pressing plate at complete restriction site.

Figure 10 a shows a kind of optional method that the cornea pressing plate is arranged.

Figure 10 b shows the releasable locking means of the pressing plate that is used for Figure 10 a.

Figure 11 a shows the locating ring that is attached to driven unit.

Figure 11 b shows the details of the locating ring at the 11b-11b place, cross section that is limited in Figure 11 a.

Figure 12 shows the unitary cross-sectional view of surgical operation that uses motor to drive the blade swing.

Figure 14 a-14e shows the details according to lens of the present invention.

Figure 15 shows the axonometric chart of the support member of the capsule bag keratome that is used to form corneal pocket.

Figure 16 shows the axonometric chart of the blade assembly of the support member that adopts Figure 15.

Figure 17 shows the front view of the blade assembly of Figure 16.

Figure 18 shows along the cutaway view of the A-A of Figure 17.

Figure 19 shows the details at the B place of Figure 18.

Figure 20 shows the upward view of the support member of Figure 15.

Figure 21 shows the vertical view of the blade assembly of Figure 16.

Figure 22 shows the axonometric chart of blade.

Figure 23 shows the axonometric chart of the support member of the capsule bag keratome that is used for optionally being used to form corneal pocket.

Figure 24 shows the axonometric chart of the blade assembly of the support member that adopts Figure 23.

Figure 25 shows the front view of the blade assembly of Figure 24.

Figure 26 shows along the cutaway view of the A-A of Figure 25.

Figure 27 shows the details at the B place of Figure 26.

Figure 28 shows the part upward view of the support member of Figure 23.

Figure 29 shows the axonometric chart of blade.

Figure 30 shows the axonometric chart of the support member that is used for another capsule bag keratome that optionally is used to form corneal pocket.

Figure 31 shows the perspective elevation of the blade assembly of the support member that adopts Figure 30.

Figure 32 shows the front view of the blade assembly of Figure 31.

Figure 33 shows along the cutaway view of the A-A of Figure 32.

Figure 34 shows the details at the B place of Figure 33.

Figure 35 shows the axonometric chart of blade.

The specific embodiment

The present invention proposes by place lens and the device of the defective of for good and all and reversibly correcting defects of vision in the capsule bag of cornea.The combination of numerous embodiments myopia correction, hypermetropia, astigmatism, presbyopia or these defectives.Suitable lens and equipment is provided, holds the corneal pocket of these lens with formation.If its maintenance is satisfactory, this rectification can be permanent, and can be reversible by take off lens from cornea.

We begin in the general introduction of slave unit, and this equipment is used for preparing corneal pocket suitable lens are remained on patient's eyes.With reference to Fig. 3,4 and 5, this equipment preferably is embodied as three independent parts: surgical operation unit 100, pedal 300 and control unit 400.Surgical operation unit 100 has four subdivisions, comprises driven unit 110 and three cutting head elements: locating ring assembly 20, optional Anchor plate kit 40 and blade fork assembly 60.Pedal 300 is sent to control unit 400 with user instruction by cable 310, and surgical operation unit 100 is connected to control unit 400 by cable 410 and vacuum hose 412.In these parts each will discuss in more detail below.

Control unit

Electric and vacuum control is preferably provided by as shown in Figure 4 control unit 400.Control unit 400 is unit of microprocessor control, makes the user can guide the operation of actuator in driven unit 110, and guiding is supplied to the level of vacuum of the locating ring assembly 20 of surgical operation unit 100.The user can for example come control operation by means of two foot switchs that are included in the pedal 300, and 450,452 and 454 and two buttons 456 and 458 of three rotation input equipments on the front panel of two foot switchs and control unit 400 are associated.On the pro-panel by means of digitizer 412,414 and 416 and a plurality of character words alpha(nu)meric display 440 to user's display operation parameter, simultaneously speaker 434 provides acoustic information.

Microprocessor on the printed circuit board (PCB) 460 is carried out the operation firmware, and this operation firmware is kept in the Reprogrammable nonvolatile memory, and can be in field reprogramming.This firmware makes microprocessor system can read switch close and rotate the rotation of control.These electronic equipments change into the voltage of control tool with operator's action, and it is applied to the driver element actuator, and can be used as default definite value and store, to call when the operator needs again.Microprocessor system is decipher pick off and control actuator also, vacuum is remained on the degree that is set by the user.

Control unit 400 is provided to surgical operation unit 100 by cable 410 with electric control signal.The vacuum pressure that is used for locating ring assembly 20 is supplied by vacuum hose 412 from control unit 400.Control unit 400 comprises vacuum tank 422, and wherein vacuum pressure is formed by vacuum pump 420, and discharges solenoid 426 by vacuum and discharge, and this vacuum pressure detected by vacuum transducer 424, to provide feedback to controlling electrical equipment.The electrical control that is used for the actuator (not shown) of driven unit 110 is provided by electrical switch 436-438.It will be understood by those skilled in the art that without limits for the version of the control surgical operation unit actuator of control unit parts and vacuum.

The surgical operation unit

With reference to Fig. 3, surgical operation unit 100 comprises driven unit 110, is used for supporting and driving three cutting head elements that contact eyes at surgical procedures.The cutting head element comprises locating ring assembly 20, Anchor plate kit 40 and blade fork assembly 60.Surgical operation unit 100 is powered by cable 410, and by the vacuum hose 412 that is attached to vacuum connection tube 22 vacuum is fed to locating ring 30.

