Patent Application
20180325655
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.
Devices are known that are adapted to deliver, implant, and position ocular devices. Some devices, however, due to a variety of factors such as, without limitation, size and/or material, may benefit from simpler, more controlled, and/or more repeatable delivery processes. The disclosure herein provides devices and methods of use that can provide at least one of these advantages.
The disclosure includes a corneal device inserter, comprising an elongate member comprising a distal region, the distal region including a top portion, a bottom portion, and a corneal device receiving space, the corneal device receiving space defined by the top portion, the bottom portion, and a receiving space proximal end, the distal region further comprising a slot in fluid communication with the corneal device receiving space, the slot extending through at least one of the top portion and the bottom portion, the slot having a slot proximal end disposed at least as far proximally as the receiving space proximal end.
The slot proximal end may be disposed proximal to the receiving space proximal end.
The slot may not extend to a distal end of the distal region.
The distal region may comprise a second slot extending through at least one of the top portion and the bottom portion and in fluid communication with the corneal device receiving space, the second slot extending to the distal end of the distal region.
The slot may extend to a distal end of the distal region.
The slot may be symmetric about a distal region longitudinal axis that extends along the distal region and through the distal end.
The distal region may comprise first and second arms extending to a distal end of the elongate region. First and second arms may be defined by the slot. First and second arms may be defined by a second slot different than the slot.
The slot may extend through the top portion and the bottom portion.
The slot proximal end can be between 0 mm and 5 mm proximal to the receiving space proximal end.
The slot may have a length from 0.5 mm and 5 mm.
The slot may have a length from 2 mm to 4 mm.
The slot may have a greatest width dimension from 0.2 mm to 2 mm.
The slot may have a greatest width dimension from 0.2 mm to 0.7 mm.
A width of the slot relative to an overall width of a distal region of the inserter can be from 5% to 40%, optionally 10% to 30%, such as 20%.
A distance between a distal end of the slot and a proximal end of the receiving space can be from 0.1 mm to 0.5 mm, optionally 0.2 mm to 0.5 mm, optionally 0.3 mm to 0.45 mm.
A distance from a distal end of the inserter to a distal end of the slot can be from 0.5 mm to 2.5 mm, optionally 1 mm to 2.25 mm.
A length of a the slot can be from 0.2 mm to 1.8 mm, optionally 0.4 mm to 1.5 mm, optionally 0.5 mm to 1.3 mm.
A width of a the slot can be from 0.2 mm to 1.5 mm, optionally 0.2 mm to 1 mm, optionally 0.2 mm to 0.7 mm.
A length of a bridge between the slot and an optional distal slot may be 0.2 mm to 1.2 mm, such as 0.5 mm to 1 mm.
A height of the receiving space can be 0.075 mm to 0.225 mm, such as 0.1 mm to 0.2 mm.
A length of the receiving space can be from 1.25 mm to 3.5 mm, such as 1.5 mm to 3 mm.
The slot may have a uniform width over at least 70% of its length.
The slot may not have a uniform width over at least 70% of its length.
The inserter may have a corneal device positioned at least partially within the corneal device receiving space, optionally in a substantially non-deformed configuration. The corneal device may be selected from the group consisting of a corneal device with a meniscus configuration and a corneal device with a pinhole configuration. The corneal device may have a water content of at least 50%, such as at least 70%.
The distal region may not be adapted to be reconfigured.
The slot and receiving space may be sized and positioned such that a corneal device can be delivered into a corneal pocket from the receiving space by proximally withdrawing the inserter, and without an active fluid delivery step and without the need for a separate delivery tool, such as a Sinskey hook.
The receiving space may extend from a first side of the distal region to a second side of the distal region.
A surface of the slot, optionally a distal surface, may be beveled.
The slot may comprise a first section and a second section, the first section having a width different than a width of the second section.
The disclosure includes a method of releasing a conical device onto corneal tissue, comprising positioning an inserter adjacent corneal tissue, optionally within a corneal pocket, wherein the inserter comprises a distal region, the distal region including a top portion, a bottom portion, and a corneal device receiving space, the corneal device receiving space defined by the top portion, the bottom portion, and a receiving space proximal end, the distal region further comprising a slot in fluid communication with the corneal device receiving space, the slot extending through at least one of the top portion and the bottom portion; and proximally retracting the inserter to release a corneal device from the receiving space, wherein the method does not require an active fluid delivery step, the use of a plunging mechanism, or reconfiguring the distal region of the inserter to release the corneal device from the receiving space.
