Abstract:
A method for inserting a lens into a corneal pocket or flap includes providing a lens inserter device, opening a first leaf and a second leaf of the device, positioning a slot of each one of a first and a second lens shaped portion over a post on a packaging of the lens, positioning the lens between the first leaf and the second leaf, inserting the lens into the corneal pocket, and releasing the lens from the lens inserter device.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 12/704,162, entitled Lens Inserter Apparatus and Method, filed Feb. 11, 2010. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to ocular surgery. More particularly, the present invention relates to a method for inserting a lens into the eye to treat presbyopia. 
       BACKGROUND OF THE INVENTION 
       [0003]    Presbyopia is the gradual loss of near vision, which often accompanies the aging process. The eyes of a person suffering from presbyopia have a diminished ability to focus on near objects such as books, magazines, or a computer screen. Symptoms of presbyopia can include difficulty reading fine print and blurred vision when transitioning the focus of the eye between near and distant objects. 
         [0004]    There are several common treatments for presbyopia. A dedicated pair of reading glasses is one such treatment. Reading glasses provide magnification of near objects to provide for improved vision. However, if a person also needs glasses to focus on distant objects switching between reading glasses and distance glasses can be inconvenient. Another treatment is bifocal glasses, which provide a portion of the glasses lens for assisting with distance vision and a portion for assisting with near vision. While bifocals provide a single pair of glasses for both near and distance vision correction, they can cause disorientation. Contact lenses for the surface of the eye have also been developed which provide vision correction for both near and distance vision. Although these treatments provide vision correction for a person suffering from presbyopia, each requires at least one an additional accessory or pair of contact lenses that must be worn or used daily. Additionally, very small lenses for insertion into the eye are being developed. However, these lenses cannot be handled manually or with conventional tools. 
         [0005]    Accordingly, it is desirable to provide an apparatus and method for inserting a lens into the cornea to improve a patient&#39;s presbyopia. 
       SUMMARY OF THE INVENTION 
       [0006]    The foregoing needs are met, to a great extent, by the present invention, wherein in one aspect an apparatus is provided that in some embodiments includes a design for a lens inserter apparatus and method. 
         [0007]    In accordance with one aspect of the present invention, a lens inserter apparatus includes a handle having a distal end and a proximal end and an outer wall of the handle defining a lumen extending through the handle and a plunger extending movably through the lumen of the handle having a distal end and a proximal end, wherein the plunger includes a distal segment which extends beyond the distal end of the handle. The lens inserter can also include an actuator coupled to the plunger configured to provide movement to the plunger. Additionally, the lens inserter can include a leaf extending from the distal end of the handle and configured to hold the lens to be inserted into the eye, wherein the leaf defines a slot configured to enable loading the lens onto the inserter. 
         [0008]    In accordance with another aspect of the present invention the lens inserter apparatus can include two leaves. The first leaf can extend from a top surface of the distal end of the handle and the second leaf can extend from a bottom surface of the distal end of the handle. The leaves can be configured to grip the lens to be inserted into the eye. Additionally, the lens inserter can include a spring disposed within the lumen of the handle against which the plunger is biased. 
         [0009]    In accordance with another aspect of the present invention, the actuator of the lens inserter can provide movement to the plunger about a radial axis of the plunger. In addition, the actuator can provide movement to the plunger about a longitudinal axis of the plunger. Alternately, the actuator of the lens inserter can provide movement to the plunger about a radial axis of the plunger and a longitudinal axis of the plunger. 
         [0010]    In accordance with another aspect of the present invention, the slot of the lens inserter can be configured to couple with a post on a package holding the lens. The distal end of the distal segment of the plunger can include a fork configured to push the lens off of the leaf. Additionally, the actuator can include a finger rest, and the leaf can include a lens shaped portion to pick up and hold the lens for insertion. 
         [0011]    In accordance with yet another aspect of the present invention, an apparatus for inserting a lens into a corneal pocket or flap includes a handle having an outer wall defining a lumen extending through the handle. The lens inserter can include a plunger extending movably through the lumen of the handle, wherein the plunger includes a distal segment, which extends beyond the distal end of the handle. The lens inserter can include an actuator coupled to the plunger and extending through an opening defined by the outer wall of the handle wherein the actuator is configured to provide movement to the plunger about a radial and longitudinal axis of the plunger. The lens inserter can also include a pair of leaves extending from the distal end of the handle and configured to grip the lens to be inserted into the eye. The leaves can define a slot configured to enable loading the lens onto the inserter, and the leaves can be biased together and can be separated by using the actuator to provide radial movement to the plunger. 
         [0012]    In accordance with another aspect of the present invention the actuator can include a finger rest. The slot at the distal end of the leaf can be configured to couple with a post on a package holding the lens. Additionally, the distal end of the distal segment plunger can include a fork configured to push the lens off of the leaf. 
         [0013]    In accordance with still another aspect of the present invention, a method for inserting a lens into a corneal pocket or flap includes opening a set of leaves of a device for inserting the lens into the pocket in the cornea; and positioning a slot at a distal end of one of the leaves over a post on a packaging of the lens. The method further includes positioning the lens between the leaves of the device for inserting the lens. Additionally, the method includes inserting the lens into the corneal pocket and releasing the lens from the leaves. 
