CN1269462C

CN1269462C - Positioning assembly for retaining and positioning cornea

Info

Publication number: CN1269462C
Application number: CNB018233996A
Authority: CN
Inventors: 约翰·F·海伦坎普
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-04-25
Filing date: 2001-04-25
Publication date: 2006-08-16
Anticipated expiration: 2021-04-25
Also published as: KR20040010629A; EP1389066A1; CN1520275A; CA2445318A1; KR100752822B1; JP2004525723A; EP1389066A4; AU2001259137B2; WO2002087451A1; BR0117001A; CA2445318C; MXPA03009827A

Abstract

The present invention relates to a positioning device (10) for maintaining and positioning an eye cornea is a surgical operation process and partly exposing the eye cornea at least, and the eye is positioned in a narrow eyepiece passage in a latitudinal direction. The positioning device (10) comprises a positioning section (20) and a flange element (24), wherein the positioning section (20) comprises a maintaining plate (23) with an orifice (25) limited into the maintaining plate (23), the orifice (25) is used for containing and exposing the eye cornea (C), and the flange element (24) surrounds the orifice (25) and is isolated with the radius of the latitudinal direction in an approaching distance to match with the eye. The positioning device (10) also comprises an air sucking device (30) which is connected with the positioning section (10) and is used for temporarily attaching the positioning section (20) to the eye at least, the air sucking device (30) comprises a vacuum hole (32) which vertically extends from the positioning section (10) and leaves a guide rail (40) integrally arranged on the maintaining plate (23) to form an angle outwards, and consequently, an arc cutting path for a cutting head device (15) of a micro cornea knife is limited. The present invention is also provided with a pivoting device which comprises at least one upright post element (50) which limits a pivot shaft which is surrounded and pivoted by a connecting device, and a cutting start control device is arranged on the upright post element (50) and is used for limiting the starting movement of the cutting head device (15) and a corresponding cutting starting point.

Description

Be used to keep and locate the positioner of cornea

Background of invention

The application be based on submitted on April 29th, 1997, application number be 08/840430, the continuous patent application of the U.S. Patent application of unexamined at present; This application number is that 08/840430 application is that to submit pending trial, application number on February 7th, 1996 be the continuous application of 598180 patent application, and this application number is that 598180 patent application is authorized on April 29th, 1997 and is U.S. Patent No. 5624456.

Invention field

The present invention relates generally to a kind of medical apparatus and instruments that in ophthalmic surgical procedures, uses; Especially, relate to a kind of air-breathing ring of improvement that is also referred to as positioner, be used for cutting cornea for example proofreading and correct ametropic surgical procedures maintenance, location and exposure patient's eye.More particularly, the present invention relates to a kind ofly be easy to assemble and positioner safe in utilization, the potential danger that this positioner will cut eyelid and/or eyes improperly drops to minimum, can also realize and remain on the eyes effectively adhering to, even can realize and remain on effectively adhering on the narrow eyes of latitude direction eyepiece path; In the middle of some individual, special the most remarkable but not exclusively be in the middle of child and Asia blood lineage's people, it is narrow latitudinal eyepiece path to occur.

Description of Related Art

The operation principle and the photographing unit of eyes are closely similar, and wherein iris or eyes are similar to shutter around the function class of the band color part of pupil, are used to regulate the light quantity that allows to enter inside ofeye.Eye's cornea or saturating window, and the crystalline lens of pupil back are used for the light beam from the observing object body is focused on the retina at eyes rear portion.Retina is given brain by optic nerve with the image transfer of observed object then.Usually, these light beams will accurately focus on the retina, can obviously and be clear that distant objects like this.But in visual process, can produce ametropia with departing from of the normal shape of anterior corneal surface, thereby eyes can not be with the image focusing of distant objects on retina, it is image blurring that the result makes that the people sees.

Many years ago, can only solve this ametropia by common spectacles or contact lens, the two all has known shortcoming for user.But from that time, developed the refractive status that surgical operation changes eyes.Design some kinds of methods and specific apparatus and finished this surgical operation that relates generally to the cornea shaping.The purpose that is appreciated that the cornea shaping is to revise the curvature of cornea, and promptly the situation according to the patient reduces or increase its curvature, thereby, by the light beam of cornea, directly focus on or converge on the retina through flexion, thereby make the patient can be clear that distant objects afterwards.

Wherein a kind of surgical operation is a keratomileusis; It need by cutting with separates cornea tissue that skim is called cornea flap, process this cornea tissue and afterwards the cornea tissue after the shaping is sewn onto position in the eyes again, carry out accurate cornea shaping.But keratomileusis is considered to have some shortcomings, is therefore abandoned in recent years.Automatically anterior lamellar keratectomy (ALK) is the another kind of surgical technic that grows up from keratomileusis.In the ALK operating process, at first eyes are anaesthetized with an anesthetis, then a device with loop configuration is placed on the eyes, with cornea location (being called " centering " in this area), this cornea will use miniature surgery instrument very small, that be called micro-keratome to cut carefully.Micro-keratome generally is a blade bogey, must be with hand propelled ground or Mechanical Driven ground incision cornea in the cutting path of transannular shape device.In the ALK operating process, in order to treat myopia, the general cornea that at first cuts and promote skim with micro-keratome, rather than cut off it, corneal is carried out shaping by making micro-keratome pass through cornea for the second time then, cutting element is adjusted to a required and predetermined CD simultaneously and passes wherein.Afterwards, the thin layer cornea tissue of raising is reapposed on the position on the cornea and recover.

