Device for inserting a flexible intraocular lens

Field of Invention The present invention relates to a device that inserts a flexible intraocular lens (IOL) into a patient's eye.

<u style="single">Background of the invention</u> The crystalline lens of the natural eye plays a major role in focusing light on the retina for proper vision. However, the crystalline lens can be damaged due to injury, or become cloudy due to aging or illness, or cataracts. To restore vision, the natural lens must be surgically removed and replaced with an artificial lens.

Many surgical methods have been developed to remove the natural crystalline lens. For example, lens ultrasound aspiration is one of the most popular methods. According to this method, an elongated tool is inserted into the natural lens through an incision formed in the eye. This tool produces ultrasonic vibrations that emulsify the crystalline lens. The emulsified portion of the crystalline lens is then aspirated through the eye through a passage provided in the device. Unlike other methods, with this lens removal method, the surgeon only needs to make a narrow incision in the eye. In general, the use of small incisions can reduce the trauma and complications experienced during and after surgery.

The flexible IOL has a central optic portion that focuses light on the retina and at least one outwardly extending haptic. Haptech can have a variety of different shapes, but either the plate-like extension or the annular shape of Optech is the most common. In each case, the haptech extends outward and aligns the optec of the lens with the pupil. The flexible IOL is particularly suitable for insertion into the eye following the lens removal procedure of lens ultrasound aspiration. In order to insert a rigid, non-foldable IOL, it is necessary to widen the incision in a small lens ultrasound aspiration, while the flexible IOL allows it to pass through a narrow incision in the eye. It can be compressed and bent. Once the crystalline lens has passed through the incision and is released into the eye, it expands to its original shape and size.

<p> Many different devices have been developed for implanting flexible IOLs into the eye. See, for example, US Pat. No. 4,573,998 of Mazzocco, No. 4,681,102 of Bartell, No. 4,919,130 of Stoy et al., And No. 5,275,604 of Rheinish et al. In general, these devices serve to pass the compressed lens through a narrow incision in the eye. However, these devices require excessive manipulation of the lens, include multiple parts, and / or cannot adequately control the lens when entering the eye.</p>

