CN103781444B - For ocular tissue's Guan Bi, the fixing and securing member of other purposes of eye prosthese, configuration system and method - Google Patents

Abstract

This application provides the method and apparatus fixed for ocular tissue's Guan Bi and eye prosthese.According to some embodiments, it is provided that for catching and clamp multiple ocular tissue and the device of eye prosthese.Multiple device embodiments are provided for ductility folder and transmit normally closed folder (i.e. shape memory).Device can accommodate multiple folder, and these folders are including, but not limited to: ductile metal, absorbable, shape memory, medicine elution and bonding agent distribution.Folder can have color, in order to the color matching of linked groups's (cornea, iris, conjunctiva, sclera, retina), is used in healing process or permanently pretends fixation clamp.According to an aspect, can be provided the smaller angle entering anatomical structure by the special angle of assembly axis with Guan Bi jaw, this Guan Bi jaw will enter eyes through less from healing corneal incision and/or any ocular tissue.

Description

For ocular tissue's Guan Bi, the fixing and securing member of other purposes of eye prosthese, configuration system System and method

Cross-Reference to Related Applications

According to 35USC119(e), this application claims the priority of U.S. Provisional Patent Application No.61/468827, this U.S. The filing date of temporary patent application No.61/468827 on March 29th, 2011, the full content of the document is attached to the application In, as reference.

Technical field

The present invention relates generally to medical treatment device, system and method, and multiple embodiments described here provide securing member, Such as folder, bail etc., be optionally used for eye surgery, more particularly to wound repair in ophthalmic surgery, cut Mouth Guan Bi and borrowed structure are fixed.

Background technology

In field of ophthalmology, there is the different clinical subspecialty organized based on the classification of diseases of eye (such as Cataract, retina, cornea etc.).In each subspecialty, relate to the different surgery handss that application-specific wounds Guan Bi is fixing with prosthese Art is treated, and needs firm and/or very difficult tissue apposition.The Main Tissues related in any given surgical operation can be Following is any or whole: cornea, iris, conjunctiva, sclera and retina.

A lot of surgical treatment processes relate to suturing skill, in order to ensure the reliable and sealing of watertight.According to processing Journey, relative to the total time length of processing procedure, stitching processes may be the most time-consuming.Suture time may be grown (such as very much The iris of common prosthese is fixed, such as intra-ocular lens), to such an extent as to some surgeon may be more willing to suggestion patient and seek help from Experienced expert and avoid special case.(this may not only process at base therapy it addition, the total cost of surgical device During cause, also cause in being exclusively used in the whole time sewing up entry site etc.) typically result in for especially complex stitching The negative cash flow of case.

In recent years, bonding agent (usually fibrin) has developed into and fixes for ocular tissue's Guan Bi and borrowed structure Alternative.But, bonding agent has shortcoming for surgeon and patient.For surgeon, bonding agent may be time-consuming Between mix, hardening time is variable, be limited to linear low force otch and/or less customizability is (with ideal situation phase Than), may cause being difficult to the clossing pressure needed for obtaining.For patient, using bonding agent may for ophthalmic procedures process Cause uncomfortable, because common cured may stay a small amount of solidification erect or protrude on predetermined anatomical structures viscous Connect agent.The height formed may cause obvious eye uncomfortable.Therefore, there is motivation to be modified to ocular tissue's Guan Bi and fixing Method and apparatus.

Summary of the invention

Present invention generally provides the medical treatment device of improvement, system and method.Multiple embodiments of the present invention use tissue Securing member, this tissue fastener is inserted into (also may select, though it is not necessary to, pass) and ties in tissue surface tissue below Structure, is typically without entering the apparent surface after organizational structure.The example embodiment of securing member is particularly well-suited to juxtaposition and closes Close organization edge (this organization edge defines the otch of ocular tissue and other wound), borrowed structure be fixed in ocular tissue's structure Deng.First supporting leg of securing member and the second supporting leg can be disposed through tissue surface and be distally advanced to tissue.Securing member Base portion so that supporting leg supports relative to each other, it is possible to include the circular arc laterally protruding from supporting leg or other bending section, its In, bending section is generally configured to be in along tissue surface, and supporting leg inserts through this tissue surface.Supporting leg can be at them along straight Or bending insert when path advances and be at an angle of towards each other or with leaving, and the plasticity of base portion, elasticity and/or hyperelastic deformation Can help to engage so that the edge of wound of tissue, supporting leg is advanced in tissue and/or along tissue surface holding securing member Base portion.

In first aspect, The embodiment provides the method fixed for surgical tissue.Method includes: make The first supporting leg obtaining surgical fasteners advances in this surface tissue below through tissue surface.Surgical fasteners The second supporting leg to advance to tissue through tissue surface interior.The base portion support legs of securing member, and base portion be rearranged into so that The supporting leg advanced keeps base portion to engage with tissue surface.The base portion reset has the bending section extended along tissue surface.

In terms of other method. a kind of method fixing for ocular tissue includes by the first supporting leg of surgical fasteners First end puncture ocular tissue surface at the first piercing site.Advance in the tissue in the first supporting leg face under the surface, and along the One path runs.The second end of the second supporting leg of securing member punctures ocular tissue surface at the second piercing site, and leads to along second Advance in tissue in road.This first and second path forms relative oblique angle with tissue surface, and this first path and second leads to Curb supporting leg configuration plane extends.Path has channel spacing, this channel spacing and the interval of the piercing site between piercing site Different.The base portion of securing member includes slender body, and this slender body has the axis extended between the legs.This axis has from supporting leg The bending section that plane is protruded along base surface, this base surface crosses supporting leg plane and extends.Base portion is rearranged into and prevents supporting leg Exit along path, and keep base surface along tissue surface, so that securing member is fixing near the first supporting leg and the second supporting leg Organizationally.

In terms of other method, a kind of method fixing for eye surgery tissue includes by surgical fasteners First end puncturing tissue surface, and this first end is advanced in tissue.Tissue includes that ocular tissue, tissue surface include Or it being arranged near the visible surface of eyes so that first end advances towards inside ofeye.Securing member is rearranged into along eye The visible surface fixation fastener body of eyeball.The visible surface of eyes has a color, and the body of securing member has abundant with eye color Corresponding color, in order to camouflage securing member.

In terms of an also method, a kind of method for being fixed on the iris of eyes by eye device includes: inserting position Put and instrument is introduced in eyes；And the ken making instrument cross eyes from position advances to allocation position.Securing member By instrument in allocation position configuration to iris.

In terms of device, The embodiment provides a kind of device fixing for surgical tissue.This device Including the first slender leg, this first slender leg limits axis and first end, and this first end is arranged at tissue Interior axial advancement.Second supporting leg limits axis and the second end, and this second end is arranged for axial advancement in tissue.Should First supporting leg axis and the second supporting leg axis define supporting leg plane.Base portion extends along base surface, and support legs.This base portion Having the bending section protruded from supporting leg plane, this base portion is arranged in after advancing so that supporting leg and deforms, so that supporting leg is along organization table Face keeps base surface.

In terms of another device, a kind of device fixing for ocular tissue includes the first supporting leg, and this first supporting leg has first End, this first end be arranged at the first piercing site puncture ocular tissue surface and for along the first path at eye Advance in tissue surface tissue below.Second supporting leg has the second end, and this second end is arranged in the second breakthrough portion Ocular tissue surface is punctured and for advancing in tissue along alternate path at Wei.First and second paths are formed with tissue surface Relative oblique angle.First path and alternate path also along supporting leg plane extend, and the channel spacing of path with piercing site it Between piercing site interval difference.Base portion extends between the legs, and this base portion includes slender body, and this slender body has axis. Axis has bending section, and this bending section protrudes along the base surface corresponding with ocular tissue surface from supporting leg plane between the legs. This base portion is arranged for deformation, in order to prevent supporting leg from exiting along path, and keeps base surface along ocular tissue surface.

In further aspect, a kind of securing member can be used in being fixed in ocular tissue eye surgery tissue, this ocular tissue Having ocular tissue surface, this ocular tissue surface includes the visible surface of eyes or is arranged near the visible surface of eyes.This fastening Part includes surgical fasteners, and this surgical fasteners has a first end, and be arranged for puncturing ocular tissue surface and For advancing in ocular tissue.Nearside from body to the first end extend, this body includes deformable metal, in order to along eyes can It is shown in Table the body of surface bearing securing member.The visible surface of eyes has a color, and the body of securing member has the most corresponding with eye color Color, in order to pretend this securing member.

In terms of an also device, The embodiment provides a kind of iris for eye device being fixed on eyes System.This system includes instrument, and this instrument has proximally and distally, and has the axle extended between which.Far-end and neighbouring Axle is arranged at the on position of Wicresoft inserting in eyes, and is also configured to for crossing regarding of eyes from position Territory advances to allocation position.Securing member is bearing in the proximate distal ends of axle configurablely.Securing member has supporting leg, and this supporting leg is worn in a organized way Barbed end, supporting leg is oriented and crosses axle, in order to can advance in iris at configuration position when instrument inserts.

