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WO2025101660A1 - Bases pour lentilles intraoculaires de réception à composants multiples et procédés associés - Google Patents

Bases pour lentilles intraoculaires de réception à composants multiples et procédés associés Download PDF

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Publication number
WO2025101660A1
WO2025101660A1 PCT/US2024/054795 US2024054795W WO2025101660A1 WO 2025101660 A1 WO2025101660 A1 WO 2025101660A1 US 2024054795 W US2024054795 W US 2024054795W WO 2025101660 A1 WO2025101660 A1 WO 2025101660A1
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WO
WIPO (PCT)
Prior art keywords
base
component
property
wall
intraocular lens
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/054795
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English (en)
Inventor
Raul BARRERA-BARRAZA
Juan Diego Perea
Cooper BURTON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shifamed Holdings LLC
Original Assignee
Shifamed Holdings LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shifamed Holdings LLC filed Critical Shifamed Holdings LLC
Publication of WO2025101660A1 publication Critical patent/WO2025101660A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1635—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648—Multipart lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1682—Intraocular lenses having supporting structure for lens, e.g. haptics having mechanical force transfer mechanism to the lens, e.g. for accommodating lenses

Definitions

  • the present technology relates to bases for multi-component accommodating intraocular lenses and associated methods for making and using such devices.
  • Cataracts can affect a large percentage of the worldwide adult population with clouding of the native crystalline lens and resulting loss of vision.
  • Patients with cataracts can be treated by native lens removal and surgical implantation of a synthetic intraocular lens (IOL).
  • IOL intraocular lens
  • IOL implantation procedures can be effective at restoring vision
  • conventional IOLS have several drawbacks.
  • many prior IOLS are not able to change focus as a natural lens would (known as accommodation).
  • Other drawbacks of conventional IOLs include refractive errors that occur after implantation and require glasses for correcting distance vision, or in other cases the IOLs can be effective in providing good far vision, but patients need glasses for intermediate and near vision.
  • multi-focal IOLs have been developed to address these drawbacks, but they too can have drawbacks.
  • multi-focal IOLs generally perform well for reading and distance vision, in at least some instances such multi-focal IOLs may cause significant glare, halos, reduced contrast sensitivity, and other visual artifacts.
  • AIOLs Accommodating intraocular lenses
  • prior AIOLs can provide insufficient accommodation after implantation or produce suboptimal refractive correction of the eye.
  • the amount of accommodation of the prior AIOLs can also decrease after implantation in at least some instances.
  • the prior AIOLs can also be too large to be inserted through a small incision of the eye and may require the incision to be somewhat larger than would be ideal.
  • at least some of the prior AIOLs can be unstable when placed in the eye, which can lead to incorrect accommodation and other errors.
  • Improved implantable intraocular lenses that accommodate with the natural mechanisms of controlling focusing of the eye that overcome at least some of the above deficiencies would be desirable.
  • improved AIOLs would provide increased amounts of accommodation when implanted, provide refractive stability, introduce few if any perceptible visual artifacts, and allow the optical power of the eye to change from far vision to near vision in response to the distance of the object viewed by the patient.
  • FIG. 1A is a partially exploded perspective views of an AIOL configured in accordance with embodiments of the present technology.
  • FIG. IB is a side cross-sectional of the AIOL taken along line 1B-1B of FIG. 1A.
  • FIG. 2 is a side cross-sectional view of a first component of an AIOL configured in accordance with embodiments of the present technology.
  • FIG. 3 is a side cross-sectional view of a first component of an AIOL configured in accordance with additional embodiments of the present technology.
  • FIG. 4 is a side cross-sectional view of a portion of an AIOL configured in accordance with another embodiment of the present technology.
  • FIGS. 5A-5C are side cross-sectional views of a first component of an AIOL that each illustrate a select step of a method for manufacturing the first component in accordance with embodiments of the present technology’.
  • FIGS. 6A-6C are side cross-sectional views of a second component of an AIOL that each illustrate a select step of a method for manufacturing the second component in accordance with embodiments of the present technology.
  • FIG. 7 is a side cross-sectional view of an AIOL that includes the first component of FIG. 5C and the second component of FIG. 6C, in accordance with embodiments of the present technology.
  • the present technology is directed to bases for multi-component AIOLs and associated methods for making and using such devices.
  • the AIOLs include a base defining an accommodating or adjustable power lens and configured to receive another, replaceable or exchangeable lens having a fixed optical power.
  • the accommodating lens can include an optical fluid chamber defined by the base and configured to change shape and/or volume, e.g., in response to forces from the patient’s eye.
  • the base can be implanted within a capsular bag of a patient’s eye and can be configured to react to forces from the capsular bag to adjust or change the optical power of the accommodating lens.
  • the base can be formed from one or more first materials having selected properties (e.g., modulus of elasticities; durometer; bioreactivities such as a fibrogenicity and/or tissue growth promotion; etc.) configured to enhance durability and/or operation of the base.