<p><u style="single">Abstract of the invention</u> The present invention is a device that allows a flexible IOL to be easily bent, compressed and inserted through an incision in the eye. Generally, the insertion device has a tubular member that houses the crystalline lens, and a plunger that pushes the crystalline lens into the eye through the tubular member. When the crystalline lens is pushed through the passage, the lens is compressed into a small shape. The structure of the present invention guarantees simple, reliable and consistent compression of the crystalline lens.</p><p> According to one aspect of the invention, the tubular member comprises an intermediate preparatory region for holding the crystalline lens in a stress-free state. Preferably, the crystalline lens is held in a suspended position by its haptec so that the optech does not substantially contact the interior of the tubular member. In this way, the device can be used as a lens package and can be shipped and stored with a lens already ready for use. As a result, unnecessary manipulation of the crystalline lens is avoided. According to another aspect of the present invention, the tip of the plunger comprises a structure that holds the crystalline lens to the plunger when the crystalline lens is extruded from the tubular member. The distal tip of the plunger is preferably bifurcated, partially forming a slot for accommodating and holding the crystalline lens. This structure allows the plunger to hold the lens as it exits the tubular member and expands in the eye. Holding the lens in this way facilitates the attachment of the lens to the eye, and the risk of the lens being uncontrolled and unbent, or associated with the uncontrolled expulsion of the lens from the insert into the eye. Is reduced.</p><p>1. A device for inserting a flexible membrane into the eye, the device having a tubular member having a passage for accommodating the flexible membrane, the passage of which is open for inserting the flexible membrane into the eye. Has a distal end and is movably housed in the passage of the tubular member for moving the flexible membrane through the open distal end of the tubular member into the eye. A device having a plunger, the plunger having a distal tip formed to hold the flexible membrane in the plunger after the entire flexible membrane has been extruded from the passage.</p><p>2. The flexible membrane is a flexible intraocular crystalline lens with an optec and at least one haptec, and the distal tip of the plunger accommodates and holds at least one haptec or the optec in the crystalline lens. The device according to item 1 to be formed.</p><p>3. A proximal portion formed by a pair of normally parallel side walls for engaging the slot of the plunger with the haptec of the lens, and a pair of optecs of the lens for engaging. The device according to item 2, wherein the device has a distal portion formed by a multi-sided side wall.</p><p>4. The device of item 1, wherein the plunger further comprises at least one spring element for returning the plunger to the passage of the tubular member.</p><p>5. To return the plunger when the spring element has a pair of elastic protrusions that engage the wall of the passage and the plunger extends outside the distal end of the passage. The device according to item 4, which applies a bias force to the device.</p><p>6. The device of item 1, further comprising an intermediate preparation area along the passage for supporting the flexible membrane in a stress-free manner before the tubular member is engaged by the plunger. ..</p><p>7. The flexible membrane is a flexible intraocular crystalline lens with an optec and at least one haptec, the optec of the crystalline lens floating in the air and substantially in contact with the interior of the tubular member in the stress-free state. 6. The apparatus of item 6, wherein the intermediate preparation region has a support surface that supports at least one haptec of the crystalline lens so as not to.</p><p>8. The support surface has a pair of distal supports and open spaces adjacent to each of the distal supports, which accommodate the sides of the lens when the lens is compressed. The device according to item 7, which is adapted to be.</p><p>9. The device of item 6, wherein the passage of the tubular member is tapered as it extends from the intermediate preparation area to the distal end.</p><p>10. The device of item 6, wherein the intermediate preparation area has a cover that can be opened to reveal the flexible membrane for inspection.</p><p>11. The device of item 10, wherein the tubular member further comprises a separate cannula element housed in the cover to keep the cover in a closed position.</p><p>12. The device of item 1, wherein the tubular member has a support surface for a cover that can be opened to reveal the flexible membrane for inspection.</p><p>13. The tubular member has a cannula and a base member, the base member has a stage supporting the flexible membrane, and the cannula is on the open distal end and the stage. The device of item 1, wherein the device has a cover, the cover being hinged for movement between the open and closed positions.</p><p>14. A device further comprising an auxiliary cover, the auxiliary cover being used to store the flexible membrane in the device and the cannula cover being used to insert the flexible membrane into the eye. , Item 13.</p><p>15. A device that inserts a flexible intraocular lens with Optech and at least one haptech into the eye, the device having a tubular member with a passage that houses the lens, the passage of which sees the lens. It has an open distal end for insertion into the lens and an intermediate preparatory area that supports the lens in a stress-free manner, with the optec of the lens floating in the air and inside the tubular member in the stress-free state. The intermediate preparation region has a support surface that supports at least one haptec of the lens, and the lens is moved to the eye through the open distal end of the tubular member so as not to substantially contact with. A device having a plunger movably housed in the passage of the tubular member for causing.</p><p>16. The support surface has a pair of distal supports and open spaces adjacent to each of the distal supports, which accommodate the sides of the lens when the lens is compressed. The device according to item 15, which is adapted to be.</p><p>17. The device of item 15, wherein the passage of the tubular member is tapered as it extends from the intermediate preparation area to the distal end.</p><p>18. The device of item 15, wherein the tubular member has a cover that can be opened to reveal the crystalline lens for inspection.</p><p>19. The device of item 18, wherein the tubular member further comprises a separate cannula element housed in the cover to keep the cover in a closed position.</p><p>20. A device further comprising a separate cannula element having the open distal end and the cover, the covers hinged for movement between the open and closed positions. The device of item 18.</p><p>21. A device further comprising an auxiliary cover, the auxiliary cover being used to store the flexible membrane in the device and the cannula element cover being used to insert the flexible membrane into the eye. The device according to item 20.</p><p>22. The device of item 15, wherein the plunger has a distal tip comprising means for holding the crystalline lens outside the passage.</p><p>23. The device of item 22, wherein the plunger further comprises a spring element for returning the distal tip of the plunger to the passage of the tubular member.