Intraocular lens injector device
By designing an IOL syringe with soft tips and concave distal surface, the problems of easy damage and uncertain orientation during the injection process are solved, stable positioning and consistent delivery of the IOL is achieved, and the operational safety of the surgery is improved.
Patent Information
- Application Number
- CN202380077291.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-11-07
- Filing Date
- 2023-11-07
- Publication Date
- 2025-07-01
AI Technical Summary
Existing IOL syringes have difficulty ensuring that the IOL is not damaged during the injection process and are difficult to achieve predictable orientation and consistent delivery of the IOL, which may cause surgeons to experience difficulties during surgery.
An IOL syringe is designed, including a plunger with a longitudinal axis and a soft tip with a concave distal surface. By this design, the concave distal surface contacts the IOL to ensure stable positioning and movement of the IOL during injection.
Through this design, it is possible to effectively prevent damage to the IOL during the injection process and ensure predictable orientation and consistent delivery of the IOL, reducing the difficulty of operation of the surgeon during surgery.
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Figure CN120239595A_ABST
Abstract
Description
Technical Field
[0001] A syringe device and method for controlling the folding of an intraocular lens for insertion into an eye. Background Art
[0002] An artificial / intraocular lens (referred to herein as an IOL or simply a lens) is an artificial lens used to replace a patient's natural crystalline lens when the natural lens is diseased or the eye is otherwise damaged. In some cases, the natural lens may remain in the patient's eye along with the implanted IOL. The IOL can be placed in the posterior chamber or the anterior chamber of the eye.
[0003] IOLs have a variety of configurations and materials. Various instruments and methods for implanting such IOLs into the eye are known. Generally, an incision is made in the patient's cornea, and the IOL is inserted into the eye through the incision. In one technique, a surgeon uses surgical forceps to grasp the IOL and insert it through the incision into the eye. While this technique is still currently practiced, an increasing number of surgeons use an IOL syringe, which offers advantages such as providing the surgeon with more control when inserting the IOL into the eye and allowing the IOL to be inserted through a smaller incision. A relatively small incision size (e.g., less than about 3 mm) is preferred over a relatively large incision (e.g., about 3.2 to 5+ mm) because a smaller incision results in reduced postoperative healing time and reduced complications, such as induced astigmatism.
[0004] To fit the IOL through a small incision, the IOL is typically folded and / or compressed before entering the eye, and in the eye, the IOL assumes its original unfolded / uncompressed shape. Since IOLs are very small and delicate articles, great care is taken in their handling both when they are loaded into a syringe and when the lens is injected into the patient's eye.
[0005] It is desirable for the IOL to be discharged from the tip of the IOL syringe and into the eye in an undamaged state and in a predictable orientation. If the IOL is damaged or discharged from the syringe in an incorrect orientation, the surgeon may need to remove or further manipulate the IOL in the eye, potentially causing trauma to the surrounding tissues of the eye. To achieve proper delivery of the IOL, it is desirable to load the IOL into the syringe device consistently, engage it consistently through the plunger tip, and have a controlled movement of the lens through the syringe lumen and into the eye, all with a limited chance of misalignment or damage to the IOL.
[0006] Various IOL syringes and other devices have been proposed and produced that attempt to address the problems associated with injecting an IOL into the eye, but there is still a need for IOL syringes and syringe components that facilitate the surgical delivery of an IOL into the eye. SUMMARY OF THE INVENTION
[0007] In various aspects of the present invention, an IOL syringe includes a plunger having a longitudinal axis and a soft tip at the distal end of the plunger. The soft tip is positioned to advance the IOL through the lumen of the syringe and into the eye. The soft tip has a concave distal surface. In a plane including the longitudinal axis, when the IOL is located in the staging area of the syringe body, this plane is perpendicular to the IOL optical axis, and the concave distal surface does not extend perpendicular to the longitudinal axis. By angling the concave distal surface in this manner, the contact between the concave distal surface and the IOL haptics is controlled, and the haptics are reliably positioned on top of the optical body of the IOL before and during folding and compressing the IOL as the IOL travels down the IOL lumen.
