WO2015006839A1 - Intraocular prosthesis for altering the areas of greater image sharpness or for shifting the eye optical axis on the retina - Google Patents
Intraocular prosthesis for altering the areas of greater image sharpness or for shifting the eye optical axis on the retina Download PDFInfo
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- WO2015006839A1 WO2015006839A1 PCT/BR2013/000259 BR2013000259W WO2015006839A1 WO 2015006839 A1 WO2015006839 A1 WO 2015006839A1 BR 2013000259 W BR2013000259 W BR 2013000259W WO 2015006839 A1 WO2015006839 A1 WO 2015006839A1
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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
- A61F2/1613—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
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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
- A61F2002/16965—Lens includes ultraviolet absorber
- A61F2002/1699—Additional features not otherwise provided for
Definitions
- the subject matter of this patent relates to a novel type of special intraocular device - either artificial lens replacing or adding to the natural lens or previously implanted Intraocular Lens - designed to displace the sharply focused light beam through damaged structures of the posterior pole. retinal areas by altering the sharpest areas of the projected image on the retina to pre-determined, preserved regions containing a considerable number of cones and rods to improve the vision of macular disease carriers of various origins as much as possible.
- Dr. Nicholas Harold Lloyd Ridley performed the first implant of an artificial Intraocular Lens - IOL, replacing a cataract lens. From that time to the present day the Intraocular Lenses have received constant improvements and are produced with flexible and foldable material, which allows implantation by about 3 mm incisions and are a valuable resource for Ophthalmology.
- AMD - Age Related Macular Disease - is defined as visual loss to varying degrees due to atrophy of retinal pigment epithelium or changes associated with subretinal neovascularization in individuals usually above 50 years of age. The condition is often bilateral, but not always symmetrically. AMD causes severe vision loss, and among the 75-year-old, about 35% of them are affected to some extent.
- Ocular Toxoplasmosis - Congenital toxoplasmosis - acquired during pregnancy - is an endemic disease commonly leading to inflammatory destruction of the macula. The onset may occur at birth or in its late form, between 10 and 30 years of age, severely compromising vision. Central lesions corresponding to the peri-macular and papillo-macular areas constitute between 36% and 50% of late toxoplasmosis cases.
- Macular hole It is a pathology that can be idiopathic or caused by causes such as high myopia, trauma, solar retinopathy and other causes.
- Figure 1 is an anteroposterior section of the human eye (1), in which we see the cornea (2), ciliary body (3), pupil (4), iris (5), ligaments (6), the lens (7), the vitreous humor (8), the sclerotic (9), the choroid (10), the retina (11), the macula (12), the fovea (13), blind spot (14), situated in the intraocular emergence of the optic nerve (15), which is also called the papilla.
- Figure 2 is a schematic cross-sectional front view of the back of the human eye to be viewed compared to the front view of the intact eye, placed next to it in Figure 2, showing the fovea (13), which is approximately circular in shape and about 1.5 mm in diameter, and the macula (12), which is in the shape of a disc about 5.5 mm in diameter - with the fovea (13) at its center - composing the extrafoveal region with the rest of the retina (11);
- Figure 3 schematically depicts the pattern of retinal nerve fiber pathways around the fovea (13) and the papilla or blind spot (14), at which point the optic nerve (15) enters the human eye (1). ).
- These fibers and nerve endings are composed of axons, dendrites and neuron endings and are connected to a population of cones and rods.
- Rods and cones are photoreceptors involved in color and shape perception. Through specialized nerve endings, they turn incident light into nerve impulses that are transmitted to the brain to make up vision.
- the graph in figure 3B shows the distribution of cones and rods in the human retina. There is a maximum concentration of cones in the fovea region; In the graph, the center of the fovea corresponds to the point with zero degree of perimeter, decaying in the macular region and remaining lower and approximately constant in the extra-macular regions of the retina.
- Rods are virtually absent in the fovea and reach a high level outside this region and the rest of the retina.
- Figure 3C shows in simplified schematic anteroposterior view the human eye (1), the cornea (2), the ligaments (6), the lens (7) and two rays of light - A and B - incident on the cornea (2) whose trajectories naturally converge on the fovea (13), which is the main focus of image formation in the eye; It also shows the blind spot (14) and the optic nerve (5).
- the human eye behaves basically as an optical system of two conjugated lenses, the first being the cornea (2), a fixed convergence lens and the second, the crystalline (7), a variable convergence lens enabling the images of near and far objects can form equally focused on the fovea allowing clear vision.
- the innovation core of the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR DISPLACING THE EYE ON THE RETINA OPTICAL", object of this Patent refers to the use of an intraocular optical device surgically implanted in the region of the or to replace it, alter the sharper region of image that would naturally occur within the eye directly over the injured central regions and generate sharp images in other uninjured regions of the retina where the cones and rods present will grasp the images received by the thus partially restore sight to patients, with invaluable quality of life gains.
- Ophthalmic examinations reveal that most patients with low or high severity macular lesions have visual perception of peripheral field.
- Clinical experience confirms that patients report poor visual perception in the direction of the axis of vision - which is true because objects are projected into focus over the damaged fovea / macula - but who still have the vision of the presence of objects on the periphery of the field of vision.