One technique for positioning a corneal device (e.g. a corneal inlay or onlay) within or on corneal tissue (which may be referred to herein as “insertion,” “delivering,” or “positioning”) is to position the device into a pocket previously created with, for example, a femtosecond laser. Corneal devices can also be positioned onto corneal tissue (e.g., stromal tissue) after a flap has been created and folded back to expose a corneal bed. Some pocket delivery methods can include one or more of active fluid delivery, a plunger mechanism being activated, or a distal end being reconfigured, to cause, or at least assist with, the deployment of the corneal device from an insertion device. It may be desirable to deliver corneal devices into pockets without one or more of these delivery assistance techniques. By not including one or more of these assistance techniques, the delivery process may be simplified, and, in the case of active fluid delivery, it may avoid delivering too much fluid into the cornea during the procedure. A merely exemplary aspect of some of the embodiments herein is that the inserters can be used to advance a corneal device into a corneal pocket and to deploy the device onto corneal tissue from the inserter device without one or more of these assistance techniques, and in some cases, without any of them. In some embodiments, however, the method may include optionally using a separate delivery tool such as Sinskey hook, examples of which are described herein.
One aspect of the delivery processes described herein is that it, when used with some hydrogel devices with relatively high water content (e.g., above 50%), it is preferred, and perhaps important, to have a “wet” environment into which to deliver the device. The methods of delivery herein thus preferably, depending on the corneal device, include steps to ensure sufficient hydration in the pocket. For example, irrigating the pocket with saline prior to insertion can help ensure sufficient irrigation in the pocket. Additionally, adding saline to the inserter itself prior to delivery can help ensure there is sufficient hydration. It is also preferred to remove any air bubbles that may be present.
The disclosure is related to the disclosure in U.S. Pat. No. 8,540,727, which is incorporated by reference herein. Suitable disclosure from U.S. Pat. No. 8,540,727 may be incorporated to the disclosure herein, such as materials used, alternative designs, and steps in methods of use.
The inserter 10 shown in
An unexpected result occurred during an initial testing of the inserter. After the inserter and device were advanced into the pocket, the inserter was then retracted back out of the pocket without applying any force on the cornea with a separate tool. The device unexpectedly deployed from the distal region of the inserter and stayed in the pocket in the desired location. The device was inserted into a pocket without any active fluid delivery, without the need of a separate tool to disassociate the device from the distal region of the inserter, without using a plunger mechanism (which can be common in intraocular lens delivery methods), and without reconfiguring the distal region of the inserter. The unexpected result was a dramatically simpler procedure and the device was delivered to the desired location within the pocket. An optional step is to purge the pocket with saline prior to insertion, which may help with the passive fluid assist.
It is of note that the tested corneal device was a corneal inlay with a diameter between 1.5 mm and 3 mm (in a testing it was about 2.0 mm), a central thickness between 20 microns and 50 microns (in a testing it was about 32 microns) and made of a hydrogel material with a relatively high water content of at least 50% (e.g., nearly 80% water). The pocket created in the test eye has dimensions in millimeters illustrated in
Without wishing to be bound by a particular theory, a possible contributing mechanism of action is that fluid and/or air may fill up (occupy) the empty slot space behind the device during the delivery process (e.g., as the inserter and device are advanced into the pocket). For example, fluid can be retained in the slot behind the device due to surface tension. As the inserter is retracted, the fluid and/or air that is within the slot may help prevent the device from being retained by the distal region. That is, the fluid and/or air may help disassociate the device from the distal region (deliver the device). This process may be considered a type of passive fluid assistance for insertion, but again the retraction step does not require an active fluid delivery towards the distal region of the inserter. The fluid in the slot can help immobilize the device as the inserter is retracted. The fluid in the slot may also help break the adhesion forces between the device and the inserter, which can cause the device to remain in place in the pocket as the inserter is retracted. Again, without wishing to be bound by theory, one possible contributing mechanism of action (although to date no evidence of this theory has been seen) is that the slot may also act as an air channel to allow fluid inside the corneal pocket to not be disturbed. The process may be analogized to putting a finger on the end of a straw in a cup of water and lifting the straw up. Keeping the finger on the end of the straw as the straw is lifted up (the fluid moves with the straw) can be compared to an inserter without an adequate slot. An inserter with an adequate slot, however (such as those described herein), can be compared to removing the finger from the end of straw and then lifting up on the straw (the fluid does not move with the straw). Again, without wishing to be bound by theory, a possible contributing mechanism of action is that the corneal tissue may conform at least somewhat to the slot cavity, and essentially “grab” the corneal device from the anterior and posterior sides during delivery. By “grabbing” the device, the corneal tissue can be thought of as holding onto the device and preventing it from being retracted with the inserter. Thinner (measured as height herein) distal regions may in some instances enhance the tissue's ability to “grab” onto and “hold” the device during the delivery process. Varying the thicknesses (height) of the inserter distal region may thus be beneficial in controlling one or more aspects of the deployment process. Some device designs/configurations/sizes may benefit from thinner or thicker distal regions, similar to varying the length and/or width of the inserter slot as described herein.
