Patent Publication Number: US-9889000-B2

Title: Corneal implant applicators

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 13/657,650, filed Oct. 22, 2012, now U.S. Pat. No. 8,668,735, which application is a continuation-in-part of U.S. application Ser. No. 13/443,696, filed Apr. 10, 2012, now U.S. Pat. No. 9,005,280, which is a continuation of U.S. application Ser. No. 13/206,200, filed Aug. 9, 2011, now abandoned, which is a continuation of U.S. application Ser. No. 11/422,815, filed Jun. 7, 2006, now U.S. Pat. No. 7,992,906, which is a continuation of U.S. application Ser. No. 11/054,639, filed Feb. 9, 2005, now U.S. Pat. No. 7,128,351, which is a continuation of U.S. application Ser. No. 10/463,091, filed Jun. 17, 2003, now U.S. Pat. No. 6,893,461, which is a division of U.S. application Ser. No. 09/843,547 filed Apr. 26, 2001, now U.S. Pat. No. 6,581,993, which is a continuation-in-part of U.S. application Ser. No. 09/660,371, filed Sep. 12, 2000, now U.S. Pat. No. 6,543,610; all disclosures of which are incorporated herein by reference. 
     U.S. application Ser. No. 13/657,650, filed Oct. 22, 2012, also claims priority to the following provisional applications: U.S. 61/550,185, filed Oct. 21, 2011; U.S. 61/679,482, filed Aug. 3, 2012; and U.S. 61/606,674, filed Mar. 5, 2012; all disclosures of which are incorporated herein by reference. 
     INCORPORATION BY REFERENCE 
     All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
    
    
     BACKGROUND 
     Corneal implants, such as corneal onlays and corneal inlays, can be small, delicate medical devices, the storage and/or handling of which should be carefully performed to prevent damage to the implants. Additionally, corneal implants can also be transparent, which, in addition to their small size, can make them difficult to see with the unaided eye. 
     Devices and methods are needed that allow for easy handling and positioning of small, delicate corneal implants without damaging the implant. 
     SUMMARY OF THE DISCLOSURE 
     One aspect of the disclosure is a corneal implant applicator apparatus, comprising a corneal applicator member comprising an applicator; a corneal implant support disposed relative to the applicator to form an implant chamber; and wherein the applicator and the corneal implant support are adapted such that a corneal implant has a greater preference for adhering to the applicator than to the corneal implant support. 
     In some embodiments the applicator is adapted such that the corneal implant has a greater preference for adhering to corneal tissue than to the applicator. The applicator can have a radius of curvature that is greater than a radius of curvature of an anterior surface of the corneal implant. 
     In some embodiments the applicator has at least one opening therethrough. The corneal implant support can also have at least one opening therethrough. 
     In some embodiments the corneal implant support has a surface with a contour different than a contour of a surface of the applicator, and wherein the different contours provide the corneal implant with the greater preference for adhering to the applicator than to the corneal implant support. The applicator surface can be smoother than the surface of the corneal implant support. 
     In some embodiments the corneal implant support is adapted to be moved relative to the applicator to provide access to the corneal implant and allow the corneal implant to preferentially adhere to the applicator. The corneal implant support can be detachably secured to the applicator. The apparatus can further comprise at least one clip adapted to detachably secure the corneal implant support to the applicator. 
     In some embodiments the apparatus further comprises a fluid disposed within the implant chamber. 
     In some embodiments the corneal implant is made from a hydrophilic, such as a hydrogel, material. 
     In some embodiments the applicator and corneal implant support are adapted such that the net adhesive forces between the applicator and the corneal implant are greater than the net adhesive forces between the implant support and the corneal implant, whereby the corneal implant will preferentially adhere to the applicator when the applicator and corneal implant support are moved relative to one another. 
     One aspect of the disclosure is a method of depositing a corneal implant onto corneal tissue, comprising providing a corneal implant applicator apparatus, the apparatus comprising a corneal implant applicator, an implant support disposed relative to the corneal implant applicator to form an implant chamber, and a corneal implant disposed in the implant chamber, moving the implant support relative to the corneal implant applicator to provide access to the corneal implant and to allow the corneal implant to preferentially adhere to the corneal implant applicator rather than the implant support, positioning the corneal implant applicator such that the corneal implant engages corneal tissue, and moving the corneal implant applicator from the corneal tissue to allow the corneal implant to preferentially adhere to the corneal tissue rather than the applicator, thereby depositing the corneal implant on the corneal tissue. 
     In some embodiment moving the implant support relative to the corneal implant applicator comprises removing a securing element that detachably secures the implant support to the corneal implant applicator. 
     In some embodiments the method further comprises wicking away fluid from within the implant chamber, wherein the wicking step occurs prior to moving the implant support relative to the corneal implant applicator. 
     In some embodiments the method further comprises, prior to the depositing step, creating a corneal flap and lifting the corneal flap to expose the corneal tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1 a -3 c    illustrate an exemplary corneal implant applicator apparatus. 
         FIG. 4  illustrates exemplary cohesive forces. 
         FIG. 5  illustrates exemplary adhesive forces. 
         FIG. 6  illustrates a liquid suspended within a loop 
         FIGS. 7-13  illustrate an exemplary corneal implant applicator apparatus. 
         FIGS. 14A-19  illustrate exemplary moderate and minimal bodies. 
         FIGS. 19-22  illustrate an exemplary corneal implant applicator apparatus. 
         FIGS. 23A-35B  illustrate components of an exemplary corneal implant applicator apparatus. 
