Bleach compatible polyolefin mattress cover
11825956 · 2023-11-28
Assignee
Inventors
- Stacey duBell Mileti (Torrington, CT, US)
- Robert J. Mileti (Torrington, CT, US)
- Kevin P. Conway (Portage, MI, US)
Cpc classification
B29K2623/00
PERFORMING OPERATIONS; TRANSPORTING
B29C66/432
PERFORMING OPERATIONS; TRANSPORTING
B29C66/1312
PERFORMING OPERATIONS; TRANSPORTING
B29C66/71
PERFORMING OPERATIONS; TRANSPORTING
B29C66/71
PERFORMING OPERATIONS; TRANSPORTING
B29C66/133
PERFORMING OPERATIONS; TRANSPORTING
B29C65/48
PERFORMING OPERATIONS; TRANSPORTING
B29K2023/00
PERFORMING OPERATIONS; TRANSPORTING
B29K2023/00
PERFORMING OPERATIONS; TRANSPORTING
B29C66/83221
PERFORMING OPERATIONS; TRANSPORTING
A47C27/082
HUMAN NECESSITIES
B29C66/73921
PERFORMING OPERATIONS; TRANSPORTING
B29C65/04
PERFORMING OPERATIONS; TRANSPORTING
International classification
A47C27/00
HUMAN NECESSITIES
B29C65/00
PERFORMING OPERATIONS; TRANSPORTING
B29C65/04
PERFORMING OPERATIONS; TRANSPORTING
B29C65/48
PERFORMING OPERATIONS; TRANSPORTING
Abstract
A bleach compatible mattress cover made of a non-woven polyolefin material and defining an interior cavity. The interior cavity configured to receive a mattress structure which may include a first and second support structure disposed in the interior cavity. In certain embodiments, the mattress cover has a Moisture Vapor Transfer Rate of greater than or equal 400 to less than 10,000, 7500 or more particularly less than 5000 grams per square meter per day and a hydrostatic head of 100 cm or greater and passes ASTM 1670 and ASTM 1671.
Claims
1. A cover comprising: a cover member defining a cavity configured to receive a support structure therein, the support structure comprising a cushion; top and bottom panels of said cover member, wherein said top panel is made of a non-woven bleach compatible polyolefin material having a moisture vapor transfer rate (MVTR) of at least 400 grams per square meter per day and a hydrostatic head which is greater than 100 cm such that the MVTR and hydrostatic head of the material creates a cover which is breathable but impervious enough to inhibit liquids, bacteria and viruses from passing through the top panel of the cover; said top and bottom panels sealed around at least 60% of a periphery thereof to create said cavity; wherein the non-woven bleach compatible polyolefin material is a laminate material; the laminate comprised of polyolefin filaments and maintains the hydrostatic head and MVTR properties after exposure to cleaning with bleach in conformance with hospital cleaning procedures for Class II medical devices.
2. The cover of claim 1 wherein the MVTR is 1000-7500 grams per square meter per day.
3. The cover of claim 1 wherein the MVTR is 2500-3500 grams per square meter per day.
4. The cover of claim 1 wherein the hydrostatic head of the top panel is at least 150 cm.
5. The cover of claim 1 wherein the top panel passes ASTM 1670 and ASTM 1671 tests.
6. The cover of claim 1 wherein the cushion is a mattress and the cover contains the mattress therein.
7. The cover of claim 1 wherein the bottom panel is a bleach compatible non-woven polyolefin material.
8. The cover of claim 1 wherein said top and bottom panels are made of different materials.
9. The cover of claim 1 wherein said bottom panel has a weight per square meter which is at least 25% larger than said top panel.
10. The cover of claim 1 wherein said bottom and top panels are joined via heat sealing around the bottom and top panels such that outer surfaces of said top and bottom panels are sealed together along at least three sides of the cover.
11. The cover of claim 1 wherein said bottom and top panels are joined via heat sealing faces of the bottom and top panels together.
12. The cover of claim 1 wherein said cover member encloses and is irremovable from the cushion and the cushion is a mattress.
13. The cover of claim 11 wherein said top and bottom panels are sealed together along at least 85% of an entire length of all sides of the cover where the top and bottom panels meet.
