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 that need to be protected from damage or loss during storage and/or when preparing them for positioning onto corneal tissue. A need still exists for safe and efficient storage and/or positioning devices and methods that will prevent damage to, or loss of, the corneal implant and that can make it easy to prepare the corneal implant for use. The disclosure herein addresses one or more of these concerns.
SUMMARY OF THE DISCLOSURE
One aspect of the disclosure is an ophthalmic lens storage apparatus, comprising a lens applicator comprising a lens applicator member adapted to position the ophthalmic lens onto tissue; and a base comprising a lens applicator guide and a lens support member, the lens applicator guide configured to receive and stably interface with the lens applicator, wherein the lens applicator member and the lens support member are configured such that, when the lens applicator is positioned in the lens applicator guide, the ophthalmic lens is secured between the lens applicator member and the lens support member.
In some embodiments the lens applicator guide has a sectional shape, such as a partial hexagon, that is at least partially complimentary to a sectional shape of a lens applicator shaft, such as a hexagon. The lens applicator shaft sectional shape can be a polygon, and the lens applicator guide sectional shape can be at least partially polygonal, with fewer sides than the lens applicator shaft polygon shape.
In some embodiments the lens applicator guide is configured to provide rotational stability to the lens applicator therein, about a longitudinal axis of a lens applicator shaft. The lens applicator guide can be configured to allow axial movement by the lens applicator within the lens applicator guide.
In some embodiments the apparatus further comprises a clip configured to stably interface with the base and the lens applicator such that the clip provides further stability to the lens applicator relative to the base. The clip can be configured to stably interface with the base and the lens applicator such that the clip provides axial stability to the lens applicator relative to the base.
In some embodiments the clip is configured to stably interface with the base and the lens applicator such that axial movement between the clip and both the base and lens applicator is resisted by the stable interface.
In some embodiments the lens applicator includes a shaft portion and an applicator member extending at a non-orthogonal angle relative to the shaft portion.
In some embodiments the lens applicator, when advanced into the lens applicator guide, comprises an applicator member disposed at an angle relative to a lens support member of the base.
In some embodiments the lens support member is releasably secured to the base.
In some embodiments the lens support member comprises a lens fence configured to provide radial stability to the lens.
In some embodiments the apparatus further comprises a handle configured to be secured to the lens applicator. The lens applicator can comprise a shaft with a surface configured to interface with a handle surface to secure the handle to the lens applicator, the shaft surface having a sectional shape that is different than a sectional shape of the handle surface. The shaft can have an outer surface with a sectional shape that is different than a sectional shape of a handle inner surface. The sectional shape of the handle inner surface can be curvilinear, such as circular. The shaft outer surface can be polygonal, such as hexagonal. One of the sectional shaft surface and the sectional handle surface can be curvilinear and the other can be polygonal. One of the sectional shaft surface and the sectional handle surface can be circular and the other can be hexagonal. The different shapes can create an interference fit. The shaft surface can be slightly oversized relative to the handle surface. The two shapes can be configured to allow for any rotational orientation of the handle relative to the shaft prior to their interface and once they are interfaced to provide rotational stability. The lens applicator and the handle can include first and second locking elements, respectively, that are configured to maintain the lens applicator and the handle in a locked position.
One aspect of the disclosure is an ophthalmic lens insertion apparatus comprising a lens applicator and a handle, the lens applicator comprising a shaft outer surface configured to interface with a handle inner surface to secure the shaft to the handle, the shaft outer surface having a sectional shape that is different than a sectional shape of the handle inner surface.
In some embodiments the sectional shape of the handle inner surface is curvilinear, such as circular.
In some embodiments the shaft outer surface sectional shape is polygonal, such as hexagonal.
In some embodiments one of the sectional shaft outer surface and the sectional handle inner surface is curvilinear such as circular and the other is polygonal such as hexagonal.
In some embodiments the different shapes create an interference fit to secure the shaft to the handle.
In some embodiments the shaft outer surface is slightly oversized relative to the handle inner surface.
