Abstract:
In an embodiment of the invention, a method includes using an implantable ocular clip to fix an intraocular lens to an iris, all without having to use a suture to permanently hold the lens in place.

Description:
[0001]    This application claims priority to U.S. Provisional Patent Application No. 60/857,964 filed on Nov. 9, 2006 entitled METHOD AND DEVICE FOR FIXATION OF OPHTHALMIC TISSUE. 
     
    
     BACKGROUND 
       [0002]    Ocular maladies present numerous challenges to health care providers. Cataracts provide one such malady. To treat cataracts, physicians often replace the problematic natural lens of the eye with an artificial intraocular lens (IOL). IOLs may have side members, referred to as haptics, which help stabilize the lens within the eye. In some cases, a clip is connected to the haptic or lens optic by the lens manufacturer. After inserting the IOL into the eye, the physician then attempts to secure the IOL in the eye by connecting the clip to ocular tissue such as the inner iris. Doing so, however, often leads to iris chafing brought on by the interaction between the clip and the inner iris, an area of the eye that is very active and non-stationary. The chafing often leads to inflammation and shedding of iris pigment epithelial cells. These cells may then occlude natural aqueous fluid drainage channels. Hindering the drainage channels may cause undesired fluid retention in the eye, thereby increasing intraocular pressure, which is a contributing factor for glaucoma. Such chafing may also lead to other maladies such as, for example, cystoid macular edema and corneal decompensation. 
         [0003]    Present ocular clips not only lead to chafing, they also are very limited in their utility. In other words, the clip is permanently affixed to a lens. Thus, if such a clip fails, the physician must typically replace the entire IOL instead of only replacing the faulty clip. 
         [0004]    Thus, use of traditional ocular clips has declined in favor of advanced suturing techniques. While such suturing techniques are clinically efficacious, they are also complicated and practiced by only highly skilled physicians. The advanced suturing techniques lead to increased procedure time which can result in increased surgical complications, chances for infection, and overall cost and inconvenience to the patient. Late suture breakage, which may occur months or years after the initial suturing is performed, may also lead to a whole new set of complications including IOL dislocation and retinal detachment. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    The accompanying drawings, incorporated in and constituting a part of this specification, illustrate one or more implementations consistent with the principles of the invention and, together with the description of the invention, explain such implementations. The drawings are not necessarily to scale, the emphasis instead being placed upon illustrating the principles of the invention. In the drawings: 
           [0006]      FIG. 1   a  includes a front view of a device in one embodiment of the invention. 
           [0007]      FIG. 1   b  includes a top view of a device in one embodiment of the invention. 
           [0008]      FIG. 1   c  includes a top view of a device in one embodiment of the invention. 
           [0009]      FIGS. 2-14  include front views of various embodiments of the invention. 
           [0010]      FIG. 15  includes a front view of a device in one embodiment of the invention. 
           [0011]      FIG. 16  includes a front view of a device in one embodiment of the invention. 
           [0012]      FIG. 17  includes a front view of an applicator and an implant in one embodiment of the inventions. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    The following description refers to the accompanying drawings. Among the various drawings the same reference numbers may be used to identify the same or similar elements. While the following description provides a thorough understanding of the various aspects of the claimed invention by setting forth specific details such as particular structures, architectures, interfaces, and techniques, such details are provided for purposes of explanation and should not be viewed as limiting. Moreover, those of skill in the art will, in light of the present disclosure, appreciate that various aspects of the invention claimed may be practiced in other examples or implementations that depart from these specific details. At certain junctures in the following disclosure, descriptions of well known devices and methods have been omitted to avoid clouding the description of the present invention with unnecessary detail. Furthermore, in the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . ”. Also, the term “couple” or “couples” is intended to mean either an indirect or direct mechanical, electrical, or other communicative connection. Thus, if a first component couples to a second component, that connection may be through a direct connection, or through an indirect connection via other devices and connections. 
         [0014]    The present invention constitutes a method and apparatus for ocular fixation. As seen in  FIG. 1   a , ocular anatomy consists of the cornea  10 , anterior chamber  20 , iris  30 , posterior chamber  40 , and sclera  90 . An IOL  50  with haptics  60  is shown in replacement of a natural lens. In one embodiment, the invention is practiced as follows. An incision is made into the anterior chamber  20 . An ophthalmic clip applicator  80  and ophthalmic clip  70  are inserted through the incision into the eye. The physician abuts an open clip  70  against the anterior iris  30  and then pierces the iris with the clip. 
         [0015]    In one embodiment of the invention depicted in  FIG. 2 , a malleable clip  70  may have a basic “U” shape with ends  72  for piercing ocular tissue. The ends  72  may include barbs with recesses  74  for retaining the clip in ocular tissue. Due to general size limitations inherent to ophthalmic surgery, the clip may have small dimensions, including a maximum inner diameter  71  of approximately 0.05 to 0.5 mm—the approximate width of an IOL haptic. Some embodiments of the invention may include a maximum inner diameter  71  of approximately 0.15 to 0.3 mm. 
