Abstract:
The present invention is a device for rolling, storing and inserting into an eye an extremely thin intraocular lens (IOL). The device performs as a roller and injector. Also disclosed herein are methods of using the lens rolling device. The chamber for rolling the intraocular lens includes curved walls, a hollow chamber, and a funnel for receiving a plunger, and a port for extruding a rolled lens. The IOL is effectively rolled by engaging the two parts of the rolling device. After rolling, the lens is ejected from the device through a cannula and into an eye.

Description:
[0001]     This United States Utility Patent Application claims benefit of co-pending U.S. Provisional Patent Application Ser. No. 60/461,994 filed Apr. 11, 2003, entitled “Intraocular Lens Storage and Insertion Device and Method of Use Thereof”, which is hereby incorporated by reference. 
     
    
       [0002]     Be it known that we, Wayne B. Callahan, a citizen of the United States, residing at 18952 Middle Dr., Abingdon, Va. 24211; Jeffery S. Callahan, a citizen of the United states, residing at 104 Eagleview Private Dr., Blountville, Tenn. 37617; James J. Simms, a citizen of the United States, residing at 37 Cochese Circle, Medford Lakes, N.J. 08055; Dimitrii D. Dementiev, M. D., a citizen of Italy, residing at Via Campo Gallo 21/25, Arese (MI) 20020, Italy; and William Bernard Wright, a citizen of the United States, residing at 556 Cedarmont Drive, Antioch, Tenn. 37013, have invented a new and useful “Intraocular Lens Storage and Insertion Device and Method of Use Thereof.” 
       BACKGROUND OF THE INVENTION  
       [0003]     Intraocular lenses (IOLs) were developed a number of years ago to replace any clouded natural lens, called a cataract. Cataracts cause individuals to lose their sight, either partially or completely, because clouding prevents light and an image from being transmitted through the lens onto the retina. When the clouding becomes severe, an individual can no longer see. Replacement of the natural lens with an IOL has become an accepted procedure for alleviating the symptoms of a cataract.  
         [0004]     Various surgical procedures have been developed for removing a cataract, ranging from physically lifting the lens from the membrane that encapsulates the lens to emulsifying the lens through the use of sound waves and suction equipment. It has been found that this latter procedure, known as phacoemulsification, is advantageous because a much smaller incision is required in the eye, generally 3 millimeters (mm) or smaller.  
         [0005]     A smaller incision is desirable because sutures are generally not required and the incision heals itself. If sutures are used to close a larger incision, typically up to 6.5-8 mm, the eyeball is deformed. Further, with incisions under 3 mm, the lack of sutures offers an even further assurance that the ocular globe or eyeball will not be deformed.  
         [0006]     A number of different attempts have been made to develop IOLs which can be inserted through the smaller incision openings. Before the availability of IOLs formed of a soft material that could be deformed or compressed, various techniques were attempted to develop a small profile IOL, ranging from forming lenses with a narrower lateral dimension to various types of lenses that could be dismantled or manipulated and rebuilt in the eye.  
         [0007]     After IOLs formed of silicon or a hydrogel material became available, IOLs could be folded, rolled or otherwise deformed or compressed so that they could be inserted into the eye through a much smaller incision than previously possible. Such lenses are described in U.S. Pat. No. 4,573,998 to Mazzocco.  
         [0008]     Various techniques and equipment have been developed for folding soft IOLs and inserting them into the eye. These include the use of forceps with relatively long blades which can engage an IOL and hold it in a folded position while it is inserted into the eye. Such technique is shown in U.S. Pat. Nos. 5,007,913; 5,100,410 and 5,178,622. The disadvantage of these forceps devices is that they are difficult to operate. For example, as the forcep blades release the IOL, the positioning of the IOL is not tightly controlled within the eye. Further, movement of the forcep blades could cause the incision to be enlarged. Any movement close to the inner surface of the cornea is undesirable because the forcep blades or lens could rub against the endothelial cells on the inner surface of the cornea, which are not regenerative, and cause permanent damage. Since the forceps are manually squeezed by the surgeon, there is also the possibility that too much pressure could damage various portions of the IOL.  
         [0009]     For example, a number of IOL inserters have been developed where an envelope or paddle is moved to project from the distal tip of the inserter. Such IOL inserters operate to fold the IOL as it is pulled back into the inserter. The IOL is implanted when the paddle is then moved to project from the tip. See, for example, U.S. Pat. Nos. 4,836,201; 4,880,000; 4,934,363 and 5,098,439.  
         [0010]     Other IOL inserters have jaw-like portions that operate to fold the IOL as they close or telescopic sections that move relative to each other to hold the lens after it has been folded. See, for example, U.S. Pat. Nos. 4,714,373; 4,747,404 and 4,834,094.  
         [0011]     An inserter was also developed, as shown in U.S. Pat. No. 4,919,130, where a cannula was designed to receive an IOL that is partially folded. A first plunger pushes the IOL through a rigid chamber of gradually diminishing diameter to fold it completely. A second plunger then pushes the IOL out of the cannula and into the eye.  
         [0012]     In another inserter, shown in U.S. Pat. No. 4,681,102, an IOL is placed in an open cartridge which has two tabs or wing-like sections that are hinged together. The IOL is folded as the sections are closed.  