In some embodiments the two shapes are configured to allow for any rotational orientation of the handle relative to the shaft prior to their interface and once they are interfaced to provide rotational stability.
In some embodiments the shaft and the handle include first and second locking elements, respectively, that are configured to maintain the lens applicator and handle in a locked position.
One aspect of the disclosure is a packaging apparatus for stabilizing an ophthalmic lens storage apparatus, comprising a package housing defining a receiving space; and an ophthalmic lens storage apparatus comprising a base, a lens applicator configured to stably interface with the base and secure an ophthalmic lens between the base and the lens applicator, and a stabilizing member configured to stably interface with the lens base and the lens applicator to provide stability to the lens applicator relative to the lens base, wherein the receiving space is configured to receive the storage apparatus therein, and wherein the receiving space, base, and stabilizing member are configured and sized such that the receiving space maintains the stable interface between the stabilizing member and the base and the lens applicator.
In some embodiments the packaging housing is a glass vial.
In some embodiments it further comprises a storage fluid in the housing, and a lid configured to create a fluid tight seal with the housing.
In some embodiments the receiving space is sized and configured such that the clip, when in the housing, is not able to move enough relative to the base to allow respective mating parts on the base and clip to become unmated.
In some embodiments the receiving space is sized and configured such that the clip, when in the housing, is not able to move enough relative to the base to allow respective mating parts on the lens applicator and clip to become unmated.
In some embodiments the receiving space is sized and configured such that the clip, when in the housing, is not able to move enough relative to the base to allow respective mating parts on the lens applicator and clip to become unmated, or to allow respective mating parts on the base and the clip to become unmated.
One aspect of the disclosure is a method of packaging an ophthalmic lens storage apparatus, comprising providing an ophthalmic lens storage apparatus comprising a base, a lens applicator stably interfacing with the base and securing an ophthalmic lens between the base and the lens applicator, and a stabilizing member stably interfacing with the lens base and the lens applicator to provide stability to the lens applicator relative to the lens base; and placing the storage apparatus in a packaging housing such that the housing maintains the stable interface between the stabilizing member and both the base and the lens applicator.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates exemplary cohesive forces.
FIG. 2 illustrates exemplary adhesive forces.
FIG. 3 illustrates a liquid suspended within a loop.
FIGS. 4, 5, 6, 7, 8, 9, and 10 illustrate an exemplary corneal implant applicator apparatus.
FIGS. 11A, 11B, 11C, 11D, 12, 13, 14, and 15 illustrate exemplary moderate and minimal bodies.
FIGS. 16, 17A, 17B, 17C, 18, and 19 illustrate an exemplary corneal implant applicator apparatus.
FIGS. 20A, 20B, 20C, 21A, 21B, 21C, 21D, 22A, 22B, 22C, and 22D illustrate components of an exemplary corneal implant applicator apparatus.
FIGS. 23A and 23B show exploded and assembled views, respectively, of an exemplary storage apparatus.
FIG. 23C is a perspective bottom view of an exemplary lens applicator secured to an exemplary lens applicator member.
FIG. 23D illustrates how an exemplary lens support can be configured to be secured to a base housing.
FIGS. 24A, 24B, 24C, and 24D show various views of an exemplary base housing.
FIGS. 25A, 25B, 25C, and 25D illustrate different views and sections of an exemplary lens support member.
FIGS. 26A, 26B, 26C, and 26D illustrate an exemplary lens applicator member, which includes an applicator portion and a support portion.
FIGS. 27A, 27B, 27C, and 27D illustrate an exemplary clip 600.
FIGS. 28A, 28B, 28C, 28D, and 28E illustrate an exemplary lens applicator.
FIGS. 29A, 29B, 29C, 29D, and 29E illustrate an exemplary handle that is configured to be secured to an exemplary lens applicator and is used to position the corneal implant onto corneal tissue after the lens applicator has been removed from the rest of the storage apparatus.
FIG. 30 illustrates an exemplary lens applicator shaft disposed within an end portion of an exemplary handle.
