Patent Grant
7240384
Not Applicable.
Not Applicable.
1. Field of the Invention
This invention pertains to cushions used to support patients in bed.
2. Description of Related Art including Information Disclosed under 37 CFR 1.97 and 37 CFR 1.98.
“Immobile” patients are those who are confined to bed. Such immobile patients do not have a tendency to change their position in bed voluntarily. It is therefore desirable for caregivers to manually turn patients in bed on a prescribed schedule (often every two hours) to avoid complications such as pressure ulcers, pneumonia and other related infections that arise from excessive time in a supine position. Published guidelines recommend turning patients 30° when in the lateral inclined position.
Bariatric patients are those patients who are morbidly obese, that is, have a Body Mass Index of 40 kg/m2 or are 45.5 kg (100 pounds) or more overweight The immobile bariatric patient population has special needs for a lateral turning and positioning device due to the tendency of the positioning devices to migrate away or “pop out” from behind the patient while in use. There also is a tendency by the bariatric patient to crush positioning devices due to the imposed heavy weight. Immobile bariatric patients also present challenges to caregivers with the tasks of frequent rotation or other manipulation of such patients.
A number of cushion devices have been described to aid in the maintenance of patients in desired positions on a bed.
U.S. Pat. No. 3,389,411 discloses a foam wedge with a cover having a trapezoidal opening on the bottom which exposes the foam. The foam has highly frictional characteristics which retard slippage of the wedge on the bed.
U.S. Pat. No. 3,811,140 discloses a body support device comprising two wedges which are attached by belts and are oriented along the length of the bed. This device is intended for maintaining alignment while in the supine position and relieving pressure from the bony prominences of the spine.
U.S. Pat. No. 3,842,977 discloses a pillow-enclosing casing in which a pillow, particularly a foam pillow, is rolled and reduced in volume and then inserted into a tubular casing.
U.S. Pat. No. 3,938,205 discloses a body positioner which extends from the neck to the thigh for use on an examination table. The positioner is made of elongated resilient deformable polyurethane foam and has three major surfaces and three minor surfaces.
U.S. Pat. No. 4,045,204 discloses a compressed foam article which is compressed and packaged by enclosure in a substantially air-tight sack and a vacuum is drawn in the sack.
U.S. Pat. No. 4,214,326 discloses a body positioner and protection apparatus similar to the above disclosure which also has a removable center portion for covering the side frame to protect the patient.
U.S. Pat. No. 4,233,700 discloses a similar body positioner with cut outs for providing ventilation to portions of the patient's body.
U.S. Pat. No. 4,711,067 discloses a method packaging a mattress to a small size, in which the mattress is squeezed by compression means which drive the air from mattress and is then placed in a closed container or case.
U.S. Pat. No. 5,095,569 discloses a cover sheet secured by hook and loop type fasteners on straps to the upper surface of a wedge shaped polyurethane foam pillow with primary and secondary air passageways to facilitate breathing by users.
U.S. Pat. No. 5,359,739 discloses a patient repositioning and position maintenance device with cushioned cylinders which maintain the patient in position. The cylinders are retained on a rectangular fabric sheet with two pockets for the cylinders. A triangular knee wedge is attached to the fabric sheet by hook and loop fasteners.
U.S. Pat. No. 5,878,551 discloses a method of packaging a foam pet industry product which involves placing the foam product inside a plastic bag, reducing the pressure to remove air from the bag, and sealing the bag.
U.S. Pat. No. 6,154,900 discloses a patient turning device which uses air pressure in bladders to laterally rotate a patient. The patient is supported from head to calf.
U.S. Pat. No. 6,292,964 discloses an inclined support pillow formed of two layers with additional hemi-cylindrical cushions which are attached by hook and loop fasteners.
U.S. Pat. No. 6,360,387 discloses a fertility cushion with a convex front having a removable cover attached by hook and loop strips. The multiple-foam construction of the cushion is disclosed.
U.S. Pat. No. 6,578,218 discloses a leg spacer pillow comprising two hinged portions with a butterfly shape and hook and loop fasteners to hold the pillow in the closed position.
U.S. Pat. No. 6,634,045, incorporated herein by reference, discloses a heel elevator support.