     
    
    
     DETAILED DESCRIPTION 
     The disclosure relates to devices for one or more of packaging, storing, positioning, and delivering corneal implants such as corneal inlays. The devices herein can be used in the movement and positioning of, for example without limitation, corneal onlays, corneal inlays, corneal replacements, and contact lenses. 
       FIGS. 1A-3C  illustrate an exemplary embodiment of an implant packaging and handling system  48  adapted to apply a corneal implant to a corneal surface. Referring to  FIG. 1A , system  48  includes implant carrier member  80  having a handle  50  extending from implant applicator  58 . Implant carrier member  80  is adapted to detachably couple to implant support member  78 . As illustrated, implant support member  78  has a handle  52  extending from implant support  56 . 
       FIG. 1B  illustrates detail “A” shown in  FIG. 1A . As illustrated in  FIG. 1B , fastening carrier member  80  and support member  78  together operably aligns implant applicator  58  and implant support  56 . In this embodiment, the handle portions  50  and  52  are positioned adjacent to one another so as to form a support handle  54  (see  FIG. 1A ). Concave surface  70  of applicator  58  is aligned with convex implant support surface  76  of implant support  56 . Surface  70  and surface  76  form chamber  88  therebetween, which provides a storage space to retain a corneal implant therein. 
       FIGS. 2A-2C  illustrate views of carrier member  80  (support member  78  not shown for clarity).  FIG. 2A  illustrates a top view of a portion of carrier member  80 , showing handle  50  and implant applicator  58 .  FIG. 2C  shows detail “B” from  FIG. 2A . In  FIG. 2C , applicator  58  includes a domed portion with upper surface  86  and lower surface  70 . Lower surface  70  is contoured with a radius of curvature that is greater than the radius of curvature of an anterior surface of the implant that is being packaged (not shown for clarity). The difference in the radii of curvature is advantageous in assisting with the release of the corneal implant from applicator surface  70 . More particularly, a corneal implant generally includes a posterior surface that is adapted to make contact with corneal bed tissue, and an anterior surface that faces in the anterior direction and is disposed under overlying corneal tissue (whether the implant is inserted under a flap or into a pocket). 
     In use, applicator surface  70  (on which an implant is retained) is first positioned immediately over the corneal bed surface such that the implant engages the corneal bed tissue. Applicator  58  (and therefore surface  70 ) is then lifted away from the corneal bed surface. The anterior surface of the implant releases from applicator surface  70  and the posterior surface of the implant remains adhered to the corneal bed surface. To enhance deposition of the implant onto the corneal bed surface and prevent the implant from remaining adhered to applicator surface  70 , applicator surface  70  has a radius of curvature that is greater than the radius of curvature of the anterior surface of the implant. Due to the difference in radii of curvature, the anterior surface of the implant and applicator surface  70  are not complementary, and thus, are more easily separated. In this manner the corneal implant preferentially adheres to the cornea over applicator surface  70 . 
     In other embodiments applicator surface  70  has an indented ring or recessed applicator surface (as is shown in FIG. 12 and indicated by numeral 29 in U.S. Pat. No. 6,581,993, incorporated by reference herein). The recessed surface can be circular, thereby allowing a substantially circular implant to be centrally positioned on applicator surface  70 . 
     To further enhance disassociation of the corneal implant from applicator surface  70 , a plurality of openings  64  are provided through applicator surface  70  through which a volume of fluid can be passed to help remove the implant. Alternatively, fluid can be withdrawn through the opening  64  from the implant that is disposed on applicator surface  70 . Particularly, the openings  64  provide a fluid passage for drawing fluid away from the implant using a cotton swab, or other absorbent material, that would be positioned against upper surface  86  of applicator  58 . Additionally, optional central opening  66  is provided in applicator  58  to assist with the proper alignment of the implant and the deposition of the implant onto the cornea surface. Specifically, a cannula or like instrument can be inserted through central opening  66  to depress and assist the release of the implant from applicator surface  70 . The diameter of central opening  66  is greater than the diameter of openings  64 . In this way, the user is provided with a central point of reference, which enables the user to align applicator surface  70  with the optical axis of the eye, and, thus, properly position the implant. 
       FIGS. 3A-3C  illustrate different views of support member  78  (carrier member not shown for clarity).  FIG. 3C  illustrates detail “A” from  FIG. 3B . Support member  78  has handle  52  extending from implant support  56 . Implant support  56  comprises platform  82  disposed about an upper support surface  76  and an opposing lower surface  90 . Lower surface  90  is recessed relative to the lower surface of the platform portion  82 . Upper surface  76  and lower surface  90  have a plurality of openings therethrough to facilitate the passage of liquid to and away from the implant. 
     As shown in  FIG. 3B , support  56  is shown at an angle of 30° relative to handle  52 . It can be advantageous for support  56  to be at an angle relative to handle  52  between about 30° and about 60°. Similarly, the angle between applicator  58  and handle  50  is generally between about 30° and about 60°. In  FIG. 2B  the angle is 30°. In some embodiments the angle between handle portions  50  and  52  and platform portions  84  and  82 , respectively, is about 45°. It is to be understood that a range of angles can be used without deviating from the scope of the present disclosure. 