  • the base can also be composed of one or more additional materials (e g., at least a second material).
  • the second material can define a second material region contained at least partially within, encapsulated at least partially by, and/or positioned on an exterior surface of the first material.
  • the base includes a first material having a first modulus of elasticity and a second material having a second modulus of elasticity less than the first property’.
  • the second material can be less resistant to deflection/deformation e.g., in response to forces from the patient’s eye. Accordingly, the inclusion of the second material can be used to increase compliance of the base and, in turn, increase an accommodative response of the adjustable power lens.
  • FIGS. 1A-7 Specific details of various embodiments of the present technology are described below with reference to FIGS. 1A-7. Although many of the embodiments are described below wi th respect to AIOLs and associated methods, other embodiments are within the scope of the present technology. Additionally, other embodiments of the present technology 7 can have different configurations, components, and/or procedures than those described herein. For instance, AIOLs configured in accordance with the present technology may include additional elements and features beyond those described herein, or other embodiments may not include several of the elements and features shown and described herein.
  • FIG. 1A is a partially exploded perspective view of an adjustable or accommodating intraocular lens system 100 (“AIOL 100”) configured in accordance with embodiments of the present technology.
  • the AIOL 100 can include an adjustable or base lens structure 102 (“base 102”) and a fixed power and/or fixed depth of focus lens 104 (“fixed lens 104”) that can be removably coupled to the base 102.
  • the fixed lens 104 includes one or more tabs 118 (FIG. 1 B) that can fit into one or more grooves or slots 112 extending radially outward toward an outer perimeter of the base 102.
  • the slots 112 in the base 102 can allow the fixed lens 104 to be replaced or exchanged with another fixed lens, e.g., while the base 102 is positioned within a capsular bag of a patient’s eye.
  • the base 102 can include one or more flow-through features 114.
  • the embodiment of the AIOL 100 illustrated in FIG. 1A comprises three outer flow-through features 114, but in other embodiments the AIOL 100 can include a greater or lesser number of flow-through features 114.
  • Each of the outer flow-through features 114 can be detents, such as recesses, distributed circumferentially along the perimeter of the base 102 and/or an anterior surface of the base 102.
  • the flow-through features 114 can create passages between the outer perimeter of the AIOL 100 and an inner surface of an eye capsule (not shown) in which the AIOL 100 is implanted.
  • each of the flow-through features 114 can allow fluid (e.g., within the capsular bag) to flow around an outer perimeter of the AIOL 100, such as from a posterior side of the AIOL 100 toward and/or to an anterior side of the AIOL 100.
  • the outer flow-through features 114 may additionally provide rotational constraint to maintain the rotational orientation of the base 102 with respect to the capsular bag when implanted, e.g., to prevent, or at least partially prevent, circumferential rotation of the base 102 relative to the eye.
  • FIG. IB is a cross-section of the base 102 taken along line 1B-1B of FIG. 1A.
  • the base 102 can include a first or anterior component 106 and a second or posterior component 108 that can be coupled together (e.g., via adhesives applied at one or more contact points between the first and second components 106, 108) to form the base 102.
  • the base 102 can define a first or outer fluid chamber or reservoir 122 and a second or inner fluid chamber or reservoir 124, each of which can be filled with a fluid.
  • the outer fluid chamber 122 can be fluidly coupled to and configured to extend at least partially or entirely around (e.g., continuously around, circumferentially around, and/or combinations thereof) the inner fluid chamber 124.
  • the fluid can have a refractive index betw een about 1 and about 2, such as at least 1.33 and/or one or more other suitable refractive indices.
  • the outer fluid reservoir 122 can be contained at least partially within a bellows or haptic region 120 of the base 102 configured to contact and/or react one or more forces from tissues (e.g. the capsular bag) of the eye when implanted within the eye.
  • the outer fluid reservoir 122 can be defined at least partially between a first or outer wall 128 and a second or inner wall 130 of the first component 106 and/or a first or outer wall 132 and a second or inner wall 134 of the second component 108.
  • the outer wall 128 can be configured to extend at least partially or entirely around (e.g., continuously around, circumferentially around, and/or combinations thereof) the inner wall 130, the first optical portion 138, the inner fluid chamber 124, and/or the adjustable lens 136.
  • the outer wall 132 can be configured to extend at least partially or entirely around (e.g., continuously around, circumferentially around, and/or combinations thereof) the inner w all 134, the second optical portion 140, the inner fluid chamber 124, and/or the adjustable lens 136.
  • the inner wall 130 can be configured to extend at least partially or entirely around (e.g., continuously around, circumferentially around, and/or combinations thereof) the first optical portion 138, the inner fluid chamber 124, and/or the adjustable lens 136.
  • the inner w all 134 can be configured to extend at least partially or entirely around (e.g., continuously around, circumferentially around, and/or combinations thereof) the second optical portion 140, the inner fluid chamber 124, and/or the adjustable lens 136.