[0008] One aspect of the present invention relates to a syringe for injecting an IOL into an eye. The syringe includes a syringe body having a lumen wall defining a lumen, and the IOL is delivered to the eye at the distal end of the lumen. The syringe also includes a plunger having a longitudinal axis and a soft tip at the distal end of the plunger. The soft tip is positioned to advance the IOL through the lumen to the distal end of the lumen. The soft tip has a concave distal surface. In a plane including the longitudinal axis, when the IOL is located in the staging area of the syringe body, this plane is perpendicular to the IOL optical axis, and the concave distal surface extends in a direction at a non-perpendicular angle relative to the longitudinal axis.
[0009] In some embodiments, the concave distal surface is elliptical in a plane perpendicular to this direction, and the concave distal surface has no curvature along this direction. In some embodiments, the concave distal surface is cylindrical in a plane perpendicular to this direction, and the concave distal surface has no curvature along this direction.
[0010] The soft tip may include an elastomer.
[0011] In some embodiments, the concave distal surface defines a concave cavity, and no feature of the soft tip extends into the concave cavity. In some embodiments, the concave distal surface has a blind hole formed therethrough that extends proximally from the concave distal surface through the soft tip.
[0012] The angle at which the concave distal surface extends relative to the longitudinal axis may be in the range of 40 degrees to 70 degrees. The angle at which the concave distal surface extends relative to the longitudinal axis may be in the range of 45 degrees to 65 degrees. In some embodiments, the angle is about 60 degrees.
[0013] In some embodiments, a syringe may have an intraocular lens (IOL) disposed in an assembly area of the syringe body, the IOL having haptics extending proximally from an optical zone, with a soft tip configured to contact less than 10% of the haptic length at an initial contact between the soft tip and the haptic, where the haptic length is measured from the circumferential edge of the optical body to the distal end of the haptic. In some embodiments, the soft tip is configured to contact no more than 50% of the haptic length at any point during plunger actuation.
[0014] The syringe body may include two or more components, each component forming part of a lumen. In some embodiments, at least one of the components constitutes an IOL shuttle.
[0015] In some embodiments, the shuttle has an IOL disposed therein in a biased state, where the center of the optical body is slightly displaced downward relative to the relative circumferential outer edge position of the optical body.
[0016] In some embodiments, the syringe body includes finger flanges and the plunger includes a thumb press.
[0017] Another aspect of the present invention relates to a plunger for use in an IOL syringe. The plunger includes a shaft having a longitudinal axis and a soft tip at the distal end of the shaft. The soft tip has a concave surface extending in a direction that forms a non - perpendicular angle with the longitudinal axis. In some embodiments, the plunger is combined with a syringe body having a lumen, and the plunger is arranged to slide within the lumen.
[0018] Yet another aspect of the present invention relates to a method of inserting an intraocular lens (IOL) including an optical body and haptics through the lumen of a syringe into an eye. The syringe includes a plunger, the plunger including i.) a shaft characterized by a longitudinal axis and ii.) a soft tip at the distal end of the shaft. The soft tip has a concave distal surface extending in a direction that forms a non - perpendicular angle with the longitudinal axis. The method includes actuating the plunger to move a portion of the haptic over the top of the optical body using the concave distal surface.
[0019] In some instances, the actuating step includes, at an initial contact with the haptic, contacting less than 10% of the haptic length measured from the optical body to the distal end of the haptic.
[0020] In some instances, the actuating step includes moving the IOL from the assembly area of the syringe body through the distal end of the lumen while contacting no more than 50% of the haptic length at any point during the movement of the IOL from the assembly area to the distal end of the lumen.
[0021] The concave distal surface may be elliptical in a plane perpendicular to the direction and have no curvature along the direction.