None of the discovered prior art disclosures provide the advantages of embodiments of the present invention. They provide a cushion constructed of microbiologically-resistant foam with a relatively strong and resilient core foam and a relatively yielding surface foam. Embodiments of the cushions have a general triangular wedge shape with the front and back surfaces convex. Embodiments have covers with friction and shear reducing properties on the patient sides and on the caregiver sides and nonslip properties on the bottoms, and with straps on the care provider sides to aid in manipulating the cushions.
This invention is a patient positioning aid comprising, a generally wedge-shaped multisided polymeric foam cushion, the cushion having the general shape of a solid with a polygonal, hemispheric or circular cross section, a length which approximates the length of a patient's torso, a height adequate to prevent the rolling of a patient, and two ends, the cushion having a caregivers panel, a patient panel having a convex shape in cross-section, and a bottom panel, the cushion comprised of a strong, resilient, high modulus of elasticity, inner core foam, an outer layer foam of soft, compliant, viscoelastic foam, and a cover comprised of a moisture proof low friction and shear reducing material, the cover having a high friction surface on the bottom panel.
Embodiments of this invention are patient positioning aids comprising, a generally wedge-shaped multisided foam cushion with a cover. Embodiments of the cushion have a polygonal, hemispheric, or circular cross section, a cushion length which approximates the length of a patient's torso, and two ends. Embodiments of the cushion have a caregiver panel, a patient panel with a convex shape in cross-section, and a bottom panel which is generally straight in cross section. Embodiments of the cushions are comprised of a strong, resilient, high modulus, inner core polyurethane or copolymer foam coated with an outer layer of soft compliant viscoelastic foam. The preferred outer layer foam is a viscoelastic or low IFD foam. Embodiments of the cushions have a cover comprised of a moisture proof low friction and shear reducing fabric material covering the upper surfaces of a cushion on the patient and caregiver contact sides. A high friction slip resistant surface is on the bottom panel. In some embodiments manipulation devices on the caregiver sides facilitate maneuvering of the aid in positioning it against the patient.
One objective of embodiments of this invention is to provide an effective aid for positioning immobile patients in a laterally elevated position.
Another objective of embodiments of this invention is to aid in positioning immobile bariatric patients in a laterally elevated position.
Another objective of embodiments of this invention is to provide a positioning aid which resists crushing by a laterally elevated patient.
Another objective of embodiments of this invention is to provide a patient positioning aid with a soft outer layer to prevent injury to a patient's skin.
Another objective of embodiments of this invention is to provide a patient positioning aid with a cushion comprising antimicrobials.
Another objective of embodiments of this invention is to provide a positioning aid with a waterproof cover which may be removed or wiped down for cleaning.
Another objective of embodiments of this invention is to provide a positioning aid with a slip-resistant coating or fabric on the bottom side of the cover which resists movement of the positioning aid on the surface of the bed so the patient maintains proper elevation and positioning throughout the full turning schedule.
Another objective of embodiments of this invention is to provide a positioning aid with manipulation devices to assist the caregiver in the proper orienting of the positioning aid under the patient.
A final objective of embodiments of this invention is to provide a positioning aid which may be manufactured easily and inexpensively without adverse effects on the environment.
“Immobile” patients are those who are confined to bed. Such immobile patients do not have a tendency to change their position in bed voluntarily. It is therefore desirable for caregivers to manually turn patients in bed on a prescribed schedule (often every two hours) to avoid complications such as pressure ulcers, pneumonia and other related infections that arise from excessive time in a supine position. Published guidelines recommend turning patients 30° when in the lateral inclined position.
Two key benefits flow from the regular rotation of immobile patients:
1. Pressure points are shifted from one lateral side of the body to another, which promotes good circulation and avoids damage to the skin over bony prominences, such as the sacrum, coccyx, and trochanter, resulting in pressure ulcers.
2. Fluid is not permitted to settle and stagnate in the lungs, which can lead to pulmonary complications such as pneumonia.
