# Patent

## Title
Lens delivery system

## Abstract

Delivery devices for delivering an ophthalmic device into an eye. In some embodiments the delivery devices are adapted to deliver an intraocular lens into an eye.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application No. 60/951,439, filed Jul. 23, 2007, the disclosure of which is hereby incorporated by reference herein.


BACKGROUND OF THE INVENTION
Intraocular implants such as an intraocular lens (“IOL”) can be delivered into the eye through a small incision made in the cornea. Delivery devices have been developed to aid in the delivery and insertion of such implants into the eye.
A corneal or scleral incision allows access to the eye and the smaller the incision the less damage will be done and the less time will be needed for the incision to heal. In addition, the intraocular lens is preferably not damaged during delivery, or at most, minimally damaged such that it will not effect the functionality of the intraocular lens.
Depending on the physical characteristics of the intraocular lens (e.g., shape, size, etc.), the shape and/or configuration of the intraocular lens may need to be reduced in size or altered during the delivery process to enable the intraocular lens to be inserted through a small incision. The reduction in size or adjustment of the configuration/shape of the lens allows for a smaller delivery profile.
A delivery device is therefore needed that will reduce the delivery profile of the intraocular lens such that it can be delivered into the eye through a small incision. Additionally, the delivery device minimizes and preferably eliminates damage done to the lens during the delivery process, including the loading of the intraocular lens into the delivery device.
SUMMARY OF THE INVENTION
One aspect of the invention is a method of hydraulically loading an intraocular lens into a delivery system. The method includes positioning an intraocular lens within a compression chamber and adjacent a delivery device, wherein the compression chamber and the delivery device are in fluid communication. The method includes flowing a fluid through the compression chamber and into the delivery device, wherein flowing the fluid through the compression chamber comprises loading the intraocular lens into the delivery device.
In some embodiments loading the intraocular lens into the delivery device comprises compressing the intraocular lens from an unstressed expanded configuration to a stressed delivery configuration. Compressing the intraocular lens can increase the length of the intraocular lens. The intraocular lens can comprise a fluid therein, and wherein compressing the intraocular lens comprises redistributing the fluid with the intraocular lens.
In some embodiments the intraocular lens comprises an optic portion, a first haptic, and a second haptic, and wherein positioning the intraocular lens within the compression chamber comprises positioning the first haptic distal to the optic portion.
One aspect of the invention is a hydraulic loading system for loading an ophthalmic device into a delivery device. The system includes a compression chamber with a tapered inner surface, wherein the compression chamber contains a fluid therein. The system includes a delivery device comprising an elongate loading element wherein the elongate loading element and the compression chamber are in fluid communication. The system includes an ophthalmic device disposed in a first configuration within the compression chamber. The system also includes a loading device adapted to cause the fluid to flow through the compression chamber and into the elongate loading element, thereby loading the ophthalmic device into the elongate loading element. In some embodiments the fluid contains a lubricant.
In some embodiments the ophthalmic device is an intraocular lens. In some embodiments the loading device comprises a plunger to direct the fluid through the compression chamber and into the elongate loading element.
One aspect of the invention is a method of loading an intraocular lens into a delivery device. The method comprises providing a delivery device comprising an everting tube comprising an inner tube portion and an outer tube portion, wherein the everting tube is coupled to a first actuation element. The method includes loading the intraocular lens into an end of the everting tube by actuating the first actuation element, wherein actuating the first actuation element everts a section of the outer tube portion into the inner tube portion about the end of the everting tube.
In some embodiments loading the intraocular lens into an end of the everting tube comprises compressing the intraocular lens within the inner tube portion. In some embodiments loading the intraocular lens into an end of the everting tube comprises loading a first haptic into the end of the everting tube before loading an optic portion of the intraocular lens. Loading the first haptic into the end of the everting tube can include forcing a volume of fluid from the first haptic into the optic portion.
In some embodiments loading the intraocular lens into an end of the delivery tube comprises engaging the intraocular lens and the inner tube portion, wherein the inner tube portion compresses the intraocular lens as the everting tube everts. In some embodiments actuating the first element moves the first actuation element in a proximal direction or a distal direction.
One aspect of the invention is a method of loading an intraocular lens into a delivery device. The method includes compressing an intraocular lens from a first configuration to a second configuration within a first portion of the delivery device, wherein compressing the intraocular lens comprises applying a compressive force to the intraocular lens in a direction generally orthogonal to a longitudinal axis of the delivery device. The method also includes actuating a second portion of the delivery device to move the second portion of the delivery device relative to the first portion of the delivery device in a direction generally parallel to the longitudinal axis of the delivery device, wherein actuating the second portion relative to the first portion loads the intraocular lens into the delivery device.
In some embodiments applying a compressive force to the intraocular lens comprises applying the compressive force indirectly to the first portion of the intraocular lens. In some embodiments applying a compressive force to the intraocular lens comprises applying the compressive force directly to a third portion of the intraocular lens, wherein the method further comprises engaging the third portion and the first portion.
In some embodiments the first portion and the second portion slidingly engage one another, and wherein actuating a second portion comprises sliding the second portion over the first portion. The delivery device can include a third portion engaging an outer surface of the first portion, and wherein sliding the second portion over the first portion displaces the third portion from the first portion.
In some embodiments compressing the intraocular lens within a first portion of the delivery device comprises moving a first half of the first portion closer to a second half of the first portion.
One aspect of the invention is a loading system for loading an intraocular lens into a delivery device. The system comprises an outer loading tube adapted to be inserted through an incision in the eye and an inner sleeve slidingly engaged with the outer loading tube and adapted to be disposed within the outer loading tube. The inner sleeve is adapted to engage an intraocular lens therein. The system includes a compressing member disposed adjacent an outer surface of the inner sleeve.
In some embodiments the inner sleeve comprises a first sleeve element and a second sleeve element, and wherein the first sleeve element and the second sleeve element are disposed apart from one another in a first configuration and are moved towards one another in a delivery configuration, thereby compressing the intraocular lens.
In some embodiments the compressing member comprises a first compressing element and a second compressing element, and the first compressing element engages an outer surface of the first sleeve element and the second compressing element engages an outer surface of the second sleeve element. The first compressing element and the second compressing element can be disposed apart from one another in a first configuration and are moved towards one another in a second configuration. The outer loading tube can be adapted to be actuated to displace the compressing member.
In some embodiments the outer loading tube is coupled to a loading tube actuator and the inner sleeve is coupled to an inner sleeve actuator, and wherein actuation of either the loading tube actuator or the inner sleeve actuator moves the outer loading tube relative to the inner sleeve.
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.



BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
FIGS. 1A-1C illustrate an exemplary fluid-driven accommodating intraocular lens.
FIG. 2-3 show an exemplary delivery device.
FIGS. 4-8 illustrate an exemplary embodiment of an everting tube with a slit therein.
FIGS. 9-10 illustrate an exemplary delivery device incorporating an everting tube.
FIGS. 11A-11D show an exemplary delivery device incorporating an everting tube.
FIGS. 12A-12C illustrate the loading of an exemplary intraocular lens in a delivery device.
FIGS. 13A-13C illustrate the deploying of an exemplary intraocular lens from a delivery device.
FIG. 14 illustrates an exemplary delivery device relative to an exemplary intraocular lens.
FIGS. 15-17 illustrate an alternative delivery device.
FIGS. 18A-18E illustrate an alternative delivery device.
FIG. 19A shows an exemplary hydraulic loading system for loading an intraocular lens.
FIG. 20B illustrates an alternative hydraulic loading system for loading an intraocular lens.
FIG. 21 illustrates an exemplary peristaltic loading concept.



DETAILED DESCRIPTION OF THE INVENTION
The present invention relates generally to delivery devices for delivering an intraocular implant, such as an IOL, through an incision in an eye. The delivery devices generally compress and increase the length of the IOL (or at least portions of the IOL) into a delivery configuration such that it can be delivered through a small incision, relative to the size of the IOL, into the eye. In addition, the delivery devices minimizes shear and tensile forces to the IOL during the delivery process to minimize and preferably eliminate damage to the IOL.
The IOLs described herein are accommodating IOLs implanted within a lens capsule after the native lens has been removed from the eye. In particular, the IOLs contain flowable media such as a fluid that is, in response to ciliary muscle movement, moved in the IOL to change the power of the IOL. Such exemplary IOLs are described more fully in U.S. Provisional Application No. 60/433,046, filed Dec. 12, 2002; U.S. Pat. Nos. 7,122,053; 7,261,737; 7,247,168; and 7,217,288; U.S. patent application Ser. No. 11/642,388, filed Dec. 19, 2006; and U.S. patent application Ser. No. 11/646,913, filed Dec. 27, 2006, the complete disclosures of which are hereby incorporated herein by reference. Is it also contemplated that the delivery devices described herein can, however, be used to deliver other types of accommodating IOLs (e.g., non fluid-driven accommodating IOLs), non-accommodating IOLs, and even other types of intraocular implants. In addition, it is contemplated that the delivery devices can be used to deliver the IOL or other ophthalmic device to portions of the eye other than within the lens capsule, such as the anterior chamber or to the posterior chamber after a lens capsule has been removed.
The delivery devices reduce the delivery profile of the IOL by compressing the IOL, or portions of the IOL, from an expanded configuration to a delivery configuration. In some embodiments the IOL assumes a generally circular shape before being loaded of the delivery device, but is compressed into a lengthened generally cylindrical shape by the delivery device. One advantage of the delivery devices is that they minimize the amount and/or types of forces acting on the IOL during the delivery procedure (including the loading and deployment), which can help minimize the amount of damage to the IOL during delivery. This can be advantageous for delicate IOLs (comprised, for example, of polymeric materials) and/or IOLs which comprise a plurality of interconnected components, the mating or bonded elements of which can be damaged by certain types of forces acting on the IOL during a loading and deployment procedure.
In preferred embodiments, the delivery devices minimize shear and tensile forces on the IOL during the delivery process, and instead reshape the IOL under compression.
FIGS. 1A-1C illustrate an exemplary fluid-driven accommodating IOL 210 that can be delivered within the lens capsule with the delivery devices described herein. IOL 210 includes a non-option peripheral portion which includes haptics 212 and 214. IOL 10 also includes an option portion which includes anterior element 216, intermediate layer 218, and posterior element, or substrate, 222. Intermediate layer 218 includes actuator 220. Haptics 212 and 214 define interior volumes 224 which are in fluid communication with active channel 226 defined by posterior element 222 and intermediate layer 218. The haptics engage the capsular bag such that zonule relaxation and tightening causes deformation of the haptics, which distributes a fluid disposed in the haptics and active channel between the haptics and the active channel. When fluid is directed from the haptics to the active channel, the pressure increase in the active channel deflects actuator 220 in the anterior direction, causing the curvature of anterior element 216 to become steeper. This increases the power of the IOL. This process is described in more detail in any of the exemplary patent applications and patents listed above.
FIG. 2 illustrates an exemplary embodiment of delivery device 2 and IOL 100. IOL 100 comprises optic portion 102 and haptics 104 (see FIG. 3) positioned within the delivery device in an unstressed, or expanded, configuration. Delivery device 2 includes inserter body 4, pull block 6, and belts 8. The pull block is connected to the belts on the belt portions that are on the exterior surfaces and bottom surface of the inserter body (bottom not shown), but is not connected to the belts on the inside of the inserter body. Movement of the pull block in either of the direction of arrows D and P moves the portion of the belts on the inside of the inserter body to move in the direction generally opposite the direction of movement of the pull block. For example, when pull block 6 is moved in the proximal, or P direction, the belt portions on the interior of the body move generally in the D direction. The belts act generally as conveyor belts to move the IOL the pull block is actuated.
