Viscoelastic soft tip plunger
The implementation of a viscoelastic soft tip with specific modulus ranges in IOL insertion tools addresses the issue of sudden IOL discharge, ensuring controlled and stable insertion into the eye.
Patent Information
- Application Number
- JP2022500718
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-07-12
- Filing Date
- 2020-06-18
- Publication Date
- 2025-06-20
- Estimated Expiration
- 2040-06-18
AI Technical Summary
Existing soft-tip plungers used in intraocular lens (IOL) insertion tools can cause sudden or self-discharge of the IOL due to stored spring energy, leading to undesirable complications during controlled insertion into the eye.
The use of a plunger with a viscoelastic soft tip having a storage modulus of about 1 MPa to 300 MPa and a loss modulus of about 1 MPa to 300 MPa, which engages the IOL and slowly releases stored spring energy, reducing the risk of sudden discharge.
The viscoelastic soft tip effectively reduces the tendency for sudden or self-discharge of the IOL, allowing for controlled and stable insertion into the eye, thereby minimizing complications.
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Abstract
Description
Technical Field
[0001] The present disclosure generally relates to ophthalmic surgery, and more specifically, embodiments may generally relate to systems, methods, and devices for inserting an intraocular lens (IOL) using a plunger having a viscoelastic soft tip.
Background Art
[0002] The human eye is susceptible to many diseases that can cause anything from mild degradation to complete loss of vision. Contact lenses and glasses can compensate for some conditions, but in other cases, ophthalmic surgery may be required. Generally, ophthalmic surgery can be classified into posterior segment procedures such as vitreoretinal surgery and anterior segment procedures such as cataract surgery. Vitreoretinal surgery may address many different eye conditions including, but not limited to, macular degeneration, diabetic retinopathy, diabetic vitreous hemorrhage, macular hole, retinal detachment, epiretinal membrane, and cytomegalovirus retinitis.
[0003] Regarding cataract surgery, in order to replace a cloudy lens with an intraocular lens (IOL), surgical procedures may require an incision and the insertion of tools into the eye. An insertion tool may be used to deliver the IOL into the eye. By way of example, the insertion tool may include a plunger for pushing the IOL out of the nozzle of the insertion tool. To avoid damaging the IOL, the plunger may include a soft tip. These soft-tip plungers are gentle on the IOL even when a large amount of force may be required to push the IOL through the nozzle of the insertion tool. However, there can be drawbacks to using soft-tip plungers. When the soft-tip plunger engages the IOL and moves within the nozzle, the soft tip can be compressed and store spring energy. When the soft tip exits the nozzle, it can expand rapidly and release the spring energy. Since the soft tip is engaged with the IOL, this spring energy can be transmitted to the IOL and lead to a sudden or self-discharge of the IOL from the nozzle. Since the insertion of the IOL into the eye should be performed in a controlled manner, this is highly undesirable and can lead to complications. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM
[0004] In an exemplary embodiment, the present disclosure provides an apparatus for delivering a lens component into the eye. The apparatus may include a housing and a plunger at least partially disposed within the housing, wherein the housing includes an elongate portion and a viscoelastic soft tip at the distal end of the elongate portion, and the viscoelastic soft tip has a storage modulus of about 1 megapascal (MPa) to about 300 MPa and a loss modulus of about 1 MPa to about 300 MPa, and the plunger. The apparatus may further include a drive mechanism operatively coupled to the plunger and configured to translate the plunger within the housing. The apparatus may further include a nozzle operatively coupled to the housing through which the plunger delivers the lens component into the eye.
[0005] In another exemplary embodiment, the present disclosure provides a method for delivering a lens component into the eye. The method may include inserting the nozzle of an insertion tool into the eye. The method may include actuating the insertion tool to move a plunger within the nozzle such that the plunger drives the lens component through the nozzle into the eye, wherein the viscoelastic soft tip of the plunger engages the lens component and the viscoelastic soft tip has a storage modulus of from about 1 MPa to about 300 MPa and a loss modulus of from about 1 MPa to about 300 MPa. The method may further include placing the lens component into the eye together with the lens capsule.