Also may select, the tissue of configuration securing member is included the ocular tissue of eyes.First supporting leg and the second supporting leg are at wound The first edge and the second edge be arranged between them in the case of insert, and carry out the deformation of base portion, thus edge pushed away Force together, for the healing of wound.In certain embodiments, securing member can be included in configuration system, this configuration system It is arranged to the predetermined configurations interval promoted between the legs so that supporting leg is promoted by the deformation of base portion towards predetermined space.One In a little embodiments, the deformation of base portion is carried out by discharging this base portion so that base portion pushes the edge of wound and abuts, optional Select sealing within the required range or other engaging force.In certain embodiments, the deformation of base portion includes regulating this base portion Bending section, in order to providing the required joint between the edge of wound, wherein, configuration is selectively by surgeon or other guarantor Strong professional carrys out manual adjustment.

Base portion and supporting leg can be integrally formed by the material of continuous length, and wherein, material selectively bends and/or with other Mode processes, in order to forms required form and has required function.In many embodiments, will include can for the material of continuous length Deformable metal line, although alternative embodiment can use deformable polymer (selectively to include biodegradable and/or can The polymer of non-bioresorbable) etc..Supporting leg, base portion etc. can also by soldering, welding, bonding agent or ultrasound wave bonding etc. and by Series of discrete parts assemble.In many embodiments, base portion will include slender body, and this slender body has: the first base portion Part, this first base segments has the first base portion axis near the first supporting leg；Second base segments, this second base segments There is the second base portion axis near the second supporting leg；And one or more middle base portion, this middle base portion has cloth Put the central base portion axis between the first base segments and the second base segments.Bending section is typically at least partially along central base portion Part is arranged.Middle base portion can include circular arc, it is possible to selectively extends about at one or two supporting leg or extends To one or two supporting leg.In an alternative embodiment, middle base portion can have sharp bend portion, selectively in assembling Joint between parts etc..Example embodiment for ophthalmically acceptable way can be formed of a wire, the cross section chi of the linear diameter of this line Very little up to about 0.010 inch, generally in the range of about 0.001 to 0.010 inch, generally from 0.002 to 0.006 English In very little scope.Tissue penetration supporting leg for this ophthalmically acceptable way generally will (and/or tissue surface works as configuration with base surface Time) separate less than about 5mm, the usually distance in the range of about 0.1 to about 0.5mm, and generally about 0.3 to greatly Distance in the range of about 0.5mm.When securing member is in and shelves state, interval between the legs can be from 0 to about 5mm In the range of.Other medical treatment and/or surgical use can use the embodiment of more large scale scope, for example, it is possible to select, By until the line of 0.020 inch range is formed.For some ophthalmically acceptable ways (for Guan Bi etc.), example embodiment can include Tantalum, mainly can be made up of tantalum, and/or can be substantially or entirely made up of tantalum.

At least when securing member is in configuration structure, the first base portion axis, the second base portion axis and central base portion axis edge Base surface extends.In many embodiments, supporting leg can protrude from base surface, it is generally desirable to base surface will be with tissue Surface is corresponding, and can extend along this tissue surface, and supporting leg will advance through this tissue surface.Base portion, fixed towards supporting leg To part can include tissue engagement surface, and supporting leg can help to keep base portion along tissue surface.Such as, the deformation of base portion The relative to force between supporting leg and tissue can be caused, in order to keep base surface along tissue surface.

First supporting leg has the first supporting leg axis, and the second supporting leg has the second supporting leg axis, the first supporting leg axis and similarly Two supporting leg axis generally define supporting leg plane or supporting leg surface.It should be known that supporting leg is not required to the most coplanar, but will be from The opposite segments of base portion extends along substantially similar orientation, in order to securing member can be advanced in tissue along configuration plane.Base The bending section of the mid portion in portion generally protrudes from supporting leg plane.

In the exemplary embodiment, tissue includes the ocular tissue of spherical curvature, the sclera of such as eyes or white tissues.Base portion Surface can be with spherical curvature so that the first base portion axis, the second base portion axis and central base portion axis are when seeing in supporting leg plane Time define the bending section along tissue surface or zigzag part, it is also possible to when being perpendicular to define along tissue surface when supporting leg surface is seen Bending section or zigzag part, wherein, bending section is preferably to include the curve corresponding with tissue curvature.

Also may select, base portion has the first and second bending sections between the legs, and the first bending section is from the of supporting leg plane Side is protruded, and the second bending section protrudes from second side contrary with the first side of supporting leg plane.Alternative embodiment can have along base The single bending section in portion or more than two bending sections.In many embodiments, particularly when tissue includes ocular tissue, tissue Surface can include the visible surface of eyes or be arranged near the visible surface of eyes so that supporting leg penetrates tissue surface and court Inside ofeye to advance.The visible surface of eyes generally has a color, and base segments can have color, this color and eye color The most corresponding, in order to camouflage securing member.Color can selectively apply (visible surface such as oriented along the rear portion of base portion), or Person can be disposed generally on above base portion and/or the supporting leg of securing member.

Supporting leg can be substantially straight, it is possible to is arranged in tissue and advances so that the first supporting leg and the second supporting leg First and second tissue access extend from the first and second piercing sites respectively, in order to form relative substantially one with tissue surface The oblique angle caused.For such embodiment, the deformation of base portion is included in the insertion process of supporting leg or changes bending section afterwards Angle so that alternatively when supporting leg advances through piercing site, the spacing distance between the first supporting leg and the second supporting leg becomes Change.In certain embodiments, supporting leg bending so that the first and second tissue access of the first supporting leg and the second supporting leg are along arc section Extend.For such embodiment, the deformation of base portion includes that the first supporting leg is wound on the first torsion near the first supporting leg, base portion Axis rotates and the second supporting leg is wound on the second torsion axis near the second supporting leg, base portion and rotates.For two types, base During the deformation in portion can be included in the advance of supporting leg or make base portion plastic deformation afterwards, and/or the deformation of base portion can To include so that base portion discharges from means of transportation, in order to make base portion promote supporting leg to advance in tissue.When the deformation of base portion is led to Crossing when discharging this base portion to realize, base portion can be retrained by means of transportation before configuration, it is possible to is biased into upon discharge The joint being maintained between base portion and tissue surface, wherein, securing member includes elastic metallic or polymer, superelastic metal or poly- Compound etc..Some embodiments can use Nitinol^TMSuperelastic alloy.Other embodiments can selectively use shape memory Material, in order to realize structure change.

In certain embodiments, tissue includes or supports the iris of eyes, and securing member can be configured so that, i.e. by making The axle obtaining configuration tool crosses the ken configuration position advance towards tissue of eyes from insertion site.Securing member can be in configuration Puncturing tissue surface, position, at least one of which supporting leg is along inserting axis orientation and/or advance, and this insertion axis crosses the axle of axle Line extends.

When body or the base portion of securing member include metal, and when fastener arrangement includes scleral tissue in tissue therein Time, white layer or color on the metal surface can help to pretend securing member.When tissue includes the iris of eyes, securing member Can select from the multiple optional securing member with different colours, so that the color of the iris of the color of securing member and eyes Coupling.

Some or all embodiments of securing member described here may be embodied in configuration system, and this configuration system has joins Putting instrument, wherein, this instrument supports securing member releasedly, is used for being arranged in external tissue surface, and tissue surface can pass through Surgical incisions etc. are close, or entered by micro-wound surgical operation hole in eyes or other organizational structure of patient.Configuration Instrument can have axle, and this axle has proximally and distally, and has axis between which.First grip element can be arranged in far-end Near, the first grip element has the first grasping surface.Second grip element also is able to be arranged in proximate distal ends, this second grasping unit Part has the second grasping surface.Second grasping surface generally can move between the first structure and the second structure, and grip element is arranged Become and when the second grasping surface is in the first structure, securing member is captured and/or grasp between which.Handle arrangements is at axle Near proximal ends so that the motion of handle is capable of the second grasping surface from the first structure to the motion of the second structure, thus work as When supporting leg aligns with the target allocation position of tissue surface, motion causes supporting leg to advance in tissue and by instrument release fastening Part.Such as, the second grip element can be slided along driving axis, and move through promotion the second grip element and (or grasp with it Make other structure of connecting) surface selectively carry out against tissue surface (supporting leg will advance through this tissue surface), and Driving axis generally extends (being selectively parallel to this plane) along the configuration of securing member or supporting leg plane.Alternative embodiment is permissible Use operate with the second grip element be connected can driving handle, in order to realize motion etc..In certain embodiments, second grasp The motion of element can realize resetting of base portion, such as by the plastic deformation of base portion, from restraining structure release fasteners Deng；It is preferably to produce or allow the spacing distance change between relatively straight supporting leg and/or the rotating against of arcuate legs Orientation differences.

Due to existing stitching and bonding agent tissue closure technology and the known restriction of method, in addition it is also necessary to alternative.According to Multiple embodiments, apparatus and method provide to ophthalmologist expects that the mechanical closure by sewing up and had by bonding agent is many The property used.According to multiple embodiments, such versatility will be obtained, the most also provided the surgeon with more predictable Guan Bi. Because the eye position of patient, therefore closes and/or the fixing ability that can be caught and clamp relevant ocular tissues by offer is come Realize.The ability that can catch also allows a surgeon to the tissue needed for a) positioning before fixing or eye prosthese；And B) (i.e. one hands catches grasper, another hands to catch pin to produce two handss needed for artificial " singlehanded " method of closing, with stitching Head) different.Because the persistent period of fixation clamp can be permanently or temporarily property, the color therefore pressed from both sides is mated with surrounding tissue will Allowing surface exposure to be clipped in healing processing procedure the most hiding, now folder can retain, takes out or absorb.Bigger in order to solve The ocular tissue of scope and prosthese, some embodiments of device can be at an angle of, in order to enters the region that there is less anatomical angulation.