  • the inner w all 130 can at least partially define one or more of the slots 112 in the base 102, e.g., a radially outer surface of the inner wall 130 can be in contact with fluid within the outer fluid reservoir 122 and a radially inner surface of the inner wall 130 can be in contact with the fixed lens 104 (FIG. 1A) when the fixed lens 104 is received within the base 102.
  • the base 102 can include an adjustable lens 136 at least partially defined by the inner fluid reservoir 124 (and, e.g., the fluid contained therein), a first optical portion 138 of the first component 106 of the base 102, and a second optical portion 140 of the second component 108 of the base 102.
  • the first and/or second optical portions 138, 140 can define a shape of the inner fluid reservoir 124 and the fluid within the inner fluid reservoir 124 can conform to that shape to provide an optical power.
  • the base 102 reacts one or more forces (e.g., accommodative forces) from the patient’s eye, the first and/or second optical portions 138, 140 can bend or flex, changing the shape and/or volume of the inner fluid reservoir 124.
  • the change in the shape of the inner fluid reservoir 124 can change the shape and/or volume of the fluid within the inner fluid reservoir 124 and thereby change the optical power provided by the adjustable lens 136.
  • the adjustable lens 136 can be positioned posterior to the fixed lens 104 and/or the lens portion 116 thereof.
  • One or both of the first optical portion 138 and the second optical portion 140 can be planar members or optical membranes. In at least some embodiments, for example, the first and/or second optical portions 138, 140 contribute zero, or substantially zero, optical power to the overall optical correction provided by the base 102.
  • one or both of the first and/or second optical portions 138, 140 can include a lens configured to provide a positive or negative optical correction (e.g., an optical power of up to ⁇ 1 D, 2 D. 3 D, 4 D, 5 D, 6D, 7D, 8D, 9D, 10D, etc.) as needed.
  • a positive or negative optical correction e.g., an optical power of up to ⁇ 1 D, 2 D. 3 D, 4 D, 5 D, 6D, 7D, 8D, 9D, 10D, etc.
  • the base 102 can define a channel 126 that extends between and fluidly couples the outer fluid reservoir 122 and the inner fluid reservoir 124 and allows fluid to flow between the outer fluid reservoir 122 and the inner fluid reservoir 124.
  • the channel 126 can be defined at least partially between a first transition region 160 of the first component 106 and/or a second transition region 170 of the second component 108.
  • the first and second transition regions 160, 170 can each extend at least partially between the bellows region 120 and the adjustable lens 136.
  • the first transition region 160 can include a first segment 162 and a second segment 164.
  • the first segment 162 can extend at least partially between the inner wall 130 and the second segment 164.
  • the second segment 164 can extend at least partially between the first segment 162 and the first optical portion 138.
  • the first segment 162 extends radially inwardly from (and, e.g., perpendicularly to) the inner wall 130 and the second segment 164 extending posteriorly from (and, e.g., perpendicularly to) the first segment 162.
  • the second transition region 170 can include a first segment 172 and a second segment 174.
  • the first segment 172 can extend at least partially between the second wall 134 and the second segment 174.
  • the second segment 174 can extend at least partially between the first segment 172 and the second optical portion 140.
  • the first segment 172 extends radially inwardly from (and, e.g., perpendicularly to) the second wall 134 and the second segment 174 extending posteriorly from (and, e.g., perpendicularly to) the first segment 172.
  • the bellows region 120 can deform and/or flex inwardly (e.g., radially inwardly) to decrease a volume of the outer fluid reservoir 122.
  • a force from the eye on the bellows region 120 can cause one or both of the outer walls 128, 132 to flex inw ardly tow ard one or both of the inner walls 130, 134. This inward flexing of the outer walls 128. 132 can decrease the volume of the outer fluid reservoir 122.
  • the decrease in volume of the outer fluid reservoir 122 can displace all, or at least a portion of, the fluid contained within the outer fluid reservoir 122 inwardly, e.g., toward and/or into the channel 126 and/or toward and/or into the inner fluid reservoir 124. Accordingly, in at least some embodiments, the compressive force can increase a volume of the inner fluid reservoir 124. e.g., by displacing fluid from the outer fluid reservoir 122 toward and/or into the inner fluid reservoir 124. Increasing the volume of fluid within the inner fluid reservoir 124 can increase the optical power of the adjustable lens 136.
  • the bellows region 120 can be configured to return to its pre-deformed state, e.g.. to return the outer fluid reservoir 122 to its original (e.g.. predeformed) volume. This, in turn, can allow displaced fluid to return toward and/or into the outer fluid reservoir 122, decreasing a volume of the inner fluid reservoir 124 and thereby decreasing an optical power of the adjustable lens 136.
  • the adjustable lens 136 can be configured to transition to any diopter in a range of diopters between about 5 D and about 7.5 D. such as between about 5.8 D and about 7.3 D. any diopter therebetween, or another suitable diopter. Additionally, or alternatively, the diopter of the adjustable lens 136 can have a range of adjustment of up to 1.5 D, 3 D, 4 D, 5 D, 7.5 D, any range therebetween, or another suitable range.
