NL2028038B1 - Method to connect and distance hydrophilic intraocular lens elements - Google Patents

Method to connect and distance hydrophilic intraocular lens elements Download PDF

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Publication number
NL2028038B1
NL2028038B1 NL2028038A NL2028038A NL2028038B1 NL 2028038 B1 NL2028038 B1 NL 2028038B1 NL 2028038 A NL2028038 A NL 2028038A NL 2028038 A NL2028038 A NL 2028038A NL 2028038 B1 NL2028038 B1 NL 2028038B1
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lens
mixture
section
mix
method comprises
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NL2028038A
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Dutch (nl)
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NL2028038A (en
Inventor
Pieter Van Lawick Willem
Christiaan Rombach Michiel
Kamentschuk Nadja
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Akkolens Int B V
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    • 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, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1602—Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes
    • A61F2/161—Posterior chamber lenses for use in addition to the natural lenses of the eyes
    • 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, corneal implants; Implanting instruments specially adapted therefor; 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
    • A61F2/1629—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 longitudinal position, i.e. along the visual axis when implanted
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/02—Artificial eyes from organic plastic material
    • B29D11/023—Implants for natural eyes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/02—Artificial eyes from organic plastic material
    • B29D11/023—Implants for natural eyes
    • B29D11/026—Comprising more than one lens
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Abstract

The method combines connecting with distancing of two hydrophilic lens elements of an accommodative intraocular lens. The lens requires connection of lens element at peripheral connection sections and requires distancing of elements at the central optical section. The connection sections are positioned at a predetermined distance and a, pre-polymerized, pre-determined volume of a mix of monomers is applied such that the mix disperses, by capillary forces, only in between the connection sections with the connection providing, after final polymerization, the required connection and distancing.

