FIELD OF INVENTION The present invention relates to intraocular lens (IOL) injectors, and more particularly to loading apparatus and methods for IOL injectors.
BACKGROUND OF THE INVENTION IOLs are artificial lenses used to replace natural crystalline lenses of eyes when the natural lenses are diseased or otherwise impaired. Under some circumstances a natural lens may remain in an eye together with an implanted IOL. IOLs may be placed in either the posterior chamber or anterior chamber of an eye.
IOLs come in a variety of configurations and materials. Various instruments and methods for implanting such IOLs in an eye are known. Typically, an incision is made in a patient's cornea and an IOL is inserted into the eye through the incision. In one technique, a surgeon uses surgical forceps having opposing blades to grasp the IOL and insert it through the incision into the eye. While this technique is still practiced today, more and more surgeons are using IOL injectors which offer advantages such as affording a surgeon more control when inserting an IOL into an eye and permitting insertion of IOLs through smaller incisions. Smaller incision sizes (e.g., less than about 3 mm) are preferred over larger incisions (e.g., about 3.2 to 5+mm) since smaller incisions have been attributed to reduced post-surgical healing time and reduced complications such as induced astigmatism.
In order for an IOL to fit through a smaller incision, it is typically folded and/or compressed prior to entering the eye where they will assume their original unfolded/uncompressed shape. Since IOLs are very small and delicate articles of manufacture, great care must be taken in their handling, both as they are loaded into an injector and as the lens is injected into a patient's eye.
It is important that an IOL be expelled from the tip of the IOL injector and into the eye in an undamaged condition and in a predictable orientation. Should an IOL be damaged or expelled from the injector in an incorrect orientation, a surgeon must remove or further manipulate the IOL in the eye, possibly resulting in trauma to the surrounding tissues of the eye. To achieve proper delivery of an IOL, consistent loading of the IOL into the injector device with a minimum opportunity for damaging the IOL is desirable.
Various IOL injectors and other devices have been proposed which attempt to address issues related to loading, yet there remains a need for an IOL injector which improves consistency of loading and reduces the likelihood of damage to an IOL.
SUMMARY Aspects of the present invention are directed to an IOL injector comprising a loading chamber comprising a component that when being closed folds the lens. Additional aspects of the present invention are directed to a vial for maintaining an IOL prior to loading. The vial includes an injector guide that receives an injector such that when the injector is rotated a folded IOL can be obtained in the injector. In some embodiments, the injector and vial are provided in a combination. As defined here in “a combination” includes but is not limited to arrangements in which the objects in the combination are packaged and are not connected to one another.
Other aspects of the present invention are directed to an injector having an opening to a loading chamber, the opening being defined by a tapered edge. Additional aspects of the present invention are directed to an IOL vial comprising a convexly curved interior surface and a flexible arm adapted to maintain an IOL against a surface opposite the convexly curved interior surface. In some embodiments, the injector having tapered edge and the vial having a flexible arm are provided in a combination.
A first aspect of the invention is directed to an IOL injector body having a lumen with a longitudinal axis, the IOL injector comprising an injector body segment defining a portion of the lumen; a first loading chamber component coupled to the injector body segment; and a second loading chamber component comprising a lens contact surface, the second loading chamber component being hingedly coupled to the first loading chamber component such that the second loading chamber component is capable of rotating about a second axis that is parallel to the longitudinal axis.
In some embodiments, the second loading chamber component is configured and arranged such that, upon rotation of the second loading chamber about the second axis, the first loading chamber component and the second loading chamber component combine to form a second portion of the lumen. In some embodiments, the first and second loading chamber components form a rotationally complete portion of the lumen. In some embodiments, the second loading component is configured and arranged to fold an IOL using the lens contact surface upon rotation about the second axis. In some embodiments, the second loading component is configured and arranged to fold the IOL such that after rotation the lens is ready for delivery.
