Noninvasive system and method for mitigating sleep-position related eye loads

Abstract

When sleeping or resting in non-supine positions, reaction forces are distributed over areas of the face and head in contact with a surface, such as a mattress or arm, following a load path through at least one eye. Aspects of the disclosed system and method provide rigid to semi-rigid load bearing facial support configured to absorb and or distribute the reaction force exerted by a surface during non-supine rest or sleep to areas of padding best suited to absorb and or distribute said force such that the load path bypasses the eye, eye orbit, and or its surrounding anatomy to prevent or mitigate deformation, stress, strain, and or damage to the eye.

Claims

1. A protective eye shield, designed solely to provide a load path that prevents external forces from deforming a wearer's eyes during sleep, comprising: a front portion and a back stabilizing portion; said front portion comprising: a load transferring support structure designed solely to support a load of the wearer's head and distribute both direct and indirect force vectors away from the wearer's eyes, eye orbits, and surrounding soft tissue when the wearer is in a non-supine sleep position; said load transferring support structure designed solely to prevent stress, strain or deformation of the wearer's eyes; said load transferring support structure constructed as a contoured barrier including one of plastic, acrylic, metal, or a composite; said load transferring support structure providing at least partial coverage of the wearer's face from the forehead to the nasal spine, without extending below the wearer's nasal spine; said load transferring support structure comprising an outward projection designed solely to create a clearance between the wearer's eyes and a sleeping surface to avoid direct contact of forces with the wearer's eyes, eye orbits, and surrounding soft tissues; said contoured barrier further comprising padding portions configured to conform to and contact the wearer's forehead boss, temporal regions, and nasal bone when the eye shield is worn in the non-supine sleep position; and said back stabilizing portion comprising a component designed solely to secure said front portion to the wearer's face, said securing component constructed of one of elastic fabric, rayon, nylon, or rubber; wherein when the eye shield is worn, external forces bypass the wearer's eye area due to said clearance between the wearer's eyes and the sleeping surface, and are redirected to the wearer's forehead boss, temporal regions, and nasal bone via said padding portions, wherein said padding portions are designed solely to absorb and distribute said forces.

Description

DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows the support-to-surface interface with respect to the surface plane when the wearer is sleeping or resting;

(2) FIG. 2 shows a partially rotated view of the system illustrating the load transferring support structure;

(3) FIG. 3 shows an overview of the system illustrating the load transferring support structure;

(4) FIG. 4 shows a cross-section of the system at the eye plane when resting on a surface;

(5) FIG. 5 shows an overview of the system when resting on a surface; and

(6) FIG. 6 shows the support system.

DETAILED DESCRIPTION OF THE EMBODIMENTS

(7) The embodiments disclosed herein are directed to a non-invasive system and method for structural load-transfer that allows normal forces to bypass the eyes. The system includes a device that may be worn during sleep so that a load, such as the weight of the head, is transferred though a load path that bypasses eye. Thus, the present system prevents loads that arise when sleeping from causing deformation of the eye and/or damage to the eye due to deformation, stress, strain and/or degradation of the eye(s)' ability to regulate intraocular pressure (IOP) such as would result from elevation of the trabecular meshwork outflow resistance, elevation of episcleral venous pressure, elevation of orbital venous pressure and/or enlargement of the choroid. The embodiments may be utilized for long-term use, such as during sleep for durations of 8 hours or more.

(8) The embodiments disclosed herein are also directed to a non-invasive system and method for mitigating deformation and eye damage, having particular utility for those who experience position shifting of prescription orthokeratology (ortho-K) contact lenses due to deformation of the eye while sleeping.

(9) The embodiments disclosed herein also provides a non-invasive system and method for assisting those diagnosed with glaucoma and/or degenerative eye diseases marked by conditions that result in permanent optic nerve damage, those which family histories of glaucoma who display evidence of contributory conditions such as thin retinal walls, optic nerve cupping, etc. By preventing external forces from deforming the eye during sleep, load transfer paths mitigate load-induced deformation of the eye, which in-turn mitigates stress and strain of cells that form the load-bearing portions of the eye walls, as well as the potential for increased outflow resistance of the trabecular meshwork.

(10) As will be understood by one of ordinary skill, the present system and method may be utilized with traditional therapies for treating a variety of degenerative and non-degenerative eye ailments.