  • the base 102 can be formed from one or more first materials 142 and/or one or more second materials 144.
  • the one or more first materials 142 can include silicone elastomer and/or one or more other suitable materials.
  • the one or more second materials 144 can define a second material region 146.
  • the second material region 146 is positioned proximate an overhang 148 that at least partially defines one or more of the slots 112 and is positioned radially inwardly from the bellows region 120, the inner wall 130 of the first component 106, and/or the second wall 134 of the second component 108.
  • the second material region 146 can have one or more other suitable positions and/or occupy a greater or lesser proportion of the base 102 than shown in FIGS. 1A and IB. Several examples of such embodiments are described in greater detail below with reference to FIGS. 2-7.
  • the second material(s) 144 can be different than the first material(s) 142.
  • the individual second materials 144 can include one or more different silicone elastomers (e.g., MED 6033, MED-6233, and/or a colored elastomer or other moldable dye such as MED-6613-7, each of which is manufactured by NuSil®, headquartered in Carpinteria, CA) and/or silicone elastomers having different physical properties than the individual first materials 142.
  • the second material 144 can include one or more dyes (e.g.. MED- 6613-7), different elastomers, and/or other additives mixed and/or otherwise combined with the first material 142.
  • the second materials 144 have a lower modulus of elasticity and/or durometer compared to the first materials 142. This, in turn, is expected to reduce a stiffness and/or increase a compliance of the second material region 146, e.g., relative to one or more other portions of the base 102.
  • one or more portions of the base 102 can be configured to deform, e.g., in response to force from the eye, to change an optical pow er of the adjustable lens 136.
  • the material properties of the first and second materials 142, 144 used to form the base 102 can, therefore, be selected to improve the accommodative response of the base 102.
  • the different material properties (e.g., increased compliance) of the second materials 144 are expected to increase an accommodative response of the AIOL 100, e.g., at least because the second material region(s) 146 including the second material(s) 144 are expected to be less resistant to deformation and/or to, in response to a given magnitude of force or change in force applied to the base 102, deform more than one or more of the other portions of the base 102 composed of the first material(s) 142.
  • changing the optical power of the adjustable lens 136 involves displacing fluid in response to a change in the volume of the outer fluid reservoir 122.
  • increasing the degree to which the volume of the outer fluid reservoir 122 can be decreased is expected to improve the accommodative response of the AIOL 100.
  • the different material properties of the second material 144 may not be suitable for forming an entirety of the base 102.
  • the first materials 142 can provide structural support and/or rigidity to allow the base 102 to accommodate and/or dis-accommodate in response to forces from the eye.
  • positioning the second material 144 at specific locations in the base 102, including those described herein, is expected to improve the accommodative response of the AIOL 100, as described previously herein.
  • additional and/or other properties of the second materials 144 can be different than the first materials 142.
  • the second material regions 146 including the second material(s) 144 have increased bioreactivity compared to the other portions of the base 102 composed of the first material(s) 142, e.g., such that the second materials 144 induce attachment to the eye (e.g., the capsular bag), via fibrogenetic tissue growth, epithelial cell growth, and/or other mechanisms, preferentially and/or at a faster rate compared to the first materials 142.
  • Coupling the base 102 to the capsular bag is expected to improve the accommodation response of the base 102 at least by allowing radial lengthening of the capsular bag (e.g., in response to dis-accommodation of the eye) to stretch or pull the base 102, in addition to allowing radial shortening of the capsular bag (e.g., in response to accommodation of the eye) to compress the base 102.
  • the second material(s) 144 can be configured to provide texture and/or other geometry (e.g., voids, ridges, etc.) at the external surface of the base 102.
  • One or more tissues of the eye can grow into the texture/geometry provided by the second material(s) 144 to generate structures against/with which the base 102 can interact, e.g.. for stability, improved accommodative response, etc. Additionally, or alternatively, the texture/geometry provided by the second material (s) 144 can create mechanical interference with one or more tissues of the eye (e.g., the capsular bag), without or substantially w ithout promoting coupling via tissue growth.
  • the base 102 includes one or more visual indicators and/or alignment features 110.
  • the alignment features 110 can be positioned anterior to the slots 112, e.g., to help a user identify where to position the tabs 118 (FIG. 1A) of the fixed lens 104 (FIG. 1A) during a procedure to dock the fixed lens 104 with the base 102.
  • the alignment features 110 can be formed from the second materials 144, e.g., molded into, encapsulated by, and/or otherwise positioned at least partially within the first materials 142 of the base 102. The second materials 144 can.
  • one or more of the alignment features 110 can be configured to improve one or more optical properties of the AIOL 100.
  • the second material region 146 and/or one or more of the second materials 144 included therein can be configured reduce light scattering through these portions of the base 102, e.g., to improve visual clarify and/or otherwise improve the optical performance of the optical portions 138, 140 and/or the adjustable lens 136.