The second axis may be aligned with a wall of the injector body. In some embodiments, the first loading chamber component is rigidly connected to the injector body. In some embodiments, the first loading chamber component is integrally formed with the injector body. The first loading chamber component and the second loading chamber component may be configured to maintain the loading chamber in a closed position. The first loading chamber component and the second loading chamber component may be configured to snap together. The injector may be in a combination with a vial comprising a vial base, an IOL-holder mount disposed in said base, and an injector guide rotatably mounted in said base.
Another aspect of the invention is directed to a IOL vial, comprising: a vial base; an IOL-holder mount disposed in said base; and an injector guide rotatably mounted in said base, whereby an injector can be inserted along the injector guide and rotated. The injector guide may be disposed on a guide support. In some embodiments, the guide support is cylindrical.
In some embodiments the IOL-holder mount may be comprised of a first prong and a second prong, the first prong and the second prong being separated from one another. The vial may further comprise a second IOL-holder mount. The second IOL-holder mount may be comprised of a third prong and a fourth prong, the third prong and the fourth prong being separated from one another.
The vial may be in a combination with a lens holder, the lens holder being disposed between the first and second prong, and between the third prong and the fourth prong. The first holder mount and the second holder mount, and the lens holder may be configured such that the lens holder is capable of being slidably held by first holder mount and the second holder mount.
The term “lens contact surface” is defined herein as a surface arranged to contact an IOL lens after the loading chamber is closed. An injector having an IOL that is “ready for delivery” is an injector that is in a condition such that actuation of its IOL ejection apparatus (e.g., a plunger) results in ejection of the IOL from the injector.
BRIEF DESCRIPTION OF THE DRAWINGS Illustrative, non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying drawings, in which the same reference number is used to designate the same or similar components in different figures, and in which:
FIG. 1A is a perspective view of an exemplary embodiment of an injector according to aspects of the present invention having an open loading chamber;
FIG. 1B is a perspective view of an exemplary embodiment of a injector according to aspects of the present invention having a closed loading chamber;
FIG. 1C is a perspective view of an exemplary embodiment of a injector according to aspects of the present invention having a tip attached;
FIG. 2A is a perspective view of an exemplary embodiment of a vial according to aspects of the present invention;
FIGS.2B-C are side views of the exemplary embodiment of the vial illustrated inFIG. 2A;
FIG. 3A is a plan view of an exemplary embodiment of a lens holder according to aspects of the present invention;
FIG. 3B is a side view of the exemplary embodiment of the lens holder illustrated inFIG. 3A;
FIG. 4 is a perspective view of the exemplary embodiment of an injector as illustrated inFIG. 1A engaged with the exemplary embodiment of a vial as illustrated inFIG. 2A, in which a portion of the vial is broken away;
FIGS. 5A-5C illustrate steps for loading an injector according to aspects of the present invention;
FIG. 6A is a perspective view of a second exemplary embodiment of an injector according to aspects of the present invention having an open loading chamber;
FIG. 6B is a perspective view of the second exemplary embodiment of the injector according to aspects of the present invention having a closed loading chamber;
FIG. 6C is a side view of the second exemplary embodiment illustrating a loading chamber opening;
FIG. 7 is a perspective view of the second exemplary embodiment of an injector as illustrated inFIG. 6A engaged with a second exemplary embodiment of a vial, in which a portion of the vial is broken away;
FIGS. 8A-8B illustrate steps for loading an injector according to aspects of the present invention; and
FIG. 9 is a perspective view of an exemplary embodiment of a flexible arm.
DETAILED DESCRIPTIONFIG. 1A is a perspective view of an exemplary embodiment of anIOL injector100 according to aspects of the present invention. As illustrated inFIG. 1A,IOL injector100 has an open loading chamber and adetached tip175.Injector100 includes a lumen having a longitudinal axis Z. Aninjector body segment110 defines a portion L′ of the lumen. As described below, another portion of the lumen is provided by theloading chamber120 when it is closed.