[0022] The term "distal" refers to a component or part of a syringe, IOL, or other device that is closer to the end of the syringe from which the IOL exits the syringe and enters the eye; and the term "proximal" refers to a component or part of a syringe or other device that is farther from the end of the syringe from which the IOL exits the syringe and enters the eye.
[0023] These and other aspects of the invention will become apparent when referring to the following detailed description and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Illustrative, non - limiting embodiments of the invention will be described by way of example with reference to the accompanying drawings, in which like reference numerals are used in different drawings to denote the same or similar components, and in which:
[0025] Figure 1 is a schematic view of an example of an assembled syringe system according to an aspect of the invention;
[0026] Figure 2 is in a disassembled state Figure 1 of an example of
[0027] Figure 3A is a schematic projection view of an example of a soft tip of a plunger according to an aspect of the invention;
[0028] Figure 3B is Figure 3A a schematic side view of the soft tip shown in the direction D;
[0029] Figure 3C is Figure 3A a schematic top view of the soft tip shown;
[0030] Figures 4A to 4C show, respectively, a distal view, a sectional side view, and a sectional top view of an example of an IOL shuttle in an open position, where the lens is held in an unbiased state;
[0031] Figures 5A to 5C show, respectively, Figures 4A to 4C a distal view, a sectional side view, and a sectional top view of an example of the shuttle shown in
[0032] Figure 6A show Figures 4A to 4C a distal view of an example of the shuttle in
[0033] Figure 6B show Figure 6AA cross-sectional side view of the shuttle member, where the offset tab is depressed to ensure that the lens is in the offset state, and one side of the shuttle member is omitted for ease of viewing the lens and offset tab structure;
[0034] Figures 7A to 7B A distal view and a cross-sectional top view of another example of the shuttle member are shown respectively;
[0035] Figure 8A is one with an offset IOL Figure 1 A schematic cross-sectional top view of the syringe body, where the plunger is actuated to the point where the soft tip is close to the lens;
[0036] Figure 8B is one with an offset IOL Figure 1 A schematic cross-sectional top view of the syringe body, where the plunger is actuated to the point where the soft tip first contacts the lens loop;
[0037] Figure 8C is one with an offset IOL Figure 1 A schematic cross-sectional top view of the syringe body, where the plunger is actuated to a point where the soft tip contacts further along the loop than shown in Figure 8B and the plunger contacts a larger portion of the posterior loop (also known as the proximal loop) than shown in Figure 8B ; and
[0038] Figure 8D is one with an offset IOL Figure 1 A schematic cross-sectional top view of the syringe body, where the plunger is actuated to the point where the posterior loop and the anterior loop are on top of the lens, and the IOL has started to advance distally into the lumen along the lumen. Detailed Description
[0039] Aspects of the present invention will be further described with reference to the following specific examples. It should be understood that these examples are given by way of illustration and are not meant to limit the scope of the claimed invention beyond the text of the claims set forth below.
[0040] Figure 1 is a schematic diagram of an example of an assembled syringe system 100 for injecting an IOL 150 into an eye (shown in Figure 2 ); and Figure 2 is a schematic diagram of the syringe system 100 shown in a disassembled state for ease of discussion.
[0041] The syringe system 100 includes a syringe body 102 and a plunger 140. The syringe body has a lumen wall 112a, 112b, 112c defining a lumen L. An IOL 150 is delivered into the eye at the distal end DL of the lumen L. The plunger 140 has a longitudinal axis LA and a soft tip 142 at the distal end of the plunger shaft 144. The soft tip 142 is positioned to advance the IOL 150 through the lumen L to the distal end DL. The soft tip 142 has a concave distal surface C (shown in Figure 3A and Figure 3B ). The IOL 150 includes an optical body 152 (including an imaging portion referred to as the optic zone), which has two or more haptics 154a, 154b extending therefrom for positioning and supporting the optic zone within the eye in which it is implanted.
