JP2017525463A - Corneal graft storage, packaging, and delivery device - Google Patents

Abstract

Apparatus and method for packaging, storing, and / or positioning ophthalmic lenses. [Selection] Figure 23A

Description

Cross-reference of related applications
[0001] The present disclosure includes the following applications, which are hereby incorporated by reference in their entirety: WO 2013/059813 published April 25, 2013, US provisional 61/550 filed October 21, 2011. , 185, US provisional 61 / 679,482, filed August 3, 2012, US provisional 61 / 606,674, filed March 5, 2012, and September 8, 2011. Related to US Publication No. 2011/0218623.
Incorporation by reference
[0002] All publications and patent applications mentioned herein are hereby 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. It is incorporated in the description.

  [0003] Corneal implants such as corneal onlays and corneal inlays can be small, sophisticated medical devices that need to be protected from damage or loss during storage and / or in preparation for positioning on corneal tissue There is. There remains a need for safe and efficient storage and / or positioning devices and methods that can prevent damage or loss of the corneal graft and facilitate the preparation of the corneal graft for use. The disclosure herein addresses one or more of these issues.

  [0004] One aspect of the disclosure is a lens applicator comprising a lens applicator member configured to position an ophthalmic lens on tissue, and a base comprising an alignment lens applicator guide and a lens support member, The lens applicator guide includes a base configured to receive and stably align with the lens applicator, the lens applicator member and the lens support member, the lens applicator being the lens applicator guide. An ophthalmic lens storage device, wherein the ophthalmic lens is configured to be secured between a lens applicator member and a lens support member when positioned therein.

  [0005] In some embodiments, the lens applicator guide has a cross-sectional shape, such as a partial hexagon, that is at least partially complementary to the cross-sectional shape of the lens applicator shaft, such as a hexagon. The cross-sectional shape of the lens applicator shaft may be polygonal, and the cross-sectional shape of the lens applicator guide may be at least partially polygonal and have fewer sides than the polygonal shape of the lens applicator shaft.

  [0006] In some embodiments, the lens applicator guide is configured to provide rotational stability about the longitudinal axis of the lens applicator shaft to the lens applicator therein. The lens applicator guide may be configured to allow axial movement by the lens applicator within the lens applicator guide.

  [0007] In some embodiments, the apparatus further comprises a clip configured to stably align with the base and the lens applicator, such that the clip provides the lens applicator with additional stability relative to the base. ing. The clip may be configured to be stably aligned with the base and the lens applicator so that the clip provides axial stability relative to the base to the lens applicator.

  [0008] In some embodiments, the clip is configured to be stably aligned with the base and lens applicator so that axial motion between the clip and both the base and lens applicator is stable. Resistance is received by matching.

[0009] In some embodiments, a lens applicator comprises a shaft portion and an applicator member that extends at a non-orthogonal angle with respect to the shaft portion.
[0010] In some embodiments, the lens applicator comprises an applicator member disposed at an angle with respect to the base lens support member when advanced into the lens applicator guide.

[0011] In some embodiments, the lens support member is releasably secured to the base.
[0012] In some embodiments, the lens support member comprises a lens enclosure configured to provide radial stability to the lens.

  [0013] In some embodiments, the apparatus further comprises a handle configured to be secured to the lens applicator. The lens applicator may comprise a shaft having a surface configured to align with the handle surface and secure the handle to the lens applicator, the shaft surface having a cross-sectional shape different from the cross-sectional shape of the handle surface. . The shaft may have an outer surface having a cross-sectional shape different from the cross-sectional shape of the inner surface of the handle. The cross-sectional shape of the handle inner surface may be a curved shape such as a circle. The outer surface of the shaft may be a polygon such as a hexagon. One of the shaft cross section and the handle cross section may be curved and the other may be polygonal. One of the shaft cross section and the handle cross section may be circular and the other may be hexagonal. Different shapes can produce an interference fit. The shaft surface may be slightly larger than the handle surface. The two shapes may be configured to allow any rotational orientation of the handle relative to the shaft prior to alignment and provide rotational stability when aligned. The lens applicator and handle may each include a first locking element and a second locking element configured to maintain the lens applicator and handle in a locked position.

  [0014] One aspect of the disclosure includes a lens applicator and a handle, the lens applicator comprising a shaft outer surface configured to align with the handle inner surface to secure the shaft to the handle, the shaft outer surface being on the handle inner surface. An ophthalmic lens insertion device having a cross-sectional shape different from the cross-sectional shape.

[0015] In some embodiments, the cross-sectional shape of the handle inner surface is a curved shape such as a circle.
[0016] In some embodiments, the cross-sectional shape of the outer surface of the shaft is a polygon such as a hexagon.
[0017] In some embodiments, one of the cross section of the shaft outer surface and the cross section of the handle inner surface is a curved shape such as a circle, and the other is a polygon such as a hexagon.

[0018] In some embodiments, different shapes create an interference fit to secure the shaft to the handle.
[0019] In some embodiments, the shaft outer surface is slightly larger than the handle inner surface.

[0020] In some embodiments, the two shapes are configured to allow arbitrary rotational orientation of the handle relative to the shaft prior to alignment and provide rotational stability when aligned.
[0021] In some embodiments, the shaft and handle comprise a first locking element and a second locking element, respectively, configured to maintain the lens applicator and handle in a locked position.

  [0022] One aspect of the disclosure is a packaging device for stabilizing an ophthalmic lens storage device, comprising a package housing that defines a receiving space and an ophthalmic lens storage device, the ophthalmic lens storage device comprising: A lens applicator configured to stably align the ophthalmic lens between the base and the lens applicator, and a lens base and the lens applicator; A stabilizing member configured to provide stability to the lens base to the lens applicator, wherein the receiving space is configured to receive the storage device therein, the receiving space, the base, and the stabilizing member are stable in the receiving space A packaging device configured and sized to maintain stable alignment between a member, a base, and a lens applicator.

[0023] In some embodiments, the packaging housing is a glass vial.
[0024] In some embodiments, the packaging device further comprises a storage fluid within the housing and a lid configured to create a fluid tight seal with the housing.

  [0025] In some embodiments, the receiving space is sized so that when the clip is in the housing, the base and the respective joint on the clip cannot move sufficiently relative to the base. Configured.

  [0026] In some embodiments, the receiving space is such that when the clip is in the housing, the lens applicator and the respective joint on the clip cannot be moved sufficiently relative to the base. Sized and configured.

  [0027] In some embodiments, when the clip is in the housing, the lens applicator and the respective joint on the clip are disengaged sufficiently, or the base and the respective joint on the clip are disengaged sufficiently. The receiving space is sized and configured so that it cannot move relative to the base.

  [0028] One aspect of the disclosure includes a base, a lens applicator that is stably aligned with the base and secures the ophthalmic lens between the base and the lens applicator, and is stably aligned with the lens base and the lens applicator Providing an ophthalmic lens storage device comprising a stabilizing member for providing stability to the lens base to the lens applicator, and disposing the storage device within the package housing, wherein the housing comprises the stabilizing member, the base and the lens applicator. A method of packaging an ophthalmic lens storage device comprising: maintaining a stable alignment with both.