</p><p>24. A device that inserts a flexible membrane into the eye, the device having a tubular member that forms a path through which the flexible member travels for insertion into the eye, the path of which is the intermediate preparation area. Extending through the lumen and open distal end, the intermediate preparation area is located in the pocket containing the flexible membrane, in front of the pocket, when the flexible membrane moves along the path. A pair of upright members that move the central portion of the flexible membrane laterally away from the sides of the tubular member, and the sides of the flexible membrane as the flexible membrane moves along the path. Has an open space adjacent to each of the upright members that are bent into it, and is movably contained within the tubular member that the flexible membrane moves to the eye along the path. A device with a plunger.</p><p>25. The device of item 24, wherein at least a portion of the lumen is tapered as it extends toward the distal end to compress the flexible membrane into a smaller shape.</p><p>26. The flexible membrane is an intraocular crystalline lens having an optec and at least one haptec, the optec of the crystalline lens floating in the air in the pocket and substantially inside the intermediate preparation region in the stress-free state. 24. The device of item 24, wherein the intermediate preparation area further comprises means adjacent to the posterior portion of the pocket to support the haptec of the crystalline lens so as not to make contact with the lens.</p><p>27. The apparatus of item 24, wherein the intermediate preparation area has a cover that can be opened to reveal the flexible membrane in the absence of stress for inspection.</p><p>28. The device of item 27, wherein the tubular member further comprises a separate cannula element housed in the cover to keep the cover in a closed position.</p><p>29. A device further comprising a separate cannula element having the open distal end and the cover, the covers hinged for movement between the open and closed positions. Item 27.</p><p>30. A device further comprising an auxiliary cover, the auxiliary cover being used to store the flexible membrane in the device and the cannula element cover being used to insert the flexible membrane into the eye. The device according to item 29.</p><p>31. The device of item 24, wherein the plunger comprises means for holding the flexible membrane on the outside of the tubular member.</p><p>32. The device of item 31, wherein the plunger comprises a distal tip and the holding means comprises a slot formed in the distal tip.</p><p>33. The device of item 31, wherein the plunger further comprises a spring element for returning the plunger to the passage of the tubular member.</p><p>34. A device that inserts a flexible membrane into the eye, having a tubular member with a base member and a cannula element, the base member and the cannula element comprehensively forming a passage for accommodating the flexible membrane. The passage has an open distal end to the cannula element into which the flexible membrane is inserted into the eye, and the base member has a stage that supports the flexible membrane in a stress-free manner. An axially rotatable cover between an open position that allows the cannula to approach the flexible membrane and a closed position above the stage for insertion of the flexible membrane into the eye. A device having and having a plunger movably housed within the tubular member for moving the flexible membrane to the eye along the passage.</p><p>35. A device further comprising an auxiliary cover, the auxiliary cover being used to store the flexible membrane in the device and the cannula element cover being used to insert the flexible membrane into the eye. The device according to item 34.</p><p>36. A method of implanting a flexible intraocular lens with Optec and at least one Haptech into the eye, the method of inserting the distal portion of the tubular member through an incision in the eye, into the tubular member. Holding the lens, engaging and holding the lens on the distal tip of the plunger, moving the lens along a path formed in the tubular member, compressing the lens to a smaller size A method comprising bending the lens and moving the lens from the tubular member to the eye as it travels along the path.</p><p>37. The method of item 36, wherein the movement of the crystalline lens through the tubular member to the eye is performed in a single continuous motion after the tubular member has been inserted through the incision in the eye.</p><p>38. Item 36, further comprising the step of holding the lens at the distal tip of the plunger and releasing the lens from the plunger when the lens moves from the tubular member. Method to describe.</p><p>39. The method of item 38, wherein the release of the crystalline lens is performed by moving the plunger in the longitudinal direction after the crystalline lens has moved from the tubular member.</p><p>40. The plunger moves such that the movement of the lens to release the lens causes the lens to engage with the distal end of the tubular member and release the lens from the plunger. 39. The method of item 39, comprising returning the lens to the tubular member.</p><p>41. The method of item 36, wherein the crystalline lens is held by the tubular member in a stress-free state.</p><p>42. The method of item 41, wherein the crystalline lens is held by the tubular member so that its optec portion floats in the air and does not substantially contact the inside of the tubular member.</p><p>43. A method of implanting a flexible membrane into the eye, the method of inserting the distal portion of a tubular member through an incision in the eye, holding the flexible membrane in the tubular member, the flexible membrane. Engaging and holding the membrane with the distal tip of the plunger, moving the flexible membrane along a path formed in the tubular member, and when moving along the path, the flexible membrane A method comprising folding the flexible membrane and moving the flexible membrane from the tubular member to the eye so that it is compressed to a smaller size.</p><p>44. The method of item 43, wherein the movement of the flexible membrane through the tubular member to the eye is performed in one continuous motion after the tubular member has been inserted through the incision in the eye.</p><p>45. When the flexible membrane moves from the tubular member, a step of holding the flexible membrane at the distal tip of the plunger and a step of releasing the flexible membrane from the plunger. The method of item 43, further comprising.</p><p>46. The method of item 45, wherein the release of the flexible membrane is performed by moving the plunger in the longitudinal direction after the flexible membrane has moved from the tubular member.</p><p>47. The movement of the flexible membrane to perform its release is such that the flexible membrane engages the distal end of the tubular member and releases the flexible membrane from the plunger. 46. The method of item 46, comprising returning the plunger to the tubular member.</p><p>48. The method of item 43, wherein the flexible membrane is held on the tubular member in a stress-free manner.</p><p>49. The method of item 48, wherein the flexible membrane is held by the tubular member so that its central portion floats in the air and does not substantially contact the interior of the tubular member.</p><p>50. A device that inserts a flexible membrane into the eye, having a tubular member with a base member, a cover, and a cannula, the tubular member further having a passage for accommodating the flexible membrane, the passage. The base member has a stage that supports the flexible membrane in a stress-free manner, with a distal end open to the cannula for inserting the flexible membrane into the eye, and the cover. Because of the movement between the open position that allows access to the flexible membrane and the closed position above the stage for insertion of the flexible membrane into the eye, the base member or A device that is axially attached to the cannula and has a plunger that is movably contained within the tubular member for moving the flexible membrane to the eye along the passage.</p>

