Not Applicable
A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. § 1.14.
This technology pertains generally to bed mattresses and medical nursing equipment for people and more particularly to pressure alleviating mattresses for bed sore prevention.
A significant concern of medical care providers with patients who are bedridden for long periods of time is the probable occurrence of bedsores or skin ulcers in areas of the body that are in constant contact with the mattress. Bed sores are caused primarily by the occurrence of increased and constant pressure on the capillaries in the dermis of the skin that results in the prolonged blockage of blood flow. Contact pressures exceeding 32 mm of Hg for longer than two hours can cause pressure sores.
Bed sores are a complex problem that are influenced by the age, nutrition, hygiene, medical conditions, moisture and prolonged higher pressure on the contact points of the patient on the surfaces of the mattress of a bed. Pressure sores typically occur in the bony prominences on the back and hips of patient when they are laying on the bed. Primary areas of the body that are candidates for bedsore development include the occipital region, scapula, sacrum. ischium, ankles and heels.
Immobile, high-risk patients may often develop bed sores within 4 to 6 hours if they are not properly and regularly repositioned. The current hospital protocol is to turn the patient every two hours. However, this repositioning requirement not only disturbs and awakens sleeping patients, it may also cause maceration due to the shear forces experienced by the often fragile and sensitive skin of the patient. Repositioning can also be a liability for the nurses who have to turn the patient, who may be overweight and difficult to move.
Different systems have been developed to prevent bed sores from occurring such as the application of pressure on different areas of the body over time to stimulate blood movement or maintain blood flow. As an alternative to turning the patient every two hours, the most effective bed sore prevention approach to date is the use of silica-bead air fluidized beds that reduce the pressure points on the patient's body. Although effective, air fluidized beds are costly and such costs may not be reimbursed by insurance or government benefits until the patient experiences stage IV bedsores, which is practically the point of no return. Even private buyers who can afford the high price of an air fluidized bed may have difficulty accommodating a fluidized bed in their home as they are extremely heavy (>0.5 ton) and difficult to transport and install.
Alternating air pressure cell mattresses are intended to have similar bed sore prevention outcomes and are less costly. However, use of air pressure mattresses is not currently backed by sufficient evidence of efficacy and durability to deserve a strong recommendation. They often require noisy pumps that constantly consume power and possess numerous valves that are complex and sometimes fragile and often leak after multiple uses.
Unfortunately, approximately 2.5 million patients are affected with bed sores every year in the United States. About sixty thousand (60,000) patients die every year as a direct result of the presence of bed sores. As a consequence, bed sores produce $9.1 to $11,6 billion in treatment costs every year in the U.S. alone. Individual patient care cost is ranging from about $20,900 to $151,700. The Centers for Medicare and Medicaid Services estimated that in 2007 each pressure sore added $43,180 in costs to a hospital stay. Pressure ulcers in managed care or hospitalized patients are one of the most litigated conditions in civil lawsuits alleging medical malpractice. The average settlement of a pressure ulcer lawsuit is in the range of $250,000 with some awards topping $312 million with 87% cases favoring the plaintiffs.
Accordingly, there is a need for mattress systems that are effective at limiting the occurrence of pressure ulcers, that are durable and that are relatively inexpensive to own and maintain.
A bi-stable compliant-mechanism mattress is provided that alternates pressure points on the body of an occupant to effectively prevent bed sores. In one embodiment, the mattress passively conforms to the body of the patient in each of its two stable configurations without the need for drawing power or repositioning the patient. The mattress provides alternating pressure points as desired depending on which of the two stable configurations of the mattress is selected.
The energy needed to reconfigure the mattress from one stable configuration to the other should be minimal since a substantial amount of strain energy is stored in the deformed resilient mechanism, which would help counteract the weight of the body of the patient. In one embodiment, the mattress can be manually actuated by pulling it from one side to the next with as little effort as it would take to open and close a drawer. Alternatively, a single small motor could be automated to shift the mattress from one stable configuration to the next every two hours using minimal power. Note also that the occupant of the bed moves with the mattress as it is reconfigured from one stable configuration to the next so that the skin of the occupant does not experience harmful shearing forces as the pressure points alternate.
The mattress will optimally alternate pressure points silently without drawing power to prevent bedsores in patients that weigh up to 600 pounds so that nurses or other caregivers will not have to physically turn the patient. The mattresses will only produce a quiet clicking noise when shifted from one state to the next in contrast to the loud squeaking noises and wear caused by friction generated within the sliding joints of traditional rigid mechanisms that often require lubricants.