         [0014]    In accordance with even another aspect of the present invention, the method can further include releasing the lens from the leaves by moving the actuator along a longitudinal axis of the plunger to move the plunger in a direction of a distal end of the device to insert the lens. The method can also include the leaves being biased together. The method can also include the device for inserting the lens including a spring for biasing against the plunger. The method can include using an actuator to rotate a plunger of the device about a radial axis of the plunger to open the leaves, and using the actuator to close the leaves in order to grip the lens between the two leaves. 
         [0015]    There has thus been outlined, rather broadly, certain embodiments of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional embodiments of the invention that will be described below and which will form the subject matter of the claims appended hereto. 
         [0016]    In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. 
         [0017]    As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1  illustrates a side view of a lens inserter apparatus in accordance with an embodiment of the invention. 
           [0019]      FIG. 2  illustrates a top view of a lens inserter in accordance with an embodiment of the invention. 
           [0020]      FIG. 3  illustrates a sectional view taken along axis “A” of the embodiment shown in  FIG. 2 . 
           [0021]      FIG. 4  illustrates a perspective view of a distal end of the lens inserter apparatus in accordance with an embodiment of the invention. 
           [0022]      FIG. 5  illustrates a top view of the distal end of the lens inserter apparatus shown in  FIG. 4 . 
           [0023]      FIG. 6  illustrates a side view of a handle of a lens inserter in accordance with an embodiment of the invention. 
           [0024]      FIG. 7  illustrates a top view of a plunger of a lens inserter in accordance with an embodiment of the invention. 
           [0025]      FIG. 8  illustrates a side view of a plunger of a lens inserter in accordance with an embodiment of the invention. 
           [0026]      FIG. 9  illustrates a step in a method of inserting a lens using a lens inserter apparatus in accordance with an embodiment of the invention. 
           [0027]      FIG. 10  illustrates a step in a method of inserting a lens using a lens inserter apparatus in accordance with an embodiment of the invention. 
           [0028]      FIG. 11  illustrates a step in a method of inserting a lens using a lens inserter apparatus in accordance with an embodiment of the invention. 
           [0029]      FIG. 12  illustrates a step in a method of inserting a lens using a lens inserter apparatus in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. An embodiment in accordance with the present invention provides an apparatus and method for inserting a lens into a flap or pocket in the cornea. This lens or pocket preferably is created by a laser used in conventional lasik surgery. The apparatus includes a handle, a plunger extending movably through the lumen of the handle, wherein the plunger includes a distal segment that extends beyond the distal end of the handle, an actuator coupled to the plunger configured to provide movement to the plunger, and a leaf extending from the distal end of the handle and configured to hold the lens to be inserted into the eye, wherein the leaf defines a slot configured to enable loading the lens onto the inserter. 
         [0031]    An embodiment of the present inventive apparatus is illustrated in  FIG. 1 .  FIG. 1  illustrates a side view of a lens inserter apparatus  10  in accordance with an embodiment of the invention. The lens inserter apparatus  10  includes a handle  12 , which has a distal end  14  and a proximal end  16 . The lens inserter  10  also includes a pair of leaves  18  and  20 , which extend from the distal end  14  of the handle  12 . Preferably, the leaves  18  and  20  have a length in a range of 10 mm to 30 mm and a width in a range of 1 mm to 4 mm. The thickness of each of leaves  18  and  20  is approximately in the range of 50 microns to 200 microns for a combined thickness in a range of 100 microns to 400 microns. The leaves can be formed from stainless steel or any other suitable non corrosive material. Top leaf  18  extends from a top surface  22  of the handle  12 , while bottom leaf  20  extends from a bottom surface of the handle  12 . The top leaf  18  and bottom leaf  20  are biased together, such that an inner surface of the top leaf  18  is in contact with an inner surface of the bottom leaf  20 , and are preferably made from a flexible, resilient material. Additionally, a plunger  26  extends through the handle  12 . The plunger  26  has a distal end portion  28 , which extends beyond the distal end  14  of the handle  12 . The plunger can be formed from titanium or stainless steel or any other suitable non corrosive material. An actuator  30  is coupled to the plunger  26  by posts  32  and  34 . The actuator  30  can be used to move the plunger  28  via finger rest  36 . The lens inserter apparatus  10  also includes a longitudinal axis “a.” 
         [0032]      FIG. 2  illustrates a top view of a lens inserter in accordance with an embodiment of the invention. The leaves  18  and  20  have a generally flat elongate surface  38  and a distal end  40 , which has a generally circular, lens shaped portion  42 , which allows for the lens to be inserted into the eye to sit on a top surface of the bottom leaf  20 . The generally circular lens shaped portion preferably has a diameter in a range of 2 mm to 4 mm. As illustrated in  FIG. 2 , the outer wall of the handle  12  also defines a slot  44  in which the actuator  30  can move in order to provide movement to the plunger  26 . The finger rest  36  of the actuator  30  can also be textured to provide friction between the actuator and the operator&#39;s finger. 