While one particular inserter design is shown in
In some embodiments slot 22 has a length of about 1.75 mm, about 2 mm, about 2.25 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.25 mm, about 3.5 mm, about 3.75 mm, about 4.0 mm, about 4.25 mm, about 4.5 mm, about 5.0 mm, about 5.25 mm, about 5.5 mm, about 5.75 mm, about 6.0 mm, about 6.25 mm, about 6.5 mm, about 6.75 mm, about 7.0 mm, or about 7.25 mm.
In some embodiments, however, the slot is longer than described above. For example, it may be beneficial to have a slot with a length greater than 7 mm. With any of the lower end of ranges herein, the upper end of the range can be 8 mm, 9 mm, 10 mm, or even greater. It is thus understood that a range that includes a lower end but not an upper end (e.g., at least 1 mm) is not indefinite in that the lower end of the range may be more important than the upper end, in which case not including an upper end of the range means that it can be any suitable upper limit, depending on the type of inserter being used.
The exemplary slot lengths listed above are different than, for example, the slot lengths shown in U.S. Pat. No. 8,540,727, co-owned by Applicant. For example, the slots in U.S. Pat. No. 8,540,727 are shown as much shorter than the device in the device holding space, and an exemplary diameter of the device therein is provided as about 1.5 mm. The slot lengths provided herein thus are described as being longer than the slot lengths in U.S. Pat. No. 8,540,727, and the reason for the increase in length is set forth herein. The slot lengths in U.S. Pat. No. 8,540,727 were apparently as long as needed to allow a tool such as Sinskey hook to simply apply some pressure onto the device through the top slot during delivery, and were not described as having lengths as set forth herein, nor were they described as providing the advantages of the slots and methods of delivery herein. The ranges and examples of slot lengths herein is thus intentionally described to differentiate over slot lengths such as in U.S. Pat. No. 8,540,727, and are not simply arbitrarily chosen lengths. The slot length can vary and still be used in the methods described herein. In one merely exemplary testing of the inserter tool and the device shown in
The slot length may vary depending on the size, configuration, and material of the corneal device that is being delivered.
As shown in the exemplary embodiment in
In exemplary embodiments the slot width (measured in the direction shown in
In some embodiments the width is about 0.25 mm, about 0.50 mm, about 0.75 mm, about 1.00 mm, about 1.25 mm, about 1.50 mm, or about 1.75 mm.
The width of a slot can vary and still allow the inserter to be used in the manner herein.
The width of a slot can be different than the ranges and examples provided herein, such as if the device size and/or configuration changes.
In alternative designs the width is not constant over substantially the entire length of the slot. For example, the distal region of a slot near the device may have a smaller width than the proximal region of the slot proximal to the device. Varying the slot width along its length may allow for more controlled and precise device delivery.
Any of the slot lengths herein (ranges or discrete numbers) can be used with any of the slot widths herein (ranges or discrete numbers).
In this embodiment the height “h” of device receiving space 36 is greater than the height of device 50. In this embodiment, the device is disposed in receiving space 36 and is in a substantially non-deformed, or non-stressed, configuration (i.e., the as-manufactured configuration). “Substantially,” as used in this manner indicates that there may be some incidental forces acting on the device, but none large enough to cause substantial deformation to the device. This can be beneficial in that stresses are not imposed on the device prior to insertion, which can prevent damage to the device.