       FIGS. 1B, 2A, and 3A  illustrate an exemplary embodiment in which support member  78  is detachably connected to carrier member  80 . Specifically, as illustrated by  FIG. 2A , the carrier member  80  is provided with a pair of notches or grooves,  68   a  and  68   b . Notches or grooves  68   a  and  68   b  are located on opposite sides of applicator  58 . Likewise, support member  78  is provided with a pair of notches or grooves,  68   c  and  68   d , located on opposite sides of implant support  56 . Carrier member  80  can be securely coupled to support member  78  by aligning notch  68   a  with  68   c , and notch  68   b  with  68   d , and then positioning a fastening element about the two members and securely within the aligned notches.  FIG. 1B  shows elastic band  69 , which is placed about members  78  and  80 , secured within each of the respective notches ( 68   a - d ) to secure members  78  and  80  together in a detachable manner. In alternative embodiments metal or plastic clips are used to fasten together members  78  and  80 . It should be understood, however, that various ways can be utilized to fasten the two members together in a detachable manner without deviating from the scope of the disclosure. 
       FIGS. 2B and 3A  illustrate an additional optional way to secure members  78  and  80  together and such that they can be easily separated to prepare the implant for use. Handle  52  includes slot  74  adapted to receive and interlock with tab  72  of carrier member  80 . Tab  72  extends from the lower surface of handle  50  of carrier member  80 . In use, carrier member  80  is positioned in overlapping relation to support member  78  such that tab  72  is inserted into slot  74 . Once inserted, tab  72  holds carrier member  80  together with support member  78 . To provide additional attachment, band  69  is then placed about implant applicator  58  and implant support  56 , as is described in more detail above. In use, the user initially removes band  69  or other attachment element from the fastened members  78  and  80 . Once removed, the user simply slides handle  50  in the direction indicated by arrow  98  shown in  FIG. 2A , which is generally a proximal direction. In this way, tab  72  slidably disengages from slot  74  and members  78  and  80  are separated. Once separated, carrier member  80  can then be used to deposit the implant onto the cornea surface as set forth above. The proximal portion of handle  50  is also adapted to be secured to a surgical-style handle or other handle device to more easily deposit the implant onto the corneal bed surface. 
     Support surface  76  of implant support  56  is adapted such that the implant will preferably remain adhered to applicator surface  70  upon separation of members  78  and  80 . In this embodiment support surface  76  has a more uneven or rough contour than adjacent applicator surface  70 . Applicator surface  70  is provided as a smooth or polished surface. In this embodiment, it is not critical that surface  70  be microscopically smooth, though it may be. In this embodiment, however, it is important that surface  70  be smoother than support surface  76 . In this manner, applicator surface  70  has a smoother surface area for directly contacting and adhering to the lens implant. 
     Support surface  76  is fabricated so as to have a contour characterized by minute bumps or rounded portions along surface  76 . In some embodiments this contoured surface can be fabricated by manufacturing support surface  76  from polypropylene comprising polytetrafluoroethylene beads embedded in the polypropylene surface. Polytetrafluoroethylene is sold under the trade name TEFLON. In this embodiment, the beads maintain their general conformation when embedded, which results in surface  76  having raised bumps, rounded portions, or the like. Alternatively, support surface  76  can be roughened, etched, notched, scored or made to be imperfect using any one of molding, stamping or other known mechanical techniques. Surface  76  is less able to adhere to the surface of the implant than is smoother applicator surface  70 , and the implant will preferentially remain adhered to applicator surface  70  upon separation of the members  78  and  80 . 
     Additionally, the implant can be further directed to remain adhered on applicator surface  70 . For example, system  48  can be removed from a storage container in which system is disposed (not shown). System  48  is turned such that carrier member  80  is facing downwards and support member  78  is on top. Next, the user simply places an absorbent material against the top surface  60  of applicator portion  58  so as to draw fluid from within chamber  88  through openings  64 . As the fluid is drawn away from chamber  88  the implant is lowered to a resting position against the applicator surface  70 . 
     One or more of the various components of system  48  can be made from a polymer or plastic material. For example, system  48  components could be made from one or a combination of the following polymers: Polytetrafluoroethylene (sold under the trade name TEFLON), Polypropylene, or Polysulfone (sold under the trade name UDEL). Alternatively, portions of each component member could be made from a polymer or plastic together with a portion comprising stainless steel or other metal or semi-metal. For instance, handle  50  of carrier member  80  can be manufactured from stainless steel, and applicator portion  58  can be manufactured from a polymer material. The handle and applicators could then be welded or interlocked together using various known fabrication techniques. It should also be understood that various other polymers or polymer combinations can be utilized without deviating from the scope of the present invention. 
     System  48  is adapted to maintain the corneal implant in a hydrated condition during storage and shipping. System  48  can be positioned within a storage device such as a vial as is described in U.S. Pat. No. 6,543,610, incorporated by reference herein. When system  48  is placed in a storage device with fluid therein, the corneal implant is in contact with a volume of storage fluid. In this way, the implant is contained within the chamber  88  and maintained in a hydrated condition by the passage of fluid through the respective openings  62 ,  64 , and  66 . 
     The corneal implant is packaged within chamber  88  defined by applicator surface  70  and carrier support surface  76 . The height of this space is designed to be sufficiently narrow that the implant remains properly oriented within chamber  88  during storage and handling conditions. In this way, the user simply detaches carrier member  80  from support member  78  and deposits the implant to the corneal surface by placing the applicator surface  70 , on which the implant is adhered, directly to the corneal surface. 
     The disclosure below describes devices and methods of use that rely at least partially on surface tension of liquids to control the positioning and/or movement of a corneal implant. The devices can be used in the storage, packaging, movement, or delivering of the corneal implants. These approaches can be used when the corneal implant is made at least partially of hydrophilic material, such as a hydrogel. 