[0029] FIG. 6 illustrates an exemplary cohesive force. [0030] FIG. 6 illustrates an exemplary adhesion force. [0031] FIG. 3 shows liquid suspended in a loop. [0032] FIG. 6 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. [0033] FIG. 6 illustrates an exemplary intermediate body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. FIG. 3 shows an exemplary middle body and minimal body. [0034] FIG. 10 illustrates an exemplary corneal graft applicator device. FIG. 17A illustrates an exemplary corneal graft applicator device. FIG. 17B illustrates an exemplary corneal graft applicator device. FIG. 17C illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. FIG. 3 illustrates an exemplary corneal graft applicator device. [0035] FIG. 20A illustrates components of an exemplary corneal graft applicator device. FIG. 20B illustrates components of an exemplary corneal graft applicator device. FIG. 20C illustrates components of an exemplary corneal graft applicator device. FIG. 21A illustrates components of an exemplary corneal graft applicator device. FIG. 21B shows components of an exemplary corneal graft applicator device. FIG. 21C illustrates components of an exemplary corneal graft applicator device. FIG. 21D shows components of an exemplary corneal graft applicator device. FIG. 22A illustrates components of an exemplary corneal graft applicator device. FIG. 22B illustrates components of an exemplary corneal graft applicator device. FIG. 22C illustrates components of an exemplary corneal graft applicator device. FIG. 22D shows parts of an exemplary corneal graft applicator device. [0036] FIG. 3 is an exploded view of an exemplary storage device. FIG. 3 is an assembly drawing of an exemplary storage device. [0037] FIG. 4 is a perspective bottom view of an exemplary lens applicator secured to an exemplary lens applicator member. [0038] FIG. 8 illustrates how an exemplary lens support can be configured to be secured to a base housing. [0039] FIG. 7 is an illustration of an exemplary base housing. FIG. 3 illustrates an exemplary base housing. FIG. 3 illustrates an exemplary base housing. FIG. 3 illustrates an exemplary base housing. [0040] FIG. 6 illustrates an exemplary lens support member. FIG. 6 is a diagram illustrating an exemplary lens support member. 2 is a cross-sectional view of an exemplary lens support member. FIG. FIG. 6 is a diagram illustrating an exemplary lens support member. [0041] FIG. 6 illustrates an exemplary lens applicator member comprising an applicator portion and a support portion. FIG. 6 shows an exemplary lens applicator member comprising an applicator portion and a support portion. FIG. 6 shows an exemplary lens applicator member comprising an applicator portion and a support portion. FIG. 6 shows an exemplary lens applicator member comprising an applicator portion and a support portion. [0042] FIG. FIG. 6 shows an exemplary clip 600. FIG. 6 shows an exemplary clip 600. FIG. 6 shows an exemplary clip 600. [0043] FIG. 6 illustrates an exemplary lens applicator. FIG. 3 illustrates an exemplary lens applicator. FIG. 3 illustrates an exemplary lens applicator. FIG. 3 illustrates an exemplary lens applicator. FIG. 3 illustrates an exemplary lens applicator. [0044] An exemplary handle configured to be secured to an exemplary lens applicator and used to position the corneal implant on the corneal tissue after the lens applicator is removed from the storage device platform. FIG. FIG. 3 illustrates an example handle configured to be secured to an example lens applicator and used to position a corneal implant on corneal tissue after the lens applicator has been removed from a storage device platform. It is. FIG. 3 illustrates an example handle configured to be secured to an example lens applicator and used to position a corneal implant on corneal tissue after the lens applicator has been removed from a storage device platform. It is. FIG. 3 illustrates an example handle configured to be secured to an example lens applicator and used to position a corneal implant on corneal tissue after the lens applicator has been removed from a storage device platform. It is. FIG. 3 illustrates an example handle configured to be secured to an example lens applicator and used to position a corneal implant on corneal tissue after the lens applicator has been removed from a storage device platform. It is. [0045] FIG. 9 illustrates an exemplary lens applicator shaft disposed within an end of an exemplary handle. [0046] FIG. 6 illustrates an exemplary package. [0047] FIG. 32 is a top view of the storage device in an assembled state after being placed in the holding space of the package of FIG.

  [0048] The present disclosure relates to an apparatus for one or more of packaging, storage, positioning, and delivery of a corneal implant, such as a corneal inlay. For example, the devices herein can be used to move and position any ophthalmic lens such as, but not limited to, corneal onlays, corneal inlays, corneal implants, and contact lenses.

  [0049] The present disclosure includes devices and methods of use that control the positioning and / or movement of a corneal implant, at least in part, depending on the surface tension of the liquid. The device can be used to store, package, transfer, or deliver a corneal implant. These approaches can be used when the corneal implant is made at least partially from a hydrophilic material such as a hydrogel.

  [0050] Surface tension is a property of a liquid that allows the surface of the liquid body to resist external forces. Surface tension allows objects that are denser than water, such as small pins and some insects, to float on the surface of the liquid. Surface tension is caused by the cohesive force of liquid molecules. Cohesive force is the attractive force between two similar molecules. As shown in FIG. 1, the average molecule in the body of the liquid does not have an overall cohesive force acting on the molecule because the cohesive force from adjacent molecules acts on the molecule in all directions. . However, only the molecules on the surface undergo a cohesive force that pulls it inward. For very small droplets, the inward force on all surface molecules causes the droplets to be generally spherical.

  [0051] On the other hand, adhesive forces are those found between different molecules. For some material combinations, these forces can be greater than the cohesive forces of the liquid molecules. This strong adhesion force causes an upward “curvature” called the meniscus (shown in FIG. 2) on the surface of the liquid, where the liquid around the edge of the container Pulled higher than the rest of the. The adhesion force is in equilibrium with the gravity that pulls up the surface of the water and pulls down the liquid body.

  [0052] For a liquid suspended in a loop, as shown in FIG. 3, adhesion from the loop acts on both the top and bottom surfaces of the liquid, and a cohesive force acts on the top and bottom surfaces. These forces are sufficient to hold the liquid in the loop until the volume of the liquid is large enough for gravity to overcome the cohesive and adhesive forces.

  [0053] For solids, meshes, or other such surfaces, adhesion and cohesion will work as well. Many factors, including material type, fluid type, and surface shape, affect the strength of adhesion and cohesion.

  [0054] Exemplary corneal grafts that can be stored and used in the following embodiments are described in US Patent Application Publication No. 2007/0203577, filed Oct. 30, 2006, which is incorporated herein by reference. US Patent Application Publication No. 2008/0262610 filed on April 20, 2007 and United States Patent Application Publication No. 2011/0218623 filed on September 8, 2010. In some embodiments, a “small diameter” (ie, about 1 mm or more and about 3 mm or less) corneal inlay is made from a hydrogel that can be primarily fluid. Because of this and the small size of the inlay, the inlay behaves somewhat like a fluid. The following disclosure takes advantage of such features of corneal implants and the adhesion between fluids and various surface shapes. Although the disclosure herein focuses on corneal inlays, any corneal implant that exhibits similar properties can be used as described herein. For example, a corneal onlay that is at least partially hydrophilic may be used as described herein.

  [0055] The devices herein rely on the “affinity” of the body for an object having fluid or fluid-like properties (eg, a hydrophilic corneal implant). As used herein, the “affinity” of a body for a fluid or fluid-like object is the strength of the net adhesion between the body and the fluid or fluid-like object and the net cohesive strength within the fluid or fluid-like object. It is influenced by the difference with the strength. In embodiments herein where there is a substantially constant fluid or fluid-like object (eg, a hydrophilic corneal inlay), the relative affinity of the two bodies for the fluid or fluid-like object is that the body and the fluid or fluid-like object are Is determined at least in part by the relative strength of the net adhesion force. For example, in an embodiment where the fluidic object is a hydrophilic corneal implant, the first body has a greater net adhesion between the first body and the graft than the net adhesion between the second body and the graft. Can also have a higher affinity for the graft than the second body.