- these objects can be perceived with less precision, since since their projections on the retina are naturally away from the focal point of focus, their images are projected out of focus on the retina, albeit in preserved regions of the retina, ie usually with lower concentration of cones and rods.
- the object of this patent is the use of an intraocular optical device to deflect the light beams by altering the most clearly occurring region of image formation naturally on the macula and fovea to other regions of the retina to form clear projected images outside. of the injured region.
- Figure 4 is a schematic representation of a human eye (1), in anteroposterior section; In it we see the cornea (2), the ligaments (6) and the lens (7), which may be replaced or added to the devices object of this patent.
- FIGS 5 and 6 are simplified schematic representations to allow comparison between conventional intraocular lenses and the prostheses object of the present invention.
- Intraocular Lenses (18) can replace crystalline lens (7) that has become opaque due to cataract or implanted in addition to correcting high errors or refractive defects.
- Intraocular Lenses (18) are transparent and have a geometric shape and carefully controlled internal refractive index to ensure correct convergence and / or refractive correction of the eye.
- Figure 5 illustrates the fact that current Intraocular lenses (18) direct the optical focus to the patient's fovea (13) as represented by the convergence of G and H light rays.
- the "INTRAOCULAR PROSTHESIS FOR CHANGING THE GREATEST IMAGE REGIONS OR DISPLACING THE EYE OPTICAL OVER THE RETAIN" (17) may or may not replace the lens and may only be implanted in addition to the natural lens or an Intraocular Lens ( 18) previously implanted.
- Figure 6 illustrates the fact that "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT EYE OPTICAL OVER THE RETAIN" (17) alters the sharper region of the projected image to the preserved retinal region as shown below. represented by the convergence of light rays I and J, thus defining greater image clarity in the extra-foveal region (16).
- the present patent describes two types of intraocular prostheses which are based on the same concept and present two preferred embodiments.
- the first is an intraocular prosthesis to displace the optical axis of the eye and alter the positioning of the retinal image projection, being transparent and having carefully controlled geometric shape and internal refractive index to ensure correct convergence and appropriate deviation of the optical axis of the eye.
- the second is an intraocular prosthesis for altering the sharpest regions of the projected image on the retina, and carefully controlled geometric shape and internal refractive index to ensure correct convergence, performing, In this case, the appropriate alteration of the regions where the images on the retina are most clearly formed, that is, the displacement of the optical axis on the retina.
- Figure 7, solution offered by the second prosthesis illustrates the regions of greatest image clarity in the retina. In situation (a) the clearest region is represented by the area of a circle with the fovea (3) approximately at its center as the image projected naturally over the retina.
- the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT THE EYE OPTICAL OVER THE RETINA" (17) should be calculated in its parameters to generate the appropriate deviation for focusing on the optically most competent retinal region for the subject.
- the "INTRAOCULAR DENTURE TO CHANGE THE GREATEST IMAGES OF THE IMAGE OR SHIFT THE EYE OPTICAL AXIS” (17) can be manufactured on a robotic industrial scale in short time and at affordable costs.
- the lens object of the patent lens is always asymmetric and therefore its positioning within the patient's eye must be performed with the utmost precision to ensure the projection of the clear image in a previously mapped region of the retina considered uninjured.
- the accuracy of this positioning is fundamental for good results.
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Abstract
The subject matter of this patent relates to a new type of special intraocular device - or artificial crystalline lens as a replacement for or addition to the natural crystalline lens or a previously implanted intraocular lens - designed for shifting the light beam focussed by the eye structures in a damaged area of the posterior pole of the retina to intact, previously determined areas containing a considerable number of rods and cones in order to improve as much as possible the vision of patients of macular diseases of various origins. The prostheses described in the present patent have a geometric shape and refractive index carefully controlled in order to ensure correct convergence and suitable alteration of the areas having the greater image projection sharpness onto the retina. Given that retinal damages have specific locations in the retina of each patient, the parameters of the intraocular prosthesis for altering the areas of greater image sharpness or for shifting the eye optical axis on the retina must be calculated to cause the alteration of the areas of greater sharpness to the areas of the retina of the individual patient which are most competent optically.
Description
"PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA". "INTRAOCULAR PROSTHESIS TO CHANGE GREATER PICTURE REGIONS OR SHIFT EYE OPTICAL AXIS OVER RETINA".
Campos desta Patente: Fields of this Patent:
· Melhora considerável da qualidade de visão aos portadores de doenças da mácula de diversas origens. · Considerable improvement in vision quality for people with macula diseases of various origins.
• Oftalmologia. • Ophthalmology.