     Surface tension is the property of liquids that allows the surface of a body of liquid to resist external forces. It is what allows objects denser then water, such as small pins and certain insects, to float on a liquid&#39;s surface. Surface tension is caused by the cohesive forces of a liquid&#39;s molecules. Cohesive forces are the attractive forces between two like molecules. As shown in  FIG. 4 , an average molecule within a body of liquid has no overall cohesive force acting upon it because it sees cohesive forces from neighboring molecules acting upon it in every direction. A molecule on the surface, however, only sees cohesive forces pulling it inwards. For very small droplets, the inward force on all surface molecules causes the droplet to be generally spherical in shape. 
     Adhesive forces, on the other hand, are those seen between unlike molecules. For some material combinations, these forces can be greater than the cohesive forces of a liquid&#39;s molecules. These strong adhesive forces are the cause of an upward ‘bowing,’ called the meniscus (as shown in  FIG. 5 ), in a liquid&#39;s surface where the liquid around the edge of a container is pulled higher than the rest of the surface by the adhesive forces between the liquid and the container. The adhesive forces pull up on the surface of the water and are in equilibrium with the gravitational forces pulling down on the body of liquid. 
     In the case of liquid suspended within a loop, as shown in  FIG. 6 , adhesion forces from the loop act on both the top and bottom surfaces of the liquid and cohesive forces act across both upper and lower surfaces. These forces are sufficient to hold a liquid within a loop up until the liquid&#39;s volume is so great that the gravitational forces overcome the cohesive and adhesive forces. 
     In the case of a solid, mesh, or other such surface, the adhesive and cohesive forces act in a similar fashion. Many factors, including the type of material, the type of fluid, and the surface geometry will affect the strength of the adhesive and cohesive forces. 
     Exemplary corneal implants that can be stored and used in the following embodiments are corneal inlays described in U.S. Pub. No. US 2007/0203577, filed Oct. 30, 2006, now U.S. Pat. No. 8,057,541, U.S. Pub. No. US 2008/0262610, filed Apr. 20, 2007, and U.S. Pub. No. 2011/0218623, filed Sep. 8, 2010, the disclosures of which are incorporated herein by reference. In some embodiments, a “small diameter” (i.e., between about 1 mm and about 3 mm) corneal inlay is made from a hydrogel, that may be primarily fluid. This, as well as the inlay&#39;s small size, causes it to behave in somewhat the same way as a fluid. The disclosure below makes use of these characteristics of the corneal implant and the adhesion forces between a fluid and various surface geometries. While the disclosure herein focuses on corneal inlays, any corneal implant that exhibits similar properties can be used as described herein. For example, corneal onlays, at least a portion of which have hydrophilic properties, can be used as described herein. 
     The devices herein rely on a body&#39;s “affinity” for a fluid or an object with fluid-like properties (e.g., a hydrophilic corneal implant). As used herein, a body&#39;s “affinity” for the fluid or fluid-like object is influenced by the difference between the strength of the net adhesive forces between the body and the fluid or fluid-like object and the strength of the net cohesive forces within the fluid or fluid-like object. In embodiments herein where there is a substantially constant fluid or fluid-like object (e.g., a hydrophilic corneal inlay), the relative affinities of two bodies for the fluid or fluid-like object is at least partially determined by the relative strengths of the net adhesive forces between the bodies and the fluid or fluid-like object. For example, in an embodiment in which the fluid-like object is a hydrophilic corneal implant, a first body can have a greater affinity for the implant than a second body when the net adhesive forces between the first body and the implant are greater than the net adhesive forces between the second body and the implant. 
     The corneal implant will remain adhered to the body with the highest net force (the sum of the adhesive and cohesive forces). 
     A first body, referred to herein as a “moderate body,” has a greater affinity for the fluid or fluid-like object than a second body, referred to herein as a “minimal body.” As used herein in this context, “body” may be used interchangeably with device, component, structure, or other similar term to indicate anything with structure. The eye, however, has a greater affinity for the fluid or fluid-like object than the moderate body. The different relative affinities can be used to handle the inlay and control the movement of the inlay as it is moved from one surface to another without a user needing to touch it with a hand or other tool. Factors that influence the relative affinities include one or more of: the type of material, the type of fluid, and the surface geometry including surface area. 
     As used herein, a corneal inlay (e.g., the fluid-like object) has a greater “affinity” for the corneal bed of the eye than it does the moderate body, and at the same time the inlay has a greater affinity for the moderate body than it does the minimal body. The eye can be described as having a greater affinity for the inlay than both the moderate body and the minimal body. Similarly, the moderate body can be described as having a greater affinity for the inlay than the minimal body. That is, the affinity between two bodies can be described relative to either body. That is, for example, the moderate body has a greater affinity for the inlay than does the minimal body, and thus the inlay will preferentially adhere to the moderate body over the minimal body. 
     In some embodiments the storage fluid is water or saline, for example. Water molecules are highly polarized, which provides for attractive forces with other materials. 
     A relative comparison of the affinity between each body and the inlay can be represented by: corneal tissue&gt;moderate body&gt;minimal body. The moderate and minimal bodies may take on many forms, including, without limitation, meshes, membranes, and/or material with different surface finishes or contours. 
     Due to the differences in affinity between the minimal body and the moderate body, the inlay preferentially remains adhered to the moderate body. It continues to adhere to the moderate body until exposed to a stronger adhesive force. The minimal and moderate bodies can therefore be any suitable material as long as the adhesive forces between the moderate body and the inlay are greater than the adhesive forces between the minimal body and the inlay. The moderate body has a greater affinity for the inlay than does the minimal body, and the adhesive properties of the materials is a factor influencing those affinities. 
