Injectors, intraocular lens systems, and related methods - Patents.com
The modular IOL system with a specialized injector addresses the challenges of IOL component entrapment and damage during injection by utilizing a plunger with varying arm configurations, resulting in efficient and precise IOL placement.
Patent Information
- Application Number
- JP2023018322
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-06-25
- Filing Date
- 2023-02-09
- Publication Date
- 2025-05-16
- Estimated Expiration
- 2038-06-26
AI Technical Summary
Existing intraocular lens (IOL) injection systems face challenges such as IOL components getting caught in the injector or being damaged due to insufficient skills and training, highlighting the need for an improved injector design.
The development of a modular IOL system with a specialized injector featuring a housing, a cartridge for holding IOL components, a distal nozzle with a tapered lumen, and a plunger with arms that vary in expansion and contraction configurations to facilitate smooth injection of IOL components into the eye.
The improved injector design ensures efficient and safe injection of IOL components, reducing the risk of components getting caught or damaged, and enhancing the overall precision and reliability of the IOL placement procedure.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of priority to U.S. Patent Application No. 16 / 017,369, filed June 25, 2018, which claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 525,317, filed June 27, 2017, and U.S. Provisional Patent Application No. 62 / 534,988, filed July 20, 2017. Each of the above related applications is incorporated herein by reference in its entirety.
[0002] The present disclosure relates generally to intraocular lens (IOL) systems and associated injectors. More specifically, the present disclosure relates to various embodiments of modular IOL systems and injector designs for improved injection of IOL components into the eye. [Background technology]
[0003] The human eye functions to provide vision by transmitting light through a clear outer portion called the cornea and focusing the image onto the retina via the lens. The quality of the focused image depends on a number of factors, including the size and shape of the eyeball and the transparency of the cornea and lens.
[0004] When the lens becomes less transparent (e.g., cloudy) due to aging or disease, vision is impaired because less light can pass through to the retina. This defect in the eye's lens is medically known as a cataract.
[0005] The accepted treatment for this condition is to surgically remove the lens from the capsule and place an artificial intraocular lens (IOL) in the capsule. Cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, an incision (capsulorhexis) is made in the anterior aspect of the capsule and a thin phacoemulsification tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating tip liquefies or emulsifies the lens, allowing it to be aspirated out of the capsule.
[0006] Once removed, the diseased lens is replaced with an IOL, which is inserted into the eye using an injector and placed into the empty capsular bag. In some cases, as in the case of a broken trailing IOL haptic, poor technique or training can result in the IOL getting stuck in the injector or breaking. To address this issue, improved injector design is needed. Summary of the Invention [Means for solving the problem]
[0007] An embodiment of the present disclosure provides an injector for injecting one or more components of an IOL system into an eye, the injector having a housing, a cartridge for holding the IOL system components, a distal nozzle having a tapered lumen, and a plunger disposed within a channel of the housing and having a tip, the plunger tip may have two arms that change between an expanded configuration when disposed at a proximal end of the nozzle lumen and a contracted configuration when disposed at a distal end of the nozzle lumen.
[0008] The arms may have a gap between them that decreases as the arms pass through the nozzle. As the arms pass through the nozzle, the arms may remain in contact with the inner wall of the nozzle lumen. The distal ends of the arms may be free, for example, or may be attached to a collapsible linkage. The arms may include inwardly extending fingers that are offset relative to one another such that the arms bypass one another as they move toward one another. The fingers may be configured to prevent an IOL system component from passing through the gap between the arms.
[0009] The distal end of the arm or the distal end of the link may include a ramp with a distal-most edge and a distal-facing surface. The distal-facing surface may be configured to engage and push against an IOL system component. The distal-most edge may contact an inner wall of the nozzle lumen to prevent the IOL system component from passing between the arm and the inner wall as the IOL system component passes through the nozzle.
[0010] Embodiments of the present disclosure also provide a modular IOL system that includes a primary component, such as a base, and a secondary component, such as a lens.
[0011] According to one aspect of the disclosure, an intraocular lens system may include a base that may include an annular body, an opening through the annular body in an axial direction of the annular body, and a recess extending circumferentially around the opening. The system may also include a lens insertable into and removable from the recess. The lens may include a central optic, a first tab protruding radially away from the central optic, and a second tab protruding radially away from the central optic. The second tab may have a greater resistance to radial compression than the first tab. The first tab may include a first arm protruding radially away from the central optic, a second arm protruding radially away from the central optic and extending away from the first arm, and a third arm extending from the first arm to the second arm. Movement of one or more of the first, second, and third arms may result in deformation of the first tab.
[0012] According to another aspect of the disclosure, an intraocular lens system may include a base including an annular body, an opening through the annular body in an axial direction of the annular body, and a recess extending circumferentially around the opening. The system may also include a lens configured to be inserted into and removable from the recess. The lens may include a central optic, a first tab extending radially away from the central optic, and a second tab extending radially away from the central optic. The second tab may have a greater resistance to compression than the first tab. The first tab may include a first arm extending radially away from the central optic, a second arm extending radially away from the central optic, and a third arm extending between the first arm and the second arm. One or more of the first, second, and third arms are configured to deform to move the first tab between a compressed state and an extended state. In the extended state of the first tab, an obtuse angle may be formed between the first arm and the second arm.