Fig. 5 is shown clearly in and driven unit 110 isolating three cutting head elements, comprises locating ring assembly 20, Anchor plate kit 40 (not being all to use in all embodiments) and blade fork assembly 60.Because each in these cutting head elements directly touches the eyes that undergoing surgery usually, preferably, easily it is taken off and can be put back on the driven unit 110 from driven unit 110, so that use cleaning and aseptic element.Based on same cause, also preferably, these cutting head elements are can be germ-resistant or aseptic disposable.

Blade fork 70 and all be the parts of blade fork assembly 60 from the blade support member 65 that blade yoke 68 hangs.Blade support member 65 is supporting blade 67 (perhaps can be an one parts) again.Blade fork 70 is connected to blade fork actuating arm 140, and it promotes whole blade fork assembly 60.Show dovetail groove or trapezoidal attachment means between blade fork 70 and the blade fork actuating arm 140.Threaded spring ball assembly 64 in the blade fork 70 makes ball be forced in the complementary locating slot (not shown) in the actuating arm 140, locatees correctly to make blade fork 70 relative actuating arms 140.This attachment means may be made in by shown in thumbscrew 142 or other devices take off.

Blade fork 70 preferably is made of titanium, but comprises that stainless other many materials also are suitable.For the blade of steam sterilization fork, be suitable such as Merlon or the stable plastics of polysulfones equidimension, and gas or gamma ray sterilization are suitable for such as other plastics such as polypropylene.

The surgical operation cutting operation

Fig. 6 a-6d shows the cutting head element that is used to excise cornea 2.The vacuum pressure that is delivered to the vacuum chamber 36 of locating ring 30 upwards attracts the sclera 3 and the cornea 2 of eyes 4, makes cornea 2 be held, and cornea 2 is compressed pressing plate boots 50 in the pressing plate embodiment.Blade yoke 70 continues to move forward, and is shaped fully up to the capsule bag.In this embodiment, do not use the guiding piece guiding blade 67 shown in Fig. 8 k.

Fig. 7 is the vertical view of corneal pocket 56.Blade fork assembly 70 has the blade yoke 68 that hangs blade support member 65.In this case, blade 67 is an integral body with blade support member 65.Cornea 2 is kept by locating ring 30.Blade 67 has entered into cornea tissue, opens cut line 59, and has entered into cornea.Blade 67 makes its driving enter into cornea 2 (Fig. 7 straight up) as the i.e. laterally swing of the left and right directions among Fig. 7 simultaneously, at least up to arriving shown point.When blade 67 enters in the cornea 2 when cut line 59 moves to the point that illustrates, the amplitude of the teeter of blade little by little increases, up to shown in the amplitude maximum of some place blade teeter, this some place has defined the wideest part of capsule bag 56.The access road edge 57 of capsule bag 56 leans on nearerly at cut line 59 places and meets each other farther when they are connected to capsule bag circumferential edge 55.(if desired, reduce the amplitude of blade teeter when moving in the cornea 2 slightly further gradually, can generally eliminate the little flat site of the capsule bag that the top end at blade 67 occurs at blade.) being used for of between edge 57, forming the slype that inserts lens stop the lens that inserted to skid off from cornea 2.

The control of corneal pocket wall thickness

Obviously, wish that accurately control remains on the thickness of the corneal epithelial tissue on the above-mentioned capsule bag.Usually, unless under the situation of some irregular corneas, wish constant capsule bag wall thickness.Turn back to Fig. 6 a-6d, show four embodiments, wherein adopt diverse ways to control each capsule bag wall thickness.

In Fig. 6 a, in cutting process, keep accurately controlling the spacing between pressing plate boots 50 and the blade 67.The selected distance of the surperficial reference plane of the position of blade 67 and pressing plate boots 50 preferably remains in the 0.050mm, and more preferably in 0.030mm.When having guiding piece (for example 63,69) and this distance of blade 67 preferably remain in the 0.5mm, and even more preferably in 0.1mm or littler, but greater than the tolerance of 0.5mm even can be acceptable, especially in the embodiment that uses guiding piece (for example 63,69).

In order to satisfy these general location tolerances, in the embodiment that does not have guiding piece 63 or 69, blade fork assembly 60 preferably is configured to blade 67 is positioned at respect to fork 70 and is attached to the surface distance 0.03mm of actuating arm 140 even more preferably apart from the known expection plane in the 0.015mm.When using with guiding piece 76, blade fork assembly 60 preferably is configured to blade 66 is positioned at respect to fork 70 and is attached to the surface distance 0.3mm of actuating arm 140 even more preferably apart from the known expection plane in the 0.15mm.Yet within the scope of the invention, allowable tolerance doubles preferred specified numerical value.

In Fig. 6 b, guiding piece 63 guides directly over blade 67, between cornea 2 and pressing plate boots 50, slide, thus the control of the spacing between guiding piece 63 and the blade 67 corneal pocket wall thickness.The perimeter of section of guiding piece 63 is advantageously little, preferably less than 2mm or at least less than 6mm.The small bore girth has several advantages: its friction that has reduced between guiding piece and the cornea is disturbed, its with the limit deformation of cornea in subrange, with the pressure of avoiding producing on eyes usually, and it has reduced to make the cornea distortion and the probability of the voids that the generation inaccuracy is cut.

In Fig. 6 c, guiding piece 69 front relative with cornea 2 in the pressing plate boots 50 is provided with.Thereby the spacing between guiding piece 69 and the blade 67 is controlled the corneal pocket wall thickness with the thickness of pressing plate boots 50.It should be noted that in some cases, ideally, determine the contour shape of the thickness of corneal pocket.By forming the thickness of pressing plate boots 50 as shown in the figure, thereby the thickness of the capsule bag that obtains can be shaped as required (thickness that the wall thickness of capsule bag will change into corresponding pressing plate boots).