Description

Method to connect and distance hydrophilic intraocular lens elements Accommodating intraocular lenses restore the accommodation of the human eye, meaning, these lenses provide the retina with a sharp image of an object at different distances, from a far distance, say, infinity, to near distance, say, reading distance, by gradually adjusting the optical power of the accommodating intraocular lens.
Accommodating lenses can vary the optical power by, for example, axial movement, meaning: movement in the direction along the optical axis, of at least one lens element, for example, movement of fixed focus intraocular lens elements, as disclosed in, for example, US2019053893 and WO2006NL50050 (EP1871299), or, alternatively, axial movement of multiple, positive largely spherical, lens elements in opposite directions, as disclosed in, for example, US2018221139 and
US2013013060 (CA2849167, US2002138140). Movements, including axial movements, of lens elements can be driven by the ciliary muscle, generally via the remains, the rim, of the capsular bag, as in US2019053893, or, alternatively, such movement can be driven by the iris, as in, for example, WO2019027845, ES2650563 and US20082151486, or, alternatively,
such movement can be driven by the ciliary mass directly, as in, for example, US2018353288. Alternatively, a gradually progressive lens element, for example, a lens with a single cubic free-form surface or, alternatively, a stepwise progressive lens element lens, for example, a bifocal or trifocal lens element can be moved in a lateral direction, as in US201010624. Radially flexible lens elements, elastic lenses which can change radial thickness, can provide a variable focus when compressed laterally, as in, for example, AU2014236688, US201562257087 and US2018256315, AU2014236688, discloses lens elements in which an elastic container contains a fluid, for example, an oil, or, alternatively, as in
US2018344453, DE11200900492, US10004595, US2018271645, US2019015198 and US9744028 which disclose a change in shape of a uniform elastic lens element and, alternatively, as in US2019000162 which discloses, in this particular case, a flexible lens element driven by pressure of the posterior vitreous of the eye.
US2012310341, US2011153015 and DE112009001492 disclose any type of shape changing lenses, radially flexible lenses, which lenses are positioned at the sulcus plane instead of inside the remains of the capsular bag of the eye with such change of shape driven directly by the ciliary mass or zonulae system of the eye, or, alternatively, by the iris, or, alternatively, by the sclera, for example by the sulcus root which is directly connected to the sclera of the eye.
Note that lateral movement a lens can be a parallel mutual shift of lens elements which is as used as the main example of variable lens elements in this document, but also a rotation of at least one element as in the rotation of lens elements comprising at least two chiral optical surfaces in a lateral plane, WO2014058315 and ES2667277, or, alternatively, a combination of wedging and rotation of at least two complex free-form surfaces, for example adapted cubic optical surfaces, as in, for example, US2012323321 in a lateral plane.
Accommodating lenses can comprise mechanical elements translate lateral compression, compression perpendicular to the optical axis, of the mechanical construction into mutual movement of the lens elements and thus provide variable optical power as disclosed in, for example, US2010106245 and multiple other documents cited above. Such construction can comprise at least one flexible lens element of which the power depends on the degree of change of shape, radial flex, of the elastic lens element as disclosed in, for example, but not limited hereto, US2011153015 and US2019015198. Such construction must comprise a mechanical element to provide translation of lateral movement of the construction into radial flex of the radially flexible lens element.
Accommodating lenses are can be implanted at the sulcus plane and ciliary plane of the eye, both positions meaning in front of, anterior of, the capsular bag of the eye and comprise at least one mechanical element providing translation of movement of the ciliary mass or zonulae or any other related anatomical structure of the eye into mutual translation of, elastically stiff, lens elements or, alternatively, in a change of shape of, elastically flexible, material.
The variable lens element can comprise at least one flexible lens element adapted to provide variable optical power which power depends on the degree of change of shape of the flexible optical element. Such elements are known from AU2014236688, US1011745 and US2018256311, which documents disclose a lens shaped elastic container filled with a fluid or a uniform flexible lens implanted in the rim of the capsular bag.
US2019000612 discloses such lenses to be implanted at the sulcus plane, in front of the capsular bag.
Any of the lens embodiments disclosed in the present document can be designed as an add-on accommodating, piggy back, intraocular lens which provides accommodating power to the eye which eye also contains a refractive lens, for example, the natural lens of the eye or, alternatively, an intraocular lens, for example a monofocal intraocular lens in which cases the refractive lens can be, for example, in the capsular bag of the eye and the accommodating intraocular lens, the add-on lens, positioned at the sulcus plane, in front of the capsular bag.
Note that the method to provide a combination of connecting and distancing of hydrophilic intraocular lens elements can be applied to any intraocular lenses referred to in the present document The method to connect and distance at least two lens elements allows to connect, connect, said elements as well as distance the elements at a pre-determined distance in a single manufacturing step.
Figures
The method presented in the present document discloses connecting, meaning: connect haptics, and distancing, meaning: distance optical sections, of at least two lens elements into an accommodative intraocular lens.