[0042] As will be discussed in more detail below, the concave surface C is configured to facilitate the positioning of the proximal haptic 154b before and / or simultaneously with the compression and folding of the IOL as the IOL advances along the lumen L. According to aspects of the present invention, as Figure 8A shown, in a plane including the longitudinal axis LA (when the lens is in the assembly area of the syringe, plane A is perpendicular to the optical axis OA of the IOL 150, and the concave distal surface C extends in a direction at a non-perpendicular angle relative to the longitudinal axis LA). The assembly area is the position within the syringe where the IOL is located before being advanced downward along the lumen by the plunger 140.
[0043] In the illustrated embodiment, the syringe body 102 includes three components (a main syringe component 110, a lens shuttle 120, and a cartridge 130), each component forming a part of the lumen L through which the IOL travels from the assembly area to the distal end DL; however, it should be understood that the syringe body may include one or more components forming the lumen. Also, in the illustrated embodiment, the shuttle 120 includes two halves 120a and 120b that snap together or are otherwise coupled together to form the entire shuttle. In the illustrated embodiment, the various components of the syringe system 100 are supported by the main syringe component 110.
[0044] The plunger 140 is provided with an actuator 142 to cause the plunger 140 to telescopically move within the syringe body and to advance the IOL 150 downward along the lumen L. In the illustrated embodiment, a finger flange 114 is formed on the syringe body, and the actuator is implemented as a thumb press, which combination facilitates the movement of the plunger within the syringe body; however, any suitable manual, electromechanical, pneumatic actuator design may be used.
[0045] Figures 3A to 3CSchematic illustration of an example of the soft tip 142 in accordance with aspects of the present invention. As described above, plane A includes a longitudinal axis LA, and when the lens is in the assembly region, plane A is perpendicular to the optical axis OA of the IOL 150. In plane A, the concave distal surface C extends in a direction D at a non-vertical angle Φ with respect to the longitudinal axis LA. For example, the concave shape can be cylindrical, having a circular curvature in a plane perpendicular to the axis extending in direction D and no curvature along the axis extending in direction D; alternatively, the concave shape can have an elliptical curvature (or another curved shape) perpendicular to the axis extending in direction D and no curvature along the axis extending in direction D. In some embodiments, in addition to the curvature in the plane perpendicular to direction D, the distal surface can have a curvature (convex or concave) along direction D.
[0046] In a plane perpendicular to direction D (at various positions along direction D), the curvature of surface C can be symmetric about direction D or can deviate from symmetry. The orientation of direction D with respect to the longitudinal axis LA and the rest of the syringe and the IOL is discussed in more detail below.
[0047] The distal surface C is selected to be concave in a plane perpendicular to direction D to facilitate positioning of the proximal loop 154b on top of the optical body 152. As discussed in more detail below with reference to Figures 8A to 8C The distal surface C is angled with respect to the longitudinal axis LA such that the distal surface C engages the proximal loop 154b in a manner such that the loop 154b is bent relative to the optical loop connection, such that the distal end DE2 of the loop and a portion of the loop arm A are moved uniformly to a position on top of the optical body 152 rather than being compressed into the side of the optical body 152.
[0048] The soft tip 142 is elastically deformable such that the soft tip can be compressed as it advances downward along the lumen L (which has a reduced cross-section to compress the IOL 150) and returns to its original shape once the deforming or compressive force is removed. For example, the soft tip is made of an elastomer (e.g., silicone rubber), a deformable plastic, or a deformable thermoplastic. The material generally has the same or less hardness than the material used to manufacture the IOL to avoid damaging the IOL. The material can be a different material or the same material as the IOL 150 to be injected. It should be understood that the concave shape of the soft tip in combination with the shape of the lumen selected to compress the tip reduces the likelihood that the proximal loop or the lens body will become positioned below the tip as the tip advances downward along the lumen. Additionally, as the soft tip advances downward along the lumen, the most distal portion of the soft tip can come together, thereby forming a gripping action around the optical body and / or the loop, thus stabilizing the lens as it moves downward along the lumen.