O objeto desta Patente se refere a um novo tipo de dispositivo intraocular especial - ou cristalino artificial em substituição ou adição ao cristalino natural ou Lente Intraocular previamente implantada - destinado a deslocar o feixe luminoso focado em maior nitidez pelas estruturas oculares em região danificada do polo posterior da retina, alterando as zonas de maior nitidez da imagem projetada sobre a retina para regiões preservadas e determinadas previamente, que contenham número apreciável de cones e bastonetes, para melhorar, ao máximo possível, a visão dos portadores de moléstias maculares de diversas origens. The subject matter of this patent relates to a novel type of special intraocular device - either artificial lens replacing or adding to the natural lens or previously implanted Intraocular Lens - designed to displace the sharply focused light beam through damaged structures of the posterior pole. retinal areas by altering the sharpest areas of the projected image on the retina to pre-determined, preserved regions containing a considerable number of cones and rods to improve the vision of macular disease carriers of various origins as much as possible.
Estado da Técnica. State of the art.
Dificuldades de enxergar sempre acompanharam a humanidade como uma cruel desdita e, para a maioria absoluta da humanidade, a dificuldade de visão vem inexoravelmente com a velhice. Difficulties in seeing have always accompanied humanity as a cruel misery, and for the overwhelming majority of humanity the difficulty of vision comes inexorably with old age.
Outros, mais desafortunados, as possuem desde o nascimento ou infância ou foram vítimas de lesões ou doenças que lhes causaram a perda total ou de grande parte da visão. Others, more unfortunate, have had them from birth or childhood, or have suffered injuries or illnesses that caused them to lose all or most of their vision.
Poderosos do Império Romano não conheciam meios de contornar as dificuldades visuais. Mighty men of the Roman Empire knew no way around visual difficulties.
A primeira referência de algo semelhante a uma lente, usada pelos mais velhos, para leitura, vem de Marco Polo, em relatos da visita que fez à China entre 1271 e 1295. The earliest reference to something similar to a lens used by older people for reading comes from Marco Polo in reports of his visit to China between 1271 and 1295.
Assim, as primeiras lentes de que a humanidade dispôs eram indicadas para a presbiopia, a visão fraca dos velhos ou para a hipermetropia. Thus, the earliest lenses available to mankind were suitable for presbyopia, poor vision of the old, or hyperopia.
As lentes côncavas para a miopia surgiram cerca de 200 anos depois, conforme referências no livro de Nicola Cusanus (1401 -1464).
Em 1775, Benjamim Franklin, estadista e cientista norte-americano, inventou os óculos bifocais; nesta época, as lentes já eram colocadas em armações que se apoiavam sobre o nariz e as orelhas. Concave lenses for myopia emerged about 200 years later, according to references in Nicola Cusanus's book (1401-1464). In 1775, Benjamin Franklin, an American statesman and scientist, invented bifocal glasses; By this time, the lenses were already placed on frames that rested on the nose and ears.
A partir daí, vieram as lentes corretoras do astigmatismo e, em seguida, lentes feitas sob medida para cada paciente, que podiam corrigir, ao mesmo tempo, o astigmatismo, a presbiopia ou a miopia. From there came astigmatism-correcting lenses, and then tailor-made lenses for each patient, which could simultaneously correct astigmatism, presbyopia, or myopia.
Em novembro de 1949, o Dr. Nicholas Harold Lloyd Ridley realizou o primeiro implante de uma Lente Intraocular - LIO, artificial, em substituição a um cristalino com catarata. Desde essa época até os dias hoje as Lentes Intraoculares têm recebido constantes aperfeiçoamentos e são produzidas com material flexível e dobrável, que permite o implante por incisões de cerca de 3 mm e constituem um valiosíssimo recurso para a Oftalmologia. In November 1949, Dr. Nicholas Harold Lloyd Ridley performed the first implant of an artificial Intraocular Lens - IOL, replacing a cataract lens. From that time to the present day the Intraocular Lenses have received constant improvements and are produced with flexible and foldable material, which allows implantation by about 3 mm incisions and are a valuable resource for Ophthalmology.
Entretanto, até o momento do surgimento do objeto desta Patente, diversas patologias que acometem a visão humana comprometendo de forma profunda a visão do paciente, não receberam soluções efetivas. However, until the moment of the object of this patent emerged, several pathologies that affect the human vision deeply compromising the patient's vision, did not receive effective solutions.
Estas patologias estão relacionadas a danos na retina na região da fóvea ou, em maior extensão, na mácula como um todo. These conditions are related to damage to the retina in the fovea region or, to a greater extent, the macula as a whole.
Os pacientes afetados pelas patologias que a seguir descrevemos sucintamente tornam-se limitados irreversivelmente para tarefas como ler, assistir televisão, deslocarem-se sozinhos, em suma, têm suas qualidades de vida drasticamente diminuídas. Patients affected by the pathologies described briefly below become irreversibly limited to tasks such as reading, watching television, moving alone, in short, their life quality is dramatically diminished.
1. DMRI - Doença Macular Relacionada a Idade:- é definida como a perda visual em diferentes graus devido à atrofia do epitélio pigmentar da retina ou alterações associadas com neovascularização sub-retiniana em indivíduos usualmente acima de 50 anos de idade. A condição é frequentemente bilateral, entretanto nem sempre de forma simétrica. A DMRI leva a severa perda da visão e, entre os mais velhos que 75 anos, cerca de 35% deles são afetados em alguma medida. 1. AMD - Age Related Macular Disease: - is defined as visual loss to varying degrees due to atrophy of retinal pigment epithelium or changes associated with subretinal neovascularization in individuals usually above 50 years of age. The condition is often bilateral, but not always symmetrically. AMD causes severe vision loss, and among the 75-year-old, about 35% of them are affected to some extent.
