Patent Publication Number: US-2012023669-A1

Title: Surface mounted, motorized upper body lift assembly for alleviating discomfort while lying down

Description:
RELATED APPLICATION 
     The present application claims the benefit of provisional application 61/400,647 filed on Jul. 30, 2010. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention generally concerns lifts to elevate the upper body, and in particular, motorized lifts used for the prevention or alleviation of pain, discomfort and complications to the circulatory, respiratory, gastro-intestinal, neurologic, integumentary and musculoskeletal systems of the human body caused by lying supine. 
     2. Description of the Prior Art 
     Symptoms of ailments specific to the aforementioned systems of the human body may be:
         temporary in nature, that is caused by a trauma, illness or surgical procedure, and thus require attention during a rehabilitative process   chronic in nature, that is needing to be managed consistently over the long term       

     The body response to the alteration of positions is due to gravity, which affects the respiratory, circulatory, neurologic, musculoskeletal and integumentary systems. 
     Some of the medical conditions that are affected by positioning are as follows: post surgical conditions, GERD (reflux), sleep apnea, HNT, varicose veins, hemorrhoids, compression of the spine, vertigo, stroke, and various secondary symptoms due to these medical conditions. 
     Gastroesophageal reflux disease (GERD), gastro-oesophageal reflux disease (GORD), gastric reflux disease, or acid reflux disease are chronic symptoms of mucosal damage caused by stomach acid coming up from the stomach into the esophagus. A typical symptom is heartburn. Another kind of acid reflux, which causes respiratory and laryngeal signs and symptoms, is called laryngopharyngeal reflux (LPR) or “extraesophageal reflux disease” (EERD). 
     Factors that can contribute to GERD:
         Hiatal hernia, which increases the likelihood of GERD due to mechanical and motility factors   Obesity: increasing body mass index is associated with more severe GERD. In a large series of 2000 patients with symptomatic reflux disease, it has been shown that 13% of changes in esophageal acid exposure is attributable to changes in body mass index.   Zollinger-Ellison syndrome, which can be present with increased gastric acidity due to gastrin production.   Hypercalcemia, which can increase gastrin production, leading to increased acidity.   Scleroderma and systemic sclerosis, which can feature esophageal dysmotility.   The use of medicines such as prednisolone.   Visceroptosis or Glénard syndrome, in which the stomach has sunk in the abdomen upsetting the motility and acid secretion of the stomach.       

     The height of the elevation is critical and must be at least 6 to 8 inches (15 to 20 cm) to be at least minimally effective to prevent the backflow of gastric fluids. Some practitioners use higher degrees of incline than provided by the commonly suggested 6 to 8 inches (15 to 20 cm) and claim greater success. Some innerspring mattresses do not work well when inclined and may cause back pain, making a further case for application of a fixed support surface, rather than a commercially available standard bed mattress not intended for elevation. 
     In studies on the effect of patient position on the reproducibility of cardiac output measurements, seventy percent of the sample population displayed a lower cardiac output in the 45-degree upright position than that obtained in the supine position. In studies published in the American Journal of Critical Care, and the Journal of Clinical Nursing, recorded measurements comprising the cardiac index in post-operative cardiac patients from an in-bed, supine position, are taken with the head of the bed (HOB) elevated at a minimum of 30°. 
     When a human being lies down and is horizontal, the heart and head are on the same plane. This eliminates the effects of gravity on brain circulation. Blood from the heart pumps powerfully into the head without gravity&#39;s resistance, increasing intracranial pressure, and blood returning from the brain to the heart must do so without gravity&#39;s assistance, causing a back-up of blood in the brain. Extended periods of time lying flat increased brain pressure and therefore accompanying migraines, glaucoma, Meniere&#39;s disease, and other problems associated with a pressurized, congested brain. In addition, fluid accumulation (edema) caused by this pressure within the brain tissue, can carry associated hypoxia and hypoglycemia. 