FIG. 31 illustrates an exemplary packaging.
FIG. 32 is a top view showing a storage apparatus in an assembled state and after it has been placed into a holding space in packaging in FIG. 31.
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 any ophthalmic lens such as, for example without limitation, corneal onlays, corneal inlays, corneal replacements, and contact lenses.
The disclosure includes 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's surface. Surface tension is caused by the cohesive forces of a liquid's molecules. Cohesive forces are the attractive forces between two like molecules. As shown in FIG. 1, 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's molecules. These strong adhesive forces are the cause of an upward ‘bowing,’ called the meniscus (as shown in FIG. 2), in a liquid'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. 3, 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'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, 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'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's “affinity” for a fluid or an object with fluid-like properties (e.g., a hydrophilic corneal implant). As used herein, a body'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>moderate body>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. 4-11D 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. 4 and 5 (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. 4 and 5. 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. 4 and 5 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. 6 (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. 7 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. 7. 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. 8 illustrates a sectional side view of the distal portion of the device. FIG. 9 shows the sectional side view from FIG. 8 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. 10 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. 11A-11D illustrate an exemplary embodiment of minimal and moderate bodies, which can be incorporated into the assembly from FIGS. 4-10. 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. 11D). 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. 11B-11D) from being compressed between the minimal and moderate bodies while being shipped or stored (see FIG. 11D). 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. 11B-11D, 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. 11D). 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. 4-10, 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. 4-10.
In some exemplary embodiments of the systems shown herein (e.g., those in FIGS. 4-11D), 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'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. 4-11D), 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'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. 12-15 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. 12 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 mm2. The perimeter of the inlay that overlaps the minimal body is about 9 mm. FIG. 13 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 mm2.
FIG. 14 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 mm2. The perimeter of the inlay is about 26 mm. FIG. 15 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 mm2.
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. 12-15, 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 in2. 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 in2. 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. 16 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'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. 17A-17C, 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. 17A, 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. 17C. The device also includes rod 330, which helps secure support assembly 314 in place relative to handle assembly 312 (see FIG. 17C), 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 torquing.
FIG. 18 is a partial exploded view of handle assembly 312 shown in FIG. 14 (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. 19 shows the assembled view from FIG. 18.
FIGS. 20A-20C 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. 20A is a top view. FIG. 20B is a side view. FIG. 20C is a detailed view of section A from FIG. 2A.
FIGS. 21A-21D 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. 21A is an exploded view, while FIG. 21B is an assembled view. FIG. 21C is a top view. FIG. 21D is a detailed view C from FIG. 21A 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. 22A-22D illustrate views of the support 338. FIG. 22B illustrates section A-A shown in FIG. 22A. FIG. 22C shows detail B from FIG. 22B, and FIG. 22D shows detail C from FIG. 22A. Recess 360 is formed in a top portion of the support 338. Mesh apertures 364 are defined by body 362, illustrated in FIGS. 22B and 22C. 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'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'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.
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.
The following disclosure describes packaging tools and assemblies that are adapted to keep the corneal 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 corneal 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's adaptation to allow the implant to preferentially adhere to the corneal tissue rather than the moderate body.
FIGS. 23A-28E illustrate an exemplary storage apparatus that is adapted to be used to store (e.g., for packaging) an ophthalmic lens such as a corneal implant (e.g., a corneal inlay), part of which is also used to insert, or position, the lens onto the eye (e.g., a corneal bed). The apparatus in FIGS. 23A-28E includes a moderate body (an example of which is a fine mesh) and a minimal body (an example of which is a course mesh) similar to embodiments described above, but the storage and insertion device include differences to the embodiments described above.
FIGS. 23A and 23B show exploded and assembled views, respectively, of storage apparatus 400. The assembled storage apparatus 400 shown in FIG. 23B can be stored for any length of time (e.g., in packaging). Storage apparatus 400 includes base housing 500, lens applicator 900, and clip 600. Lens applicator 900 includes lens applicator member 800 (in this example is a fine mesh, which is an example of a moderate body). Base housing 500 includes lens support member 700 (in this example is a course mesh, which is an example of a minimal 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 simply be referred to herein as a “base,” but it is intended to be considered a “base housing.”