  • FIG. 2 is a side cross-sectional view of a first component 206 of another AIOL 200 configured in accordance with embodiments of the present technology.
  • the AIOL 200 can be at least generally similar or identical in structure and/or function to the AIOL 100 of FIGS. 1A and IB.
  • the first component 206 can be formed from the one or more first materials 142, define the bellows region 120, and include a second material region 246 composed of the one or more second materials 144.
  • the second material region 246 can occupy a greater portion of the first component 206. For example, as show n in FIG.
  • the second material region 246 extends from at or proximate to the overhang 148 at least partially into the bellow s region 120, e.g., radially outward of the inner wall 130 of the first component 206.
  • the second materials 144 can have one or more different properties (e.g., a different Young’s modulus and/or durometer) than the first materials 142. Because the second material region 246 occupies a greater portion of the first component 206, the AIOL 200 is expected to have further improved compliance, e.g., relative to the AIOL 100 (FIGS. 1A and IB).
  • FIG. 3 is a side cross-sectional view of a first component 306 of another AIOL 300 configured in accordance with embodiments of the present technology.
  • the AIOL 300 can be at least generally similar or identical in structure and/or function to the AIOL 100 of FIGS. 1 A and IB and/or the AIOL 200 of FIG. 2.
  • the first component 306 can be formed from the one or more first materials 142, define the bellows region 120, and include a second material region 346 composed of the one or more second materials 144.
  • the second material region 346 can occupy a greater portion of the first component 306.
  • the second material region 346 extends from at or proximate to the overhang 148 at least partially around a comer or curved portion 350 of the bellows region 120 and/or into an equatorial and/or peripheral portion of the bellows region 120, e.g., directly or immediately radially outward from the inner wall 130.
  • the second material region 346 can include an even greater region of the first component 306.
  • the second material region 346 can define an entirety of the bellows region 120 and/or all, or at least a portion of the first transition region 160, such as all or at least a portion of the first segment 162 and/or the second segment 164.
  • the second material region 346 can include every portion of the first component 306 except for the first optical portion 138.
  • the second materials 144 can have one or more different properties (e.g., a different Young's modulus and/or durometer) than the first materials 142. Because the second material region 346 occupies a greater portion of the first component 306, the AIOL 300 is expected to have further improved compliance, e.g., relative to the AIOL 100 (FIGS. 1A and IB) and/or the AIOL 200 (FIG. 2).
  • FIG. 4 is a side cross-sectional view of a portion of another AIOL 400 configured in accordance with embodiments of the present technology.
  • the AIOL 400 is shown implanted within a capsular bag 454 of a patient’s eye.
  • At least some aspects of the AIOL 400 can be at least generally similar or identical in structure and/or function one or more of the AIOLs described previously herein.
  • the AIOL 400 can include a base 402 having a first component 406 and a second component 408 composed of the one or more first materials 142.
  • the base 402 can define the bellows region 120 and can include the one or more second materials 144 in a second material region 446.
  • the second material region 446 is positioned external (e.g., fully external) to the base 402.
  • the second material region 446 can be a coating or surface treatment applied to one or more exterior portions of the base 402, e.g., including all, or at least a portion, of the bellows region 120.
  • the second material region 446 and/or the second materials 144 can have increased fibrogenecity compared to the first materials 142, e.g., such that the second materials 144 induce fibrogenesis with the capsular bag 454 preferentially and/or at a faster rate compared to portions of the base 402 composed of the first material(s) 142.
  • the coating or surface treatment can, for example, add texture and/or other geometry (e.g.. voids, ridges, etc.) to, e.g., the equatorial or peripheral portion 352 of the bellows region 120 which, in turn, is expected to induce/increase fibrogenetic coupling between the base 402 and the capsular bag 454.
  • texture and/or other geometry e.g.. voids, ridges, etc.
  • one or more other tissues of the eye can grow into and/other couple to the texture and/or other geometry from the surface treatment.
  • tissue growth is expected to generate structures against/with which the base 102 can interact, e.g., to improve stability of the base within the capsular bag, improve the accommodation response, etc., as descnbed previously with reference to at least FIG. IB.
  • one or more exterior portions of the base 402 can be textured and/or otherwise configured to include/increase fibrogenesis, e.g., without using the second materials 144.
  • inducing fibrogenesis with the capsular bag 454 is expected to increase the accommodative response of the AIOL 400, e.g., by causing the bellows region 120 to move with accommodative movement (e.g., radial shortening) and dis-accommodative movement (e.g., radial expansion) of the capsular bag 454, as described previously herein.
  • FIGS. 5A-5C are side cross-sectional view s of a first component 506 of a base 502 of an AIOL 500 illustrating select steps of a method of manufacturing the first component 506 in accordance with embodiments of the present technology. At least some aspects of the first component 506, the base 502, and/or the AIOL 500 can be at least generally similar or identical in structure and/or function to one or more of the first components, bases, and/or AIOLs described herein.