Accompanying drawing explanation

Figure 1A-1J illustrates for catching organization edge and the example of device (mechanism) they being clamped together simultaneously Embodiment, this tissue is injured or otch.

Fig. 2 A-2J illustrates for catching prosthese and ocular tissue and this prosthese and ocular tissue being clamped together simultaneously The example embodiment of device.It is only used as example, illustrates and intra-ocular lens haptics (haptic) is fixed on iris.

Fig. 3 A and 3B illustrates the example embodiment of device, wherein, may be positioned such that and eye for applying the clamp of eye folder The surface of eyeball approximates tangent angle, and folder may be positioned such that approximately perpendicular to the tissue closed or fix.

Fig. 4 A-4C illustrates the example embodiment of distally configuration device, and this distally configuration device is for prolonging of normally opening Malleability is pressed from both sides, and this folder may be used for the edge of fixing organization or is fixed on eyes by eye prosthese.Example embodiment illustrates folder It is configured to be fixed on iris the haptics of intra-ocular lens.

Fig. 5 A and 5B illustrates the example embodiment of distally configuration device, and this distally configuration device is for normally closed bullet Property or marmem folder.This example embodiment is illustrated by example once to press from both sides and releases from axle, and elastic or shape memory closes Gold is back to its normal closed position, therefore the edge of fixing organization or be fixed in eyes by borrowed structure, such as will The haptics of intra-ocular lens is fixed on iris.

Fig. 6 A-6C illustrates the example embodiment of distally configuration device, and this distally configuration device is for normally closed bullet Property or marmem folder.This example embodiment is illustrated by example once to press from both sides and releases from guiding piece, elastic or shape note Recall alloy and be back to its normal closed position, therefore the edge of fixing organization or borrowed structure is fixed in eyes, example As the haptics of intra-ocular lens is fixed on iris.

Fig. 7 illustrates the example embodiment for the method close to the ocular tissue closed or fix.Temporary transient or preferred Method can pass through transparent (clear) corneal incision, and this corneal incision crosses the vision axis of eye.Cornea enters otch can With sufficiently small, in order to self-healing.

Fig. 8 illustrates the example sectional view of the method shown in Fig. 7, and wherein, temporary transient or preferred method can be by thoroughly Bright corneal incision, this corneal incision crosses vision axis in the ken of eyes.Cornea enters otch can be sufficiently small, with Just self-healing.

Fig. 9 illustrates the example embodiment of folder, and this folder has been characterised by two piercing portions or supporting leg, and the two punctures Part or supporting leg have axis, and this axis is relative to each other, and is connected by base portion, and this base portion has adjustable circular arc, at this circular arc On the surface crossing piercing portions.

Figure 10 illustrates the folder of Fig. 1, and this folder elastically deformable is to open position, and this double-layered quilt is biased into towards lax or just Often structure and elasticity (and/or super-elasticity) return.

Figure 11-11B illustrates the tip of the transporter being centered in above organization edge to be closed, and this tip has The parts that can slide relative to each other, in order to release folder, and gradually allow this folder to return its normal closed position, in order to will tissue Edge compression is together.

Figure 12 illustrates the driving during folder release of the slidable member of configuration device.

Figure 13 illustrates transporter, fully retracted slidable member.

Figure 14 illustrates the folder of release, and to be in the organization edge of its preferred make position and formation close.

Figure 15 illustrates another example embodiment of folder, and this accompanies two piercing portions or supporting leg, the two piercing portions Or supporting leg includes two circular arcs, the two circular arc is relative to each other, and is connected by base portion, and this base portion includes other scalable Circular arc, this scalable circular arc is in and crosses on the surface that piercing portions is arranged.

Figure 16 illustrates the optional structure of the folder of Figure 15, wherein, base portion elastic deformation, so that the supporting leg of folder is in The pre-configured position opened, and this supporting leg rotates around the adjacent part of base portion when folder release.

Figure 17 A and 17B illustrates the tip of the transporter being centered in organization edge to be closed, and this tip has can phase To the parts slided over each other, in order to release folder, and this folder is gradually allowed to return its normal closed position, so that organization edge It is kept into sealing engagement.

Figure 18 illustrates the slidable member of configuration device pivotal motion during folder release.

Figure 19 illustrates the release pressed from both sides from configuration device.

Figure 20 illustrates the folder of release, and to be in the organization edge of its preferred make position and formation close.

Figure 21 illustrates another example embodiment of folder, and this accompanies two piercing portions or supporting leg, the two piercing portions Or supporting leg includes two circular arcs, the two circular arc is relative to each other, and is connected by base portion, and this base portion includes other scalable Circular arc, this scalable circular arc is in and crosses on the surface that piercing portions extends.

Figure 22,22A and 22B illustrate the tip of transporter, and this tip can be centered in organization edge to be closed, Wherein, the piercing portions of the folder of Figure 21 starts tissue penetration.

Figure 23 illustrates moulding of pressing from both sides when slip clamp hammer (clip hammer) of piercing portions and the means of transportation of folder engages Property deformation so that the folder of Figure 21 piercing portions rotate to allocation position.

Figure 24 illustrates and is promoting folder hammer through the feelings of piercing portions along the plane tangent with the circular arc on piercing portions The formation of the folder of Figure 21 is completed under condition.

Figure 25 and 25A illustrates the release folder of Figure 21 and is in its configuration or the organization edge of make position and formation connects Closely.

Figure 26 illustrates the yet another exemplary embodiment of folder, and this accompanies two supporting legs or piercing portions, the two supporting leg or wear Thorn part has axis, and the two axis is relative to each other, and is connected by base portion, and this base portion becomes the form of scalable circular arc, should Scalable circular arc is in the plane being approximately perpendicular to piercing portions.

Figure 27 illustrates the example embodiment of the transporter of the folder for Figure 26.

Figure 27 A and 27B illustrates the tip of transporter, wherein accompanies at least one supporting leg exposed or piercing portions, To facilitate this folder of operation, in order to use a piercing portions of folder penetrate an organization edge and obtain this organization edge Control.

Figure 28 illustrates transporter, and two supporting legs of folder expose, to facilitate use folder to make the first organization edge Close to minor microstructure edge.

Figure 29 illustrates the pivotal motion release folder of the jaw of clamp device.

Figure 30 illustrates the folder of release in the tissue after base portion deforms, wherein base portion shelve into close tissue and Organization edge is concordant.

Figure 31 illustrates the yet another exemplary embodiment of folder, and this accompanies two straight supporting legs or piercing portions, the two supporting leg Or piercing portions has axis, this axis is relative to each other, and is connected by base portion, and this base portion becomes the form of two scalable circular arcs, The two scalable circular arc is disposed in crossing in the curved tissue surface that piercing portions extends.

Figure 32 illustrates the top view of the folder of Figure 31, and indicates its dual adjustable pitch circle arc.

Figure 33 illustrates the sweep connecting arc part of folder can include bending section, preferably in radii pattern, from And coordinate with the curvature of tissue surface such as eye.

Figure 34 illustrates the folder of Figure 31 and configures in the tissue.

Figure 35 illustrates another example embodiment of folder, and this fixture has supporting leg or piercing portions, this supporting leg or piercing portions Including circular arc, this circular arc is relative to each other, and is connected by base portion, and this base portion is the form of dual adjustable pitch circle arc, this dual can Regulation circular arc is in the plane or other plane that are basically perpendicular to piercing portions extension.

Figure 36 illustrates the top view of the folder of Figure 35, and shows its dual adjustable joint property.

Figure 37 illustrates the curvature connecting circular arc portion of the folder of Figure 35 and can include with tissue surface (such as at eyes Place) the radius of Curvature Matching.

Figure 38 illustrate configuration in the tissue, the folder of Figure 35.

Detailed description of the invention

Present invention generally provides the medical treatment device of improvement, system and method.Multiple embodiments of the present invention use tissue Securing member, this tissue fastener is inserted into and/or is passed through tissue surface tissue below structure, is typically without entering in group Knit structure apparent surface below.Novel securing member described here can use structure and tissue interaction, this phase interaction With there being the characteristic of some surgical staples, folder, line or even stitching thread, therefore, securing member can the most selectively It is used as folder, bail etc..The example embodiment of securing member is arranged for fixing ocular tissue and for being fixed on ocular tissue, example As being used for attaching and close organization edge, this organization edge defines (and/or below them) of sclera, cornea, iris etc. Otch and other wound.These or related embodiment can be also used for solid to haptics or other borrowed structure of intra-ocular lens It is scheduled in iris or other ocular tissue's structure.When for close incisions or other wound, securing member generally will be configured so that, i.e. By making the first supporting leg and the second supporting leg distad be inserted in the tissue of wound either side, so that slit edge edge is mutual Near to or in contact with.The base portion of securing member can include circular arc or other bending section, and this circular arc or bending section are laterally protruding from supporting leg, Wherein, this bending section is generally configured to arrange along tissue surface (supporting leg inserts through this tissue surface).Supporting leg can be along insertion Path inserts, and when supporting leg is distally advanced, this insertion path is angled towards each other, and the bending section of base portion can set again Being set to the predetermined space provided between the legs, the edge of tissue is kept together by this supporting leg.Also may select, bending section is permissible Be rearranged into and border elastic (including super-elasticity) pressed against together, and/or base portion can configuration during or configure it Rear manual adjustment, in order to the supporting leg interval being suitable for this particular arrangement is provided.It thus provides for closing and fixing ocular tissue Method and apparatus.