14. A cover comprising: a bleach compatible cover comprising a non-woven polyolefin material which is configured to secure around a support structure which comprises a cushion; the bleach compatible cover passes ASTM 1670 and 1671 tests and has a moisture vapor transfer rate (MVTR) of at least 400 grams per square meter per day and a hydrostatic head which is greater than 100 cm; wherein the non-woven polyolefin material is a laminate material; the laminate comprised of polyolefin filaments and maintains the hydrostatic head and MVTR properties after cleaning with bleach at a level adequate to kill C. difficile.
15. The cover of claim 14 wherein said cover is configured with retaining portions on three or more corners thereof, the retaining portions configured to hold the support structure around the sides thereof.
16. The cover of claim 14 wherein said cover completely surrounds the cushion mattress and said cushion is a mattress.
17. The cover of claim 14 wherein said cover includes an opening for inserting and removing the mattress.
18. The cover of claim 17 wherein said opening has a releasable closure.
19. The cover of claim 14 wherein said cover comprises bottom and top panels sealed together around their edges.
20. The cover of claim 19 wherein the outer surfaces of the bottom and top panels are sealed together at the edges.
21. The cover of claim 14 wherein the mattress is a fluid retaining bladder with a plurality of cells whose fluid pressures can be modified by a pump.
22. A cover comprising: a cover member defining a cavity configured to receive a support structure therein, the support structure comprising a cushion; top and bottom panels of said cover member, wherein said top panel is made of a non-woven bleach compatible polyolefin material having a moisture vapor transfer rate (MVTR) of at least 400 grams per square meter per day and a hydrostatic head which is greater than 100 cm such that the MVTR and hydrostatic head of the material creates a cover which is breathable but impervious enough to inhibit liquids, bacteria and viruses from passing through the top panel of the cover; said top and bottom panels sealed around at least 60% of a periphery thereof to create said cavity; wherein the non-woven bleach compatible polyolefin material is a laminate material; the laminate comprised of polyolefin filaments and maintains the hydrostatic head and MVTR properties after cleaning with bleach at a level adequate to kill C. difficile.
23. The cover of claim 22 wherein the cushion is a mattress.
24. A cover comprising: a bleach compatible cover comprising a non-woven polyolefin material which is configured to secure around a support structure which comprises a cushion; the bleach compatible cover passes ASTM 1670 and 1671 tests and has a moisture vapor transfer rate (MVTR) of at least 400 but less than 7500 grams per square meter per day and a hydrostatic head which is greater than 100 cm; wherein the non-woven polyolefin material is a laminate material; the laminate comprised of polyolefin filaments and maintains the hydrostatic head and MVTR properties after exposure to cleaning with bleach in conformance with hospital cleaning procedures for Class II medical devices.
25. The cover of claim 24 wherein the cushion is a mattress.
26. A cover comprising: a bleach compatible cover comprising a non-woven polyolefin material which is configured to secure around a support structure which comprises a cushion; the bleach compatible cover passes ASTM 1670 and 1671 tests and has a moisture vapor transfer rate (MVTR) of at least 400 but less than 7500 grams per square meter per day and a hydrostatic head which is greater than 100 cm; wherein the non-woven polyolefin material is a laminate material; the laminate comprised of polyolefin filaments and maintains the hydrostatic head and MVTR properties after exposure to cleaning with bleach in conformance with protocols for cleaning reusable medical devices.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
(10) Referring now to the drawings, wherein like reference numerals designate corresponding structure throughout the views. The following examples are presented to further illustrate and explain the present invention and should not be taken as limiting in any regard.
(11) The cover provided herein either when used in a single patient use configuration or in a conventional hospital mattress is both soft and compatible with bleach. Thus hospitals are able to clean the cover with bleach while significantly lowering or eliminating the strikethrough risk described herein.
(12) For high risk patients, the single patient use configuration provides an affordable and disposable mattress, eliminating the risk of cross contamination. During the patient's stay in the hospital, the mattress can be cleaned with bleach or other aggressive cleaning agents. The pressure relieving features provide therapy to reduce the risk of bed sores, or treat existing ones.