[0049] In some embodiments, the distal surface C does not have features that extend into the recessed cavity CA formed by the distal surface C. However, in some embodiments, it has been found beneficial to have material voids (e.g., blind holes B) that extend through the distal surface and proximally through the soft tip, which facilitates compression of the tip as the tip advances distally along the lumen L. In some embodiments, the distal surface has a continuous curvature in a plane perpendicular to direction D (except in any plane that includes the blind hole).
[0050] Voids V1, V2 may be formed in the outer profile of the soft tip 142 to facilitate compression of the tip 142, and / or for the design of the soft tip 142 to extend beyond the distal end DL of the lumen when the plunger 140 is depressed (as Figure 1 shown), to facilitate re-entry of the soft tip 142 into the lumen L when the plunger is retracted.
[0051] As Figure 3C shown, in plane A, the concave distal surface C extends in direction D, and direction D extends at a non-vertical angle Φ with respect to the longitudinal axis LA. The angle Φ may have a value in the range of 40 to 70 degrees; and in some cases, an angle such as 45 to 65 degrees may be used; and an angle of about 60 degrees may be used; where Φ is specified herein using the acute angle between D and LA; of course, the angle between direction D and LA may be specified using the obtuse angle between D and LA, which is equivalent to the acute angle specified above. The above angles are representative and may be selected based on the IOL structure (including loops or other structures). As discussed in more detail below with reference to Figure 8B the plunger, in some embodiments, starts by contacting less than 10% of the loop length (measured from the edge of the optical body 152 to the distal end DE2 of the loop), and generally contacts more of the loop as the plunger advances and the loop bends. Although the percentage of the loop contacted by the soft tip need not decrease as the plunger is advanced, it is generally beneficial for the plunger not to contact more than 50% at any point during plunger actuation (i.e., until and including delivery of the IOL through the distal end of the lumen into the eye).
[0052] Figures 4A to 4C A distal view, a sectional side view, and a sectional top view of an example of the shuttle 400 (corresponding to the shuttle 120 in Figure 1 ) in the open position and holding the IOL in an unbiased state are shown respectively. By holding the lens in a stress-free state, the lens can be stored long-term without affecting the physical and optical properties of the lens.
[0053] In the illustrated embodiment, shuttle 400 includes a first plate 420a and a second plate 420b, which are constructed and operate substantially as described in U.S. Patent No. 11,278,395 to Valle et al., the entire content of which is incorporated herein by reference. Although shuttle 400 is shown as including two components, in some embodiments, the shuttle is a single integrated component ( Figure 7A and Figure 7B ), and in other embodiments includes three or more components.
[0054] Figure 4A and Figure 4B An edge view of plane A is shown. Plane A includes a longitudinal axis LA, and when the IOL is in the assembly area of shuttle 400 and / or syringe system 100 (as Figure 1 shown), plane A is perpendicular to the optical axis OA of IOL 150.
[0055] In the illustrated embodiment of shuttle 400, a biasing tab 445 is included. The biasing tab moves IOL 150 (primarily the optical body 152) from a substantially flat shape (i.e., the unbiased state) to a slightly U-shaped shape (also referred to as a smile shape; as Figure 5A shown), where the center of the optical body 152 is slightly displaced downward relative to the circumferential outer edge position of the optical body 152 (e.g., such that the optical body contacts and can partially conform to the lumen wall 412a).
[0056] In Figures 4A to 4C the illustrated embodiment, as Figure 4B shown, biasing tab 445 is positioned to be disposed between the first plate 420a and the second plate 420b; after connecting components 420a and 420b together, components 420a and 420b hold biasing tab 445 therebetween. Biasing tab 445 includes a finger press portion 446, retractable fingers 447a and 447b, and a lens press portion 448. The operation of the biasing tab is discussed below with reference to Figure 5A and Figure 5B . In some embodiments, an inclined surface 414 (also referred to as a ramp) having an increasing height in the distal direction is added to the side of lumen L such that when loop 154b is advanced downward along lumen L toward the distal end DL (as Figure 1 shown), the distal end DE2 of loop 154b travels upward along the ramp, further assisting in properly positioning the folded loop 154b on top of the optical body 152.