Figure 1A-1J illustrates for catching edge E1, E2 of tissue (this tissue injured or otch) and by it simultaneously The example embodiment 10 of device (mechanism) that is clamped together.Device 10 can include two groups of axles stacked 12,14, each axle 12,14 have distally jaw 16,18.One axle 12 and jaw 16 are designed to grab histozoic edge E1, E2 and they are pulled to one Rise.Second axle 14 and jaw 18 are designed to carry normally open ductility folder 20, and this ductility folder 20 can pass through jaw 18 And compress, in order to form the folder 20 of Guan Bi, thus two edges E1, E2 of tissue are fixed together.The axle 12,14 of stacking can To be connected with handle, this handle provide each jaw relative to the forwardly and rearwardly axially-movable of anvil 24, this anvil 24 surround axle 12, 14。

In the operation of the example embodiment of Figure 1A-1C, when grasping axle 12 and being pulled by handle, grasp the jaw 16 of axle with Anvil 24 interferes and is compressed.Hook or protruding 26 at the distal side edge grasping jaw 16 can pierce through and holding group Knit, thus when grasping jaw compression, edge E1, E2 of tissue are pulled to together.About this example, additionally it is possible to see Fig. 1 D-1F, Grasping axle 12 and jaw 16 is pulled to handle 22, the organization edge caught is also pulled into instrument, thus relative to being maintained at second Ductility folder 20 in group jaw 18 pulls organization edge.Tissue is pulled to instrument so that piercing is worn organization edge or enters Organization edge is compressed together by one step.Continue organization edge to be kept together and in place relative to folder 20 when grasping jaw Time, as understood with reference to Fig. 1 G-1J, handle 22 can pull the jaw 18 of folder relative to anvil 24, thus the jaw of compression clip, and Force ductility folder 20 pierce through and deform, thus organization edge E1, E2 are kept together.May select, folder 20 can be not yet Pierce through organization edge, but can deform, in order to organization edge is compressed and is fixed together.

Fig. 2 A-2J illustrates for catching prosthese 32 and ocular tissue and being clamped together with ocular tissue by prosthese 32 simultaneously The example embodiment 30 of device.Embodiment illustrates intra-ocular lens haptics 32(prosthese by example) it is fixed on iris group Knit on IT.Device in Fig. 2 A-2J can include that two groups of axles stacked 34,36, each axle 34,36 have distally jaw.One axle and Jaw design becomes catch tissue and prosthese and they pulled towards distally instrument.Second axle becomes carrying generally to beat with jaw design The ductility folder 22 opened, this ductility folder 22 can be compressed by jaw, in order to forms the folder of Guan Bi, thus by IOL Body haptics is fixed on iris.The axle 34,36 of stacking can be connected with handle 22, and this handle provides each jaw relative to anvil Forwardly and rearwardly axially-movable, this anvil surrounds axle.

In the operation of the example embodiment of Fig. 2 A-2C, when grasping axle and being pulled by handle in operation, grasp axle 12 Jaw 34 interferes with anvil 24 and is compressed.Hook, projection or conduit at the distal side edge grasping jaw can keep Tissue IT, thus tissue is pulled to around haptics, as shown in Fig. 2 D-2F when grasping jaw 34 and compressing.About this example, when When grasping axle 12 and jaw 34 are pulled to handle 22, the tissue caught and haptics are also pulled into instrument, thus relative to holding Ductility folder 22 in second group of jaw 36 pulls tissue IT and haptics 32.Tissue is pulled to instrument so that piercing is worn Tissue.When grasping jaw and continuing organization edge to be kept together and be in place relative to folder, handle can draw relative to anvil The jaw of dynamic folder, thus the jaw of compression clip, and force ductility piercing wear and deform, thus tissue and haptics are maintained at Together, as shown in Fig. 2 G-2J.Also may select, folder can not pierce through organization edge, but can deform, in order to will tissue and Haptic compression and being fixed together.

Fig. 3 A and 3B illustrates the example embodiment 40 of device, wherein, may be positioned such that for applying the clamp of eye folder 20 With the surface of the eye E tangent angle of approximation in a plane, and folder may be positioned such that approximately perpendicular to close or fixing Tissue.Device 40 includes clamp 42, and this clamp 42 can include jaw, for fixing normally open ductility folder.In example In operation, when the handle 44 of clamp presses together, hinged clamp jaw 46 is pulled to together, and this makes ductility folder 20 close Close.Leaf spring 48 or other spring can be connected with the handle of clamp, in order to make jaw be maintained at normally open position, until outward Section doctor wishes to configure this folder.Once double-layered quilt configuration, surgeon can be released in the pressure on handle 44, thus spring makes Clamp is back to open position, so that folder is the most in place, and can take out clamp.

Fig. 4 A-4C illustrates the example embodiment of distally configuration device 50, and this distally configuration device is for normally open Ductility folder 20, this folder may be used for the edge of fixing organization or eye prosthese 32 be fixed on tissue (the such as iris of eyes IT) on.Example embodiment illustrates folder 20 and is configured to be fixed on iris the haptics 32 of intra-ocular lens.Exemplary device bag Include center driver 52 and the anvil 54 around this driver.The normally open folder 20 of ductility may remain in anvil 54 In cavity.In order to configure this folder, driver 52 distad can be promoted by handle 22, and this can force folder 20 to skid off the sky of anvil Outside chamber and in entrance tissue IT.When pressing from both sides 20 and distad being promoted by driver 52, the end of folder can be by inside anvil 54 The edge of cavity and be pushed into together.For this example embodiment, the angle of cavity becomes so that folder with the angle design of folder end Can distad slide under the effect of the power of driver, but the end of folder is pushed into one by the compression stress only around anvil When rising.As it can be seen, ductility folder 20 can pierce through tissue IT, and deform around haptics 32, so that tissue and haptics May remain in together.Also may select, folder can not pierce through organization edge, but can deform, in order to will tissue and sense of touch Portion compresses and is fixed together.

Fig. 5 A and 5B illustrates the example embodiment 60 of distally configuration device, and this distally configuration device is for normally closed Elastic or marmem presss from both sides 70.Once folder 70 is released from axle 62 by driver 64, and elastic or marmem is back to Its normally closed position, the therefore edge of fixing organization or borrowed structure 32 is fixed in eyes.The example of Fig. 5 is implemented Example illustrates normally closed folder 70 and is configured to be fixed on iris tissue IT the haptics 32 of intra-ocular lens.Device includes Driver 64 and the axle 62 of this driver of receiving.Normally closed folder 70 can stay open and be limited in the inside of axle 62.Root According to this example, become close-shaped at folder this folder 70 priority bending of 70() and the inwall of axle between friction be enough to folder is maintained at axle In.In order to configure this folder, surgeon can operate handle, and this handle distad promotes driver in axle.Driver 64 can Distad to promote folder 70, so that folder leaves this axle, after folder leaves this axle, folder returns preferential close-shaped, thus Tissue is captured together with prosthese in the closing section of folder.

Fig. 6 A-6C illustrates the example embodiment 80 of distally configuration device, and this distally configuration device is for normally closed Elastic or marmem presss from both sides 90.This example embodiment illustrates once to press from both sides by example and releases from guiding piece 82, elastic or The normally closed positions that marmem folder 90 is back to it, the therefore edge of fixing organization or borrowed structure is fixed on In eyes, such as, the haptics 32 of intra-ocular lens is fixed on iris.The device of Fig. 6 can include peripheral driver 84, This peripheral driver 84 has inner clamps guiding piece 82.One purpose of folder guiding piece 82 is to be maintained at normally closed folder 90 to beat Open position.It addition, folder 90 can be positioned in the conduit in the far-end of guiding piece, and become one relative to the axis 96 of guiding piece 92 Determine angle (can select, the angle of about 45 degree).The angle of folder can allow collocation mechanism to be in the plane tangent with eyes Plane on, therefore folder is positioned to relative to close or fixing to be organized as 45 degree of angles.As instrument self poisoning Cheng Yuxiang When incisal plane is 45 degree, folder is also configured as being almost 90 degree (or the biggest) relative to ocular surface.The top of folder Portion is in outside the surface of guiding piece, and this provides contact surface, and wherein, driver 84 can promote folder to leave guiding piece 82.When When driver distad drives, folder 90 can be promoted fully out guiding piece, and drives to tissue below.By joining Putting, folder 90 can be back to its normally closed position.In this example, the clip pack configured completely is enclosed iris tissue IT and adjoins Crystalline lens haptics 32.Also may select, folder need not pierce through tissue, but around haptic compression tissue, thus can incite somebody to action They are fixed together.