In use, when the pull block is pulled in the proximal direction (the direction of arrow P in FIG. 2), this causes the portion of the belts on the inside of the inserter body to move in the general distal direction (the direction of arrow D) along the interior surfaces of the inserter body. The belts on the outside and bottom of the inserter body move in the proximal direction as well. As the portion of the belts on the inside of the inserter body move distally, they eventually move around distal end 5 of the inserter body to the outside of the inserter body.
Similarly, when the pull block is pushed distally, or in direction D, the portion of the belts on the outside and bottom of the inserter body move distally and the portion of the belts on the inside of the inserter body move proximally. This causes the IOL in the inside of the body to move in the proximal direction.
The delivery device is configured so that only the belts and not the inserter body (or as little of the inserter body as possible) engage the IOL. Because the IOL does not make contact with the inserter body (or any other parts of the delivery device that may be added), the inserter body does not apply tensile force or shear forces/stress on the IOL as the IOL is moved by the belts. In addition, because the belts move with the IOL, the amount of shear and tensile forces applied to the IOL by the belts are minimized. As shown in FIG. 2, there is an opening or space 10 formed in the bottom surface of the inserter body. The opening in the inserter body is created to avoid contact between the inserter body and the IOL to help minimize unwanted forces on the IOL.
To deliver the IOL into the eye, the IOL is positioned in the interior of the inserter body, making contact with substantially only the belts. The IOL is positioned in an expanded configuration so it is just barely making contact with the belts (as shown in FIG. 2). The pull block is actuated in the proximal direction and the IOL is moved in the distal direction towards the distal end 5 of the device. Because of the reduced width of the distal end of the device compared to proximal end 7, the IOL is compressed as it moves distally and then passes out of distal end 5. It is delivered from the distal end of the device into the eye, where it expands after being released from the delivery device.
When compressing a closed-system fluid-filled IOL (as is shown in 1A-1C and in FIG. 2) in the conveyor system, the portion of the IOL nearest to distal end 5 of inserter body 4 will begin to compress before the rest of the IOL. As the distal end of the IOL begins to compress, fluid contained within the IOL will generally be squeezed or forced into more proximally positioned portions of the IOL. In addition, the first portion of the IOL to be deployed from the delivery device will begin to expand, and while more proximal portions of the IOL continue to be compressed, some fluid will begin to be squeezed distally into the now free and expanding distal portion of the IOL.
It may therefore be advantageous to orient the IOL in the inserter body prior to compression such that fluid will be distributed throughout the IOL in a predictable manner to enable compression and minimize damage to the IOL. For example, FIG. 3 shows distal end 5 of the inserter body in more detail. The IOL is positioned in the inserter body so that a leading (or distal) haptic 12 begins to be deployed first from the inserter body. When the leading haptic begins to be released from the inserter body, the leading haptic can receive fluid that is squeezed from the optic portion and/or trailing haptic 14.
This embodiment may require high tensile forces on the belts, so a pulling mechanism would preferably utilize features designed to increase mechanical advantage. Levers, screws, and/or ratchets could be used to give a user the control as well as the required force.
The inserter body is generally a rigid structure with a general tapered shape with the width decreasing towards the distal end to compress the IOL as it is moved in the distal direction. In some embodiments the distal end of the inserter body is less than about 50% of the width of the proximal end. This is not intended to be a limitation and may be less than about 40%, about 30%, about 20%, about 10%, or less, than the width of the proximal section. While the embodiment shown only includes a bottom surface, the inserter body could also have a top surface (with a similar space as in the bottom surface to avoid sliding). If the inserter body did have a top surface, a fourth belt could then also be included in the device.
The pull block and belts can be made of a relatively rigid material such as Mylar or an elastomeric material such as a silicone.
While three belts are shown in this embodiment there may be more, such as 4, or fewer in the delivery device.
FIG. 4 illustrates a second embodiment of a delivery device. In this embodiment the delivery device comprises an everting tube 30 that includes at least one slit or cut 32 along at least a portion of the length of the tube. The term everting as used herein generally means that at least one section of the tube is adapted to roll back or fold back onto the tube, like a pair of socks or the cuff on a pair of pants. In some embodiments, however, the everting tube does not have a slit.
Everting as used herein can refer both to the step when the inner surface of the tube rolls outward and back and becomes an outer surface of the tube, or when an outer surface of the tube rolls inward and becomes an inner surface.
FIG. 4 shows everting tube 30 in a non-everted state (no section of tube is everted, or rolled back). Slit 32 is shown running parallel to the longitudinal axis LA of the tube 30.
FIG. 5 is a cross sectional view of the tube with a distal portion 34 everted, however the portion of the tube including slit 32 has not yet been everted.
FIG. 6 shows a perspective view of an exemplary everting tube 30 as the portion of the tube including the slit has begun to evert. The slit in the tube causes the portion of the tube circumferentially surrounding the slit to “blossom” as the distal end of the slit reaches the distal end of the tube and as the portion of the tube circumferentially surrounding the slit begins, and continues, to evert. FIG. 7 shows the slit continuing to blossom. FIG. 8 is a distal end view of the slit blossomed. Once the slit portion of the tube is fully everted, the remainder of the tube continues to evert in the same manner as did the portion of tube disposed proximally to the slit. It is in this manner that the slit in the tube allows for a greater expansion or opening of the tube as it is everted.