[0057] Figures 5A to 5C Distal views, sectional side views, and sectional top views of shuttle 400 in a closed position that holds lens 150 in a biased state are shown, respectively.
[0058] As described in U.S. Patent No. 11,278,395, the holding tabs 420a, 420b can be used to interact with the syringe body 110 (shown in Figure 1 and Figure 2 ) to effect the closing of the shuttle and the holding of the shuttle in the closed position, or the closing can be achieved by any other suitable technique. For example, the holding tabs 420a and 420b can be provided with a snap structure (not shown) such that the holding tabs are snapped together by manual operation without flexing or hinging the shuttle (e.g., components 420a, 420b) to achieve the closed position.
[0059] Regardless of the technique used to close the shuttle 400, as described in U.S. Patent No. 11,278,395, when the shuttle is closed, the inner surfaces of the gathering regions move together such that the width dimension of the lumen is slightly smaller than the outer dimension of the optical body to slightly compress the optical body, and the elliptical cross-sectional shape of the lumen allows the optical body to be biased downward.
[0060] Although the lumen shape can be selected to effect the biasing of the lens when the shuttle is closed, the biasing tab 445 can be used to ensure the downward biasing of the lens before actuating the plunger (i.e., a portion of the optical body at the optical axis OA is set downward relative to the opposite circumferential outer edges OE1 and OE2). Figures 6A to 6B A distal view and a sectional side view of the shuttle 400 are respectively shown, in which the biasing tab 445 is depressed and the lens 150 is in the biased state. In Figure 6A , the shuttle 400 is in such a configuration where the lumen walls form a closed circumference (also referred to as the closed state or the loading configuration; shown as elliptical lumen walls), and the biasing tab is depressed to ensure that the lens is in the biased state. As Figure 6B shown, when pressure is applied to the finger press portion 446 and the biasing tab 445 is depressed, the retracting fingers 447a and 447b move outward along the platforms 449a and 449b respectively. When the pressure on the finger press portion 446 is removed, the fingers 447a and 447b move inward along the platforms 449a and 449b, causing the lens press portion 448 to retract. Since the optical body 152 is slightly compressed when located in the gathering region, the pressure on the optical body causes the IOL 150 to reach and maintain a smile shape.
[0061] Figures 7A to 7B A distal view and a sectional top view of another example of the shuttle 700 are respectively shown. In the illustrated embodiment, the shuttle 700 is formed of a single rigidly constructed part (i.e., no moving parts, as compared to the above reference Figures 4A to 4C(which is different from the described embodiments), or may include two or more components to facilitate manufacturing or for other reasons. Figure 7A A distal edge view of plane A is shown. The plane includes a longitudinal axis LA and is perpendicular to the optical axis OA of the IOL 150 when the IOL is in the assembly area. The shuttle 700 holds the IOL 150 in a biased state in contact with at least a portion of the lumen wall 712. Although the above embodiments are described as automatically obtaining an IOL in a biased state when the shuttle is closed or the biasing tab is depressed. In Figure 7A and Figure 7B In the illustrated embodiment, any suitable technique can be used to obtain the biased state. For example, a human finger or forceps can be used to manually bias the lens into the biased state by manipulating the lens.
[0062] As described above, the IOL 150 is advanced downward along the lumen L by the plunger 140 (as Figure 1 shown). As described above, a ramp 714 may be present on a side of the lumen corresponding to the free end of the proximal loop 154b to facilitate placing the proximal loop on top of the optical zone, although this is not required. Additionally, although the lens is shown as being biased when in the assembly area, in some embodiments, biasing of the lens in the assembly area is not required. For example, an oval lumen wall combined with a reduced cross-section of the lumen can cause the center of the optical body (i.e., near the optical axis) to be lower than the sides of the lens (i.e., the portions of the lens disposed at the extremes of the oval).