Fig. 7 and 8 illustrates the example embodiment for the method entered and close to the ocular tissue closed or fix.Temporarily Or preferably method can use the axle 102 of configuration device 100 by corneal incision A, this axle 102 crosses the visual axis of eye Line.Cornea enters otch can be sufficiently small, in order to self-healing.Corneal incision can allow instrument 100 to approximate with eyes Tangent angle operates.Instrument can comprise angled distal part, in order to makes folder can be configured to 45 degree or bigger Angle, as shown in Figure 6.The folder applied by folder applicator can be normally closed " pre-formed " folder C, F or generally beat Ductility (deformable) folder opened.The folder of configuration may be used for the iris by eyes or adjacent tissue E and eyes supporting ophthalmic is brilliant Shape body D.

Fig. 8 illustrates the example sectional view of the method shown in Fig. 7, and wherein, temporary transient or preferred method can use axle By corneal incision A, this axle crosses the vision axis 102 of eye in ken FOV of eyes.Cornea enters otch can be sufficient Enough little, in order to self-healing.

For the example embodiment of the device in Fig. 1-4, the folder of ductility can be by biocompatible deformable metal Manufacturing, folder selectively includes one or more metals, such as tantalum, gold, platinum, rustless steel and/or titanium.Such folder can also Manufactured by bioabsorbable material, including polyglycolic acid, polylactic acid, polydioxanone and caprolactone.Except them can Biocompatibility and ductility, previous materials the most hardly or will not be by magnetic force, thereby ensure that for temporarily or forever The use of the folder of property for a long time, once cloth postpones, and nuclear magnetic resonance (MRI) and other magnetic energy source produce unfavorable shadow all without to this folder Ring.

For can being manufactured by biocompatible marmem, such as with described example folder Fig. 5 and 6 Suo Shi NiTi (NiTi), this NiTi can produce elastic metallic when correct process, and this elastic metallic is given tacit consent to preferential shape.

According to multiple embodiments, folder can utilize pigment to make, and this pigment carrys out pseudo-clamping by its adjacent tissue.There is face The folder (by the natural color of base material or having color by changing surfacing) of color is desirably used for cosmetic purpose, such as, The shade of white is for mating with scleral tissue.And, the shade of brown, blueness, green and other color may be used for and rainbow Membrane tissue mates.Also may select, transparent folder may be used for any surrounding tissue color that disguises oneself as.

Surface color can realize in several ways.Such as, tantalum and titanium and their alloy can anodization.Sun Polarization is the process forming oxide layer on the surface of base material.The face of broader group it is obtained in that by changing the thickness of oxide layer Color.The color seen represents from substrate reflectance, the wavelength of light through layer.Relevant to the anatomical structure of eyes coupling Color can be formed, including white for mate with scleral tissue by these metals and the anodization of their alloy Color shade and for the various browns, blueness and the green overcast that mate with iris tissue.

For providing the other method of required surface color to be the surface by color material being had to be layered in folder.Such as, Coloured polymer (such as nylon) can be layered on the surface of folder in pyrocondensation processes.A kind of such method can be led to Cross and carry out so that coloured polymer pipe slides on base material, heat-shrinkable material (such as polyolefin or fluoropolymer) Second pipe has been arranged in above color convergence thing and base material.By apply heat, polyolefin or fluoropolymer heating, compression and The following color convergence logistics that has is moved, and therefore it is layered on base material.Coloured polymer can be widely used multiple face Color, including by the color relevant to ocular anatomy structure, including the shade of white for mating with scleral tissue and for Various browns, blueness and the green overcast of iris tissue coupling.

Below with reference to Fig. 9, optional folder described here or multiple embodiments of securing member have the first supporting leg and second Lower limb or piercing portions 110,112.Supporting leg 110,112 is supported relative to each other by base portion 114.Supporting leg 110,112 from base portion 114 to far Side extends to sharp-pointed distal tip 116, and the axis 118,120 that supporting leg is more generally arranged through along supporting leg promotes this supporting leg And penetrate to tissue surface and be distally advanced in following tissue.Therefore, supporting leg axis 120 will substantially limit tissue Penetrate path, and this path generally defines (being arranged in though it is not necessary to) supporting leg or configuration plane 122.

Referring also to Fig. 9, base portion 114 generally will not placed along supporting leg plane 122, but generally has from supporting leg or configuration At least one bending section 124 that plane is protruded, some of them embodiment (below with reference to as described in Figure 31-38) have from supporting leg plane Opposite side protrude at least two bending section.Base portion 114 can be arranged along base surface 126, wherein, when in supporting leg plane When seeing (as shown in the figure) and/or when being perpendicular to supporting leg plane and seeing, base surface selectively bends, and some embodiments bend to There is the ball curvature that the spherical with ocular tissue substantially corresponds to.Base portion 114 can be included in first near supporting leg 110 Divide 114A, the Part II 114B near supporting leg 112 and one or more mid portions between which.Each base portion portion Divide and have central axis 130A, 130B, the 130C being associated, and bending section is arranged approximately along at least mid portion, and define The angle between axis near supporting leg.These axis can be arranged along base surface, and this base surface is alternatively with substantially straight Angle crosses supporting leg surface.The convex shoulder part 132 extended along supporting leg plane between supporting leg 110,112 and base portion 114 can joined Help relative to tissue stabilization structure when putting.

Folder embodiment shown in Fig. 9 is made up of line, and is preferably formed as puncturing and make two edges of tissue close. In this example, a diameter of 0.004 inch of line, but can be in the range of 0.001-0.010 inch, generally at 0.002- In the range of 0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, titanium, tantalum or include these Alloy with other material.Preferably material can carry out heat treatment and/or hardening processing, in order to provides for being kept by tissue Desirable strength in place and deformation characteristic.In shown structure, supporting leg 110,112 is formed and is arranged to penetrate two portions of tissue Point.Although the supporting leg of example embodiment and base portion are generally used suitable bending section to be formed by continuous structure, complete for structure Whole property, intensity and easily manufacture, but alternative embodiment can be assembled by separate part.

The central axis 118,120 of penetrating component is arranged to angle of inclination relative to base surface, and substantially relative to each other, Wherein, these and other example embodiment formed and the angle energy of plane of the continuous camber line of base portion 114 or bending section 124 Enough is the scope from 30 degree to 60 degree, it is possible to select so that in tissue, the path of these structures is at least some of necessarily Distance, this distance penetrates the spacing distance different (the least) of the position to tissue surface from supporting leg.More generally, prop up Lower limb (or part of supporting leg) generally forms angle of inclination with tissue and/or base surface, and angle of inclination is generally about 20 Spend in the range of about 80 degree.The end 116 of piercing portions can be with bevel or the most sharpened, to facilitate tissue Penetrate.Piercing portions is connected by circular arc 124, a diameter of about 0.050 inch of this circular arc 124.Circular arc is substantially in edge With the plane that the plane of piercing portions becomes 90 degree so that circular arc can shelve into be flat against tissue surface (supporting leg pass this tissue Surface is inserted) on.Piercing portions or supporting leg may be preferred that in circular arc plane depth below and be arranged so that folder and do not penetrate through The whole thickness of tissue (it inserts in this tissue).But, folder is preferably designed to for segment thickness tissue penetration.Circular arc 124 can perform at least three function one, some or all.First, circular arc can connect piercing portions, and this makes (such as) two organization edge can be kept together with juxtaposition by those parts.Second, circular arc can regulate or selectively become Shape, in order to control the distance between two piercing portions.Circular arc can selectively be arranged in one or more prepsetting gap. Also may select, clinician can in surgical operation or surgical site infections use clamp regulate gap, in order to puncture The junction of part is clutched or expanding circle arc.3rd, if when circular arc before configuration by mechanical restriction at open position, circular arc Can be used in elastic storage energy.

In this embodiment, line carries out spring temper or hardening so that when in elasticity (or super-elasticity) limit of material During stretching, it will return preferable shape.Folder 140 shown in Fig. 9 is in its normally closed position when being preferably to be clipped in static Release when putting or configuration structure.Figure 10 indicates how folder 140 in the circular arc of base portion 114 or the plane of bending section 124 Elastic stretching is opened, and wherein supporting leg 110,112 separates, bending section the angle that formed reduces, such as, join by being limited in by folder Structure before putting.