Fig. 6 d shows a kind of embodiment that does not use pressing plate.Guiding piece 63 provides the spacing controlled with blade 67, and blade 67 is controlled the corneal pocket wall thickness again.In Fig. 6 c and 6d as seen, the cornea tissue of capsule bag blade 67 by after get back to contact condition.Certainly in this embodiment, need not consider with the clamp surface reference plane apart from tolerance.

Blade and guiding piece structure

Fig. 8 a-8g shows the details of a plurality of blade configuration.Blade support member 65 in every width of cloth figure is suspended between the blade yoke 68, yet can use accurately any device of supporting blade.Shown in Fig. 8 a and sectional view 8b, blade 67 may simply be the edge on the stainless steel blade support member 65, perhaps can be in conjunction with cutter support member 65 such as independent materials such as sapphires.Blade guiding piece 63 is preferably along the blade edge profiles of blade 67.At least cornea tissue since the situation of passing through to twist of guiding piece 63 under, the angle at the edge of shown blade 67 helps to reduce the skew of the blade shown in Fig. 6 b.Yet different blade edge geometries can be used according to whole surgical operation cutting situation.

Fig. 8 c and sectional view 8d show the blade 67 that forms narrow edge rather than continue with blade support member 65.In this specific embodiment, blade bar 67 is by bonding or be attached to a side of blade support member 65, and blade guiding piece 63 is attached to the opposite side of blade support member 65 similarly.Yet any method that forms suitable interval between blade and guiding piece all is gratifying.Blade and guiding piece can for example be stainless.In this embodiment, blade guiding piece 63 has oval cross section, to increase the intensity that is complementary with blade 67.This embodiment is preferably used for forming corneal pocket under the situation of not using pressing plate, and shown blade 67 optional edges are being effective aspect the distortion of the cornea tissue that correspondingly reduces this method.

Fig. 8 e and sectional view 8f have described the blade configuration that is used to cut shown in Fig. 6 c in detail.Guiding piece 69 leans on the upside of blade support arm 68, and protuberance 70 rests on the face side of pressing plate boots 50 (Fig. 6 c).In this embodiment, there is not guiding piece near the blade 67.Although not shown, those skilled in the art will be understood that guiding piece 69 may be made in easily and take off, to allow to touch the eyes (after taking off pressing plate, as described later) that undergoing surgery.

Fig. 8 g is very similar to Fig. 8 f, and it has taken off guiding piece 69.In this structure, corneal pocket can form with accurate cutting head element exactly by accurate surgical operation unit, and basic dispensing with bootstrap spare.Blade 67 is supported by blade support yoke 68, and blade support yoke 68 is driven by the surgical operation unit that also supports pressing plate.

Anchor plate kit

With reference to Fig. 5,6a, 9a, 9b and 10a, pressing plate boots 50 are parts of Anchor plate kit 40, and this Anchor plate kit comprises the surface that is used at cutting process restriction cornea.Anchor plate kit 40 shown in Fig. 5,9a and 9b comprises that pressing plate keeps insert 42, optional hinge 44, pressing plate boots support member 46 and pressing plate boots 50.Pressing plate boots 50 are preferably made by and abrasion-resistant material transparent such as glass or sapphire etc., and indicate crosshair 52, so that the surgeon can see cutting operation.If pressing plate is not hinged, then insert 42 and support member 46 can be the subassemblies of same parts.

Pressing plate keeps insert 42 and boots support member 46 preferably to have trapezoidal edge, and be slipped into the recess 108 of driven unit 110 and match, locating them at this is located by the screw thread mooring ball spring assembly on the side, and it is, fixing by the thumbscrew on the opposite side 114 with following locating ring keeper 34 described modes similar (Figure 11 b) about locating ring assembly 20.

As above described about blade fork assembly 60, various materials can be used for constructing pressing plate and keep insert 42, pressing plate boots support member 46 and pressing plate boots 50.Do not touch the form of pressing plate boots 50 for guiding piece 76, it is comparatively inessential to resistance to wear.As mentioned above, selected material must be suitable for the method for guaranteeing that element is aseptic, no matter the method for using is such as heating, steam, gas or gamma ray, or this element is aseptic disposable.Can use and blade fork assembly 60 identical materials, comprise the transparent material that is preferably used for pressing plate boots 50.

Anchor plate kit 40 preferably can swing open, to expose the cornea that remains on the eyeball in the retaining ring 30.In a preferred mechanism that allows this swing shown in Fig. 9 a and the 9b.In Fig. 9 a, the recess 108 of cornea Anchor plate kit 40 from its driven unit of installing 110 partly extracted out, make hinge 44 expose, and pressing plate boots 50 can keep preferably about 60 degree of insert 42 swings with respect to the pressing plate that remains in the recess 108 with support member 46.In Fig. 9 b, Anchor plate kit 40 playbacks fully, makes hinge 44 be tethered in the recess 108.

In second preferred implementation that can swing shown in Figure 10 a.Here, hinge 44 allows pressing plate boots 50 and support member 46 to keep insert 42 to leave pivotally from pressing plate, keeps simultaneously being positioned at same plane with insert 42.Figure 10 a illustrates boots 50 and keeps insert 42 to leave pivotally with support member 46 from pressing plate, exposes latch piece 47.When closure, latch piece 47 is fixed on make position with pressing plate thus releasedly with combined spring ball 48.Figure 10 b show the cross-section details of bonded bolt lock mechanism 48.

