Barrier sleeve usable with a medical gown and method of using the same

Abstract

A barrier sleeve that can be used with a protective gown, the barrier sleeve comprising a tubular cuff section that includes a cuff material and has a first end of the cuff section and a second end of the cuff section, and a tubular gasket section having a gasket material, the gasket section having a first end of the gasket section at the second end of the cuff section and a second end of the gasket section, the gasket material also including gathered material and / or extensible material, the gasket material having a first thickness and being capable of exhibiting a thickness change of at least about 40% upon compression, the barrier sleeve. Also disclosed are systems, methods of making, and methods of using the barrier sleeve.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 18 / 330,066, filed Jun. 6, 2023, and U.S. Provisional Application No. 63 / 350,281, filed Jun. 8, 2022, the entire contents of which are incorporated herein by reference.

[0002] Technical Field The present disclosure relates to barrier sleeves that can be used with medical gowns and medical gloves.

Background Art

[0003] In a medical environment, the interface between gloves and gowns is identified as one of the areas that are most problematic for medical professionals because fluid intrusion at the interface is frequent.

[0004] There are several known causes of fluid intrusion (i.e., leakage) at the glove / gown interface (i.e., fluid entering between the inner surface of the glove and the outer surface of the gown), and these are often additive. First, in hospitals and other medical environments, to limit the number of required gown sizes (and thus reduce inventory costs), over - sized gowns are often utilized. However, the excess material in the gown sleeve can cause the beads of the glove to roll down, creating a breach at the glove / gown interface. Further, gloves tend to slip due to the low - friction interface between the inner surface of the glove and the outer surface of the gown. Additionally, the excess material in the sleeve portion of conventional medical gowns can be folded to create a longitudinal channel in the gown sleeve between the inner surface of the glove and the outer surface of the gown. These channels can allow for a passage of fluid between the external environment and the wearer.

[0005] Another potential cause of fluid ingress is surgical glove sizing, which is generally sized to fit the hand but is often too large in the forearm and wrist regions. If the glove does not fit snugly around the user's wrist and forearm, fluid can leak under the edge of the glove and run down into the wrist area. Additionally, if there is excessive glove material at the forearm portion and / or the edge of the glove, there is a greater risk that the glove will fold over and slip, thus increasing the risk that the cuff of the gown will be exposed to fluid. There are also cases where the surgical glove fits the hand but the edge of the glove is too tight around the forearm. In this case, the edge of the glove folds over and the cuff is exposed, leaving no barrier against liquid.

[0006] Previous attempts to solve the problem of fluid ingress at the glove / gown interface have been inadequate. For example, some existing proposed solutions attempt to eliminate only some of the causes of fluid leakage, such as glove folding or slipping, without properly addressing, for example, the formation of longitudinal channels in the gown sleeve material. In another example, it has been proposed to add cuffs to existing medical gown sleeves so that the cuffs can be folded over the edge of the glove. However, this alternative requires additional steps in the process of donning and removing the medical gown and gloves, which may be a non-issue for medical professionals trained in the conventional donning and removal processes that do not include these additional steps of donning and removing such cuffs.

[0007] Accordingly, there is a need in the art for medical gowns and systems that reduce or eliminate fluid leakage at the glove / gown interface. SUMMARY OF THE INVENTION

[0008] The present disclosure relates to a barrier sleeve that can be used with a protective gown, the barrier sleeve including a tubular cuff section that includes a cuff material and has a first end of the cuff section and a second end of the cuff section, and a tubular gasket section that includes a gasket material with gathers, where the gasket section has a first end of the gasket section and a second end of the gasket section at the second end of the cuff section, and the gasket material with gathers has a first thickness and is configured to exhibit a thickness change of at least about 40% upon compression.

[0009] A system including a protective gown having a body portion, a first sleeve portion, and a second sleeve portion, and a barrier sleeve attached to an inner surface of the first sleeve portion or the second sleeve portion, the barrier sleeve including a tubular cuff section having a first end of the cuff section attached to the inner surface of the first sleeve portion or the second sleeve portion, and the cuff section including a cuff material that includes at least two layers of nonwoven material having one or more stretchable strands between the layers. The above system is also disclosed.

[0010] A method of making a barrier sleeve having a gasket section, the method including providing a gasket section having a gasket material with gathers, the gasket material with gathers providing one or more stretchable strands in an extended position, attaching the one or more stretchable strands in the extended position to one or more layers of nonwoven material, and enabling the one or more stretchable strands to contract such that the one or more layers of nonwoven material attached thereto become gathered. The above method is also disclosed.