Figure 11-11B, 12 and 13 illustrate the embodiment of the fastener arrangement system including pressing from both sides 140 and instrument, and this instrument sets It is set to limit folder releasedly and configure this folder (shown in Fig. 9 and 10).Together with this folder 140, configuration device also includes three Critical piece: handpiece 142, folder pusher 144 and anvil 146.Anvil 146 has conduit, and this conduit is arranged to limit and promote The folder that device coordinates, and guide folder 140 gradually to return its normally closed structure.Folder pusher 144 and anvil 146 include flat basis Body, this flat body has adjacent parallel surfaces, and these parallel surfaces can slide relative to each other.Clip slot in anvil 146 Road 148 is at an angle of the piercing portions of cutting, this angle and the folder base surface relative to base portion and the angle connecting circular arc of folder Coupling.Therefore, by the conduit of anvil discharge folder will not make tissue closer to because piercing portions is merely able to so that supporting leg Along axis 118,120(when initial structure penetrates with the same axis organized the formation of) deeper drive to tissue in.Work as clinic Doctor wish to keep before folder configuration current tissue close to time, this feature is highly advantageous.In this embodiment, there is incision anvil The central channel 150 of platform 146, this conduit coordinates with the boss 152 on folder pusher, in order to by excellent for the relative motion on two surfaces Selection of land is limited to sliding axially in one direction, and the direction is approximately perpendicular to tissue surface.Folder pusher 144 is attached or fixing In handpiece 142 so that handpiece and (therefore) folder pusher cause the compression of slidably anvil towards the motion organized.Bullet Spring can selectively be arranged between folder pusher and anvil so that when system quiescence, and folder is fixedly held at both parts Between.It addition, spring can be arranged to produce configuration power, this configuration power corresponding to being inputted the minimum institute of handpiece by clinician Power need to be inputted.And, spring force can be contoured to correspond in preferred tissue compression power.In an alternative embodiment, at slider With the relative motion between anvil can be produced by the pivotal motion of the actuator of handpiece etc..

Figure 11 A illustrates the initial placement of configuration device so that folder 140 is vertical with tissue surface TS, and approximation is centered in On two organization edge E1, E2 to be connected.Central channel or other labelling on anvil 146 may be used for the center of folder It is shown to clinician, to facilitate this folder that preferably aligns.Figure 12 illustrates anvil 146 and is pressed against organizationally, so that anvil Return relative to folder pusher 144.Returning so that folder pusher can be by the tissue penetration componental movement of folder to tissue of anvil In.It addition, when anvil 146 is return relative to folder pusher 144, the base portion 114 of folder and (particularly) bending section 124 or circular arc Part can return to its preferred normally closed position.When press from both sides 140 advance along anvil conduit 148 and close time press from both sides supporting leg 110, 112 or piercing portions inwardly pull along their axis relative to tissue T, therefore the connecing of organization edge during the configuration of folder Closely will not change.Also may select, when the angle of conduit and the angle of supporting leg are different (both relative to tissue surface or base portion table Face), particularly when supporting leg than conduit closer to time vertical, press from both sides along conduit move the edge of tissue can be pulled to together and/ Or help to draw in tissue supporting leg.Figure 13 illustrates anvil and fully returns relative to folder pusher so that press from both sides from configuration device Discharge completely, and its make position can be back to, therefore keep the close of organization edge.Once configure, including pressing from both sides 140 The base portion 114 of circular arc is shelved into concordant, as shown in Figure 14 with the surface TS of tissue T.

Folder embodiment shown in Figure 15 and 16 is also made up of line, and this line is preferably formed as puncturing two organization edge Close with making them.In this example, a diameter of 0.004 inch of line, but can be in the scope of 0.001-0.010 inch In, generally in the range of 0.002-0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, titanium, Tantalum or include the alloy of one or more of which.Preferably material can carry out heat treatment and/or hardening processing, in order to Desirable strength for being held in place by tissue and deformation characteristic are provided.In shown structure, have and be arranged to penetrate the two of tissue Individual leg portion 202,204.Piercing portions defines relative to each other two circular arc 206,208.The end of piercing portions is permissible Bevel or the most sharpened, to facilitate tissue penetration.Penetrating component is connected by base portion 210, and this base portion has circle Arc, a diameter of about 0.050 inch of this circular arc.Circular arc is substantially in the plane that the plane with piercing portions becomes 90 degree, makes Circular arc can be shelved into and flats against organizationally.Piercing portions may be preferred that in circular arc plane depth below and is designed so that Press from both sides and do not penetrate through the whole thickness of tissue.But, folder is preferably designed to for segment thickness tissue penetration.Connect piercing portions Circular arc 210 can perform three functions.First, circular sliding slopes piercing portions, this makes these parts can keep two groups Selvedge edge close.Second, connect circular arc and can be plastically deformed or be adjusted to control the distance between two piercing portions. Circular arc can be arranged in one or more prepsetting gap.Also may select, clinician can be in surgical operation or surgery hands Postoperative use clamp or have other instrument of jaw etc. to regulate gap, in order to selectively pinch in the junction with piercing portions Tight or expanding circle arc 210.3rd, when circular arc by mechanical restriction open position until configuration time, circular arc 210 and/or base portion are big Enable is enough in elastic storage energy.

In this embodiment, line carries out spring temper or hardening so that when in elasticity (or super-elasticity) limit of material During stretching, folder 200 will towards and/or be back to preferable shape.Folder 200 shown in Figure 15 is be in it when static usual The preferably folder of make position.Figure 16 illustrates how folder 200 can be arranged or the rotation in the plane puncturing circular arc of elastic deformation one-tenth Turn and open.

Figure 17 A, 17B, 18 and 19 illustrate the embodiment of the configuration system including pressing from both sides 200 and instrument, and this instrument is arranged to Folder shown in configuration Figure 15 and 16.Together with this folder 200, configuration device also includes the work with following four critical pieces Tool: handpiece 220, folder pusher 222, trigger 224 and keeper 226.Handpiece 220 is attached on folder pusher 222, The motion making handpiece is directly passed to press from both sides pusher.Folder pusher 222 and trigger 224 are neighbouring with parallel structure, They can slide relative to each other along hinge axes 230.Folder pusher includes conduit 228, and this conduit 228 guides trigger 224 slide on axis 230, and this axis 230 is approximately perpendicular to tissue surface TS during configuration.It addition, folder pusher 222 Being characterised by recessed circular arc, this circular arc mates with the radius puncturing circular arc of the compatible folder 200 of Figure 15 and 16.Folder pusher Another feature be groove 232, the connection circular arc of this groove 232 fixation clamp 200.Similar with folder pusher, trigger 224 is cut Enter the circular arc of each side, in order to mate with the relevant radii puncturing circular arc on each side being positioned at folder 200.Keeper 226 is used for will Trigger 224 captures on folder pusher 222.Spring can selectively be arranged between folder pusher and anvil so that when being When uniting static, folder is fixedly held between both parts.It addition, spring may be used for producing required configuration power, this configuration Power corresponding to being inputted the minimum required input power of handpiece 220 by clinician.And, spring force can be contoured to correspond in excellent The tissue compression power of choosing.

Figure 17 A illustrate configuration device initial placement so that puncture circular arc in the plane vertical with tissue surface, and Approximation is centered on to be connected two organization edge E1, E2.The position of trigger 224 may be used for vision and/or sense of touch ground The center of folder 200 is shown to clinician, to facilitate this folder that preferably aligns.Beat to make folder be maintained at before configuration Open position, folder 200 is maintained at three positions.The first two position is that the circular arc base portion in each side by incision trigger 224 produces Clamping point, as shown in figure 17 a, this folder is limited in incision folder each side of pusher 222 in circular arc in.For folder the 3rd Restriction site is the groove 232 in incision folder pusher 222, the connection circular arc of this groove fixation clamp 200.Figure 18 illustrates tactile Send out device 224 and be pressed against the effect of tissue surface TS so that trigger is return, and slide relative to folder pusher along axis 230.Trigger The motion of device eliminates the clamping point in each side of trigger at circular arc base portion.Therefore, folder 200 becomes and does not limits, and freely Return it preferably is off position.And, once not limiting, press from both sides and guided by the circular arc in incision folder pusher 222, this ensures folder Gradually can engage along the direction being perpendicular to tissue surface with tissue below.When folder self rotates close by means of pressing from both sides pusher During conjunction, piercing portions is along inserting path movements, and the radius of this insertion path mates with tissue inlet point, thus keeps organization edge Close, and arcuate legs substantially about adjacent base part axis rotate, these rotation axiss are generally in the path of circular arc Plane radially across supporting leg extends.Figure 19 illustrates trigger 224 and exits completely relative to folder pusher 222 so that folder 200 From configuration device release, and its make position can be back to.Finally, configuration device is return, and the connection circular arc of folder 200 is sliding Go out its groove in folder pusher 222, so that the connection circular arc (with the remainder of base portion) of folder is shelved into and tissue The flush of TS, as shown in Figure 20.

Folder embodiment 300 shown in Figure 21-25A is also made up of line, and this line is preferably formed as puncturing two tissue limits Edge and make them close.In this example, a diameter of 0.004 inch of line, but can be at the model of 0.001-0.010 inch In enclosing, generally in the range of 0.002-0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, Titanium, tantalum or include the alloy of one or more of which.Preferably material can carry out heat treatment and/or hardening processing, To provide the desirable strength for being held in place by tissue.In shown structure, there are two leg portion 302,304 or set Count into the part penetrating tissue.Piercing portions includes relative to each other two circular arc.The end of piercing portions can with bevel or The most sharpened, to facilitate tissue penetration.Piercing portions is connected by base portion 306, and this base portion includes circular arc, this circle A diameter of about 0.050 inch of arc.Circular arc is in the plane that the plane with piercing portions becomes 90 degree so that circular arc can be put It is set to flat against organizationally.Piercing portions may be preferred that in circular arc plane depth below and is designed so that folder and do not penetrates through group The whole thickness knitted.Folder is preferably designed to for segment thickness tissue penetration.