The lens comprises at least one optical section to provide variable optical power and at least one haptic section to provide anchoring of the lens in the eye and movement of at least one intraocular element in the eye with the haptic section comprising at least one connection section.
The method can include the following manufacturing steps: Preparation of a mix of monomers, and, connecting of the lens elements, and pre-polymerization of the monomer mix, and, application of the polymerized mix to the connection section, and, removal of remaining air-sockets in the connection, final polymerization of the pre-polymerized mix, with all steps which can be applied by at least one robot, by automation.
Preparation of a mix of monomers can include a mix of monomers similar to the mix of monomers of which the lens elements are composed.
For example, a HEMA mix providing a Poly Ethoxy-ethyl methacrylate polymer, or, for example, a mix of an aromatic acrylate monomer, an aromatic methacrylate monomer and an alkoxyalkyl methacrylate monomer.
Connecting of the lens elements provides a capconnectionillary connection which connection is both suitable for filling of the connection by capillary forces, meaning: achieving connection of the haptics, with a monomer mix or a partly polymerized mix as well as a pre-determined distancing connection between the lens elements, meaning: distancing the optical sections of the lens.
Pre-polymerization of the monomer mix can be necessary with the mix pre- polymerized, increasing viscosity of the mix, to such a degree that the viscosity of mix is adapted to fill the capillary connection and provide for the required distancing. So, the mix is also pre-polymerized to such a degree that the viscosity of mix is adapted to provide the distancing connection.
The mix can be applied on top of at least one of the connection sections prior to connecting, or, alternatively, can be applied along at least one ridge of the capillary connection following connecting. The mix can be applied by a micro-manipulator dispenser, or, alternatively, by dipping at least one connection section into the mix, or alternatively, by a stamping pad, containing the mix, onto, at least one, of the connection sections. The combination of the viscosity of the pre-polymerized mix and the specifications, dimensions and shape, of the capillary connection is adapted to provide filling of the connection between the connection sections by capillary force with the mix and to prevent filling of any other section of the lens with the mix. Furthermore, remaining air-sockets, bubbles, can be removed by vacuum pressure treatment applied to the lens, or, alternatively, by ultrasonic treatment applied to the lens.
Final polymerization of the pre-polymerized mix can be achieved by light which light comprises frequencies adapted to provide said polymerizing, for example, light which comprises UV-light frequencies. Also, the mix can be polymerized by heat adapted to provide polymerization of the mix, for example, by light comprises IR- light frequencies adapted to provide said polymerization. All light can be provided by at least one laser light source.
Automated robots can aid manufacturing, for example, a generalist robot can be adapted to provide to carry out multiple manufacturing steps, or, alternatively, multiple specialist robots cab be adapted to each provide to carry out one of the manufacturing steps.
Clearly, the connecting and distancing procedures of the accommodative lens are followed by standard procedures such as hydration of the accommodative lens, washing and cleaning of the lens to, for example, remove any remaining monomers and quality control of the finalized product.
5 So, the present document discloses a novel invention concerning a method to provide a combination of connection and distancing hydrophilic lens elements to manufacture an accommodative intraocular lens with each lens element comprising at least one central optical section to provide an optical function, and, at least one peripheral haptic section to provide anchoring of the lens in the eye and to provide transfer movement of a driving element in the eye to the optical section with each haptic section comprising at least one connection section and with the distance between the optical sections in the accommodative lens depending on the distance between the connection sections with the method is including positioning of the dehydrated lens elements at a pre-determined connection distance, and, application of a mix of pre-polymerized monomers to at least of the connection sections with the degree of viscosity of the pre-polymerized mix and the volume of the mix adapted to provide dispersion by capillary forces such that the mix disperses only between the connection sections.
The method includes preparation of a mix of monomers which mix includes monomers similar to the mix of monomers of which the lens elements are composed.
The method can include application of the mix onto the top of at least one of the connection sections prior to positioning of the lens elements, or, alternatively, the method can include application of the mix along at least one ridge at the ridge of the connection sections after positioning of the lens elements.
The application can include application of the polymerized mix by a micro- manipulator dispenser, or, alternatively, by dipping at least one connection section into the mix, or, alternatively, by a stamping pad onto at least one of the connection sections.
The method can include removal of remaining air-sockets from connected section by vacuum pressure, or, alternatively, by ultrasound treatment, or, alternatively, by a combination of vacuum pressure and ultrasound treatment.
The final polymerization of the pre-polymerized mix can be achieved by light which light comprises frequencies adapted to provide said polymerizing which light can comprises UV-light frequencies, or, alternatively, the method can include final polymerization of the pre-polymerized mix by heat which heat can be applied by IR- light.