[0013] According to another aspect of the disclosure, a method for assembling an intraocular lens system may include inserting one of (a) a first tab and (b) a second tab of a lens of the intraocular lens system into a recess of a base of the intraocular lens system. The second tab may have a greater resistance to compression than the first tab. The lens may include a central optic, a first tab extending radially away from the central optic, and a second tab extending radially from the central optic. The first tab may include a first arm extending radially away from the central optic, a second arm extending radially away from the central optic and away from the first arm, and a third arm connecting the first arm and the second arm. The base may include an annular body and an opening through the annular body axially of the annular body. The recess may extend circumferentially around the opening. The method may also include inserting the other of the first and second tabs into the recess. At least one of the first tab and the second tab may be inserted into the recess while the other of the first tab and the second tab is in the recess.
[0014] Various other aspects and advantages of the embodiments of the present disclosure are described in the following detailed description and drawings. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, depict exemplary embodiments of the present disclosure and, together with the description herein, serve to explain the principles of the present disclosure. The drawings are not necessarily to scale, may include similar elements that are numbered the same, and may include dimensions (in millimeters) and angles (in degrees) by way of example, but not necessarily by way of limitation. [Brief description of the drawings]
[0016] [Figure 1A] FIG. 1 is an exploded view of an IOL system injector according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is an assembled view of the IOL system injector shown in FIG. 1A. [Diagram 2] FIG. 2 is a side view of the plunger of the IOL system injector shown in FIGS. 1A and 1B. [Figure 2A] 3 is an enlarged side view of the tip portion of the plunger shown in FIG. 2. [Figure 2B] 3 is an enlarged end view of the tip portion of the plunger shown in FIG. 2. [Figure 2C] FIG. 3 is an enlarged perspective view of a tip portion of the plunger shown in FIG. 2. [Figure 3A] FIG. 13 is an enlarged perspective view of an alternative plunger tip. [Figure 3B] FIG. 13 is an enlarged perspective view of another alternative plunger tip; [Figure 4A-4C] FIG. 3 is a schematic diagram showing how the tip of the plunger of FIG. 2 is crushed as the tip passes through the nozzle. [Diagram 5] FIG. 2 is a perspective view of the base of a modular IOL system. [Figure 5A] FIG. 6 is a cross-sectional view taken along line AA in FIG. 5. [Figure 6] FIG. 2 is a top view of a lens of a modular IOL system. [Figure 7] FIG. 2 is a perspective view of a loading cartridge for use with the IOL system injector shown in FIGS. 1A and 1B. [Figure 7A] FIG. 8 is an end view of the loading cartridge shown in FIG. 7. [Figure 7B] FIG. 8 is a cross-sectional view taken along line BB in FIG. 7. [Figure 7C] FIG. 7C is the same cross-sectional view as shown in FIG. 7B, with the base disposed therein. [Figure 8] 2 is a perspective view of an alternative holder for use with the IOL system injector shown in FIG. 1. [Figure 8A] FIG. 9 is an enlarged perspective view of the holder shown in FIG. 8. [Figure 8B] FIG. 9 is an enlarged perspective view of the holder shown in FIG. 8 with a base disposed therein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] overview The following detailed description describes various embodiments of the IOL system injector. Features described with reference to any one embodiment may be applied and incorporated in other embodiments.
[0018] Exemplary embodiments With reference to FIG. 1A, an IOL system injector 10 generally includes an injector housing 20, a plunger 30, a loading cartridge 40, a nozzle (aka cartridge tip) 50, and a spring 60. The housing 20 includes a finger grip 22, a nozzle holder 24, a cartridge holder 26, and an internal channel 28 extending therethrough. The plunger 30 includes a thumb pad 32, a proximal shaft 34, a distal shaft 36, and a plunger tip 70. The IOL system loading cartridge 40 includes a first folding wing 42, a second folding wing 44 having a locking mechanism, and a chamber 46 configured to hold the IOL system when the wings 42, 44 are closed. The nozzle 50 includes an internal lumen (not visible) having a cross-sectional area that decreases from proximal to distal. The nozzle 50 also includes a beveled tip 52 for insertion into an incision in the eye.
[0019] The injector 10 is modular in nature, such that the nozzle 50 may be inserted into the nozzle holder 24 of the housing 20, the cartridge may be inserted into the cartridge holder 26 of the housing 20, the spring 60 may be disposed on the distal shaft 36 of the plunger 30, and the plunger 30 together with the spring 60 may be inserted into the channel 28 of the housing 20, thereby forming the assembled IOL system injector 10, as shown in FIG. 1B.