[0056] The corneal implant remains attached to the body with the highest net force (total of adhesion and cohesion).
[0057] A first body, referred to herein as a "medium body," has a higher affinity for a 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 other similar terms indicating a device, part, structure, or something having a structure. However, the eye has a higher affinity for fluids or fluid-like objects than the middle body. Different relative affinities can be used to handle the inlay and control the movement of the inlay as it moves from one surface to another without the user having to touch the inlay with their hands or other tools it can. Factors that affect relative affinity include one or more of the surface type including material type, fluid type, and surface area.

  [0058] As used herein, a corneal inlay (eg, a fluid-like object) has a higher “affinity” to the corneal bed of the eye than a central body, while at the same time the inlay is less than a minimal body. Has a high affinity for the middle body. The eye can be described as having a higher affinity for the inlay than the middle body and the minimal body. Similarly, the intermediate body can be described as having a higher affinity for the inlay than the minimal body. That is, the affinity between two bodies can be described for either body. That is, for example, the intermediate body has a higher affinity for the inlay than the minimal body, and therefore the inlay preferentially adheres to the intermediate body over the minimal body.

[0059] In some embodiments, the storage fluid is, for example, water or saline. Since water molecules have high polarity, they provide attraction with other materials.
[0060] A relative comparison of the affinity between each body and the inlay can be expressed as corneal tissue> medium body> minimal body. The intermediate body and the minimal body can take many shapes including, but not limited to, meshes, membranes, and / or materials with different surface finishes or profiles.

  [0061] Due to the difference in affinity between the minimal body and the middle body, the inlay remains preferentially attached to the middle body. The inlay continues to adhere to the middle body until it is exposed to stronger adhesion. Therefore, the minimal body and the middle body may be made of any appropriate material as long as the adhesion force between the middle body and the inlay is larger than the adhesion force between the minimal body and the inlay. The middle body has a higher affinity for the inlay than the minimal body, and the adhesion properties of the material are factors that affect such affinity.

  [0062] FIGS. 4-11D are exemplary embodiments of a device with an intermediate body and a minimal body, where the device separates the minimal body from the corneal implant and the intermediate body. It also includes an actuation mechanism that is used. The device can be used to store the corneal implant, prepare to deliver the corneal implant, and / or deliver the corneal implant onto or into the eye. 4 and 5 (side view and side cross-sectional view, respectively) show the device 100 with a handle 112 secured to the distal portion 114. Actuator 116 is disposed on handle 112 and distal portion 114, and handle 112 and distal portion 114 are configured such that actuator 116 penetrates the interior. Spring 126 maintains actuator 116 in a stationary or non-actuated configuration as shown in FIGS. Actuator 116 has a small sized distal portion 128 disposed in a smaller sized distal channel in distal portion 114.

  [0063] The distal end of the device 100 has a first portion 118 secured to the intermediate body 122. The second portion 120 is fixed to the minimal body 124 and is detachably fixed to the first portion 118 around the pin 134. A corneal implant (not shown in FIGS. 4 and 5 for clarity) is placed between the intermediate body and the minimal body in a nest formed by the intermediate body and the minimal body. Second portion 120 is configured to rotate relative to first portion 118 about pin 134. FIG. 6 (side sectional view) shows the device after the actuator 116 has been pushed down. When the actuator 116 is pushed, the spring 126 is compressed and the distal portion 128 moves forward or distally through the channel of the distal portion 114. The distal end of the distal portion 128 contacts the second portion 120 and pushes the second portion 120 downward as it rotates about the pin 134. Because the corneal implant has a higher affinity for the intermediate body 122 than the minimal body 124, the cornea is rotated when the second portion 120 and the minimal body 124 rotate away from the first portion 118 and the intermediate body 122. The graft remains attached to the intermediate body 122. When the curved portion of the second portion 120 is disengaged from the pin 134, the second portion 120 is disengaged from the first portion 118 and thus from the device 100 to prepare (or partially) deliver the corneal implant. In this embodiment, the corneal implant is delivered using a separate delivery device).

  [0064] FIG. 7 is a perspective view of the distal region of the device 100. FIG. First portion 118 is secured to second portion 120 with clip 132 biased in the closed configuration shown in FIG. When actuating force from the actuator 116 is applied, the clip 132 is in an open configuration and the second portion 120 and the minimal body 124 can be rotated away from the first portion 118.

  [0065] FIG. 8 is a cross-sectional side view of the distal portion of the device. FIG. 9 is a cross-sectional side view of FIG. 8 with the second portion 120 rotating away from the first portion 118 after the actuator 116 is actuated. The corneal implant 140 remains attached to the intermediate body 122 due to the higher affinity of the intermediate body. FIG. 10 is a side view after the second portion 120 has been completely disconnected from the first portion 118. The actuator 116 is then released, causing the distal portion 128 to retract to the distal portion 114. Corneal implant 140 is ready to be delivered and can be delivered as described above. In some embodiments, the corneal implant is positioned relative to stromal corneal tissue and the inlay has a higher affinity for corneal tissue than the intermediate body, so the inlay is separated from the intermediate body and into the corneal tissue. Adhere to.

  [0066] FIGS. 11A-11D are exemplary embodiments of minimal and intermediate bodies that can be incorporated into the assemblies of FIGS. 4-10. The minimal body 224 has a recess 225 formed therein, and forms a nest that holds the inlay when the intermediate body and the minimal body approach each other (see FIG. 11D). The recess has an overall circular configuration (similar to the overall configuration of the minimal body 224), but other configurations may be suitable. Recess 225 is configured to receive a corneal implant within the recess. The recess 225 is also sized to prevent the inlay 140 (FIGS. 11B-11D) from being compressed between the minimal body and the middle body during transport or storage (see FIG. 11D). Thus, the corneal implant is maintained in a substantially unstressed or undeformed configuration. Since the inlay has a defined curvature, it may be preferable to prevent the inlay from being distorted during transport and / or storage, and the recess (and therefore the nesting) is sized to help prevent inlay distortion. obtain. In addition, due to the fluid nature of some inlays, it can be difficult to constrain the inlay laterally between two parallel surfaces without a recess. The recess formed in the minimal body allows easy confinement without applying excessive force to the inlay. The nest formed by the intermediate body and the miniature body acts as a storage compartment and prevents compression and / or damage to the inlay.

  [0067] As seen in FIGS. 11B-11D, the size of the recess is larger than the size of the inlay. In particular, in this embodiment, the diameter of the recess (“dr”) is larger than the diameter of the inlay (“di”). In addition, the diameter of the middle body (“dM”) is larger than the diameter (“dr”) of the recess formed in the minimal body (see FIG. 11D). The diameter of the minimal body (“dm”) is larger than the diameter of the middle body (“dM”).

  [0068] 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 stress free configuration. This ensures that at least a portion of the corneal implant is maintained in contact with the intermediate body and the minimal body. If at least a portion of the corneal implant is not in contact with the intermediate body, the corneal implant can remain attached to the minimal body rather than the intermediate body when the intermediate body and the minimal body move away from each other. . In an exemplary embodiment, the material thickness of the corneal implant is about 38.1 microns, the total height of the implant in an unstressed configuration is about 152.4 microns, and the depth of the recess is about 63.5 microns. More than about 114.3 microns.

  [0069] Similar to the embodiment of FIGS. 4-10, the intermediate body 222 is secured to the first portion 218 and the minimal body 224 is secured to the second portion 220. The system is used in a manner similar to the embodiment of FIGS.