In one embodiment of the everting tube concept as shown in FIG. 9, the everting tube is coupled to a syringe-like device 40. Device 40 includes an outer body 42 comprising an inner bore or channel through which inner body 44 passes. Inner body 44 includes handle 46 at its proximal end. The proximal end 50 of everting tube 30 is coupled to distal portion 45 of inner body 44 and distal end 52 of the everting tube 30 is coupled to outer body 42. When inner body 44 is actuated in the distal direction (e.g., by pushing handle 46 distally), inner body 44 moves distally relative to outer body 42. Because the proximal end of the everting tube is coupled to distal portion 45 of the inner tube, this movement also moves the proximal portion of the everting tube in the distal direction. Distal end 52 of the everting tube remains coupled to outer body 42 and thus does not move. Similarly, when the inner body is moved or pulled proximally, such as by pulling on the handle in the proximal direction (or otherwise actuating inner body 44), inner body 44 moves proximally relative to outer body 42 and therefore so does the proximal end of the everting tube. It is noted that it is the relative movement of the inner and outer bodies that controls the movement (and thus the everting) of the everting tube, and the outer body can similarly be advanced in the distal direction or retracted in the proximal direction over the inner body to cause the relative movement.
In addition the inner and outer bodies may be disposed within an outer sheath such that the user of the delivery device would not see the inner and outer bodies. The inner and outer bodies could also be coupled to an actuator such as a control knob which a user could use to carefully control the advancement of the inner body relative to the outer body or the retraction of the outer body relative to the inner body. This could give the user precise control over the delivery of the IOL.
To deliver an IOL into the eye, an IOL is first loaded into the distal end of the delivery device shown in FIG. 9 as follows. Handle 46 is advanced distally (or a knob is rotated, or other actuator to control the relative movement of the inner and outer bodies) as shown in FIG. 9 such that a portion of the everting tube is disposed outside and distal to outer body 42. The slit in the everting tube is exposed, or outside of the outer body, and has “bloomed.” The IOL is placed into the blooming opening and the handle is then actuated in the proximal direction, or the outer body is advanced in the distal direction, or both. As the inner layer of the everting tube moves in the proximal direction, causing more of the outer layer of the tube to roll inward and become part of the inner layer of the tube, the slit is retracted within the outer layer of the tube. The slit is thereby forced closed and the device is compressed in the tube via the hoop forces on the closed, or intact, portion of the tube.
Because the tube is everting inward and moving with the IOL (similar to the belts in the embodiment shown in FIGS. 2 and 3), the amount of shear and tensile forces on the IOL are minimized. Substantially all of the sliding (and accompanying shear forces) occurs between the two layers of the everting tube, so there is no (or very little) sliding between the everting tube and the IOL. In some embodiments a lubricant is applied to the everting tube to minimize shear and forces.
As the handle continues to be pulled in the proximal direction, the IOL continues to be loaded into the outer body as the IOL moves further proximally into the channel. In this embodiment, the compression is accomplished as the hoop forces force the IOL to be compressed as it is drawn into the everting tube.
FIG. 10 shows a cross sectional view of an exemplary IOL 100 with a portion of the IOL loaded into the delivery device (and within the everting tube), as described by the loading process above. The exemplary IOL 100 is a soft, flexible, accommodating IOL which includes an optic portion 102 and a peripheral portion comprising haptics 12 and 14 in fluid communication with the optic portion. The IOL comprises fluid which is transferred between the haptics and optic portion to accommodate the IOL in response to ciliary muscle movement.
When compressed into the delivery configuration, the length of IOL 100 increases (as is shown in FIG. 10) while the IOL narrows. When compressed, the fluid within the IOL is squeezed from the portion of the IOL loaded first. As shown in FIG. 10, proximal, or trailing, haptic 14 is loaded first, which squeezes the fluid from the proximal haptic into the optic portion (and likely into distal haptic 12 as well). As the optic portion is loaded into the delivery device (e.g., as the handle continues to be pulled proximally), the optic portion is compressed by the everting tube and the fluid in the optic portion is squeezed into the distal haptic 12.
FIG. 10 shows the IOL in the loaded, or delivery, configuration. Distal haptic 12 is external to the delivery device and contains a larger volume of fluid that it contains when the IOL is in an expanded configuration. Similarly, optic portion 102 and trailing haptic 14 contain less fluid than they do when in an expanded configuration. In this delivery configuration, the IOL has been partially compressed and elongated, and much of the fluid has been squeezed into the distal, or leading, haptic.