     There is a well-documented need for motorized and non-motorized lifts and cushions that perform at least one of the following functions:
         elevate the upper body to protect the user from exacerbating pain or discomfort from an existing pathology or injury, such as traumatic injury, acid reflux disease, hypotension, vertigo, a surgical procedure, etc . . .   pad or protect the user while lying supine to allow comfort or alleviate symptoms while sleeping, recuperating, resting, reading, watching TV, etc . . .   allow for a variation in angle of elevation, set and adjusted by the user on an as-needed basis, for the purpose of alleviating or preventing symptoms of an existing pathology or injury   create an ergonomically correct posture and position while lying supine, maintaining the position set by the user, without losing postural support       

     A number of products are known that have attempted to address these needs for the protection from, prevention and alleviation of symptoms. 
     Among these is the well known “hospital bed”, which is a manual or motorized spring based bed frame, topped with a standard sized mattress. The frame mechanism allows for the elevation of the upper body, lower body or both. It is common for medical professionals to prescribe the use of such a bed either after, or instead of, hospitalization for the prevention or alleviation of symptoms that are created or exacerbated by lying flat. The purchase or rental of such a bed requires the removal and replacement of the existing bed, or other sleeping/resting furniture. Alternatively, a hospital bed may be placed in another area of the home, resulting in the user sleeping/resting/working in a space that is not intended for these purposes, not private, or impeding the use of the space by others. Examples of such beds are disclosed in U.S. Pat. Nos. 5,216,769, 5,713,091, 3,310,289, 5,555,582, and 4,685,160. 
     A number of post-operative standards for elevation of the head of the bed (HOB) are known: 
     1) Cataract surgery: elevate HOB 30-45 degrees. Turn client on back or non-operative side to prevent edema of site. 
     2) Mastectomy: HOB elevated at least 30 degrees with affected arm elevated on pillow to promote lymphatic fluid return. 
     3) Naso-Gastric tubes: Elevate HOB 30 degrees to prevent aspiration. Maintain elevation for continuous feeding or 1 hour after intermittent feedings. 
     4) Abdominal Aneurysm Resection: limit HOB elevation to 45 degrees to avoid flexion of graft. 
     5) Cerebral aneurysm: Complete bed rest with HOB elevated 30 to 45 degrees to prevent pressure on aneurysm site. 
     6) Craniotomy: Not on operative site. Elevated HOB 30-45. Maintain head in midline, neutral position to facilitate venous drainage from head. 
     7) Hemorrhagic stroke: HOB elevated 30 degrees to reduce ICP and facilitate venous drainage. 
     8) Intracranial Pressure: Elevate HOB 30-45, maintain head in midline, neutral position. Avoid extreme hip and neck flexion. 
     While the hospital bed does provide for elevation of the upper body, it is neither intended, nor practicable, for home use. Neither is it possible to transport the hospital bed to allow for the use of an inclining lift in various areas, or on various surfaces, of the home. 
     There is a variety of lifts intended for the elevation of the body that are inflatable, requiring either placement of such a product between the box-spring and mattress of a standard bed configuration in order to elevate the upper body, or on top of a sleeping surface, but limited to the repositioning of the entire body. While initially providing workable solutions, these products are ineffective due to:
         the inability of most users suffering pain or discomfort caused by an injury to lift the existing mattress, hold up the mattress while placing the lift atop the box-spring or platform frame, then placing the mattress back in its original position.   properties of current mattresses whereby they are designed firmer, taller and less flexible for increased comfort above that of older mattresses, but preventing the mattress from flexing/lifting as intended by the lift.   the placement of such lifts affecting not only the user&#39;s side of the bed, but impeding on a second occupant of the same bed.   the unacceptable noise level created by any such product which utilizes an air-filled bladder operating with high noise levels while inflating, thus disturbing the sleep of both the user of any such inflatable solution and any other person in the same room, same bed, or in an adjoining room. Complaints are well documented in reference to the Mattress Genie, one such inflatable device intended to be placed between the box spring and mattress of a standard bed assembly, and the Inflatable Incline Mattress, U.S. Pat. No. 7,607,185, which inclines the upper body while declining the lower body.   Loss of postural support and position from deflation of an inflatable product due to gravitation forces and body weight. A similar effect occurs with products which rely on a foam, or other commonly used support materials, but are of insufficient density to maintain the desired, and ergonomically correct, postural support and position.       