  • the first component 506 can be formed from the second material 144 such that, for example, an entirety' of the first component 506 defines a primary- second material region 546’.
  • the first component 506 can be molded (e.g., rotomolded, injection molded, etc.), cryo-machined, additively manufactured (e.g., 3-D printed), and/or formed using one or more other suitable manufacturing techniques.
  • the first optical portion 138 (FIG. 5A), and/or one or more other portions of the first component 506 that are positioned radially inw ardly from the first transition region 160, can be removed from the first component 506. Removing the first optical portion 138 (and/or the one or more other portions) can create a secondary second material region 546" that has a reduced volume compared to the primary second material region 546’ (FIG. 5A). To remove the first optical portion 138, the first optical portion 138 can be cut, ablated, eroded, melted, and/or removed using one or more other suitable techniques. In some embodiments, rather than removing the first optical portion 138 (FIG. 5 A).
  • the first component 506 can be formed without the first optical portion 138 such that the process step illustrated by FIG. 5A can be omitted.
  • one or more other portions of the first component 506 can be removed along with the first optical portion 138 (FIG. 5A).
  • the first optical portion 138 is removed along with a portion of the transition region 160, e.g., by cutting through the transition region 160, such as at a cut location 576 (shown in dashed line) in the second segment 164.
  • the first optical portion 138 can be formed (e.g., reformed) from the first material 142.
  • the first optical portion 138 can molded (e.g., rotomolded, injection molded, etc.), cryo-machined. additively manufactured (e.g., 3-D printed), and/or formed from the first material 142 using one or more other suitable manufacturing techniques.
  • the first optical portion 138 can be formed by placing the secondary second material region 546“ in a mold and molding (e.g.. overmolding) the first optical portion 138 onto the secondary second material region 546”.
  • the first component 506 can be coupled to a second component, including any of the second components described herein, to form a base.
  • the first component 506 can be coupled to the second component 608 to form a base 702 of an AIOL 700, as best shown in FIG. 7.
  • first material 142 can be used to form the first optical portion 138 and at least a portion of the transition region 160, e.g., up to the cut location 576 (shown in dashed line).
  • Forming or reforming the first optical portion 138 and at least a portion of the transition region 160 from the first material 142 is expected to introduce fewer distortions and/or other optical defects (or even introduce no such defects) compared to embodiments in which only the first optical portion 138 is formed/ reformed from the first material 142.
  • FIGS. 6A-6C are side cross-sectional views of a second component 608 of a base 602 of an AIOL 600 illustrating select steps of a method for manufacturing the second component 608 in accordance with embodiments of the present technology. At least some aspects of the second component 608, the base 602, and/or the AIOL 600 can be at least generally similar or identical in structure and/or function to one or more of the first components, bases, and/or AIOLs described herein.
  • the second component 608 can be formed from the second material 144 such that, for example, an entirety of the second component 608 defines a primary second material region 646’.
  • the second component 608 can be molded (e.g., rotomolded, injection molded, etc.), cryo-machined. additively manufactured (e.g., 3-D printed), and/or formed from the second material 144 using one or more other suitable manufacturing techniques.
  • the second optical portion 140 (FIG. 6A), and/or one or more other portions of the second component 608 that are positioned radially inwardly from the second transition region 170, can be removed from the second component 608. Removing the second optical portion 140 (and/or the one or more other portions) can create a secondary second material region 646’ ' that has a reduced volume compared to the primary second material region 546' (FIG. 5A). To remove the second optical portion 140, the second optical portion 140 can be cut, ablated, eroded, melted, and/or removed using one or more other suitable techniques. In some embodiments, rather than removing the second optical portion 140 (FIG.
  • the second component 608 can be formed without the second optical portion 140 such that the process step illustrated by FIG. 6A can be omitted.
  • one or more other portions of the second component 608 can be removed along with the second optical portion 140 (FIG. 6A).
  • the second optical portion 140 is removed with a portion of the transition region 170, e.g., by cutting through the transition region 170, such as at a cut location 678 (shown in dashed line) in the second segment 174.
  • the second optical portion 140 can be formed (e.g., reformed) from the first material 142.
  • the second optical portion 140 can be molded (e.g., rotomolded, injection molded, etc.), cryo-machined. additively manufactured (e.g., 3-D printed), and/or formed from the first material 142 using one or more other suitable manufacturing techniques.
  • the second optical portion 140 can be formed by placing the secondary second material region 646” in a mold and molding (e g., overmolding) the second optical portion 140 onto the secondary second material region 646”.
  • the second component 608 can be coupled to a first component, including any of the first components described herein, to form a base.
  • the second component 608 can be coupled to the first component 506 to form the base 702 of the AIOL 700 (FIG. 7).
  • the first material 142 can be used to form/reform the second optical portion 140 and at least a portion of the transition region 170, e.g., up to the cut location 678 (shown in dashed line).
  • Forming or reforming the second optical portion 140 and at least a portion of the transition region 170 from the first material 142 is expected to introduce fewer distortions and/or other optical defects (or even introduce no such defects) compared to embodiments in which only the second optical portion 140 is formed/reformed from the first material 142.