Bariatric patients are those patients who are morbidly obese, that is, have a Body Mass Index of 40 kg/m2 or are 45.5 kg (100 pounds) or more overweight. The immobile bariatric patient population has special needs for a lateral turning and positioning device due to the tendency of the patients to crush positioning devices or pillows due to the heavy weight imposed on positioning devices or pillows. Immobile bariatric patients also present challenges to caregivers with the tasks of frequent rotation, repositioning, or other manipulation of such patients. In fact, manipulation and assistance of bariatric patients is a frequent source of occupational injuries for caregivers.
Rolled pillows or blankets are the most common positioning devices conventionally used. These improvisations are placed or shoved under the side of the body the caregiver wishes to elevate. Unfortunately, these pillows or blankets tend to compress under the weight of the immobile patient, or tend to slide away from the patient's body. In either case the desired effect in maintaining the patient in the desired position is lost. The patient then assumes the supine back-lying position with the risk of pressure ulcers and fluid in the lungs. All of the deficiencies of using rolled pillows or blankets as positional aids are magnified in the case of bariatric patients
In the first and second embodiments of the positioning aid the angle formed by the bottom panel 15 and 215 and the patient's panel 13 and 215 is approximately 30°, α on
Visible in
Since the patient side of the tenth embodiment is flat rather than convex, the tenth embodiment aid is more apt to be displaced by the patient than the other embodiments. This disadvantage, however, is countered by the relative ease and economy of manufacture, and associated reduction in cost, of the tenth embodiment.
In the disclosed embodiments, the cushion is comprised of a relatively high resilience and relatively firmer internal core foam. In a preferred embodiment the cushion material is hypo-allegenic and latex-free. The inner core resists compression by the patient's weight. An outer foam layer which is relatively soft and viscoelastic is attached to the patient side of the inner foam. The outer layer is soft and yielding, and does not injure the patient's skin. The outer layer is attached to the inner core by adhesive, preferably polyurethane adhesive.
In the disclosed embodiments, the inner core foam may be comprised of any suitable foam material, such as polyurethane foam, copolymer foam, or latex foam. A preferred foam is polyurethane foam. The preferred foam is available in several variations, such a 1A high resiliency and HD high density which has very high density. Latex foam is less preferred because of the chance of incurring allergic reactions to the foam. The foam density range is from 1.4 to 4.6 pounds per cubic foot. The firmness of foam is measured by indention force deflection (IFD). A preferred foam has an IFD of 30 to 80.
The outer layer foam may be comprised of the same materials as the inner core foam except that it is of lower density and lower resilience. The outer layer foam is a pressure reducing grade of foam that is not less than 1.2 pounds per cubic foot in density and has a maximum of 30 IFD. Preferably the outer layer foam is viscoelastic, that is, has appreciable and conjoint viscous and elastic properties. Viscoelastic foam tends to be more dense than other polyurethane foam.
In a preferred foam an antimicrobial additive is included in the foam. One preferred antimicrobial is VINYZENE antimicrobial additive for plastics, a trademark for solutions of 10,10′-oxybisphenoxarsine owned by Rohm and Hans, Philadelphia, Pa.
The cover of the first through eighth and tenth embodiments is removable for cleaning. A preferred material is 70 denier nylon taffeta manufactured by Stafford Textiles of Toronto, Ontario, Canada. Other suitable fabric materials may be used, such vinyl and rayon may be used. The fabric material is coated, preferably on the bottom, with a suitable water-resistant polymer such as polyurethane, butyl rubber, vinyl, latex, and thermoplastic urethane. A preferred coating includes polycast coat laminate and STAPH CHECK medical grade vinyl. STAPH CHECK is a trademark owned by Herculite Products of Emigsville, Pa.
In the first through eighth and tenth embodiments, the cover has an opening through which the cushion is inserted. The cover may be removed for cleaning. In some embodiments the opening extends along the intersection between the sides of the cover from one end to the other. In another embodiment, the opening extends around the intersection between the panels and one end panel, allowing the end panel to be swung open as a flap. In the first through eighth embodiments the opening is closed by suitable fasteners which securely hold the opening closed when desired yet do not injure the skin of the patient. A preferred fastener is a zipper. Other suitable fasteners include hood and loop fabric fasteners, buttons and snaps. The fastener may be covered by a flap of fabric running along the opening.