A firstloading chamber component120ais coupled to the injector body segment; and a secondloading chamber component120bis hingedly coupled to the first loading chamber component such that the second loading chamber component is capable of rotating about a second axis Y that is parallel to longitudinal axis Z. In some embodiments, the second axis may be aligned with a wall of the injector body as illustrated inFIGS. 1A-1C. However, coincidence is not necessary and the second axis may be offset from the wall of the lumen.
Firstloading chamber component120amay be coupled toinjector body100segment110 in any suitable manner. For example, the first loading chamber component may be rigidly connected to the injector body. In some embodiments, the first loading chamber component may be integrally formed (e.g., molded as a single part) with the injector body segment. Other suitable techniques of attachment include, but are not limited to snap fit or compression fit or by using a connector such as a screw or other threaded structure.
As illustrated inFIG. 1B, when secondloading chamber component120bis rotated about second axis Y such that the loading chamber is closed, the first loading chamber component and the second loading chamber component combine to form a second portion L″ of the lumen. Preferably, the first loading chamber component and the second loading chamber component fixedly couple together when the loading chamber is closed such that they maintain a closed loading chamber after rotation of the second loading chamber component. For example, a molded snap fit structure may be provided on the first and second loading chamber components (i.e., they are configured to snap together). As illustrated inFIG. 1A, in some embodiments, the snap fit structure may comprise aprojection121bon one of the bottom surface of first loading chamber component and the top surface of second loading chamber component, and adetent121aon the other ofbottom surface121aandtop surface121a.
Also as illustrated inFIGS. 1A and 1B, secondloading chamber component120bcomprises alens contact surface122. It is to be appreciated that in the illustrated embodiment the second loading chamber component is configured and arranged to fold an IOL150 (also referred to herein simply as a “lens”), using the lens contact surface, upon rotation of the second loading chamber component about second axis Y. As illustrated inFIG. 1B, in some embodiments, the first and second loading chamber components form a rotationally complete portion L″ of the lumen.
Upon rotation of the second loading chamber component,IOL150 is located in loading chamber ready for delivery (i.e., the lens is located such that upon depressing ofplunger180,IOL150 is expelled from the injector).Plunger180 is aligned in the lumen such thattip182 advances the lens after it has been obtained in the injector. The tip may be conventional fork shaped tip or a soft silicone tip as is known in the art. As illustrated inFIG. 1C, according some embodiments of the invention, upon rotation of the second loading chamber component, such that the loading chamber is closed, atip175 may be attached to an end of the injector body.
FIG. 2A is a perspective view of an exemplary embodiment of anIOL vial200 according to aspects of the present invention.Vial200, comprises avial base210, and an IOL holder mount including afirst support220aand asecond support220bdisposed in the vial base.Vial200 also includes aninjector guide230 that is configured to be rotatably mounted in the vial base. As discussed in greater detail below with reference toFIGS. 5A-5C, an IOL injector (e.g.,injector100 illustrated inFIG. 1A) can be inserted alonginjector guide230 and rotated such that a folded IOL can be obtained in the injector. As illustrated inFIG. 2A,injector guide230 may be coupled to aguide support235 that maintainsinjector guide230 relative to vial base and supports220aand220b. As discussed in greater detail below with reference toFIG. 5B, theguide support235 extends below the bottom ofguide230.
It is to be appreciated that, in the illustrated embodiment, guidesupport235 is cylindrical so as to conform to the shape of the vial base. The guide support may form a continuous cylinder or have a gap. Also, as illustrated in greater detail inFIG. 5A, guidesupport235 is sized to fit between asidewall214 of the vial base and afixed stop212.
FIG. 2B illustratesholder mount220aof avial base210 in greater detail. Holder mount220acomprises afirst prong221aand asecond prong221b.FIG. 2C illustratesholder mount220bofvial base210 in greater detail. Holder mount220bcomprises afirst prong222aand asecond prong222b. In some embodiments,prong222bis slightly lower thanprong222a. As described below, the space betweenprong221aandprong221b, and the space betweenprong222aandprong222bare selected so that holder mounts220aand220bslidably hold a lens holder as described in greater detail below.