FIG. 23C is a perspective bottom view of lens applicator 900 secured to lens applicator member 800. In this embodiment lens applicator member 800 includes a base portion with a plurality of apertures (two shown) that are each adapted to receive an extension at the base of lens applicator member 900 for added stability. In this embodiment lens applicator member 800 is heat staked to lens applicator foot 904, which is described below.
FIG. 23D illustrates how lens support 700 is configured to be secured to base 500. To secure the components, lens support member 700 is first positioned in a receiving area of base 500, then rotated to “lock” the lens support into base 500. Lens support member 700′ is shown in a secured position in base 500. Lens support member 700 includes a plurality of extensions 701 configured to be received by the base receiving area, and are adapted to engage locking elements on base 500 when the lens support is rotated. Extensions 701 can have varying sizes and configurations to facilitate a specific orientation of the lens support member 700 relative to base 500.
Storage apparatus 400 also includes clip 600, which is configured to stably interact with base 500 and lens applicator 900 to provide stability between lens applicator 900 and base 500 (described in more detail below).
Although not shown in FIGS. 23A-23D, the lens applicator member and the lens support member are configured to secure a corneal implant between them, similar to the embodiments described above. One difference in this embodiment is that there is not a dedicated actuator to separate the two members. Lens support member 700 is secured to base 500, so that when the corneal implant is to be implanted, lens applicator 900 is separated from base 500, and the inlay remains adhered to lens applicator member 800 due to the preferential adhesion described above.
One of the benefits of base 500 and clip 600 is that they together provide stability to lens applicator 900 and secure it in place during storage periods. The configurations of the base and lens applicator are such that the lens applicator is prevented from rotating relative to the base, and the clip is configured to stably interface with the base and lens applicator to prevent the lens applicator from moving axially (i.e., up and down) relative to the base. The lens applicator is stabilized both rotationally and axially. This stabilizes the lens within the storage assembly and prevents it from escaping from the between the lens support member and the lens applicator member. When used herein, stable, stabilize, and secure do not necessary preclude any relative movement, simply that any movements are so minimal as to be inconsequential.
FIGS. 24A-24D show various views of base 500. FIG. 24A is a perspective view of base 500 and shows the lens support member receiving area 502, which is configured to receive and stabilize lens support member 700. Base 500 also includes lens applicator guide 504, which is configured to provide rotational stability to the lens applicator. In this embodiment guide 504 has a plurality of surfaces disposed relative to each other to allow the lens applicator to be advanced into and rotationally stabilized relative to base 500. In this embodiment guide 504 includes five surfaces that are configured to receive and rotationally secure therein the hexagonally configured outer surfaces of lens applicator 900 (described in more detail below). FIG. 24B shows a top view of base 500, showing the configuration of guide 504 and lens support member receiving area 502. FIG. 24C shows a front view of base 500. FIG. 24D illustrates Section A-A shown in FIG. 24C. A lens support member receiving area plane is at a non-orthogonal angle relative to the longitudinal axis (i.e., up and down in FIG. 24C) guide 504.
FIGS. 25A-25D illustrate different views and sections of exemplary lens support member 700. FIG. 25A shows a perspective view of lens support member 700, showing extensions 701, inlay recess 702, and inlay fence 703. Inlay fence 703 is circular in shape and defines recess 702. Fence 703 is in contrast to the partial fence in the lens support member recess shown in FIG. 11A. FIG. 25B shows a top view of lens support member 700, showing recess 702 defined by fence 703. FIG. 25C shows Section A-A from FIG. 25B. FIG. 25D shows Detail B from FIG. 25B, highlighting recess 702, fence 703, and apertures in the lens support member.