The cornea limiting surface of pressing plate boots 50 preferably can be smooth, perhaps can be curved surface profile.Blade usually guiding for " the surperficial reference plane " of pressing plate boots at a distance of controlled distance, this plane is the plane of " just contact " cornea limiting surface, and is parallel to desirable cutting planes.

The locating ring assembly

Figure 11 a and 11b have described the details of locating ring assembly 20.Locating ring 30 is provided with the vacuum chamber 36 of vacuum, makes that the eyeball of placing against this locating ring can be inhaled within it, makes keratectasia, and this cornea compresses pressing plate boots 50 usually then, shown in Fig. 7 a-7d.By vacuum connection tube 22 supply vacuum, the vacuum hose (not shown) is placed on the vacuum union joint 24 and by vacuum tube backstop 26 and stops.Alternatively, vacuum can be carried by ring support member 32 and driven unit 110, and with cancellation vacuum connection tube 22, vacuum hose 412 then is connected to driven unit 110 and preferably joins electric control cable 410 to.

With reference to upward view 11a and sectional view 11b, locating ring support member 32 preferably includes the keeper 34 with locating slot 35.Keeper 34 slides into recess 120 in the driven unit 110 and matches.The ball 117 of institute's mooring navigates in the locating slot 35 under the pressure of mooring spring 115, so that locating ring assembly 20 is correctly located.Then, thumbscrew 118 is keeper 34 fixedly, makes its side of the recess 120 in the head 112 that firmly is formed at driven unit 110 securely.(notice that Figure 11 a has omitted thumbscrew 114, it is arranged in the head 112 relative with thumbscrew 118, and is used for fixing Anchor plate kit).

As described about blade fork assembly 60 and pressing plate 40, various materials can be used for locating ring 20.This selection depend on whether be by the element relevant with method for disinfection to re-use or use aseptic disposable elements to guarantee aseptic.Suitable material comprises such as metals such as rustless steels with such as plastics such as Merlon, polysulfones, polypropylene.

Driven unit

Figure 12 and 13 shows the details of the preferred implementation of surgical operation unit 100, and shows the details of the preferred implementation of driven unit 110 especially, and its major part is by 160 sealings of driven unit lid.

With reference to Figure 12, the main actuator in the driven unit 110 is mobile motor 180 and rotary actuator 170.Mobile motor 180 is by gear train 182 driving shafts 184.Clutch 190 is couple to screw rod 192 with restricted moment of torsion.Threaded traveller 194 changes rotatablely moving of screw rod 192 into rectilinear motion.Pivot assembly 196 is couple to blade fork actuating arm 140 with the motion of the front end of traveller 194, allows the pivotally swing of actuating arm 140 around pivot assembly 196 simultaneously.Blade trip backstop adjusting knob 150 preferably rotates screw member, and adjustable ground stops blade fork the mobile of actuating arm 140.

Actuating arm 140 preferably includes its upper surface and bottom surface section, the two be made for almost parallel to each other and with controlled distance separately (upper surface and lower surface be on the direction of the pivot axis that is parallel to pivot assembly 196 from the surface farthest, center of actuating arm 140, upper surface is farther from locating ring 30).The upper surface of actuating arm 140 and lower surface preferably the flatness in the stroke range of their 1.5cm within 0.005mm, and by bearing surface 136 and 138 mooring slidably of driven unit head 112.Bearing surface preferably is restricted to 0.01mm with the gap up and down of actuating arm 140, perhaps more preferably is restricted to 0.05mm.

Driven unit head 112 keeps Anchor plate kits 40 and blade fork actuating arm 140, makes that when blade 66 moves blade is retained as with pressing plate boots 50 and leaves known distance, as above is described in the part of " blade fork assembly " at title.Between actuating arm and pressing plate installation surface, form the needed tolerance of accurate relative localization preferably by the placement pad or by head 112 machinings are formed (referring to Fig. 5,6).The position of the recess 108 of Anchor plate kit 40 is perhaps regulated in the position of the bearing surface 136,138 of this step scalable actuating arm 140.To the control of the blade trip of reality and pressing plate boots reference plane and depend on the accurate structure of the cutting head element that those are discussed in separately the part in the above.Be parallel in the embodiment of guiding piece 76 (not shown) of the blade 66 on the blade fork 70 in utilization, the distance between blade 66 and the pressing plate boots 50 preferably is controlled to be in ± 0.5mm, perhaps more preferably is controlled to be ± 0.25mm.

Swing can be applied to actuating arm 140 by the slide block of swinging 176 in the direction perpendicular to paper.Slide block 176 is interfered the edge of groove in the actuating arm 140, and groove allows actuating arm 140 shift-ins and shifts out driven unit 110 simultaneously.Slide block 176 receives wobble drive by axle 172 and cam pin 174 from rotary actuator 170.Cam pin 174 is located in the grooving in the slide block 176, and grooving absorbs the vertical component of cam pin 174, but transmits transverse movement.

In order to make corneal pocket form the opening of widening, the swing infeed stroke must little by little increase at the most of stroke that moves forward along with blade.In this embodiment, rotary actuator 170 is preferably stepper motor, and it does not move on whole semicircle, but direction conversion ground forms the camber line that increases gradually.

Figure 13 shows the optional embodiment that oscillating motion is applied to the device of actuating arm 140.In this embodiment, actuating arm 140 comprises ferromagnetic material 144, and it is subjected to along the effect in the magnetic field that the coil 175 of the sidepiece setting of actuating arm 140 is produced.Position feedback transducer can be used for accurately controlling the amplitude of teeter.In this embodiment, if does not feed back the use location, then preferably the actuating arm infeed stroke is controlled by the interference piece with inclined plane shape, it allows to extend and bigger stroke is arranged along with actuating arm, makes the trip along with actuating arm 100 extends and little by little is subjected to less restriction (promptly little by little increasing degree) from the surgical operation unit.