[0006] It is needless to say that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, further aspects, features and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description.
Brief Description of the Drawings
[0007] These drawings show some specific aspects of embodiments of the present disclosure and should not be used to limit or define the present disclosure.
[0008]
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Figure 5B
Figure 5C
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[0009] For the purpose of facilitating an understanding of the principles of the present disclosure, reference is now made to the implementation forms shown in the drawings and they are described in a specific language. Nevertheless, it will be understood that no limitation of the scope of the disclosure is intended. Any alternative forms and further modifications to the devices, apparatuses, and methods described, as well as any further applications of the principles of the present disclosure, are fully contemplated as being normally thought of by those skilled in the relevant technical fields to which the present disclosure pertains. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one or more implementation forms may be combined with the features, components, and / or steps described with respect to other implementation forms of the present disclosure. For the sake of simplicity, in some cases, the same reference numerals are used throughout the drawings to refer to the same or similar parts.
[0010] Embodiments can generally relate to ophthalmic surgery. More specifically, embodiments can generally relate to systems, methods, and devices for inserting an intraocular lens (IOL). Embodiments can include an insertion tool for preparing and delivering an IOL assembly, including a plunger, a nozzle, and an IOL holder, into a patient's eye. Embodiments of the IOL can include a modular IOL including a base portion and a lens portion. In some embodiments, the plunger may include a viscoelastic soft tip. The viscoelastic soft tip may engage a lens component and drive the lens component through the nozzle. The lens component may be an individual component of the modular IOL, such as the IOL itself or the base portion of the lens portion. Advantageously, the viscoelastic soft tip should reduce the tendency of the soft tip plunger to effect an undesired rapid or self-discharge of the IOL, for example by the release of spring energy stored by compression of the soft tip. By appropriately selecting the viscoelastic properties of the viscoelastic soft tip, the stored spring energy should be released slowly and, therefore, may reduce or even eliminate an undesired rapid and self-discharge of the IOL.
[0011] FIG. 1 shows one embodiment of a modular IOL 10. The modular IOL 10 can be any suitable modular interocular lens. As shown, the modular IOL 10 may include a base portion 12 and a lens portion 14. In the illustrated embodiment, the lens portion 14 is disposed within the base portion 12. In operation, the modular IOL 10 can enable the lens portion 14 to be modified or adjusted while leaving the base portion 12 in a predetermined position, either during or after surgery. By way of example, the modular IOL 10 can be implanted in the eye. After implantation, the lens portion 14 may be modified, adjusted, and / or replaced while the base portion 12 remains disposed within the eye. In at least one embodiment, the modular IOL 10 may be assembled within the eye. For example, the base portion 12 may first be implanted in the eye. Thereafter, the lens portion 14 may be delivered into the eye and attached to the base portion 12.
[0012] FIG. 2 shows the base portion 12 of the modular IOL 10 of FIG. 1 according to an embodiment of the present disclosure. In the illustrated embodiment, the base portion 12 includes a base 16 and a haptic extension 18. The haptic extension 18 may be an arm (or other suitable extension) extending from the base 16 and can stabilize the base portion 12 when the base portion 12 is disposed within a patient's eye. In the illustrated embodiment, the base 16 may define a hole 19, which may be located at the center of the base 16 as shown in FIG. 2. The hole 19 is shown as a through hole penetrating the base 16, but in embodiments, it is also conceivable that the hole 19 is a blind hole that does not penetrate the base 16. For example, the base 16 may be a solid disk that is not an annular ring with the hole 19 penetrating the base 16, but a blind hold where the hole 19 does not penetrate the base 16. The hole 19 may be defined by the inner circumferential surface 20 of the base 16. In at least one embodiment, a concave groove 22 is formed in the inner circumferential surface 20. The concave groove 22 may include a lower rim 24 and an upper rim 26. The upper rim 26 may have an insider diameter that is the same as or larger than the outer diameter of the lens portion 14 (excluding the tab 30 shown in FIG. 3) such that the lens portion 14 can rest inside the hole 19 of the base 16. All or part of the lower rim 24 may have an inner diameter smaller than the outer diameter of the lens portion 14 (excluding the tab 30 shown in FIG. 3) such that the lower rim 24 can function as a protrusion or a stop for the lens portion 14 when the lens portion 14 is disposed within the hole 19 of the base 16. The base portion 12 may be integrally formed or may be formed from components combined or attached in any suitable manner.