To deploy the IOL into the eye (e.g., into the lens capsule of which the native lens has been removed), the distal, or leading, haptic is pushed through the corneal incision and into the capsule. Then inner body 42 is pushed distally (or the outer body is pulled proximally, or both), which causes the everting tube and the loaded IOL to move distally together, deploying the IOL from the delivery device and into the eye by squeezing out through the blooming slit portion of the everting tube. As the optic portion of the IOL begins to be released from the outer body, the fluid moves from the distal haptic to the optic portion, causing the optic portion to expand in volume. Then, as the proximal haptic is released from the delivery device it begins to refill with fluid and increases in volume. Once the IOL has completely been deployed outside of the delivery device (and into the capsule), the IOL has generally returned to its pre-loaded, generally expanded, configuration (although the shape of the IOL may be slightly altered after implantation due to forces acting on the IOL by the lens capsule). The delivery device is then removed from the eye.
FIGS. 11A-11D show an alternative embodiment of delivery device 70 comprising outer body 72 and inner body 74 with knob 76. To load the IOL, knob 76 is rotated which actuates inner body 74 in the proximal direction and/or actuates the outer body in the distal direction. To deploy the IOL, the knob 76 is rotated which actuates the inner body in the distal direction and/or actuates the outer body 72 in the proximal direction. Sheath 73 covers outer body 72 and provides the surgeon a stable handle with which to work. FIG. 11D shows a close-up perspective view of distal end 77 of everting tube 78.
In the embodiments shown in FIGS. 11A-11D, distal end 77 of the everting tube can be adapted such that it does not move relative to the eye during the implantation procedure. The tube will evert (the inner tube become outer tube, or the outer tube becomes inner tube), however the distal end remains substantially fixed in space. This is important because the user does not have to worry about distal end 77 contacting and disrupting the eye during the procedure. The user also does not have to worry about moving the distal end of the delivery system relative to the eye during the deployment procedure.
FIGS. 12A-12C show the loading of IOL 80 into delivery device 70 as described above. IOL 80 comprises trailing haptic 82, optic portion 84, and leading haptic 86. Delivery of the IOL into an eye occurs in the reverse order of the steps shown in FIGS. 12A-12C.
FIGS. 13A-13C show deployment of IOL from delivery device 70. FIG. 13A shows a leading haptic extending from the distal end of the everting tube. FIG. 13B shows the optic portion emerging, and FIG. 13C shows the trailing haptic almost completely deployed. FIG. 14 illustrates the size of delivery device 70 next to IOL 80.
In some embodiments the everting tube is a thin, tough, generally stretchy material that is adapted to be everted. To evert a tube it is generally preferred to be somewhat stretchy and very thin relative to the inner diameter of the tube. A composite material with relatively different axial and circumferential stiffnesses may also be used. For instance, a tube can contain fibers running along the longitudinal axis of the tube that serve to stiffen the tube in the axial direction while maintaining the elastic properties in the circumferential direction. Alternatively, the everting tube can be formed by being drawn to provide extra stiffness along its length.
While the embodiments above show and describe one slit in the everting tube, the delivery device may have more than one slit, such as 2, 3, 4, 5, or more slits. The slits may be positioned around and along the length of the tube in any orientation that helps minimize the shear and tensile forces on the IOL during loading or deployment. In some embodiments the everting tube has no slits.
A variety of actuation mechanisms may be used to deliver the device. For example without limitation, a knob, a trigger, or a lever mounted on a grip may be used as alternatives to the syringe design.
FIG. 15 illustrates an alternative delivery device 60 which comprises body 62, inserter 64, and advancement mechanism, or actuator, 66, which is coupled to inserter 64. Inserter 64 is a sheet that is rolled up along its length wherein one edge of the inserter overlaps the other, as shown in FIG. 16. The proximal end (not shown) of inserter 64 is coupled to the distal end (not shown) of advancement mechanism 66. As advancement mechanism 66 is actuated in the proximal direction, inserter 64 is withdrawn into body 62. Body 62 generally compresses inserter 64 when inserter 64 is withdrawn in to body 62. This causes the diameter of inserter 64 to decrease and the sheet forms a tighter roll or curl.
FIG. 16 is a distal end view of the inserter and FIG. 17 shows a perspective view of a distal end of body 62 with inserter 64 withdrawn into body 62.
To load the IOL into the delivery device 60, the advancement mechanism is pushed distally to deploy inserter 64 from the distal end of body 62 (as shown in FIG. 15). The distal end of the inserter body will assume a more open (i.e., the curl is not as tight), or first, configuration, allowing the IOL to be positioned in the distal end of the inserter. After placement of the IOL in the distal opening of the inserter, the advancement mechanism is pulled proximally (or body 62 is pushed distally). This pulls the inserter into body 62 whereby the body 62 exerts a compressive force on the inserter, causing it to fold more tightly into itself. The inserter thus applies a compressive force to the IOL. As in the other embodiments above, because the IOL moves proximally with the inserter, it is compressed within the inserter. The inserter and IOL move together and therefore shear and tensile forces acting on the IOL are minimized.
Once loaded into the delivery device, the IOL can then be inserted through the wound as described above.
Once body 62 has been advanced into the wound advancement mechanism 66 is advanced distally, which begins to deploy the folded inserter from the body. The IOL moves with the inserter as it is advanced out of body 62. As the inserter is pushed from body 62, it begins to unroll, or open, allowing the optic and trailing haptic to begin to expand and again fill with fluid that had been squeezed into the leading haptic when the IOL was in the loaded delivery configuration.