  [0070] In some exemplary embodiments of the systems shown herein (eg, those shown in FIGS. 4-11D), the intermediate body is stainless steel. In some embodiments, the intermediate body can be about 0.1 mm thick. As shown in the drawing, the plurality of openings of the intermediate body have a hexagonal configuration as a whole. In some exemplary embodiments, the dimension from the first side of the hexagon to the second side parallel to at least a substantial number of the first sides of the hexagon (ie, the hexagonal centroid distance 2 times) is about 0.35 mm. In some embodiments, this dimension can be about 0.02 mm or more and about 0.12 mm or less. The distance between the hexagons (ie, the distance from the first side of the first hexagon to the first side of the second hexagon; the sides are parallel to each other and the hexagons are directly adjacent to each other) is about Although it is 0.05 mm, this distance may be about 0.01 mm or more and about 0.25 mm or less. The diameter of the intermediate body can be about 3 mm, but in some embodiments is about 0.25 mm or more and about 13 mm or less. The above numerical limitations are exemplary only and are not intended to be limiting.

  [0071] In some exemplary embodiments of the system described herein (eg, those shown in FIGS. 4-11D), the minimal body is stainless steel and is about 0.2 mm thick except for the recesses. It is. As shown in the drawing, each of the openings of the minimal main body has a hexagonal configuration. In some exemplary embodiments, the dimension from the first side of the hexagon to the second side parallel to at least a substantial number of the first sides of the hexagon (ie, the hexagonal centroid distance 2 times) is about 1 mm. In some embodiments, this dimension may be between about 0.1 mm and about 3 mm. The distance between the hexagons (ie, the distance from the first side of the first hexagon to the first side of the second hexagon. The sides are parallel to each other and the hexagons are directly adjacent to each other) is approximately 0. This distance may be about 0.02 mm or more and about 0.12 mm or less. The diameter of the minimal body can be about 6.5 mm, but in some embodiments is about 3 mm or more and about 13 mm or less. The above numerical limits are not intended to be limiting.

  [0072] In some embodiments, the diameter of the minimal body is at least about twice the diameter of the intermediate body. In some embodiments, the diameter of the minimal body is at least about 1.5 times the diameter of the intermediate body. In some embodiments, the size of the hexagons of the minimal body is at least about twice the size of the hexagons of the intermediate body. In some embodiments, these may be at least about 3 times or at least about 4 times.

[0073] FIGS. 12-15 are additional views showing the relative sizes and dimensions of the mesh body and corneal inlay. In this embodiment, the inlay has a diameter of about 2 mm. FIG. 12 illustrates a minimum mesh body 224, a recess 225 formed in the minimum mesh body, the periphery of the inlay 140, and a surface area 240 (shown by diagonal lines) of the minimum body 224 that overlaps the inlay when the inlay is positioned in the recess 225 It is a top view. In this particular embodiment, the surface area 240 of the minimal body 224 overlying the inlay is about 0.9 mm ² . The circumference of the inlay that overlaps the minimal body is about 9 mm. FIG. 13 shows a surface area 242 (hatched with diagonal lines) of an opening 244 (only three openings 244 are labeled) that overlap the inlay 140 when the inlay 140 is in the recess and around the micromesh body 224. Show). In this particular embodiment, the surface area 242 is about 2 mm ² .

[0074] FIG. 14 shows the middle mesh body 222 and the periphery of the inlay 140 disposed thereon. The surface area 250 of the intermediate body 222 is the surface area of the intermediate body that overlaps the inlay when the inlay is positioned within the nest and at least a portion thereof contacts the inlay. In this particular embodiment, the surface area is about 0.75 mm ² . The circumference of the inlay is about 26 mm. FIG. 15 shows the surface area 254 (indicated by hatching) of the middle body 222, the periphery of the inlay 140, and the openings 252 (only three openings 252 are labeled) that overlap the inlay. The surface area 254 is about 2.3 mm ² .

  [0075] In some embodiments, the intermediate body and the minimal body each have one or more openings or openings through the body. The ratio of the median aperture circumference (or the sum of aperture circumferences for multiple apertures) to the median aperture area (or the sum of aperture apertures for multiple apertures) is the minimum aperture area (or The sum of the opening areas), or the ratio of the minimum opening perimeter (or the sum of the perimeters of openings in the case of multiple openings). Although not necessarily bound by a specific theory, the higher the ratio, the greater the force applied to the corneal graft from the intermediate body than the minimal body, and thus higher affinity for the corneal graft than the minimal body. Give to the middle body. As the intermediate body and the minimal body move away from each other, the greater force applied to the implant keeps the implant attached to the intermediate body rather than the minimal body.

[0076] By way of example only, in the embodiment shown in FIGS. 12-15, the total perimeter of the opening in the intermediate body overlying the graft is determined to be about 1.03 inches, the total opening area overlapping is determined to be about 0.007742cm ² (0.0012 square inches). The ratio of perimeter to area for this particular medium body was about 338 cm ⁻¹ (858 inches ⁻¹ ). The total circumferential length of the opening of the minimum body overlaps the implant about 0.9271cm determined in (0.365 inches), the total opening area overlapping the implant about 0.009032cm ² (0.0014 square inches) Was decided. The ratio of perimeter to area for this particular middle body was about 102 cm ⁻¹ (260 inches ⁻¹ ). Thus, the ratio is greater for the middle body than for the minimal body.

  [0077] FIG. 16 is a partially exploded view of an exemplary corneal graft storage and positioning device. The positioning device 310 generally comprises a handle assembly 312, which is configured to actuate or move the intermediate body, a support assembly 314 including a minimal body, and the support assembly 314 relative to the handle assembly 312. An actuator assembly 316. Due to the higher inlay affinity for the middle body, the inlay adheres to the middle body when the support assembly 314 is actuated.

  [0078] The actuator assembly 316 includes a push rod 320 coupled to the button 321 and a spring 322. The handle assembly 312 includes a handle 324 coupled to a distal portion 326 that includes a middle body. The distal end of spring 322 is secured within an 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. 17A-17C, the distal end of pushrod 320 has a hole 328 extending therethrough that is configured to receive dowel 318. As shown in FIG. 17A, when the push rod 320 is advanced distally within the handle assembly 312 and extends out of the distal end of the handle assembly 312, the dowel 318 is advanced through the hole 328. The dowel 318 prevents the push rod 320 from retracting proximally within the handle assembly 312, but the dowel 318 also places the support assembly 314 in place relative to the handle assembly 312 as shown in FIG. 17C. An engaging surface is provided to the base assembly 314 for securing. The apparatus also includes a rod 330 that helps to secure the support assembly 314 in place relative to the handle assembly 312 (see FIG. 17C), but when the actuator is actuated, the support assembly 314 is Allow rotation around the rod 330. The dowel 318 is also involved in the operation of the support assembly. Actuation of the button 321 advances the push rod 320 and the associated dowel 318 distally within the handle assembly 312. This applies a force with the dowel 318 generally directed distally to the support assembly 314, causing the dowel 318 to push the support assembly 314 down. When this force is applied, the support assembly 314 begins to rotate around the rod 330 and the minimal body mesh 338 moves away from the middle mesh body 334. Further rotation of the support assembly 314 releases the support assembly 314 from the rod 330 and completely disconnects the support assembly 314 from the handle assembly 312. Once disconnected, the corneal implant remains attached to the intermediate body 334 and is ready for use, such as for delivery into or on corneal tissue. When the micromesh body is moved, the user can release the button 321 and the spring 322 returns the actuator 316 to the rest or non-actuated position relative to the handle assembly 312.

[0079] Incorporating the rod 330 prevents the support assembly 314 from rotating in one direction relative to the handle assembly 312 and applying torque.
[0080] FIG. 18 is a partially exploded view of the handle assembly 312 shown in FIG. 14 (actuator and base assembly not shown). The assembly 312 includes a handle 324, a distal tip portion 342, a dowel 318, an applicator base 336, and an applicator 334. The handle 324 is secured to the distal tip portion 342 and the distal end of the distal tip portion 342 is disposed within the bore of the applicator base 336. Applicator 334 is secured to applicator base 336. FIG. 19 is an assembly view of FIG.

