NUCLEO-RETICULAR MULTI-CELL DUAL-SYSTEM EYE IMPLANT
20210177572 · 2021-06-17
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. Nucleo-reticular Multi-cell Dual-system Eye Implant, which consists of two interrelated systems, the Muscular Motor Multi-cell System (MMM) and the Reticular Fibrovascular Nucleus System (NRF), formed first by an outer structure that has multicells for sudden irrigation of vascularization, bordered by poles and nodes for suturing clamping; and second by an optional system constituted inside by a multi-level nucleus of micro reticules and filaments that achieve vascularization and fibrovascularization.
2. (canceled)
3. (canceled)
4. (canceled)
5. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1 is manufactured with any type of biocompatible material, natural or synthetic, such as ceramic, metal, polymer, organic, vegetable, cellular, from the space industry or any other.
6. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1 is manufactured under any procedure whether by molding, casting, die-cutting, injecting, cast pressing, weaving, sublimation, cell induction, stereolithography, or any other way that the shape allows and is compatible with the purposes and functions of claim 1.
7. (canceled)
8. (canceled)
9. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1 has nodes at the intersection points of the poles, which allow a diagonal suturing that complements the other muscle sutures, each node is identifiable in relation to the cell to which it belongs and its position therein, which allows to write down the clinical record of the patient in detail.
10. (canceled)
11. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1 is endowed with the multi-cell system which increases the suturing methods by having conditions and accessibility so that the surgeon has technical freedom to hold the implant, both in cases of evisceration and enucleation, by establishing posts and nodes, the first being vertical or horizontal clampings and the second, diagonal which combined allow avoiding the risks of extrusion or migration of the implant; it has multiple implant placement options and there is a natural placement position, which can vary in cases that the surgeon deems appropriate, without such variation impeding the potentialities of the implant.
12. (canceled)
13. (canceled)
14. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1 has a nucleus that makes up its inner system of filaments and platforms of levels that establish in its entirety a base for fibrovascularization with circulatory and oxygenating qualities that achieve a base of vital organic tissue which is integrated into the outer system.
15. In the Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1, wherein the inner or nucleus system is fixed to the outer structure by inner surfaces that constitute the micro-reticular multilevels, which are a fine tissue that has the function of consolidating and allowing blood flow and consequent oxygenation, all distributed in a multi-level structure, consisting of several platforms positioned with alignment to the parallels, with the function of optimizing structural resistance and at the same time, achieving fibrovascularization with the complement of intra-level filaments.
16. The Nucleo-reticular Multi-cell Dual-system Eye Implant of claim 1, wherein the inner structure or nucleus is equipped with fibrovascularized filaments, which form fibers that are located between each multilevel being cementifying, connective and conductive of blood flow, provide excellent means of fibrovascularization.
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
21. (canceled)
22. (canceled)
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. (canceled)
Description
BRIEF DESCRIPTION OF FIGURES
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DETAILED DESCRIPTION OF THE INVENTION
[0065] The Nucleo-reticular Multi-cell Dual-system Eye Implant filed in the patent refers to a new generation of multi-cell spherical structures (
[0066] The MMM system is the outer structure of the implant, which has a number of functional components, each accurately identifiable, its characteristics are: spherical shape with calculated axial length, equipped with a multi-cell, light, suturable, slip-resistant, vascularizable, fibro vascularizing and motor-enhancing mesh. It is the basic structure on which the cells are distributed throughout and wide, receiving each cell a Cartesian identification (
[0067] 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.
[0068] 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.
1.—Muscular Motor Multi-Cell System
[0069] 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 (
1.2 The Poles
[0070] 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. (
1.3 The Nodes
[0071] The cross sections of two or more poles make up a structural joint called Node (
[0072] 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.
[0073] 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.
[0074] 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 (
[0075] The implant when placed, defines in the part that directs to the forehead of the receiving patient, the upper point and accordingly, the corresponding cell is the southern cell 1 (equivalent to number 12 of clock hands) being the count of the meridians (numbers) upstream clockwise and the parallels (letters) upstream from the front point to the rear one of the eye structure (
2.—Fibrovascular Reticular Core System
[0076] 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.
[0077] It represents a system designed inside the sphere and aligned to the parallels, it is constituted by a series of multilevels (
[0078] 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 (
2.1 Multilevels
[0079] 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 (
2.2 Micro Reticules
[0080] 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 (
2.3 Filaments
[0081] 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 (
Light Weight
[0082] The Nucleo-reticular Multi-cell Dual-system Eye Implant in its initial C-100 model (
[0083] 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.
[0084] 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 (
[0085] 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%.
[0086] For the various measurements of the C-100 implant structure made of polylactic acid (PLA), which has a density of 1.25gr/cm.sup.3, the best measurement-weight ratio results are achieved, which are referred to in the table of
[0087] Regarding the methodology to arrive at the certainty of the coefficients previously set forth, the following equations were performed: [0088] PLA Density−1.25 gr/cm.sup.3 [0089] 1 cm.sup.3×1 milliliter [0090] If diameter is 18 mm [0091] radius is 9 mm (10 mm×1 cm)=0.9 cm [0092] solid volume=sphere volume=4/3 π (r.sup.3) [0093] 4/3π(0.9 cm).sup.3×3.0536 cm.sup.3=3.0536 ml [0094] PLA solid sphere mass [0095] d=m/v [0096] m=dv=1.25g/cm.sup.3 (3.0536 cm)=3.817 g [0097] Mass ratio [0098] Celled sphere mass=1.48 g [0099] Solid1 sphere mass=3.817 g [0100] % by mass is (1.48 g)(100)/3.817 g=38.773% by weight of the celled sphere compared to the solid sphere. [0101] That is, a decrease in: [0102] 100−38.773%=61.22% by weight reduction compared to solid weight.
Suturable
[0103] 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 (
[0104] The C-100 model of the present invention comprises a structure of 100 oval multicells, of which 80 (
[0105] 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 (
[0106] 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 (
[0107] The suturing described above is applicable in cases of evisceration, i.e. casting of the eyeball with scleral shell preservation escleral the 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 (
Vascularizable
[0108] 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.
[0109] The outer structure of the MMM system makes vascularization immediately flood (
[0110] 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 (
[0111] The C-100 model is cited in a 18 mm diameter with a design of 100 oval multicells, (
[0112] 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
Biocompatible Material
[0125] 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.
[0126] 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 1960s) 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).
Motor Skills
[0127] 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 (
[0128] The implant of the present invention, in its model type C-100, contains a structure of 100 oval multicells, of which 80 (
[0129] 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 (
[0130] 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.
[0131] The implant filed for patent has a multi-cell scheme with Cartesian location (
[0132] 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.