         [0013]     Because of the moving parts in many of the folding devices discussed above, the IOL can easily be pinched or torn during the folding or insertion process.  
         [0014]     In addition, folding and loading an IOL requires a certain amount of manual manipulation of the IOL, which takes time and complicates the surgical procedure. For example, in the device where a cannula is used, a first plunger is used to fold the lens, which must be removed and replaced by a second plunger for inserting the lens in the eye.  
         [0015]     Thus, there is a need for an apparatus and method for rolling and storing an IOL and positioning it for insertion in the eye which removes the disadvantages of the currently available devices and methods.  
       SUMMARY OF THE INVENTION  
       [0016]     The present invention provides an intraocular lens rolling, storing and insertion device which eliminates the disadvantages associated with the currently known designs.  
         [0017]     The lens rolling system includes a first member having a first concave surface, and a second member having an opening defined by a first shelf, a second shelf, and a second concave surface, wherein the first member removably engages the opening of the second member, so that a cavity is formed. The lens rolling system may also include the second member having an operational cannula, wherein the operational cannula aligns with the cavity so that a lens located in the cavity may exit the cavity through the operational cannula. Also, the lens rolling system may include the second member having an operational funnel, wherein the operational funnel aligns with the cavity so that the operational cannula, the cavity, and operational funnel define an opening therethrough. It also includes a rod removably engaged to the operational funnel, cavity, and operational cannula. The lens rolling system further includes a luer lock attached to the second member.  
         [0018]     The present invention also discloses a method of rolling and inserting an intraocular lens including providing a first member having a first concave surface; providing a second member having an opening defined by a first shelf, a second shelf, and a second concave surface; inserting a lens into the opening of the second member; engaging the first member with the second member so that the lens rolls upon itself; and moving the lens from the engaged first member and second member into an eye. The method also includes pushing the lens through an operational cannula. The method further includes attaching a syringe to the second member and irrigating the lens with a fluid. In certain embodiments, moving the lens further includes contacting the lens with a rod and advancing the lens through the operational cannula and out of the engaged first member and second member. The method also includes placing a tip of the operational cannula into an incision of the eye.  
         [0019]     The present invention discloses an apparatus for rolling, storing, and inserting an intraocular lens, including a first member having a first arm, a first cannula half, a first funnel half, a first surface, a second surface, and the first member having a first hole defined therein; and a second member having a second arm, a second cannula half, a second funnel half, a third surface, a fourth surface, and the second member having a second hole defined therein. The apparatus also includes a plunger slidably engaged with the first funnel half and the second funnel half.  
         [0020]     Regarding the present invention, the method of rolling an intraocular lens includes providing a lens rolling device, having a first member and a second member; placing a lens on a shelf of the first member; and sliding the first member into engagement with the second member so that the lens is rolled and compressed within a cavity formed by the engagement of the first member and second member. The method also includes positioning a plunger in the cavity; and pushing the plunger through the cavity so that the lens is expelled from the cavity. In certain embodiments, placing the lens on the shelf includes placing the lens between two shelves. The method includes inserting the lens into an eye through an incision in a cornea. The incision in the cornea is from about 2 millimeters to about 0.5 millimeter.  
         [0021]     The lens rolling device includes a first member having a first insertion arm, a first shelf, a first concave surface, the first concave surface having a first end and a second end, and the first member having a first hole defined therein; and a second member having a second insertion arm, a second shelf, a second concave surface, the second concave surface having a first end and a second end, and the second member having a second hole defined therein, wherein a cavity is formed when the first concave surface and the second concave surface engage. The cavity may be round, oval, or any combination thereof. The device includes a first cannula half attached to the first end of the first concave surface and a second cannula half attached to the first end of the second concave surface of the second member, wherein the first cannula half has a first distal end and the second cannula half has a second distal end, wherein a diameter of the first distal end of the first cannula half and a diameter of the second distal end of the second cannula half are about 1.32 millimeters. Further, the length of the first distal end of the first cannula half and a length of the second distal end of the second cannula half are about a thickness of a cornea. The device includes a first funnel half attached to the second end of the first concave surface and a second funnel half attached to the second end of the second concave surface so that the first funnel half and the second funnel half are opposite of the first cannula half and second cannula half. A container may be provided so that the device is sealed and sterilized in the container. Finally, the device includes a plunger frictionally engaged with the cavity so that the first funnel half and the second funnel half align the plunger and the full cavity.  
         [0022]     The lens rolling device includes a first member having an insertion arm, a shelf, a half of a roller cavity, and an opening for receiving an insertion arm; and a second member having an insertion arm, a shelf, a half of a roller cavity, and an opening for receiving an insertion arm. In certain embodiments, the lens rolling device may also include a first member having a portion of a cannula and portion of a funnel; a second member having a portion of a cannula and a portion of a funnel; and a plunger.  
         [0023]     The present invention also discloses a method of using the storage and insertion device. The method of using the storage and insertion device (1) eliminates moving parts which can pinch or tear the IOL, (2) reliably delivers the IOL into the eye without damaging either the IOL or the eye, and (3) eliminates unneeded steps in the folding process. The method includes providing the lens rolling device which has a first member and a second member, placing a lens on the first member, sliding the first member into engagement with the second member so that the lens is rolled and compressed within a cavity which is formed by the engagement of the two members. This method may further include positioning a plunger in the cavity, and pushing the plunger through the cavity so that the lens is expelled from the cavity and into the eye of a patient. The method may also include transporting the rolled lens from the rolling device to the eye of a patient in any conventional manner.  