FIGS. 26A-26D illustrate lens applicator member 800, which includes an applicator portion 803 and a support portion 804, wherein the support portion includes a plurality of apertures 801 and 802. Applicator portion 803 includes a plurality of generally hexagonally shaped apertures, which are generally described above. Exemplary dimensions, configurations, and relative position of the plurality of hexagonally shaped apertures are shown. Support portion 804 is secured to lens applicator 900 as described herein, and includes apertures 801 and 802 that are configured to receive extensions on lens applicator 900 for added stability. FIG. 26A shows a perspective view of lens applicator member 800. FIG. 26B shows a top view of lens applicator member 800. FIG. 26C is a side view, and FIG. 26D is Detail A from FIG. 26B.
In this embodiment the lens support member and the lens applicator member define planes that are at slightly different angles relative to one another when in their stored positions, such as is shown in FIG. 23B. This helps keep them together and keeps the lens secure between the two members. There is a chance that if the members are disposed at the same angle, and a small gap exists between the two due to tolerances, the lens could fall out. In other embodiments, however, the two members could be substantially parallel.
The relative affinities of the lens applicator member (e.g., fine mesh, or moderate body) and the lens support member (e.g., course mesh, or minimal body) as described above apply to this embodiment as well.
FIGS. 27A-27D illustrate exemplary clip 600, which is configured to stably interface with base 500 and lens applicator 900. When this disclosure refers to two components that stably interface, it refers to two components have mating, or fitted, structural features such that motion in at least one direction by one of the components is resisted due to the mating, or fitted, features. Two flat surfaces are not considered to be mating features. Any suitable known mating structures can be used to stably interface two components. When two parts are stably interfaced relative motion in at least one direction can occur. For example, when this disclosure describes a clip that is configured to stably interface with a base, it refers generally to the clip and the base as having mating, or fitted, structural features, that when mated, resist the clips movement in at least one direction, but can allow for the clips movement in another direction. Also for example, the lens applicator and the base guide are configured to stably interface within one another. In this embodiment clip is configured to stably interface with base 500 in that clip 600 includes wings 602 that are configured to be advanced into guides 506 in base 500 (see FIG. 24A). When wings 602 are advanced into guides 506, upward movement of wings 602 relative to guides 506 is resisted (by the guides), yet clip 600 can still be pulled to remove wings 602 from guides 506. FIG. 27A is a perspective view of clip 600, FIG. 27B is a top view of clip 600, FIG. 27C is a front view of clip 600, and FIG. 27D shows Section A-A from FIG. 27B. Clip 600 also includes extension 604 that is adapted to stably interface with a guide in lens applicator 900 to provide axial stability (i.e., up and down), which is described in more detail below.
FIGS. 28A-28E illustrate exemplary lens applicator 900 without lens applicator member 800 for clarity. Lens applicator 900 includes foot portion 904, to which the base portion of lens applicator member 800 is secured, and shaft portion 902, which is configured to be advanced into and stably interface with guide 504 in base 500. Lens applicator 900 also includes guide 912, which is configured to receive extension 605 on clip 600 (see FIGS. 27A and 27B) for added stability. Lens applicator 900 also includes lock element 910 that is adapted to engage with and secure to a corresponding locking element on the handle, which is described below, but which is configured to mate with lens applicator 900. FIG. 28A is a perspective view of lens applicator 900, FIG. 28B is a front view, FIG. 28C is a top view, FIG. 28D is Section A-A from FIG. 28B, and FIG. 28E is view B-B shown in FIG. 28D.
As described above, shaft portion 902 is configured to be advanced into guide 504 of base and is further configured to be rotationally stabilized therein. In this embodiment shaft portion 902 has a hexagonal configuration, and five of its six surfaces are configured to be secured within the five surfaces of guide 504. Extension 604 on clip 600 is advanced into guide 912 in the lens applicator, which provides axial (i.e., up and down) stability to the lens applicator, while the configurations of the shaft portion 902 and guide 504 provide rotational stability to the lens applicator.
FIGS. 29A-29G illustrate exemplary handle 1000 that is configured to be secured to lens applicator 900 and is used to position the corneal implant onto corneal tissue after the lens applicator has been removed from the rest of the storage apparatus. FIG. 29A shows a perspective view, FIG. 29B shows a side view, and FIG. 29C shows an end view. FIG. 29D shows Section A-A shown in FIG. 29C. FIG. 29E shows detail view C from FIG. 29D.