[0020] In this configuration, the IOL system components may be loaded or preloaded into the chamber 46 of the loading cartridge 40. The loading cartridge 40 is placed in the cartridge holder 26 in the housing 20. The wings 42, 44 are then folded or closed and the IOL system components are essentially rotated or folded so that they have a reduced profile suitable for injection. Using one hand, with two fingers on the finger grip 22 of the housing 20 and a thumb on the thumb pad 32 of the plunger 30, the plunger 30 may be advanced distally through the channel 28 in the housing 20 until the tip 70 of the plunger 30 engages the IOL system components in the loading cartridge 40. With the nozzle tip 52 inserted into the incision in the eye, further advancement of the plunger 30 will force the IOL system components out of the loading cartridge 40 and into the nozzle 50. As the plunger tip 70 and IOL system component are pushed through the nozzle 50, the tapered lumen within the nozzle 50 further reduces the profile of the rolled IOL system component making it suitable for injection through a small incision in the eye. The plunger 30 may then be advanced further until the IOL system component exits the tip 52 of the nozzle 50 and is delivered into the eye.
[0021] With the exception of the plunger 30 and its associated features (and the alternative loading cartridge and holder described below), the other components of the injector 10 may be similar to the injector sold under the trade name Accuject 2.2-HT by Medicel of Switzerland. As described in more detail below, the plunger 30 has many unique attributes. Thus, the features of the plunger 30 may be incorporated into other injector designs known in the art.
[0022] With reference to Figure 2, the plunger 30 is shown in greater detail. As discussed above, the plunger 30 includes the thumb pad 32, the proximal shaft 34, the distal shaft 36, and the tip 70. The tip 70 is shown in greater detail in Figures 2A, 2B, and 2C. The plunger tip 70 includes a first (upper) arm 72 and a second (lower) arm 74. The arms 72, 74 are connected to and extend distally from the distal shaft 36. As shown, the distal ends of the arms 72, 74 may be free and have no connection therebetween.
[0023] The arms 72, 74 are flexible and pivot about their connection to the distal shaft 36, thereby allowing them to change between an extended configuration when disposed at the proximal end of the lumen in the nozzle 50 and a contracted configuration when disposed at the distal end of the lumen in the nozzle. The arms 72, 74 have a gap between them that decreases as the arms 72, 74 pass through the nozzle 50. In other words, the arms 72, 74 are crushed together as the tip 70 passes through the nozzle 50. The outwardly facing surfaces of the arms 72, 74 remain in contact with the inner wall of the lumen of the nozzle 50 as they pass through the lumen.
[0024] Fingers 76, 78 extend inwardly in a curved proximal direction from arms 72, 74, respectively. As shown, the proximal ends of fingers 76, 78 may be attached to arms 72, 74 at a position set back from the distal-most ends of arms 72, 74, and the distal ends of fingers 76, 78 may be free. As best shown in FIG. 2B, fingers 76, 78 may be laterally offset relative to one another so as to bypass one another when arms 72, 74 are crushed together.
[0025] 2B, the profile of the arms 72, 74 may be configured (e.g., a rectangular profile having a height greater than its width when viewed in end view) such that the upper side of the upper arm 72 and the lower side of the lower arm 74 remain in contact with the interior walls defining the lumen within the nozzle 50, but the sides of the arms 72, 74 do not. This configuration allows the arms 72, 74, along with the fingers 76, 78, to span the entire lumen within the nozzle 50 in one direction, preventing the tip 70 from bypassing IOL system components as the tip 70 advances through the nozzle 50, which could otherwise cause the IOL to get stuck within the nozzle 50. Additionally, because the sides of arms 72, 74 do not contact the interior walls defining the lumen within nozzle 50, even when plunger tip 70 bypasses an IOL system component, space is provided therebetween for the trailing haptics of the IOL system component to be released as the haptics exit tip 52 of nozzle 50, thus preventing the IOL system component from becoming stuck within nozzle 50. This configuration also reduces friction between tip 70 and the interior walls defining the lumen within nozzle 50, because only the upper and lower sides of arms 72, 74 contact the interior walls, not the sides.
[0026] 2A and 2B, the dimensions are provided by way of example and not necessarily by way of limitation. The arms 72, 74 have an expanded (unconstrained) height that is greater than the inner diameter of the lumen in the nozzle 50 and greater than the outer diameter of the distal plunger shaft 36, thereby allowing them to flare outward and distally. Each arm 72, 74 may have an overall length at least twice as large as their expanded height. The height and width of each arm 72, 74 may be at least five times less than their overall length, and their heights may taper along their lengths. The arms 72, 74 may be diametrically opposed (i.e., 180 degrees apart) and their overall lengths may be approximately equal.
[0027] As best seen in FIG. 2C , a ramp 80 may be provided at the distal end of one or both of the arms 72, 74. The ramp 80 may include a distal-most edge 82 and a distally-facing surface 84. The ramp 80 may be angled proximally and inwardly away from the inner wall of the lumen of the nozzle 50 such that the edge 82 contacts the inner wall and the ramp of the ramp 80 biases the IOL system components away from the inner wall. This configuration reduces the IOL system components from getting caught between the tip 70 and the inner wall of the lumen within the nozzle 50 as the tip 70 advances through the nozzle 50.