[0011] The present disclosure also relates to a medical glove that can be used with a protective gown as described herein. Methods of making and using the barrier sleeve, medical gown, and / or system described herein are also included.

Brief Description of the Drawings

[0012]

Figure 1

[0013]

Figure 2

[0014]

Figure 3

[0015]

Figure 4

[0016]

Figure 5

[0017]

Figure 6A

[0018]

Figure 6B

[0019]

Figure 6C

[0020]

Figure 6D

[0021]

Figure 6E

[0022]

Figure 6F

[0023]

Figure 6G

[0024]

Figure 7

[0025]

Figure 8A

[0026]

Figure 8B

MODE FOR CARRYING OUT THE INVENTION

[0027] In connection with the accompanying figures, the detailed description set forth below is intended as a description of various configurations and is not intended to represent the only configuration in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details.

[0028] Throughout this disclosure, the terms "substantially" or "approximately" may be used as modifiers relating to the geometric relationship between elements or to the shape of an element or component. The terms "substantially" or "approximately" are not limited to specific variations and may include any variation that would be understood by one of ordinary skill in the art as an acceptable variation, although some examples are provided as follows. In one example, the terms "substantially" or "approximately" may include variations of less than 10% of the dimensions of the object or component. In another example, the terms "substantially" or "approximately" may include variations of less than 5% of the dimensions of the object or component. In another example, the terms "substantially" or "approximately" may include variations of less than 3% of the dimensions of the object or component. When the terms "substantially" or "approximately" are used to define the angular relationship of one element to another element, one non-limiting example of the terms "substantially" or "approximately" may include variations of 5 degrees or less. Another non-limiting example of the terms "substantially" or "approximately" may include variations of 3 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on an understanding of the limitations acceptable to one of ordinary skill in the relevant art.

[0029] The word "about" is used herein to mean within ±5%, optionally within ±4%, optionally within ±3%, optionally within ±2%, and optionally within ±1% of the value recited.

[0030] For purposes of this disclosure, directional terms are generally presented with respect to a standard framework when the systems and devices described herein are installed in the orientation in which they are used.

[0031] Terms such as "a", "an", and "the" are not intended to refer only to singular entities and are intended to include general types for which specific examples may be used for illustration. The terms "a", "an", and "the" may be used interchangeably with the term "at least one". For lists that follow, the phrases "at least one" and "including at least one" refer to any one of the items in the list and any combination of two or more items in the list. All numerical ranges include endpoints and non-integer values between the endpoints unless otherwise stated.

[0032] Among other numerical values, in particular, the terms "first", "second", "third", and "fourth" may be used in this disclosure. Unless otherwise stated, it will be understood that these terms are used only in their relative sense. In particular, in some aspects, certain components may be present interchangeably and / or in the same multiple (e.g., pairs). With respect to these components, the designations "first", "second", "third", and / or "fourth" may be applied to the components as a matter of convenience only in the description of one or more aspects of this disclosure.

[0033] Regarding the background, an overview of the aspects of this disclosure and the advantages provided by this disclosure are provided. This overview, and the following detailed description, are presented for purposes of illustration and explanation. It is not intended to be exhaustive or to limit this disclosure to the form described. Many modifications are possible, including combinations of the aspects described above, in light of the above explanation. Some of these modifications are discussed and others will be understood by those of ordinary skill in the art. Various aspects are selected and described to best illustrate the principles and various aspects of this disclosure as suitable for a particular intended use. The scope of this disclosure is, of course, not limited to the examples or aspects shown herein and may be used by those of ordinary skill in the art in any number of applications and equivalent devices. Rather, the scope is intended to be defined by the appended claims.

[0034] The present disclosure relates to a barrier sleeve that can be used with a medical gown and is configured to provide a reduction in fluid transfer between the wearer and the external environment. According to some aspects, the barrier sleeve includes at least one of a cuff section, a gasket section, and a bellows section, and at least a portion of the barrier sleeve is configured to be wearable under the sleeve portion of the medical gown. The present disclosure also relates to a medical gown with the barrier sleeve attached thereto, and to a system including the barrier sleeve as described herein, the medical gown as described herein, and / or a medical glove that can be used with the medical gown as described herein. Also included are methods of making and using the barrier sleeve, medical gown, and / or system described herein.