Other great progress are being arranged in the art.For example, a kind of laser corneal of using is carried out operation shaping and/or shaping, that be called Laser in Situ Keratomileusis (LASIK), having become more and more is accepted as a kind of safety, no pain and operation fast and effectively that is used for the correct vision problem, and wherein said visual problems is such as but not limited to myopia, hypermetropia and regular and irregular astigmatism.It is best that lasik surgery is considered at present, because it can corneal carry out moulding and not damage adjacent tissue, also because assisting down at computer, can be by the tissue mass that the surgeon programme to laser and control is more accurately removed, and allow more selection significantly and come corneal to carry out shaping.In the LASIK process, generally will eye location in a ring device, generally, cut and raise the cornea tissue of skim, thereby the bottom that exposes eyes is treated with laser also to use the micro-keratome cutter head device as initial step.The so-called keratectomy of the cutting of the cornea tissue of thin layer, under the most common situation, will cut " cornea flap " so that the tissue hinge portion attached on the cornea; But also have the special circumstances that " free flap " downcut, wherein the layer of raising of cornea tissue breaks away from eyes.

More specifically turn to how eyes to be remained on the lasik surgery desired position, use above-mentioned ring device usually, and it temporarily is attached on the eyeball by suction or vacuum.Like this, this device often is called air-breathing ring, common air-breathing ring comprises that a circular hollow ring that defines a center port and one have standard-sized uncovered bottom side, wherein this aperture allows cornea therefrom to pass and comes out, and this bottom side is configured to and the surface engagement of eyes around cornea.Air-breathing ring generally communicates the uncovered bottom side fluid communication of this suction nozzle and this ring with the suction nozzle of a hollow.Usually use suction nozzle to add general relative vacuum between 20 to 28 inches of mercury, under this feasible externally atmospheric effect air-breathing ring is pumped on the eyeball to these air-breathing circulating application.Like this, air-breathing ring is attached on the surface of eyes around cornea, applies suction and with rational reliable fashion environmental protection is held on the eyeball in whole LASIK process.As a result, air-breathing ring becomes device commonly used in the ophthalmology operation, it should be noted, serves a large amount of patients thereby it is designed to reuse in its service life.

Although the use of this air-breathing ring is very common in the art, they still have some shortcomings.For example, the structure of known air-breathing ring and size can not easily cosily and/or correctly be positioned at them in many people's the eyepiece path.More specifically, determined that there is some physical trait in some people, particularly child and Asia blood lineage's people, the zone that causes placing air-breathing ring is restricted slightly.For example, these people's eyepiece path is narrower, and/or can not open eyes as other people widely, particularly at latitude direction and/or above-below direction.This restricted path causes difficulty because being used for the surf zone deficiency of the air-breathing ring of correct unchangable traditions to the doctor who carries out surgical operation such as LASIK on eyes through regular meeting.

The result makes, a kind of micro-keratome device and particularly a kind of air-breathing ring of improvement that uses with this micro-keratome device are provided, and will be useful especially; This improves the eyes that air-breathing ring is specially adapted to all patients, is included in the less patient of latitude direction eyepiece path.But the air-breathing ring of being developed of any this improvement should be effectively and cosily is fixed on the expose portion of patient's eye, still exposes and present simultaneously the enough degree of depth and/or the diameter of cornea, is used for being cut by the micro-keratome cutter head device.In addition, if develop any this improved air-breathing ring, then it is configured to be highly profitable with following this cutter head device use effectively; This cutter head device is configured to along cutting as a disclosed curved path in the U.S. Patent No. 5624456, and many people think and carry out the corneal ablation best results with it, even also can not influence cutting process and/or reduce its precision in the zone of limitation more or eyepiece path.

Should also be noted that conventional air-breathing ring may be difficult to make and/or assembling, particularly in given safety and more be difficult to make and/or assembling when effectively using necessary degree of accuracy in the ophthalmic surgical procedures.If the air-breathing ring that develops is applicable to the less eyepiece path that has usually in child or Asia blood lineage people, then must address these problems equally satisfactorily.Therefore, it will be useful providing following this improved air-breathing ring or positioner; This air-breathing ring or positioner all required parts be integrated into one efficiently, in streamlined and the compact structure, this structure can be accurately and accurately manufacturing, and still can be safely and accurately use the micro-keratome device.At last, the following this improved air-breathing ring of exploitation then is useful equally; This air-breathing ring can guarantee reasonably that the micro-keratome cutter head device begins corneal ablation in identical with respect to eyelid and/or cornea one and quite accurate position in the corneal ablation operation process, thereby avoids taking place the probability of incorrect cutting.More particularly, it is useful providing following this improved air-breathing ring or positioner; This air-breathing ring or positioner do not allow to begin to cut an otch, unless cutter head device is properly oriented.