These mattresses also allow air to passively flow through the geometry of the mattress to prevent the occupant from perspiring. The topology of the layers with spatially hollow geometry allows natural air convection through the breathable top foam layer to enable drying of any moisture. This geometry also allows the use of forced air from a source for convective drying or air flow cooling or heating as desired.
In one embodiment, the mattresses are designed with horizontal panels that can be adjusted along their length so that the patient's feet and torso can be lowered while their knees and head are lifted like that of traditional hospital beds without modification to the mattress design.
According to one aspect of the technology, a dynamic, compliant mechanism based mattress design is provided that can reduce the occurrence of bed sores in the existing immobile and aging population and improve the lives of many patients every year.
According to another aspect of the technology, a low power, functional mattress design is provided that is substantially lower in cost compared to the cost of silica-bead air fluidized beds.
Another aspect of the technology is to provide a pressure sore limiting mattress design that is affordable while also being robust, lightweight, and transportable.
Another aspect of the technology is to provide a mattress with dynamically produced points of contact that can be readily changed while the bed is occupied eliminating the need for regular position interventions.
A further aspect of the technology is to provide a mattress with undulations with a height that is controllable by the geometry of the elements of the deformable panels.
Another aspect is to provide a compliant-mechanism platform that can be adapted for use as wheelchair cushions and also improve the comfort of airline, car, or truck passengers that have to sit in seats for extended periods of time.
Further aspects of the technology described herein will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the technology without placing limitations thereon.
The technology described herein will be more fully understood by reference to the following drawings which are for illustrative purposes only:
Referring more specifically to the drawings, for illustrative purposes, devices, systems and methods for decreasing pressure points and pressure sores in immobile and aging patients are generally shown. Several embodiments of the technology are described generally in
Turning now to
In the expanded embodiment of
Below the bottom surface of top pad 12 is an open grid of straps 16 that allows air to pass through its geometry into the holes 14 of the foam pad 12 of the mattress 10. The straps of the grid 16 are preferably oriented orthogonally to form a grid with openings to allow the flow of air through holes 14 of pad 12. In one embodiment, the intersections of the vertical and horizontal straps may be joined together. In another embodiment, the vertical and horizontal straps simply overlap.
The straps of grid 16 also provide lateral support for the elongate horizontal compliant panels below them in the dynamic mechanism layer 18. In one embodiment, corresponding straps of grid 16 are oriented and mounted to the top surface of each of the parallel horizontal compliant panels forming the dynamic mechanism layer 18 of the mattress 10.
The individual panels forming the dynamic mechanism layer 18 are mounted to a foundation layer 20 that supports the whole mattress. The foundation layer 20 may segmented or sectioned across the width as shown in
The four layers affixed together forming the mattress 10 are shown in
As shown in detail in
There are two panels 22, 24 illustrated in
The individual panels 22 have a base with triangle shaped stops 28 along its length with two rigid legs 26 spaced and mounted between the triangles with thin compliant and resilient hinges or joints 30 as seen in the detail of
The top end of each of the legs 26 is mounted to an upper layer 34 with thin compliant hinges or joints 32. The top hinges 30 and the bottom hinges 32 of the legs 26 are also resilient in one embodiment so that the legs 26 return to a starting position.
The upper layer 34 of the panel is preferably formed from top 42 and bottom 44 flexible strips separated by a layer of deformable diamond elements 38. The base of the panel with triangular shaped stops is mounted to the foundation 20 layer with bolts, glue or other type of fastener. The top strip of the upper layer 34 with the deformable diamonds 38 of each panel 22, 24 is mounted to the strips of the grid layer 16.
As seen in the side views of
The layer with diamond shaped flexures 38 of the upper layer 34, shown in
The sections of the panels that are shown in
The movement of the elements of the panels and the mechanism of deformation into one of its two stable configurations when it is loaded from above producing undulating pressure points on the patient's body are shown in the side views of
Referring now to
With the application of a load, as shown in
These deformations result in the creation of a stable undulation 48 in the panels and a pressure point on the load. These undulations 48 transfer through the foam pad 12 onto the back of the occupant to produce a grid or pattern of stable pressure points configured by the panel deformations.