[0013] Referring to FIG. 3, there is shown the lens portion 14 of the modular IOL 10 of FIG. 1 according to an embodiment of the present disclosure. In the illustrated embodiment, the lens portion 14 includes an optical portion 28 and one or more tabs 30. FIG. 3 shows two of the tabs 30, although an embodiment may include only one of the tabs 30, or instead, three, four or more tabs 30. Additionally, the tabs 30 on the lens portion 14 may be identical to or different from each other. The tabs 30 are shown as being fixed to the optical portion 28, but one or more of the tabs 30 are actuated to move from a compressed state for delivery to a hole 19 in the base 16 (e.g., as shown in FIG. 2) to an uncompressed expanded state for placement in a groove 22 in the base 16 (e.g., as shown in FIG. 2), thereby forming an interlock connection between the base portion 12 and the lens portion 14. It should be understood that the outer curved portion of the tab 30 may have a radius that matches the inner radius of the groove 22. This configuration should limit relative movement between the base portion 12 and the lens portion 14 once connected. In an embodiment, a suitable optical portion 28 may be shaped similar to the shape of the natural lens in the eye and may be made from a suitable material such as silicone, acrylic, and / or combinations thereof. The optical portion 28 is shown as being circular, although the optical portion 28 may be any suitable shape such as an ellipse or oval, for example, with the tabs 30 arranged adjacent to the major axis. Thus, this configuration defines a gap between the edge of the optical portion 28 along its minor axis and the inner circumferential surface 20 of the base 16. The gap can allow access for a probe or similar device to remove the lens portion 14 from the base portion 12 when separation is required.
[0014] FIG. 4 shows a schematic view of the insertion tool 32. In some embodiments, the insertion tool 32 may include a drive mechanism 34, a plunger 36, a lens holder 38, and a nozzle 40. The plunger 36 may be at least partially disposed within the housing 35. For example, the plunger 36 may extend from the housing 35 and engage the drive mechanism 34 outside the housing 35. In other embodiments, the plunger 36 may be disposed within the housing 35. In some embodiments. The drive mechanism 34 may be operatively coupled to the plunger. As shown, the plunger 36 may include a viscoelastic soft tip 42. The insertion tool 32 may be operable to deliver the lens component 44 into the patient's eye. The lens component 44 may include any suitable component of the IOL, including the IOL itself or components of the modular IOL 10 shown in FIG. 2, such as the base portion 12 or the lens portion 14.
[0015] The drive mechanism 34 can be any suitable combination of components for actuating the plunger 36. For example, the drive mechanism 34 may use a lever and / or a pneumatic system. The plunger 36 may be operatively coupled to the drive mechanism 34. The drive mechanism 34 may actuate the plunger 36 by any suitable means including, but not limited to, an electric drive unit, a mechanical drive unit, a hydraulic drive unit, a pneumatic drive unit, and / or combinations thereof. The plunger 36 may be actuated and move within the lens holder 38. The lens holder 38 may be disposed at any suitable position within the insertion tool 32. For example, the lens holder 38 may be housed or inserted within the housing 35. The plunger 36 is driven through the housing 35. In some embodiments, the lens holder 38 may be positioned between the drive mechanism 34 and the nozzle 40. In some embodiments, the lens holder 38 may house the lens component 44. In some embodiments, the lens component 44 may be loaded within the lens holder 38 in a deployed configuration. To deliver the nozzle 40, the lens holder 38 can be actuated to fold the lens component 44. As used herein, folding of the lens component 44 shall also include winding the lens component 44. For example, the haptic extension 18 of the base portion 12 shown in FIG. 2 may be folded onto the base 16, and thereafter, it may be further folded or wound. As a further example, the lens portion 14 shown in FIG. 2 may be folded or wound into a folded configuration for delivery through the nozzle 40. As the plunger 36 moves within the lens holder 38, the plunger 36 can displace the lens component 44 within the nozzle 40. The viscoelastic soft tip 42 should engage the lens component 44 as the lens component 44 moves within the nozzle 40.
