This disclosure relates to personal protective equipment (PPE) for containment and disposal of hazardous drug contaminated infusion liquid bags (IV's), syringes, transfer devices, chemotherapy IV bags, infusion sets, and the like. The personal protective equipment comprises one or more sealable, releasable pockets coupled thereto.
Accidental exposure to chemotherapy and hazardous drugs from IV infusions pose reproductive and cytotoxic risks to healthcare workers who handle and administer them. Infusion liquid containers can be in the form of an infusion liquid bag, an infusion liquid syringe and the like. Healthcare workers don and doff personal protective equipment (PPE) to help guard against accidental exposure from spills and the like during administration, delivery, and disposal of hazardous drug waste. Accidental exposure can occur when preparing and/or delivering a hazardous drug or during the disposal of empty drug containers, IV bags, syringes, transfer devices, and the like. Either of these situations poses risks and concerns.
In a first example, a disposable medical gown is provided, the disposable medical gown comprising: a front side; at least one side portion coupled to the front portion; at least one arm portion coupled to and extending from the front portion; and a pocket, the pocket detachable from the front side or the at least one side portion, the pocket configured to receive contaminated medical waste.
In one example, the pocket is essentially impervious to liquid and vapor so as to substantially protect a wearer of the disposable medical gown. In another example, alone or in combination with any one of the previous examples, the pocket includes a substantially liquid and/or vapor impervious closure.
In another example a disposable medical gown is provided, the disposable medical gown comprising: a front side; at least one side portion coupled to the front portion; at least one arm portion coupled to and extending from the front portion; and a pocket-securing assembly, the pocket-securing assembly configured to receive a detachable pocket, the pocket-securing assembly coupled to the front side or the at least one side portion, the detachable pocket configured to receive contaminated medical waste. In another example, at least a portion of the pocket is coupled to the pocket-securing assembly with one or more perforations, welds, stitches, or an pressure sensitive adhesive.
In another example, alone or in combination with any one of the previous examples, the pocket is essentially impervious to liquid and vapor so as to substantially protect a user of the disposable medical gown. In another example, alone or in combination with any one of the previous examples, the pocket includes a substantially liquid and/or vapor impervious closure.
In another example, alone or in combination with any one of the previous examples, the pocket comprises a sealable opening, a vertical side and a horizontal side, the pocket further comprising an expandable gusset along the vertical side configured to allow the pocket to be freestanding when separated from the pocket-securing assembly.
In another example, a method of disposing contaminated medical devices, the method comprising providing a disposable medical gown of any one of the previous examples, providing for the introduction of contaminated medical waste to the at least one sealable pocket, and providing for the detachment of the at least one sealable pocket comprising contaminated medical waste from the disposable medical gown.
The present disclosure will now be described, by way of non-limiting examples only, with reference to the accompanying drawings:
Examples will now be described more fully with reference to the accompanying drawings. Examples are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are provided, such as examples of specific components, devices, and methods, to provide a thorough understanding of examples of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example examples may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example examples, well-known processes, well-known device structures, and well-known technologies are not described in detail. The present disclosure provides a chemotherapy protective gown that allows effective and substantially complete user protection from chemotherapy and hazardous drug treatments.
When an element or layer is referred to as being “on,” “engaged to,” “connected to,” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to,” “directly connected to,” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example examples.
Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” “front,” “rear,” “horizontal,” “vertical,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
In one example, the presently disclosed gown is a chemotherapy protective gown comprised of lightweight, flexible, non-linting poly-coated fabric with long sleeves and knit cuffs configured to be donned with the back open and secured around the waist with attached poly-coated ties.
In one example, the presently disclosed gown comprises a sealable or resealable (“(re)sealable”), releasably engageable pocket 110 coupled (or detachably coupled) to an outward facing surface of the gown.
With reference to
Pocket 110 comprises a sealable or resealable closure mechanism 117 along one or more vertical edges 112a, 114a or horizontal edge 125. Pocket 110 is secured to the front of the gown by a pocket-securing assembly comprising horizontal members 112, 114 of the pocket-securing assembly is a break in the perforated poly-coated fabric to allow for a pass through opening from side to side behind the pocket 110. In one example, pocket 110 is coupled to a pocket-securing assembly that is coupled to gown 100, the pocket-securing assembly providing for detachment of pocket 110 from the pocket-securing assembly. Pocket-securing assembly, configured to releasably detach pocket 110 from gown 100, comprises lower horizontal member 112 vertically separated from upper horizontal member 114. Pocket-securing assembly members 112, 114 remain attached to gown 100 after removal of pocket 110. In one example, pocket 110 is coupled to pocket-securing assembly of gown 100 in any suitable manner that provides release of pocket 110 from pocket-securing assembly members 112, 114, including a perforated horizontal region, a weak seam, a heat seal, an adhesive, Velcro or stitches. Pocket-securing assembly is secured directly to gown 100 using a seam, a heat seal, an adhesive, Velcro or stitches.
In the example gown 100 shown in
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In yet another aspect, the (re)sealable closure mechanism of pocket 110 comprises a flap with an adhesive tab or corresponding Velcro components. In one example the adhesive tab used as a sealable closure of pocket 110 is configured to be essentially vapor and liquid impervious.
Closure mechanism 117 is shown positioned adjacent to edge 112a, but can be along horizontal edge 125.