(13) The mattress 1 has a cover comprised of top 2 and bottom 8 panels. The interior 6 of the mattress may be constructed of a number of different materials and configurations. In one embodiment, the support 6 includes an inflatable bladder with a number of cells 6 and a pump 11 inflates the cells and may provide alternating pressure therapy or may be provided to inflate the mattress and then be disconnected. In certain aspects, the support is made of a non-porous material. One example configuration of the interior 6 includes the inflatable mattress systems or structures shown and described or made in accordance with in U.S. Pat. Nos. 6,775,868, 6,817,050, 8,935,820, 9,079,371, 9,481,152, 7,174,589, 7,455,744 and application Ser. Nos. 15/008,073, 15/230,092 and 15/296,776 the content of all of these patents/applications are incorporated by reference herein. It is contemplated that other internal mattress support structures or manufacturing methods known in the art may be used in connection with the cover. It is further understood that the support can be a variety of mattress support structures or pillows or cushions.
(14) The cover is made of a non-woven polyolefin material that is compatible with aggressive cleaners such as bleach or other FDA/EPA registered sporicidal and germicidal materials. More particularly, a polyethylene or polypropylene material may be used and the material may have hydrophobic properties. The material may be constructed as a laminate. In particular embodiments, the material used is compatible with disinfectants such as: a sodium hypochlorite solution of at least 5000 free chlorine particles; UV light, UV-C light, EtO or quaternary ammonia.
(15) The cover is assembled at seam 12 via heat sealing. In some embodiments, the top 2 and bottom 8 panels of the cover may be made of the same material. In other embodiments the top 2 and bottom 8 panels are made from different materials. For example, the bottom 8 may be made of a less expensive material that does not have the same breathable properties as the top 2.
(16) The material of the top 2 panel has a hydrostatic head greater than 100 cm, 150 cm or more particularly greater than 175 cm. In certain embodiments, the hydrostatic head is within the range of 100-300 cm or more particularly, 150-250 cm or even more particularly 175-225 cm as measured between the outer 20 and inner 22 surfaces. In other aspects, the hydrostatic head is greater than 250 cm. Hydrostatic head testing evaluates the behavior of fabrics/materials under increasing hydrostatic pressures. The fabric is sealed to the test apparatus and a water pressure is applied and the water column (pressure) is slowly increased. When sufficient pressure is applied, water will penetrate the fabric and liquid strike-through will occur and thus indicate the hydrostatic head value of the particular material. The mattress cover is also designed to meet the standards of ASTM 1670 and 1671 which relate to AAMI Level 4 claims on surgical gowns. By passing such tests and meeting other parameters described herein, the cover material has a small enough pore 200 size to allow moisture vapor thorough but is not large enough to allow liquids or viruses through and cause contamination. Typically, the pore 200 size is on the order of several microns. This allows the pores to exert relatively strong capillary forces that prevent the penetration of liquids such as water. However, pores can become clogged over time which can lead to the deterioration of the MVTR properties. Therefore, it is preferable if the cover can be disposed of and replaced to avoid contamination of the mattress and to further enable consistent performance and avoid degradation. Alternately, the cover can be provided on a single patient use mattress to increase comfort of the mattress.
(17) The material used for the cover, particularly the outer 20 surface is hydrophobic such that bodily fluids will not penetrate the cover such that they may be easily blotted or wiped away. The hydrostatic head of the material is important in that it avoids or reduces the possibility that fluids will seep into the interior of the mattress. In addition, the moisture vapor transfer rate (MVTR) of the top 2 panel may be at least about 400 grams per square meter per day (24 hours) or in the range of 400-20,000, 400-15,000, 400-5000 or more particularly 1000-4500 or even more particularly 1000-3000 grams per square meter per day (24 hours). More particularly, a fabric with a MVTR range of 2500-4000 or more particularly 3000-3500 grams per square meter per day may be used for the top 2 panel. The MVTR rates described herein allow for appropriate breathability of the cover for comfort and skin protection. Other properties of the top 2 panel may include a weight of 60-100 or more particularly 70-90 or even more particularly 75-85 all in grams/square meter. The bottom 8 panel may be constructed as the same material as the top 2 panel. However, in some embodiments, the bottom 8 panel is a different material. The weight of the bottom 8 panel material may be in the same ranges as those described for the top 2 panel. However, the MVTR may be lower than the top panel for example, less than 2000 or more particularly, less than 1000, less than 500 or even more particularly less than 250 grams per square meter per day. In some aspects, the bottom 8 panel is made from a non-breathable material or laminate in other aspects the bottom is at least 20% or at least 40% or even more particularly at least 50% heavier (grams/square meter) than the top.