         [0024]     As further described herein, the first member is placed in engagement with the second member so that the lens is rolled and compressed within a chamber that is formed by portions of the first member engaging portions of the second member. Similarly, a funnel, used to guide a plunger during expulsion of the rolled lens, is formed by the engagement of the two members. Also, a cannula, which is used to deliver the rolled lens into an eye, is formed by the engagement of the two members.  
         [0025]     Accordingly, one aspect of the present invention is to provide a lens rolling device that rolls a lens for insertion into an eye through a small incision.  
         [0026]     Another aspect of the present invention is a lens rolling device which provides a cannula through which a rolled lens is delivered into an incision of the eye.  
         [0027]     Still another aspect of the present invention is a lens rolling and delivery device providing a seamless cavity through which a rolled lens travels in order to be delivered into an eye.  
         [0028]     Still another aspect of the present invention is the formation of a rolled lens cavity, a cannula, and a funnel by the engagement of two separate members in order to form a seamless cavity through which a rolled lens is pushed by a plunger without snagging or tearing the lens.  
         [0029]     Another aspect of the present invention is to provide a method of rolling, storing, and inserting an intraocular lens in a time efficient manner.  
         [0030]     Still another aspect of the present invention is to provide a method of rolling and inserting an intraocular lens into an eye so that the lens is delivered into an eye by placing the tip of the cannula within the incision. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0031]      FIG. 1  is an elevated side view of one embodiment of the present invention. The figure shows the engagement with the first member with the second member in order to create a cavity.  
         [0032]      FIG. 2  is a perspective view the first member of an embodiment of the present invention. The first member and the second member are assembled by aligning the arms into the corresponding holes on the opposite member. The first member has a first shelf on which a lens can be placed for the rolling procedure. Also shown are the shoulder stops which prevent over compression of the lens within the cavity.  
         [0033]      FIG. 3  is a top view of the second member of an embodiment of the present invention. The figure shows the arm and the hole present within the member.  
         [0034]      FIG. 4  is a side elevation of an embodiment of the present invention, along with an intraocular lens, submerged in balanced salt solution within a container.  
         [0035]      FIG. 5  is an elevated side view of an embodiment of the present invention showing the engagement of the first member with the second member. The hatched lines show the hidden position of the arms being inserted into the holes. As engagement occurs, the lens is rolled and compressed within the cavity.  
         [0036]      FIG. 6  is a diagram of an intraocular lens being rolled within an embodiment of the present invention. The lens is placed on the lens holding shelf. The lens is placed with the lenticular surface or continuous convex surface facing away from the lens holding shelf on which it sits, and the concave surface of the lens facing the holding shelf on which the lens sits. As the first member and the second member are engaged, the first edge of the lens starts to roll inwardly. As the cavity is formed, the lens is rolled and compressed to fit within the cavity. As the first edge of the lens starts to roll, the second edge remains in approximately the same position as prior to applying pushing forces on the first member and second member of the lens rolling device.  
         [0037]      FIGS. 7A and 7B  are perspective views of an embodiment of the present invention. In  FIG. 7A , the first member is shown having a first cannula half and a first funnel half which are used to form the operational cannula and operational funnel upon engagement with the second member. The distal end of the first cannula half has a narrower wall as compared to the portion of the first cannula half which is located next to the first concave surface. In  FIG. 7B , the second member is shown having a second cannula half and a second funnel half which are used to form the operational cannula and operational funnel upon engagement with the first member  
         [0038]      FIG. 8  is a side elevation of an embodiment of the present invention. The invention has an operational cannula and operational funnel. Also shown is the distal end of the operational cannula. The distal end having a narrower wall for insertion of the distal end through the insertion in the cornea in order to deliver the rolled lens of the eye of the patient. The operational funnel is used to guide the plunger into the cavity in order to push the lens from the cavity and through the operational cannula.  
         [0039]      FIG. 9  is an elevated cross section side view showing the placement of the lens rolling device into the injector barrel. An alignment tab is placed behind the front bulkhead to position the lens rolling device snugly between the bulkhead and the alignment tab. The top surface and bottom surface of the injector barrel are sized to keep the lens rolling device fully engaged. The operational cannula protrudes through a hole in the front bulkhead. The rib and the back plate each have holes along the center line of the injector barrel for receiving the plunger.  
         [0040]      FIG. 10  is a side elevation of an embodiment of the present invention showing the operational cannula and operational funnel.  
         [0041]      FIGS. 11A and 11B  show an embodiment of the second member.  FIG. 11A  shows a top view of an embodiment of the second member with hatched lines showing the cavity therethrough. Also shown is the opening of the second member.  FIG. 11B  shows an elevated side view of the first member and second member with hatched lines showing the opening and cavity therethrough.  