The circular arc 306 connecting piercing portions 302,304 performs three functions.First, circular sliding slopes piercing portions, this makes Those parts can keep the close of two organization edge.Second, connect circular arc 306 and can be adjusted to control in two puncture portions Distance between/.Circular arc can be arranged in one or more prepsetting gap.Also may select, clinician can be at surgery hands In art or surgical site infections uses clamp etc. to regulate gap, in order to clutch in the junction with piercing portions 302,304 or expand Exhibition connects circular arc 306.3rd, connect circular arc for arranging the folder degree of depth in the tissue, and during configuration and post processing Any being not intended to preventing folder in journey enters.

In this embodiment, line has sufficient ductility so that can be carried out forever easily by the plastic deformation of line Property mechanically deform for a long time.Folder 300 shown in Figure 21 was expressed as before being arranged in its piercing portions deformation of tissue neutralization.

Figure 22,22A, 23 and 24 illustrate the embodiment of the configuration system including pressing from both sides 300 and instrument 310, and this instrument 310 sets It is set to the folder 300 shown in deformation and configuration Figure 21.Together with this folder, configuration device includes three critical pieces: handpiece 312, folder hammer 316 and anvil 314.Handpiece 312 is attached in folder hammer and anvil part, so that clinician can will be pressed from both sides It is positioned at desired location.And, handpiece controls folder hammer and slides along the relative of axis relative to anvil.In order to be formed and configure Folder, in the structure shown in Figure 22 A, first the tip of device is centered in above two organization edge that will be close.Puncture portion The tip divided is outside collocation mechanism so that before engaging this formation, collocation mechanism, the surface of they puncturing tissue.When folder hammer When pushing down on relative to the anvil against tissue surface, the piercing portions forcing folder 300 is wound on the boss of each side of anvil to Lower rotation, as shown in Figure 22 A and 23.The rotation of piercing portions makes organization edge compress towards each other, so that edge Close.When folder hammer is forced through piercing portions in the plane tangent with the circular arc on piercing portions, the formation of folder completes, as Shown in Figure 24 and 25.

Spring can selectively be arranged in folder hammer with anvil between so that when system quiescence, folder be fixedly held at this two Between individual parts.It addition, spring may be used for producing configuration power, this configuration power is corresponding to being inputted handpiece by clinician Little required input power.

Folder embodiment 400 shown in Figure 26-30 is also made up of line, and this line is preferably formed as puncturing two organization edge Close with making them.In this example, a diameter of 0.004 inch of line, but can be in the scope of 0.001-0.010 inch In, generally in the range of 0.002-0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, titanium, Tantalum or include the alloy of one or more of which.Preferably material can carry out heat treatment and/or hardening processing, in order to Desirable strength for being held in place by tissue is provided.In shown structure, have be designed to penetrate through tissue two supporting legs or Part.The central axis of piercing portions is relative to each other, and with base portion or is connected circular arc surface formation 30 degree to 60 degree in the range of Angle.The end of piercing portions can be with bevel or the most sharpened, to facilitate tissue penetration.Piercing portions passes through Circular arc connects, a diameter of about 0.050 inch of this circular arc.Circular arc is in the plane with piercing portions and becomes the plane of 90 degree In so that circular arc can be shelved into and flat against organizationally.Piercing portions may be preferred that design in circular arc plane depth below Become to make folder and do not penetrate through the whole thickness of tissue.But, folder can be designed for segment thickness tissue penetration.Circular arc is certainly Body performs three functions.First, circular sliding slopes piercing portions, this makes those parts can keep two organization edge and make They juxtapositions are together.Second, circular arc can be adjusted to control the distance between two piercing portions.Circular arc can be arranged at In one or more prepsetting gaps.Also may select, clinician can be in surgical operation or surgical site infections uses clamp etc. Regulate gap, in order to clutch or expanding circle arc in the junction with piercing portions.3rd, connect circular arc and be clipped in group for setting The degree of depth in knitting, and during configuration and in last handling process, prevent any being not intended to of folder from entering.

Figure 27 illustrates specimen holder transmission system, and this specimen holder transmission system includes means of transportation or device 410 and Figure 26 Shown in folder 400.In this embodiment, there are top jaw 402 and lower holding jaw 404, as shown in Figure 27 A-29.Work as extruding When the upper part of connecting gear or handle 412, the jaw at device tip mutually leaves, and discharges folder.For closed injury Two edges of mouth, clinician so uses this instrument, i.e. by first using a piercing portions of folder 400 at a tissue Tissue is penetrated near edge E1.Then, the organization edge that clinician's pull unit and (therefore) are pressed from both sides and be attached is to second Approximated position needed for organization edge E2, as shown in Figure 28.Once two organization edge are in required position close to each other (example As when providing the required joint between edge), clinician can handle this device, in order to the second piercing portions of folder Tissue is penetrated, as shown in Figure 28-30 so that two organization edge are all disposed within piercing portions near minor microstructure edge E2 Between.By being in the folder of desired location, the upper part of transporter can by extruding handpiece and pivotal motion so that Obtain lower holding jaw mutually leave and discharge this folder.When jaw is in an open position, user makes transporter with smaller angle Exit and leave tissue, in order to discharge this folder completely.Figure 30 illustrates the folder of release and provides the close of two organization edge.

It should be known that folder transporter is example, various mechanism may be used for mutually leaving to discharge so that jaw Folder.

Folder embodiment 500 shown in Figure 31-34 is also made up of line, and this line is preferably formed as puncturing two organization edge Close with making them.In this example, a diameter of 0.004 inch of line, but can be in the scope of 0.001-0.010 inch In, generally in the range of 0.002-0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, titanium, Tantalum or include their alloy.Preferably material can carry out heat treatment and/or hardening processing, in order to provides for by group Knit the desirable strength being held in place.In shown structure, there is two supporting legs or the part being designed to penetrate through tissue.Piercing portions Central axis relative to each other, and the angle in the range of forming 30 degree to 60 degree with base portion.The end of piercing portions can become oblique Angle or the most sharpened, to facilitate tissue penetration.Piercing portions is connected by base portion, this base portion have two contrary Circular arc, a diameter of about 0.025 inch of each circular arc.Circular arc is in the plane that the plane with piercing portions becomes 90 degree so that Circular arc can be shelved into and flat against organizationally, and circular arc protrudes from the opposite side of the plane of piercing portions.Piercing portions is at two The plane depth below connecting circular arc may be preferred that the whole thickness being designed to press from both sides and do not penetrate through tissue.Folder preferably sets Count into for segment thickness tissue penetration.It addition, line can be with spring temper or hardening so that when it is in elastic limit of materials During stretching, it will return preferable shape.

The circular arc of the base portion of the folder embodiment 500 of Figure 31-34 is able to carry out five functions.First, circular sliding slopes puncture portion Point, this makes those parts two organization edge to be kept together.Second, circular arc can each be adjusted to control two Distance between individual piercing portions.Circular arc can also be arranged in one or more prepsetting gap.Also may select, clinician's energy Reach in surgical operation or surgical site infections uses clamp to regulate gap, in order to clutch in the junction with piercing portions or expand Exhibition circular arc.3rd, when circular arc by mechanical restriction open position until configuration time, circular arc can be used in elastic storage energy.The Four, connect circular arc and be used for arranging this folder degree of depth in the tissue, and during configuration and in last handling process, prevent appointing of folder Why not want to enter into.5th, tissue surface there are two circular arcs any being not intended to preventing folder rotated.

Folder embodiment 700 shown in Figure 35-38 is made up of line, this line be preferably formed as puncturing two organization edge and Make them close.In this example, a diameter of 0.004 inch of line, but can be in the scope of 0.001-0.010 inch In, generally in the range of 0.002-0.006 inch, and multiple material can be used to manufacture, including rustless steel, NiTi, titanium, Tantalum or include their alloy.Preferably material can carry out heat treatment and/or hardening processing, in order to offer is used for will tissue The desirable strength being held in place.In structure shown here, there is two supporting legs or the part being designed to penetrate through tissue.Puncture Part includes two reciprocal circular arcs.The end of piercing portions can be with bevel or the most sharpened, with convenient Tissue penetration.Piercing portions is connected by two circular arcs, a diameter of about 0.025 inch of each circular arc.Connect circular arc to be in With in the plane that the plane of piercing portions becomes 90 degree so that circular arc can be shelved into and flat against organizationally.Piercing portions is at two The plane depth below connecting circular arc may be preferred that the whole thickness being arranged to press from both sides and do not penetrate through tissue.But, folder It is preferably designed to for segment thickness tissue penetration.It addition, line can be with spring temper or hardening so that when it is in the elasticity of material In (or super-elasticity) limit during stretching, it will towards or return preferable shape.

The circular arc of folder 700 is able to carry out five functions.First, circular sliding slopes piercing portions, this makes those parts can Two organization edge are kept together with juxtaposition.Second, circular arc can each be adjusted to control between two piercing portions Distance.Circular arc can also be arranged in one or more prepsetting gap.Also may select, clinician can be in surgical operation Or surgical site infections uses clamp to regulate gap, in order to clutch or expanding circle arc in the junction with piercing portions.3rd, when Circular arc is by mechanical restriction when open position is until configuration, and circular arc can be used in elastic storage energy.4th, connect circular arc and be used for This folder degree of depth in the tissue is set, and during configuration and in last handling process, prevents any being not intended to of folder from entering.The Five, tissue surface there are two circular arcs any being not intended to preventing folder rotated.