While various configurations of gown 100, 200 are possible, in one example, the gown can be provided in a variety of sizes such as Gown Size: Small—Gown body 37 inches long by 50 inches wide, Sleeves 28 inches long from shoulder to cuff, Elastic cuffs 3 inches long; Gown Size: Large—Gown body 39 inches long by 52 inches wide, Sleeves 29 inches long from shoulder to cuff, Elastic cuffs 3 inches long; Gown Size: Extra Large—Gown body 41 inches long by 54 inches wide, Sleeves 30 inches long from shoulder to cuff, Elastic cuffs 3 inches long; Gown Size: Double Extra Large—Gown body 43 inches long by 56 inches wide, Sleeves 31 inches long from shoulder to cuff, Elastic cuffs 3 inches long, etc.
In one example, the dimensions of the sealable, releasable pocket 110, 210a, etc., are configured dimensionally about 9 inches wide by about 11 inches tall and are of the thickness of between 2-10 mil. In one example, sealable closure mechanism 117 comprises a lanyard 119 with loop to allow for opening with a single finger pull. In another example, pocket 110, 210a, etc. contains gussets 118 long along both vertical sides so that once the pocket is detached and removed from gown 100, 200 via breakage from the pocket-securing assembly, gussets 118 can be expanded to allow for the pocket to be free standing, if desired.
In one example, the disposable medical gown 100, 200 disclosed herein may be made from any suitable thermoplastic polymer, including polypropylene, polypropylene with a polyethylene coating, etc. In other examples, the disposable medical gowns may utilize spunbond-meltblown-spunbond (SMS) materials.
In one example, the body of gown 100, 200 is comprised of lightweight, flexible, non-linting poly-coated fabric (woven or nonwoven fabric of thermoplastic polyolefin, polyurethane, polyethylene to, polycarbonate, or nylon, for example) with long sleeves and knit cuffs. In one example, a poly-coated fabric that is impervious to cisplatin, cyclophosphamide, dacarbazine, doxorubicin, etoposide, fluorouracil, methotrexate, mitomycin, paclitaxel, vincristine with no breakthrough for up to 240 minutes (without displaying swelling and degradation) is employed.
In one example, the medical gown 100 provides a barrier to blood and viral agents, and meets the requirements of ASTM F1670 and ASTM F1671. In another example, the gown is breathable to provide comfort to the wearer, e.g., has a breathability, expressed in terms of MVTR as measured by ASTM E96 of at least 250 g/m2/24 hr at standard conditions of about 75° F. and a relative humidity of about 65%.
In one example, pocket 110, 210a, etc., is made of a liquid impervious fabric or material. In another example, pocket 110, 210a, etc is made of a vapor and liquid impervious fabric or material. In one example, pocket 110, 210a, etc. is comprised of barrier plastic with a (re)sealable opening at the top and heat sealed edges to provide liquid leak resistant barrier. For example, a thermoplastic olefin barrier that is impervious to many chemotherapy agents and drugs such as cisplatin, cyclophosphamide, dacarbazine, doxorubicin, etoposide, fluorouracil, methotrexate, mitomycin, paclitaxel, vincristine, with no breakthrough of these chemotherapy agents for up to 240 minutes is employed.
In one example, the releasable pocket 110, 210a, etc is formed of a material configured to resist cutting, tearing, puncturing and abrasion while maintaining flexibility for receiving the contaminated medical device. Such durability can be provided and/or controlled by adjusting the thickness of the material used to make the pocket. One or more portions of pocket 110, 210a, etc can be reinforced or augmented, e.g., increased thickness about the edges, or can be strengthened or toughened using other known methods of reinforcement, so as to minimize or eliminate puncture or tear by contaminated medical devices, such as those having sharp points or edges, etc.
In one example, the pocket 110, 210a, etc is prepared from a continuous single layer or multiple layer chemical barrier material having chemical barrier properties, for example, material normally used for protection against military warfare agents as well as other toxic industrial chemicals and materials, such as for example polyvinylidene chloride (PVDC), ethylene vinyl alcohol copolymer (EVOH), nylons, acrylonitrile methacrylate copolymer (AN-MA), polyvinyl alcohol (PVOH), and others. In one example, the pocket is constructed of material that provides softness and flexibility, for example, multi-layer coextruded films such as, but not limited to polyvinylidene chloride (PVDC) with exterior layers of melt processable polymers (i.e., linear low density polyethylene (LLDPE), ethylene vinyl acetate (EVA), and chlorinated polyethylene (CPE)), commercially available examples of which include the Saranex® series of barrier films available from Dow Chemical Company, Midland Mich., such as Saranex® 14P, Saranex® 23P, Saranex® 35P, Saranex® 520, Saranex® 750, Saranex® 452, Saranex® 650G, and Saranex® 652G.
The disposable medical gown 100 and/or pocket-securing assembly and pocket 110, 210a, etc disclosed herein may be formed monolithically with a front surface 102, at least one side portion 103, at least one arm portion 104. Some or all portions (including the releasably engageable pocket) of the disposable medical gown 100, 200 may be formed individually and coupled together to form the disposable medical gown 100, 200. In one example, the front surface 102, at least one side surface 103, and at least one arm portion 104 are coupled together in any suitable manner, including by a perforated material, a weak seam, a heat seal, an adhesive, or stitches, etc.
For example, to wear an example gown (e.g., gown 100, 200) of the present disclosure, the user inserts his/her head within the opening of collar 106 and his/her arms into the arm portions 104. The user then may couple the straps 107 so that the gown fits comfortably around the user (e.g., the front portion of the gown, etc.). Alternatively, and depending on the user, the tie strings 107 can be secured together at the rear portion of the gown, etc. (again, depending on the size of the user and so that the gown comfortably fits around the user).
The foregoing description of the examples has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular example are generally not limited to that particular example, but, where applicable, are interchangeable and can be used in a selected example, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.
This application claims priority to U.S. Patent Application No. 62/878,684, filed Jul. 25, 2019, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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62878684 | Jul 2019 | US |