         [0042]      FIGS. 12A and 12B  show the first member and second member positioned for engagement, and a close up of the first member.  FIG. 12A  provides an enlarged view of the first concave surface of the first member shown in  FIG. 12B .  FIG. 12B  is a cross sectional view of the first member and second member drawn along line  2 - 2  of  FIG. 11B , showing the lens positioned in the opening and the first member positioned to be inserted into the opening in order to roll the lens.  
         [0043]      FIG. 13  is an elevated side view of the invention, showing the first member inserted into the opening of the second member and a syringe attached to the second member by the luer lock. Also shown is the rolled lens being pushed into the operational cannula by a rod, which is attached to the plunger of the syringe. Hatched lines show the cavity therethrough. Hatched lines show the position of the plunger inside of the syringe. Also shown is the rod being pushed through the cavity in order to move the rolled lens.  
         [0044]      FIG. 14  is an elevated side view of the rod attached to the gasket and plunger. The casing of the syringe is not shown.  
         [0045]      FIG. 15  is a view of the lens rolled within the cavity. Note that the flatter of the two concave surfaces ( 26 ) is the surface in contact with the portion of the lens that is located on the exterior portion of the rolled lens. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0046]     The present invention relates to intraocular lenses formed of a material such as a hydrophilic acrylic, hydrophobic acrylic, silicone, co-polymer or other material that allows the intraocular lens (IOL) to be folded, rolled or otherwise deformed or compressed. The present invention is a device and method for rolling, deforming or compressing IOLs and positioning them for insertion into the eye of a patient.  
         [0047]     Most intraocular lenses have a center thickness of approximately one millimeter or greater for a 20 diopter lens. The commonly known rolling instruments include instruments to compress the thicker lenses made of a soft, flexible material, which typically allows the thicker lenses to be implanted through an insertion having a size of four millimeters or less. Thicker lenses made of a soft, flexible material can be folded upon themselves and implanted. Such folding is shown in the teachings of Mazzocco and others.  
         [0048]     The current invention rolls a very thin intraocular lens and is designed to allow the rolled lens to be implanted into an eye through an incision which is two millimeters or less. The lens  12  can be shipped in the lens rolling device  10 , but not rolled. After the lens is rolled in the lens rolling device  10 , the lens  12  and the injector roller, also called lens rolling device  10 , can then be placed in a bottle, or container  14 , containing a balanced salt solution, sealed and sterilized. The lens rolling device  10 , also called a rolling and storage device, may be manufactured of any hard plastic, ceramic material, metal, or equivalent which is compatible with human tissue. The lens rolling device  10  may be sterilized by autoclaving. In certain embodiments, autoclaving may occur at temperatures from 121° C. to 135° C. These materials are readily commercially available and known to those of skill in the art. The material could be moldable and should be durable to function under the conditions described herein. Those of skill in the art are familiar with the standard processes of molding, or tooling, etc. which may be employed to make the invention disclosed herein.  
         [0049]     An additional aspect of the present invention is that the lens rolling device  10  and an unrolled lens  12  are shipped within a container  14 . The container  14  has a balanced salt solution, or equivalent used for short term storage, so that the lens rolling device  10  and an unrolled lens  12  are submerged. The lens rolling device  10  may be used to roll the lens  12  and the container  14  may be used to store the rolled lens  16  for a short period prior to insertion into the eye of a patient. Briefly, when the lens rolling device  10  is ready to be used, the container  14 , also called a bottle, is opened to expose the previously sealed and sterilized lens rolling device  10  and unrolled lens  12 . After the lens rolling device  10  rolls the lens  12 , as described herein, it can be placed in a plunger assembly to allow insertion of the lens  12  into the eye of a patient.  
         [0050]      FIG. 1  shows the lens rolling device  10  in a fully assembled orientation. The lens rolling device  10  also called a rolling and storing device, or injector roller, may be manufactured of any hard plastic, ceramic material, metal, or equivalent material which is compatible with human tissue. The material should be moldable and should be durable to function under the conditions described herein. Methods of manufacturing specifically shaped hard plastic, ceramic material, metal, or equivalent material are well known in the art. The lens rolling device  10  disassembles into a first member  18  and a second member  20 .  
         [0051]      FIG. 2  shows a half of the lens rolling device  10 . The first member  18  and second member  20  have similar structural features. The first member  18  includes a first insertion arm  22 , also called a first arm, a first shelf  24 , also called a first surface, a first concave surface  26 , also called a second surface, and a first hole  28 . The similar structural features for the second member  20  are shown in  FIGS. 5 and 7 B. The second member  20  includes a second insertion arm  30 , also called a second arm, a second shelf  32 , also called a third surface, a second concave surface  34 , also called a fourth surface, and a second hole  36 , shown in  FIG. 3 .  
         [0052]     As shown in  FIG. 4 , the lens rolling device  10  and unrolled lens  12  may be shipped in a container  14 , also called a bottle. The lens  12  is an intraocular lens formed of a material such a hydrophilic acrylic, hydrophobic acrylic, silicone, or other material that allows the intraocular lens to be folded, rolled or otherwise deformed or compressed. For illustration, but not limitation, an example of a lens  12  is disclosed in U.S. Pat. No. 6,096,077. The container  14  may be a bottle or vial capable of being sterilized and sealed, as known in the art. Containers  14  are commercially available and the method of manufacture is known to those of skill in the art. The lens rolling device  10  and lens  12  are suspended in a balanced salt solution, or equivalent within the container  14 . Balanced salt solution is readily commercially available and its method of manufacture is known to those of ordinary skill in the art. The container  14 , and its contents, are sterilized and sealed to be transported. When ready to use the lens  12 , the lens rolling device  10 , with the lens  12  in an unrolled state, are removed from the container  14 . The lens rolling device  10  is used as described herein in order to roll or compress the lens  12 . While the lens  12  is rolled within the lens rolling device  10 , as further described below, both components may be stored in the balanced salt solution for up to thirty minutes, prior to insertion of the lens  12  into the eye of a patient.  