Summary of the invention

The present invention is configured to these and other needs of being devoted to exist in the prior art, relates to a kind of improved air-breathing ring; More specifically, thus relate to and a kind ofly be used for keeping and position patient eyes cornea carries out operating positioner thereon.Positioner of the present invention is specially adapted to eyepiece groove or eyepiece path at least in one embodiment the narrow patient of latitude direction, promptly as in child and Asia blood lineage people, find usually, corresponding to the patient of narrow dimension of direction nictation.In addition, although the present invention is applicable to any patient's eyes, it is generally acknowledged to be applicable to human eyes.

More particularly, the present invention relates to a kind of positioner, be used for eyes being exposed at least in part, locating and keep at surgical procedures.Therefore, this positioner preferably is mounted to the part of micro-keratome device, and the result makes and can be used in combination with the micro-keratome device that is configured to form otch and/or stride the eyes cutting in eyes, no matter whether this can cause producing cornea flap.This positioner comprises a location section, and this location section is configured in surgical procedures eyes be kept and locate, thereby cornea is remained on the position of correct exposure in whole process.Like this, above-mentioned location section comprises a holding plate.This holding plate is a general plane structure preferably, and comprises an aperture that is limited to wherein.This orifice structure becomes to hold therein eye's cornea and it is exposed, thereby roughly limits the zone that will cut; In a preferred embodiment, this aperture roughly be positioned on the holding plate center or among.

The location section also comprises a flange component.This flange component roughly dangles downwards from holding plate, and with preferably around the setting that concerns of aperture sealing.Like this, flange component is configured to cooperate with eyes along its bottom margin at least basically.Therefore, between the bottom margin of aperture, flange component and the ocular surface of between it, extending, roughly define a vacuum chamber.Flange component of the present invention also preferably is arranged at least roughly spaced apart with relative close distance with the aperture of location section along its latitude direction radius.The result makes, at patient's eyepiece passage under the narrow situation of latitude direction, need be in order not realize locating effective contact between section and the eyes, and enough cornea amounts are exposed between the aperture and expose too many ocular surface via the eyepiece passage.

Positioner of the present invention also comprises a getter device at least in part.Especially, getter device preferably operationally links with above-mentioned location section at vacuum chamber, thereby at least temporarily above-mentioned location section is attached on the eyes.Particularly, above-mentioned getter device comprises a vacuum port, is connected between vacuum chamber and the external vacuum source this vacuum port fluid flow communication.The result makes, applies suction on vacuum chamber, effectively positioner is fixed on the eyes.Different with the vacuum port of traditional vertical orientation, this vacuum port leaves the vertical axis in aperture and outside angulation at least in part, thereby as below describing, is provided for the effective clearance that the micro-keratome cutter head device moves but preferably.

In preferred embodiment of the present invention, positioner of the present invention comprises a guide rail.This guide rail is preferably integrally formed with the location section, and further defines one and be preferably arcual cutting path, and this cutting path to small part is striden and is limited to the aperture in the holding plate and guides the micro-keratome cutter head device.This guide rail preferably extends beyond the above-mentioned holding plate of above-mentioned location section in the latitude direction, and preferably closely is provided with near vacuum port.Like this, vacuum port leaves guide rail and the outside attribute of angulation, has guaranteed that the suction nozzle that connects with vacuum port or similar structures can not disturb the mobile of the cutter head device that links with the guide rail operation.

In addition, this positioner preferably includes a pivoting device and associated coupling member.Particularly, this pivoting device defines a pivot that is used for cutter head device, and described pivot preferably extends across the aperture and arc moves, and this aperture is at least by guide rail, preferably limited by pivot device.Preferably, comprise an oriented stud members that limits above-mentioned pivot in the pivoting device, cutter head device rotates around this pivot; At least be used for this purpose, connection element interconnects oriented stud members and above-mentioned cutter head device pivotally.But above-mentioned pivoting device also comprises a cutting start control.This cutting start control is configured to limit at least one starting point, and this starting point is used for above-mentioned connection element and correspondingly is used for the exercisable pivoting action of beginning that cutter head device is striden the location section.The result makes it possible to guarantee Xiang the doctor, and cutter head device only cooperates with eyes at the edge in correct point such as aperture and begins to form otch, and general can by mistake location the and begin to form otch at the intermediate point place of exposure cornea.

In the detailed description and relevant drawings of back, these and other features of the present invention have been described in further detail.

Brief description

In order to understand essence of the present invention more all sidedly, should be with reference to the detailed description of doing below in conjunction with accompanying drawing, wherein:

Fig. 1 is the perspective view of positioner of the present invention.

Fig. 2 is the cutaway view of positioner of the present invention.