  [0081] FIGS. 20A-20C illustrate exemplary dimensions of the applicator 334, including mesh dimensions, as described above. For example, the dimensions of the mesh that contribute to preferential attachment of the implant to the intermediate body over the minimal body are shown. FIG. 20A is a top view. FIG. 20B is a side view. FIG. 20C is a detailed view of part A of FIG. 2A.

  [0082] FIGS. 21A-21D show the support assembly 314 of FIG. 17 with a support base 340 secured to the graft support 338. FIG. Support base 340 and graft support 338 are secured together, similar to the applicator base and applicator described above. FIG. 21A is an exploded view, and FIG. 21B is an assembly view. FIG. 21C is a top view. FIG. 21D is a detail view C of FIG. 21A of the applicator 338 showing the recess 360 defined by the recess sidewall 356 and the recess base surface 358. The implant is configured and sized to be placed in the recess so as to be positioned between the minimal and intermediate meshes prior to removal of the minimal body.

  [0083] FIGS. 22A-22D show a support 338. FIG. FIG. 22B shows a cross section AA shown in FIG. 22A. 22C shows detail B of FIG. 22B and FIG. 22D shows detail C of FIG. 22A. A recess 360 is formed on the support 338. A mesh opening 364 is defined by the body 362 as shown in FIGS. 22B and 22C. The dimensions shown are exemplary and are not intended to be limiting. The mesh opening of the minimal body is larger than the mesh opening of the middle body, which is one factor that preferentially attaches the graft to the middle body in this particular embodiment.

  [0084] Generally, the recess in the micromesh body is sized to prevent force or a substantial amount of force from being applied to the corneal implant when positioned within the nest between the middle and microbody before use. Should be decided.

  [0085] The mesh openings and recesses may be created by any suitable technique such as chemical etching, laser cutting, micro water jet cutting, and the like. In some cases, chemical etching provides a cleaner section and requires less post-fabrication processing of the body. The mesh opening can be formed only from one side, or in some embodiments, half of the opening thickness is formed from one side and the other half of the opening is formed from the other side. In some embodiments, the recess is etched from one side and the mesh opening is formed on the other side. Any combination or variation of these techniques can be used. In some embodiments, the recess is formed by a plunge electric discharge machine (“EDM”).

  [0086] Generally, the net force acting on the corneal implant is greater from the medium mesh body than from the minimal mesh body. Water polarity is an important factor when corneal implants are formed from hydrophilic materials. This is because in such cases, the implant has water-like properties and itself behaves like water. The relative affinity may be changed by modifying the mesh dimensions, mesh configuration, mesh body, and other factors.

  [0087] As described above, the diameter of the minimal mesh body is larger than the diameter of the medium mesh body (both are shown as having a generally circular configuration). Since the diameter of the microbody is large, it acts like a shock absorber and protects the entire distal region of the device during storage and use prior to actuation of the actuator. In the particular example described above, the thickness of the minimal body is approximately twice the thickness of the middle body.

  [0088] The diameter of the middle body is larger than the recess, and the diameter of the minimal body is larger than the diameter of the middle body. In some embodiments, it may help the physician to visualize the pupil when positioning the corneal implant within the cornea. For example, this may be desirable when implanting an inlay having a diameter smaller than the diameter of the pupil, such as a corneal inlay of 1 to 3 mm diameter, into the cornea. For these applications, the intermediate mesh body can be sized so as not to interfere with the visualization of the pupil. That is, the intermediate mesh body portion is sized so that the physician can see the pupil while delivering the graft to the corneal tissue. Starting from this constraint, the size of other parts can then be determined.

  [0089] The use of "diameter" herein does not imply that the outer surface of the mesh body is a perfect circle or a shape that is considered a circle. The two mesh portions may be square or rectangular in which the width and length of the minimal mesh portion are larger than the width and length of the middle mesh portion.

  [0090] In the above embodiment, the affinity of the graft for the intermediate body has been described as being primarily due to the size and configuration of the intermediate mesh body for the minimal body, but for a given body There are many ways to establish and control graft affinity. In some embodiments, this can be accomplished using a medium body that is different from the minimal body. In some embodiments, one or more surfaces of the intermediate body and the minimal body can be finished. In order to control preferential adhesion, the finish may be different between the medium body and the minimal body. In some embodiments, the middle body has a better finish than the minimal body. In some embodiments, the minimal body has a matte finish.

  [0091] One or more parts of the devices described herein may be stainless steel or titanium. For example, applicator base 36 and applicator 34 may both be stainless steel, one may be titanium and the other stainless steel, or both may be titanium.

  [0092] Once the corneal implant is loaded into the device between the intermediate body and the minimal body, the implant can be used immediately, or the implant can be stored in the package for any suitable period of time. it can. When a corneal implant is made from a hydrogel material, it is important to maintain the implant in a fully hydrated state during storage.

[0093] The following disclosure describes packaging tools and assemblies configured to maintain a corneal implant in sufficient hydration during storage.
[0094] Embodiments herein describe both a medium body and a minimal body. However, in some embodiments, the device or method of use need not include a minimal body. Without a minimal body, the corneal implant is not positioned within the corneal nest defined by the medial and minimal bodies. Thus, there is no need to package the implant within the intermediate body. For example, the implant can be packaged in a separate package. In these embodiments, the intermediate body can retrieve or lift the corneal implant from its packaging using preferential attachment to the implant, as described above. This eliminates the restriction on how the corneal implant needs to be packaged. For example, the implant can be stored in a vial suspended in a storage medium. When the graft is ready to be positioned on the corneal tissue, the intermediate body that can be connected to the handle is positioned adjacent to the graft in the storage medium, such as by scooping the corneal graft to a position adjacent to the opening. Is done. Due to its preferential attachment adaptation, the corneal graft preferentially attaches to the intermediate body. Once the graft is attached to the medial body, it can be placed on the cornea as described above by relying on the adaptation of the medial body to allow the graft to adhere preferentially to corneal tissue rather than the medial body. Ready to be burned.

  [0095] FIGS. 23A-28E are configured to be used for storing (eg, packaging) an ophthalmic lens, such as a corneal implant (eg, a corneal inlay), with a portion of the lens in the eye (eg, 1 shows an exemplary storage device that is also used for insertion or positioning on the corneal floor). The apparatus of FIGS. 23A to 28E includes a middle body (as an example, a fine mesh) and a minimal body (as an example, a coarse mesh) similar to the above-described embodiment, but the storage and insertion device is the above-described embodiment. Has different points.

  [0096] FIGS. 23A and 23B are an exploded view and an assembled view of the storage device 400, respectively. The assembled storage device 400 shown in FIG. 23B can be stored for any amount of time (eg, in a package). The storage device 400 includes a base housing 500, a lens applicator 900, and a clip 600. The lens applicator 900 includes a lens applicator member 800 (in this example, a fine mesh that is an example of a middle body). The base housing 500 includes a lens support member 700 (in this example, a coarse mesh which is an example of a minimal main body). Although not shown, when the cartridge is assembled as shown in FIG. 23B, an ophthalmic lens, such as any of the corneal inlays described herein, is secured between the lens applicator member and the lens support member. A “base housing” may also be referred to herein simply as a “base”, which is intended to be considered a “base housing”.

  [0097] FIG. 23C is a perspective bottom view of lens applicator 900 secured to lens applicator member 800. FIG. In this embodiment, the lens applicator member 800 has a base having a plurality of apertures (two shown) each configured to receive an extension at the base of the lens applicator member 900 to add stability. Is provided. In this embodiment, the lens applicator member 800 is heat staken on the foot 904 of the lens applicator described below.