         [0053]      FIG. 5  shows the engagement with the first member  18  with the second member  20  which results in the assembled lens rolling device  10 . The action of engagement also results in the rolling and/or compression of the lens  12 . Details of the rolling and/or compressing are provided below within  FIG. 6 . Prior to engaging the first member  18  with the second member  20 , the lens  12  is placed on the first shelf  24 . In an alternate embodiment, the lens  12  may be placed on the second shelf  32  by flipping the orientation of both the first member  18  and the second member  20 . The proper orientation of the first member  18  and second member  20  is shown in  FIG. 5 . Engagement occurs when the first insertion arm  22  is aligned with and inserted into the second hole  36  and the second insertion arm  30  is aligned with and inserted into the first hole  28 . Such an orientation results in the second shelf  32  of the second member  20  being located above the lens  12 . Further insertion of the arms into the holes results in the formation of a cavity  38 . The cavity  38  has a diameter of approximately one millimeter. In alternate embodiments, the cavity  38  has a diameter of approximately two millimeters. In yet another alternate embodiment, the cavity  38  has a diameter from about one millimeter to two millimeters. In still another embodiment, the cavity  38  has a diameter of 0.5 millimeters to 1.0 millimeters. In certain embodiments, the cavity  38  is circular or round. In other embodiments of the present invention, the cavity  38  is oval, or a combination of circular and oval.  
         [0054]      FIG. 6  shows the formation of the cavity  38  by the engagement of the first concave surface  26  of the first member  18  and the second concave surface  34  of the second member  20 . The lens  12  is placed on the first shelf  24  of the first member  18  so that the convex surface  40  is facing away from the first shelf  24 . As the first concave surface  26  moves towards the second concave surface  34  the first edge  42  of the lens  12  begins to roll. Upon continued advancement of the first concave surface  26  and second concave surface  34  the lens  12  continues to roll and shown in  FIG. 6 . At or near engagement of the first concave surface  26  with the second concave surface  34  the cavity  38  is formed. Within the cavity  38  is the rolled lens  12  with the first edge  42  located within the rolled lens  12  and the second edge  44  located at the exterior of the rolled lens  12 . Since the lens  12  has a convex surface  40  and a concave surface  46 , the lens  12  will roll towards the concave surface  46 . The rolled lens  12  may be stored within the lens rolling device  10  for up to thirty minutes when submerged in a balanced salt solution or equivalent. In certain embodiments, the rolled lens  12  is submerged for approximately twenty minutes, for example, while a surgeon is extracting a cataractous natural lens of the eye. The shoulder stops  48 , shown in  FIG. 5 , prevent overcompression of the rolled lens  12  by preventing further movement of the first member  18  towards the second member  20 . Engagement of the first member  18  and second member  20  is accomplished by holding and engaging those members with one&#39;s hands along the body  50  of each member. The cavity is shown in  FIGS. 1, 4 ,  5  and  6 .  
         [heading-0055]     Multiple Embodiments of the Device for Rolling a Lens  
         [0056]     As shown in  FIGS. 11A, 11B ,  12 A,  12 B, and  13 , in certain embodiments of the lens rolling device  10  the first shelf  24 , second shelf  32 , and second concave surface  34  are present on the second member  20 . As best seen in  FIGS. 11A, 11B , and  12 B, an opening  33  within the second member  20  is defined by the first shelf  24 , second shelf  32 , and second concave surface  34 . The opening  33  is oriented along the longitudinal axis of the second member  20  and is intended to receive a lens  12  having a diameter of around 11 millimeters, or standard sized lenses  12 . In a certain embodiment, the width of the opening  33  is approximately 1.29 millimeters, or in a range from about 1.285 millimeters to about 1.29 millimeters. In such an embodiment, the first member  18  provides only the first concave surface  26  of the cavity  38 . The width of the first member  18  which is inserted into the opening  33  of the second member  20  is from about 1.320 millimeters to about 1.325 millimeters. This provides a force fit for the parts. In other embodiments, the first member  18  is lightly larger in width than the width of the opening  33  in order to provide a force fit of the parts. In certain embodiments, the first member  18  may also have a flattened edge  19  to allow a user to comfortably push the first member  18  into engagement with the second member  20 .  