The optional embodiment of surgical device

Those skilled in the art will appreciate that many optional embodiments can be arranged in the scope of the present invention.Some possible versions of blade fork assembly have been discussed in the superincumbent blade fork components.The version of miscellaneous part is discussed below, probability is carried out exhaustive but do not represent, but they represent to have within the scope of the invention various widely mechanisms as example.

Blade is pitched all actual configuration that assembly is attached to the connecting interface surface of blade fork actuating arm removedly can be provided and realize predictable location required for the present invention.The component of interface is described as trapezoidal here or " dovetail groove ", but can take to have any form of locating features, comprises sawtooth, rectangle, eccentric elliptic, keyhole or other many shapes that must be difficult to enumerate.

Similarly, the device that is used for fixing connecting interface is depicted as thumbscrew here, but can be the cam lock bar, perhaps realize by means of following mode: magnetic attraction, spring load locating slot or are coupled to the fastener that reduces of the recess that partly is formed at each component.The closely any known method of predictable relation that two parts are fixed into separatably that can use in this area.

The preferred implementation of pressing plate comprises pivot, opens so pressing plate can pivot from cornea.The hinge of all known types and pivot are just in time within the scope of the invention.Flexible chain, cable, belt or rope can keep the pressing plate boots when rigid attachment is separated; Perhaps pressing plate can form retractible.

Can use and blade can be pitched at any blade of the position of good control with respect to the installation surface support of connecting interface.Blade fork not necessarily must be a fork, and can support from the single arm that is attached to driving mechanism rather than from the blade of both arms.

The cornea fastening can be locating ring as discussed above or pressing plate or prevent that eyes from moving the some other equipment that also allows to be touched by the corneal pocket blade cornea simultaneously in surgical operation.For example transparent cornea fastening can form and be similar to the batting helmet a little, and helmet is along pointing to the keratome driving mechanism, with allow to enter into cornea tissue and around the edge of cornea tissue and sclera to limit eyes securely.The inboard of this cornea fastening forms the bottom surface of aforesaid pressing plate, and this cornea fastening is arranged to be close in the middle part of cornea, for cutting.The top of this cornea fastening can be smooth, to hold the guiding piece 69 that is used for the corneal pocket blade, shown in Fig. 8 f.Thereby single cornea fastening can play preferred up till now locating ring and be in the same place with pressing plate.

A kind of corneal pocket blade assembly can also be provided, and it is for example guided by the ensuing groove that is connected to the cornea fastening rigidly.Thereby the present invention not necessarily is limited to blade and the supporting construction of describing in the mode of example here.

Preferred implementation of the present invention comprises aseptic disposable or can germ-resistant disposable cutting head element.The various nonrestrictive material that is suitable for this embodiment is chosen in and regards to each cutting head element and be described, and various cutting head elements do not need all to be disposable or all to be nonvolatil, and blended type also is fit to.

User instruction can be discerned in any known mode, comprises being arranged on surgical operation unit or other pick off or switches that makes things convenient for the reception phonetic order of position and detect user action.Thereby the instruction of being discerned can apply control by any combination of control element, and it can comprise machinery, direct electric control or intelligent electric-controlled system, and its intelligence is provided by any device known in the art.In fact instruction identification and control element can be positioned at any available position, and can major part or be placed on fully in the surgical operation unit as an example.

Lens

Figure 14 a-14e shows the numerous embodiments that is suitable for lens of the present invention.Inessential and preferably, lens have makes it remain on characteristic in the corneal pocket.In many situations, such as when the essential astigmatism, ideally, lens are in case insert and just keep its given orientation.

Figure 14 a is illustrated in and is roughly the lens that have refractive material 202 in the circular periphery 204.Be slidingly matched in order to transmit oxygen and to form in corneal pocket, ideally, these lens are made by water wetted material, and it a bit expands with hydrate the time.For example this material of hydrogel is used for some present contact lenses.Thereby lens can be fully and hydrate flexibly be engaged in the capsule bag, perhaps dehydration at least in part makes follow-up hydration help to make it to be fixed on cooperation in the capsule bag.

Figure 14 b shows preferably semirigid lens, makes interference piece 206 to interfere with cornea tissue, thereby prevents that it from losing or move in corneal pocket.The example of another shape of position skew after Figure 14 c shows and can be used for preventing to insert.In the reality, feature 206 is not a wedge angle.

Because its limited refractive index and limited thickness, the lens shown in Figure 14 a-14c are limited in the scope of the vision correction that they can work to a certain extent.This lens are being restricted aspect the ability of its rectification presbyopia especially.Lens shown in Figure 14 c are Fresnel lenses, and comprise a series of annular lens components 208 between periphery 204 and middle body 209.Fresnel lens still can be used in the cornea tissue that can not stimulate epithelial surface because its rigid surface may not be suitable for the contact-type lens on anterior corneal surface.It is useful especially correcting presbyopia by the refraction wider and control that Fresnel lens allowed for method and apparatus according to the invention.Certainly, Fresnel lens can also have the retention performance shown in Figure 14 b and 14c; And self will prevent lateral displacement the annular ridge of Fresnel lens.

Lens with single focal length are enough to correct simple myopia or hypermetropia usually, and can be used for realizing the present invention certainly.Yet the lens that refractive index or lens shape change or the both changes can be advantageously used for parts of the present invention to form multi-focus lens.The focal length of this lens is not constant, but changes along with the expansion of lens.This many focuses property can be used for compensating presbyopia, if light source is when far, and by making a part of light enter eyes focusing on, and when light source nearly (in reading time), the light focusing of other parts.The focal length of the variation of the annular surface of lens can be used for astigmatism.The present invention can be embodied as the many focal length lenses of use, to correct or to compensate the combining form of various defectives simultaneously, comprises myopia, hypermetropia, astigmatism and presbyopia.