  [0098] FIG. 23D shows the lens support 700 configured to be secured to the base 500. FIG. To secure the part, the lens support member 700 is first positioned within the receiving area of the base 500 and then rotated to “lock” the lens support within the base 500. The lens support member 700 ′ is shown in a fixed position within the base 500. The lens support member 700 includes a plurality of extensions 701 configured to be received by the base receiving region and is configured to engage the locking element of the base 500 when the lens support is rotated. The extension 701 may vary in size and configuration to facilitate a specific orientation of the lens support member 700 relative to the base 500.

  [0099] Storage device 400 also includes a clip 600 configured to stably interact with base 500 and lens applicator 900 to provide stability between lens applicator 900 and base 500 ( This will be explained in more detail below).

  [0100] Although not shown in FIGS. 23A-23D, similar to the previously described embodiments, the lens applicator member and the lens support member are configured to secure a corneal implant therebetween. One difference in this embodiment is that there is no dedicated actuator that separates the two members. The lens support member 700 is fixed to the base 500 and the lens applicator 900 is detached from the base 500 when implanting the corneal implant, so the inlay attaches to the lens applicator member 800 for preferential attachment as described above. Will remain.

  [0101] One advantage of the base 500 and clip 600 is that they both provide stability to the lens applicator 900 and lock the lens applicator 900 in place during storage. The base and lens applicator configuration prevents the lens applicator from rotating relative to the base, the clip is stably aligned with the base and lens applicator, and the lens applicator is axial with respect to the base. It is configured to prevent movement (ie up and down). The lens applicator is stabilized in both rotational and axial directions. This stabilizes the lens within the storage assembly and prevents the lens from escaping between the lens support member and the lens applicator member. Stable, stable, and fixed, as used herein, does not necessarily exclude any relative movement, but simply that any movement is very minimal and unimportant.

  [0102] FIGS. 24A-24D show various views of the base 500. FIG. FIG. 24A is a perspective view of the base 500 and shows a lens support member receiving area 502 configured to receive and stabilize the lens support member 700. Base 500 also includes a lens applicator guide 504 configured to provide rotational stability to the lens applicator. In the present embodiment, the guide 504 has a plurality of surfaces arranged with respect to each other, so that the lens applicator can be advanced into the base 500 and can be rotationally stabilized with respect to the base 500. In this embodiment, the guide 504 has five surfaces that are configured to receive and rotationally lock the hexagonal outer surface of the lens applicator 900 (described in more detail below). FIG. 24B is a top view of base 500 showing the configuration of guide 504 and lens support member receiving area 502. FIG. 24C is a front view of the base 500. FIG. 24D shows the cross section AA shown in FIG. 24C. The plane of the lens support member receiving area is at a non-orthogonal angle with respect to the longitudinal axis of the guide 504 (ie, up and down in FIG. 24C).

  [0103] FIGS. 25A-25D show different views and cross sections of an exemplary lens support member 700. FIG. FIG. 25A shows a perspective view of the lens support member 700 showing the extension 701, the inlay recess 702, and the inlay enclosure 703. The inlay enclosure 703 is circular and defines a recess 702. The enclosure 703 is in contrast to the partial enclosure of the concave portion of the lens support member shown in FIG. 11A. FIG. 25B is a top view of the lens support member 700 showing the recess 702 defined by the enclosure 703. FIG. 25C shows a cross section AA of FIG. 25B. FIG. 25D shows detail B of FIG. 25B, highlighting the recess 702, enclosure 703, and aperture of the lens support member.

  [0104] FIGS. 26A-26D show a lens applicator member 800 comprising an applicator portion 803 and a support portion 804, the support portion comprising a plurality of apertures 801,802. The applicator portion 803 comprises a plurality of generally hexagonal apertures as generally described above. Exemplary dimensions, configurations, and relative positions of a plurality of hexagonal apertures are shown. As described herein, the support 804 includes apertures 801, 802 that are fixed to the lens applicator 900 and configured to receive an extension of the lens applicator 900 to add stability. FIG. 26A shows a perspective view of the lens applicator member 800. FIG. 26B is a top view of the lens applicator member 800. 26C is a side view and FIG. 26D is Detail A of FIG. 26B.

  [0105] In this embodiment, the lens support member and the lens applicator member define planes that are at slightly different angles with respect to each other when in the storage position as shown in FIG. 23B. This helps maintain the lens support member and the lens applicator member together and keeps the lens fixed between the two members. If the members are placed at the same angle and there is a small gap between the two members due to tolerances, the lens may fall. However, in other embodiments, the two members may be substantially parallel.

  [0106] The relative affinity of the lens applicator member (eg, fine mesh or intermediate body) and lens support member (eg, coarse mesh or minimal body) described above also applies to this embodiment.

  [0107] FIGS. 27A-27D illustrate an exemplary clip 600 configured to be stably aligned with the base 500 and the lens applicator 900. FIG. When this disclosure refers to two parts that are stably aligned, the two parts have a joining or mating structure function, and movement in at least one direction by one of the parts is a joining or mating function. Mention more resistance. The two flat surfaces are not considered bonding functions. Any suitable known joining structure may be used to stably align the two parts. When the two parts are stably aligned, relative movement in at least one direction can occur. For example, when this disclosure describes a clip that is configured to be stably aligned with a base, it will generally refer to the clip and the base having a joining or mating structure function, which function when joined. Resists movement of the clip in at least one direction, but may allow movement of the clip in another direction. Also, for example, the lens applicator and the base guide are configured to be stably aligned within each other. In this embodiment, the clip 600 is configured to stably align with the base 500 in that it includes a wing 602 configured to advance into a guide 506 (see FIG. 24A) of the base 500. . As the wing 602 advances into the guide 506, the upward movement of the wing 602 relative to the guide 506 is resisted (by the guide) and the wing 602 can still be removed from the guide 506 by pulling the clip 600. 27A is a perspective view of the clip 600, FIG. 27B is a top view of the clip 600, FIG. 27C is a front view of the clip 600, and FIG. 27D shows a cross section AA of FIG. 27B. Clip 600 also includes an extension 604 that is configured to be stably aligned with the guide of lens applicator 900 to provide axial stability (ie, up and down), as will be described in more detail below.

  [0108] FIGS. 28A-28E illustrate an exemplary lens applicator 900 that omits the lens applicator member 800 for clarity. The lens applicator 900 includes a foot 904 to which the base of the lens applicator member 800 is fixed, and a shaft 902 configured to advance into the guide 504 of the base 500 and stably align with the guide 504. . The lens applicator 900 also includes a guide 912 configured to receive the extension 605 (see FIGS. 27A and 27B) of the clip 600 to add stability. The lens applicator 900 also includes a locking element 910 configured to engage and secure a corresponding locking element of the handle, which will be described below and is configured to join the lens applicator 900. Is done. 28A is a perspective view of the lens applicator 900, FIG. 28B is a front view, FIG. 28C is a top view, FIG. 28D shows a cross-section AA of FIG. 28B, and FIG. 28E is a perspective view shown in FIG. BB.

  [0109] As previously described, the shaft portion 902 is configured to advance into the guide 504 at the base and is further configured to be rotationally stable within the guide 504. In the present embodiment, the shaft portion 902 has a hexagonal configuration, and five of the six surfaces are configured to be fixed within the five surfaces of the guide 504. The extension 604 of the clip 600 advances into the lens applicator guide 912 to provide axial (ie, up and down) stability to the lens applicator, but the configuration of the shaft portion 902 and guide 504 is rotational. Provides stability to the lens applicator.