[0063] Figure 8A is Figure 1 A schematic top cross-sectional view of the syringe body 100 as shown. In Figure 8A it, the IOL 150 is in the assembly area and the plunger 140 is actuated to the point where the soft tip 142 is close to the lens 150. For example, the IOL can be a hydrophobic acrylic IOL from Bausch & Lomb. In Figure 8A it, the IOL 150 has not yet been impacted by the soft tip 142.
[0064] Figure 8B is a schematic top cross-sectional view of the syringe body 100, where the plunger 140 is actuated to the point where the soft tip 142 first contacts the proximal loop 154b. In Figure 8BIn this case, it is obvious that the soft tip 142 will start to fold the proximal loop 154b under pressure at relatively local positions along the proximal loop 154b (e.g., contacting less than 10% of the loop length). As determined by the inventors, folding the proximal loop 154b under local pressure along the loop length (particularly, at the start of the loop folding process) allows the folding to occur with a reduced likelihood of the loop being in an incorrect position (i.e., the proximal loop being compressed against one side of the optical body 152).
[0065] Figure 8C is a cross-sectional top view schematic of the syringe body 100, where the plunger 140 further contacts along the loop 154b (i.e., closer to the optical zone-loop connection), and the plunger 140 contacts a larger portion of the loop 154b. Since loop folding typically occurs gradually, starting from contacting a relatively low percentage of the loop length and progressing to contacting a larger percentage of the loop length, the folding continues with an increased likelihood that the loop 154b will remain positioned on top of the optical body 152 and not be compressed against the side of the optical body. Although the concave distal surface C and the angle Φ combined with the biasing of the optical body 152 (e.g., using the biasing tab 445 ( Figure 4A shown in)) increase the likelihood that the loop 154b will be properly positioned on top of the optical body 152, in some embodiments, an inclined surface 414 is added to the side of the lumen L such that when the IOL 150 is advanced down the lumen, the distal end DE2 of the loop 154b travels up the ramp, thereby further assisting in the proper positioning of the folded loop 154b on top of the optical body 152.
[0066] Figure 8D is a cross-sectional top view schematic of the syringe body 100, where the plunger 140 is actuated to the point where the soft tip 142 has moved the loop 154b on top of the optical body 152 in preparation for further compression by the lumen wall.
[0067] The reduced cross-section of the lumen L causes the distal loop 154a to fold towards the optical body 152. In some embodiments, it is advantageous if the distal loop (similar to the proximal loop 154b) is folded such that the distal end DE1 of the proximal loop is on top of the optical body when the optical body is compressed. As shown, it is generally acceptable if the distal loop 154a is folded to a lesser extent than the proximal loop 154b. In some embodiments, it is advantageous to include one or more loop restraining elements that impede the advancement of the distal portion of the distal loop relative to the optical body. In the illustrated embodiment, the loop restraining element 420a extends into the lumen L to engage the distal end DE1 of the distal loop 154a as the IOL is advanced down the lumen. The loop restraining element 420a is a protrusion that extends radially inwards from the lumen wall and may have a greater slope than the portion of the lumen wall adjacent to the restraining element; and the loop restraining element 420b is the exposed edge of the loop wall that has a greater slope than the portion of the lumen wall adjacent to the restraining element.
[0068] Figure 9 is a schematic projection view of the IOL 150 according to aspects of the present invention as described above, where the distal loop 154a and the proximal loop 154b have been folded onto the top of the optical body 152; and the sides of the optical body have been rolled towards each other in a conventional manner through the lumen wall to form an object commonly referred to as a "taco fold". In a taco fold, the opposing edges of the optical body may contact each other (as shown), overlap each other, or may be separated from each other. Although in the illustrated embodiment, the lens has a taco fold as it emerges from the distal end of the lumen, the plunger as described herein can be used with any suitable technique for folding the optical body.
[0069] Although various embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions, etc. can be made without departing from the spirit of the present invention, and thus such modifications, additions, substitutions, etc. are considered to be within the scope of the present invention as defined in the appended claims.