       FIGS. 7-14D  illustrate an exemplary embodiment of an apparatus that comprises a moderate body and a minimal body, wherein the apparatus also includes an actuation mechanism that is used to separate the minimal body from the corneal implant and the moderate body. The apparatus can be used to store the corneal implant, prepare the corneal implant for delivery, and/or deliver the corneal implant onto or into the eye.  FIGS. 7 and 8  (side view and sectional side view, respectively) illustrate device  100  including handle  112  secured to distal portion  114 . Actuator  116  is disposed in both handle  112  and distal portion  114 , both of which are adapted to allow actuator  116  to pass therethrough. Spring  126  maintains actuator  116  in the at-rest, or non-actuated, configuration shown in  FIGS. 7 and 8 . Actuator  116  has a distal section  128  with a reduced size that is disposed in a smaller sized distal channel in distal portion  114 . 
     The distal end of apparatus  100  includes first portion  118  secured to moderate body  122 . A second portion  120  is secured to minimal body  124  and is also detachably secured to first portion  118  around pin  134 . The corneal implant (not shown in  FIGS. 7 and 8  for clarity) is disposed between the moderate body and the minimal body in a nest formed by the moderate and minimal bodies. Second portion  120  is adapted to rotate with respect to first portion  118  around pin  134 .  FIG. 9  (sectional side view) illustrates the device after actuator  116  has been pressed down. When actuator  116  is pressed, spring  126  is compressed, and distal section  128  moves forward, or distally, through the channel in distal portion  114 . The distal end of distal section  128  makes contact with second portion  120 , forcing it downward as it rotates around pin  134 . Because the corneal implant has a higher affinity for moderate body  122  than minimal body  124 , the corneal implant will remain adhered to moderate body  122  as second portion  120  and minimal body  124  are rotated away from first portion  118  and moderate body  122 . Once the curved portion of second portion  120  clears pin  134 , second portion  120  is detached from first portion  118  and therefore from device  100 , preparing the corneal implant for delivery (or, in some embodiments the corneal implant is delivered using a separate delivery device). 
       FIG. 10  illustrates a perspective view of the distal region of device  100 . First portion  118  is secured to second portion  120  with clip  132 , which is biased to the closed configuration shown in  FIG. 10 . Upon the application of the actuation force from actuator  116 , clip  132  is forced into an open configuration, allowing second portion  120  and minimal body  124  to be rotated away from first portion  118 . 
       FIG. 11  illustrates a sectional side view of the distal portion of the device.  FIG. 12  shows the sectional side view from  FIG. 11  after actuator  116  has been actuated and second portion  120  is rotating away from first portion  118 . Corneal implant  140  remains adhered to moderate body  122  due to the higher affinity of the moderate body.  FIG. 13  illustrates a side view after second portion  120  has been completely disengaged from first portion  118 . Actuator  116  is then released to cause distal section  128  to retract back into distal portion  114 . Corneal implant  140  is now ready for delivery and can be delivered as described above. In some embodiments the corneal implant is positioned against stromal corneal tissue, and because the inlay has a higher affinity to the corneal tissue than to the moderate body, the inlay will disassociate from the moderate body and adhere to the corneal tissue. 
       FIGS. 14A-14D  illustrate an exemplary embodiment of minimal and moderate bodies, which can be incorporated into the assembly from  FIGS. 7-13 . Minimal body  224  includes recess  225  formed therein such that when moderate body and minimal body are moved towards one another, they form a nest in which the inlay is retained (see  FIG. 14D ). The recess has a generally circular configuration (similar to the general configuration of minimal body  224 ), but other configurations may be suitable. Recess  225  is adapted to accommodate the corneal implant within the recess. Recess  225  is also sized to prevent inlay  140  (see  FIGS. 14B-14D ) from being compressed between the minimal and moderate bodies while being shipped or stored (see  FIG. 14D ). The corneal implant is therefore maintained in substantially unstressed, or non-deformed, configuration. Because the inlay has a defined curvature, it may be preferred to not allow the inlay to be distorted during shipping and/or storage, and the recess (and thus the nest) can be sized to help prevent it from being distorted. Additionally, because of the fluidic nature of some inlays, it can be difficult to constrain the inlay laterally between two parallel surfaces without the presence of a recess. The recess formed in the minimal body allows for easy containment without excess force being applied to the inlay. The nest formed by the moderate and minimal bodies prevents compression and/or damage to the inlay while acting as a storage compartment. 
     As can be seen in  FIGS. 14B-14D , the recess size is larger than the inlay size. Particularly, in this embodiment, the diameter of the recess (“dr”) is greater than the diameter of the inlay (“di”). Additionally, the diameter of the moderate body (“dM”) is greater than the diameter of the recess (“dr”) formed in the minimal body (see  FIG. 14D ). The diameter of the minimal body (“dm”) is greater than the diameter of the moderate body (“dM”). 
     The depth of the recess is greater than the material thickness of the inlay, but is preferably slightly less than the height of the corneal implant in a non-stressed configuration. This ensures that at least a portion of the corneal implant is maintained in contact with both the moderate body and the minimal body. If at least a portion of the corneal implant is not in contact with the moderate body, the corneal implant can remain adhered to the minimal body rather than the moderate body when the moderate and minimal bodies are moved away from one another. In an exemplary embodiment the material thickness of the corneal implant is about 38.1 microns, the overall height of the implant in a non-stressed configuration is about 152.4 microns, and the depth of the recess is between about 63.5 microns and about 114.3 microns. 
     Similar to the embodiment in  FIGS. 7-13 , moderate body  222  is secured to first portion  218 , while minimal body  224  is secured to second portion  220 . The system is used in the same manner as the embodiment in  FIGS. 7-13 . 