[0016] In some embodiments, the insertion tool 32 may be pre-loaded. That is, when provided to the end user, the insertion tool 32 may already have the lens component 44 (e.g., the modular IOL 10, the base portion 12, or the lens portion 14) in a deployed state present within the insertion tool 32 and be ready for delivery. By pre-loading the lens component 44 into the insertion tool 32, the number of steps that the user may need to perform before delivering the lens component 44 into the patient's eye should be reduced. The reduction in the number of steps may reduce the flaws and risks associated with the delivery of the lens component 44 to the patient. Further, the amount of time required for the delivery of the lens component 44 may also be reduced. In some embodiments, the lens component 44 may be pre-loaded into the lens holder 38.
[0017] Here, an exemplary technique for implanting the modular IOL 10 into the patient's eye 46 will be described with respect to FIGS. 5A-5C. As shown in FIG. 5A, the insertion tool 32 may first supply the base portion 12 into the patient's eye 46. In an embodiment, an incision 48 may be created in the eye 46 by a surgeon. For example, the incision 48 may be created through the sclera 50 of the eye 46. The incision 48 may be of an appropriate width or length. Without limitation, an appropriate width and / or length may be less than about 4 millimeters. For example, the incision 48 may have an appropriate width and / or length of about 1 millimeter to about 4 millimeters, about 1 millimeter to about 3 millimeters, about 2 millimeters to about 3 millimeters, or about 2 millimeters to about 2.5 millimeters. After creation of the incision 48, the nozzle 40 of the insertion tool 32 may be inserted through the incision 48 into the inner portion 52 of the eye 46. The insertion tool 32 may be actuated to supply the base portion 12 into the lens capsule 54 of the eye 46. For example, a plunger 36 having a viscoelastic soft tip 42 may engage the base portion 12 and drive the base portion 12 (in a folded (or wound) configuration) through the nozzle 40 into the inner portion 52 of the eye 46. Upon supply, the base portion 12 should expand and fit within the lens capsule 54 of the eye 46 as shown in FIG. 5B. The haptic expansion portion 18 may be manipulated, for example, to engage within the equator 56 of the lens capsule 54. The haptic expansion portion 18 can engage the lens capsule 54 and firmly fix the base portion 12 within the lens capsule 54.
[0018] As shown in FIG. 5C, the lens portion 14 may be disposed within the inner portion 52 of the eye 46. In the illustrated embodiment, the lens portion 14 is shown disposed within the base 16 of the base portion 12. Although not shown in FIG. 5C, an insertion tool 32 as shown in FIG. 5A or other suitable inserter may be used to deliver the lens portion 14 into the eye 46. The lens portion 14 may be delivered in a folded (or wound configuration) and unfolded after being discharged from the inserter. The lens portion 14 may be disposed within the base 16 of the base portion 12 and fixed to the base portion 12, for example, by using the tabs 30 shown in FIG. 3, to form the modular IOL 10. However, the embodiments should not be limited to the interlocking of the lens portion 14 and the base portion 12 using the tabs 30, and other suitable locking mechanisms may be used to fix the lens portion 14 to the base portion 12 to form the modular IOL 10. The base portion 12 may hold the lens portion 14 within the eye 46 such that the lens portion 14 can refract light and focus it onto the retina (not shown).