Except Guan Bi tissue and fixing eye prosthese, folder may be provided for attendant advantages, including medicine elution or administration.So Beneficial drugs including, but not limited to antibiotic, anti-inflammatory agent, steroid, anticoagulant, anti-vegf(angiogenesis factor) and anti- Fibrosing agent.In certain embodiments, folder can be coated with medicine.Also may select, folder can be designed to hollow or porous, in order to Elute or bestow medicine.

Folder can also bestow bonding agent.As described in the background art, bonding agent is occasionally used for closing in ocular tissue Otch or the edge of wound.Hollow or porous folder may be used for elution or bestows the bonding agent for superior strength.And, empty The folder of the heart or porous may be used for being arranged in below organizational structure by bonding agent, in order to alleviates structures surrounding stimulation Problem.

Embodiment described here is exemplary.Although describe these embodiments by reference to accompanying drawing, but ability Field technique personnel should appreciate that described method and/or special construction can carry out multiple change or change.

In description above, describe the present invention by reference to only certain embodiments of the present invention, but this area skill Art personnel it should be known that and the invention is not limited in this.Multiple features of foregoing invention and aspect can make either individually or in combinations With.And, in the case of without departing from the broad spirit of description and scope, the present invention can be used in exceeding described here appointing Meaning environment and purposes.Therefore, specification and drawings is considered to be exemplary rather than limits.It should be known that and make here Term " include ", " comprising " and " having " will be used in particular for being read as the open term of this area.

Claims (16)

1., for the device that surgical tissue is fixing, described device includes:

First supporting leg, described first supporting leg limits the first supporting leg axis and first end, and described first end is arranged for wearing Cross the first piercing site to advance along the first supporting leg axis in tissue；

Second supporting leg, described second supporting leg limits the second supporting leg axis and the second end, and described the second end is arranged for First supporting leg advances along the second supporting leg axis in tissue through the second piercing site while advancing through the first piercing site, Described first supporting leg axis and the second supporting leg axis define supporting leg plane, the first supporting leg axis and the second supporting leg axis and just During beginning tissue penetration identical with the axis organized the formation of；And

Base portion, described base portion extends along base surface, and supports the first supporting leg and the second supporting leg, and described base portion has puts down from supporting leg The bending section that face is protruded, described base portion is arranged in the first supporting leg and advances with the second supporting leg through second through the first piercing site Piercing site deforms during advancing so that the configuration of described device is maintained at the tissue before the configuration of described device close to journey Degree, and the first supporting leg and the second supporting leg keep base surface along tissue surface after the first supporting leg and the second supporting leg are advanced.

Device the most according to claim 1, wherein: base portion includes that slender body, described slender body have: the first base portion Part, described first base segments has the first base portion axis near the first supporting leg；Second base segments, described second base Portion's part has the second base portion axis near the second supporting leg；And middle base portion, described middle base portion has The central base portion axis being arranged between the first base segments and the second base segments, bending section is at least partially along central base portion portion Distribution is put, and the first base portion axis, the second base portion axis and central base portion axis extend along base surface.

Device the most according to claim 2, wherein: tissue includes the ocular tissue of spherical curvature, described base portion spherical curvature, Make the first base portion axis, the second base portion axis and central base portion axis when in configuration plane observed time curved along tissue surface Song, bends along tissue surface when being perpendicular to supporting leg plane and being observed.

Device the most according to claim 2, wherein: base portion has the first bending between the first supporting leg and the second supporting leg Portion and the second bending section, the first bending section extends from the first side of supporting leg plane, and the second bending section is from supporting leg plane and the first side The second contrary side extends.

Device the most according to claim 1, wherein: tissue includes that ocular tissue, tissue surface include the visible front portion of eyes Surface or be arranged near the visible anterior face of eyes so that the first supporting leg and the second supporting leg penetrate tissue surface and towards eye Advancing in eyeball rear portion, the visible anterior face of eyes has a color, and base portion has the most corresponding with eye color so that camouflage is described The color of device.

Device the most according to claim 1, wherein: the first supporting leg and the second supporting leg are straight, and advance in the tissue, make The minor microstructure path of the first tissue access of the first supporting leg and the second supporting leg is respectively substantially straight, and with tissue surface shape Becoming relative oblique angle, base portion is arranged for making the angular distortion of bending section so that the first supporting leg and the second supporting leg it Between spacing distance change.

Device the most according to claim 2, wherein: the first supporting leg and the bending of the second supporting leg so that the first supporting leg and second Supporting leg is arranged to form the first tissue access extended along two contrary circular arcs and minor microstructure path, and base portion is arranged to become Shape, in order to realize the first supporting leg and rotate substantially about the second base portion axis substantially about the first base portion axis rotation and the second supporting leg.

Device the most according to claim 1, wherein: during base portion is arranged in the advance of the first supporting leg and the second supporting leg Or plastic deformation afterwards.

Device the most according to claim 1, wherein: base portion has configuration pre-structure and release structure, configures pre-structure quilt It is biased into so that permission base portion is promoted the first supporting leg and the second supporting leg by the described device fixing for surgical tissue of release Advancing in tissue, the base portion of release is biased into the joint kept between base portion and tissue surface.

Device the most according to claim 6, wherein: base portion be arranged in the first supporting leg and second at least partially Plastic deformation during or after the advance of lower limb elasticity, in order to strengthen tissue fixing by described device.

11. devices according to claim 1, wherein: tissue includes or support the iris of eyes, and described device also includes joining Putting instrument, described configuration tool has axle, and supports described device releasedly, and wherein the first supporting leg and the second supporting leg are oriented Cross described axle and be oriented by make described configuration tool cross that the ken of eyes advances to from insertion site will be by The configuration position of the tissue that one supporting leg and the second supporting leg puncture and configure.

12. devices according to claim 1, also include: configuration tool, described configuration tool supports described dress releasedly Putting, described configuration tool has:

Axle, described axle has proximally and distally, and have axle proximally and distally between axis；

First grip element, described first grip element is arranged in proximate distal ends, and the first grip element has the first grasping surface；

Second grip element, described second grip element is arranged in proximate distal ends, and described second grip element has the second grasping Surface, described second grasping surface can move between the first structure and the second structure, and the first grip element and second grasps unit Part is arranged to the capture of described device when the second grasping surface is in the first structure and/or catches in the first grip element and the Between two grip element；And

Handle, described handle arrangements is at the near proximal ends of axle so that the motion of handle is capable of the second grasping surface from first Structure is to the motion of the second structure, thus when the first supporting leg and the second supporting leg align with the target allocation position of tissue surface, Described second grasping surface causes the first supporting leg and the second supporting leg to advance in tissue from the first structure to the motion of the second structure With the described device of release.

13. devices according to claim 1, wherein, described device is ocular tissue's fixing device, wherein:

First supporting leg with first end is arranged for puncturing ocular tissue surface and for making the first supporting leg along first Path advances in ocular tissue's surface tissue below；

Second supporting leg with the second end is arranged for puncturing ocular tissue surface and for making the second supporting leg along second Path is advance in tissue, and the first path and alternate path form relative oblique angle with tissue surface so that the first path and the Two-way curb supporting leg plane extends, the piercing site interval between the first path and the channel spacing of alternate path and piercing site Different；And

Wherein, described device is made up of shape-memory material, and described shape-memory material can be rearranged into from the first structure Two structures, in order to prevent the first supporting leg from exiting along the first path and exit along alternate path with the second supporting leg.

14. devices according to claim 5, wherein: tissue includes that scleral tissue, eye color are included in the white on metal Layer.

15. devices according to claim 5, wherein: tissue includes the iris of eyes, and described device also includes multiple optional Securing member, these securing members have different colours so that the color of the securing member of selection is mated with eye color.

16. 1 kinds of ocular tissue's fixing devices, it is for being fixed together the first organization edge and the minor microstructure edge of wound, Described ocular tissue fixing device includes:

Handle, described handle is arranged to be kept by operator；

Anvil, described anvil is connected with the far-end of handle, and be arranged to restriction have the first supporting leg, the second supporting leg and supporting first The tissue fastener of the base portion of supporting leg and the second supporting leg；And

Driver, described driver is connected with handle, and is arranged in distally and is driven, thus the tissue that configuration is limited by anvil Securing member；

Wherein, anvil and driver coordinate, in order to configure tissue fastener during actuating driver；

Wherein, the first supporting leg of tissue fastener can advance through tissue surface also at the first piercing site of wound the first side In tissue surface tissue below；

Wherein, the second supporting leg of tissue fastener can advance through tissue surface also at the second piercing site of wound the second side In tissue surface tissue below, described second piercing site and the first piercing site are spaced a distance；

Wherein, described base portion can be rearranged into so that at tissue fastener during the first supporting leg and the second supporting leg advance The distance between the first piercing site and the second piercing site is kept after the configuration carried out with driver and anvil, and Make also to keep the first organization edge and second group after the configuration that tissue fastener is carried out with driver and anvil Degree of closeness between selvedge edge.