         [0016]    Returning to  FIG. 1 , after piercing the iris, the clip ends  72  are positioned across an IOL haptic  60 . The physician then depresses a lever  81  on the ophthalmic clip applicator  80 , thereby causing cam link  82  to constrict applicator members  1510 ,  1520  about the clip  1570  ( FIG. 15 ). Thus, the physician manipulates the ophthalmic clip applicator  1580  to couple the ophthalmic clip  1570  to the haptic  60  and iris  30 . The physician then removes the ophthalmic clip applicator from the eye. 
         [0017]    In one embodiment of the invention, the clip  70  is pierced through the peripheral portion of the iris  30 . By doing so, iris chafing is reduced as compared to affixing the clip  80  to the inner iris because, for example, the peripheral iris is more static and less active than the inner iris. In addition, the invention is not limited to an anterior approach. The clip may be deployed using a posterior approach whereby the haptic  60  is located in either the anterior chamber  20  or posterior chamber  40 . Thus, the haptic may be held between the end portions  76  of the clip and the iris ( FIG. 1   b ). However, the haptic may also be held between the main body of the clip  75  and the iris ( FIG. 1   c ). Regardless, the clip  70  is deployed to hold the haptic  60  against the iris  30 . 
         [0018]    In addition, the clip  70  is not limited to affixing IOLs to the eye. The clip may be used to repair, for example, scleral tears, conjunctival tears, irregularly shaped iris tissue, or iris and corneal tissue injuries. These clips may also be used to secure both lamellar or full-thickness corneal surgery (e.g., corneal transplantation). In one embodiment of the invention, the physician inserts an ophthalmic clip applicator and an ophthalmic clip into the eye. The physician or health care provider then manipulates the ophthalmic clip applicator to couple the ophthalmic clip to a first ocular tissue and a second ocular tissue. The physician then removes the ophthalmic clip applicator from the eye. In a certain embodiment of the invention, the physician couples the ophthalmic clip to a first portion of the sclera that includes the first ocular tissue and a second portion of sclera that includes the second ocular tissue. In another embodiment of the invention, the physician couples the ophthalmic clip to a first portion of the iris that includes the first ocular tissue and a second portion of iris that includes the second ocular tissue. In yet another embodiment of the invention, the physician couples the ophthalmic clip to a first portion of the iris that includes the first ocular tissue and a first portion of sclera that includes the second ocular tissue. In short, the clip may be used to couple various portions of the eye and is therefore beneficial for numerous ophthalmic procedures. 
         [0019]      FIGS. 1   a ,  15 , and  16  illustrate various embodiments of a surgical clip applicator.  FIG. 16  shows an applicator  1600  that comprises a housing  1680 , and a handle assembly  1650 ,  1651 ,  1660  coupled to the housing  1680 . The applicator  1600  also includes a jaw assembly including jaws  1610 ,  1620  which extend distally from the housing  1680 . The jaw assembly is movable from an open position to a closed position using mechanics  1670 ,  1671 ,  1640 ,  1641 ,  1630 ,  1631  known to those of ordinary skill in the art. In one embodiment of the invention, a clip  70  ( FIG. 2 ) is coupled to the jaw assembly in an open state. When the jaw assembly is manipulated into a closed position, the clip  70  is closed. 
         [0020]    In one embodiment of the invention, the clip applicator  1580  may employ applicator members with cutting edges (not illustrated). Thus, the physician may first pierce ocular tissue with the cutting edges before deploying a clip that does not possess cutting edges. Applicator members dedicated for cutting ocular tissues may be used in cooperation with other applicator members dedicated to clip deployment (i.e., applicator members that do not employ cutting edges). 