[0019] FIG. 6 shows a plunger 36 according to an embodiment of the present disclosure. In the illustrated embodiment, the plunger 36 includes an elongate portion 58 and a viscoelastic soft tip 42. The elongate portion 58 may be formed from any suitable material. For example, suitable materials for the elongate portion 58 may include metals such as stainless steel or titanium. However, the elongate portion 58 may be formed from any suitable material including, but not limited to, polymers, metals, ceramics, or other suitable materials. The viscoelastic soft tip 42 may be coupled to the distal end 60 of the elongate portion 58. Any suitable technique may be used to couple the viscoelastic soft tip 42 to the elongate portion 58. For example, the coupling of the viscoelastic soft tip 42 to the elongate portion 58 may be achieved using extrusion, casting, molding, injection molding, insert molding, welding, adhesives, or other desired or appropriate methods. In some embodiments, the coupling may be achieved using a combination of two or more of these methods. In some embodiments (not shown), the viscoelastic soft tip 42 and the elongate portion 58 may be integral, and the viscoelastic soft tip 42 may be an extension of the elongate portion 58.
[0020] The elongate portion 58 may have any suitable dimensions. For example, the elongate portion 58 may have a length of from about 0.5 centimeters to about 10 centimeters. As a further example, the elongate portion 58 may have an outer diameter of from about 0.05 centimeters to about 0.3 centimeters. The viscoelastic soft tip 42 may also have any suitable dimensions. For example, the viscoelastic soft tip 42 may have a length of from about 0.2 centimeters to about 1 centimeter. As a further example, the viscoelastic soft tip 42 may have an outer diameter of from about 0.1 centimeters to about 0.8 centimeters. Further, in some embodiments, the outer size and shape of the viscoelastic soft tip 42 may match the size and shape of the elongate portion 58, thereby creating a smooth transition between the elongate portion 58 and the viscoelastic soft tip 42.
[0021] The viscoelastic soft tip 42 may be adapted to provide non-abrasive engagement with a lens component 44 (e.g., shown in FIG. 4) such as a buffer and / or base portion 12 (e.g., shown in FIG. 2) or a lens portion 14 (e.g., shown in FIG. 3). Thus, the hardness of the viscoelastic soft tip 42 may be selected, for example, to provide non-abrasive engagement with the buffer and / or lens component 44. For example, the material forming the viscoelastic soft tip 42 may have a durometer value of 20A on the Shore hardness scale. In other examples, the material forming the viscoelastic soft tip 42 may have a durometer value of about 20OO - 50D on the Shore hardness scale. As used herein, the durometer value is a Shore hardness value. However, the present disclosure is not so limited. Rather, these hardness values are provided as merely examples. Thus, the material forming the viscoelastic soft tip 42 may have any suitable hardness desirable for a particular application.
[0022] In addition to hardness, the viscoelastic soft tip 42 may also be characterized by viscoelasticity. For example, the viscoelastic soft tip 42 may exhibit both viscous and elastic properties when deformed. Due to the pressure applied when pushing the lens component 44 through the nozzle 40 (e.g., shown in FIG. 4), the viscoelastic soft tip 42 may deform, e.g., compress, when being pushed through the nozzle 40 while engaged with the lens component 44. The viscoelastic soft tip 42, by having elastic properties, should return to its original state, for example, when the stress is removed after exiting the nozzle 40. However, if the viscoelastic soft tip 42 does not include sufficient viscous properties, the viscoelastic soft tip 42 may return to its original state too quickly when bouncing back to its original state, potentially pushing the lens component 44 unnecessarily. Thus, embodiments may include a selection of viscous properties such that the viscoelastic soft tip 42 slowly returns to its original state without accompanying unwanted auto-ejection of the lens component due to the viscoelastic soft tip 42 bouncing back to its original state too quickly.