2. Toxoplasmose Ocular: - a toxoplasmose congénita - adquirida durante a gestação - constitui uma doença endémica levando comumente à destruição inflamatória da mácula. O aparecimento pode se dar no nascimento ou em sua forma tardia, entre 10 e 30 anos de idade,
comprometendo severamente a visão. As lesões centrais correspondendo às áreas peri-macular e papilo-macular constituem entre 36% e 50% dos casos de toxoplasmose tardia. 2. Ocular Toxoplasmosis: - Congenital toxoplasmosis - acquired during pregnancy - is an endemic disease commonly leading to inflammatory destruction of the macula. The onset may occur at birth or in its late form, between 10 and 30 years of age, severely compromising vision. Central lesions corresponding to the peri-macular and papillo-macular areas constitute between 36% and 50% of late toxoplasmosis cases.
3. Buraco Macular: - trata-se de uma patologia que pode ser idiopática ou ocasionada por causas como alta miopia, trauma, retinopatia solar e outras causas. 3. Macular hole: - It is a pathology that can be idiopathic or caused by causes such as high myopia, trauma, solar retinopathy and other causes.
4. Outras patologias comprometem a mácula como a serosa central, as maculopatias tóxicas e outras, mas, possuem menor incidência na população. 4. Other pathologies compromise the macula such as central serosa, toxic and other maculopathies, but have lower incidence in the population.
As investigações sobre o uso de células tronco para recomposição das regiões danificadas estão ainda em fase inicial e ainda não apresentaram resultados aplicáveis e, portanto, não é possível afirmar que através deste método se poderá conseguir repor uma população de cones e bastonetes equivalente à da região danificada. Investigations into the use of stem cells to repair damaged regions are still in their early stages and have not yet yielded any applicable results, so it is not possible to state that this method will be able to restore a population of cones and rods equivalent to that of the region. damaged.
O recurso ótico atualmente existente para tais patologias é o uso de lupas para ampliação das imagens. Este procedimento, entretanto, é extremamente incómodo e de uso em situações bastante restritas. The currently existing optical resource for such pathologies is the use of magnifying glasses for image enlargement. This procedure, however, is extremely cumbersome and of use in very restricted situations.
Avanços no Estado da Técnica trazidos pela "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA", objeto desta Patente. Advances in the state of the art brought by the "INTRAOCULAR PROSTHESIS TO CHANGE GREATEST IMAGE REGIONS OR SHIFT THE EYE OPTICAL AXIS ON THE RETINA", object of this Patent.
São os seguintes os campos anatómico, histológico e fisiológico nos quais se inserem os avanços ao Estado da Técnica do objeto desta Patente. The following are the anatomical, histological and physiological fields in which advances in the state of the art of the object of this patent are inserted.
1 - Anatomia do olho humano. 1 - Anatomy of the human eye.
A Figura 1 representa um corte no sentido anteroposterior do olho humano (1), no qual vemos a córnea (2), o corpo ciliar (3), a pupila (4), a íris (5), os ligamentos (6), o cristalino (7), o humor vítreo (8), a esclerótica (9), a coroide (10), a retina (11 ), a mácula (12), a fóvea (13), ponto cego (14), situado na emergência intraocular do nervo óptico (15), local este também denominado papila. Figure 1 is an anteroposterior section of the human eye (1), in which we see the cornea (2), ciliary body (3), pupil (4), iris (5), ligaments (6), the lens (7), the vitreous humor (8), the sclerotic (9), the choroid (10), the retina (11), the macula (12), the fovea (13), blind spot (14), situated in the intraocular emergence of the optic nerve (15), which is also called the papilla.
A Figura 2 representa uma visão frontal, esquemática, em corte, da parte posterior do olho humano, para ser vista em comparação com a vista frontal
do olho íntegro, colocado ao lado na mesma Figura 2, mostrando a fóvea (13), que tem forma aproximadamente circular e diâmetro de cerca de 1 ,5 mm e a mácula (12), que tem a forma de um disco com cerca de 5,5 mm de diâmetro - com a fóvea (13) em seu centro - compondo a região extra-foveal com o restante da retina (11); na mesma Figura 2 vemos a córnea (2), a pupila (4), a íris (5) e o nervo óptico (15). Figure 2 is a schematic cross-sectional front view of the back of the human eye to be viewed compared to the front view of the intact eye, placed next to it in Figure 2, showing the fovea (13), which is approximately circular in shape and about 1.5 mm in diameter, and the macula (12), which is in the shape of a disc about 5.5 mm in diameter - with the fovea (13) at its center - composing the extrafoveal region with the rest of the retina (11); In the same Figure 2 we see the cornea (2), the pupil (4), the iris (5) and the optic nerve (15).
2 - Histologia parcial do olho humano. 2 - Partial histology of the human eye.