The effect of this different focal lens depends on the reliable location of lens provided by the present invention, avoiding the erroneous arrangement of lens, and simplifies the adaptability of many focal lengths by the vision treatment facility.For example astigmatism can reduce preferably compensating less than the zonule of 3mm diameter of lens by focal length is set at CC.This location will hour have better effect (for example usually when reading) when pupil under the high optical condition, and under the light conditions such as nighttime driving, correspondingly have relatively poor effect when pupil is big.Thereby lens must be kept with respect to the position of pupil, and brain will more easily adapt to the non-homogeneous focus that is at least constant eyes.

Many focuses property can realize by using aforesaid Fresnel lens, perhaps uses the non-Fresnel lens of the refractive index of refraction shape with variation and/or variation to realize.Have the refractive index of variation shown in Figure 14 e and having the cross section of both non-Fresnel lenses of refraction shape of variation.The lens of Figure 14 e are preferably made by hydrogel material, and the refractive index of this material is changing annular ring to middle body 234 from outside annular ring 221.(vertical view of this lens will demonstrate and be very similar to Figure 14 d; Can there be line between the annular section, but invisible.)

For example, the refractive index of lens material slightly changes between each adjacent annular section of lens by the water content that changes lens as known.For example, outermost annular ring 221 can have very high water content, and refractive index be about 1.37 (with coupling around the refractive index of cornea tissue).The most inboard part 234 of lens has lower water content, and refractive index is about 1.46.Between the two refractive index between adjacent part with about 0.01 refractive index step change.Thereby the refractive index that the refractive index of annular ring 221 is about 1.37, the second outermost circles 222 is 1.38, and the refractive index of each annular ring increases constantly, and up to annular ring 230, its refractive index is about 1.46.This higher refractive index has strengthened refraction feature 214, makes short focal length be subjected to this feature affects.Then, as mentioned above, the refractive index of annular ring 231 is about 1.445, the circle 232 be about 1.43, the circle 233 be about 1.445, middle body 234 be about 1.46.The representative size of the lens of Figure 14 e is middle body 234 diameter 0.9mm, and the radius of each annular ring 221-220 and 232-233 is 0.15mm; And the radius of annular section 231 is 0.75mm.

Change of refractive can strengthen by the lens contour feature such as 210,211,212,213 and 214 focal length variations that caused on the whole lens.For example feature 210 provides focal length to reduce part at CC, and as mentioned above, ideally, this is compensating presbyopia by the zone that produces ' reading ' focal length in pupil center, and this effect strengthens by the higher refractive index of the ratio of middle body 234.Feature 212 and 214 can provide another circle of short focal length, perhaps can be used as the part that the anchor ring of focus changes, and with the astigmatism defect of compensation patient's eyes, and this effect can get help by correspondingly changing in the refractive index of lens material once more.The actual selection that it will be understood by those skilled in the art that the refraction profile depends on the defective for the treatment of corrigent eyes, and Figure 14 e only demonstrates out the combination of refractive index and profile variations.

As mentioned above, refractive index is lower than cornea tissue change of refractive form, is reducing advantageous particularly aspect the edge glare effect.Light returns (have the roughly interface of discontinuous refractive index, light is sentenced acute angle incident at this) from the edge of lens, and causes and dazzle the eyes owing to this at random light basically enters into eye.Yet, by forming the rims of the lens of coupling around the refractive index of cornea tissue, light this reflection or that return and causedly dazzle the eyes and can reduce or avoid.

The annular ring of refractive index variable can form with the tubular portion that forms lens material by the material of using pantostrat, and single lens can be from this tubular portion cutting.After each pantostrat material is arranged on the core, should realize lens material crosslinked of adjacent part, so that various piece fuses; This for example can realize by ultraviolet or other high-energy radiations.In the lens of Figure 14 e, exemplary size comprises that diameter is the middle body 216 (high-index material) of 3mm.10 annular rings that each 0.15mm is thick are reduced to the refractive index stepping refractive index of cornea on the radius of 1.5mm, make that the overall diameter of lens is 6mm.

The further embodiment of capsule bag keratome

In U.S. Patent No. 6,623, having discussed in 497 does not need further developing of the capsule bag of pressing plate keratome, and its content is incorporated herein for your guidance (referring to related application above).

First embodiment of capsule bag keratome

In further developing, the present invention is a capsule bag keratome, and it will cut the capsule bag that can insert lens or other equipment in cornea.

Capsule bag keratome has blade support member and guiding elements, and it is configured to single-piece, and on the driving mechanism that is installed in type as mentioned above, this mechanism can drive forwards this capsule bag keratome when traverse motion.Here employed term " single-piece " is meant that it is made by a material, and this material is preferably rustless steel.Particularly, this blade support member and guiding elements are made by one.Blade is installed on the blade support member, accurately to locate with respect to guiding piece.And be provided with aforesaid centring ring.

According to the main purpose of capsule bag keratome, blade support member and guiding elements are configured to when blades, and it can very accurately control the controllable degree of depth of otch in the cornea.The degree of depth of otch is controlled to the size of the distance of blade by limiting guiding elements.These distances are the vertical distance of blade edge under guiding surface and the spacing of the rear portion peripheral surface of blade edge and guiding piece.