         [0057]     Referring to  FIG. 12 , the first member  18  is inserted into the second member  20  after placing the lens  12  onto either the first shelf  24  or the second shelf  32  of the second member  20 . The size of the cavity  38  is decreased, and the lens  12  is rolled as previously described herein. Note that in certain embodiments the first concave surface  26  has an extended portion  27  which is flattened so that no sharp edge is present which could rip or grasp the lens  12  during the rolling process. In some embodiments, the extended portion  27  has a width of about 5 microns at the point most distal from the body of the first member  18 . In alternate embodiments, the first concave surface  26  has a radius surface of 0.79 millimeters and the radius is less than a half circle. Stated another way, if a line were drawn between the two extended portions  27  shown in  FIG. 12A , then less than half a circle would be visualized and the shape would more resemble half of an oval. Thus, the first concave surface  26  has a flatter curvature than the second concave surface  34  of the second member. As seen in  FIG. 15 , the portion of the lens  12  in contact with the more rounded second concave surface  34  initiated rolling and is found in the interior area of the rolled lens  12 . The flatter curvature of the first concave surface  26  creates more resistance to movement of the portion of the lens  12  contacting it.  
         [0058]     As shown in  FIGS. 7A, 7B , and  8 , in certain embodiments of the present invention, the lens rolling device  10  further includes a first cannula half  52  attached to the first end  54  of the first concave surface  26  and a second cannula half  58  attached to the first end  60  of the second concave surface  34  of the second member  20 . As shown in  FIGS. 8 and 10 , when the first member  18  fully engages the second member  20  an operational cannula  96  is formed as the first cannula half  52  contacts, or engages, the second cannula half  58 . Again, the individual halves are shown in  FIG. 8 . As shown in  FIGS. 7A and 7B , in certain embodiments, the first member  18  and the second member  20  may be identical It is understood that each cannula half may be approximately one half of the cannula, or a portion that is less than or more than one half. Thus the term cannula half is understood to mean a cannula portion, such that two cannula halves, or cannula portions, create an operational cannula upon engagement. The same understanding is present for the funnel halves, which engage to form an operational funnel  98 . Accordingly, the funnel halves, or portions, do not have to be exactly one half of the funnel.  
         [0059]     The  FIGS. 8 and 10  show the operational cannula  96  which has a narrow tip  100  used for inserting the lens  12  through an incision in the cornea of the eye of a patient. The first distal end  64  of the first cannula half  52  and the second distal end  66  of the second cannula half  58  contact in order to form the narrow tip  100  of the operational cannula  96  which is inserted through the incision in the cornea so that the lens  12  is inserted into the eye. The internal diameter of the narrow tip  100  of the operational cannula  96  is from about 1.32 millimeters to about 1.27 millimeters. In alternate embodiments of the present invention, the internal diameter of the operational cannula  96  is from about 1.32 millimeters to about 1.27 millimeters. With regard to the internal diameter of the bore which runs the entire length of the second member  20 , as shown in  FIGS. 11A and 11B , that internal diameter is from about 1.27 millimeters to about 1.32 millimeters.  
         [0060]     There is not a tendency for the lens  12  to hang, tear or become blocked as it moves from the cavity  38  through the operational cannula  96  and into the eye of the patient. As stated above, the operational cannula  96  of the current invention is made when the first cannula half  52  and the second half cannula half  58  are joined. Any seams present from the engagement or connection of those parts is parallel to the axis of movement of the lens  12  when the lens  12  travels from the cavity  38  and into the operational cannula  96 . Accordingly, when the lens  12  is pushed from the cavity  38  into the operational cannula  96 , the lens  12  will not become stuck or damaged in any capacity. As best seen in  FIGS. 8 and 10 , the narrow tip  100  of the operational cannula  96  has a thinner wall for insertion of that portion of the operational cannula into an incision site of an eye. The length of the thinner walled section provides a sufficient length for insertion of that portion of the operational cannula into the incision site. The thin walled section of the first distal end  64  of the first cannula half  52  is approximately 20 microns thick. Similarly, the thickness of the thin walled section of the second distal end  66  of the second cannula half  58  is also approximately 20 microns. The length of each of these distal ends is approximately 500 microns, which is approximately the thickness of the cornea. Stated another way, the length of the first distal end  64  of the first cannula half  52  and the length of the second distal end  66  of the second cannula half  58  are about the thickness of the cornea. In alternate embodiments, they are about twice the length of the thickness of the cornea.  
         [0061]     As shown in  FIGS. 11-13 , certain embodiments of the invention have an operational cannula  96  located on the second member  20 . As shown in  FIG. 11B , the first cannula half  52  and second cannula half  58  are part of the second member  20 .  
         [0062]     As shown in  FIGS. 7, 8  and  10 , certain embodiments of the present invention may have an operational funnel  98  in addition to an operational cannula  96 . As best seen in  FIGS. 7A and 7B , the lens rolling device  10  includes a first funnel half  68  attached to the second end  56  of the first concave surface  26  and a second funnel half  70  attached to the second end  62  of the second concave surface  34  so that the first funnel half  68  and the second funnel half  70  are opposite of the first cannula half  52  and the second cannula half  58 . Thus, when the first member  18  engages the second member  20 , an operational funnel  98  is provided.  
         [0063]     Certain embodiments of the invention, as shown in  FIGS. 11-13 , have an operational funnel  98  within the second member  20 . When the first funnel half  68  and the second funnel half  70  are present on the second member  20  to form the operational funnel  98 , the plunger  72  is guided through the device in order to push the lens  12  out of the device and into the eye.  