         [0033]      FIG. 3  illustrates a sectional view taken along axis “a” of the embodiment shown in  FIG. 1 . The outer wall  46  of the handle  12  defines a lumen  48 , which extends through the length of the handle  12 . The plunger  26  is positioned within the lumen  48  of the handle  12 . The plunger  26  includes a body portion  50  having a longitudinal and radial axis and is coupled to the actuator  30  via posts  32  and  34 . The body  50  of the plunger  26  is movably disposed within the lumen  48  of the handle and can be moved along both the longitudinal and radial axis of the plunger  26 . The plunger  26  can also be biased against a spring  52  disposed about a distal end  54  of the plunger  26  within the lumen  48  of the handle  12 . The plunger  26  also includes the distal segment  28 , which extends beyond the distal end  54  of the plunger  26  and the distal end  14  of the handle  12 . The distal segment  28  of the plunger  26  is positioned between the leaves  18  and  20  of the lens inserter  10 . The distal segment  28  of the plunger  26  preferably has a thickness in a range of 100 microns to 300 microns. The plunger  26  can also include a ring  53  at the proximal end  54  of the body portion  50  of the plunger  26 . The ring  53  preferably can be formed of a material, which slides easily within the lumen  48  of the handle  12 . 
         [0034]      FIG. 4  illustrates a perspective view of a distal end of the lens inserter apparatus  10  in accordance with an embodiment of the invention, and  FIG. 5  illustrates a top view of the distal end of the lens inserter apparatus  10  shown in  FIG. 4 .  FIGS. 4 and 5  show the distal end  40  of the leaves  18  and  20 . The distal end  40  of each of the leaves  18  and  20  includes a generally flat lens shaped portion  42 . The lens shaped portion  42  is configured to allow a lens designed be inserted into a flap or pocket in the cornea of the eye to sit on top of the surface of the distal end  40  of the bottom leaf  20 . The distal end  40  of the leaves  18  and  20  also includes a slot  56 . The slot  56  can be configured to enable loading the lens onto the inserter  10 . Additionally, the inner surfaces of the distal end  40  of the leaves  18  and  20  sit on top of one another in order to grip the lens for insertion into the pocket or flap in the cornea. 
         [0035]      FIG. 6  illustrates the handle  12  of the lens inserter  10  in further detail. The handle  12  includes an outer wall  46  that defines an opening  58 . The actuator  30 , not shown, can extend through the opening  58  and move within the opening  58 . The opening can be shaped such that the actuator  30  can be moved along the longitudinal axis of the plunger  26  or the radial axis of the plunger  26 . The opening  58  includes notches  60  and  62  such that the actuator  30  can be moved along the radial axis of the plunger  26 . 
         [0036]      FIG. 7  illustrates a top view of a plunger  26  of a lens inserter  10  in accordance with an embodiment of the invention, and  FIG. 8  illustrates a side view of a plunger  26  of a lens inserter  10  in accordance with an embodiment of the invention.  FIGS. 7 and 8  illustrate the distal segment  28  of the plunger  26 . The distal segment  28  is generally flat and includes a fork  64  at the distal end  66  of the distal segment  28  configured to push the lens off of the lens shaped portion  42  of the leaves  18  and  20 . 
         [0037]      FIGS. 9-11  illustrate a method of inserting a lens into a pocket or flap in a cornea in accordance with an embodiment of the invention.  FIG. 9  illustrates the lens inserter  10  and a lens  66  for placement in the pocket or flap in the cornea. However, it is important to note that the lens inserter  10  can be used with any lens and packaging for the lens. Preferably, the lens  66  is approximately 2.5 mm to 3.5 mm in diameter and has an edge thickness of less than 20 microns. Although any lens suitable for insertion into a pocket or flap in a cornea can be used. As shown in  FIGS. 9-11 , the lens  66  is disposed in packaging  68 . Packaging  68  includes a post  70 . As shown in  FIG. 10 , the actuator  30  can be rotated about the radial axis of the plunger  26  into notches  60  and  62  of the handle  12 , in order to open the leaves  18  and  20 . As the plunger  26  is rotated it spreads the leaves  18  and  20  enough to place the bottom leaf  20  under the lens  66 . The slot  56  at the distal end  40  of the leaves  18  and  20  can slide around the post  70  of the packaging to enable grasping of the lens  66 . When the lens  66  is positioned on the lens shaped portion  42  of the bottom leaf  20 , the actuator  30  can be rotated back out of the notches  60  and  62  in order to close the leaves and grasp the lens. 
         [0038]      FIG. 12  illustrates a method of inserting a lens into a pocket or flap in a cornea in accordance with an embodiment of the invention. Step  100  shows the distal end  40  of the leaves  18  and  20  grasping the lens  66 , and a pocket  72  in the cornea  74  of the eye  76 . Step  110  shows the lens inserter  10  inserted into the pocket  72 . Step  120  shows the plunger  26  being advanced to push the lens  66  off of the leaves  18  and  20 . Additionally, step  130  shows the lens  66  placed in the eye  76  and the lens inserter  10  being removed from the eye  76 . 
         [0039]    The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention, which fall within the true spirit, and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.