<u style="single">Detailed description of preferred embodiments</u> The present invention relates to a device 10 (FIG. 1) that inserts a flexible IOL 12 into the patient's eye 14 (FIG. 26). The device has an outer tubular unit 16 and an inner plunger 18. In one embodiment, the tubular unit 16 is formed by a base member 20, a cover 21 and a cannula 22 that are connected to each other (FIGS. 1, 13 and 14). The components of device 10 can consist of plastic or metallic materials. For example, the components can be made of polycarbonate or polypropylene. The plunger 18 and the cannula 22 are preferably made of polypropylene. However, a wide range of materials can be used.

Base member 20 has a relatively large opening at the proximal end 26, and an inner passage 24 with a reduced size opening 27 near the distal end but away from the distal end 28. It is an elongated tubular member forming the (Figs. 1, 5, 13 and 14). A shelf 29 extending forward protrudes from the opening 27 (FIGS. 5, 13 and 14). Preferably, the base member 20 generally has an elliptical cross section, but other shapes may be used.

The inner passage 24 of the base member 20 is formed so as to movably accommodate the plunger 18 therein. The longitudinal groove 34 is selectively located along one of the side walls 32 forming the inner passage 24 (FIG. 13). The groove 34 engages with a flange 35 projecting laterally from the plunger 18 to ensure that the plunger is oriented appropriately when placed in the base member 20. However, the groove structure can be replaced with another structure to ensure proper mounting, such as forming at least a portion of the inner passage 24 and the plunger 18 in a D shape. Near the distal end 28, the base member 20 forms a narrowed neck 39. The neck 39 forms a distal opening 27 through which a portion of the plunger passes and engages the crystalline lens 12. Convergence guide 41 is located along the opposite inner side of passage 24 and leads to neck 39 (FIGS. 5, 13 and 14). The guideway 41 serves to facilitate passage over the shelf 29 through the neck 39 of the plunger for engaging with the crystalline lens 12.

The shelf 29 is formed as an extension of approximately half the length of the tubular base member 20. The shelves 29, together with the cover 21, form an intermediate reserve area compartment 45 for holding the crystalline lens 12 (FIGS. 5-11 and 13-14). Lens 12 preferably has a central optech and a pair of adjacent web or plate haptechs 49a, 49b (FIGS. 14 and 24). However, other lens structures such as the crystalline lens of the annular Haptec can also be used. The inner surface of the shelf portion 29, in part, is a pair of ledges 51a, 51b adjacent to the neck 39, a pair of depressed central planes 52a, 52b, and a pair of lamps 53a, 53b separated from the front of the planes 52a, 52. It is formed by (Figs. 5 to 11 and 13 to 14). The ledges 51a, 51b and the lamps 53a, 53b are formed with top surfaces 54a, 54b, 55a, 55b, respectively, engaging and supporting the haptecs 49a, 49b of the crystalline lens 12 in the initial stress-free position. There is. The lamps 53a, 53b further have slopes 59a, 59b tilted towards planes 52a, 52b. The planes 52a, 52b are recessed with respect to the top surfaces 54a, 54b, 55a, 55b to form a pocket 60 for accommodating the Optec 48.

The cover 21 faces the shelf 29, forms an intermediate preparation area compartment 45, and traps the crystalline lens 12 in its initial stress-free position (FIG. 13). The cover 21 has recesses 61a and 61b on its inner surface, the central portion of which faces the proximal halves of the planes 52a and 52b. A pair of adjacent flat portions 63a, 63b face the ledges 51a, 51b and form a gap 65 adapted to engage, accommodate and hold the proximal Haptec 49a. The haptech 49a is loosely accommodated in the gap 65 for easy extrusion from the intermediate preparation area 45 during the insertion process. The ledges 51a, 51b, flats 63a, 63b and lamps 53a, 53b comprehensively support the crystalline lens 12 by Haptec 49a, 49b. In this initial position, the Optech 48 is held floating in the pocket 60 so that the Optech does not come into contact with the inner wall of the intermediate preparation area compartment 45.

The crystalline lens 12 may be installed in the compartment 45 in the manufacturing plant and shipped to the user in device 10 with or without the cannula 22. In this method, the device 10 can conveniently also serve as a lens package. Since the lens 12 is generally supported in the air and without stress, the lens can be stored for a considerable period of time, perhaps as long as 10 years. The cover can be fixed to the base member 20, but is designed to be removed to allow examination of the crystalline lens prior to implantation into the eye. As shown in FIG. 14, the cover 21 is separable from the base member 20 and is secured in place by a clasp, tape or other fixing means. However, the cover may be hinged to the cannula 22, shelf 29 or neck 39.