     Also available is a variety of non-motorized, non-inflatable cushions and pillows that allow placement by the user to provide support and stability, but must be continually moved and adjusted in order to maintain the desired position. Even advanced products of this type, while potentially configurable or allowing for placement at several discrete positions, do not allow for infinite angle placements in a continuous range. 
     It might be superficially considered that existing products designed and intended for use as general-purpose ramps or lifting devices may be adapted, with the addition of padding, in order to be used to address some of the above clinical or medical needs. Such adaptation, however, would be ineffective to meet those needs, for several reasons. 
     As a rule, safe and appropriate angles of elevation for ramps carrying foot traffic are well regulated and documented by both Occupational Safety and Health Administration (OSHA) and in standardization bodies such as the National Institute of Building Sciences. Though most commonly associated with the Americans with Disabilities Act (ADA) in reference to the maximum allowable slope for a wheelchair ramp, the recommended elevation maximum of 1:12 also applies to commercial and industrial ramps carrying foot traffic, representing an angle of elevation of 4.76 degrees. In order for any such ramp to be used to incline the upper body of a human being from the supine position, given a 28″ upper body allowance, the maximum height achieved upon this maximum elevation would be only 2.32″. Even for an unoccupied mobility device, the maximum ADA compliant slope is 3:12, representing an angle of only 14%. This particular configuration is known as the industry standard “one-in-four slope” ramp as referenced extensively by Civil Engineering and Building Regulation standards bodies. If such a device is used to incline the upper body of a human being, given a 28″ upper body allowance, the head would be raised only 6.77 inches. In no case is there a commercial or industrial standard or regulation that allows for an angle of elevation providing even the minimum prescribed lift in order to decrease or prevent symptoms of the medical conditions for which the Inclinator was designed. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention, herein referred to as the Inclinator assembly, to provide an inclining lift that addresses the above issues in a unique and more effective manner than currently available lifts or cushions. In addition, the present invention addresses previously unaddressed issues pertaining to the need for portability, durability, placement on any stable surface and an acceptable level of noise while in operation. 
     This object is achieved in accordance with the present invention by an inclining upper-body lift that is formed by a static frame joined to an inclining “lift platform” in a hinged seam. A motor and linear actuator assembly is operated by an attached remote control. The lift platform has hook and loop tape attachments which secure a padded cushion to the top surface. For stability, adjustable straps are attached to the frame for attachment around the desired surface, and non-skid pads are attached to the underside of the frame which contacts that surface. For storage and portability, the assembly is set in a closed position at the lowest angle. The Inclinator may be easily moved within the home by the patient or caregiver to provide access to visitors, entertainment, activities or privacy, and rests easily on any stable surface such as a couch, chaise lounge, bed or the floor. This allows patients to maintain desired/required elevation levels while the bedroom and linens are being cleaned, as well as privacy in the bedroom when a common area in the house is noisy or not conducive to patient rest, rehabilitation or examination/procedures. 
     The entire product is encased in a durable carrying case with indexing wheels for transporting outside, to other rooms, or up/down flights of stairs without lifting the Inclinator or carrying case over either a step, curb, or other obstacle. 
     The Inclinator assembly is lightweight, portable and durable to withstand the effects of handling on traditional forms of public transportation, making it unique and ideal for use in various locations both home and away. The Inclinator assembly is intended and appropriate for use on any stable surface or piece of furniture where the user is engaged in sleeping, resting, reading, laptop computing, watching TV, eating, conversing, etc . . . for either short or long periods of time, including overnight. 
     Compared to existing products, the Inclinator assembly exhibits superior portability, flexibility, durability and user-set adjustability, thereby making the Inclinator assembly much more amenable to use in both medical and recreational applications in most types of environments. Because the Inclinator assembly is lightweight, sturdy, durable and of the size/shape allowable as check-through luggage in air travel, users are, for the first time, able to transport a solution that is less expensive, smaller, lighter and portable, where previously no solution existed. 