Fig. 3 is the coupling arrangement of positioner and the decomposition diagram of the micro-keratome cutter head device that links.

Fig. 4 is the separate sides view of the oriented stud members of pivoting device of the present invention.

Fig. 5 is the vertical view of oriented stud members.

Fig. 6 is the cutaway view of coupling arrangement.

Fig. 7 is the vertical view of positioner of the present invention, and wherein oriented stud members and coupling arrangement are not connected on it.

Fig. 8 is the exemplary plot that suitably is arranged on patient's the corresponding eyes, the micro-keratome device of positioner of the present invention is housed.

Fig. 9 A-9C is one group of precedence diagram, shows the normal cutting path that is used for the micro-keratome device, and positioner wherein of the present invention preferably links with the micro-keratome device.

In some views of whole accompanying drawings, identical reference number is represented identical parts.

DETAILED DESCRIPTION OF THE PREFERRED

As shown in whole accompanying drawings, present invention relates in general to a kind ofly improvedly be used for patient's eye, be preferred at surgical operation the patient's eye cornea that is cut being kept and positioning means for positioning, wherein this positioner is generally represented by Reference numeral 10.More specifically, the present invention relates to a kind of compactness, assembling and higher, the safer and more stable positioner 10 of the accuracy of manufacture more, this positioner 10 not only can be used for general patient, and can be used for the patient that the eyepiece path diminishes on the latitude direction effectively, wherein eyes are contained in the described eyepiece path.Especially, the eyelid that the eyepiece path is commonly defined as eye socket and links, but they all limit and/or limit the exposed region of the patient's eyeball that for example is used for being fastened on the positioner.In some cases, be for child and patient more at large with Aisan's facial characteristics, the eyepiece path presents than the littler latitude direction size of normal value (for the needs that illustrate, latitude direction dimension definitions is the size up and down with respect to patient's contours of the face, the last eyebrow that refers to towards the patient, the following lower jaw that refers to towards the patient).The result makes that conventional positioner generally can not match with the latitude direction side of eyeball fully.Naturally, such restriction causes centering incorrect, and/or the cornea that is used to cut of coming out is less.As described below, the invention provides a kind of compact structure more, this structure not only is of value to the situation that the eyepiece path diminishes on the latitude direction, and because multiple reason comprises that assembling easily and precision height, safety and stablize etc. and be of value to usually eyes are carried out surgical operation in cutting process.

Positioner 10 of the present invention preferably uses together with the micro-keratome device of describing for example but in the U.S. Patent No. 5642456 that needn't be identical, and quotes this United States Patent (USP) here as a reference.As shown in Fig. 1,2 and 7, positioner 10 comprises a location section 20 that is also referred to as the eye location ring.The ring structure that location section 20 preferably includes a sealing with farthest with the cooperating of eyes, and be used for the centering eyes, promptly to be used for the cornea that the accurate and aligned mode of surgical operation keeps, locatees and correctly present patient's eyeball.Thereby location section 20 has a main body, comprises in this main body and defines a preferred blind bore mouth 25.Aperture 25 is sized to have the predetermined degree of depth, and holds and allow eye's cornea C therefrom to pass and come out, in order to cut in surgical procedures.Usually, in surgical procedures,, be moved through the surface of location section 20 and then during through the cornea C that exposes, cornea C will be cut when micro-keratome cutter head device 15, the part of micro-keratome device preferably; As shown in the drawing, aperture 25 is passed in the cornea C projection.The gravel size decision in aperture 25 self is defined as exposing the cornea of q.s, thereby can cut roughly about 7.5 to 10 millimeters diameter.Location section 20 is preferably made by rigid material, and is preferably made by metal material.But ideally, location section 20 is made by high-grade stainless steel; This high-grade stainless steel can strengthen and the cooperating of eyeball, and can make the surface smoothness with level and smooth, safety and dazzle sluggishness, and makes and be easy to sterilization.According to these principles, although this positioner can be made into disposable use, is made of a variety of materials and/or by plastics or metal-molding, in the embodiment shown, positioner 10 preferably is processed into and reaches general required degree of accuracy and quality.

As shown in the drawing, the main body of location section 20 preferably is defined as a circular shape around the aperture 25, but is appreciated that it can be made into other shapes that have around aperture 25, as square, rectangle, hexagon or other shapes, and still play a role for predetermined purpose.In addition, whole positioner 10 preferably is configured to one and is roughly teardrop type shape.In a preferred embodiment, the main body of location section 20 comprises a holding plate 23, it comprises the aperture 25 that is limited to wherein, and preferably also comprises a flange component 24, and this flange component 24 roughly extends downwards and defines one to roughly uncovered bottom side, main body 22 ground from holding plate 23.Ideally, flange component 24 be limited to aperture 25 in the holding plate 23 spaced apart and roughly ring formation around relation and be provided with.In the preferred embodiment, the flange component 24 of location section 20 preferably includes a bottom margin 27 equally, and these bottom margin 27 structures also are arranged to cooperate with the part of eyes around cornea in fluid-tight mode.Similarly, holding plate 23 can also say and comprise an internal edges along 26 that this internal edges is provided with around aperture 25 with the relation that centers on and limit along 26, and is configured to cooperate with the eyes that are placed in one in fluid-tight mode equally.Therefore be arranged to cooperate in case be appreciated that location section 20, reach around the vacuum chamber 22 between holding plate 23 and the flange component 24 around eyeball with eyes, just can realize one effectively, roughly gastight sealing.In addition, as shown in Figure 2, also can limit a passage 29 in vacuum chamber 22, passage 29 can be separately or with rigidity or flexible insert as being provided in the U.S. Patent No. 5772675, strengthens the effect of the vacuum that applies.