[0035] According to some aspects, the barrier sleeve includes a cuff section configured to be worn on the wearer's arm, particularly on the wearer's wrist and / or hand. The cuff section may include a cuff material. In some non-limiting aspects, the cuff material may include an extensible material. As used herein, "extensible material" refers to a material that has sufficient stretchability such that, with respect to a structure formed from the material (such as the cuff section), when worn, it remains in substantial contact with the wearer. In some non-limiting examples, the cuff material may include an extensible material such that, when worn, the cuff section remains in substantial contact with the wearer's wrist and / or hand. In particular, the cuff material has sufficient stretchability such that, during use, under the glove, the cuff section remains in contact with the wearer's wrist and / or hand so as to reduce or eliminate fluid transfer between the wearer and the external environment of the cuff section and / or to reduce or eliminate slippage of the cuff section relative to the wearer's arm during use.

[0036] Examples of cuff materials useful in accordance with the present disclosure include, but are not limited to, one or more nonwoven materials, one or more woven materials (e.g., polyester), one or more knit fabrics, one or more stretchable materials (e.g., spandex or rayon), one or more foamed substances, or combinations thereof. Non-limiting examples of nonwoven materials include nonwoven materials comprising polyolefins such as polyethylene, polypropylene, blends thereof, and copolymers thereof. In some non-limiting examples, the nonwoven material includes a spunbond material, a meltblown material, a spunbond-meltblown-spunbond (SMS) laminate material, or combinations thereof. As used herein, an "SMS laminate material" refers to a material having a first spunbond layer and a second spunbond layer with a meltblown layer therebetween. In accordance with some aspects, the cuff material may include one or more layers of spunbond material, one or more layers of meltblown material, and / or one or more layers of SMS laminate material as described herein.

[0037] Additionally or alternatively, the cuff material may include a laminate of a nonwoven material and an elastomeric film. Non-limiting examples of laminates useful in accordance with the present disclosure include bilaminates (e.g., a laminate of one layer of nonwoven material and one layer of elastomeric film), and trilaminates (e.g., a laminate of one layer of nonwoven material on both sides of an elastomeric film). In some examples, as will be described herein, the elastomeric film is stretchable and the nonwoven material may be bonded to the stretched film. Non-limiting elastomeric films useful in accordance with the present disclosure include those described in U.S. Patent No. 9,327,477, the entire contents of which are hereby expressly incorporated herein.

[0038] Additionally or alternatively, the cuff material may include a woven material, a knit material, or a combination thereof. In some non-limiting examples, the cuff material may include a circular knit material. As used herein, the term "circular knit" refers to the form of weft knit where the knitting needles are knitted within a circular knitting bed.

[0039] Additionally or alternatively, the cuff material may include a foam material. Non-limiting examples of foam materials include silicone foam materials, urethane foam materials, and combinations thereof.

[0040] In accordance with some embodiments, the cuff material can also include one, two, three, four or more layers of nonwoven material as described herein, and each layer can include the same nonwoven material or a different nonwoven material than another layer. In accordance with some embodiments, each nonwoven material layer can independently include an SMS laminate material or a spunbond material. In accordance with some embodiments, each nonwoven material layer can independently have a weight of about 1 to 20 gsm, optionally about 5 to 15 gsm, optionally about 8 to 16 gsm, and optionally about 12 gsm. In accordance with some embodiments, each nonwoven material layer can independently have a weight of about 1 to 20 gsm, optionally about 10 to 50 gsm, optionally about 20 to 50 gsm, optionally about 20 to 25 gsm, optionally about 25 to 30 gsm, optionally about 30 to 35 gsm, optionally about 35 to 40 gsm, optionally about 40 to 45 gsm, optionally about 22 gsm, optionally about 34 gsm, and optionally about 44 gsm.

[0041] Additionally or alternatively, the cuff material may include one or more stretchable strands. As used herein, a "strand" can refer to a material component having fibers or filaments that are twisted, braided, and / or arranged in parallel to form a unit for further twisting and / or braiding into yarns, threads, ropes, and / or cords. Examples of materials useful for one or more stretchable strands include, but are not limited to, stretchable textile fibers including polymers such as polyurethane and / or poly(urethane-urea) polymers. In accordance with some embodiments, one or more stretchable strands may include spandex strands. Commercially available spandex strands include those sold under the trade names Lycra, Creora, Roica, and Dorlastan. In accordance with some embodiments, the cuff material may include two or more nonwoven fabrics, woven fabrics, knits, and / or stretchable materials as described herein, including one or more stretchable strands provided between two or more layers.