[0028] 3A, an alternative plunger tip 70 is shown in detail. In this embodiment, the plunger tip 70 does not include fingers 76, 78, but rather includes a link 90 extending from and between the distal ends of the arms 72, 74. Other aspects of the plunger tip 70 may be the same or similar to those previously described. The link 90 may include a hinge and / or may be formed of a highly flexible material such that it can collapse when the arms 72, 74 are crushed together as they advance through the nozzle 50. This configuration allows the arms 72, 74, along with the link 90, to span in one direction across the lumen within the nozzle 50, preventing the tip 70 from bypassing IOL system components that may otherwise get stuck within the nozzle 50 as the tip 70 advances through the nozzle 50. The link 90 may include a ramp 80 that functions as described above.
[0029] 3B, another alternative plunger tip 70 is shown in detail. In this embodiment, the plunger tip 70 does not include fingers 76, 78, but rather includes a tongue 96 that extends from arm 74 and into a groove defined by walls 92, 94 extending from arm 72. Other aspects of the plunger tip 70 may be the same or similar to those previously described. This tongue and groove configuration may serve the same or similar purpose as the fingers 76, 78.
[0030] 4A-4C, the advancement of the plunger tip 70 through the lumen in the nozzle (or cartridge tip) 50 is shown step by step and diagrammatically. For this purpose, the nozzle 50 is shown in perspective with the distal beveled tip 52, the distal opening 54, and the through lumen 56, and only the distal portion of the plunger 30 including the tip 70 is shown. As already mentioned, the cross-sectional area or diameter of the lumen 56 in the nozzle 50 gradually decreases from the proximal end to the distal end. Thus, the arms 72, 74 are gradually crushed together as the tip and IOL (not shown) pass through the nozzle 50. In FIG. 4A, the arms 72, 74 are in an expanded state when they are in the proximal portion of the nozzle 50. In FIG. 4B, as the tip 70 advances, the arms 72, 74 are crushed by the inner walls that define the nozzle lumen 56 and change to a compressed or contracted state. In Fig. 4C, the arms 72, 74 are in a contracted state when at the proximal portion of the nozzle 50. Note that in Fig. 4A, the distal ends of the fingers 76, 78 bypass each other, in Fig. 4B they abut the inner surface of the arms 72, 74, and in Fig. 4C they bend inward. All the while, the arms 72, 74 along with the fingers 76, 78 span across the lumen 56 in at least one direction (but not all), keeping the IOL system components in front of the tip 70 and preventing them from getting caught between the tip 70 and the inner wall of the nozzle lumen 56. It will be apparent that in a plane perpendicular to the illustrated plane, the sides of the arms 72, 74 and the fingers 76, 78 do not contact the inner wall of the nozzle lumen 56, thereby reducing friction.
[0031] The injector 10 may be used with a wide variety of IOL system components, including modular IOL system components and non-modular IOLs (e.g., one-piece and / or monolithic IOLs). By way of example and not limitation, the injector may be used to inject base and optic components that, when assembled, form a modular IOL system. The base and optic may be injected separately into the eye and assembled in the eye, or assembled outside the eye and injected together into the eye. An exemplary base component 400 is described with reference to FIGS. 5 and 5A, and an exemplary optic component 500 is described with reference to FIG. 6. Further details regarding similar modular IOL system configurations are described in U.S. Nonprovisional Patent Application No. 15 / 585,901, entitled "Intraocular Lens Designs for Improved Stability," filed May 3, 2017, which is incorporated herein by reference.
[0032] 5, the base 400 includes an annular ring 402 that defines a central bore 404. A pair of haptics 406 extend radially outward from the annular ring 402. The annular ring 402 includes a lower rim 408, an upper rim 410, and an inwardly facing recess 412 into which a lens 500 can be inserted to form a modular IOL system.
[0033] The lower rim 408 may include a pair of diametrically opposed (180 degrees) folding notches 414, and the upper rim 410 may include a corresponding pair of folding notches 416. The folding notches 414, 416 may be aligned with a mid-portion of the haptics 406 and are configured to provide a natural crease for folding the base in half within the loading cartridge 40 of the injector 10, such that the mid-portion of the haptics is aligned with the plunger tip 70. The notches 414, 416 may also provide access to a probe (e.g., a Sinskey hook) during surgery, thereby allowing the base 400 to be more easily manipulated. The haptics 406 may include holes 415 adjacent the annular ring 402 for intra-operative manipulation by a probe. A series of vent holes 413 may be distributed around the upper rim 410.
[0034] 5A, a cross-sectional view taken along line AA in FIG. 5, the recess 412 may have a tapered profile defined by a horizontal posterior surface 418, a vertical side or outer surface 422, and a flared anterior surface 426 extending radially inward and forward outward from the vertical outer surface 422. The inner diameter of the posterior rim 408 may be smaller than the inner diameter of the anterior rim 410. With this configuration, the lens 500 may be placed through the circular opening 404 defined by the anterior rim 410 to land or rest on the posterior rim 408, and the flared anterior wall 426 together with the flared posterior wall 428 may act as a funnel to guide the tabs 504 and 506 of the lens 500 into the deeper portion of the recess 412. A pair of square edges 417 may extend around the posterior periphery of the annular ring 402 to help reduce cellular growth (posterior capsular opacification or PCO) on the lens 500.