The embodiment of capsule bag keratome has been shown among Figure 21-28.Blade assembly is similar to above-mentioned blade assembly in some aspects.For this illustrative purposes, blade cartridge assembly 500 comprises support member 502, blade 504 and screw 506.Box 500 has front portion 508 and rear portion 510, and the two is connected together with 512 (b) by post 512 (a).

The rear portion 510 of blade assembly has cloudy dovetail groove structure, is used to be attached to above-mentioned driving mechanism.It also has the blade support post 514 that is positioned at central authorities that dangles.Grooving 516 forms the bottom surface 518 of passing dovetail groove, and separates and enter into blade support post 514.Grooving 516 allows the dovetail groove bending, makes it to be engaged on the driving mechanism nearly and accurately.

Post 512 is 510 spaced apart and extend to anterior 508 from the rear portion with downward gradient.Anterior 508 have following clearing end 520a and 520b.Horizontal expansion is guiding piece 522 between infra clearing end 520a and the 520b, and its end 524a and 524b are attached to down clearing end 520a and 520b respectively.Guiding piece 522 has leading edge 526, and transitional surface 528 extends to smooth lower surface 530 from this leading edge, and laterally extends through guiding piece 522.What laterally be positioned at guiding piece 522 centers is hole portion (well) 532, and it is semicircle, and combines with rear surface 534a and 534b at either side.Hole portion 532 laterally aligns with the grooving 536 at place, blade support post 514 bottoms, and following institute further explains.

The grooving 536 of blade support post 514 bottoms has surface 540 and the relative 542a of wall portion and 542b and screw 544.

Box 500 has blade 504.Blade 504 has the assembly fixture 546 that has hole 548 in its back-end and extends and end at the axle 550 of blade 552 forward.Blade 552 snaps to and is positioned at the place, end of lower surface 554.At blade 552 rears is fillet 560a and 560b, and it is set to be used for making blade 504 to enter cornea smoothly.Blade 504 has contact shoulder 556, and it helps to realize the accurate location of desired blade 504.Blade 504 is fixed to support member 502 by the screw 506 that is screwed in the screw 544.Blade has lower surface 558.

Blade 552 forms with hole portion 532 concentricity, is semicircle in this exemplary form.Knife-blade is extended with the semicircles of about 180 degree identical with hole portion 532, and tolerance be+0 with-10 °.

Support member 502 is processed by the single-piece stainless steel machinery.This makes only has two cumulative limits to determine the spacing of knife-blade 552 and hole portion 532.In equipment, realize tolerance very closely in this way.This makes to have very high precision and concordance when forming corneal pocket.In this embodiment, knife-blade 0.300mm+0 at interval below hole portion 532 ,-0.025, and with hole portion 532 at a distance of 0.5mm ± 0.02.The depth of cut of the capsule bag in the clearance control cornea that between the inferior horn of hole portion 532 and knife-blade 552, limits thus.Can make this equipment have enough precision, thereby in formed corneal pocket, can realize very accurate with the consistent degree of depth.

And, by the elongated shaft 550 that is provided for blade 504, and being fixed in the rear portion of the support member 502 on the post 514, blade 504 can enter away from eye center and near the cornea of cornea periphery.This makes the center of otch away from more benign cornea that enter of corneal pocket.

In use, box 500 is installed to driving mechanism, and it also has aforesaid locating ring.This locating ring is by the eyes of suction fit to the patient.Cornea attracts outstanding amount will determine that knife-blade 552 enters into the point of cornea on ring.As mentioned above, deep well entrance is provided by elongated shaft 550 now.When driving mechanism move forward and from a side when opposite side is swung, cornea is ready to below guiding piece 522, so that blade 552 enters.Blade 552 and the spacing of hole portion 532 will be determined the degree of depth of capsule bag otch, and the obtainable tolerance of this spacing is more little, and the accuracy and the concordance of the degree of depth of capsule bag that enters into cornea is good more.The amplitude and the blade width of swing will finally be determined the width of capsule bag otch.

Optional capsule bag keratome

An optional embodiment of the keratome of corneal pocket has been shown among Figure 29-35.As previously mentioned, this embodiment is coupled to aforesaid moving forward and the driving mechanism from a side oscillation to opposite side; And has a locating ring.

Blade cartridge assembly 600 has support member 602, blade 604, screw 606 and alignment pin 608.

Support member 602 has rear portion 610, and it has dovetail groove structure 612, so that it is attached to driving mechanism.What extend below dovetail groove 612 is blade support post 614, and it has the installation surface 616 that blade 604 is installed.Post 618a that is spaced laterally apart and 618b 610 extend to down clearing end 620a and 620b from the rear portion.What support between infra clearing end 620a and the 620b is guiding piece 621, its have crooked, be preferably circular transitional surface 622, this transitional surface 622 be attached to extend back and end at the bonded hole of trailing edge 28 portion 626 in lower surface 624.Hole portion 626 is preferably circle and extends to semicircle.

Blade 604 has attachment area 630, and it extends vertically, and by using screw 606 and alignment pin 608 to be coupled to vertical installation surface 616.The axle 632 that ends in the blade 634 extends to attachment area 630 with the right angle.According to the situation in the aforesaid embodiment because blade support post 614 relies on rear portion 610, thereby and separate with hole portion 626, long capsule bag is possible and allows the center of inlet point away from cornea.Blade 634 is slightly wideer than the width of axle 632, and extends 180 degree with semi-circular shape.Blade 634 is formed by double inclined plane 636 and 638, and has fillet 640 and 642.

Support member 602 is by single-piece stainless steel machinery processing, and it is of a size of blade 634 0.15mm ± 0.025mm below the lower surface 624 of guiding piece 621, and concentrically with 626 spacings, the 0.5 ± 0.1mm of hole portion.