     In some exemplary embodiments of the systems shown herein (e.g., those in  FIGS. 7-14D ), the moderate body is stainless steel. In some embodiments it can be about 0.1 mm thick. As shown in the figures, the plurality of openings in the moderate body have general hexagon configurations. In some exemplary embodiments the dimension from a first side of the hexagon to a second side that is parallel to the first side (i.e., double the hexagon&#39;s apothem) of at least a substantial number of the hexagon shapes is about 0.35 mm. In some embodiments that dimension could be between about 0.02 mm to about 0.12 mm. The distance between hexagons (i.e., the distance from a first side of a first hexagon to a first side of a second hexagon, wherein the sides are parallel to one another and the hexagons are directly adjacent to one another) is about 0.05 mm, although this distance could be between about 0.01 mm and about 0.25 mm. The diameter of the moderate body can be about 3 mm, but in some embodiments it is between about 0.25 mm and about 13 mm. The above numerical limitations are merely exemplary and not intended to be limiting. 
     In some exemplary embodiments of the systems shown herein (e.g., those shown in  FIGS. 7-14D ), the minimal body is stainless steel, and is about 0.2 mm thick, except in the recess section. As shown in the figures, the openings in the minimal body each have general hexagon configurations. In some exemplary embodiments the dimension from a first side of the hexagon to a second side that is parallel to the first side (i.e., double the hexagon&#39;s apothem) of at least a substantial number of the hexagon shapes is about 1 mm. In some embodiments that dimension could be between about 0.1 mm to about 3 mm. The distance between hexagons (i.e., the distance from a first side of a first hexagon to a first side of a second hexagon, wherein the sides are parallel to one another and the hexagons are directly adjacent to one another) can be about 0.2 mm, although this distance could be between about 0.02 mm to about 0.12 mm. The diameter of the minimal body can be about 6.5 mm, but in some embodiments it is between about 3 mm and about 13 mm. The above numerical limitations are not intended to be limiting. 
     In some embodiments the diameter of the minimal body is at least about 2 times the diameter of the moderate body. In some embodiments the diameter of the minimal body is at least about 1.5 times the diameter of the moderate body. In some embodiments the size of the plurality of hexagons in the minimal body is at least about 2 times the size of the plurality of hexagons in the moderate body. In some embodiments they could be at least about 3 times, or at least about 4 times. 
       FIGS. 15-18  illustrate additional views illustrating the relative sizes and dimensions of the mesh bodies and a corneal inlay. In this embodiment the inlay has a diameter of about 2 mm.  FIG. 15  is a top view illustrating minimal mesh body  224 , recess  225  formed in minimal mesh body, periphery of inlay  140 , and the surface area  240  (shown in hash lines) of minimal body  224  that overlaps with the inlay when the inlay is positioned in recess  225 . In this particular embodiment surface area  240  of minimal body  224  that overlaps with the inlay is about 0.9 mm 2 . The perimeter of the inlay that overlaps the minimal body is about 9 mm.  FIG. 16  illustrates minimal mesh body  224  and periphery of inlay  140 , and the surface area  242  (shown in hash lines) of openings  244  (only three openings  244  labeled) that overlaps the inlay when the inlay is in the recess. In this particular embodiment the surface area  242  is about 2 mm 2 . 
       FIG. 17  illustrates moderate mesh body  222  and the periphery of inlay  140  disposed thereon. Surface area  250  of moderate body  222  is the surface area of the moderate body that overlaps the inlay, at least a portion of which is in contact with the inlay, when the inlay is positioned in the nest. In this particular embodiment surface area is about 0.75 mm 2 . The perimeter of the inlay is about 26 mm.  FIG. 18  illustrates moderate body  222 , periphery of inlay  140 , and the surface area  254  (shown in hash lines) of openings  252  (only three openings  252  are labeled) that overlap the inlay. Surface area  254  is about 2.3 mm 2 . 
     In some embodiments the moderate body and the minimal body each have one or more openings, or apertures, extending through the bodies. The ratio of the moderate aperture perimeter (or sum of the aperture perimeters if more than one aperture) to the moderate aperture area (or sum of the apertures areas if more than one aperture) is greater than the ratio of the minimal aperture perimeter (or sum of the aperture perimeters if more than one aperture) to the minimal aperture area (or sum of the aperture areas if more than one aperture). Without necessarily wishing to be bound by a particular theory, the greater ratio results in greater forces being applied to the corneal implant from the moderate body than the minimal body, and thus provides the moderate body with a higher affinity for the corneal implant than the minimal body. When the moderate and minimal bodies are moved apart relative to one another, the greater forces applied to the implant will cause the implant to remain adhered to the moderate body rather than the minimal body. 
     By way of illustration only, in the embodiments shown in  FIGS. 15-18 , the sum of the perimeters of the apertures in the moderate body that overlap the implant were determined to be about 1.03 in, while the sum of the aperture areas that overlap the implant were determined to be about 0.0012 in 2 . The ratio of perimeter to area for this particular moderate body was about 858 in −1 . The sum of the perimeters of the apertures in the minimal body that overlap the implant were determined to be about 0.365 in, while the sum of the aperture areas that overlap the implant were determined to be about 0.0014 in 2 . The ratio of perimeter to area for this particular moderate body was about 260 in −1 . The ratio is therefore greater for the moderate body than for the minimal body. 
       FIG. 19  is a partial exploded view of an exemplary corneal implant storage and positioning device. Positioning device  310  generally includes a handle assembly  312  that includes the moderate body, support assembly  314  that includes the minimal body, and actuator assembly  316  that is adapted to actuate, or move, support assembly  314  with respect to handle assembly  312 . Due to the inlay&#39;s greater affinity for the moderate body, the inlay will adhere to the moderate body when the support assembly  314  is actuated. 