The shaft portion 1002 of handle can be configured in any number of ways. Distal end portion 1004 is configured to be secured to the shaft portion of lens applicator 900. In this embodiment distal end portion 1004 has opening 1006 at its distal end that extends proximally within end portion 1004 (see FIG. 29F). Opening 1006 is configured and sized so that end portion 1004 can be advanced over the lens applicator shaft. FIG. 30 illustrates the lens applicator shaft 902 disposed within the end portion 1006 of the handle.
It is important that after the user attempts to attach the handle to the lens applicator, the handle and lens applicator must not come apart. If the lens applicator separates from the handle, the lens applicator (to which the lens is adhered) could fall on the floor, the lens could be lost, etc. It is thus crucial that when a user attaches the handle, the handle and lens applicator stay together and do not come apart. One challenge in having the configuration of the opening 1006 and lens applicator shaft 902 the same is that the tolerances for the sizes of each are very small, possible making manufacturing more difficult. If the two components have the same outer surface configuration (e.g., two circular cross sectional shapes) it is easy for the two components to come apart. In this embodiment, to make sure the lens applicator and handle do not come apart, the lens applicator shaft 902 has a configuration that is different than the configuration of opening 1006. Specifically, lens applicator shaft 902 has a hexagonal configuration while the opening 1006 is circular (see FIG. 29C). When the handle is pushed down onto the lens applicator, the six points on the lens applicator shaft are interference-fit against the round hole of opening, securing the two components together. The shaft of the lens applicator is slightly oversized with respect to the size of the round opening of the handle to provide a more secure fit and provides for anti-rotation of the two components relative to the other. The six points deform slightly due to the oversized lens applicator shaft and create sufficient friction to keep the lens applicator in place. The relative configurations thus help ensure that the handle does not disengage from the lens applicator during use. One additional benefit of this design is that the hole and shaft can be oriented in any degree relative to each other and still function as designed. A user thus need not make sure the handle is oriented is a specific way relative to the lens applicator before securing the two together.
In this embodiment lens applicator shaft (which may be referred to herein as “pin”) includes an undercut 910 (see FIG. 28B) that is configured to mate with circumferential bump 1008 (see FIG. 29F) on the inside of handle opening. The relative configurations of bump 1008 and undercut 910 provides an additional locking mechanism as well as an audible and tactile “click,” allowing the user to know that the handle and lens applicator are assembled.
As set forth above, the design of the handle and lens applicator provides for anti-rotation of the two shafts relative to each other, and provides user feedback to know the components are fully assembled.
While in this embodiment the lens applicator shaft is hexagonally shaped, other shapes can be used as well and still provide the anti-rotation benefits, such as triangular, square, octagonal, etc. Additionally, in other embodiments other types of undercuts may be used on the lens applicator shaft, such as a rounded profile instead of a sloping profile.
In use, once the handle is secured to the lens applicator, an optional step can be performed to help the corneal implant move towards, or become adhered to, the lens applicator member. After the clip has been removed and the top of the lens applicator member is exposed, an absorbent material is placed on top of the lens applicator member apertures, pulling fluid and the corneal implant towards the absorbent material and thus towards the lens applicator member apertures. This can help ensure that that the corneal implant will adhere to the lens applicator member when the handle and lens applicator member are lifted away from the lens support member and base.
One aspect of the disclosure is packaging that is configured to keep at least two of the storage assembly components stably interfaced in a secure relationship so that they do not disassociate from one another while housed in the packaging. As set forth above, two components can be stably interfaced but still move relative to one another. FIG. 31 illustrates exemplary packaging 1100, which includes housing 1102 and a lid, not shown. In this embodiment housing 1102 is a glass vial. The packaging also includes a lid that is configured to be secured on top of housing 1102 and provides a fluid tight seal between the lid and the housing. Housing 1102 has an inner chamber 1104 that defines holding space 1106. The storage assembly is placed in holding space 1106 for packaging and the holding space is filled with fluid to keep the lens hydrated.