Further observe flange component 24, in the embodiment shown, because it defines the periphery that cooperates with eyes, thereby compare with the situation of conventional positioner, flange component 24 is arranged to the relation of close more aperture 25 peripheries spaced apart.Though only on latitude direction radius, limit this more close interval corresponding to the aperture 25 of narrow eyepiece path smaller dimension, but preferably flange component 24 limits a circular configuration generally speaking, and this circular configuration and aperture 25 be intervals and help the correct centering of eyes evenly.In the embodiment shown, roughly be positioned at the latitude direction diameter of the flange component 24 on the bottom margin 27 that cooperates with eyes generally in about 0.675 to 0.725 inch scope.More accurately, less than the latitude direction diameter of about 0.79 inch or 0.708 inch (18 millimeters) is preferred, with corresponding to big in 0.350 to 0.475 inch scope aperture 25 diameters or corresponding to be more accurately 0.420 inch to form one 8.5 millimeters lobe.For example, the present invention can only become to have corresponding 0.375 inch, 0.420 inch and 0.465 inch diameter by the modification of dimension with the aperture, utilizes the otch near isolated flange component 24 7.5 millimeters, 8.5 millimeters, 9.5 millimeters of formation or other sizes.But be appreciated that the diameter that reduces flange component 24, keep necessary sized opening simultaneously, can reduce positioner 10 and can drop on the degree of depth on the eyes downwards.But still need to keep passing cornea, preferably pass the same diameter of the eyes that come out in standard-sized aperture 25, thereby produce the cornea flap of suitable shape.Like this, the present invention comprises also that preferably the degree of depth of the location section 20 that is limited by flange component 24 reduces.In the embodiment shown, the degree of depth of the location section 20 that limited of the bottom margin 27 from the upper surface of holding plate 23 to flange component 24 roughly is preferably less than about 0.175 inch, more preferably between 0.1 to 0.15 inch.In the illustrated embodiment of the flange component of aperture 25 of using preferred 0.420 inch diameter and 0.708 inch diameter, shown in preferred depth be 0.115 inch.But because the setting of front, can pass aperture 25 and expose the eyes of enough parts, and eliminate the restriction that causes owing to the patient's body feature near the eyes aspect, locate simultaneously section 20 fully with securely with the surface engagement of eyes.

Positioner of the present invention also relates to and uses and comprise that at least in part a getter device 30, this getter device 30 are used for after location section 20 correctly is positioned on the eyes that will undergo surgery, at least temporarily will locate section 20 and be attached to eyes.Preferably, getter device 30 comprises a vacuum port 32 and a vacuum equipment (not shown) that is used to provide suction that is formed in the section 20 of location.This vacuum equipment is configured to apply a suction, this suction is enough to location section 20 is attached on the eyeball around cornea C, and upwards promote cornea and make cornea pass the aperture 25 of location section 20 and give prominence to, simultaneously suction is again by force to eyeball is caused damage.From accompanying drawing, be appreciated that be formed on that the vacuum port 32 of location in the section 20 operationally connects with this vacuum equipment and with it fluid flow ground be communicated with, wherein apply suction thereby pass.Particularly, preferably in firm and fluid-tight mode a detachable externally threaded vacuum handle (not shown) that has is screwed in the vacuum port 32, this vacuum handle provides the device that makes things convenient for that grasps and handle positioner 10.In fact, can fasteningly guarantee not have betwixt the gap of possibility obstruction owing to the vacuum handle, this structure that has female thread of at least a portion ground vacuum port 32 has been guaranteed more firm cooperation, help the cleaning of positioner 10 significantly, and the inside that is easy to enter vacuum port 32 is cleared up.In addition, in a preferred embodiment, vacuum port 32 passes holding plate 23 or flange component 24 extends to the bottom surface 28 of location section 20, and enters in the vacuum chamber 22.Like this, after the vacuum equipment starting, vacuum port 32 is set up to a point that is positioned at aperture 25 radially outers and flange component 24 inner radial suction is provided, thereby forms sealing around the eyes cornea that will undergo surgery.Should be understood that the structure of location section 20 is used for correctly locating and aiming at the cornea C that is used to perform the operation at this some place with suction, and roughly keeps this position in operation process this moment.Usually, use the vacuum of on the sea level, measuring about 25 inches of mercury.