  [0110] FIGS. 29A-29G are configured to be secured to the lens applicator 900 and used to position the corneal implant on the corneal tissue after the lens applicator has been removed from the storage device platform. An exemplary handle 1000 is shown. 29A is a perspective view, FIG. 29B is a side view, and FIG. 29C is an end view. FIG. 29D shows a cross section AA shown in FIG. 29C. FIG. 29E is a detailed view C of FIG. 29D.

  [0111] The shaft portion 1002 of the handle may be configured in any number of ways. The distal end 1004 is configured to be secured to the shaft portion of the lens applicator 900. In this embodiment, the distal end 1004 has an opening 1006 at the distal end that extends proximally within the end 1004 (see FIG. 29F). Opening 1006 is configured and sized so that end 1004 can be advanced onto the lens applicator shaft. FIG. 30 shows a lens applicator shaft 902 disposed within the handle end 1006.

  [0112] It is important that the handle and the lens applicator must not be separated after the user attempts to attach the handle to the lens applicator. If the lens applicator is separated from the handle, the lens applicator (to which the lens is attached) may fall to the floor and the lens may be lost. Therefore, it is very important that when the user attaches the handle, the handle and the lens applicator remain together and do not fall apart. One problem with having the aperture 1006 and lens applicator shaft 902 in the same configuration is that their size tolerances are very small and can be more difficult to manufacture. If two parts have the same outer surface configuration (eg, two circular cross-sectional shapes), the two parts are likely to fall apart. In this embodiment, the lens applicator shaft 902 has a configuration different from the configuration of the opening 1006 in order to ensure that the lens applicator and the handle do not fall apart. Specifically, the lens applicator shaft 902 has a hexagonal configuration and the opening 1006 is circular (see FIG. 29C). When the handle is pushed down onto the lens applicator, six points on the lens applicator shaft are tightly fitted into the round holes in the opening, securing the two parts together. The lens applicator shaft is slightly larger than the size of the round opening in the handle, providing a tighter fit and preventing rotation of the two parts relative to each other. The six points are slightly deformed by the large lens applicator shaft, creating enough friction to keep the lens applicator in place. Thus, the relative configuration helps to ensure that the handle does not disengage from the lens applicator during use. One further advantage of this design is that the holes and shaft can be oriented to any degree relative to each other and can function as designed. Thus, the user need not verify that the handle is oriented in a particular manner relative to the lens applicator before securing the handle and the lens applicator together.

  [0113] In this embodiment, a lens applicator shaft (sometimes referred to herein as a "pin") is configured to join a circumferential ridge 1008 (see FIG. 29F) inside the handle opening. An undercut 910 (see FIG. 28B) is provided. The relative configuration of the ridge 1008 and the undercut 910 provides additional locking mechanisms and audible and tactile “clicks” to allow the user to know that the handle and lens applicator have been assembled.

  [0114] As previously described, the handle and lens applicator design provides anti-rotation of the two shafts relative to each other, providing feedback to the user to know that the part has been fully assembled.

  [0115] In this embodiment, the lens applicator shaft is hexagonal, but other shapes such as triangles, squares, octagons, etc. may be used as well to provide anti-rotation benefits. In addition, in other embodiments, other types of undercuts may be used on the lens applicator shaft, such as a round profile rather than a tilted profile.

  [0116] When in use, when the handle is secured to the lens applicator, an optional step is performed to help the corneal implant move toward or adhere to the lens applicator member be able to. When the clip is removed and the top of the lens applicator member is exposed, the absorbent material is placed on top of the aperture of the lens applicator member and directs the fluid and corneal implant toward the absorbent material and thus the lens applicator member. Pull towards the aperture. This can help to ensure that the corneal implant adheres to the lens applicator member when the handle and lens applicator member are lifted from the lens support member and base.

  [0117] One aspect of the disclosure is a package configured to maintain at least two of the stably aligned storage assembly parts in a fixed relationship, while these parts are stored in the package, They are not separated from each other. As mentioned above, the two parts are stably aligned but can move relative to each other. FIG. 31 shows an exemplary package 1100 comprising a housing 1102 and a lid (not shown). In this embodiment, the housing 1102 is a glass vial. The package also includes a lid configured to be secured to the top of the housing 1102, providing a fluid tight seal between the lid and the housing. The housing 1102 has an internal chamber 1104 that defines a holding space 1106. The storage assembly is placed in the holding space 1106 for packaging and the holding space is filled with fluid to keep the lens in a hydrated state.

  [0118] FIG. 32 is a top view of the storage device (base, lens applicator, and clip) after assembly and placement in the holding space 1106 of the housing 1102 shown in FIG. As mentioned above, since a lens such as a hydrophilic inlay is positioned and secured between the base and the lens applicator, the lens applicator must not be able to escape axially upward from the base during storage. Otherwise, the lens may be lost. As previously described, the clip is stably aligned with both the base and the lens applicator to provide the lens applicator with axial stability relative to the base. However, when the storage device is in the package, the clip must remain in stable alignment with the base and lens applicator to ensure that the base and lens applicator are not pulled apart. As the clip wings and extensions exit the corresponding joints of the base and lens applicator, the lens applicator moves axially relative to the base, possibly losing the lens. In this embodiment, as shown in FIG. 32, the housing 1102 (and particularly the internal chamber 1104), the clip 600, the base 500, and the lens applicator 900 are assembled into the housing 1102 with the storage device assembled as shown in FIG. Once positioned, the clip 600 is configured and sized to be maintained in stable alignment with both the base 500 and the lens applicator 900. Thus, the packaging maintains its role as a packaging for the storage device and a stable alignment between the clip and both the base and the lens applicator so that the lens applicator and the base are not pulled apart during storage. To play a role. If the housing, clip, base, and lens applicator are not sized and configured in this way, the clip may be pulled away from the base and lens applicator, so the lens applicator will slide out of the base and the lens will be stored May be lost in solution.

  [0119] The base 500 is also sized and configured to fit into the internal chamber 1104 so that it does not move significantly relative to the internal chamber 1104. This helps prevent the base and hence the lens from bumping or rattling when in the internal chamber, thus preventing damage and allowing the lens to escape between the base and the lens applicator Can be reduced. The internal chamber may be circular in cross section. In practice, however, the assembly can rotate within the internal chamber, but the clip is in stable alignment with the base and lens applicator in that situation.

  [0120] The packaging and assembly of FIGS. 31 and 32 is a packaging device for stabilizing an ophthalmic lens storage device comprising a package housing defining a receiving space and an ophthalmic lens storage device, wherein The lens storage device is stable with the base, the base and the lens applicator configured to secure the ophthalmic lens between the base and the lens applicator, and the lens base and the lens applicator. And a stabilizing member configured to provide stability to the lens applicator to the lens applicator, wherein the receiving space is configured to receive the storage assembly therein, the receiving space, the base, and the stabilizing member being In an example of a packaging device configured and sized to maintain a stable alignment between the stabilizing member, the base and the lens applicator That. The embodiment of FIGS. 31 and 32 also illustrates a method of packaging the lens storage assembly.

  [0121] FIGS. 23A-28E show parts of an assembly that can be stored for any period of time, such as for packaging. When transplanting a corneal implant, the packaging (eg, vial) is opened to access the storage device. Thereafter, the handle 1000 (or other user interface) is pushed down onto the shaft portion 902 of the lens applicator 900 and the handle 1000 is used to remove the storage device from the package. Thereafter, the clip 600 is removed from the base 500. Thereafter, the handle 1000 is grasped and moved upward (in the axial direction) relative to the base 500 to attach the corneal implant to the lens applicator member rather than the lens support member due to the preferential attachment described above. The corneal implant attached to the lens applicator member is then ready to be positioned on the tissue (eg, corneal bed). As described herein, a corneal implant can be positioned on a corneal bed created by lifting a corneal valve or creating a corneal pocket. The storage device and packaging provide a very easy procedure to make the corneal implant ready for delivery. The user simply removes the storage device from the packaging housing, removes the clip, attaches the handle to the lens applicator, pulls the lens applicator upward, and the lens is ready for implantation into the eye.