[0035] 6, a top (front) view of a lens 500 is shown. The lens 500 may include an optic portion 502 and one or more tabs 504 and 506. As shown, the tab 504 is fixed, while the tab 506 may be actuated. In one example, the tab 504 has a higher resistance to radial deformation (e.g., compression and / or expansion) than the tab 506. The fixed tab 504 may include a through hole 508 such that a probe (e.g., a Sinskey hook) or similar device may be used to engage the hole 508 and manipulate the tab 504. The actuable tab 506 may be actuated between a compressed position for delivery into the hole 404 of the base 400 and a non-compressed, extended position (as shown) for deployment into the recess 412 of the base 400, thereby forming a mating connection between the base 400 and the lens 500. It is also contemplated that the actuable tab 506 may be inserted into the recess 412 and may be actuated between a compressed position that facilitates entry of the fixed tab 504 into the recess 412 and a non-compressed, extended position that further inserts the fixed tab 504 into the recess 412 to form an interlocking connection between the base 400 and the lens 500.
[0036] The actuatable tab 506 may include two arms 510 and 512 that extend radially outward in different (e.g., opposite) directions. In one example, an obtuse angle may be formed between the directions. Each arm 510, 512 may have one end connected to an edge of the optic 502 and the other end connected to the intermediate arm 511. A hinge portion may connect the ends of the arms 510 and 512 to the optic 502 and the other ends of the arms 510 and 512 to the intermediate arm 511. Each of the arms 510, 511, and 512 may include one or more straight portions. In one example, the intermediate arm 511 may include two straight portions that meet at a mid-portion of the intermediate arm 511. The intermediate arm 511 may be angled radially inward to have an apex at its mid-portion, as shown. The apex may be a hinge portion. A portion of the optic 502 and the arms 510, 511, and 512 may form a ring around a hole through the actuatable tab 506. The size of the hole may change as the actuatable tab 506 moves between the compressed and extended states.
[0037] In this configuration, actuatable tab 506 may bend along all three arms 510, 511, 512 and / or bend along hinged portions as it moves between its compressed and extended states, but may provide a single portion (the apex of middle arm 511) for initial insertion into recess 412 of base 400. Rim 514 may extend around the periphery of optic 502 and terminate away from arms 510 and 512, thus allowing arms 510 and 512 to be fully compressed against the edge of optic 502. The edge of optic 502 may be planar and may contact one or more planar surfaces of arms 510 and / or arms 512. The rim 514 of the lens 500 may have an outer diameter that is larger than the inner diameter of the rear rim 408 of the base 400 so that the lens 500 will not fall through the opening 404 of the base 400 and the lens 500 is supported circumferentially around its periphery by the rear rim 408 of the base 400. A gusset with a guide hole 516 may be disposed between the two arms 510 and 512 to facilitate manipulation by a probe. Similarly, the locking tab 504 may be provided with a guide hole 508 to provide access for a probe (e.g., a Sinskey hook) or similar device to manipulate the locking tab 504 into the recess 412 of the base 400. A notch 518 may be provided in the locking tab 504 to provide an asymmetry that visually indicates that the front side is up (rather than down) when the notch is in the counterclockwise direction of the hole 508.
[0038] The base 400 and lens 500 may be formed by cryogenically cutting and grinding a hydrophobic acrylic material, including alternative embodiments described herein. Optionally, the base 400 may be manufactured by forming two (anterior and posterior) components and connecting them together with an adhesive. For example, the two components may be cryogenically cut from hydrophilic acrylic connected together with a UV-curable adhesive. Alternatively, the two components may be formed from different materials connected together with an adhesive. For example, the anterior component may be formed from a hydrophilic acrylic that does not adhere to ocular tissue, and the posterior component may be formed from a hydrophobic acrylic that adheres to ocular tissue.
[0039] As a further alternative, the base 400 may be manufactured by cryogenically machining a first component and overmolding a second component. The first component may include geometric features that mate when overmolded, thus eliminating the need for adhesives to connect the components. For example, the base 400 may be manufactured by cryogenically machining a hydrophilic acrylic to form a rear component and overmolding a front component of a moldable material such as silicone.
[0040] Whether made from a single component, two components connected with an adhesive, or two components molded one over the other, all or a portion of the annular ring 402 may include coloring to enhance the visibility of the tabs 504, 506 relative to the recess 412 to better determine whether the tabs 504, 506 are in front of, within, or behind the recess 412. In this embodiment, the annular ring 402 may be a first color and the tabs 504, 506 may be a second (different) color. Alternatively, if the annular ring 402 includes a front component and a rear component, either or both of the front and rear components may be a first color and the tabs 504, 506 may be a second (different) color. By way of example, the annular ring 402 may be blue (blue dye monomer additive) and the tabs 504, 506 may be natural (clear) color. In this example, when viewed from front to rear, the anterior rim 410 has a larger inner diameter than the aft rim 408, so that the inner portion of the aft rim 408 may appear light blue and the overlap between the anterior rim 410 and aft rim 408 may appear dark blue. This color difference makes the location of the tabs 504, 506 relative to the recess 412 more visually apparent and may facilitate easier assembly of the optical component 500 onto the base 400.