[0023] The viscoelasticity of the viscoelastic soft tip 42 can be characterized by its storage modulus (or elastic modulus) (G’) and loss modulus (G’’). By way of example, the storage modulus and loss modulus of the viscoelastic soft tip 42 can be selected to provide a desired viscoelasticity. Suitable storage moduli of the viscoelastic soft tip 42 at room temperature (23 °C) can range from about 1 megapascal (MPa) to about 300 MPa, from about 1 MPa to about 10 MPa, from about 10 MPa to about 50 MPa, or from about 50 MPa to about 300 MPa. For example, the viscoelastic soft tip 42 can have a storage modulus at room temperature (23 °C) of about 1 MPa, about 10 MPa, about 30 MPa, about 50 MPa, about 100 MPa, about 200 MPa, or about 300 MPa. Suitable loss moduli of the viscoelastic soft tip 42 at room temperature (23 °C) can range from about 1 MPa to about 300 MPa, from about 1 MPa to about 10 MPa, from about 10 MPa to about 50 MPa, or from about 50 MPa to about 300 MPa. For example, the viscoelastic soft tip 42 can have a loss modulus at room temperature (23 °C) of about 1 MPa, about 10 MPa, about 30 MPa, about 50 MPa, about 100 MPa, about 200 MPa, or about 300 MPa. As used herein, the storage modulus and loss modulus are measured at a frequency of 1 Hz using the standard test procedure described in ASTM D 4065 for dynamic mechanical analysis (“DMA”). Those of ordinary skill in the art having the benefit of this disclosure should be able to select suitable storage moduli and loss moduli for the viscoelastic soft tip 42 for a particular application.
[0024] According to this embodiment, the viscoelastic soft tip 42 may be formed from any suitable viscoelastic material. In particular, in some embodiments, the viscoelastic soft tip 42 may be formed from any medically compatible viscoelastic material. The viscoelastic soft tip 42 may be formed from materials including, for example, polyurethane, acetate, acrylate, polyester, polyamide, and combinations thereof. In some embodiments, the viscoelastic soft tip 42 may include a viscoelastic polymer. Foams of the same material classification may also be considered. In some embodiments, the elongate portion 58 and the viscoelastic soft tip 42 may include the same or similar materials.
[0025] Figure 7 shows plunger 36 according to another embodiment of the present disclosure. In the illustrated embodiment, plunger 36 includes an elongate portion 58 and a viscoelastic soft tip 42. In contrast to the viscoelastic soft tip 42 shown in FIG. 6, the viscoelastic soft tip 42 is disposed around the distal end 60 of plunger 36. The viscoelastic soft tip 42 can be disposed around the distal end 60 of plunger 36 using any suitable technique, including but not limited to extrusion, casting, molding, insert molding, welding, adhesives, or other desired or appropriate methods. In some embodiments, two or more of these methods can be used to attach the viscoelastic soft tip 42 around the distal end 60 of plunger 36.
[0026] FIG. 8 shows a plunger 36 having a viscoelastic soft tip 42 that pushes through a lens component 44 within a nozzle 40. As shown, the plunger 36 may include a viscoelastic soft tip 42 at its distal end 60. In the illustrated embodiment, the viscoelastic soft tip 42 engages the lens component 44 and pushes the lens component 44 through the nozzle 40. The viscoelastic soft tip 42 can be compressed or deformed by the force necessary to push the viscoelastic soft tip 42 and the lens component 44 through the nozzle 40. As a result of this deformation, the viscoelastic soft tip 42 can store spring energy. The viscoelastic soft tip 42 is expected to advance within the nozzle 40 until the lens component 44 is discharged from the nozzle outlet 62. By adjusting the viscoelasticity of the viscoelastic soft tip 42, the stored spring energy should not be released unnecessarily when the viscoelastic soft tip 42 exits the nozzle outlet 62 upon release of this compressive force. As a result, the problems typically associated with soft tips can be reduced or possibly even avoided by the use of the viscoelastic soft tip 42 from leading to an undesired sudden and self-discharge of the lens component 44. Further, as shown in FIG. 9, a plunger 36 having a soft tip 64 without viscoelasticity adjustment expands rapidly after exiting the nozzle outlet 62 and may thus prevent the soft tip 64 from retracting into the nozzle 40 for removal from the patient's eye. However, as shown in FIG. 10, a plunger 36 having a viscoelastic soft tip 42 should expand slowly after exiting the nozzle outlet 62 to allow the nozzle 40 to be removed from the patient's eye and allow retraction into the nozzle 40.