FIGS. 3A and 3B illustrate an exemplary embodiment of alens holder300 suitable for use with theinjector100 andvial200. AnIOL350 is disposed in avalley310 between tworidges315aand315b. The width W of the valley is selected such thatIOL350 can be maintained between the ridges due to friction between the IOL haptics352a-352dand theridges315aand315b.Holder300 has a thickness T at the ridges. As discussed below,IOL350 may be removed frommount300 by application a force F to a side ofIOL350 such that force F overcomes the friction holding IOL between the ridges. It is to be appreciated that any suitable IOL and IOL holder may be used with aspects of the present invention. For example, the IOL may have any suitable optic shape and may have any suitable number of haptics (e.g., one, two or three), and the IOL holder may have any suitable shape.
FIG. 4 is a perspective view ofinjector body110 as illustrated inFIG. 1A engaged with the exemplary embodiment of avial200 as illustrated inFIG. 2A. As discussed above,injector body110 can be inserted along injector guide230 (in the direction indicated by arrow1) and rotated (in the direction of arrow2) such that a foldedIOL350 can be obtained in the injector body.
It is to be appreciated that although in some applications it is advantageous to provide and/oruse injector100 with avial200,injector100 may be used with any suitable structure capable of maintaining an IOL such that the second loading chamber component can be used to interact with the IOL in a manner such that the IOL is obtained in loading chamber.
FIGS. 5A-5C illustrate an exemplary progression of steps for loading aninjector body110 with anIOL350 according to aspects of the present invention. It is to be appreciated that only a portion of theinjector body110 proximate theloading chamber120 is illustrated inFIGS. 5A-5C to avoid obfuscation.
As illustrated inFIG. 5A,IOL holder300 is supported by IOL supports220aand220bof IOL holder support220. A thickness T (seeFIG. 3B) is sized relative to the distance betweenprongs221aand221b(seeFIG. 2A), and the distance betweenprongs222aand222b(seeFIG. 2B) so as to form a friction fit betweenprongs221aand221bofIOL support220aand to form a friction fit betweenprongs221band222bofIOL support220b. Accordingly,lens holder300 is slidably held by thesupports220aand220bsuch that upon application of a force F′ to the lens holder,IOL holder300 slides between pair ofprongs221a,222aand pair orprongs221b,222btoward the bottom of the vial. It is to be appreciated that asIOL holder300 slides between the prongs,IOL350 is contacted by aprojection505 such that a force F, which is capable of overcoming the friction between haptics352a-352dand holder300 (as described above with reference toFIG. 3A), is applied tolens350.Lens350 can thereby be detached from theholder300.Projection505 may be attached to or separate ofvial base210.Vial base210 may be provided with a holder (not shown), such as a hollow cylinder, disposed on its bottom to facilitate positioning ofprojection505.Fixed stop212 is included inFIG. 5A for clarity.
FIG. 5B illustratesIOL holder300 after it has been displaced in the direction of arrow1 (i.e., toward the bottom of vial300) a sufficient distance such thatIOL350 is completely detached fromIOL holder300 and is located proximate loading chamber120 (i.e., the lens is proximate firstloading chamber component120aandsecond loading chamber120b).
It is to be appreciated that, as illustrated inFIG. 5B,injector body110 is pushed into the vial base210adistance such that firstloading chamber component120ais at least a small distance aboveholder mount220aand a small distance belowinjector guide230, thus exposing the bottom of firstloading chamber component120a. As discussed above, with reference toFIG. 2A, theguide support235 extends below the bottom ofinjector guide230. Accordingly, there is a separation between the bottom ofguide230 and the top ofsupport220asuch that the bottom of firstloading chamber component120ais exposed during rotation.