The cover 21 has protrusions 67a, 67b that match recesses 68a, 68b formed in the shelf 29. In addition, the shelf 29 has proximal outer walls 70a, 70b and distal outer walls 72a, 72b. Proximal walls 70a, 70b are adjacent to the outer parts of the recesses 61a, 61b. Similarly, the distal walls 72a and 72b are adjacent to the walls 73a and 73b of the cover 21. The distal walls 72a, 72b preferably collapse with respect to the proximal walls 70a, 70b, increasing the suitability of the cover 21. The cover may be closed and held by cannula 22, tape and / or other means to prevent the lens from being inadvertently dislodged during shipment of the device.

Valleys 75a, 75b are formed on the shelf 29 by extending the medial wall surface 78 of the compartment 45 downward between the lateral distal sides of the planes 52a, 52b and the distal walls 72a, 72b. Valleys 75a, 75b are provided to accommodate the opposite side of the lens 12 as it is bent or rolled along the inner wall surface 78. In a preferred embodiment, the valley is deeper than planes 52a, 52b.

The cover 21 has a sloping, central, generally flat surface 88 that extends away from the shelves 29. Normally, the conical portion 91 surrounding the inclined surface 88 faces the lamps 53a and 53b. Together with the lamps 53a, 53b, these surfaces 88, 91 begin the desired bending of the crystalline lens, bringing it into a compressed state.

Cannula 22 is an elongated tubular member with an open proximal end 93 and an opposite open distal end 95 (FIGS. 1 and 12-14). The cannula 22 is preferably further divided into three stages, parts 97-99. The proximal portion 97 is typically rectangular and forms an internal cavity 101 sized to engage and accommodate the assembled shelves 29 and cover 21. The portion 97 extends from the distal end 28 of the base member 20 to the neck 39 and serves to hold the cover 21 against the shelf 29. A shaft groove 102 is formed along one wall of the cavity 101 and is housed in engagement with a ridge 103 extending from a cover 21. A hole 104 formed at the proximal end 93 of the cannula 22, along with a bias lock 106 of the base member 20, anchors the cannula in place.

The central 98 of the cannula 22 is significantly smaller than the proximal 97 so that the rim 110 is formed in between. The rim 110 acts as a shoulder adjacent to the side-by-side distal ends 28, 111 of the base member 20 and cover 21. The inner wall of the central portion 98 narrows to form a funnel-shaped passage 112. The funnel portion 112 preferably has an elliptical cross section, but other shapes may be used. This funnel effectively rolls and compresses the crystalline lens into the eye.

The last distal part 99 of the cannula 22 is an elongated tube that forms the inner lumen 114. The distal part 99 is inserted through a narrow incision in the eye. Like the central portion 98, preferably the distal portion 99 and the lumen 114 have an elliptical cross section. Of course, other shapes may be used if desired. Manufacture of Lens 12 To further facilitate compression, the lumen 114 is formed with a slight taper as it extends forward. The distal end 95 of the cannula 22 is beveled to facilitate insertion of the cannula into the incision and to facilitate the gradual enlargement of the lens as it exits the lumen 114.

The distal portion of the cannula can have various cross sections. For example, the cannula may have the shape of a cloverleaf tip 22A, a foldable bag-shaped tip 22B, or a corrugated tip 22C (FIGS. 27-29). The tips of these shapes increase the force of the tips, which allows the use of narrower structures. The tip of the cannula can also be formed with a collet-like structure 22D. In this embodiment, the tip has four separable leaf springs 23 that expand when the crystalline lens is pushed into the eye. The leaf spring 23 is urged to close naturally after the crystalline lens is placed in the eye and the plunger is pulled.

In a preferred embodiment, the cover 221 is hinged to the base member 220 of the tubular unit 216 (FIGS. 34-37). The internal shape of the cover 221 is essentially the same as the internal shape of the cover 21, except that the protrusion 267 is interconnected with the flat portion 263 by a portion 264. Similarly, the internal shape of the shelf 229 is substantially the same as the internal shape of the shelf 29. As seen in FIG. 37, the shelf 229 comprises a corresponding interconnect with the ledge 251 of the recess 268. Further, the central groove 224 of the shelf portion 229, which accommodates the passage of the plunger, is enlarged beyond the central portion. These deformations do not affect the compression and insertion of the lens into the eye.

Further, as an arbitrary component, the hall 246 may be provided so as to pass through the shelf portion 229. In embodiments where the cover is secured to the shelf or otherwise not opened by the surgeon, the hole can be used to insert a viscoelastic material.