Positioner 10 of the present invention preferably also comprises formation guide rail 40 thereon.Guide rail 40 preferably is formed directly on the section 20 of location and forms one with it, thereby guides also moving of convenient micro-keratome cutter head device 15 in the operation on cornea cutting process.Shown in more compact structure embodiment in, preferred integral body is processed, because can guarantee firmly with stably being connected between in All Time guide rail 40 and the location section 20 like this, and guarantee and can and make and alignment error not take place betwixt owing to assembling.Especially, some positioners comprise a separately guide rail of processing, and this guide rail is by one but generally be that two or more screws are fastened on the section 20 of location.General two or more screw is preferred, because if make and assembling process in can not keep extreme careful and accurate, use a screw may cause the incorrect aligning of guide rail with respect to the aperture.But on the basis of the more cramped construction of illustrated embodiment, comprise that a plurality of screws are unpractical.Therefore, shown in compact more embodiment in and in other embodiments, in order to keep assembly precision and to be easy to assembling, preferably make with location section integral body by guide rail 40 is worked into about 0.03 inch width.In addition, with reference to Fig. 1 and 2, in a preferred embodiment, guide rail 40 is along one section extension of at least one side of location section 20, but preferably extends beyond location section 20 in the latitude direction, make occur in cooperating between cutter head device and the guide rail front, aperture a bit.The present invention recognizes that although cooperate the size that must use qualification with the most external of eyes for flange component 24, elevated guide 40 does not need not be limited to identical degree relatively.Guide rail 40 of the present invention is configured to extend beyond holding plate 23, thereby before striding aperture 25 cuttings or in the process, further guiding and/or stable micro-keratome cutter head device 15, and then guarantee in the aperture shaping of the cornea flap that a starting point of 25 front, edge need as a rule to be finished.Be further appreciated that from accompanying drawing guide rail 40 comprises that a toothed upper surface 42 and one keep antelabium 44, and roughly stride the location section in arc or the semicircular path and extend at one.Thereby guide rail keeps and/or constraint operationally is engaged in cutter head device 15 on the eyes downwards, and can be along arc cutting path at illustrated best among Fig. 9 A-9C of left eye, as the cooperation of gear structure on the band tooth upper surface 42 of guide rail 40, guide moving of cutter head device 15 at least in part by cutter head device 15.

Observe the vacuum port 32 of getter device 30 once more, as shown in the drawing, the vertical axis that it preferably leaves aperture 25 outwards and/or leave guide rail 40 outside angulations.The result makes, when flexible pipe or other conduits are connected to when being used to suction is provided on it, vacuum port or conduit can not hinder or disturb cutter head device 15 mobile at least partially on the guide rail 40.In addition, in the embodiment shown, this structure can keep locating section 20 compact more, circular structure preferably, vacuum chamber 22 effectively still leads suction simultaneously.In addition, guide rail 40 with the location section, generally be the monolithic molding of vacuum port 32, further help to form compact structure more, because needn't be provided for the space of screw and/or other securing members.Should also be noted that vacuum port 32 self does not preferably extend, and helps to realize the streamlined attribute of this positioner 10 equally above guide rail 40 is planar.

Equally in the embodiment shown, the present invention also preferably includes a pivoting device.This pivoting device is configured at it along providing enhanced stability to cutter head device 15 in the curved path moving process, and preferably limits a pivot, and this pivot can combine with guide rail 40 and stable or further guide moving of cutter head device 15.This pivoting device preferably includes an oriented stud members 50.This oriented stud members 50 is a rigidity upright that roughly is oppositely arranged with guide rail 40 preferably.As understanding from accompanying drawing equally, in a preferred embodiment, wherein positioner 10 has teardrop-like shape, and the bottom 55 of a pivoting device part equally preferably is integrally formed and therefrom extend out with location section 20.As will be described, this bottom 55 provides an area supported in assembling process, and the preferred oriented stud members that is shaped separately is fastened on this area supported.In addition, can be clear in the explanation from behind, in a preferred embodiment, guide rail 40 and oriented stud members 50 can be guided cutter head device 15 of the present invention effectively and be contained in securely on the positioner 10 two positions, can and steadily and slidably being passed through along a roughly arcual path, cutter head device 15 locate section 20 by making pivoting action simultaneously around the pivot that limits by oriented stud members 50.Certainly, positioner 10 also can be configured as and comprise another guide rail, this guide rail is one section, preferably upward extension of surface thereon of the opposite side of location, edge section 20 equally preferably, thereby can cutter head device 15 of the present invention be guided effectively and be contained in securely on the section 20 of location two positions equally, still make simultaneously cutter head device 15 along a roughly arcual path steadily and slidably through location section 20.The result makes that pivoting device and/or one or more guide rail move as the arc of guiding cutter head device 15.

