Nucleo-reticular multi-cell dual-system eye implant
11654013 · 2023-05-23
Inventors
Cpc classification
A61F2220/0008
HUMAN NECESSITIES
A61L2430/16
HUMAN NECESSITIES
A61F2002/0081
HUMAN NECESSITIES
A61F2250/0067
HUMAN NECESSITIES
C08L67/04
CHEMISTRY; METALLURGY
A61L27/18
HUMAN NECESSITIES
C08L67/04
CHEMISTRY; METALLURGY
A61L27/18
HUMAN NECESSITIES
A61F2002/0086
HUMAN NECESSITIES
International classification
Abstract
The Nucleo-reticular Multi-cell Dual-system Eye Implant consists of a spherical structure with calculated and variable axial length depending on the needs required by the orbital eye socket, composed of a cell mesh with alternative designs that in turn, makes up the MMM System, in which suturing is provided in any technique, either in cases of evisceration or enucleation. Thanks to its multi-cell structural design, it favors its placement and reduces the risk of migration, extrusion, exposure and extraction. As it is an arrangement with structural holes, it provides a higher percentage of the volume for its vascularization; it also houses inside a Reticular Fibrovascular Core System, which has a structure based on multilevels equipped with micro-reticular tissue and an intra-level communication based on filaments; with the capacity to contain medicines and/or technology by presenting a dual-system of two screw-on pieces, being able to manufacture in different structural designs and biocompatible materials. The C100 model made of polylactic acid (PLA), an ideal material for implants, consists of 100 oval cells. Since it is a light eye implant, it prevents depressure due to settlement or gravity and it can be manufactured in any size.
Claims
1. A Nucleo-reticular Multi-cell Dual-system Eye Implant, comprising a Muscular Motor Multi-cell System (MMM) eye implant as an outer structure, the MMM comprising a substantially spherical structure of cells having an axial length, an inner space, and lineal structures of transverse and vertical poles, said lineal structures being interconnected with each other at the cross-section of two or more poles to form a node and defining a plurality of cells distributed throughout, each cell provides an opening to the inner space of the structure of cells, wherein the Nucleo-reticular Multi-cell Dual-system Eye implant also comprises an inner Reticular Fibrovascular Nucleus system (NRF) structure, the NRF structure comprising micro-reticular mesh platforms separated by fibrous structures.
2. The implant of claim 1, wherein the structure of cells is spherical.
3. The implant of claim 2, wherein each cell on the structure of cells is identifiable by cartesian coordinates consisting of a parallel coordinate defined with a letter and a meridian coordinate defined with a number; the meridian being parallel to the axial length and the parallel being perpendicular to the axial length.
4. The implant of claim 1, wherein the poles are configured to support vertical and horizontal sutures between said dual-system eye implant and antagonist/agonist muscles or/and scleral tissue.
5. The implant of claim 1, wherein the nodes are configured to support diagonal sutures between said MMM and antagonist/agonist muscles or/and scleral tissue.
6. The implant of claim 1, wherein the micro-reticular platforms are organized in multilevels parallel to each other and perpendicular to the axial length of the substantially spherical structure of cells.
7. The implant of claim 1, wherein the fibrous structures fill the inner space between said micro-reticular platforms.
8. The implant of claim 1, comprising a natural or synthetic biocompatible material selected from the group consisting of metal, polymer, organic, plant and cellular material.
9. The implant of claim 8, wherein the biocompatible material is polylactic acid.
10. The implant of claim 9, wherein the polylactic acid has a density of 1.25 g/cm.sup.3.
11. The implant of claim 1, wherein the NRF comprises a natural or synthetic biocompatible material selected from the group consisting of ceramic, metal, polymer, organic, plant and cellular material.
12. The implant of claim 11, wherein the biocompatible material is polylactic acid.
13. The implant of claim 12, wherein the polylactic acid has a density of 1.25 g/cm.sup.3.
14. The implant of claim 1, manufactured by a process selected from the group consisting of molding, casting, die-cutting, injecting, cast pressing, weaving, sublimation, cell induction and stereolithography.
15. A method of filling an orbital space or eye socket after evisceration or enucleation of the eyeball comprising implanting the implant of claim 1 into the orbital space or eye socket.
Description
BRIEF DESCRIPTION OF FIGURES
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DETAILED DESCRIPTION OF THE INVENTION
(30) The Nucleo-reticular Multi-cell Dual-system Eye Implant filed in the patent refers to a new generation of multi-cell spherical structures (
(31) The implant has a spherical structure with calculated axial length, to make the placement easier in the orbital cavity, since anatomically the area where the implant is positioned has an ovoid shape. The MMM system can operate independently of the FRC system, with the option to contain technology or to supply medicines, or conveniently by consolidating the dual system with the interaction of the systems that constitute the patent.
(32) The MMM system can contain a multilevel Core that is designed to achieve the greater integration of the eye implant into the orbital cavity that constitutes the Fibrovascular Reticular Core (FRC) system, from this synergy the so-called dual-system arises.