Additionally, the top of secondloading chamber component120bextends aboveholder mount220b, such that upon rotation of the injector (in the direction of arrow2) as indicated inFIG. 5C, the bottom of firstloading chamber component120aand the top of secondloading chamber component120bcontact one another and become attached to one another, for example using a snap fit as discussed above with reference toFIG. 1A. Accordingly, upon rotation of theinjector body110, the loading chamber is closed and a foldedIOL150 is achieved ininjector100. As discussed above with reference toFIG. 2C,second prong222bmay be slightly lower thanprong222a, thereby facilitating closure. In some embodiments, fixedstop212 operates to prevent over rotation of the second loading chamber component relative to the first loading chamber component.
FIG. 6A is a perspective view of a second exemplary embodiment of anIOL injector600 according to aspects of the present invention. As illustrated inFIG. 6A, the injector has anopen loading chamber620.Injector600 comprises aninjector body610 defining a lumen extending along a longitudinal axis Z. The injector has anopening624 to the loading chamber that is defined at least in part by atapered edge625 extending in the direction of longitudinal axis Z.
Tapered edge625 is illustrated in the cross-sectional view ofinjector600 inFIG. 8A. As illustrated inFIG. 8A, in some embodiments, the lumen has a substantially circular cross section. However, the lumen may be elliptical or oval. In some embodiments, having a substantially circular cross section, it is advantageous thattapered edge625 be located further from a center K of the substantially circular lumen (i.e., a distance d2from K) than an opposingedge626 of opening624 (i.e., a distance d2from K) thereby facilitating loading a lens by scooping the lens into the loading chamber as described below. In some embodiments, regardless of the shape of the lumen, taperededge625 is located further from the middle ofsurface622 than opposingedge626. It is to be appreciated that taperededge625 may be sharp. It is also to be appreciated that to be sharp, an edge need not come to point at a microscopic level.
Referring toFIG. 6C, opening624 is illustrated in a side view ofinjector600. The length of taperededge625 can extend along the entire length L of opening624 (e.g., the opening may be rectangular and the tapered edge may extend along a side of the rectangle) or the tapered edge can extend along only a portion of length L that is adequate to engage an IOL in the manner discussed below with reference toFIGS. 8A and 8B. It is also to be appreciated that taperededge625 can be aligned parallel to axis Z; however, taperededge625 may be disposed other than parallel so long as it extends at least some distance along the direction of axis Z. In some embodiments, only edge625 is tapered andedge626 is non-tapered.
Referring again toFIG. 6A, in some embodiments,injector600 may have anexterior surface622 that is configured to facilitate loading of a lens into the injector in a manner as discussed below with reference toFIGS. 8A and 8B.Injector tip175 may be integrated withinjector body610 or may be attachable to the body using any suitable technique.
As illustrated inFIGS. 6A and 6B, adoor630 may be provided which can be closed to maintain a lens within the loading chamber of theinjector600. Although the illustrated door is configured and arranged to slide alonginjector body610 into a closed position, the door may be disposed on a hinge or may simply snap into a closed position.Plunger180 is aligned in the lumen such thattip182 advances the lens after it has been obtained in the injector. The tip may be conventional fork shaped tip or a soft silicone tip as is known in the art.
FIG. 7 is a perspective view of the second exemplary embodiment of an injector as illustrated inFIG. 6A that is engaged with a second exemplary embodiment of anIOL vial700. As discussed in greater detail with reference toFIGS. 8A and 8B,injector600 can be inserted (in the direction indicated by arrow1) intovial700; and the injector body can be rotated relative to the vial (in the direction indicated by arrow2) to obtain the IOL in the IOL injector body. In some embodiments, the injector is rotated about a curvedinterior surface640 of the vial by contactingsurface640 with at least a portion ofsurface622 of the injector.