In some embodiments the height of any of the receiving spaces herein (i.e., the distance between the extensions) is between 0.075 mm and 0.225 mm, between 0.075 mm and 0.200 mm, between 0.075 mm and 0.175 mm, between 0.075 mm and 0.150 mm, between 0.075 mm and 0.125 mm, between 0.075 mm and 0.100 mm, between 0.100 mm and 0.225 mm, between 0.100 mm and 0.200 mm, between 0.100 mm and 0.175 mm, between 0.100 mm and 0.150 mm, between 0.100 mm and 0.125 mm, between 0.125 mm and 0.225 mm, between 0.125 mm and 0.200 mm, between 0.125 mm and 0.175 mm, between 0.125 mm and 0.150 mm, between 0.150 mm and 0.225 mm, between 0.150 mm and 0.200 mm, between 0.150 mm and 0.175 mm, between 0.175 mm and 0.225 mm, between 0.175 mm and 0.200 mm, or between 0.200 mm and 0.225 mm. The height of the receiving space may vary depending on the size and/or configuration of the device being delivered, and is not limited the ranges herein.
In some embodiments the corneal device has a height (which may be different than the central thickness depending on the shape of the device) that is about between about 0.050 mm and 0.100 mm, such as about 0.075 mm.
In this embodiment the height of the receiving space is greater than the height of the corneal device, and is about two times the height.
In some embodiments the height of the distal region, or at least the distal end of the distal region, is between 0.25 mm and 1.25 mm, such as between 0.25 mm and 1.00 m, between 0.25 mm and 0.75 mm, such as about 0.50 mm.
The lengths, widths, and heights described herein may be combined in any desired manner.
In some embodiments in which a hydrogel corneal device is delivered with the inserter, the device may be retained at the distal region of the inserter at least partially by surface tension.
Possible contributing mechanisms of actions for delivering the device have been described herein. It may be possible to vary the length of the slot and still create enough space so that the device is properly deployed as the inserter is withdrawn. In some embodiments the slot may be just slightly longer than the length (or diameter) of the device when disposed in the receiving space. For example, the length of the slot behind the device may be smaller than shown in
The disclosure herein includes inserters in which a slot proximal end is disposed at least as far proximally as the device receiving space proximal end, and optionally further proximally than the device receiving space proximal end. For example, in the embodiment of the inserter shown in
In some embodiments the slot may not extend all the way through top surface 16 or bottom surface 18. For example, it may only be needed to have slot extend through one of the top and bottom surfaces.
It is also conceivable that in some embodiments, if the width of the slot is great enough, the slot may not need to extend back proximally as far, and may in fact have a proximal end that extends only as far as the device receiving space proximal end.
The disclosure herein also includes systems that include the inserter and the device positioned with the inserter. The device can be positioned at a distal region of the inserter (as shown in
It has also been shown that inserter 10 can be used to position the device 50 on a stromal bed after a flap has been created and lifted. Inserter 10 can thus be used to deliver an device after flap or pocket creation. When placed after a flap has been lifted, the inserter may be able to deliver the device without one or more of the assistance techniques described herein (e.g., active fluid delivery).
In some embodiments the length of the slot is greater than the length of the device receiving space. In some embodiments the slot length is at least 105% of the device receiving space length, at least 110% of the device receiving space length, at least 115% of the device receiving space length, at least 120% of the device receiving space length, at least 125% of the device receiving space length, at least 130% of the device receiving space length, at least 135% of the device receiving space length, at least 140% of the device receiving space length, at least 145% of the device receiving space length, at least 150% of the device receiving space length, at least 155% of the device receiving space length, at least 160% of the device receiving space length, at least 165% of the device receiving space length, at least 170% of the device receiving space length, at least 175% of the device receiving space length, at least 180% of the device receiving space length, at least 185% of the device receiving space length, at least 190% of the device receiving space length, at least 195% of the device receiving space length, or at least 200% of the device receiving space length.
In systems herein that include a corneal device within the receiving space of the inserter, the slot can extend at least as far proximally as the proximal end of the device when positioned in the device receiving space.
The inserters herein may be used with caps that cover the distal region, such as caps described in U.S. Pat. No. 8,540,727 and U.S. Pub. No. 2013/0023892.
In some embodiments, one or more inserter slots do not extend all of the way to the distal end of the inserter. For example,
The slot can have a length that is the same as or shorter than the device receiving space, and can be shorter than the device. For example, the inserter distal end may be configured so that a slot length is adequate to allow the device to be delivered into a pocket as described herein. A shorter slot may create more stability for the corneal device during, for example, packaging. The slot width can be varied along with slot length to create a slot space that allows the device to be properly delivered.