  [0122] All dimensions shown and described herein are exemplary only.

Claims (45)

A lens applicator comprising a lens applicator member configured to position an ophthalmic lens on tissue;
A base housing comprising a lens applicator guide and a lens support member, wherein the lens applicator guide is configured to receive the lens applicator and to be stably aligned with the lens applicator; The lens applicator member and the lens support member are disposed between the lens applicator member and the lens support member when the lens applicator is positioned in the lens applicator guide. An ophthalmic lens storage device configured to be secured to a lens.   The storage device of claim 1, wherein the lens applicator guide has a cross-sectional shape that is at least partially complementary to a cross-sectional shape of a lens applicator shaft.   The storage device according to claim 2, wherein a cross-sectional shape of the lens applicator guide is a partial hexagon, and a cross-sectional shape of the lens applicator shaft is a hexagon.   The cross-sectional shape of the lens applicator shaft is polygonal, and the cross-sectional shape of the lens applicator guide is at least partially polygonal and has fewer sides than the polygonal shape of the lens applicator shaft. The storage device described in 1.   The storage device of claim 1, wherein the lens applicator guide is configured to provide rotational stability about a longitudinal axis of a lens applicator shaft to the lens applicator therein.   The storage device of claim 5, wherein a lens applicator guide is configured to allow axial movement by the lens applicator within the lens applicator guide.   The clip of claim 1, further comprising a clip configured to be stably aligned with the base housing and the lens applicator, wherein the clip provides the lens applicator with additional stability relative to the base housing. The storage device described in 1.   The clip is configured to be stably aligned with the base housing and the lens applicator so that the clip provides axial stability to the lens applicator relative to the base housing. 8. The storage device according to 7.   The clip is configured to be stably aligned with the base housing and the lens applicator so that axial movement between the clip and both the base housing and the lens applicator resists stable alignment. A storage applicator according to claim 1, adapted to receive.   The storage device according to claim 1, wherein the lens applicator includes a shaft portion and an applicator member extending at a non-orthogonal angle with respect to the shaft portion.   The storage device of claim 1, comprising an applicator member disposed at an angle relative to a lens support member of the base housing when the lens applicator is advanced into the lens applicator guide.   The storage device of claim 1, wherein the lens support member is releasably secured to the base housing.   The storage device of claim 1, wherein the lens support member comprises a lens enclosure configured to provide radial stability to the lens.   The storage device of claim 1, further comprising a handle configured to be secured to the lens applicator.   The lens applicator includes a shaft having a surface configured to be aligned with a handle surface to secure the handle to the lens applicator, the shaft surface having a cross-sectional shape different from the cross-sectional shape of the handle surface. The storage device according to claim 14.   The storage device according to claim 15, wherein the shaft has an outer surface having a cross-sectional shape different from a cross-sectional shape of an inner surface of the handle.   The storage device according to claim 16, wherein a cross-sectional shape of the inner surface of the handle is curved.   The storage device according to claim 16, wherein a cross-sectional shape of the inner surface of the handle is circular.   The storage device according to claim 16, wherein the outer surface of the shaft is polygonal.   The storage device of claim 19, wherein the shaft outer surface is hexagonal.   The storage device according to claim 15, wherein one of the shaft cross section and the handle cross section is curved and the other is a polygon.   The storage device according to claim 21, wherein one of the shaft cross section and the handle cross section is circular and the other is hexagonal.   The storage device of claim 15, wherein the interference fit is produced by different shapes.   The storage device of claim 15, wherein the shaft surface is slightly larger than the handle surface.   The storage device of claim 15, wherein the two shapes are configured to allow arbitrary rotational orientation of the handle relative to the shaft prior to alignment and to provide rotational stability when aligned.   15. The storage of claim 14, wherein the lens applicator and the handle comprise each of a first locking element and a second locking element configured to maintain the lens applicator and the handle in a locked position. apparatus.   A lens applicator and a handle, the lens applicator having a shaft outer surface configured to align with the handle inner surface to secure the shaft to the handle, the shaft outer surface being different from a cross-sectional shape of the handle inner surface An ophthalmic lens insertion device having a cross-sectional shape.   The insertion device according to claim 27, wherein a cross-sectional shape of the inner surface of the handle is curved.   The insertion device according to claim 28, wherein a cross-sectional shape of the inner surface of the handle is circular.   The insertion device according to claim 27, wherein a cross-sectional shape of the outer surface of the shaft is a polygon.   The insertion device according to claim 30, wherein a cross-sectional shape of the outer surface of the shaft is a hexagon.   The insertion device according to claim 27, wherein one of the cross section of the outer surface of the shaft and the cross section of the inner surface of the handle is curved, and the other is a polygon.   The insertion device according to claim 32, wherein one of a cross section of the outer surface of the shaft and a cross section of the inner surface of the handle is circular and the other is a hexagon.   34. The insertion device of claim 33, wherein the shaft outer surface is hexagonal and the handle inner surface is circular.   28. The insertion device of claim 27, wherein the shaft is secured to the handle by producing an interference fit with different shapes.   28. The insertion device of claim 27, wherein the shaft outer surface is slightly larger than the handle inner surface.   28. The insertion device of claim 27, wherein the two shapes are configured to allow any rotational orientation of the handle relative to the shaft prior to alignment and to provide rotational stability when aligned.   28. The insertion device of claim 27, wherein the shaft and the handle comprise each of a first locking element and a second locking element configured to maintain the lens applicator and handle in a locked position. A package housing defining a receiving space;
A packaging device for stabilizing an ophthalmic lens storage device, comprising an ophthalmic lens storage device,
The ophthalmic lens storage device comprises:
A base housing;
A lens applicator configured to stably align with the base housing and secure an ophthalmic lens between the base housing and the lens applicator;
A stabilizing member configured to stably align with the base housing and the lens applicator to provide the lens applicator with stability relative to the base housing;
The receiving space is configured to receive the storage device therein, and the receiving space, the base housing, and the stabilizing member are stable between the stabilizing member, the base housing, and the lens applicator. Packaging device configured and sized to maintain consistent alignment.   40. The packaging device of claim 39, wherein the packaging housing is a glass vial.   40. The packaging device of claim 39, further comprising a storage fluid in the housing and a lid configured to create a fluid tight seal with the housing.   When the clip is in the housing, the receiving space is sized and configured so that it cannot move relative to the base housing sufficiently to disengage the base housing and the respective joints on the clip. The packaging device according to claim 39.   When the clip is in the housing, the receiving space is sized and configured so that it cannot move relative to the base housing enough to disengage the lens applicator and the respective joint on the clip. The packaging device according to claim 39.   When the clip is in the housing, the lens applicator and the respective joints on the clip are disengaged, or the base housing and the joints on the clip are sufficiently disengaged from the base. 40. The packaging device of claim 39, wherein the receiving space is sized and configured so that it cannot move. Base housing,
A lens applicator that is stably aligned with the base housing and secures an ophthalmic lens between the base housing and the lens applicator, and is stably aligned with the base housing and the lens applicator; Providing an ophthalmic lens storage device comprising a stabilizing member that provides the lens applicator with stability relative to a base housing;
Placing the storage device in a packaging housing such that the housing maintains a stable alignment between the stabilizing member and both the base housing and the lens applicator. A method of packaging storage equipment.