Equally preferably, the part as pivoting device comprises connection element 70.Although cutter head device 15 can directly and movably cooperate with location section 20, come eyes are undergone surgery, but preferably use connection element 70 as a part of the present invention, this connection element 70 is constructed and arranged to preferably come movably by oriented stud members 50 and operationally cutter head device 15 is connected with location section 20, allows cutter head device 15 to move with respect to location section 20 simultaneously.As shown in Figure 3, connection element 70 preferably includes two sections: a) keep section 72 and b) pivot section 74.Keep section 72 preferably to be constructed and arranged to be assembled on the end face of cutter head device 15, thereby be fastened on it effectively and removably, and move relatively with moving of cutter head device 15.Turn to the pivot section 74 of connection element 70, it is constructed and arranged to be connected on the oriented stud members 50, and allows connection element 70 and correspondingly allow cutter head device 15 to connect thereon, in order to move pivotly around pivot.Preferably, pivot section 74 comprises a lining that wherein forms a hole 75, and this lining is sized to hold quite a few height of oriented stud members 50, thereby it is caught therein.

Observe pivoting device once more and reach preferably its oriented stud members 50, this oriented stud members 50 preferably defines a cutting start control.This cutting start control is configured to being used for as shown in Fig. 9 A and limits at least one starting point, on this starting point, makes connection element 70 and correspondingly makes cutter head device 15 beginnings do operationally to pivot to move around pivot.Especially, thereby being configured to guarantee basically cutter head device 15, the cutting start control can not cooperate the formation otch, unless it correctly is arranged on a suitable starting point with eyes and/or guide rail 40.In addition, the cutting start control guarantees that also delocalization cutter head device 15 is to begin to cut holding plate 23, eyelid and/or in the aperture 25 and eyes periphery other instruments and the object that are provided with.In the embodiment shown, the cutting start control comprises at least one but the preferably a pair of

slit

51,52 that is limited in the oriented stud members 50.Slit the 51, the 52nd, preferred but not necessarily general vertical orientation, each slit limits a starting point that for example is used for left and right sides eyes, and opens with about 100 degree angle intervals from the centrage to the centrage in the embodiment shown.Especially, as shown in Figure 8,, therefore must on the opposite side of location section 20, limit different starting points according to traffic direction because positioner 10 of the present invention preferably is configured to be used on arbitrary eyes.But in either case,

slit

51,52 is configured to hold at least in part the limiting element 78 in the hole 75 that preferably is limited to connection element 70.Particularly, this limiting element is constructed and arranged to be assemblied between the

corresponding slit

51,52, if but slit 51,52 correctly aim at, then limit connection element 70 by being placed on the oriented stud members 50.According to these principles, should be noted that, can use a plurality of and/or exquisiter structure comparably, so that do not have restriction is provided on time at element.In addition, although limiting element 78 can inadvertently enter in the

incorrect slit

51,52, but can carry out necessary location to above-mentioned

slit

51,52, exceed aperture 25 so that cutter head device 15 is arranged to its blade, thereby can not produce incorrect cutting.

Because

slit

51,52 roughly defines the position of starting point with respect to the orientation of location section 20, so be necessary to guarantee that oriented stud members 50 is fastened on the bottom 55 with accurate alignment so.Although can provide to a certain degree accurate aligning with a plurality of helicitic textures, but in the embodiment shown, oriented stud members 50 comprises that is aimed at a section 57, and this alignings section 57 is configured to operationally cooperate with bottom 55, thus guarantee oriented stud members 50 correctly axially align thereon fastening.Especially, bottom 55 comprises an alignment edges 56, and this alignment edges 56 cooperates with the aligning section 57 coupling ground of oriented stud members 50.In the embodiment shown, aiming at section 57 and alignment edges 56 is straight surfaces, and they can cooperate mutually Face to face providing aligned fastening, but also can use other matching structure.But be based on preceding structure, for example can make tightening member pass through the bottom in 55 opening 55 ' and arrive oriented stud members 50, and bottom realizing oriented stud members 50 correct accurately be fastened on with aiming on 55.

The result makes that on aforementioned basis, cutter head device 15 does not cooperate with eyes, unless it is positioned at suitable starting point.But further, in order between oriented stud members 50 and connection element 70, to realize necessary pivoting action, preferably in oriented stud members 50, form a groove 58, thereby, allow limiting element 78 therefrom to pass through slidably at connection element 70 and correspondingly in the pivot moving process of cutter head device 15 with respect to oriented stud members 50.Certainly can understand, limiting element can be arranged on the oriented stud members comparably, and slit is limited in the connection element.But in any structure, groove 58 is used to also guarantee that connection element 70 does not pivot with respect to oriented stud members 50, but with the essentially identical mode of mode that keeps antelabium 44 at guide rail 40 places constraint cutter head device 15, be constrained in the identical plane of motion.

Owing to can carry out multiple modification, variation and change to described the preferred embodiments of the present invention, in the description of front and the whole items shown in the accompanying drawing all be interpreted as schematically, rather than determinate.Therefore, scope of the present invention should be determined by additional claim and jural equivalent thereof.

It more than is the description of this invention.