This embodiment may be used with an additional secondary advancement mechanism to further advance the IOL from the rolled inserter. For example, a plunger-like device could be disposed within an internal bore or channel in the advancement mechanism. The plunger-like device could be pushed distally through the advancement mechanism to make contact with the IOL to completely deploy the IOL from the folded inserter. Because the IOL might be in a generally uncompressed state after the inserter has been pushed as far distally as possible, only a small amount of additional force may be needed to completely push the IOL from the folded inserter. Therefore the plunger-like device would not damage the IOL.
An alternative secondary advancement mechanism uses a hydraulic force to fully deploy the IOL from the folder inserter. A lumen within the advancement mechanism can be used to deliver fluid within the inserter thereby forcing the IOL out of the inserter. Fluid will also minimize the amount of shear or tensile forces acting on the IOL. A sealing mechanism such as a plug or other insert (such as a silicone material) can also be positioned into the rolled inserter to help create a seal between the IOL and the inserter to aid in the hydraulic ejection of the IOL.
In general the rolled inserter is a very thin material. In one embodiment the rolled inserter comprises mylar and is about 0.004′′ thick. The cross section of the inserter may assume a variety of cross-sectional shapes, such as round, oval, or elliptical.
FIGS. 18A-18E illustrate an embodiment of loading and delivery system 300 for loading and delivering intraocular lens 310. The system includes rigid outer tube 302, flexible inner sleeve 304 (split into two halves as shown), and compressor clips 306. Outer tube 302 is adapted to fit through about a 4 mm incision in the eye. Outer tube 302 is coupled to outer tube actuator 322 and inner sleeve 304 is coupled to inner sleeve actuator 324. The outer tube and inner sleeve can axially move with respect to one another by actuation of one or both of outer sleeve actuator 322 and inner sleeve actuator 324. The compressor clips can be lightly bonded (e.g., using a weak bonding material such as Loctite 495) or unbonded to the inner sleeve.
To load lens 310 into outer tube 302, the intraocular lens is first positioned in the system as shown in FIG. 18A (also shown in more detail in FIG. 18B). Haptics 312 are first positioned axially from optic portion 314 (one haptic leading and the other haptic trailing). This assists in the loading process. A compressive force in the general direction of arrows C is then applied to one or both of compressor clips 306. The compressive force can be applied by a vise or other similar device that brings two elements together to cause compressive force C to be applied to the compressor clips. As a result, a compressive force is applied to the lens and causes the lens to be compressed between the two halves of the inner sleeve. The inner sleeves, and not the compressor clips, engage the lens. The compressive force is applied until the two halves of the inner sleeve come together such that the lens is fully compressed within the two halves of the inner sleeve. The compressor clips can be compressed until they engage with each other or there may be a slight space between the edges of the compressor clips. During the compression process the lens is compressed and elongated.
After the compressor clips are compressed to the closed (or substantially closed) position shown in FIG. 18C, outer tube actuator 322 is advanced distally in the direction of arrow D (shown in FIG. 18D) and inner sleeve actuator 324 is held in place. The movement of outer tube actuator 322 causes the outer sleeve to be advanced distally over the inner sleeve (which is held in place). The inner sleeve could also be retracted proximally while the outer tube is held in place. Advancing the outer tube displaces the compressor clips in the distal direction, which also move relative to the inner sleeve. The outer tube is advanced until the inner sleeve (and therefore the lens) is disposed within the outer tube, as shown in FIG. 18E. During this loading step sliding occurs between the outer tube and the inner sleeve, not between the lens and the inner sleeve. This minimizes shear and tensile forces acting on the lens.
The outer tube is then advanced through an incision made in the eye. To deploy the lens from the delivery system and into the lens capsule, inner sleeve actuator 324 is advanced distally in direction D. This causes inner sleeve to be advanced distally relative to the outer tube. As the inner sleeve emerges from the distal end of the outer tube, the inner sleeve will begin to split along the slit and the lens will begin to expand. The lens can therefore be delivered into the capsule.
The outer tube is generally rigid and in one embodiment is a stainless steel tube. The inner sleeve is generally a flexible material and in one embodiment is PTFE. The compressor clips can be any suitably rigid material.
Increasing the outer tube volume increases the volume into which the lens can be compressed. It is generally desirable for the outer tube to have the largest cross sectional area possible while still allowing the outer tube to be advanced into the smallest incision possible. It has been found than using an outer tube in which the cross section is generally elliptically-shaped allows the largest cross sectional area through the smallest incision.
In an alternative embodiment the inner sleeve as shown in FIGS. 18A-18E can be replaced with a rolled sheet such as inserter 64 shown in FIGS. 15-17. The system would work similarly to the described above in references to FIG. 18A-18E.
FIGS. 19-21 shows alternative embodiments of a hydraulic lens loading system. Using a hydraulic system to load the intraocular lens into the delivery device (as well as a hydraulic system to deploy the intraocular lens) minimizes shear and tensile forces on the lens. The lens is forced into a delivery device using a generally lubricous liquid or fluid, which minimizing shear and tensile forces acting on the lens as it is compressed and elongated. FIG. 19A shows loading system 400 for loading intraocular lens 402 into loading tube 408. The system includes syringe 404 including plunger 406. Distal region 412 of syringe 404 includes a tapered inner surface 410 which has a smaller cross sectional diameter at the distal end than at the proximal end. The distal region of the syringe contains the lens as well as fluid 414. The fluid can be a liquid such as saline and can include or can be a known viscoelastic lubricant such as, for example without limitation, aqueous solutions of sodium hyaluronate, hydroxypropylmethyl cellulose, and chondroitin sulfate.