In some embodiments the slot length varies when comparing the slot length along the top and bottom surfaces. For example, the slot may extend to the end in one of the top and bottom surfaces, but not the other. For example, the slot may extend to the end of the top surface but not the end of the bottom surface. The slot may not even extend through any of one of the surfaces, but it may extend through at least a portion of the other surface.
In some embodiments herein, the extensions of each arm (when the embodiment includes them, unlike
The top and bottom surfaces and portions of the distal regions of the inserters can be flat as shown herein, or may have a slight curve to them (when viewed from the side). The top surface (such as top surface 16) of the top portion may be slightly beveled downward toward the distal end, which may make it easier to advance the inserter.
As used herein, “slot,” when used generally, may be interchanged with “space” or “volume” unless indicated otherwise. For example, slot 22 in
In some embodiments the inserter may have more than one inserter slot (as used herein “inserter slot” is different than a “corneal device receiving slot”). For example, the inserter can have a plurality of inserter slots across the width of the inserter. In these embodiments the distal region could be similar to two forks on top of each other. There can thus be more than two sets of “extensions” or prongs in the distal region.
In some embodiments the one or more slots are not symmetrical top-to-bottom. For example, one or more of the prongs (the extensions) can also be offset from one another, in a top view of the distal region. When looking down on the inserter in a top view, one could thus see at least a portion of one or more bottom extensions in this type of non-symmetrical design. Additionally, in some embodiments the top surface has a different number of slots than the bottom surface. Alternatively, a top slot can have different dimensions and/or shape than the bottom slot. Alternatively, the inserter may have no slot on one surface and one or more slots on the other surface, or differing number of slots on the top and bottom surfaces. Alternatively, for example, the inserter could have a top and a bottom slot on different sides of the center line (e.g., top slot left of the center line of the distal region, and the bottom slot right of the center line, or vice versa). The inserter could also have multiple slots on different sides of a centerline. The offset slotted designs can be beneficial in still allowing the tissue to conform and “grab” the device as described above, but making it harder for the device to escape during storage or transport (more security during storage and/or transport).
All of the description above applies to all of the description below, including the exemplary examples below. For example, any of the dimensions described above can apply to any of the embodiments and aspects of the disclosure described below.
Without wishing to be bound by theory, proximal slot 104 may allow for fluid flow to “push” the device out of the device receiving space, as described above, when retracting the inserter during a pocket procedure. And again, without wishing to be bound by theory, an additional possible contributing factor, in addition those set forth above, for which some evidence has been seen, is that the proximal slot, when in communication with the device receiving space, helps replace the volume of the device as it is being displaced out of the receiving space. As the inserter is moved within the corneal pocket, the corneal device begins to exit the inserter. In designs without the proximal slot, the device may get sucked back into the receiving space if the inserter is pulled back too quickly. The corneal device does not, however, get pulled back into the receiving space when the proximal slot is present. This can be equated to retracting a plunger from a syringe with a very small diameter needle (the plunger being analogous to the device). If you retract the plunger too fast, the plunger will move back into position because the fluid does not have a chance to fill the newly created volume (it creates a vacuum). Adding the proximal slot to the inserter is equivalent to adding another hole to the needle and/or syringe and creating another avenue for the fluid to replace the volume, thus reducing the vacuum created by the moving plunger (in this analogy, the corneal device).
Proximal slot 104 has a constant width 112 along substantially its entire length, and a length 114 from distal to proximal end. The proximal end “PE” of the corneal device receiving space is also shown in dashed in the top view of
In some embodiments, length 114 of proximal slot 104 is from 0.5 mm to 5 mm, such as from 2 mm to 4 mm, such as from 2.8 mm to 3.1 mm.
In some embodiments, width 112 of proximal slot 104 is from 0.2 mm to 1.5 mm, such as from 0.2 mm to 1 mm, such as 0.2 mm to 0.7 mm, such as 0.3 mm to 0.6 mm, such as 0.4 mm to 0.5 mm.
In some embodiments, the width 112 of slot 104 relative to the overall width of the inserter distal region is from 5%-80%, such as from 5% to 50%, such as 5% to 40%, such as 5% to 30%, such as 10% to 30%, such as 20%.