     Actuator assembly  316  includes push rod  320  coupled to button  321 , and spring  322 . Handle assembly  312  includes handle  324  coupled to distal portion  326 , which includes the moderate body. The distal end of spring  322  is secured within the internal channel within handle  312 , and the proximal end of spring  322  is secured to the distal end of button  321 . Push rod  320  is configured to be disposed within the internal lumen of spring  322 . As shown in more detail in  FIGS. 20A-20C , the distal end of push rod  320  includes bore  328  therethrough, adapted to receive dowel  318  therein. When push rod  320  has been advanced distally within handle assembly  312  and extends just out of the distal end of handle assembly  312 , as shown in  FIG. 20A , dowel  318  is advanced through bore  328 . Dowel  318  both prevents push rod  320  from retracting proximally within handle assembly  312 , but it also provides base assembly  314  with a surface to engage in order to secure support assembly  314  in place relative to handle assembly  312 , as shown in  FIG. 20C . The device also includes rod  330 , which helps secure support assembly  314  in place relative to handle assembly  312  (see  FIG. 20C ), but allows support assembly  314  to rotate around rod  330  when the actuator is actuated. Dowel  318  is also involved in the actuation of the support assembly. Actuating button  321  causes push rod  320 , and thus dowel  318 , to be advanced distally within handle assembly  312 . This causes dowel  318  to apply a generally distally directed force to support assembly  314 , which causes dowel  318  to push down on support assembly  314 . Upon the application of this force support assembly  314  will begin to rotate around rod  330 , causing minimal body mesh  338  to move away from moderate mesh body  334 . Further rotation of support assembly  314  will free support assembly  314  from rod  330 , allowing support assembly  314  to be completely disengaged from handle assembly  312 . Once disengaged, the corneal implant will remain adhered to moderate body  334  and is ready for use, such as delivery into or onto corneal tissue. Once the minimal mesh body is moved, the user can release button  321 , and spring  322  causes actuator  316  to return to an at-rest, or non-actuated, position relative to handle assembly  312 . 
     By incorporating rod  330 , support assembly  314  rotates with respect to handle assembly  312  in only one direction, which prevents torqueing. 
       FIG. 21  is a partial exploded view of handle assembly  312  shown in  FIG. 17  (actuator and base assembly not shown). Assembly  312  includes handle  324 , distal tip portion  342 , dowel  318 , applicator base  336 , and applicator  334 . Handle  324  is secured to distal tip portion  342 , and the distal end of distal tip portion  342  is disposed within a bore in applicator base  336 . Applicator  334  is secured to applicator base  336 .  FIG. 22  shows the assembled view from  FIG. 21 . 
       FIGS. 23A-23D  illustrate alternative views of the assembly of applicator base  336 , applicator  334 , and rod  330 .  FIG. 23A  is an exploded perspective bottom view.  FIG. 23B  is a perspective top view illustrating how rod  330  is disposed within applicator base  336 .  FIG. 23C  is a bottom view showing applicator  334  secured to applicator base  336  and a plurality of attachment points  350  for securing applicator  334  to applicator base  336 .  FIG. 23D  is a front view showing applicator  34  secured to applicator base  336 , and rod  330  disposed within applicator base  336 . Applicator  334  and applicator base  336  can be secured together by any suitable technique. In one embodiment applicator  334  is welded to base  336 , such as by resistance welding or laser welding. Applicator  334  includes the moderate mesh body. 
       FIGS. 24A-24I  illustrate a variety of views of a particular embodiment of applicator base  336  described above. The internal bore through which the actuator extends can be seen in the sectional side view of  FIG. 24D . The dimensions indicated in the figures are merely exemplary to this particular embodiment and are not limiting. 
       FIGS. 25A-25C  illustrate exemplary dimensions for applicator  334 , including the mesh dimensions, described above. For example, dimensions of the mesh that contribute to implant preference to adhere to the moderate body over the minimal body are shown.  FIG. 25A  is a top view.  FIG. 25B  is a side view.  FIG. 25C  is a detailed view of section A from  FIG. 25A . 
       FIGS. 26A-26D  illustrate support assembly  314  from  FIG. 17 , which includes support base  340  secured to implant support  338 . Support base  340  and implant support  338  are secured to one another similarly to the applicator base and the applicator described above.  FIG. 26A  is an exploded view, while  FIG. 26B  is an assembled view.  FIG. 26C  is a top view.  FIG. 26D  is a detailed view C from  FIG. 26A  of applicator  338  showing recess  360  defined by recess sidewalls  356  and recess base surface  358 . The implant is configured and sized to be disposed within the recess such that it is positioned between the minimal and moderate meshes prior to removal of the minimal body. 
       FIGS. 27A-27E  illustrate front, sectional side, side, and top views of support base  340 . 
       FIGS. 28A-28D  illustrate views of the support  338 .  FIG. 28B  illustrates section A-A shown in  FIG. 28A .  FIG. 28C  shows detail B from  FIG. 28B , and  FIG. 28D  shows detail C from  FIG. 10A . Recess  360  is formed in a top portion of the support  338 . Mesh apertures  364  are defined by body  362 , illustrated in  FIGS. 28B and 28C . The dimensions shown are exemplary and not intended to be limiting. The mesh apertures of the minimal body are larger than the mesh apertures of the moderate body, which is one of the contributing factors for why in this particular embodiment the implant preferentially adheres to the moderate body. 