[0042] In accordance with some embodiments, the cuff material may include one or more stretchable strands having a linear weight and / or percent elongation sufficient for the cuff section to function as described herein. For example, one or more stretchable strands may have a linear weight and / or percent elongation such that, as described herein, during use, the cuff section has sufficient stretch for the wearer's arm, wrist, and / or hand to remain in substantial contact with the cuff section.

[0043] In accordance with some embodiments, the cuff material may be sufficiently stretchable such that, during glove wearing and use, the wearer's hand and the cuff section remain in substantial contact, and in particular, such that during use, slippage (e.g., proximal slippage) of the cuff section relative to the wearer's hand is reduced or eliminated.

[0044] In some non-limiting examples, one or more stretchable strands can have a linear weight of at least about 400 dtex, optionally at least about 500 dtex, optionally at least about 600 dtex, optionally at least about 700 dtex, optionally at least about 800 dtex, optionally at least about 900 dtex, optionally at least about 1000 dtex, and optionally at least about 1100 dtex. Additionally or alternatively, one or more stretchable strands can have a linear weight of about 300 - 900 dtex, optionally about 400 - 800 dtex, optionally about 500 - 700 dtex, and optionally about 540 - 680 dtex. In some non-limiting examples, one or more stretchable strands can have a percent elongation of about 100% - 500%, optionally about 200% - 400%, optionally about 200% - 350%, and optionally about 300%.

[0045] In accordance with some aspects, the cuff material can include one or more spaced-apart stretchable strands such that, as described herein, during use, the cuff section remains in substantial contact with the wearer's hand and / or wrist. For example, in accordance with some aspects, the distance between at least a first stretchable strand and a second stretchable strand can be about 1 - 15 mm, optionally about 1 - 11.5 mm, optionally about 2 - 7.5 mm. In accordance with some aspects, the cuff material can include from 1 to 40 stretchable strands, optionally about 10 - 30, and optionally about 20. In accordance with some aspects, the cuff material can include 1 strand, optionally 2 strands, optionally 3 strands, optionally 4 strands, optionally 5 strands, optionally 6 strands, optionally 7 strands, optionally 8 strands, optionally 9 strands, optionally 10 strands, optionally 10 strands, optionally 11 strands, optionally 12 strands, optionally 13 strands, optionally 14 strands, optionally 15 strands, optionally 16 strands, optionally 17 strands, optionally 18 strands, optionally 19 strands, and optionally 20 strands.

[0046] According to some aspects, the cuff material may include one or more elastic strands such that when the cuff section is worn by the wearer, at least a portion of the elastic strands extends laterally or substantially laterally with respect to the length direction of the appendage (e.g., the arm).

[0047] According to some aspects, the cuff material may include one or more elastic strands that are spaced substantially uniformly in the longitudinal direction of the appendage when the cuff section is worn by the wearer. Alternatively, the cuff material may include one or more elastic strands that are spaced non-uniformly in the longitudinal direction of the appendage when the cuff section is worn by the wearer. For example, the spacing between the strands may decrease in the distal direction, i.e., away from the wearer's body. That is, the strands may be closer together at the first or distal end of the cuff section than at the second or proximal end of the cuff section. In this manner, the pressure provided by the distal end of the cuff may be reduced. In some aspects, the one or more elastic strands may run parallel or substantially parallel to each other. In some non-limiting examples, one or more portions of the cuff section may not include strands.

[0048] According to some aspects, the cuff material may include a first portion of elastic strands that extend laterally or substantially laterally with respect to the length direction of the appendage and a second portion of elastic strands that extend longitudinally or substantially longitudinally with respect to the length direction of the appendage when the cuff section is worn by the wearer, thereby forming a web of elastic strands.

[0049] According to some aspects, the cuff material may include a "gathered" material. As used herein, the term "gathered" refers to a material that is modified to increase the thickness of the material when compared to the same material without gathers. For example, a gathered material may be wrinkled or ridged when compared to the same material without gathers.

[0050] According to some aspects, a gathered material may be formed by a process that includes one or more gathering steps. In one non-limiting example, the one or more gathering steps may include providing one or more stretchable strands as described herein in an extended position, attaching the one or more stretchable strands to one or more layers of a nonwoven material, and enabling the one or more stretchable strands to contract so that the one or more layers of nonwoven material attached to the stretchable strands gather. The step of attaching the one or more stretchable strands to one or more layers of a nonwoven material may be performed by any step suitable for gathering as described herein, including but not limited to adhesives (e.g., hot melt adhesives), ultrasonic bonding, ultrasonic welding, sewing, and combinations thereof.