Capsule bag keratome uses in same as mentioned above mode.Locating ring is set in correct position, and is outstanding thereon to allow cornea, and begins to drive to push ahead box 600, moves to opposite side ground from a side oscillation simultaneously.Guiding piece 621 is prepared cornea, makes it accurately locate, thereby makes blade 634 enter cornea with controlled, accurate with the consistent degree of depth.

Another optional capsule bag keratome

Another optional form of capsule bag keratome has been shown among Figure 36-41.

As the above-mentioned form of capsule bag keratome, this form has blade cartridge assembly 700, and blade cartridge assembly 700 has support member 702, blade 704 and screw 706.

Support member 702 has rear portion 708, and it has the dovetail groove structure, so that it is attached to driving mechanism.That 708 extensions downwards is isolated post 710a and the 710b that ends at clearing end 712a and 712b from the rear portion, has screw or hole in this clearing end, to allow closely cooperating of holding element.Guiding piece 714 horizontal expansion between clearing end 712a and 712b.Here support member 702 and guiding piece are made by single-piece once more, are preferably processed by the single-piece stainless steel machinery.The leading edge 716 of guiding piece 714 is straight and has camber line 718 guiding cornea below its lower surface 720 in its lower edge, to prepare to be used for the cornea of blade inlet.The trailing edge of guiding piece 714 has the hole portion 722 that is limited by protuberance 724a and 724b.

Blade 700 has attachment area 726, and it has crooked shank 728a and 728b, is attached to clearing end 712a and 712b in its distal-most end by screw or drive installation post etc.Shank 728a and 728b are attached to central shank 730, and should be bowed downward to backward curve 732 then by central authorities' shank 730.Blade shaft 734 extends forward, ends at blade 736.Blade 736 is circular and slightly is wider than axle 734, and is bibeveled.

During assembling, knife-blade 736 will be coupled to hole portion 722 concentrically.Its will be below lower surface 720 0.15 ± 0.025mm, and concentrically with 722 spacings, the 0.50 ± 0.025mm of hole portion.

As mentioned above, when driving mechanism moves forward blade cartridge assembly 700 and makes it when a side direction opposite side is swung, guiding piece 714 is pressed in cornea is contacted with lower surface 720, prepares the blade inlet of cornea in the use.Then, the degree of depth that knife-blade 736 is determined with the size of tight maintenance, as one man and can expectedly cut the capsule bag, this size limits the lower surface 720 of hole portion 712 and the space between the knife-blade 736.

Disclosed herein is illustrative embodiments of the present invention.Thereby, be to be understood that under the situation that does not depart from the appended the spirit and scope of the present invention that claim and equivalents thereof limited, can obtain various modifications, substitute, modification etc.Certainly, appended claim attempts to cover literal scope and the interior all such modifications of equivalents thereof that fall into claim.

Claims (11)

1. a corneal pocket blade assembly that is used for the corneal pocket keratome comprises

The keratome chip module, it comprises;

Support member and blade, this support member is made of from one piece, and comprises the guiding piece on the front portion of this support member, and this guiding piece laterally extends through the path to front travel, and this guiding piece has transitional surface and is positioned at the hole portion of its rear surface;

Blade is installed on this assembly, has blade at front end, and this blade and this hole portion are spaced apart concentrically, with the rear of this hole portion and below form predetermined space.

2. a corneal pocket keratome comprises

The keratome driving mechanism, it supports the described corneal pocket blade assembly of claim 1, and said mechanism comprises;

The main driving machine structure, with this blade assembly of driving in the path forward of stroke, and transversal driving mechanism, when it is driven forwards, this blade assembly is laterally swung;

The cornea limiting device.

3. a method of cutting corneal pocket comprises

The keratome of corneal pocket as claimed in claim 1 is provided;

This cornea limiting device is applied to eyes, so that this cornea is limited thereon, this blade support assembly is set to be used for this blade and enters this cornea, and this guiding piece is prepared this cornea in this blade the place ahead, make this blade enter this cornea, and move in this cornea of being prepared by this guiding piece along straight line, the degree of depth of this capsule bag is determined by the predetermined concentric space of this blade at this subordinate side, hole and rear.

4. corneal pocket blade assembly as claimed in claim 1, wherein said further support member has backward and this isolated rear portion of hole portion, and described rear portion has the part that is used to install this blade, and this blade has the axle that extends forward and end at this blade.

5. corneal pocket blade assembly as claimed in claim 1, wherein said further blade is at the place of clearing end forward of the axle that extends back.

6. corneal pocket blade assembly as claimed in claim 1, wherein said further blade is at the clearing end place of blade shaft, and this blade shaft has one or two in upper surface or the lower surface, and this blade aligns with this upper surface or lower surface.

7. corneal pocket blade assembly as claimed in claim 6, wherein said blade shaft has lower surface, and described blade aligns with described lower surface.

8. corneal pocket blade assembly as claimed in claim 5, wherein this lower surface of this guiding piece extends to each side and the horizontal clearing end of this hole portion, and should hole portion be circular, and it extends upward and is bonded to either side with the rear surface from this lower surface.

9. corneal pocket blade assembly as claimed in claim 5, wherein said transitional surface are crooked in horizontal plane, and be cup-shaped to form.

10. corneal pocket blade assembly as claimed in claim 5, wherein said transitional surface be roughly horizontal expansion as the crow flies between transverse end.

11. corneal pocket blade assembly as claimed in claim 5, wherein said hole portion is limited by the protuberance at this trailing edge place of this guiding piece.

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