To advance the lens into loading tube 408, the plunger is actuated in the distal D direction which causes fluid 414 and lens 402 to be advanced distally towards loading tube 108. The plunger continues to be advanced distally until the lens is forced through proximal end 416 of loading tube 108. By moving the lens with a lubricious material, shear and tensile forces on the lens are minimized.
FIG. 20B shows an alternative hydraulic loading system 600 for loading intraocular lens 602 into loading tube 608. The system is similar to previous embodiments and includes syringe 604 with plunger 606. The syringe includes lens chamber 612 which has a generally circular shape to retain the generally circular shape of lens 602. The syringe also includes tapered section 610 which directs the lens into loading tube 608. Lens 602 is initially positioned in lens chamber 612 with distal haptic 605 extending distally from optic portion 603 and into tapered section 610 while proximal haptic 607 is not extending proximally from optic portion 603. This initial positioning helps direct the lens into a compressed configuration within loading tube 608 (which includes proximal end 616) when fluid 614 is forced through lens chamber 612. The plunger is advanced distally to direct a fluid through lens chamber 612, which forces lens 602 into loading tube 608.
In an alternative design the intraocular lens can be loaded into the loading tube under vacuum pressure.
After the lens is loaded into the loading tube, the lens is hydraulically delivered into the eye. The loading tube is first detached from the loading apparatus. The loading tube is then inserted through an incision in the eye and a fluid (such as a lubricious fluid) is directed through the loading tube to eject the lens from the loading tube and into the eye. Hydraulic deployment also minimizes shear and tensile forces acting on the lens. A syringe can be used to direct the fluid through the loading tube. Alternatively, a small piston drives down the tube, pushing a short column of fluid distally to the piston. The piston is controlled with an actuator such as a knob, lever, ratchet, etc. The piston can be attached to either end of the loading tube. This means the lens can be ejected from the same end in which it is loaded, or it can be deployed from the other end of the loading tube.
FIG. 21 illustrates an alternative loading system concept using peristaltic movement to load an intraocular lens (not shown). In this design, purely compressive loads on the lens are separated in time from shear loads on the lens. The lens is “inched” along into a fully compressed state. System 700 includes rigid large tube 702, rigid small tube 706, and flexible tube 704 with a generally conical or tapered shape. Fluid 710 is contained within the system to lubricate the system and also to help push the lens through the system. The lens is moved from the rigid large tube 702 through flexible tube 704 and into a fully compressed state within small rigid tube 706. Large tube 702 has a larger diameter than small tube 706. There is generally a pressure gradient between P1 and P2 with P1 being higher. The difference in pressure between P1 and P2 (which is the driving pressure) is equal to P1 minus P2. The pressure P3 from a compressive force on the flexible tube is used to compress the lens in a direction that is substantially orthogonal to the axis A. P3 is pulsed out of phase from the driving pressure, which is also pulsed. To load the lens, P3 is initially increased to compress the lens radially. Then P3 is decreased while the driving pressure is increased, so the device is pushed in the direction D a small distance and reexpands radially. When P3 is decreased the flexible wall moves radially away from the lens and shear forces are reduced. P3 is then increased again, compressing the lens radially. P3 is then decreased as the driving pressure is increased, which again moved the lens in the direction D. The lens is therefore moved in small increments in the distal direction D, compressing it as it moves. This movement is repeated until the lens is fully compressed within small tube 706. The lens can then be deployed using any of the methods described herein.
In any or all of the embodiments described herein, the method of delivery includes creating a wound in the eye which generally comprises an incision in the eye. In some embodiments the incision is about 4 mm and preferably about 3.7 mm. The incision can, however, be slightly larger or smaller.
In any of the embodiments described herein, the position and/or orientation of the IOL may need to be adjusted for the loading step. For example, when loading an IOL with haptics, it may be necessary to align the haptics so they are oriented generally along the longitudinal axis of the delivery device before compressing the lens (see, for example, FIG. 18B). Alternatively, only one haptic may be straightened while a second haptic can be positioned peripherally around the optic portion (see, for example, FIG. 21A). These orientations can provide for a better delivery profile and minimizes the chance of damage to the IOL during deployment.
To compress any of the fluid-filled accommodating IOL described herein, it may be necessary to apply a compressive side force of about 0.5 pounds. This can vary, however, depending on the size, composition, and volume of the IOL.
While only these embodiments have been described, they all attempt to minimize the amount of shear and tensile forces acting on the IOL during the loading and/or delivery process. One common method is minimizing the amount of sliding that occurs between the IOL and the delivery system components. Other embodiments are included in this invention which allow the IOL to be loaded into and deployed from the delivery device with (or in conjunction with) a delivery device component, in order to reduce these unwanted forces.