In some embodiments, distance 116 between the distal end of slot 104 and the proximal end PE of the device receiving space can be 0.1 mm to 0.5 mm, such as 0.2 mm to 0.5 mm, such 0.3 mm to 0.45 mm.
In some embodiments, the distance 122 (see
In some embodiments, the length of slot 102 can be from 0.2 mm to 1.8 mm, such as 0.4 mm to 1.5 mm, such as 0.5 mm to 1.3, such as 0.9 mm.
In some embodiments, the width of slot 102 is from 0.2 mm to 1.5 mm, such as from 0.2 mm to 1 mm, such as 0.2 mm to 0.7 mm, such as 0.3 mm to 0.6 mm, such as 0.4 mm to 0.5 mm.
In some embodiments, the length of bridge 108 is 0.2 mm to 1.2 mm, such as 0.5 mm to 1 mm, such as 0.94 mm.
In some embodiments, the height 120 of the device receiving space is from 0.075 mm to 0.225 mm, such as 0.1 mm to 0.2 mm, such as 0.15 mm.
In some embodiments, the length of device receiving space 106, measured from the distal end of the inserter to the proximal end PE of the device receiving space 106, is from 1.25 mm to 3.5 mm, and this length can depend on the size of the device being deviceed. The length can be greater than 3.5 mm for larger devices, for example. In some embodiments the length is 1.5 mm to 3 mm, such as 2.2 mm.
The embodiment in
The inserter in
The embodiment in
The embodiment in
The embodiment in
The embodiment in
The embodiment in
Additionally, the material of the inserter and/or surface roughness, of at least the distal region, can also influence the delivery of the device. For example, one or more coatings on one or more portions of the distal region can aid in the delivery of the inserter into, and/or removal from, a pocket.
The inserter and devices described in exemplary
Any corneal devices can be used, regardless of size, configuration, and material. For example, corneal devices that may be inserted or positioned with any inserter herein can have a shape, dimensions, and be made of materials other than those descried herein, such as disc-shaped, ovoid-shaped, spherical, non-hydrogel, for presbyopia, for myopia, for hyperopia, etc. The inserter body may need to be modified (e.g., one or more dimensions), however, from those embodiments herein, to accommodate a particular device.
As used herein, “slot” generally refers to an inserter slot, and is different than an device slot, or device receiving slot.
The disclosure also includes the following additional embodiments:
A corneal device inserter, comprising: an elongate distal region comprising a corneal device receiving space, and a slot.
A corneal device inserter, comprising: an elongate distal region comprising a corneal device receiving space and a slot extending along at least a portion of the distal region.
A corneal device inserter, comprising: an elongate distal region comprising a corneal device receiving space and slot extending through at least one of top and bottom surfaces of the distal region.
A corneal device inserter, comprising: an elongate distal region comprising a corneal device receiving space and a slot, at least a portion of the slot being proximal to, or behind, the corneal device receiving space.
A corneal device inserter, comprising: an elongate distal region comprising a corneal device receiving space and a slot, the corneal device receiving space and the slot being in fluidic communication.
The inserter of any of the additional embodiments, wherein the slot defines first and second arms on either side of the slot.
The inserter of any of the additional embodiments, wherein the slot extends through the midline of the elongate distal region.
The inserter of any of the additional embodiments, wherein the corneal device receiving space is at least partially defined by a top surface and a bottom surface.
The inserter of any of the additional embodiments, wherein the corneal device receiving area includes device slots formed in first and second arms, the two arms at least partially defining the device slot.
The inserter of any of the additional embodiments, wherein the slot has any length described herein.
The inserter of any of the additional embodiments, wherein the slot has any width described herein.
The inserter of any of the additional embodiments, wherein the slot has any height described herein.
The inserter of any of the additional embodiments, wherein the distal region includes a top surface, a bottom surface, and two side walls.
The inserter of any of the additional embodiments, wherein the corneal device receiving area includes an device slot is the distal region.
The inserter of any of the additional embodiments, wherein the slot extends through both a top and a bottom surface of the distal region.
The inserter of any of the additional embodiments, wherein the slot extends through at least one of a top and bottom surface of the distal region.
The inserter of any of the additional embodiments, wherein the slot has a constant width over a substantial portion of its length.
The inserter of any of the additional embodiments, wherein the slot does not have a constant width over a substantial portion of its length.