[0027] The foregoing description generally pertains to the use of a plunger 36 having a viscoelastic soft tip 42 (e.g., as shown in FIGS. 6 or 7) with a modular IOL 10 (e.g., as shown in FIG. 1), although the viscoelastic soft tip 42 is considered to be usable in any suitable application for delivering lens components such as a lens component 44 (e.g., FIG. 4). The lens component 44 can be the modular IOL 10, or its specific component (e.g., the base portion 12 of FIG. 2 or the lens portion 14 of FIG. 3), although the lens component 44 can also include a non-modular IOL in which the base and lens portions of the IOL are fixed to each other and the lens portion cannot be replaced without removal.
[0028] The operation and structure of the present disclosure are considered to be apparent from the foregoing description. The devices and methods shown or described above are characterized as preferred, but various changes and modifications can be made thereto without departing from the spirit and scope of the present disclosure as defined in the following claims. Also, the present disclosure includes the following inventions. A first aspect is an apparatus for delivering a lens component into the eye, comprising a housing, a plunger at least partially disposed within the housing, the plunger including an elongate portion and a viscoelastic soft tip at a distal end of the elongate portion, the viscoelastic soft tip having a storage modulus of about 1 megapascal to about 300 megapascals and a loss modulus of about 1 megapascal to about 300 megapascals; a drive mechanism operatively coupled to the plunger and configured to translate the plunger within the housing; a nozzle operatively coupled to the housing, through which the plunger delivers the lens component into the eye; and the apparatus includes. A second aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip is disposed around the distal end of the elongate portion. A third aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip includes a viscoelastic polymer. A fourth aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip includes at least one material selected from the group consisting of polyurethane, acetate, acrylate, polyester, polyamide, foams thereof, and combinations thereof. A fifth aspect is the apparatus according to the first aspect, wherein the elongate portion includes metal and the viscoelastic soft tip includes a viscoelastic polymer. A sixth aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip is an extension of the elongate portion and the viscoelastic soft tip and the elongate portion are integral. A seventh aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip has a length of about 0.2 centimeters to about 1 centimeter and the elongate portion has a length of about 0.5 centimeters to about 0 centimeters. An eighth aspect is the apparatus according to the first aspect, wherein the viscoelastic soft tip has a durometer value of about 20OO to about 50D on the Shore hardness scale. A ninth aspect is the apparatus according to the first aspect, wherein the storage modulus of the viscoelastic soft tip is about 10 megapascals to about 50 megapascals and the loss modulus of the viscoelastic soft tip is about 50 megapascals to about 300 megapascals. The 10th aspect is the device according to the 1st aspect, wherein the drive mechanism is an electric drive unit, a mechanical drive unit, a hydraulic drive unit, a pneumatic drive unit, or a combination thereof. The 11th aspect is the device according to the 1st aspect, further including a lens holder coupled to the housing, and through the lens holder, the nozzle drives the lens component. The 12th aspect is the device according to the 11th aspect, further including the lens component disposed within the lens holder. The 13th aspect is the device according to the 12th aspect, wherein the lens component includes a base portion of a modular intraocular lens or a lens portion of the modular intraocular lens. The 14th aspect is the device according to the 12th aspect, wherein the lens component includes an intraocular lens. The 15th aspect is a method for delivering a lens component into the eye, comprising: inserting a nozzle of an insertion tool into the eye; operating the insertion tool to move the plunger within the nozzle such that the plunger drives the lens component through the nozzle into the eye, wherein a viscoelastic soft tip of the plunger engages the lens component, and the viscoelastic soft tip has a storage modulus of about 1 megapascal to about 