## Claims

1. A method of loading an intraocular lens, comprising:
providing an intraocular lens with a flowable media therein within a loading chamber and adjacent a delivery device, wherein the loading chamber and the delivery device are in fluid communication, the intraocular lens including an optic portion, a distal haptic, and a proximal haptic; and
positioning the distal haptic such that it extends distally from the optic portion while the proximal haptic is not extending proximally from the optic portion; and
loading the intraocular lens into the delivery device, wherein loading comprises redistributing the flowable media within the intraocular lens.

2. The method of claim 1 wherein loading the intraocular lens into the delivery device comprises compressing an optic portion of the intraocular lens from an unstressed expanded configuration to a stressed delivery configuration.

3. The method of claim 2 wherein compressing the optic portion comprises increasing the length of the intraocular lens.

4. The method of claim 1 wherein the flowable media is a fluid, and wherein the loading step comprises redistributing the fluid within a fluid channel or chamber within the intraocular lens.

5. The method of claim 1 wherein loading the intraocular lens into the delivery device comprises redistributing the flowable media from within the distal haptic to within the optic portion of the intraocular lens.

6. The method of claim 1 wherein positioning an intraocular lens within a loading chamber comprises positioning the intraocular lens within the loading chamber such that an optic portion of the intraocular lens is in a substantially unstressed configuration within the loading chamber.

7. The method of claim 1 wherein the width of the loading chamber is greater than the diameter of an optic portion of the intraocular lens when the optic portion is an unstressed expanded configuration.

8. The method of claim 1 wherein the flowable media channel or chamber is within an optic portion of the lens.

9. A method of loading an intraocular lens into a delivery system, comprising:
an intraocular lens comprising an optic portion in fluid communication with a distal haptic and a trailing haptic, and a flowable media movable between the distal and proximal haptics and the optic portion;
positioning the intraocular lens within a loading chamber such that the distal haptic extends distally from the optic portion while the proximal haptic is not extending proximally from the optic portion; and
loading the intraocular lens from the loading chamber into the delivery device, wherein loading the intraocular lens comprises redistributing the flowable media from within the optic portion to within the distal haptic.

10. The method of claim 9 wherein loading the intraocular lens comprises flowing a fluid into the loading chamber.

11. The method of claim 10 wherein loading the intraocular lens comprises flowing a fluid from the loading chamber into the delivery device.

12. The method of claim 9 wherein the positioning step comprises positioning the optic portion in the loading chamber in a substantially undeformed configuration.