  • the AIOL devices described herein may be implanted by preparing the eye and removing the native lens from the capsule in any appropriate manner.
  • the fluid-filled adjustable base may then be placed in the capsule of the eye.
  • the patient may then be evaluated for a base optical powder and/or astigmatic correction, and a fixed lens can be selected to provide the desired based power or astigmatic correction for the fluid-filled adjustable base in the implanted state in the capsule of the eye.
  • the specific fixed lens to provide the post-implant base power or astigmatic correction is then inserted into the previously implanted fluid-filled adjustable base of the AIOL.
  • the chosen fixed lens may then be coupled to the fluid-filled adjustable base within the eye capsule.
  • the fixed lenses are anteriorly-positioned when implanted, e.g., positioned anterior to the adjustable lens and/or attached to an anterior first component of the adjustable base.
  • one or more of the fluid-filled adjustable base or fixed lens may each be flexible such that they may be reconfigured (e.g., folded) to a reduced-profile delivery configuration for delivery into the lens capsule.
  • it may be required to make a further correction to the fixed portion after the time of the surgery. Such instance may occur anywhere from days to years after the surgery. At such times, the patient may return to the physician and the fixed lens may be replaced with a new fixed lens having a different optical power or other prescription.
  • the new prescription may be characterized prior to or after removal of the original fixed lens.
  • the new 7 fixed lens may be fabricated and implanted at the time of the examination, in others the patient may return for implantation of the fixed lens sometime after the examination.
  • Several embodiments of the present technology are directed to a kit having an adjustable base (e.g.. a fluid-filled adjustable base or other AIOL) and a first fixed lens that has no optical base power.
  • the kit can further include one or more second fixed lenses having various based powers or other optical properties.
  • the adjustable base can be implanted into the native eye capsule, and then the first fixed lens can be coupled to the adjustable base.
  • the optical properties of the implanted adjustable base can then be assessed in situ with the first fixed lens in place to determine the desired optical properties of the fixed lens. If the optical properties of the assembled adjustable base and first fixed lens without a base power are appropriate, then the system can remain implanted without additional changes. However, if a different base power or some other optical property is desired (e.g., toric or other asymmetrical optics), then the first fixed lens without a base power can be replaced with a second fixed lens having the desired optical properties based on the optical properties of the implanted adjustable base with a fixed lens attached.
  • a different base power or some other optical property e.g., toric or other asymmetrical optics
  • the fixed lens may be fabricated from materials different from the adjustable base. Such materials include hydrophilic or hydrophobic methacrylate or silicones and any other materials traditionally used in non-accommodating IOLS.
  • the fixed lens may be fabricated from materials harder than those used for the adjustable base.
  • One or both of the adjustable base and the fixed lens may be machined, cast molded (e.g., reactive cast molded), injected molded, and/or formed by other processes or combinations of processes. Any or all of the structures described herein may be constructed from a transparent or translucent material.
  • the above-described adjustable bases and fixed lenses can be constructed from transparent materials, even if they are illustrated as opaque in the associated figures.
  • An intraocular lens system comprising: a base configured to be positioned within a native capsule of an eye of a patient, wherein the base includes — an optical portion formed from a first material having a first property; an inner wall extending continuously circumferentially around the optical portion, wherein the inner wall is formed at least partially from a second material different than the first material and having a second property different than the first property; and an outer wall extending continuously circumferentially around the inner wall to at least partially define a chamber therebetween, wherein the outer wall is formed from the second material, wherein, when the base is positioned within the native capsule, the outer wall is configured to, in response to a force from the eye, flex inwardly toward the inner wall to decrease a volume of the chamber.
  • the optical portion, the inner wall, and the outer wall are. respectively, a first optical portion, a first inner wall, and a first outer wall
  • the base includes a first component having the first optical portion, the first inner wall, and the first outer wall
  • the base further includes a second component configured to be coupled to the first component, the second component having a second optical portion, a second inner wall, and a second outer wall.
  • the chamber is an outer reservoir
  • the optical portion at least partially defines an inner chamber
  • the outer reservoir and the inner chamber are configured to contain a fluid
  • the base in response to the force from the eye, the base is configured such that the decrease in the volume of the outer reservoir causes the fluid to redistribute radially inwardly from the outer reservoir toward and/or into the inner chamber.
  • the optical portion at least partially defines an adjustable lens of the base, wherein the adjustable lens is configured to provide an adjustable optical correction, and the inner wall and the outer wall at least partially define a bellows region operably coupled to the adjustable lens and configured to react the force from the eye to cause an adjustment to the adjustable optical correction provided by the adjustable lens.
  • the base is configured to detachably retain a fixed lens.
  • the intraocular lens system of any of examples 1-11 further comprising a fixed lens, wherein, while the base is positioned within the native capsule, the base is configured to detachably receive the fixed lens.