(33) 1.—Muscular Motor Multi-Cell System
(34) 1.1 MULTICELLS are the combination of modules in a structure with ideal benefits for the total integration of the implant into the eye socket with facilities for suturable processes, fluid conduction and fibrovascularization. The multi-cell structure of the proposed patent is equipped with structural holes (
(35) 1.2 The Poles
(36) The cell consists of perimeter poles, said poles aim to lay solid bases for the predominantly vertical and horizontal suturing, each cell can be endowed with the number of poles that are determined according to the previously estimated structural needs. (
(37) 1.3 The Nodes
(38) The cross sections of two or more poles make up a structural joint called Node (
(39) The number of poles and nodes will depend on the shape that is assigned to the cell, in any case, they enable vertical or horizontal suturing on the poles, diagonal on the nodes or combined, the availability of multicells and their components allows the external system to meet the requirements to improve muscle motor skills.
(40) The availability of cells predisposes the conditions to shorten the intervention times in the operating room, make complicated suturing more viable and allow to accurately identify the procedure followed, with the option of subsequent scheduled operations.
(41) The MMM system allows the identification of each of the cells that make up the eye implant, this by means of the Cartesian coordinate system, where the parallels are identified with letters (
(42) The implant when placed (Ref. 1,
(43) 2.—Fibrovascular Reticular Core System
(44) The FRC system consists of a multilevel Core, composed of micro-reticular and semi-permeable surfaces, supported by optimal filaments for fibrovascularization. The Core can also contain medicines and/or technology or be replaced by these.
(45) It represents a system designed inside the sphere and aligned to the parallels, it is constituted by a series of multilevels (
(46) The platforms or multilevel arranged in variable quantity, (according to the number of parallels), are semipermeable structures of vascularizable and integrable base, which are formed and operate because they are a micro-reticular mesh (
(47) 2.1 Multilevels
(48) They are platforms that in their sum, make up the Core, aligned and fixed to the parallels of the MMM system They are composed of micro-reticular tissue (
(49) 2.2 Micro Reticules.—
(50) They are the tissue that consist of multilevels and has the function of communication of the following strata, their tissue being semipermeable allows to adjust the blood flow and sets the structural basis for the fibrovascular establishment (
(51) 2.3 Filaments
(52) Among the multilevels, a mesh of fibrous structures is laid out; they connect and reinforce each level with the immediate ones through their action, supply the blood flow and by adhesion allow vascularization and accordingly fibrovascularization (
(53) Light Weight
(54) The Nucleo-reticular Multi-cell Dual-system Eye Implant in its initial C-100 model (
(55) The dual-system design of the outer multi-cell implant and micro-reticular multi-level core makes the structure of the sphere be composed of greater free spaces due to the presence of outer cellular and reticular nuclear spaces.
(56) The lightness is appreciated in the implant due to the low density surfaces due to its structure, verbi gratia, it is considered standardized in the matter, taking as an initial reference the implant with a diameter of 18 mm, to that extent, in the model C-100 with design of 100 oval multicells, presents in its widest extent 20 cells (E and F) of 3.20 mm by 1.50 mm (
(57) Regarding the weight, it shows that this initial model of 18 millimeters (mm) in diameter has a volume of 3.05 milliliters (ml). The density of polylactic acid (PLA) is 1.25 grams/cubic centimeter (gr/cm.sup.3), if it were a solid sphere, it would weigh 3.81 gr. However, thanks to the multi-cell design and micro-reticular multi-level Core and polylactic acid (PLA) material, a weight of only 1.48 gr is reached, and the percentage obtained for the volume to be vascularized is 61.22%.
(58) For the various measurements of the C-100 implant structure made of polylactic acid (PLA), which has a density of 1.25 gr/cm.sup.3, the best measurement-weight ratio results are achieved, which are referred to in the table of
(59) Regarding the methodology to arrive at the certainty of the coefficients previously set forth, the following equations were performed:
(60) PLA Density—1.25 gr/cm.sup.3
1 cm.sup.3×1 milliliter
(61) If diameter is 18 mm
radius is 9 mm(10 mm×1 cm)=0.9 cm
solid volume=sphere volume=4/3π(r.sup.3)
4/3π(0.9 cm).sup.3×3.0536 cm.sup.3=3.0536 ml
(62) PLA Solid Sphere Mass
d=m/v
m=dv=1.25 g/cm.sup.3(3.0536 cm.sup.3)=3.817 g
(63) Mass Ratio
Celled sphere mass=1.48 g
Solid1 sphere mass=3.817 g
(64) % by mass is (1.48 g)(100)/3.817 g=38.773% by weight of the celled sphere compared to the solid sphere.
(65) That is, a decrease in:
(66) 100−38.773%=61.22% by weight reduction compared to solid weight.