300 megapascals and a loss modulus of about 1 megapascal to about 300 megapascals; placing the lens component into the eye together with the lens capsule; and including. The 16th aspect is the method according to the 15th aspect, wherein the viscoelastic soft tip includes a viscoelastic polymer. The 17th aspect is the method according to the 15th aspect, wherein the viscoelastic soft tip includes at least one material selected from the group consisting of polyurethane, acetate, acrylate, polyester, polyamide, foams thereof, and combinations thereof. The 18th aspect is the method according to the 15th aspect, wherein the plunger includes an elongated portion, the viscoelastic soft tip of the plunger is at a distal end of the elongated portion, the elongated portion includes metal, and the viscoelastic soft tip includes a viscoelastic polymer. The 19th aspect is The viscoelastic soft tip has a durometer value of about 20OO to about 50D on the Shore hardness scale, the storage modulus of the viscoelastic soft tip is about 10 megapascals to about 50 megapascals, and the loss modulus of the viscoelastic soft tip is about 50 megapascals to about 300 megapascals, which is the method in the 15th aspect. The 20th aspect is The lens component includes a base portion of a modular intraocular lens, and the method further includes disposing a lens portion on the base portion in the eye to form the modular intraocular lens, which is the method in the 15th aspect.
Claims
1. An apparatus for delivering a lens component into the eye, comprising a housing, a plunger at least partially disposed within the housing, the plunger including an elongate portion and a viscoelastic soft tip at a distal end of the elongate portion, the viscoelastic soft tip having a storage modulus of about 1 megapascal to about 300 megapascals and a loss modulus of about 1 megapascal to about 300 megapascals at 23°C, the plunger; a drive mechanism operatively coupled to the plunger and configured to translate the plunger within the housing; a nozzle operatively coupled to the housing, through which the plunger delivers the lens component into the eye, the nozzle; the apparatus providing cushioning and wear-free engagement with the lens component during translation of the drive mechanism and delivery through the nozzle.
2. The apparatus according to claim 1, wherein the viscoelastic soft tip is disposed around the distal end of the elongate portion.
3. The apparatus according to claim 1, wherein the viscoelastic soft tip comprises a viscoelastic polymer.
4. The apparatus according to claim 1, wherein the viscoelastic soft tip comprises at least one material selected from the group consisting of polyurethane, acetate, acrylate, polyester, polyamide, foams thereof, and combinations thereof.
5. The apparatus according to claim 1, wherein the elongate portion comprises metal and the viscoelastic soft tip comprises a viscoelastic polymer.
6. The apparatus according to claim 1, wherein the viscoelastic soft tip is an extension of the elongate portion and the viscoelastic soft tip and the elongate portion are integral.
7. The viscoelastic soft tip has a length of 0.2 centimeters to 1 centimeter, and the elongated portion has a length of 0.5 centimeters to 10 centimeters, the device according to claim 1.
8. The viscoelastic soft tip has a durometer value of 20OO to 50D on the Shore hardness scale, the device according to claim 1.
9. The storage elastic modulus of the viscoelastic soft tip is about 10 megapascals to about 50 megapascals, and the loss elastic modulus of the viscoelastic soft tip is about 50 megapascals to about 300 megapascals, the device according to claim 1.
10. The drive mechanism is an electric drive unit, a mechanical drive unit, a hydraulic drive unit, a pneumatic drive unit, or a combination thereof, the device according to claim 1.
11. The device further includes a lens holder coupled to the housing, and through the lens holder, the nozzle drives the lens component, the device according to claim 1.
12. The device according to claim 11, further including the lens component disposed in the lens holder.
13. The lens component includes a base portion of a modular intraocular lens or a lens portion of the modular intraocular lens, the device according to claim 12.
14. The lens component includes an intraocular lens, the device according to claim 12.
Citation Information
Patent Citations
Intraocular lens insertion device with mild flexible tip
JP2008544816A
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