  • An intraocular lens system comprising: a fluid-filled base configured to be positioned within a native capsule of an eye of a patient, wherein the base includes — an inner fluid chamber defined at least partially by first membranes comprising a first material having a first property; and an outer fluid reservoir fluidly coupled to and extending continuously circumferentially around the inner fluid chamber, wherein the outer fluid reservoir is defined at least partially by second membranes comprising a second material different than the first material and having a second property' different than the first property', wherein, when the base is positioned within the native capsule, the base is configured to cause fluid to redistribute between the outer fluid reservoir and the inner fluid chamber responsive to an imparted force from the native capsule.
  • the second membranes include the first material and a coating or texture applied to the first material, wherein the coating or texture includes the second material.
  • the first membranes and the inner fluid chamber at least partially define an adjustable lens of the base, wherein the adjustable lens is configured to provide an adjustable optical correction
  • the second membranes and the outer fluid reservoir at least partially define a bellows region operably coupled to the adjustable lens and configured to react the force from the eye to cause an adjustment to the adjustable optical correction provided by the adjustable lens.
  • a method of manufacturing an adjustable intraocular lens comprising: forming a first component of a base of the adjustable intraocular lens from a first material having a first property and a second material having a second property different than the first property', wherein forming the first component includes — forming at least part of a bellows portion of the first component from the second material, and forming an optical portion of the first component from the first material; and coupling the first component to a second component of the base to thereby form the base.
  • forming the bellows portion from the second material includes: forming the first component, including the bellows portion and the optical portion, from the second material, and removing the optical portion formed from the second material from the first component.
  • the method of example 22 or example 23 wherein forming the first component from the second material includes molding the first component from the second material.
  • forming at least part of the bellows portion from the second material includes: forming the bellows portion from the first material, and applying a coating or texture to the first material, wherein the coating or texture includes the second material.
  • forming the first component includes forming one or more slots in the first component, wherein the one or more slots are configured to exchangably receive a fixed lens.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente technologie concerne des bases pour des lentilles intraoculaires de réception à composants multiples (AIOLs) et des procédés associés de fabrication et d'utilisation de tels dispositifs. Les bases configurées conformément à des modes de réalisation de la présente technologie peuvent être configurées pour fournir une correction optique qui s'ajuste en réponse à des forces d'accommodation provenant de l'œil d'un patient et peut être formée à partir d'un ou de plusieurs premiers matériaux et d'un ou de plusieurs seconds matériaux. Par rapport au premier matériau, le second matériau peut être moins résistant à la déviation/déformation, par exemple, en réponse à des forces provenant de l'œil du patient. Par conséquent, l'inclusion du second matériau dans la base peut augmenter la conformité de la base et, dans au moins une certaine instance, augmenter la réponse de la base à des forces d'accommodation provenant de l'œil.
PCT/US2024/054795 2023-11-07 2024-11-06 Bases pour lentilles intraoculaires de réception à composants multiples et procédés associés Pending WO2025101660A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12465483B2 (en) 2017-06-07 2025-11-11 Shifamed Holdings, Llc Adjustable optical power intraocular lenses

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190274823A1 (en) * 2016-12-23 2019-09-12 Shifamed Holdings, Llc Multi-piece accommodating intraocular lenses and methods for making and using same
US20200121447A1 (en) * 2017-05-30 2020-04-23 Shifamed Holdings, Llc Surface treatments for accommodating intraocular lenses and associated methods and devices
US20200246134A1 (en) * 2015-06-10 2020-08-06 Powervision, Inc. Intraocular lens materials and components
US20200246133A1 (en) * 2010-09-30 2020-08-06 KeraMed, Inc. Corneal Implants
US20230063391A1 (en) * 2020-02-05 2023-03-02 Shifamed Holdings, Llc Accommodating intraocular lenses and associated methods
WO2023081417A1 (fr) * 2021-11-05 2023-05-11 Shifamed Holdings, Llc Lentilles intraoculaires d'accommodation et procédés associés

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200246133A1 (en) * 2010-09-30 2020-08-06 KeraMed, Inc. Corneal Implants
US20200246134A1 (en) * 2015-06-10 2020-08-06 Powervision, Inc. Intraocular lens materials and components
US20190274823A1 (en) * 2016-12-23 2019-09-12 Shifamed Holdings, Llc Multi-piece accommodating intraocular lenses and methods for making and using same
US20200121447A1 (en) * 2017-05-30 2020-04-23 Shifamed Holdings, Llc Surface treatments for accommodating intraocular lenses and associated methods and devices
US20230063391A1 (en) * 2020-02-05 2023-03-02 Shifamed Holdings, Llc Accommodating intraocular lenses and associated methods
WO2023081417A1 (fr) * 2021-11-05 2023-05-11 Shifamed Holdings, Llc Lentilles intraoculaires d'accommodation et procédés associés

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12465483B2 (en) 2017-06-07 2025-11-11 Shifamed Holdings, Llc Adjustable optical power intraocular lenses

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