(67) Suturable
(68) The Nucleo-reticular Multi-cell Dual-system Eye Implant, in its MMM outer system, is intended to facilitate suturing of the implant to fix the extraocular muscles and the back of the eye socket, due to the design with multicells, poles and nodes available in the required abundance (
(69) The C-100 model of the present invention comprises a structure of 100 oval multicells, of which 80 (
(70) The plurality of poles, nodes and angles facilitate suturing; and has the advantage of decreasing time in the operating room. In contrast, the implants commercially available have settled specific tunnels for suturing in clamping, and they are complicated and limited. In the case of the present invention, it represents an inventive novelty, the arrangement of multicells with poles and nodes is distinguished by its great versatility that efficiently solves this procedure. A clear example is the 18 mm diameter implant of the C-100 model that has 20 cells in its largest size (E and F) of 3.20 mm by 1.50 mm (
(71) The poles and nodes described are identifiable in each cell, which as described is nominated according to its Cartesian location (with the corresponding parallel letter and the number of the meridian) in such a way that each pole receives the determinant “p” and each node, the determinant “n”. The number of each pole is defined according to its clockwise position, number 1 being the upper (12 on the clock hands); the nodes are identified according to the same procedure (
(72) The suturing described above is applicable in cases of evisceration, i.e. casting of the eyeball with scleral shell preservation escleralthe Nucleo-reticular Multi-cell Dual-system Eye Implant allows an excellent suturing clamping to the sclera and can be attached thereto or even encompass such suturing to the available extraocular muscles, whereby there is an increase in clamping and mobility with greater use of scleral tissue (
(73) Vascularizable
(74) The design of the structures in the MMM and FRC systems has the function of increasing the volume of blood flow or vascular integration as it is an open duct implant.
(75) The outer structure of the MMM system makes vascularization immediately flood (
(76) One of the main contributions that represent novelty and inventive to the Nucleo-reticular Multi-cell Dual-system Eye Implant consists of immediate vascular flooding, provable in the first seconds of its placement in surgical time by the oculoplastic surgeon (
(77) The C-100 model is cited in a 18 mm diameter with a design of 100 oval multicells, (
(78) With the measurements of the structure of the model C100 implant, manufactured with polylactic acid (PLA), which has a density of 1.25 gr/cm.sup.3, the best results of measurement-to-weight ratio are achieved, the same as referred to in the table in
(79) Volume of the Celled Sphere
d=m/v
m=1.48 g.fwdarw.celled sphere mass
d=1.25 g/cm.sup.3
v=m/d=1.48 g/1.25 g/cm.sup.3−1,184 cm.sup.3(cell volume.Math.Total sphere)
Solid Volume=3.0536 cm.sup.3
Material volume PLA=1.184 cm.sup.3
Free Volume=3.0536.fwdarw.100%
Volume to be filled=1.8696 cm.sup.3
(80) PLA
x=1.8696 cm.sup.3(100%)/3.0536 cm.sup.3
material(solid sphere)=61.22%
(81) Biocompatible Material
(82) The Nucleo-reticular Multi-cell Dual-system Eye Implant of calculated axial length filed for patent, can be manufactured with multiple materials, synthetic or natural, inert, provided that they are biocompatible and harmless. The structural capacity of the exhibited design presented has conditions to be manufactured with materials of natural or synthetic origin, in a molded, pressed, emptied, by stereolithography or any other that are experimentally designed and integrated.
(83) In the different models, polylactic acid (PLA) has been used as it is a material that does not present rejection by the body, with ideal density, weight and accessibility, being highly biocompatible. The material used in all models of the multi-cell structural implants is a “polymer made up of lactic acid molecules, with properties similar to those of polyethylene terephthalate (PET). It has been previously used (since the 1960 s) in a variety of medical and surgical applications such as suturing material (reabsorbable thread), orthopedic materials (such as screws and plates) and implants. The polylactic acid has become an essential material in medical industry, where it has been used for years. As polylactic acid is a biodegradable and bioabsorbable polymer (i.e., it can be assimilated by our biological system), PLA is an ideal candidate for bone or tissue implants (orthopedic surgery, ophthalmology, orthodontics, controlled launch of cancer drugs), and for suturing (eye surgery, chest and abdomen surgery).”.sup.(5).
(84) Motor Skills
(85) The Muscular Motor Multi-cell system (MMM) takes advantage of the arrangement of agonist and antagonistic muscles and/or scleral tissue, which determine natural movement; in connection with enucleative and evisceral injuries (
(86) The implant of the present invention, in its model type C-100, contains a structure of 100 oval multicells, of which 80 (
(87) Using the poles and nodes that define the multicells to hold the muscles with the sutures with increased efficiency and higher expectations of mobility, a better integration is allowed to help in the voluntary mobility of basal structures that integrate with the implant, which generates a greater range of mobility to implants (
(88) Due to the availability created by the multicells of the MMM system, the implant clamping process has conditions that favor the suturing with wide margin of technical and operational resources, the surgeon being able to identify the most suitable poles and/or nodes of the multicells, achieving the precision in the identification of the suture points, obtaining greater performance by having the availability for direct fixation to the extraocular muscles.
(89) The implant filed for patent has a multi-cell scheme with Cartesian location (
(90) In the C-100 model based on the 100 oval multi-cell scheme there are 80 useful cells with poles and nodes identifiable for suturing, being the suggested implant a device that increases the possibilities of muscle clamping, providing suturing variability. Models of different design and number of cells can be selected according to the specific conditions of the receiving patient.