[0041] As will be appreciated from the foregoing, the optic 500 may be sized similarly to a conventional IOL, and the base 400 may be slightly larger to allow the optic 500 to fit within it. A conventional loading cartridge may be used for both the base 400 and the optic 500. However, it may be desirable to use a modified loading cartridge 40 for the base, as described with reference to Figures 7-7C.
[0042] With particular reference to Figures 7 and 7A, the loaded cartridge 40 includes a first folding wing 42, a second folding wing 44 having a locking mechanism, and a chamber 46 configured to hold the base 400 when the wings 42, 44 are closed. With reference to Figure 7B, a cross-sectional view taken along line BB of Figure 7A, the sides of the chamber 46 may include shoulders 48 such that the proximal width of the chamber 46 is wider than the distal width of the chamber 46. By way of example and not limitation, the proximal width may be about 7.9 mm and the distal width may be about 6.6 mm. This configuration defines a tapered chamber lumen such that as the plunger 30 pushes the base 400 distally, the relatively large base 400 is gradually compressed into the proximal portion of the nozzle lumen 56. 7C, shoulder 48 abuts annular ring 402 of base 400, thereby providing a backstop for base 400 to maintain the axial (longitudinal) position of base 400 within loading cartridge 40, particularly when tip 70 of plunger 30 proximally engages base 400. Folding notch 414 in base 400 may be aligned with the longitudinal axis of loading cartridge 40 to provide a hinge for uniform diametric folding of base 400 when wings 42, 44 of loading cartridge 40 are closed.
[0043] As mentioned above, the base 400 and / or the optical component 500 may be loaded or preloaded into the chamber 46 of the loaded cartridge 40. If preloaded, a holder 100 may be used to hold the base 400 or the optical component 500 in the chamber 46 of the loaded cartridge 40 during packaging and shipping, as shown in FIGS. 8-8B. The holder 100 may include a retaining plate 102, a connector portion 104, an arm 106, and a retaining pin 108. The retaining plate 102 may cover all or a portion of the base 400 or the optical component 500 in the chamber 46. The connector portion 104 may be attached to a wing 44 of the cartridge 44, and the arm 106 may engage the other wing 42 of the cartridge 40 via one or more slots. The retaining pin 108 may extend from a side edge of the retainer plate 102 at a position set back from the proximal edge of the retainer plate 102 so as to be located between the annular ring 402 and the trailing or proximal haptic 402 of the base 400, as shown in FIGURE 8B. This configuration, when combined with the shoulder 48 of the cartridge, retains the base 400 and limits movement in any direction during packaging and shipping.
[0044] The foregoing discussion of the present disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the present disclosure to the form disclosed herein. Although the present disclosure includes one or more embodiments and descriptions of certain variations and modifications, other variations and modifications are within the scope of the present disclosure, for example, as may be within the skill and knowledge of a person skilled in the art after understanding the present disclosure. The intention is to obtain the right to include alternative embodiments, including alternative, interchangeable and / or equivalent structures, functions, ranges, or steps, to the extent permitted by the claims, regardless of whether such alternative, interchangeable and / or equivalent structures, functions, ranges, or steps are disclosed herein, and without the intention of providing any patentable subject matter to the public.
[0045] Although the principles of the disclosure have been described herein with reference to illustrative embodiments for particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and having access to the teachings provided herein will recognize that all additional modifications, applications, embodiments, and equivalent substitutions are within the scope of the embodiments described herein. Accordingly, the present invention should not be considered as limited by the foregoing description. The present disclosure also includes the following inventions. The first aspect is Annular bodies, an opening extending through the annular body in an axial direction of the annular body; and a base including a recess extending circumferentially around the opening; a lens insertable into and removable from the recess, the lens comprising: Central optics, a first tab projecting radially away from the central optic; and a second tab projecting radially away from the central optic and having a greater resistance to radial compression than the first tab; The first tab includes: a first arm projecting radially away from the central optic; a second arm projecting radially away from the central optic and extending away from the first arm; and a third arm extending from the first arm to the second arm; a lens, wherein movement of one or more of the first, second, and third arms results in deformation of the first tab; The intraocular lens system includes a first hinge portion connecting the first arm to the central optic and a second hinge portion connecting the second arm to the central optic. The second aspect is The intraocular lens system of the first aspect, wherein a central portion of the third arm includes an apex of the third arm, the apex being a radially outermost portion of the third arm. The third aspect is The intraocular lens system of the first aspect, wherein each of the first, second, and third arms has at least one straight segment. The fourth aspect is The intraocular lens system of a third aspect, wherein the third arm has a first straight segment and a second straight segment, the first straight segment and the second straight segment being joined at an apex. The fifth aspect is An intraocular lens system according to a third aspect, wherein an obtuse angle is formed between the first linear segment and the second linear segment. The sixth aspect is An intraocular lens system in a first aspect, wherein the first arm extends from the central optical component in a first direction and the second arm extends from the central optical component in a second direction, the second direction being different from the first direction and an obtuse angle being formed between the first direction and the second direction. The seventh aspect is The second tab includes: a first side surface protruding from a first radially outer surface of the central optic, the first side surface forming a first angle with the first radially outer surface; a second side surface protruding from a second radially outer surface of the central optic, wherein a second angle is formed between the second side surface and the second