The inserter of any of the additional embodiments, further comprising a corneal device positioned at least partially within the corneal device receiving space, optionally in a substantially non-deformed configuration.
The inserter of any of the additional embodiments, further comprising a corneal device positioned completely within the boundary of the corneal device receiving space.
The inserter of any of the additional embodiments, further comprising a corneal device comprising a hydrogel.
The inserter of any of the additional embodiments, further comprising a corneal device with a water content at least 50%.
The inserter of any of the additional embodiments, further comprising a corneal device with a meniscus configuration or a pinhole configuration.
An inserter with a distal region not adapted to be reconfigured, the inserter adapted to deliver a corneal device within a corneal pocket without an active fluid delivery step.
An inserter with a distal region not adapted to be reconfigured, the inserter adapted to deliver a corneal device within a corneal pocket without an active fluid delivery step and without the need for a separate tool, such as a Sinskey hook.
An inserter with a slot in at least a portion of a distal region, the slot having any combination of length, width, and height described herein.
A corneal device inserter, comprising: an inserter slot through at least one of a top and a bottom surface of a distal region of the corneal device inserter; at least one device receiving slot in communication with a distal end of the inserter and in communication with the inserter slot, wherein at least a portion of the inserter slot is proximal to the at least one device receiving slot.
A corneal device inserter, comprising: a distal region including a corneal device slot that extends from a first side to a second side of the distal region, and a space in communication with the corneal device slot that extends further proximally than the corneal device slot, wherein the space does not extend to the first side and the second side of the distal region.
A corneal device inserter comprising a space proximal relative to an device receiving space in a distal region of the inserter.
Any of the additional embodiment inserters, wherein a top extension and a bottom extension, in a top view, have the same configuration and dimensions and thus overlap one another.
Any of the additional embodiment inserters, wherein the inserter slot includes a proximal-most surface, the proximal most surface extending from a bottom surface of the distal region to a top surface of the distal region.
A method of releasing a corneal device from an inserter, wherein releasing the corneal device does not require active fluid delivery, a plunger mechanism, or reconfiguring the distal region of an inserter.
Any of the additional embodiment inserters, wherein a corneal device receiving space has a constant height along a length of the corneal device receiving space (for example,
Any of the additional embodiment inserters, wherein the inserter is adapted so that a top surface and a bottom surface of a distal inserter region are adapted to be moved away from each other.
A corneal device inserter, comprising an device receiving space and a plurality of slots or recesses in a distal region, optionally wherein one or more of the slots extends further proximally than the device receiving space.
Any of the additional embodiments inserters, wherein the inserter comprises first and second slots, optionally wherein one slot is a window slot that does not extend to an outer (i.e., side) edge of the inserter, in a top view.
Any of the additional embodiment inserters, wherein a surface of the slot is beveled.
Any of the additional embodiment inserters, wherein the slot does not have a constant width over its entire length, such as a slot that tapers in the proximal direction.
Any of the additional embodiment inserters, wherein the slot comprises a first section and a second section, the first section having a width different than a width of the second section.
Any of the additional embodiment inserters, wherein an inserter side, or edge, wall narrows in the region of the proximal portion of a corneal device receiving space to expose a proximal region of the corneal device receiving space.
Any of the additional embodiment inserters, wherein the slot extends to the edge of a side wall of the inserter.
Any of the additional embodiment inserters, comprising a plurality of slots, optionally a first of which is on one side of a midline of the inserter and a second slot is on a second side of the midline.
Any of the additional embodiment inserters, comprising a nonsymmetrical slot, optionally nonsymmetrical about a midline of the inserter.
A method of releasing a corneal device from an inserter into a corneal pocket, comprising: retracting the inserter proximally out of the pocket, wherein retracting the inserter proximally causes the device to be released from the inserter and deposited in the pocket.
The method of additional embodiments 43 wherein the method does not require active fluid delivery, reconfiguring a distal region of the inserter, or using a separate tool, to release the device from the inserter.
This application claims priority to U.S. Provisional Application No. 62/254,112, filed Nov. 11, 2015, and to U.S. Provisional Application No. 62/302,687, filed Mar. 2, 2016, the disclosures of which are incorporated by reference herein. This application is related to U.S. Pat. No. 8,540,727, the disclosure of which is incorporated by reference herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2016/061775 | 11/14/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62254112 | Nov 2015 | US | |
| 62302687 | Mar 2016 | US |