Claims (13)

ConclusiesConclusions 1. Werkwijze om een combinatie te verschaffen van verbindings- en afstandselementen van een hydrofiele lens, teneinde een accommodatieve intraoculaire lens te vervaardigen waarbij elk lenselement omvat: - ten minste één centrale optische sectie om een optische functie te verschaffen; - ten minste één perifere haptische sectie om verankering van de lens in het oog te verschaffen en om een overdrachtsbeweging van een aandrijvende element in het oog te verschaffen naar de optische sectie; - waarbij elke haptische sectie ten minste een verbindingssectie omvat; - waarbij de afstand tussen de optische secties in de accommodatieve lens afhankelijk is van de afstand tussen de verbindingssecties; met het kenmerk dat de werkwijze is aangepast om te omvatten: - het positioneren van de gedehydrateerde lenselementen op een vooraf bepaalde verbindingsafstand; - het aanbrengen van een mengsel van gepre-polymeriseerde monomeren op ten minste de verbindingssecties; - waarbij de mate van viscositeit van het gepre-polymeriseerde mengsel en het volume van het mengsel, zijn aangepast om dispersie door capillaire krachten te verschaffen, zodanig dat het mengsel zich slechts verdeelt tussen de verbindingssecties.A method of providing a combination of connecting and spacer elements of a hydrophilic lens, to produce an accommodative intraocular lens, each lens element comprising: - at least one central optical section to provide an optical function; - at least one peripheral haptic section to provide anchoring of the lens in the eye and to provide transfer motion from a driving element in the eye to the optical section; - wherein each haptic section comprises at least one connecting section; - wherein the distance between the optical sections in the accommodative lens is dependent on the distance between the connection sections; characterized in that the method is adapted to comprise: - positioning the dehydrated lens elements at a predetermined connection distance; - applying a mixture of prepolymerized monomers to at least the connecting sections; - wherein the degree of viscosity of the prepolymerized mixture and the volume of the mixture are adjusted to provide dispersion by capillary forces, such that the mixture only distributes between the connecting sections. 2. Werkwijze volgens conclusie 1, met het kenmerk dat de werkwijze het bereiden van een mengsel van monomeren omvat, waarbij de monomeren vergelijkbaar zijn met de monomeren waaruit de lenselementen zijn samengesteld.Method according to claim 1, characterized in that the method comprises preparing a mixture of monomers, wherein the monomers are comparable to the monomers from which the lens elements are composed. 3. Werkwijze volgens conclusie 1, met het kenmerk dat de werkwijze het aanbrengen van het mengel op de bovenkant van ten minste een van de verbindingssecties omvat, voorafgaand aan het positioneren van de lenselementen.A method according to claim 1, characterized in that the method comprises applying the mixture to the top of at least one of the connecting sections, prior to positioning the lens elements. 4. Werkwijze volgens conclusie 1, met het kenmerk dat de werkwijze het aanbrengen van het mengel langs ten minste een verhoging bij de verhoging van de verbindingssecties omvat, na het positioneren van de lenselementen.Method according to claim 1, characterized in that the method comprises applying the mixture along at least one elevation at the elevation of the connection sections, after positioning the lens elements. 5. Werkwijze volgens conclusie 3 of 4, met het kenmerk dat de werkwijze het aanbrengen van het gepolymeriseerde mengel door middel van een micro- manipulatie verdeler omvat.Method according to claim 3 or 4, characterized in that the method comprises applying the polymerized mixture by means of a micromanipulation distributor. 6. Werkwijze volgens conclusie 3 of 4, met het kenmerk dat de werkwijze het aanbrengen van het gepolymeriseerde mengel omvat, door ten minste één verbindingssectie in het mengsel te dopen.A method according to claim 3 or 4, characterized in that the method comprises applying the polymerized mixture by dipping at least one connecting section into the mixture. 7. Werkwijze volgens conclusie 3 of 4, met het kenmerk dat de werkwijze het aanbrengen van het gepolymeriseerde mengel omvat door middel van een stempelvlak op ten minste één verbindingssectie omvat.Method according to claim 3 or 4, characterized in that the method comprises applying the polymerized mixture by means of a stamping surface on at least one connecting section. 8. Werkwijze volgens elk van de combinaties van conclusies 1-7, met het kenmerk dat de werkwijze het verwijderen van achterblijvende luchtholtes uit de verbindingssectie omvat, door toepassing van vacuümdruk.A method according to any one of the combinations of claims 1-7, characterized in that the method comprises removing residual air voids from the connecting section, by applying vacuum pressure. 9. Werkwijze volgens elk van de combinaties van conclusies 1-7, met het kenmerk dat de werkwijze het verwijderen van achterblijvende luchtholtes uit de verbindingssectie omvat, door een ultrageluid behandeling.Method according to any of the combinations of claims 1-7, characterized in that the method comprises removing residual air voids from the connecting section, by an ultrasound treatment. 10. Werkwijze volgens elk van de combinaties van conclusies 1-9, met het kenmerk dat de werkwijze een eindpolymerisatie omvat van het gepre- polymeriseerde mengsel door licht, welk licht frequenties omvat die geschikt zijn om de genoemde polymerisatie tot stand te brengen.A method according to any one of the combinations of claims 1-9, characterized in that the method comprises a final polymerization of the prepolymerized mixture by light, which light comprises frequencies suitable to effect said polymerization. 11. Werkwijze volgens conclusie 10, met het kenmerk dat het licht frequenties van UV-licht omvat.Method according to claim 10, characterized in that the light comprises frequencies of UV light. 12, Werkwijze volgens elk van de combinaties van conclusies 1-9, met het kenmerk dat de werkwijze een eindpolymerisatie omvat van het gepre- polymeriseerde mengsel door warmte.Process according to any of the combinations of claims 1-9, characterized in that the process comprises a final polymerization of the prepolymerized mixture by heat. 13. Werkwijze volgens conclusie 12, met het kenmerk dat de warmte wordt verschaft door ÍR-licht.Method according to claim 12, characterized in that the heat is provided by ÍR light.
NL2028038A 2020-05-11 2021-04-22 Method to connect and distance hydrophilic intraocular lens elements NL2028038B1 (en)

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