radially outer surface; The intraocular lens system of the first aspect, wherein the first angle and the second angle have different magnitudes. The eighth aspect is Annular bodies, an opening extending through the annular body in an axial direction of the annular body; and a base including a recess extending circumferentially around the opening; a lens configured to be inserted into and removable from the recess, the lens comprising: Central optics, a first tab extending radially away from the central optic; and a second tab extending radially away from the central optic and having a greater resistance to compression than the first tab; The first tab includes: a first arm extending radially away from the central optic; a second arm extending radially away from the central optic; and a third arm extending between the first arm and the second arm; one or more of the first, second, and third arms are configured to deform to move the first tab between a compressed state and an extended state; a lens, wherein an obtuse angle is formed between the first arm and the second arm in the extended state of the first tab; The intraocular lens system includes a first hinge portion connecting the first arm to the central optic and a second hinge portion connecting the second arm to the central optic. The ninth aspect is the first tab includes a first planar surface; The intraocular lens system of an eighth aspect, wherein the central optic includes a second planar surface. A tenth aspect is 10. The intraocular lens system of claim 9, wherein in the extended state of the first tab, an acute angle is formed between the first plane and the second plane. An eleventh aspect is An intraocular lens system according to a ninth aspect, wherein the first plane and the second plane are configured to move towards each other as the first tab moves from the extended state to the compressed state. A twelfth aspect is An intraocular lens system according to an eighth aspect, wherein the central optical component includes a flat surface, and in the compressed state, one of the first arm and the second arm abuts the flat surface. A thirteenth aspect is the third arm includes a third hinge portion; An intraocular lens system according to an eighth aspect, wherein the first, second and third hinge portions are configured to bend as the first tab moves between the extended state and the compressed state. A fourteenth aspect is the first, second, and third arms and the central optic form a closed ring surrounding an aperture; An intraocular lens system according to an eighth aspect, wherein the aperture width narrows as the first tab moves towards the compressed state. The fifteenth aspect is An intraocular lens system including a base and a lens, The base is an annular body including an upper rim and a lower rim; an opening extending axially through the annular body; a first pair of diametrically opposed folding notches in the upper rim and a second pair of diametrically opposed folding notches in the lower rim configured to provide creases for folding the base; a recess extending circumferentially around the opening, the lens is insertable into and removable from the recess; A central optic; a first tab projecting radially away from the central optic; a second tab projecting radially away from the central optic and having a greater resistance to radial compression than the first tab; The first tab includes: a first arm projecting radially away from the central optic; a second arm projecting radially away from the central optic and extending away from the first arm; a third arm extending from the first arm to the second arm; movement of one or more of the first, second, and third arms results in deformation of the first tab; The intraocular lens system includes a first hinge portion connecting the first arm to the central optic and a second hinge portion connecting the second arm to the central optic. A sixteenth aspect is 15. An intraocular lens system according to claim 14, wherein the central portion of the third arm includes an apex of the third arm, the apex being a radially outermost portion of the third arm. A seventeenth aspect is The intraocular lens system of a fifteenth aspect, wherein each of the first, second, and third arms has at least one straight segment. The eighteenth aspect is In a sixteenth aspect of the intraocular lens system, the third arm has a first straight segment and a second straight segment, the first straight segment and the second straight segment being connected at a vertex. A nineteenth aspect is An intraocular lens system according to a seventeenth aspect, wherein an obtuse angle is formed between the first straight line segment and the second straight line segment. The twentieth aspect is An intraocular lens system in accordance with a fifteenth aspect, wherein the first arm extends from the central optical component in a first direction, the second arm extends from the central optical component in a second direction, the second direction being different from the first direction, and an obtuse angle being formed between the first direction and the second direction. A twenty-first aspect is The second tab includes: a first side surface protruding from a first radially outer surface of the central optic, the first side surface forming a first angle with the first radially outer surface; a second side surface protruding from a second radially outer surface of the central optic, wherein a second angle is formed between the second side surface and the second radially outer surface; The intraocular lens system of a fifteenth aspect, wherein the first angle and the second angle have different magnitudes.
Claims
1. 1. An injector for injecting an intraocular lens into an eye, the injector comprising: a housing forming a channel therein; a nozzle connected to a distal portion of the housing, the nozzle defining a nozzle tip and a nozzle lumen extending therethrough from a proximal end to a distal end, the nozzle lumen tapering from a relatively larger cross-sectional area at the proximal end to a relatively smaller cross-sectional area at the distal end; 11. An injector comprising: a plunger disposed within the channel of the housing, the plunger comprising a shaft and a plunger tip, the plunger tip attached to the shaft and comprising a plurality of arms extending distally from the shaft, the arms having an expanded configuration when disposed at the proximal end of the nozzle lumen and a contracted configuration when disposed at the distal end of the nozzle lumen, the arms having proximal and distal ends, at least one of the arms having a sloped portion at its distal free end, the sloped portion forming a distal-most edge and a distal-facing surface, the distal-facing surface configured to press against the intraocular lens, each of the arms comprising an inwardly extending intermediate finger.