A figura 3 representa, esquematicamente, o padrão do trajeto das fibras nervosas da retina em torno da fóvea (13) e da papila ou ponto cego (14), ponto no qual o nervo óptico (15) ingressa no interior do olho humano (1). Estas fibras e terminações nervosas são compostas por axônios, dendritos e terminações de neurónios e estão conectados a uma população de cones e bastonetes. Figure 3 schematically depicts the pattern of retinal nerve fiber pathways around the fovea (13) and the papilla or blind spot (14), at which point the optic nerve (15) enters the human eye (1). ). These fibers and nerve endings are composed of axons, dendrites and neuron endings and are connected to a population of cones and rods.
Os bastonetes e cones são fotorreceptores envolvidos na percepção de cores e de formas. Através de terminações nervosas especializadas, transformam a luz incidente em impulsos nervosos que transmitidos ao cérebro constituirão a visão. Rods and cones are photoreceptors involved in color and shape perception. Through specialized nerve endings, they turn incident light into nerve impulses that are transmitted to the brain to make up vision.
São eles os responsáveis, também, pela visão periférica. They are also responsible for peripheral vision.
O gráfico da figura 3B apresenta a distribuição de cones e bastonetes na retina humana. Existe uma concentração máxima de cones na região da fóvea; no gráfico, o centro da fóvea corresponde ao ponto com zero grau de ângulo perimetral, decaindo na região macular e mantendo-se em nível inferior e aproximadamente constante nas regiões extra-maculares da retina. The graph in figure 3B shows the distribution of cones and rods in the human retina. There is a maximum concentration of cones in the fovea region; In the graph, the center of the fovea corresponds to the point with zero degree of perimeter, decaying in the macular region and remaining lower and approximately constant in the extra-macular regions of the retina.
Os bastonetes por outro lado, estão praticamente ausentes na fóvea e atingem um nível elevado fora desta região e no restante da retina. Rods, on the other hand, are virtually absent in the fovea and reach a high level outside this region and the rest of the retina.
A distribuição de cones e bastonetes fora da região da fóvea é fundamental para a visão periférica no ser humano. The distribution of cones and rods outside the fovea region is fundamental for peripheral vision in humans.
As inovações nucleares do objeto desta patente, conforme adiante descritas, utilizam a sensibilidade luminosa extra-foveal provida por estes mesmos cones e bastonetes envolvidos na visão periférica de forma a restituir parcialmente a visão àqueles que possuem graves lesões foveais ou maculares, oriundas das patologias citadas neste Relatório.
3 - Fisiologia da visão humana. The nuclear innovations of the subject-matter of this patent, as described below, utilize the extra-foveal light sensitivity provided by these same cones and rods involved in peripheral vision in order to partially restore vision to those with severe foveal or macular lesions arising from the aforementioned pathologies. in this report. 3 - Physiology of human vision.
A Figura 3C mostra em corte anteroposterior, de forma esquemática simplificada, o olho humano (1 ), com a córnea (2), os ligamentos (6), o cristalino (7) e dois raios de luz - A e B - incidentes sobre a córnea (2) que têm suas trajetórias naturalmente convergindo sobre a fóvea (13), que é o foco principal da formação de imagem no olho; nela vê-se, também, o ponto cego (14) e o nervo óptico ( 5). Figure 3C shows in simplified schematic anteroposterior view the human eye (1), the cornea (2), the ligaments (6), the lens (7) and two rays of light - A and B - incident on the cornea (2) whose trajectories naturally converge on the fovea (13), which is the main focus of image formation in the eye; It also shows the blind spot (14) and the optic nerve (5).
O olho humano se comporta basicamente como um sistema óptico de duas lentes conjugadas, sendo a primeira, a córnea (2), uma lente de convergência fixa e a segunda, o cristalino (7), uma lente de convergência variável possibilitando que as imagens de objetos próximos e distantes possam se formar igualmente focadas sobre a fóvea permitindo uma visão nítida. The human eye behaves basically as an optical system of two conjugated lenses, the first being the cornea (2), a fixed convergence lens and the second, the crystalline (7), a variable convergence lens enabling the images of near and far objects can form equally focused on the fovea allowing clear vision.
Assim, o núcleo de inovação da "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA", objeto desta Patente, se refere a utilização de um dispositivo ótico intraocular, implantado cirurgicamente na região do cristalino ou em substituição a este, alterar a região de maior nitidez de imagem que naturalmente ocorreria no interior do olho diretamente sobre as regiões centrais lesadas e gerar imagem nítidas em outras regiões não lesadas da retina onde os cones e bastonetes presentes apreenderão as imagens recebidas pelo olho e restituirão, assim, parcialmente, a visão aos pacientes, com inestimáveis ganhos de qualidade de vida. Thus, the innovation core of the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR DISPLACING THE EYE ON THE RETINA OPTICAL", object of this Patent, refers to the use of an intraocular optical device surgically implanted in the region of the or to replace it, alter the sharper region of image that would naturally occur within the eye directly over the injured central regions and generate sharp images in other uninjured regions of the retina where the cones and rods present will grasp the images received by the thus partially restore sight to patients, with invaluable quality of life gains.