Cover 221 has a pair of rearwardly extending arms 265 with knobs 266 at the free end. The arm 265 is provided to pivot the cover to the neck 239. Specifically, the neck portion 239 has a pair of sockets 242. Socket 242 holds a substantially square opening 243 (although other shapes may be used) to accommodate the knob 266, and arm 265 as the cover 221 moves to the closed position (not shown). It is formed so as to include a groove portion 244 for accommodating. A recess 245 is formed in the outer wall of the opening 243 to accommodate the outward protrusion of the knob 266 (FIG. 35). By accommodating the knob 266 in the recess 245, the cover 221 acts to be held by the base member 220.

In another embodiment, the cannula 160 comprises a hinged cover 162 for movement between the open and closed positions (FIG. 32). The cannula 160 has essentially the same structure as the cannula 22 except that the cover 162 is integrated into the proximal portion 164. The cover 162 has substantially the same structure as the cover 21, including the same internal shape, and supports and compresses the crystalline lens.

Proximal portion 164 of the cannula 160 has a base 166 and a cover 162. The base has a pair of side walls 170 that extend up only to the same height as the bottom wall 168 and the shelf 29. The inner surfaces of the bottom wall 168 and the side wall 170 are shaped to engage and accommodate the outer surface of the shelf 29. A pair of upright flanges 172 are provided at the proximal end 174 of the base 166 and engage the neck 39 to provide sufficient support for the cannula. A hole 176 is provided to lock the cannula to the base member 20 together with a protrusion (not shown) on the shelf 29.

The cover 162 is movably connected to the base 166 by a living hinge 178, but other hinge structures may be used. The cover is axially rotatable to an open position that allows examination of the lens and a closed position for inserting the lens into the patient's eye. The lower end of the side wall 180 of the cover is formed by a conventional structure (not shown) so that it lock-engages and stays on the base 166. However, other fixed structures may also be used. The internal structure of the cover 162 is aligned with the internal structure of the shelf portion 29 in the same manner as the cover 21. The cover 162 further has a proximal tab 182 protruding between the flanges 172 and engages the locking protrusion 106 in the hole 184.

As another structure, the side wall 170a of the cannula 160a extends to the entire depth of the proximal 164a, and the cover 162a has a flat structure (Fig. 33). The inner surface of the cover 162a has the same shape as the cover 21 described above and a relative position with the shelf 29. The end 180a of the cover 162a is preferably constructed such that it lock-engages and stays at the end 181a of the side wall 170a. However, other fixed structures may also be used.

Preferably, the cannulas 162, 162a are made of polypropylene or other thermoplastic material. A disposable cover (not shown) can be used to ship and store the IOL within the device 10. Preferably, the disposable cover has the same general size and shape as the covers 162, 162a and is capable of engaging and retaining the bases 166, 166a. Disposable covers can have a variety of internal structures if the IOL is well supported and protected (as mentioned above for other covers).

The plunger 18 is adapted to move through the internal passage 115 formed by the tubular unit 16 (FIGS. 1 and 13). The plunger preferably comprises a body 116 having a cross section (FIGS. 2-3). As mentioned above, one flange 35 of the body is housed in the groove 34 to ensure proper installation of the plunger. A flat thumb pad 119 is provided at the proximal end of the body 116 for manual operation of the device. However, other structures may be provided for the plunger 18 to travel through the tubular unit 16. The front end of the body 116 includes a pair of separate O-rings 120a, 120b. The O-ring provides a level of resistance that allows for more controlled manual operation of the plunger. The O-ring also helps prevent the plunger from inadvertently moving when the surgeon operates device 10 during surgery. Other structures, such as friction flanges, can also be used in place of O-rings.

A thin rod 122 protrudes forward beyond the body 116 of the plunger 18. The rod is adapted to pass through the intermediate preparation area 45, the funnel 112 and the lumen 114. The shelves 29 form a groove 124 and the cover 21 has a relief 125 to provide sufficient space for the rod 122 (FIGS. 5-11 and 13-14). Since the surface 88 is separated from the inner surface of the shelf 29, the relief 125 extends only halfway through the cover 21, which provides ample space for the rod 122. The rod 122 can have a variety of shapes, but preferably has a circular or slightly elliptical shape adapted to pass through the distal end 95 of the cannula 22 (FIG. 25).

The distal end 128 of the rod 122 is preferably bifurcated to form a pair of teeth or (prong) 131a, 131b separated by a slot 132 (FIGS. 23, 1618, Figures 24 and 25). The slots are shaped to accommodate and hold the proximal haptec 49a and optec 48 of the crystalline lens 12. The teeth and the ends 135a, 135b of 131a, 131b are chamfered and comprehensively form a pair of walls 137a, 137b that normally form a V-shape. Depending on the robustness of the proximal haptech, the walls 137a, 137b may or may not engage with the proximal end of the optec 48. The teeth and 131a and 131b are preferably identical to each other. However, one tooth or 131a is formed narrower than the other tooth or 131b so that the lens 12 creates extra space for winding and compressing while passing through the lumen 114 and into the patient's eye. obtain. However, under normal circumstances, no extra space is needed.