(11) FIG. 1 shows a wearer of the system disclosed herein. The illustrated system includes a device D having a front portion 1 and a back stabilizing portion 2. The support-to-surface interface S with respect to the surface plane S, as shown in FIG. 1, is the surface against which the wearer of device D is sleeping or resting. The surface S may refer to any resting or sleeping surface such as a mattress or pillow. The weight of the head is supported by the portion of the face resting on the mattress, and this portion of the face bears the resulting reaction force N. For the purposes of this disclosure, the reaction force N on the face is equal but in opposite direction to the weight of the head. The surface S exerts a force equal and opposite in direction against the wearer's face proportional to the force of the wearer against the surface. Device D provides an alternative load path to absorb and or distribute such reaction forces N that would otherwise be exerted against the wearer's face by way of a path including the wearer's eye during sleep or rest. In use, device D of the system ensures adequate ventilation to the cornea and mitigates or prevents stress, strain, and or deformation of the eye.

(12) As shown in FIG. 2, the front portion 1 of device D includes a load transferring support structure 1a configured to fit snugly around the front of the wearer's face as provided by padding 1b, side padding 1c and 1c, forehead padding 1d, and nose bridge padding 1e. The load transferring support structure 1a (also referred to herein as support structure 1a) may be constructed as a contoured, translucent barrier made of e.g., plastic, acrylic, metals, composite, as selected to support the maximum loads likely to be encountered during sleep or rest without deforming. Load transferring support structure 1a may also be a contoured, translucent barrier that provides continuous coverage from the longitude of the nasal spine to the forehead boss or frontal bone. Alternatively, support structure 1a may be a contoured, translucent barrier that provides partial coverage of the wearer's anatomical features. By serving as load-bearing structure, support structure 1a allows for external loads to bypass the eye by distributing reaction forces N and loads to padded areas 1b through 1e corresponding to bony facial structure such as the nasal bone, zygomatic bone, and forehead, while allowing ventilation of the eye area and preventing contact between the eye and the surface. Support structure 1a provides sufficient outward projection to accommodate the nasal bone and structure of the nose, to which additional padding may be applied to avoid pressure points.

(13) Support structure 1a may also be configured of a meshwork structure made from wire, plastic, a fiber matrix or the like such that the structure is sufficiently rigid to bear loads described previously. The support structure 1a may be configured to provide continuous coverage from the longitude of the nasal spine to the forehead boss or frontal bone. Alternatively, support structure 1a may also be configured to provide partial coverage of anatomical features and serve as a load-bearing structure thereby enabling external loads to bypass the eye and be distributed over the nasal bone, zygomatic bone, forehead, while also allowing optimal ventilation of the eye area. Additionally, load transferring support structure 1a may include a translucent portion for visibility. The translucent portion of support structure 1a may be tinted and or may have a prescription applied in the manner of a conventional eye glass lens. The device D is intended to be worn for long periods of time, typically 8 hours or more and when muscles are relaxed. It is under these circumstances when maximum force loads are likely to be encountered.

(14) The device D includes a back stabilizing component portion 2, as shown in FIG. 2 and FIG. 3. Stabilizing component 2 is utilized for securing the front portion 1 such that the wearer may securely retain the device D on their face. Support structure 1a may include one or more apertures, such as apertures 2a and 2a, through which one or more stabilizing components 2 may be secured. Component 2 may be constructed so as to be adjusted 2b for individual comfort. The component 2 may be constructed of e.g., elastic fabric, rayon, nylon, rubber or other tightening or adjustable material. In another embodiment, the stabilizing component of 2 may include a helmet or cap attached to support structure 1a. The ability to properly fit the device D on the wearer's face as secured by stabilizing component 2 in addition to padding 1b through 1e is a feature of the disclosed embodiments since the wearer may roll, toss or turn, or else be positioned on their side, face down, or with an object e.g., an arm or pillow resting on or against the support-to-surface interface plane S.

(15) Front portion 1 includes an upper padded portion 1b that conforms to the upper surface of front portion 1 and the wearer's face. Front portion 1 also includes side padded portions 1c and 1c configured to be positioned on each side of the wearer's face. Front portion 1 also includes an interior position having a padded portion 1d as shown in FIG. 2 to absorb loads channeled to the system's center and approximately corresponding to the rigid underlying anatomical structure of the glabellar region of frontal bone. Front portion 1 also includes a medially padded portion 1e that is configured to fit the wearer's face snugly in the area of the nose bridge. In use, the device D is placed on the wearer's face thereby providing a load path which bypasses the eye, eye orbit, and its surrounding anatomy during sleep or rest in non-supine positions. Front portion 1 is constructed of material sufficiently rigid to bear loads, such as the weight of the head by providing a complete or partial load transferring support structure 1a to the surface S interposed with padding 1b through 1e configured to fit snugly on the wearer and absorb and distribute loads exerted by the support-to-surface interface S. The surface S may include but is not limited to a mattress surface, a pillow or the like. The device D absorbs and distributes the reaction force exerted by surface S such that of those loads bypasses the eye. The front portion 1 may distribute such loads across e.g., the forehead, cheekbones, temples, nasal bridge.