     In general, the recess in the minimal mesh body should be sized to prevent forces, or a substantial amount of forces, from being applied to the corneal implant while it is positioned in the nest between the moderate and minimal bodies prior to use. 
     The mesh apertures and the recess can be created by any suitable technique, such as chemical etching, laser cutting, micro water jet cutting, etc. In some instances chemical etching provides for a cleaner cut and does not require as much post-manufacture processing of the body. The mesh apertures can be created from only one side, or in some embodiments half of the thickness of the aperture is created from one side, while the other half of the aperture is created from the other side. In some embodiments the recess is etched from one side, while the mesh apertures are created in the other side. Any combination or variation on these techniques can be used. In some embodiments the recess is created by plunge electrical discharge machining (“EDM”). 
     In general, the net forces acting on the corneal implant are greater from the moderate mesh body than from the minimal mesh body. The polarity of water is an important factor when the corneal implant is formed of a hydrophilic material because in these instances the implant has properties like water and as such behaves like water. The dimensions of the mesh, configuration of the mesh, mesh body, and other factors can be modified to alter the relative affinities. 
     As described above, the minimal mesh body diameter is larger than the moderate mesh body diameter (both are shown to have a generally circular configuration). The minimal body diameter, due to its larger size, acts like a bumper, protecting the entire distal region of the apparatus during storage and use prior to actuation of the actuator. In the specific example shown above, the minimal body thickness is about twice as thick as the moderate body. 
     The moderate body diameter is larger than the recess, while the minimal body diameter is larger than the moderate body diameter. In some embodiments it may be helpful for the physician to be able to visualize the pupil when the corneal implant is being positioned in the cornea. For example, this may be desirable when implanting an inlay into the cornea wherein the inlay has a diameter less than the diameter of the pupil, such as a 1-3 mm diameter corneal inlay. For these applications the moderate mesh body can be sized such that it does not interfere with the visualization of the pupil. Specifically, the moderate mesh body portion is sized to allow the physician to be able to see the pupil during the delivery of the implant on corneal tissue. Starting with this constraint, the size of the other components can then be determined. 
     The use of “diameter” herein is not to suggest that the mesh body outer surfaces are perfectly circular or are circular at all. The two mesh portions could be square or rectangular-shaped, with the width and length of the minimal mesh portion larger than the width and length of the moderate mesh portion. 
     While in the embodiments above the implant&#39;s affinity for the moderate body is described as largely due to the size and configuration of the moderate mesh body relative to the minimal body, there are many ways to establish and control the implant&#39;s affinity for a given body. In some embodiments this can be accomplished by using a moderate body that is different than the minimal body. In some embodiments a finish could be applied to one or more of the surfaces of the moderate and minimal bodies. The finish can be different on the moderate and the minimal body to control the preferential adhesion. In some embodiments the moderate body has a better finish than the minimal body. In some embodiments the minimal body has a matte finish on it. 
     One or more components of the devices described herein can be a stainless steel or titanium. For example, applicator base  36  and applicator  34  can both be stainless steel, one can be titanium while the other is stainless steel, or both can be titanium. 
       FIGS. 29A-29D  illustrate views of distal tip  342  from the handle assembly described above.  FIG. 29A  is a view looking from the proximal end to the distal end,  FIG. 29B  is a view from the distal end to the proximal end,  FIG. 29C  is a sectional side view, and  FIG. 29D  is a front view. The distal tip is secured to the handle, and the distal end of it is disposed in the applicator base  336 . 
       FIGS. 30A-30E  illustrate in detail actuator assembly  316  from  FIG. 19 . The actuator includes button  321 , push rod  320 , and bore  328  at the distal end of push rod  320 .  FIG. 30A  is an exploded view,  FIG. 30B  is an assembly view,  FIG. 30C  is a side sectional view of section A-A shown in  FIG. 30E , and  FIG. 30D  is a detail view of section B shown in  FIG. 30C . 
       FIGS. 31A-31D  illustrate detailed views of button  321 .  FIGS. 32A-32D  illustrate detailed views of push rod  320 , including bore  328 . 
       FIGS. 33A-33D  illustrate detailed views of handle  324 .  FIGS. 34A and 34B  illustrate detailed views of spring  322 .  FIGS. 35A and 35B  illustrate detailed viewed of dowel  18 . 
     Once the corneal implant is loaded in the apparatus between the moderate and minimal bodies, the implant can be used right away or it can be stored in packaging for any suitable period of time. When the corneal implant is made of a hydrogel material, it is important to keep the implant adequately hydrated during storage. 
     Embodiments herein describe both a moderate body and a minimal body. In some embodiments, however, the apparatus or its method of use need not include the minimal body. Without the minimal body, the corneal implant is not positioned within a corneal nest defined by the moderate and minimal bodies. The implant therefore need not be packaged with the moderate body. For example, it can be packaged in a separate packaging. In these embodiments the moderate body can utilize its preferential adhesion for the implant as set forth above to retrieve, or pick up, the corneal implant from its packaging. This can eliminate restrictions on how the cornel implant needs to be packaged. For example, the implant can be stored in a vial, free-floating in a storage medium. When the implant is ready to be positioned on the corneal tissue, the moderate body, which can be coupled to a handle, is positioned adjacent the implant in its storage medium, such as by scooping up the corneal implant into a position adjacent the apertures therein. Due to its preferential adhesion adaptation, the corneal implant will preferentially adhere to the moderate body. Once it has adhered to the moderate body, the implant is ready to be deposited onto the cornea as set forth above by relying on the moderate body&#39;s adaptation to allow the implant to preferentially adhere to the corneal tissue rather than the moderate body.