FIGS. 8A-8B are cross-sectional views taken alongline8A-B ofFIG. 6A that illustrate steps for loading an injector according to aspects of the present invention. As discussed above,injector600 is inserted intovial700.Vial700 is provided with aflexible arm635 adapted to maintain anIOL350 against a surface of the vial.Injector600 may be rotated relative to the vial to obtain the IOL in the IOL injector body.
In some embodiments, a portion of an interior surface of the vial is selected to conform to an exterior surface of the injector in a regionproximate opening624. For example, in some embodiments surface622, which may be located on a substantially opposite side ofinjector600 from opening624, has concave curvature that substantially matches a convexly curvedinterior surface640 of vial700 (e.g., they have substantially the same radius of curvature and may share a center of curvature C). Accordingly,injector600 can be rotated about center of curvature C (i.e., in the direction of arrow2) in a stable and reliable manner. In some embodiments,surface622 is convex andsurface640 is concave.
In some embodiments, the distance R fromsurface622 to taperededge625 is substantially equal to the distance fromvial surface640 to vial surface612 (e.g., over an angle θ), such that theinserter600 remains contained betweensurfaces640 and612 upon rotation, thereby adding to the stability and reliability of the rotation ofinserter600. It is to be appreciated thatflexible arm635 maintainsIOL350 against a surface disposed oppositecurved surface640. Althoughflexible arm635 is illustrated having a hook shaped cross section, any suitable shape may be employed. For example an arm having a simple straight shape that collapses upon the application of sheer force as would occur when the inserter is rotated about thecurved surface640 and thereby contacts a side of the flexible arm.Flexible arm635 may be attached to the vial base atlocation645 using a hinge or other suitable rotatable structure, or the flexibility of flexible arm may be selected such that the flexible arm folds or wraps aroundlocation645 upon contact with the injector without the use of a hinge.
As illustrated inFIG. 8B,injector600 may be rotated relative to the vial in the manner described above (i.e., withsurface622 of theinserter contacting surface640 of the vial) to obtain the IOL in the IOL injector body. Upon rotation of the inserter about center of curvature C, taperededge625 engageslens350 and in a shovel-like manner lifts the lens into the loading chamber. Astop610 may be located to hold the lens in place as the lens is contacted by the tapered edge. It is to be appreciated that the curved shape of the interior of the loading chamber causes the lens to fold the IOL as the IOL encounters the interior surface of the lumen. As the lens is engaged by the tapered edge, a portion of theinserter602 engagesflexible arm625 thereby moving the flexible arm out the way as illustrated inFIG. 8B.
It is to be appreciated that although in some application is advantageous to provide and/oruse injector600 with avial700,injector600 may be used with any suitable structure capable of maintaining an IOL such that thetapered edge625 can be used to interact with the IOL in a manner such that the IOL is obtained inloading chamber620.
FIG. 9 is a perspective view of an embodiment of aflexible arm635 illustrating further details of the flexible arm. The arm is configured to maintainlens350 against a wall of the vial as discussed above, and flexible enough such that the movement aboutattachment645 allow arm to be moved away fromlens350 during loading as discussed above with reference toFIG. 8B. The arm preferably has a shape such that contact with the lens is made over a substantial area to avoid damage to the lens. Preferably, the portion of the arm contacting the lens is smooth to facilitate movement away or sliding along the lens without causing damage.
Injectors and vials as described herein are preferably made from a biocompatible and sterilizable material. For example, the injector and/or vial (including the flexible arm) may be made of polypropylene or polyetherimide (e.g. Ultem™ available from General Electric Corp.). In some embodiments, it is advantageous if the material used for an injector and/or vial is transparent to facilitate viewing of the lens during loading.
Having thus described the inventive concepts and a number of exemplary embodiments, it will be apparent to those skilled in the art that the invention may be implemented in various ways, and that modifications and improvements will readily occur to such persons. Thus, the embodiments are not intended to be limiting and presented by way of example only. The invention is limited only as required by the following claims and equivalents thereto.