Descrição e ilustrações e funcionamento dos avanços no Estado da Técnica trazidos pela "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA", objeto desta Patente. Description and illustrations and operation of the state of the art advances brought by the "INTRAOCULAR PROSTHESIS TO CHANGE THE GREATEST IMAGE REGIONS OR DISPLACE THE EYE OPTICAL AXIS ON THE RETINA", object of this Patent.
Os exames oftalmológicos revelam que a maioria dos pacientes com quadro de lesões maculares de baixa ou alta severidade possui percepção visual de campo periférico. A experiência clínica confirma que os pacientes relatam baixa percepção visual na direção do eixo de visão - o que é verdade, pois, os objetos são projetados em foco sobre a fóvea/mácula danificada - mas
que ainda assim possuem a visão da presença dé objetos na periferia do campo de visão. Naturalmente, estes objetos podem ser percebidos com menor precisão, pois uma vez que suas projeções sobre a retina estão naturalmente afastadas do ponto central de foco, suas imagens são projetadas desfocadas na retina, ainda que em regiões preservadas da retina, ou seja, usualmente com menor concentração de cones e bastonetes. Ophthalmic examinations reveal that most patients with low or high severity macular lesions have visual perception of peripheral field. Clinical experience confirms that patients report poor visual perception in the direction of the axis of vision - which is true because objects are projected into focus over the damaged fovea / macula - but who still have the vision of the presence of objects on the periphery of the field of vision. Of course, these objects can be perceived with less precision, since since their projections on the retina are naturally away from the focal point of focus, their images are projected out of focus on the retina, albeit in preserved regions of the retina, ie usually with lower concentration of cones and rods.
O objeto desta Patente consiste no emprego de um dispositivo ótico intraocular para desviar os feixes luminosos alterando a região de maior nitidez de formação de imagem que ocorre naturalmente sobre a mácula e fóvea, para outras regiões da retina de maneira a se formarem nítidas imagens projetadas fora da região lesada. The object of this patent is the use of an intraocular optical device to deflect the light beams by altering the most clearly occurring region of image formation naturally on the macula and fovea to other regions of the retina to form clear projected images outside. of the injured region.
A Figura 4 é uma representação esquemática de um olho humano (1), em corte anteroposterior; nela vemos a córnea (2), os ligamentos (6) e o cristalino (7), o qual poderá ser substituído ou receber o acréscimo dos dispositivos objeto desta patente. Figure 4 is a schematic representation of a human eye (1), in anteroposterior section; In it we see the cornea (2), the ligaments (6) and the lens (7), which may be replaced or added to the devices object of this patent.
Nesta Figura 4 vemos o ponto cego (14), o nervo óptico (15) e, também, a fóvea (13) e um ponto extra-foveal (16), para o qual foram deslocados, em foco calculado previamente para a correta e exata fabricação do artefato, os raios luminosos A e B, incidentes sobre a córnea (2) e que, pelas condições de refração do objeto desta Patente, assumiram as direções dos raios luminosos representados na forma tracejada E e F e incidiram sobre a região extra-foveal definindo uma nova região de imagem nítida, na região extra- foveal (16) - onde, conforme detectado nos exames prévios à tal operação - há suficiente capacidade de visão pela presença de cones e bastonetes permitindo uma apreciável recuperação da visão em foco do paciente. In this Figure 4 we see the blind spot (14), the optic nerve (15) and also the fovea (13) and an extra-foveal point (16), to which they were displaced, in focus previously calculated for the correct and exact manufacture of the artifact, the light rays A and B, incident on the cornea (2) and which, by the refractive conditions of the object of this patent, assumed the directions of the light rays represented in dashed form E and F and focused on the extra region. -foveal defining a new region of clear image in the extrafoveal region (16) - where, as detected in the previous examinations to such operation - there is sufficient vision capacity by the presence of cones and rods allowing an appreciable recovery of the focus vision of the patient.
As Figuras 5 e 6 são representações esquemáticas simplificadas para permitir a comparação entre as lentes intraoculares convencionais e as Próteses objeto da presente patente. Figures 5 and 6 are simplified schematic representations to allow comparison between conventional intraocular lenses and the prostheses object of the present invention.
As Lentes Intraoculares convencionais (18) podem substituir o cristalino (7) que se tornou opaco em razão de catarata ou implantados em adição ao mesmo com função de correção de altos erros ou defeitos refracionais. As Lentes Intraoculares (18) são transparentes e possuem formato geométrico e
índice de refração interno, cuidadosamente controlados, de forma a assegurar a correta convergência e/ou correção refracional do olho. Conventional Intraocular Lenses (18) can replace crystalline lens (7) that has become opaque due to cataract or implanted in addition to correcting high errors or refractive defects. Intraocular Lenses (18) are transparent and have a geometric shape and carefully controlled internal refractive index to ensure correct convergence and / or refractive correction of the eye.
A figura 5 ilustra o fato de que as lentes Intraoculares (18) atuais direcionam o foco óptico para a fóvea (13) do paciente conforme representado na convergência dos raios luminosos G e H. Figure 5 illustrates the fact that current Intraocular lenses (18) direct the optical focus to the patient's fovea (13) as represented by the convergence of G and H light rays.