Claims

1. a positioner is used at surgical procedures, eye's cornea is kept, locatees and exposes at least in part, and this positioner comprises:

A) location section, described location section comprises a holding plate;

B) described holding plate comprises an aperture that is limited to wherein, and this orifice structure becomes to hold eye's cornea therein and with its exposure;

C) pivoting device, this pivoting device is configured to define cutter head device and strides the pivot that the aperture arc moves;

D) described pivoting device comprises that at least one limits the oriented stud members of described pivot;

E) connection element, described connection element interconnects described oriented stud members and described cutter head device pivotally; And

F) described pivoting device also comprises a cutting start control, the starting point that the pivot operated that this cutting start control is configured to be defined for described connection element and correspondingly to be used for described cutter head device moves.

2. positioner as claimed in claim 1, wherein said cutting start control defines at least two starting points corresponding to right and left eyes.

3. positioner as claimed in claim 1, wherein said cutting start control comprises a slit that is limited in the described oriented stud members, and described connection element comprises a limiting element, this limiting element is configured to limit described connection element and cooperates with operating of described oriented stud members, unless this limiting element correspondingly is arranged in the described slit.

4. positioner as claimed in claim 3, a position of wherein said slit define the mobile starting point of the pivot operated that is used for described connection element and correspondingly is used for described cutter head device.

5. as claim 3 or 4 described positioners, also comprise a groove, this groove extends around described oriented stud members at least in part from described slit, thereby allows described limiting element therefrom to pass through, and correspondingly allows described connection element to carry out pivotal rotation around it.

6. positioner as claimed in claim 4 comprises two slits in the described slit, and the described slit of wherein each defines of the described starting point that is used for right and left eyes.

7. positioner as claimed in claim 1, wherein said oriented stud members comprises the cutting start control at least in part.

8. positioner as claimed in claim 7, wherein said oriented stud members define at least two starting points corresponding to right and left eyes.

9. as the described positioner of claim 1,6 or 7, also comprise a bottom, described oriented stud members is operationally extended from described bottom.

10. positioner as claimed in claim 9, wherein said oriented stud members comprise that is aimed at a section, and this aligning section is configured to operationally cooperate with described bottom, thereby guarantees that described oriented stud members is fastened on the described bottom with correctly axially aligning.

11. positioner as claimed in claim 10, wherein said bottom comprise an alignment edges, the described aligning section of described oriented stud members is configured to cooperate with described alignment edges coupling ground.

12. positioner as claimed in claim 10, wherein said aligning section is guaranteed the correct aligned qualification to described starting point.

13. positioner as claimed in claim 1 is characterized in that also comprising:

A getter device, this getter device operationally link with described location section, are used at least temporarily described location section being attached to eyes; Described getter device comprises a vacuum port, described vacuum port depart from out at least in part described aperture vertical axis and outwards shape have a certain degree.

14. the positioner described in claim 13 also comprises a guide rail, described at least rail configurations becomes to be directed to the cutter head device that small part extends across described aperture.

15. positioner as claimed in claim 14, wherein said vacuum port are integrally formed with described guide rail at least in part.

16. positioner as claimed in claim 14, wherein said vacuum port has the axis that departs from out described guide rail at least in part and outwards form certain angle, thereby will drop to minimum to the interference that described cutter head device moves.

17. positioner as claimed in claim 14, wherein said guide rail and described location section are integrally formed.

18. positioner as claimed in claim 14, wherein said guide rail extend beyond the described holding plate of described location section on the latitude direction.

19. as claim 14,16,17 or 18 described positioners, wherein said guide rail define an arcual path.

20. positioner as claimed in claim 13, wherein said vacuum port has an axis that departs from out described vertical axis at least in part and outwards form certain angle, thereby will drop to minimum across the interference of moving of described location section to cutter head device.

21. positioner as claimed in claim 13, wherein, described location section also comprises a flange component around the setting of described aperture, and this flange component is configured to cooperate with eyes, and described flange component is arranged to spaced apart with close distance with described aperture at least diametrically.

22. positioner as claimed in claim 21, the diameter of wherein said flange component is between 17.1 to 18.4mm.

23. positioner as claimed in claim 21, wherein said flange component diameter is less than 20mm.

24. positioner as claimed in claim 23, the diameter in wherein said aperture is between 8.89 to 12.1mm.

25. positioner as claimed in claim 24, the degree of depth of wherein said location section from the contact surface of described flange component to the upper surface of the described holding plate in described aperture is less than 4.45mm.

26. positioner as claimed in claim 23, the degree of depth of wherein said location section from the contact surface of described flange component to the upper surface of the described holding plate in described aperture is 2.5 to 3.8mm.

27. positioner as claimed in claim 13, wherein, described location section also comprises a flange component around the setting of described aperture, and this flange component also is configured to match with the eyes that are arranged on wherein, and the diameter of described flange component is between 17.1 to 18.4mm.

28. positioner as claimed in claim 1, wherein said pivoting device are integrally formed with described location section at least in part.

29. positioner as claimed in claim 28, wherein said pivoting device comprise a bottom, described oriented stud members is operationally extended from this bottom.