         [0064]     The material of construction for the operational cannula  96  and operational funnel  98  are the same as the materials of construction for the first member  18  and the second member  20  of the lens rolling device  10 .  
         [0065]     Since each half of the funnel is attached to the respective concave surface in the same manner that the cannula halves are attached to the respective concave surfaces, a seamless transition is provided between the operational funnel  98  and the cavity  38 . Stated another way, in a manner similar to the generation of the cavity  38  and the operational cannula  96 , the operational funnel  98  if provided upon engagement of the first funnel half  68  and second funnel half  70 . With regard to the operational funnel  98 , the diameter of the portion closer to the cavity  38  is smaller than the diameter of the operational funnel  98  further from the cavity  38 . As further described below, certain embodiments of the present invention include a plunger  72  which the operational funnel  98  guides into the cavity  38  so that the rolled lens  12  is pushed from the cavity  38  through the operational cannula  96  and into the eye of a patient.  
         [0066]     As further described below, an injector barrel  74  may be used to transfer the rolled lens  12  from the cavity  38  into the eye of a patient. An injector barrel  74  is shown in  FIG. 9 .  
         [0067]     As best seen in  FIG. 9 , an alignment tab  76  holds the lens rolling device  10  in position along an axis perpendicular to the axis of engagement of the first member  18  and the second member  20 . The front bulkhead  78  of the injector barrel  74  holds the lens rolling device  10  with the alignment tabs  76 . A top horizontal wall  80  and a bottom horizontal wall  82  hold the lens rolling device  10  in a compressed or engaged position. A first hole  84  within the front bulkhead  78  allows the operational cannula  96  to pass therethrough. Also present is a rib  86  which has a first hole  88  to allow insertion of the plunger  72 . The back plate  90  of the injector barrel  74  has a first hole  92  located along the center line of the back plate  90 . The first hole  92  allows passage therethrough of the plunger  72 . Thus, the plunger  72  is positioned by first hole  92  of the back plate  90 , and the first hole  88  of the rib  86 . Attached to the plunger  72  is a flat plate  94  used to compress the plunger  72  against the rolled lens  12 .  
         [0068]     As seen in  FIGS. 11-14 , certain embodiments of the invention do not use the injector barrel  74  in combination with a plunger  72 . As previously described herein, in certain embodiments, a second member  20  contains an operational cannula  96  and operational funnel  98 . In such an embodiment, an injector barrel  74  is not required to stabilize the engagement between the first member  18  and the second member  20 . As best seen in  FIG. 13 , the lens rolling device  10  is placed in alignment to receive the plunger  72 . Again, the plunger  72  is used to transition the rolled lens  12  from the cavity  38  through the operational cannula  96  and into the eye of a patient.  
         [0069]     Still referring to  FIG. 13 , certain embodiments of the present invention have a push rod  102  which is used to push the rolled lens  12  from the cavity  38  through the operational cannula  96  and into the eye of a patient. The diameter of the push rod  102  is less than the diameter of the cavity  38 , operational cannula  96 , and operational funnel  98 . In certain embodiments, the push rod  102  has a width of approximately 1.27 millimeters. The push rod  102  may be constructed of a rigid material, such as metal or polyethyl-ethyl-ketone (PEEK). The tip  103  of the push rod  102  is slightly rounded in order to avoid unintended ripping or grasping of the lens  12  by a sharp edge of the tip  103 . The push rod  102  may be attached to the plunger  72  in a variety of ways. For example, the push rod  102  may have a flange  104  which is embedded into the gasket  106  of the plunger  72 , such as a plunger of a commercially available syringe  101 . An example of such a syringe is the three millimeter syringe from Becton Dickinson and Company (BD). In certain embodiments, the gasket is removed from the plunger  72  and a hole of approximately 1.3 millimeters is cut in the center thereof. Then the flange  104 , is inserted into the gasket. Such an attachment allows the tip  103  of the push rod  102  to be free to self align with the cavity  38  as the push rod  102  moves toward the rolled lens  12 .  
         [heading-0070]     Methods of Using the Lens Rolling Device  
         [0071]     The present invention also disclosed a method of rolling, storing and inserting an intraocular lens into the eye of a patient. The steps of the method include providing a lens rolling device  10 , having a first member  18  and a second member  20 , placing the lens  12  on a shelf, for example the first shelf  24 , and sliding the first member  18  into engagement with the second member  20  so that the lens  12  is rolled and compressed within a cavity  38  formed by the engagement of the first member  18  and second member  20 .  
         [0072]     If the lens rolling device  10  and the lens  12  are received in a container  14 , then the lens  12  is to be removed from the container  14  and the balanced salt solution, or equivalent, within. The lens  12  is placed on the first shelf  24  by using forceps, or an equivalent. More specifically, the lens  12  is placed on the first shelf  24  of the first member  18  so that the convex surface  40  is facing away from the first shelf  24 . In certain embodiments of the present invention, as shown in  FIG. 6 , the first edge  42  of the lens  12  starts to roll inwardly as the second concave surface  34  of the second member  20  moves toward the first concave surface  26  of the first member  18 . As the two concave surfaces continue to approach each other, the lens  12  continues to roll up such that the lens is rolled or compressed within the cavity  38 . The first edge  42  of the lens  12  being positioned at the interior of the rolled lens  12  and the second edge  44  of the lens  12  having an external location. The direction of rolling is predictable since the lens  12  has a concave/convex shape so that, regardless of the power of the lens  12 , it always rolls in the same direction. Also, the unrolling process is predictable.  