FIG. 32 is a top view showing the storage apparatus (base, lens applicator, and clip) in an assembled state and after it has been placed into holding space 1106 in the housing 1102 shown in FIG. 31. As described above, a lens such as a hydrophilic inlay is positioned and secured between the base and the lens applicator, and thus the lens applicator must not be allowed to come up axially out of the base during storage or the lens could be lost. The clip stably interfaces with both the base and the lens applicator as described above to provide axial stability to the lens applicator relative to the base. When the storage apparatus is in the packaging, however, the clip must remain stably interfaced with the base and lens applicator to make sure the base and lens applicator do not disassociate. If the clip wings and extension were to come out of the corresponding mating parts on the base and lens applicator, the lens applicator could move axially relative to the base, perhaps causing the lens to be lost. In this embodiment, as shown in FIG. 32, housing 1102 (and in particular inner chamber 1104), clip 600, base 500, and lens applicator 900 are configured and sized such that, when the storage apparatus is assembled and positioned within housing 1102 as shown in FIG. 32, clip 600 is maintained stably interfaced with both base 500 and lens applicator 900. The packaging thus serves a role as packaging for the storage apparatus, as well as a role in maintaining the stable interface between the clip and both the base and lens applicator so that the lens applicator and base don't disassociate during storage. If the housing, clip, base, and lens applicator were not sized and configured in this manner, the clip could disassociate from the base and lens applicator, and thus the lens applicator could come up out of the base, and the lens could be lost in the storage solution.
Base 500 is also sized and configured to fit within inner chamber 1104 such that it does not move around to any noticeable degree relative to inner chamber 1104. This helps prevent the base, and thus the lens, from jostling or rattling about when in the inner chamber, which can prevent damage and reduce the likelihood that the lens escapes from between the base and the lens applicator. The inner chamber may be circular in cross section, however, so in fact the assembly could rotate within the inner chamber, but the clip would still be stably interfaced with the base and lens applicator in that situation.
The packaging and assembly in FIGS. 31 and 32 are an example of a packaging apparatus for stabilizing an ophthalmic lens storage apparatus, comprising a package housing defining a receiving space; and an ophthalmic lens storage apparatus comprising a base, a lens applicator configured to stably interface with the base and secure an ophthalmic lens between the base and the lens applicator, and a stabilizing member configured to stably interface with the lens base and the lens applicator to provide stability to the lens applicator relative to the lens base, wherein the receiving space is configured to receive the storage assembly therein, and wherein the receiving space, base, and stabilizing member are configured and sized such that the receiving space maintains the stable interface between the stabilizing member and the base and the lens applicator. The embodiments in FIGS. 31 and 32 also illustrate a method of packaging a lens storage assembly.
FIGS. 23A-28E illustrate components of an assembly that can be stored for any period of time, such as for packaging. When the corneal implant is to be implanted, the packaging (e.g., a vial) is opened to access the storage apparatus. Handle 1000 (or other user interface) is then pushed down onto the shaft portion 902 of lens applicator 900, and handle 1000 is used to remove the storage apparatus from the packaging. Clip 600 is then removed from base 500. Handle 1000 is then grasped and moved up (axially) relative to base 500, and the corneal implant adheres to the lens applicator member rather than the lens support member for preferential adhesions reasons described above. The corneal implant, adhered to the lens applicator member, is then ready to be positioned on tissue (e.g., a corneal bed). As set forth herein, the corneal implant can be positioned onto a corneal bed created by lifting a corneal flap or by creating a corneal pocket. The storage apparatus and packaging create for a very easy procedure to get the corneal implant ready for delivery. The user can simply removes the storage apparatus from the packaging housing, remove the clip, attach the handle to the lens applicator, pull the lens applicator upward, and the lens is ready to be implanted in the eye.
All dimensions shown or described herein are merely exemplary.
Patent Application
20160051359