     In general, the Inclinator assembly provides relief and prevention of pain and discomfort experienced by persons seeking relief from such issues related to lying supine. The Inclinator assembly offers an alternative to costly or insufficient products available to persons who have a range and variety of issues with unsatisfactory existing products, or who have issues that have yet to be addressed by a product such as the Inclinator assembly. The Inclinator assembly is lightweight, portable, adjustable and does not impede on the comfort or space of a second occupant in the user&#39;s bed. The range of motion and quiet motorized operation of the Inclinator assembly provides the user with many positions as desired to either alleviate or prevent pain and discomfort caused by performing activities such as sleeping, reading, watching TV, etc . . . while lying supine. The Inclinator assembly offers relief to persons who desire, or are required to, maintain a position of upper body elevation, whether due to a medical condition, as the result of a traumatic injury, as part of a post-operative recovery/rehabilitation program or to provide comfort during sleeping, resting or recreational activities. Users of the Inclinator assembly are no longer limited to solutions that are intended and appropriate for use only in a hospital setting or in a static position within the home or rehabilitation facility. 
     The Inclinator assembly can be made available in various heights, widths, lengths and ranges of motion so as to provide a range of models that suit all body types, sizes and user activities. Even with the use of the “standard” model of the Inclinator assembly, having dimensions to accommodate the “average” person, the versatility and adjustability of the Inclinator assembly allows the user a significant degree of customization to configure the Inclinator assembly to provide each person with the most comfortable configuration that simultaneously maximizes relief and minimizes the introduction of new, or exacerbation of existing, pain, discomfort, or other physical symptoms. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top view of the Inclinator assembly in accordance with the present invention with the frame, mechanical components and platform concealed by the cushion. 
         FIG. 2  is a bottom view of the Inclinator assembly in accordance with the present invention with view of platform, upper and lower frames, linear actuator, motor, power cord and angle adjustment remote control. 
         FIG. 3  is a side view of the Inclinator assembly in accordance with the present invention with layered construction of the upper member, attachment of the linear actuator with motor and its connection to the upper and lower frames. 
         FIG. 4  is a side view of the Inclinator assembly in accordance with the present invention placed on a flat surface showing various possible angles between the upper and lower frames. 
         FIG. 5  is a top view of the Inclinator assembly in accordance with the present invention, placed on the surface of a standard, 60″×80″ common bed. 
         FIG. 6  is a side view of the Inclinator assembly in accordance with the present invention, placed on the surface of a standard, 60″×80″ common bed. 
         FIG. 7  is a side view of the Inclinator assembly in accordance with the present invention with the detail and construction of the upper frame, lower frame hinges and bumpers. 
         FIG. 8  is a 3-D view of the Inclinator assembly in accordance with the present invention with a possible hinge placement. 
         FIG. 9  is a 3-D view of the Inclinator assembly in accordance with the present invention with a possible bumper placement. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIG. 1  shows a top view of an Inclinator assembly in accordance with the invention. The Inclinator assembly has two frames, and upper frame UF and a lower frame LF, that are joined together with hinges H, which allow the angle between the upper and lower frames, UF and LF, respectively, to be selectively adjusted. 
     As explained in more detail below, the Inclinator assembly shown in  FIG. 1  is intended to be placed on a bed, couch or other surface on which a human user will be lying supine.  FIG. 2  shows a bottom view of the Inclinator assembly, i.e. the portion of the Inclinator assembly that will be adjacent to the lying surface when the Inclinator assembly is in use. As shown in the embodiment of  FIG. 2 , the bottom surface of the lower frame LF will contact the lying surface, while the top surface will house the lower connection point LCP. When in the closed position, or when configured to the least possible angle between the upper frame UF and lower frame LF, the upper frame UF fits entirely within the lower frame LF. The bottom surface of the upper frame houses the upper connection point, while the top surface has attached to it a resting platform, which in turn will support the cushion C, as is shown in  FIG. 1 . 
     The upper frame UF has a length corresponding to the length of an average adult&#39;s back from shoulders to hips, and a width corresponding to the shoulder-to-shoulder width of an average adult. Customized sizes for infants, children or non-average adults, however, are also possible. 