         [0021]    Other embodiments of the applicator may have similar pincher mechanisms and internal mechanics such as those found in, for example, Flexline™ Vitroretinal instruments from Medtronic. As those of ordinary skill in the art will appreciate, such applicators have similar ergonomic designs and mechanics so as to be readily adoptable by physicians. U.S. Pat. No. 5,868,761 discloses a representative applicator. More specifically, a clip applicator may include a handle housing formed from a pair of housing halves and secured together in a conventional manner. The handle housing may enclose a pair of handle members which are pivotable about a pivot point at the proximalmost point of the handle housing. An elongated body portion may extend from the handle housing and terminate in a jaw assembly for crimping clips upon actuation of the handle members. With reference to the handle housing, the handle members include pivot holes which are positioned about a pivot post on the handle housing halves. Pivot post, along with post members, which fit into holes, secures the housing in a snapfit-type arrangement, although other suitable means for securing the handle halves together in a conventional manner is acceptable. The handle housing halves include boss members which facilitate assembly of the components positioned within handle housing, and define a path of travel for several of the components within the handle portion. Located within the handle housing may be a cam link, which serves to advance the channel assembly to close the jaw members towards each other to crimp a clip positioned there between. The cam link may include a pair of angled slots, into which fit pins of handle members, so that as handle members are closed, pins ride within slots to drive the cam link in a distal direction. Releasing the handles permits a compression spring to drive the cam link in a proximal direction, retracting channel assembly from the jaw assembly to open the jaw members to permit the next clip in the series of clips to be fed between the jaw members. The feeding process is accomplished by a feed spring which urges a spring guide in a distal direction to advance a pusher rod, which extends through the cam link, into the elongated body portion. The pusher rod abuts against an indicator, to urge the indicator in the distal direction. The indicator abuts a proximal end of pusher nose, which in turn abuts against the series of clips to urge the clips in a distal direction and into position between the jaw members. Of course in other embodiments of the invention, the applicator may be as simple as conventional forceps that may be manipulated to deploy the implantable device in the eye. 
         [0022]    Turning to  FIG. 3 , an additional embodiment of the present invention is illustrated. An ophthalmic clip  70  has first  72  and second ends  73 . The first end forms a cutting surface for piercing ocular tissue. The second end abuts the first end. As seen in  FIG. 17 , the clip  1770  may be resilient whereby in a relaxed state, the ends  1771 ,  1772  abut one another. The clip  1770 , housed within an applicator  1740 , may be deployed into the eye. The clip  1770  may then be positioned outside the applicator  1740 . Force may be exerted by the applicator extensions  1730 ,  1731  in an outward direction, thereby separating clip ends  1771 ,  1772  from one another in a stressed state. The clip  1770  may then be positioned to couple, for example only, a haptic to the iris. The applicator extensions  1730 ,  1731  may then be relaxed and the clip  1770  returned to its unstressed state. In the alternative, the ends of a clip may abut one another only when compressed. Of course, in alternative embodiments of the invention the two ends are separated by a small space once implanted in the eye. A person of ordinary skill in the art will appreciate that the present invention is not limited to having only one or two ends. 
         [0023]      FIG. 4  discloses a barbless clip.  FIG. 5  discloses a barbed clip with barbs facing inward.  FIGS. 6 ,  7 ,  10 , and  11  disclose clips with receptacles  73  for coupling to cutting ends  72 . For example,  FIG. 6  may function in a manner similar to a “zip tie” wherein the shaft portion has ledges that allow for graduated advancements of the shaft through the orifice  73 .  FIG. 11  may include a body  75  constructed of a suture like material such as, for example, nylon or any other biocompatible, flexible, suture-like material.  FIG. 9  discloses an embodiment of the invention whereby each end  72 ,  73  of the clip  70  comprises a cutting edge. Once the ends penetrate ocular tissue, the recesses  74  secure the clip and prevent the ends from withdrawal from the tissue. In this embodiment, the ends need not abut, overlap or even finally reside near one another. In another embodiment of the invention, only one end  74  pierces ocular tissue. For example, one end  72  might pierce the iris from the anterior side, and then pierce the optic of an IOL while the other end  73  remains on the anterior side of the iris. In another embodiment of the invention, one end  72  might pierce the iris from the anterior side, and then pierce the optic (i.e., device need not couple to a haptic) of an IOL. In another embodiment, one end  72  might pierce the iris from the anterior side, and then capture the haptic of an IOL. In some embodiments of the invention, the optic or haptic that is to be pierced may have predrilled holes for receiving the haptic. The optic or haptic may instead have a region comprising a more easily penetrable material for promoting piercing by the clip. 
         [0024]    End  73  may be pointed or blunted (e.g.,  FIG. 8 ). The clips may be resilient and may be deployed into the eye in a compressed state, such as that shown in  FIG. 13 . The clip may then resume a noncompressed state once deployed in the eye. That noncompressed state may place the apparatus in a linear form in one embodiment of the invention.  FIG. 14  illustrates another embodiment of the invention whereby a guide wire, similar to those used in PTCA procedures, is used. Thus, the physician inserts the piercing end  72  of the device through ocular tissue and/or the haptic. Once penetration has occurred, the guide wire is removed leaving the clip  70  in place. The aforementioned clips may be composed of, for example, at least one of the following materials: titanium, gold, platinum, steel, nylon, polymethyl methacrylate, polyethylene (e.g., high density polyethylene), silicone, hydrophobic or hydrophilic acrylic and polypropylene, or suture-like materials. 
         [0025]    While the present invention has been described with respect to a limited number of embodiments, those skilled in the art will appreciate numerous modifications and variations therefrom. It is intended that the appended claims cover all such modifications and variations as fall within the true spirit and scope of this present invention.