The parallel panels 22 can also be moved to a second stable position by moving legs 26 of the panel from engaging one triangular stop 28 to engage an adjacent triangular stop 28 as illustrated in
The reconfiguration to the second stable position as shown in
These undulations not only occur along the length of each panel but also occur in two-dimensions along the length of the bed when the bed is loaded as shown in
Referring now to
It can also be seen that there is a lot of open space between the panels for air to pass through the straps and the holes in the foam mattress to passively flow air to and from the body of the occupant from below.
The application of a load on the mattress will cause the formation of undulations 54 from deformations in the top layer of the panels with the pivoting movements of the legs 26 as illustrated in
As shown in
A particularly attractive feature of the design is that when the patient lays on the bed, the mattress passively deforms to one of the two configurations shown in
One important feature of the mattress is that the patient can move with the mattress during transition between stable states. As a consequence, there is no relative motion and friction between the occupant and the mattress. There is also no pulling or pushing of any portion of the body of the occupant required eliminating any shear forces on the skin during transition.
Although manual actuation of the dynamic panel elements from a first configuration to a second configuration is illustrated, it will be understood that the configuration changes could be accomplished mechanically. For example, electric motors or solenoids could be used to perform the conformational changes. In one embodiment, a single linear motor could be automated to reconfigure the mattress to each of its two stable positions every hour or other designated time points. The motor would use minimal power since most of the energy necessary to lift the patient from one configuration to the next is passively stored as strain energy in the deformed compliant joints 30, 32 of the legs 26 (
The mattress 10 embodiment shown in
From the description herein, it will be appreciated that the present disclosure encompasses multiple embodiments which include, but are not limited to, the following:
wherein the plurality of panels comprises a plurality of first panels and a plurality of second panels; wherein the first panels configured with an offset that is out of phase from the second panels; and wherein the plurality of panels is configured such that the first and second panels are positioned in a sequentially alternating pattern.
wherein each panel in the plurality of panels comprises a series of trapezoid-shaped four-bar mechanisms; and wherein each bar in the four-bar mechanisms is joined to the panel by compliant joints that deform under load to produce an undulating pattern.
As used herein, the singular terms “a,” “an,” and “the” may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.”
As used herein, the term “set” refers to a collection of one or more objects. Thus, for example, a set of objects can include a single object or multiple objects.
As used herein, the terms “substantially” and “about” are used to describe and account for small variations. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation. When used in conjunction with a numerical value, the terms can refer to a range of variation of less than or equal to ±10% of that numerical value, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%. For example, “substantially” aligned can refer to a range of angular variation of less than or equal to ±10°, such as less than or equal to ±5°, less than or equal to ±4°, less than or equal to ±3°, less than or equal to ±2°, less than or equal to ±1°, less than or equal to ±0.5°, less than or equal to ±0.1°, or less than or equal to ±0.05°.
Additionally, amounts, ratios, and other numerical values may sometimes be presented herein in a range format. It is to be understood that such range format is used for convenience and brevity and should be understood flexibly to include numerical values explicitly specified as limits of a range, but also to include all individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly specified. For example, a ratio in the range of about 1 to about 200 should be understood to include the explicitly recited limits of about 1 and about 200, but also to include individual ratios such as about 2, about 3, and about 4, and sub-ranges such as about 10 to about 50, about 20 to about 100, and so forth.
Although the description herein contains many details, these should not be construed as limiting the scope of the disclosure but as merely providing illustrations of some of the presently preferred embodiments. Therefore, it will be appreciated that the scope of the disclosure fully encompasses other embodiments which may become obvious to those skilled in the art.
All structural and functional equivalents to the elements of the disclosed embodiments that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed as a “means plus function” element unless the element is expressly recited using the phrase “means for”. No claim element herein is to be construed as a “step plus function” element unless the element is expressly recited using the phrase “step for”.
This application claims priority to, and is a 35 U.S.C. § 111(a) continuation of, PCT international application number PCT/US2020/044561 filed on July 31, 2020, incorporated herein by reference in its entirety, which claims priority to, and the benefit of, U.S. provisional patent application Ser. No. 62/882,283 filed on Aug. 2, 2019, incorporated herein by reference in its entirety. Priority is claimed to each of the foregoing applications. The above-referenced PCT international application was published as PCT International Publication No. WO 2021/026013 A1 on Feb. 11, 2021, which publication is incorporated herein by reference in its entirety.
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Number | Date | Country | |
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20220175601 A1 | Jun 2022 | US |
Number | Date | Country | |
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62882283 | Aug 2019 | US |
Number | Date | Country | |
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Parent | PCT/US2020/044561 | Jul 2020 | WO |
Child | 17585271 | US |