The distal tip of the plunger 18 can also be formed with other structural shapes that hold the lens when it is extruded from the cannula. For example, when implanting an IOL with an annular haptec, the plunger may be formed with a closed vertical slot (not shown) along the top of the rod 122 instead of an open horizontal slot 132. .. In this structure, the crystalline lens is located in the intermediate preparation area 45, with the haptec extending from a point along the side of the tubular unit. The back-wound haptec can be inserted into the vertical slot when the lens is placed in the intermediate preparation area. The plunger can be secured in place by the use of latches, tape or other fixing means to prevent the Haptech from being inadvertently dislodged during shipping and storage. In either case, the plunger engages the optec portion of the crystalline lens with its distal end, which is formed with only an inclined surface such as, for example, 137a, 137b. When the crystalline lens first extends beyond Cannula 22, the haptec described above remains trapped in a slot that has not yet appeared on the outside of Cannula 22. When wishing to release the crystalline lens, the plunger is pushed slightly further forward, revealing a vertical slot and releasing the trapped haptech. The plunger can then return to the tubular unit 16 while the crystalline lens remains in the eye.

In one embodiment, a pair of elastic spring elements 140a, 140b extend laterally from rod 122 near the proximal end of the rod (FIGS. 2-3). The spring element acts to press the guide path 41 when the free end 128 of the rod 122 extends beyond the cannula 22. Engagement with this guideway 41 pushes the spring elements 140a, 140b back, which creates a bias force that pulls the plunger into the rear tubular unit 16. In a suitable structure, the spring element (not shown) typically extends from the front end of the body to the front in parallel with the rod 122. In this structure, the spring element may be designed to engage the guide path 141 and wind inward. In addition, coil springs (not shown) can be secured around the plunger / rod to provide the desired bias force. Of course, other spring structures can also be used. The spring can also be omitted and the plunger can be manually replaced by the surgeon.

Once the lens is inspected, device 10 can be assembled. Typically, the viscoelastic material used in such surgical procedures is typically placed on the cannula 22 as a lubricant in the insertion process prior to attachment of the cannula 22 to the assembly. Once the device 10 is assembled, the surgeon inserts the distal end of the cannula 22 into the incision 142 of the eye 14. The surgeon then grasps the lateral flange 141, pushes the pad 119, and continuously moves the plunger 18 forward (Fig. 1). The continuous movement of the rod 122 through the tubular unit 16 engages the lens 12 through the distal end 128 (FIG. 24). Proximal Haptec 49a and possibly a portion of Optec 48 are housed and held in slot 32 between walls 137a, 137b. The crystalline lens is then pushed forward by the plunger 18 and the distal flank of the Optec 48 is laterally moved towards the cover 21 by the slopes 59a, 59b of the ramps 53a, 53b. That is, the slopes 59a and 59b guide the central part of Optec 48 away from the planes 52a and 52b (FIGS. 19 and 20). The slanted surface 88 and the conical surface 91 provide ample space for this movement of the crystalline lens. As the center of the lens moves over the lamps 53a, 53b, the sides of the lens are usually pushed by the inner wall 78 of the cover 21 in the opposite direction of the lamp. Specifically, the conical surface 91 of the cover 21 involves the crystalline lens 12 in the valleys 75a and 75b. As the crystalline lens continuously advances through the tapered passage of the tubular unit 16, the crystalline lens is continuously wound and compressed.

The crystalline lens continues to move forward until the plunger 18 pushes the crystalline lens 12 and crosses the cannula 22. In a suitable structure, the plunger 18 is manually pushed forward in a controlled manner, but other means such as an electric motor or pneumatic drive may also be used.

The earlier Haptec 49b is placed in the distal dead end 152 of the capsule-shaped bag 154. As the lens 12 exits the cannula 22, the lens expands to a completely stress-free state (FIGS. 22, 24 and 26). However, the crystalline lens remains held in slot 132 of the plunger 18. Plunger retention of the lens reduces the risk of the lens exiting the cannula in an uncontrolled manner and damaging the interior of the eye. Also, by holding the crystalline lens with the plunger, control when mounting the crystalline lens into the eye is enhanced. To release the lens, the plunger returns into the tubular unit 16 and the lens is pushed out of slot 132 by the distal end 95 of the cannula 22 (FIG. 23). Preferably, the bias spring elements 140a, 140b automatically return the plunger 18 when pressure is removed from the thumb pad 119. An additional tool, or perhaps device 10, is typically required to properly position the Proximal Haptec 49a in the capsule-shaped bag 154.