A "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA" (17) pode substituir o cristalino ou não, podendo também ser apenas implantada em adição ao cristalino natural ou a uma Lente Intraocular (18) previamente implantada. The "INTRAOCULAR PROSTHESIS FOR CHANGING THE GREATEST IMAGE REGIONS OR DISPLACING THE EYE OPTICAL OVER THE RETAIN" (17) may or may not replace the lens and may only be implanted in addition to the natural lens or an Intraocular Lens ( 18) previously implanted.
A figura 6 ilustra o fato de que a "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA" (17) altera a região de maior nitidez da imagem projetada para região preservada da retina conforme representado na convergência dos raios luminosos I e J definindo, assim, uma maior nitidez da imagem na região extra-foveal (16). Figure 6 illustrates the fact that "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT EYE OPTICAL OVER THE RETAIN" (17) alters the sharper region of the projected image to the preserved retinal region as shown below. represented by the convergence of light rays I and J, thus defining greater image clarity in the extra-foveal region (16).
A presente patente descreve dois tipos de próteses intraocular que se são baseadas no mesmo conceito a apresentam duas formas de realização preferida. The present patent describes two types of intraocular prostheses which are based on the same concept and present two preferred embodiments.
A primeira é uma prótese intraocular para deslocar o eixo ótico do olho e alterar o posicionamento da projeção de imagens na retina, sendo transparente e possui formato geométrico e índice de refração interno, cuidadosamente controlados, de forma a assegurar a correta convergência e o apropriado desvio do eixo óptico do olho. The first is an intraocular prosthesis to displace the optical axis of the eye and alter the positioning of the retinal image projection, being transparent and having carefully controlled geometric shape and internal refractive index to ensure correct convergence and appropriate deviation of the optical axis of the eye.
A segunda, da mesma forma que a primeira, é uma prótese intraocular para alterar as regiões de maior nitidez de imagem projetada sobre a retina possui e formato geométrico e índice de refração interno, cuidadosamente controlados, de forma a assegurar a correta convergência, realizando, neste caso, a apropriada alteração das regiões onde se forma com maior nitidez as imagens sobre a retina, ou seja, o deslocamento do eixo ótico sobre a retina. A figura 7, solução oferecida pela segunda prótese, ilustra as regiões de maior nitidez de imagem na retina. Na situação (a) a região de maior nitidez é
representada pela área de um círculo com a fóvea ( 3) aproximadamente em seu centro como naturalmente se dá a projeção da imagem sobre a retina. Nas situações (b) e (c) as regiões de maior nitidez de projeção de imagem são alteradas pela "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA" (17), de forma a ocorrerem na região extra- foveal (16) e tomando forma ou número diverso. The second, like the first, is an intraocular prosthesis for altering the sharpest regions of the projected image on the retina, and carefully controlled geometric shape and internal refractive index to ensure correct convergence, performing, In this case, the appropriate alteration of the regions where the images on the retina are most clearly formed, that is, the displacement of the optical axis on the retina. Figure 7, solution offered by the second prosthesis, illustrates the regions of greatest image clarity in the retina. In situation (a) the clearest region is represented by the area of a circle with the fovea (3) approximately at its center as the image projected naturally over the retina. In situations (b) and (c) the sharpest regions of image projection are altered by the "INTRAOCULAR PROSTHESIS TO CHANGE THE GREATEST IMAGE REGIONS OR SHIFT THE EYE OPTICAL AXIS" (17). occur in the extrafoveal region (16) and taking different form or number.
Considerando que danos na retina são localizados de forma específica na retina de cada paciente a "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA" (17) deve ser calculada em seus parâmetros para gerar o desvio apropriado para a focalização na região da retina opticamente mais competente para o indivíduo. Considering that retinal damage is specifically located on each patient's retina, the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT THE EYE OPTICAL OVER THE RETINA" (17) should be calculated in its parameters to generate the appropriate deviation for focusing on the optically most competent retinal region for the subject.
Da mesma forma que lentes para óculos, próteses dentárias, intraoculares ou ortopédicas que podem ser encontradas no mercado, a "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM OU DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA" (17), pode ser fabricada, em escala industrial robotizada, em curtos espaços de tempo e a custos acessíveis. As with eyeglass, dental, intraocular or orthopedic prosthesis lenses that can be found on the market, the "INTRAOCULAR DENTURE TO CHANGE THE GREATEST IMAGES OF THE IMAGE OR SHIFT THE EYE OPTICAL AXIS" (17) can be manufactured on a robotic industrial scale in short time and at affordable costs.
A lente objeto da persente patente é assimétrica sempre e, portanto seu posicionamento no interior do olho do paciente deve ser realizado com máxima precisão para assegurar a projeção da imagem nítida em uma região previamente mapeada da retina e considerada não lesada. A precisão deste posicionamento é fundamental para a obtenção de bons resultados.
The lens object of the patent lens is always asymmetric and therefore its positioning within the patient's eye must be performed with the utmost precision to ensure the projection of the clear image in a previously mapped region of the retina considered uninjured. The accuracy of this positioning is fundamental for good results.