     As shown in  FIG. 3 , a motor M and linear actuator LA are positioned to be protected and contained within the space left empty when the angle between the upper frame UF and lower frame LF is at its minimum, whereby the bottom of the upper frame UF and the bumpers B on the lower frame LF. Also shown, is the layered construction comprised of the upper frame UF, the platform P, and the cushion C. The ends of the linear actuator are connected to the bottom of the upper frame UF at the upper connection point UCP and the top of the lower frame LF at the lower connection point LCP. 
       FIG. 4  shows how the Inclinator assembly can be selectively configured to provide different angles Θ between frames UF and LF. The top portion of  FIG. 4  shows the frames UF and LF in a relatively open position, representing a reclining position for a human user. As the angle Θ decreases, as shown in the middle and bottom portions of  FIG. 4 , the configuration approximates a flat surface on which a human user would lie supine. 
       FIG. 5  shows a top view of the Inclinator assembly while placed on a standard bed which accommodates 2 users. Placed on one half of the bed, close to the head or headboard H, the Inclinator Lift Assembly allows for use by one user, while the half of the bed occupied by the second user is undisturbed.  FIG. 6  shows a side view of the preferred placement of the Inclinator assembly. 
       FIG. 7  shows the frames UF and LF of the Inclinator assembly a detail of the upper frame UF and lower frame LF when the angle Θ between them minimized such that the bottom of the upper frame UF contacts the top end of the bumper B which is permanently affixed to the top surface of the lower frame LF.  FIG. 8  shows a 3-D view of the frame-only portion of the Inclinator assembly to provide clarity and detail of the components and assemblage of the infrastructure of the Inclinator assembly.  FIG. 9  shows an additional 3-D view with a detail of the 2 bumpers B on which the upper frame UF rests when the angle Θ between the upper frame UF and lower frame LF is at its minimum. 
     The frames, bumpers and hinges can be constructed of aluminum square tubing having a width/depth in a range between approximately 0.35″ and 2.35″, and length in a range between 19″ and 48″, in order to accommodate infants, children and adults. The platform P can be constructed of a hard plastic material, having a length and width equal to the size of the upper frame UF of the Inclinator assembly, with a depth in a range from 0.0125″ to 0.625″ depending on the overall size of the Inclinator assembly. 
     The cushion C may be constructed of a flat soft core, having a length and width equal to the size of the upper frame UF of the Inclinator assembly, with a depth in a range from 0.5″ to 6.0″ according to user preference and requirements. The core material of the cushion may be foam, gel, batting, or any suitable material that provides sufficient and desirable degree of support, padding and protection from the platform P. A waterproof covering will protect the soft core from soil and damage, allowing for thorough and easy cleanup to maintain hygiene and protect the user from possible infection. The covering may be held in place on the core material simply by a custom-fit, with the covering being provided with a slip or other type of opening in order to insert and remove the core material. Alternatively, the cover may be provided with a zipper, snaps, or other releasable closure at a location that does not come into contact, and thus cause discomfort to, a user of the Inclinator assembly. Another alternative is a vinyl cover. 
     The dimensions of the Inclinator assembly disclosed herein are directly related to its clinical effectiveness. 
     a. The motorized linear actuator permits lifting from lying with a full load already on the ramp 
     b. The minimum lift (from horizontal) of the Inclinator assembly equals the maximum recommended lift for GERD patients, who require the lowest angle of elevation among patients whose conditions are addressed by the Inclinator assembly 
     c. The length of the platform is 28″ to accommodate average to above-average human upper body 
     d. The width of the platform is 30″ to prevent impinging on a second user in a standard 60″×80″ bed 
     The above-described structural dimensions and design achieve a number of important features of the Inclinator assembly that allow the Inclinator assembly described herein to satisfy the earlier-described clinical and medical needs. The Inclinator assembly can achieve a highest angle of elevation that is approximately 85°. The motorized linear actuator can produce a lift of up to 450 pounds, thereby allowing the Inclinator assembly to be operated to move a person lying on the assembly substantially flat to any angle of elevation, up to the maximum angle of elevation. The overall weight of the Inclinator assembly is approximately 25 pounds, and is preferably under 20 pounds, making the assembly easily able to be carried by most persons, thereby making the assembly readily portable. 
     Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution of the art.