Claims
1. A syringe for injecting an IOL into an eye, comprising: a syringe body having a lumen wall defining a lumen, wherein the IOL is delivered to the eye at the distal end of the lumen; and a plunger having a longitudinal axis and a soft tip at the distal end of the plunger, the soft tip being positioned to push the IOL through the lumen to the distal end of the lumen, the soft tip having a concave distal surface, in a plane including the longitudinal axis, when the IOL is located in the assembly area of the syringe body, the plane is perpendicular to the IOL optical axis, and the concave distal surface extends in a direction at a non-vertical angle relative to the longitudinal axis.
2. The syringe according to claim 1, wherein the concave distal surface is elliptical in a plane perpendicular to the direction, and the concave distal surface has no curvature along the direction.
3. The syringe according to claim 1, wherein the concave distal surface is cylindrical in a plane perpendicular to the direction, and the concave distal surface has no curvature along the direction.
4. The syringe according to claim 1, wherein the soft tip comprises an elastomer.
5. The syringe according to claim 1, wherein the concave distal surface defines a concave cavity, and wherein no feature of the soft tip extends into the concave cavity.
6. The syringe according to claim 1, wherein the concave distal surface has a blind hole formed therethrough, the blind hole extending proximally from the concave distal surface through the soft tip.
7. The syringe according to claim 1, wherein the angle is in the range of 40 degrees to 70 degrees.
8. The syringe according to claim 1, wherein the angle is in the range of 45 degrees to 65 degrees.
9. The syringe according to claim 1, wherein the angle is about 60 degrees.
10. The syringe according to claim 1, having an intraocular lens (IOL) disposed in the assembly area of the syringe body, the IOL having haptics extending proximally from the optical zone, the soft tip being configured to contact less than 10% of the haptic length measured from the distal end of the optical body to the distal end of the haptic at the initial contact between the soft tip and the haptic.
11. The syringe according to claim 10, wherein the soft tip is configured to contact no more than 50% of the haptic length at any point during actuation of the plunger.
12. The syringe according to claim 1, wherein the syringe body comprises two or more components, each component forming a part of the lumen.
13. The syringe according to claim 12, wherein at least one of the components constitutes an IOL shuttle.
14. The syringe according to claim 13, wherein the shuttle has an IOL disposed therein in a biased state, and the center of the optical body is slightly displaced downward relative to the relative circumferential outer edge position of the optical body.
15. A plunger for use in an IOL syringe, comprising: A shaft having a longitudinal axis, and a soft tip at a distal end of the shaft, the soft tip having a concave surface extending in a direction that forms a non-perpendicular angle with the longitudinal axis.
16. The plunger according to claim 15, in combination with a syringe body having a lumen, the plunger being arranged to slide within the lumen.
17. A method of inserting an intraocular lens (IOL) including an optical body and haptics through a lumen of a syringe into an eye, the syringe including a plunger, the plunger including i.) a shaft characterized by a longitudinal axis and ii.) a soft tip at a distal end of the shaft, the soft tip having a concave distal surface extending in a direction that forms a non-perpendicular angle with the longitudinal axis, the method comprising: Actuating the plunger to move a portion of the haptic over the top of the optical body.
18. The method according to claim 17, wherein the actuating step comprises contacting less than 10% of the haptic length measured from the optical body to the distal end of the haptic at an initial contact with the haptic.
19. The method according to claim 17, wherein the actuating step comprises: Moving the IOL from an assembly area of the syringe body through a distal end of the lumen while contacting no more than 50% of the haptic length at any point during the movement of the IOL from the assembly area to the distal end of the lumen.
20. The method according to claim 17, wherein the concave distal surface is elliptical in a plane perpendicular to the direction and the concave distal surface has no curvature along the direction.
Citation Information
Patent Citations
Method for intraocular lens injector assembly having shuttle assembly retaining intraocular lens in storage vial and operably presenting intraocular lens in injector assembly
US11278395B2