The first through eighth and tenth embodiments cover panels are attached to each other by sewing along the seams. The first through eighth and tenth embodiments positioning aid is constructed by first shaping the cushion, assembling the cover by sewing together the cover panels, inserting the cushion into the cover through the opening defined by the fastener, and closing the opening using the fastener. Other suitable methods for attaching the panels together, such as radio frequency welding, heat sealing, or gluing with permanent adhesives, such as epoxy adhesives, may be used.
The handles in the first through sixth and eighth through tenth embodiment covers are in the form of straps which extend from the top to the bottom of the caregiver panel. Any other suitable handles which allow the caregiver a purchase on the positioning aid when manipulating the positioning aid, and which is soft and yielding, and therefore unlikely to injure the skin of the patient, may be used. For example, a strap which extends from one end panel to the other end panel on the caregiver's side may be used. The handles preferably are of a color distinct from that of the rest of the positioning aid to assist the caregiver in orienting the aid for use.
In the embodiments, the interior side of the cover, that is, the side facing the cushion, preferably is treated to make it waterproof, for example, coated with polyurethane or butyl rubber.
In the embodiments, the upper sides of the cover, that is, the side to which the patient is exposed, are made of friction and shear reducing fabrics, such as nylon or polyurethane fabrics. The use of friction and shear reducing fabrics alleviates and minimizes trauma to the skin of the patient.
In the embodiments, a variety of materials may be used as the non-slip coating applied to the side of the bottom panel which makes contact with the sheet and mattress of the patient positioning aid cover. Any durable suitable material which provides a slip-resistant or non-slip effect which prevents and retards the sliding of the positioning aid on the surface of the bedsheet may be used. A preferred material is the no-slip material sold under the trademark SOFTGRIP BLUE # 2915C coating which is available from Ventrex, Inc., Great Falls, Va. Other suitable materials include ANTISLIP GRIP TAPES, tapes having an antislip surface and self-adhesive backing and are available from ALLTAPES.COM, Chatsworth, Calif. Suitable antislip materials include 3M SAFETY WALK trademark general purpose tapes & treads 600 Series products available from Martinson-Nicholls, Inc., Willoughby, Ohio. Other suitable non-slip materials include NAMCO vinyl backing mats and nitrile rubber gripper backing available from North American Mat Company, Holleandale, Minn.
Although the ninth embodiment positioning aid has been described using the first embodiment positioning aid structure with a disposable cover, the cover of the ninth embodiment may be used with the structure of any of the embodiments.
It is desirable that embodiments of the positioning aid be capable of reduction in volume during shipping, storage, and generally when not in use. The relatively large volume of the positioning aids places severe burdens on the storage facilities of hospitals and nursing facilities when the aids are stored. This burden is especially high with disposable ninth embodiment positioning aids which have high inventory requirements.
The volume problem is alleviated by reducing the volume of packaged positioning aids. In this process, the positioning aid is first compressed and reduced in volume to not more than 15% of freely expanded volume and the compressed positioning aid is then packaged by tightly wrapping with a suitably strong material, such as plastic film or fabric straps. In an alternative process the compressed positioning aid is placed into a cylindrical cover which is manufactured of a suitable strong material such as plastic film or fabric. Removal of the packing material or the cylindrical cover allows the positioning aid to resume a freely expanded volume and be ready for use.
In a second method of packing positioning aids, the first through eighth embodiment positioning aid cushion without a cover is compressed and reduced in volume to not more than 15% of freely expanded volume and the compressed positioning aid is then packaged by tightly wrapping with a suitably strong material, such as plastic film or fabric straps. In an alternative process the compressed positioning aid is placed into a cylindrical cover which is manufactured of a suitable strong material such as plastic film or fabric. To prepare the positioning aid for use, the packing material or cover is removed, the cushion is allowed to resume the freely expanded volume, and a first through eighth embodiment cover is placed over the cushion, thus providing a complete positioning aid ready for use.
It will be apparent to those skilled in the art that the examples and embodiments described herein are by way of illustration and not of limitation, and that other examples may be used without departing from the spirit and scope of the present invention, as set forth in the appended claims.
This application claims priority from provisional application Ser. No. 60/485,584, filed Jul. 8, 2003.
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