2. 2. The injector of claim 1, wherein the arms define gaps therebetween that decrease as the arms pass from the proximal end to the distal end of the nozzle lumen.
3. The injector of claim 2 , wherein the arms remain in contact with an interior wall defining the nozzle lumen as they pass from the proximal end to the distal end of the nozzle lumen.
4. The injector of claim 3 , wherein the proximal ends of the arms are attached to the shaft and the distal ends of the arms are free.
5. 5. The injector of claim 4, wherein said fingers have proximal and distal ends, said proximal ends of said fingers being attached to said plurality of arms and said distal ends of said fingers being free.
6. The injector of claim 5 , wherein the fingers are offset relative to one another such that the fingers bypass one another when the plurality of arms change from the extended configuration to the retracted configuration.
7. 7. The injector of claim 6, wherein the ramp slopes proximally and inwardly, and the distal-most edge of the ramp contacts the inner wall of the nozzle lumen to prevent the intraocular lens from passing between the arm and the inner wall as the arm passes from the proximal end to the distal end.
8. The injector of claim 7 , wherein the fingers are configured to prevent the intraocular lens from passing through the gaps between the arms.
9. The injector of claim 8 , wherein the plurality of arms and fingers have a collective cross-sectional height and a collective cross-sectional width, the collective cross-sectional height being greater than the collective cross-sectional width.
10. 10. The injector of claim 9, wherein the arms and fingers collectively extend in a first cross-sectional direction across the nozzle lumen, and the arms and fingers collectively extend in a second cross-sectional direction across less than the nozzle lumen, the first cross-sectional direction being orthogonal to the second cross-sectional direction.
11. The injector of claim 3 , wherein the proximal ends of the arms are attached to the shaft and the distal ends of the arms are attached to a collapsible link extending therebetween.
12. 12. The injector of claim 11, wherein the link is attached to the ramp, and the distal-most edge of the ramp contacts the inner wall of the nozzle lumen to prevent the intraocular lens from passing between the arms and the inner wall as the arms pass from the proximal end to the distal end of the nozzle lumen.
13. The injector of claim 12 , wherein the link is configured to prevent the intraocular lens from passing through the gaps between the arms.
14. 14. The injector of claim 13, wherein the link has a cross-sectional height and a cross-sectional width, the cross-sectional height being greater than the cross-sectional width.
15. 15. The injector of claim 14, wherein the link extends in a first cross-sectional direction across the entire nozzle lumen, and the link extends in a second cross-sectional direction across less than the entire nozzle lumen, the first cross-sectional direction being orthogonal to the second cross-sectional direction.
16. The injector of claim 1 , further comprising a cartridge disposed within the housing proximal to the nozzle, the cartridge configured to house the intraocular lens.
17. 1. An injector for injecting an intraocular lens into an eye, the intraocular lens including two haptics extending from an optic, the injector comprising: a) a housing forming a channel therein; b) a nozzle connected to a distal portion of the housing, the nozzle defining a nozzle tip and an extending nozzle lumen; c) a plunger disposed within the channel of the housing, the plunger comprising a shaft and a plunger tip, the plunger tip comprising a plurality of arms attached to and extending distally from the shaft, the plurality of arms having an expanded configuration when disposed at a proximal end of the nozzle lumen and a contracted configuration when disposed at a distal end of the nozzle lumen, the plurality of arms having proximal and distal ends, at least one of the plurality of arms having a ramp at its distal free end, the ramp forming a distal-most edge and a distal-facing surface, the distal-facing surface configured to press against the intraocular lens, each of the plurality of arms comprising an inwardly extending intermediate finger; d) a cartridge disposed within the housing proximal to the nozzle, the cartridge having two wings having an open position and a closed position, the wings being configured to fold relative to each other to form a chamber for holding the intraocular lens, the chamber having walls configured to position the intraocular lens so that the plunger tip engages an intermediate portion of a trailing haptic of the intraocular lens, the walls forming a bottom surface, a first side wall and a second side wall when the wings are in the open position, a first distance between the side walls at a proximal portion of the cartridge being greater than a second distance between the side walls at a distal portion of the cartridge.
18. 20. The injector of claim 17, wherein the second distance between the sidewalls is less than a diameter of the optic and the first distance between the sidewalls is approximately equal to the diameter of the optic.
19. 18. The injector of claim 17, wherein the walls are configured to place the intraocular lens on the bottom surface with the trailing haptic extending into the proximal portion of the cartridge such that the first and second side walls extend the first distance away from each other, and a leading haptic extending into the distal portion of the cartridge such that the first and second side walls extend the second distance away from each other, and the optical component is disposed between the trailing haptic and the leading haptic such that the optical component contacts the first and second side walls at a location where a distance between the first and second side walls transitions from the first distance to the second distance.
Citation Information
Patent Citations
Spring-biased deformable intraocular lens implanter
JP2000516487A
Inserting appliance of lens for intraocular insertion
JP2004290690A
injector for injecting an intraocular lens
JP2004528078A
Device for inserting flexible intraocular lens
JP2005103315A
Intraocular lens insertion appliance
JP2008012016A