Claims
REIVINDICAÇÕES
"PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM SOBRE A RETINA", destinado a restituir parcialmente a visão àqueles que possuem graves lesões foveais ou maculares, caracterizada por utilizar a sensibilidade luminosa extra-foveal provida pelos cones e bastonetes envolvidos na visão periférica e ser um dispositivo intraocular especial ou cristalino artificial em substituição ou adição ao cristalino natural ou Lente Intraocular previamente implantada, destinado a alterar o eixo óptico e deslocar o feixe luminoso focado pelas estruturas oculares em região danificada do polo posterior da retina, para regiões preservadas e determinadas previamente, que contenham número apreciável de cones e bastonetes para formar o foco fora da região lesada. "PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM SOBRE A RETINA", de acordo com a reivindicação 1 , caracterizada por ser transparente e possuir formato geométrico e índice de refração interno, cuidadosamente controlados, de forma a assegurar a correta convergência e o apropriado desvio do eixo óptico do olho e ser implantado cirurgicamente na região do cristalino ou em substituição a este. "INTRAOCULAR PROSTHESIS TO CHANGE THE HIGHER RETINAL IMAGE REGIONS", intended to partially restore vision to those with severe foveal or macular lesions, characterized by utilizing the extra-foveal light sensitivity provided by the cones and rods involved in peripheral vision and be a special intraocular device or artificial lens in place of or in addition to the previously implanted natural lens or Intraocular Lens, intended to alter the optical axis and displace the focused light beam through the damaged retinal posterior pole ocular structures to preserved regions and previously determined, which contain an appreciable number of cones and rods to form the focus outside the injured region. "INTRAOCULAR PROSTHESIS FOR CHANGING THE HIGHEST RETINAL IMAGE REGIONS" according to claim 1, characterized in that it is transparent and has carefully controlled geometric shape and internal refractive index to ensure correct convergence and correctness. appropriate deviation of the optical axis of the eye and be surgically implanted in or replacing the lens region.
"PRÓTESE INTRAOCULAR PARA ALTERAR AS REGIÕES DE MAIOR NITIDEZ DE IMAGEM SOBRE A RETINA", de acordo com a reivindicação 1 , caracterizada por gerar um novo ponto focal que é o ponto extra-foveal (16). "INTRAOCULAR PROSTHESIS FOR CHANGING THE LARGER IMAGE RETINAL REGIONS" according to claim 1, characterized in that it generates a new focal point which is the extrafoveal point (16).
"PRÓTESE INTRAOCULAR PARA DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA", que é uma variante construtiva da prótese descrita nas reivindicações anteriores, sendo um dispositivo intraocular especial - ou cristalino artificial em substituição ou adição ao cristalino natural ou lente Intraocular previamente implantada, prótese esta destinada a restituir parcialmente a visão junto aos portadores de moléstias maculares de diversas origens, caracterizada por deslocar o feixe luminoso focado em maior nitidez pelas estruturas oculares em região danificada do polo posterior da retina, alterando as zonas de maior nitidez da imagem
projetada sobre a retina para regiões preservadas e determinadas previamente, que contenham número apreciável de cones e bastonetes, sendo que o cristalino (7) poderá ser substituído ou receber o acréscimo da presente prótese. "INTRAOCULAR PROSTHESIS FOR DISPLACING THE OPTICAL EXIS OF THE RETINAL", which is a constructive variant of the prosthesis described in the preceding claims, being a special intraocular device - either artificial crystalline in place of or in addition to the previously implanted Intraocular lens or prosthesis It is designed to partially restore vision to people with macular diseases of various origins, characterized by moving the focused light beam more clearly through the ocular structures in the damaged region of the posterior pole of the retina, altering the sharpest areas of the image. projected on the retina to previously determined and preserved regions that contain a considerable number of cones and rods, and the lens (7) may be replaced or added to this prosthesis.
5. "PRÓTESE INTRAOCULAR PARA DESLOCAR O EIXO ÓTICO DO OLHO SOBRE A RETINA", de acordo com a reivindicação 4, caracterizada por ser preferencialmente projetada e fabricada especificamente através de cálculo e parâmetros específicos de cada caso para gerar o desvio apropriado para a focalização na região da retina opticamente mais competente para o indivíduo, deslocando os raios luminosos A e B, incidentes sobre a córnea (2) para um ponto extra-foveal (16), sendo que a prótese (17) possui formato geométrico e índice de refração interno, cuidadosamente controlados, de forma a assegurar a correta convergência e a apropriada alteração das regiões onde se forma com maior nitidez as imagens sobre a retina.
5. "INTRAOCULAR PROSTHESIS FOR DISPLACING THE EYE OPTICAL SHAFT OVER THE RETINAL" according to claim 4, it is preferably designed and manufactured specifically by case-specific calculation and parameters to generate the appropriate deviation for focusing on the retina. optically more competent retinal region for the individual, shifting the light rays A and B, incident on the cornea (2) to an extra-foveal point (16), and the prosthesis (17) has geometric shape and internal refractive index carefully controlled to ensure correct convergence and appropriate alteration of the regions where the retinal images are most clearly formed.
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