The above description relates to preferred embodiments of the present invention. Various other embodiments, many modifications and modifications, can be made without departing from the spirit and broader aspects of the invention as described in the claims. For example, a preferred embodiment relates to the insertion of a flexible IOL into the eye, but the present invention is not limited thereto. The teachings of the present invention are applicable to the insertion of flexible membranes, including synthetic membranes, biopolymer membranes and natural body cells.

<figref num="1">FIG. 1 is a perspective view of an insertion device according to a preferred embodiment of the present invention.</figref><figref num="2">FIG. 2 is a side view of the plunger of the insertion device.</figref><figref num="3">FIG. 3 is a plan view of the plunger.</figref><figref num="4">FIG. 4 is a cross-sectional view taken along the line 4-4 of FIG.</figref><figref num="5">FIG. 5 is a partial cross-sectional view of the tubular unit of the insertion device, including the intermediate preparation area, the cover removed, turned inside out, and the cannula omitted.</figref><figref num="6">FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5 with the cover placed on the shelf.</figref><figref num="7">FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 5 with the cover placed on the shelf.</figref><figref num="8">FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 5 with the cover placed on the shelf.</figref><figref num="9">FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 5 with the cover placed on the shelf.</figref><figref num="10">FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 5 with the cover placed on the shelf.</figref><figref num="11">FIG. 11 is a cross-sectional view taken along line 11-11 of FIG. 5 with the cover placed on the shelf.</figref><figref num="12">FIG. 12 is a cross-sectional view taken along the line 12-12 of FIG.</figref><figref num="13">FIG. 13 is a partial cross-sectional view taken along line 13-13 of FIG. 1 with the IOL in the intermediate preparation region.</figref><figref num="14">FIG. 14 is an exploded view of FIG.</figref><figref num="15">FIG. 15 is a partial plan view of the tubular unit of the insertion device with the IOL in the intermediate preparation area and the cover and cannula omitted.</figref><figref num="16">FIG. 16 is a side view of the distal tip of the plunger.</figref><figref num="17">FIG. 17 is a front view of the distal end of the plunger.</figref><figref num="18">FIG. 18 is a plan view of the distal end of the plunger.</figref><figref num="19">19 to 23 are schematic partial cross-sectional views taken along line 19-19 of FIG. 1, respectively, illustrating the movement of the plunger during insertion of the IOL into the eye.</figref><figref num="20">19 to 23 are schematic partial cross-sectional views taken along line 19-19 of FIG. 1, respectively, illustrating the movement of the plunger during insertion of the IOL into the eye.</figref><figref num="21">19 to 23 are schematic partial cross-sectional views taken along line 19-19 of FIG. 1, respectively, illustrating the movement of the plunger during insertion of the IOL into the eye.</figref><figref num="22">19 to 23 are schematic partial cross-sectional views taken along line 19-19 of FIG. 1, respectively, illustrating the movement of the plunger during insertion of the IOL into the eye.</figref><figref num="23">19 to 23 are schematic partial cross-sectional views taken along line 19-19 of FIG. 1, respectively, illustrating the movement of the plunger during insertion of the IOL into the eye.</figref><figref num="24">FIG. 24 is an enlarged plan view of the distal tip of the plunger holding the IOL.</figref><figref num="25">FIG. 25 is a front end view of the insertion device in which the plunger extends to the distal end of the cannula.</figref><figref num="26">FIG. 26 is a cross-sectional view of an eye illustrating insertion and attachment of an IOL.</figref><figref num="27">FIG. 27 is a perspective view of another structure of the distal end of the cannula.</figref><figref num="28">FIG. 28 is a perspective view of a second alternative structure at the distal end of the cannula.</figref><figref num="29">FIG. 29 is a perspective view of a third alternative structure at the distal end of the cannula.</figref><figref num="30">FIG. 30 is a side view of a fourth alternative structure at the distal end of the cannula.</figref><figref num="31">FIG. 31 is a front view of a fourth alternative structure at the distal end of the cannula.</figref><figref num="32">FIG. 32 is a perspective view of another embodiment of the cannula.</figref><figref num="33">FIG. 33 is a perspective view of yet another embodiment of the cannula.</figref><figref num="34">FIG. 34 is a partial longitudinal sectional view of another embodiment of the tubular unit with the cover open and the cannula removed.</figref><figref num="35">FIG. 35 is a cross-sectional view taken along the line 35-35 of FIG. 34 without cover.</figref><figref num="36">FIG. 36 is a plan view of the inside of the cover of another tubular unit embodiment of FIG. 34.</figref><figref num="37">FIG. 37 is a plan view of the interior of the shelf of another tubular unit embodiment of FIG. 34.</figref>