(16) Additionally, the front portion 1 may distribute the load over load-bearing structures 1a and the padding portions 1b through 1e. Padding portions 1b through 1e are constructed to be interposed between support structure 1a and the wearer and made of deformable or semi-deformable material including but not limited to low to high density foam, semi-solids, fabric, synthetic fiber, gel and rubber. Padding portions 1b through 1e are configured to absorb and distribute forces across the surface area of the support 1 such that the load path bypasses the eye. Additionally, padding portions 1b through 1e are interposed between the support 1a and the wearer's facial structure, e.g., across the forehead and or spanning the nasal bridge and cheek bones, in order to distribute and absorb loads such that they bypass the eye area and are channeled to anatomical features better suited to bear loads, e.g., with bony structure, than soft-tissues and facial muscle, which may otherwise lead to deformation of the eye and or degradation of the eye(s)' ability to regulate IOP. Impairment of the eye(s)' ability to regulate IOP may result from independent or combined trabecular meshwork outflow resistance increase, episcleral venous pressure increase, orbital venous pressure increase and choroidal expansion.

(17) Applying padding such as padding 1d corresponding in position to the forehead boss or glabella regions projects the support-to-surface interface plane S towards the surface plane S, and directs external forces to anatomical structure particularly suitable to bear loads without creating uncomfortable pressure points. These anatomical structures include but are not limited to the forehead, temples, cheekbones, and chin. In a preferred embodiment, padding 1c is interposed between support structure 1a and the wearer's head e.g., at the parietal and temporal bones, extending downwards towards the wearer's jaw e.g., zygomatic bone, to distribute and absorb direct or indirect loads such that they bypass the eye and provide optimal stability during movement or rotation by providing a snug fit to the wearer's face.

(18) As further shown in FIG. 2 through FIG. 5, front portion 1 creates clearance C between the eye(s) and the surface S. In FIG. 2, H is the anterior plane of the head including the face and vertical plane of the nose bridge B. E is the axial eye plane running from ear to ear horizontally through the eye area as shown in relation on the system to illustrate the amount of clearance C between the eye and surface S created by wearing the system. At the intersection of the head H and eye E planes the clearance is zero (C.sub.0) because this represents the surface of the eye. Front portion 1 includes a load transferring support structure 1a serving as a barrier to the surface S yielding clearance C between the eye and the support-to-surface interface of S as large as C.sub.max (i.e., the maximum clearance). Clearance C may vary depending on position, degree of force, rotation, depression of padding, and other factors.

(19) As shown in FIG. 4 and FIG. 5, force distribution F across the device D follows a load path along the front portion 1 by providing a load transferring support structure 1a to absorb forces directly and indirectly with padding 1b through 1e interposed between support structure 1a and the wearer. Forces are thus directed to structure particularly suitable to bear loads e.g., forehead by padding portions 1b and 1d, nasal bridge by padding 1e, and jaw or zygomatic bone by padding portions 1c and 1c. Reaction forces N exerted by the surface S bypass the eye area by clearance C. The force distribution F across the device D is further characterized by direct forces F.sub.dir including vertical forces exerted against the front portion 1 by the surface S in addition to indirect forces F.sub.ind due to moment(s) introduced by the angle of rotation along the surface plane S. Forces are balanced according to the scheme of support structure 1a interposed with padding 1b through 1e to provide a load path which bypasses the eye by clearance C to avoid direct contact as well as create alternative force distribution along F to mitigate or prevent stress, strain, deformation, and pressure against soft tissue or facial muscle.

(20) Additionally, support structure 1a and padding portions 1b through 1e may be customized or individualized by obtaining an impression of the wearer's face. Memory foam, rigidized foam castings, and the like may be utilized to provide the customization feature. As will be understood to one of ordinary skill the load transferring support structure 1a and the padding portions 1b through 1e are of a dimension and configuration so as to provide a balance between rigidity, flexibility, elasticity, softness, density, weight such that it provides the optimal load bearing structure commensurate with the scope and objectives of the disclosed embodiments.