         [0073]     In alternate embodiments, the lens rolling device  10 , with the lens  12  in an unrolled conformation in the cavity  38  thereof, is removed from a bottle of balanced salt solution, and squeezed to roll the lens  12 .  
         [0074]     Subsequent to compressing, or rolling, of the lens, the lens rolling device  10  may be place in the container  14  which contains a balanced salt solution, or equivalent. The rolled lens  12  and lens rolling device  10  are place within the container  14  for storage purposes. Under such conditions, the rolled lens  12  may be stored for up to thirty minutes.  
         [0075]     At the time for insertion of the lens  12  into the eye of a patient, the lens  12  may be removed from the cavity  38  as disclosed below. In certain embodiments of the present invention, the surgeon may disengage the first member  18  from the second member  20  in order to expose the rolled lens  12 . The surgeon may then grasp the rolled lens  12  with forceps, or an equivalent, and place the rolled lens  12  into the eye of the patient. Such a transitioning of the rolled lens  12  may be accomplished using a lens rolling device  10  which does not have an operational cannula  96  or an operational funnel  98 . Also, the method may be performed using a lens rolling device  10  which does have an operational cannula  96  and an operational funnel  98 .  
         [0076]     In an alternate embodiment of the present invention, when a lens rolling device  10  which has an operational cannula  96  and an operational funnel  98  is used, after the lens  12  is rolled as described above, the rolled lens  12  may be pushed from the cavity  38  into the operational cannula  96  and ultimately into the eye of the patient. At the time for insertion of the lens  12 , the lens rolling device  10  is placed in the injector barrel  74  such that the operational cannula  96  is received by the first hole  84  of the front bulkhead  78 . The injector barrel  74  holds the first member  18  and second member  20  in a fully engaged position. The plunger  72  is positioned to be received by the first hole  92  of the back plate  90  and the first hole  88  of the rib  86 , so that the plunger  72  is received in the cavity  38 . The plunger  72  is then pushed through the cavity  38  so that the lens  12  is expelled from the cavity  38 . The lens  12  travels from the cavity  38  through the operational cannula  96  and into the eye of the patient. Accordingly, the lens  12  is inserted into the eye through an incision in the cornea.  
         [0077]     In another embodiment, the rolled lens  12  is discharged from the lens rolling device  10  without the use of the injector barrel  74 . In the same manner, a plunger  72  is used to push the rolled lens  12  from the cavity  38  through the operational cannula  96  and into the eye. Certain embodiments may additionally use a push rod  102  in order to push the rolled lens  12  from the cavity  38  through the operational cannula  96  and into the eye of the patient. A syringe having a plunger  72  may be attached to the second member  20  by a standard luer lock  108 , in the same manner that a needle and syringe engage. In still other embodiments, a viscoelastic material, for example Healon® by Pharmacia, is injected into the second member  20  and an unrolled lens  12  is placed on either the first shelf  24  or second shelf  32  of the second member  20  and rolled by engaging the first member  18  and the second member  20 , as described herein.  
         [0078]     In other embodiments of the present invention, after the lens  12  has been rolled, the narrow tip  100  of the operational cannula  96  is placed in the corneal incision which has a size of one millimeter or less. The plunger  72  is pushed into the cavity  38  and the rolled lens  12  is injected into the eye through the operational cannula  96 . As best seen in Figurer  13  and  14 , in other embodiments, a syringe  101  is attached to the second member  20 , before or after rolling the lens  12 , and the lens  12  is pushed from the cavity  38  through the operational cannula  96  and into the incision by a rod  102  which is attached to the plunger  72  of a syringe  101 . The plunger  72  and rod  102  are easily manipulated by the hands of the user. The thin lens  12  is designed to unroll within the eye in approximately 15 seconds after coming in contact with the warm aqueous of the eye. The narrow tip  100  of the operational cannula  96  is removed from the incision site and the surgeon positions the lens  12  using the same incision opening. In certain embodiments of the present invention, the incision in the cornea is from about 2 millimeters to about 0.5 millimeters. In still other embodiments of the present invention, the incision in the cornea is from about 1 millimeter to about 0.25 millimeters.  
         [0079]     In all of the embodiments of the present invention, it is understood that the lens  12  is placed on the shelf of a member of the lens rolling device  10 . It is understood that the lens  12  may be place upon either the first shelf  24  of the first member  18 , or the second shelf  32  of the second member  20 . Upon engagement of the first member  18  and the second member  20 , the lens  12  is placed, or positioned, between two shelves, specifically the first shelf  24  and the second shelf  32 .  
         [0080]     All references, publications, and patents disclosed herein are expressly incorporated by reference.  
         [0081]     Thus, it is seen that the apparatus and method of the present invention readily achieves the ends and advantages mentioned as well as those inherent therein. While certain preferred embodiments of the invention have been illustrated and described for purposes of the present disclosure, numerous changes in the arrangement and construction of parts may be made by those skilled in the art, which changes are encompassed within the scope and spirit of the present invention as defined by the following claims.