(18) The interior of the mattress between interior surfaces 22 and 82 includes the interior space which may include an inflatable bladder 6. In addition, a batting 4, filling or padding material is between the top 2 and the bladder 6 or interior 6 of the mattress. The bladder and/or batting may be individually or collectively considered support and/or padding structures and it is understood that support/padding structures used in connection with the cover are not limited to only the batting/fluid bladder described herein. For example, other support/padding structures known in the art may be used in connection with the cover described herein. The batting 4 material may be made of a polyester material, non-absorbent and non-porous materials may be employed for the batting structure. However, other materials such as foams or porous/absorbent materials and the like may be substituted. In certain embodiments the cover has anti-viral or antibacterial properties. In certain embodiments the cover has fire-retardant properties. The mattress provided may be designed for single patient use with low pressure alternating pressure therapy. The bleach or aggressive cleaner compatible cover enables easy cleaning and disinfecting while providing protection from contamination. The mattress when assembled and covered can be packaged in a container that is less than 15 lbs to enable easy shipping of replacement mattresses and easy installation. In certain embodiments, this 15 lbs package size includes a mattress, tube set and pump. In particular embodiments, the mattress including cover and support structures is less than 10 lbs, more particularly, less than 8 lbs or even more particularly less than 7.0 lbs.
(19) Furthermore, as shown in
(20) Furthermore, a pillowcase style cover can also be used as shown in
(21) The cover may be removable from the mattress so as to allow cleaning services to clean the cover. More optimally however, the cover may be designed as a single patient use cover which is not appropriate for cleaning, but rather can be discarded or recycled. In addition, the cover may have a moisture or heat activated ink 60 which bleeds or becomes visible or changes in color or undergoes other visual changes after a particular amount of moisture exposure or penetration to indicate that the cover has reached its useful life, or can no longer be used safely. Particularly, the ink 60 may become visible at a predetermined condition of use prior to the cover or top panel/portion failing ASTM 1670 and/or ASTM 1671 or when the MVTR or hydrostatic head is expected to be outside of predetermined design requirements. In other aspects, the cover may be permanently or irremovably secured around the mattress, typically in a single patient use mattress.
(22) The covers and materials herein are in certain embodiments are designed for single patient use in that they are not suitable for passing through laundry. Particularly, a hospital laundry may clean fabrics at 160 f (71 c) for 25 minutes, typically using bleach or other aggressive chemicals/detergents. The materials herein generally have melt temperatures below 320 f (160 c), typically from 221 f (105 c) to 320 f (160 c). Exemplary material melt temperatures are: LDPE 105 c; LLDPE 122 c; Polypropylene 165 c; Spun Bond Polypropylene 150 c; PLA 150-160 c. Non-woven materials are typically made by using multiple filaments of material which are bonded with heat, binders or entangled in another manner using mechanical methods. In this manner, the appropriate pore size is created such that the materials are hydrophobic but still allow vapor to pass. However, once the material is exposed to an elevated temperature, for example over 120 f (48 c), the properties of the material may be distorted such that they no longer act as designed in the hydrophobic but breathable manner. Laundering may also cause the materials to de-laminate, shrink, suffer degradation from abrasion or suffer other damage to their physical or functional properties.
(23) Furthermore studies show that hospital laundering facilities and equipment can be contaminated by C. difficile and other infectious organisms, and thus become a source for HAIs.
(24) Particularly, the materials used herein once exposed to a water temperature of above 140 f or above 150 f or at about 160 f for more than 20 minutes, the MVTR may increase at least 10%, at least 20% or even more particularly at least 25% and the Hydrostatic head may decrease at least 10%, at least 20% or even more particularly at least 25%.
(25) As shown in
(26) Furthermore, in the preferred embodiments the materials used herein are sealed by thermal impulse welding rather than radio frequency energy sealing. Particularly, the materials used are not susceptible or visible to radio frequency sealing without the use of additives, buffers or mechanical catalysts.
(27) It is understood that other methods of joining the materials may be used as would be apparent to those skilled in the art. These methods include ultrasonic welding, RF welding and the use of adhesives.
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(29) Although the invention has been described with reference to a particular arrangement of parts, features and the like, these are not intended to exhaust all possible arrangements or features, and indeed many other modifications and variations will be ascertainable to those of skill in the art.