(21) Additionally, front portion 1, as shown in FIG. 2 through FIG. 5, is constructed so as to absorb and distribute loads associated with pressure on the eye. In one manner, front portion 1 covers the eye area by clearance C while padded sections 1b through 1e act to project load bearing anatomical structures particularly suited to bear loads so as to intercept reaction forces N such that they bypass the eye and are thus distributed or absorbed by the device D.

(22) In another manner, front portion 1 is also configured to absorb and distribute both direct F.sub.dir and indirect F.sub.ind force vectors associated with sustained physiological deformation, stress and strain on the eye, eye orbit, and its surrounding anatomy that contribute to degenerative and non-degenerative eye disease such as glaucoma by distributing and absorbing reaction forces. N. These diseases include but are not limited to impairment of the eye's ability to regulate IOP as associated with sustained elevation of episcleral venous pressure, orbital venous pressure, trabecular meshwork outflow resistance, and choroidal expansion. In a preferred embodiment, device D is constructed so as to alleviate sustained physiological deformation, stress and strain on the eye by channeling forces to anatomical structures particularly suitable to bear loads by distributing direct forces F.sub.dir and indirect forces F.sub.ind along the support structure 1a to be absorbed by padding 1b through 1e in addition to creating clearance C to avoid direct contact. The clearance C margin and alternative load path with force distribution F ensure that stress is not exerted on soft tissue or anatomy surrounding the eye since forces are directed to anatomical structure particularly suitable to bear loads by way of padding e.g., forehead by padding portions 1b and 1d, nasal bridge by padding 1e, and jaw and zygomatic bone by padding portions 1c and 1c.

(23) The system disclosed herein also provides for a force distribution support 3 as shown in FIG. 6. The force distribution support 3 may be utilized alone or in combination with device D to provide force distribution commensurate with the scope of the embodiments discussed above. As shown in FIG. 6, the upwards facing profile of distribution support 3 is contoured such that it provides a raised portion 3a to support the forehead, a concave portion 3b yielding a clearance C along the eye plane E, a second raised portion 3c to support the cheek and chin, and a second concave portion 3d to meet and support the neck. The downwards facing profile of support 3 is flat to rest squarely and securely on the surface plane S, yielding a support-to-surface interface S area capable of further distributing and absorbing the reaction force N. Portions 3a through 3d may be contiguous and gradually sloping, thereby allowing the force distribution support 3 to provide a uniform load distribution over the selected regions of the face and neck of the wearer and away from the eye.

(24) As shown in FIG. 6, force distribution support 3 supports the forehead, cheek, chin, and neck regions at 3a through 3d, respectively. The depression of 3b yields a clearance C between the eye and the support-to-surface interface of S as large as C.sub.max (i.e., the maximum clearance). Clearance C may vary depending on position, degree of force, rotation, depression of padding, and other factors. Concave portion 3b is further constructed such that the eyes of the wearer receive no contact in non-supine sleep or rest positions, such as in a slide-sleeping or face down position, by a maximum level of clearance C.sub.max. In this manner, force distribution support 3 may be used in conjunction with device D to provide optimal load bearing support bypassing the eyes, commensurate with the objectives described herein. As will be understood to one of ordinary skill, support 3 is constructed so as to provide a balance between rigidity, flexibility, elasticity, softness, density, weight such that it provides the optimal load dispersal and can be constructed of materials that provide a balance between cushioning and load distribution commensurate with the scope of the embodiments disclosed herein. Such materials may include but are not limited to foams, cotton, polyesters and hypo-allergenic materials.

(25) In a preferred embodiment, support 3 is constructed of a continuous hypo-allergenic foam pillow sufficiently rigid to comfortably support the forehead at 3a, cheek bone and chin at 3c, and neck at 3d while providing maximum clearance C.sub.max along the eye plane E at 3b. Raised portions 3a and 3b are configured to protrude in correspondence with bony anatomical structure particularly suitable to bear loads, e.g., at the forehead boss and glabellar regions corresponding to 3a and at the zymoatic bone spanning portions of the cheek and chin corresponding to 3b.

(26) Reaction force N exerted through the upwards facing profile of support 3 yields a unique force distribution profile selectively channeled through the raised portions of 3a and 3c and not through the eye plane E at the depression of 3b. As shown in FIG. 6, the force normal bypasses the eye plane E yielding a maximum clearance C.sub.max where the eye, eye orbit, and surrounding anatomy would otherwise be in contact with the surface S. Instead, forces are channeled to the raised portions 3a and 3c where the reaction force exerted by 3a against the user's forehead is F.sub.dirA and the reaction force exerted by 3c against the user's check and chin is F.sub.dirB.