[0051] Additionally or alternatively, the one or more gathering steps may include providing an elastomeric film as described herein in an extended position, attaching the elastomeric film to one or more layers of a nonwoven material, and enabling the elastomeric film to contract so that the one or more layers of nonwoven material attached to the elastomeric film gather. In this example, the elastomeric film may be extended in the machine direction, in a direction transverse to the machine, or both in the machine direction and in a direction transverse to the machine.

[0052] Furthermore or alternatively, one or more gather formation steps may include a dry mechanical compression process, such as that performed by a microcreper system (e.g., the Micrex® process). In one non-limiting example, one or more gather formation steps may include creping one or more layers of a nonwoven material as described herein without the need for a stretchable material.

[0053] It should be understood that one or more gather formation steps as described herein may impart stretchability to the material. For example, a non-stretchable nonwoven material as described herein may be gathered as described herein to provide a stretchable material, i.e., a material that can recover its normal shape after being stretched or compressed.

[0054] In some non-limiting examples, one or both ends of the cuff section may be folded and secured, and thus the strength and durability of the corresponding cuff edge may be increased. In some examples, a layer of material is folded over itself (i.e., a cuff section without strands) and / or over all or part of a cuff section having one or more strands, such that at one or both ends of the cuff section, one, two, three, four, or more layers of material as described herein may extend a certain distance beyond the last strand. In some non-limiting examples, the certain distance may be such that a cuff section without strands may be folded over the entire portion of a cuff section having one or more strands. That is, the certain distance may be, longitudinally along the length of the appendage, at least approximately the length of the portion of the cuff section having one or more strands. However, it should be understood that the present disclosure is not limited to this example. That is, one or both ends of the cuff section may have strands and may be folded as described herein. According to some aspects, the folded portion may have a longitudinal length along the length of the appendage of about 1 to 10 mm, optionally about 5 mm. According to some aspects, securing the folded portion may include the step of providing a permanent attachment. As used herein, the terms "permanently attached" and "permanent attachment" refer to an attachment that is not readily separable, such as attachment through an adhesive (e.g., hot melt adhesive), a stitch (e.g., ultrasonic stitch), ultrasonic bonding, thermal bonding, tape, sealing (e.g., heat sealing), glue, and combinations thereof.

[0055] In accordance with some aspects, the thickness of the cuff material may be selected to reduce the inhibition of the wearer's movement by the wrist and / or hand cuffs proximal to the cuff section. As used herein, the thickness of the material may refer to the distance between its first side and second side and may be measured using a device such as a caliper. In accordance with some aspects, the cuff material may have a first thickness of about 1 to 10 mm, optionally about 1 to 5 mm, optionally about 2.5 mm, and optionally about 2.5 mm or less.

[0056] In accordance with some aspects, the cuff section may generally define a tubular shape sufficient to fit over the wearer's arm, wrist, and / or hand as described herein. As used herein, the term "tubular" can refer to an elongated, enclosed hollow shape and is not necessarily limited to a particular cross-sectional shape. In some examples, a general tubular shape may have a circular cross-sectional shape. In some examples, a general tubular shape may have an oval cross-sectional shape. In accordance with some aspects, a general tubular shape may be formed by attaching together two, three, four, or more sections of cuff material as described herein along the length of the tubular shape to provide the cuff section. In accordance with some aspects, a general tubular shape may be formed by attaching together two sections of cuff material having substantially the same size along the length of the tubular shape through a permanent attachment as described herein. Additionally or alternatively, the cuff section may be formed by attaching together two, three, four, or more tubular sections of cuff material as described herein along its outer perimeter to provide the cuff section. In some non-limiting examples, two, three, four, or more tubular sections may be attached through a permanent attachment along their outer perimeter(s).

[0057] According to some embodiments, the cuff section can have a diameter of about 1 to 10 inches, optionally about 1 to 5 inches, optionally about 2 to 4 inches, and optionally about 2.75 inches. As used herein, the term "diameter" can refer to the maximum diameter of a cylindrical shape (e.g., the diameter with respect to the outer surface of a cylindrical component). For the purposes of this application, a conversion of 1 inch is 2.54 centimeters.

[0058] In some non-limiting examples, the cuff section can have a gathered outer perimeter of about 1 to 20 inches, optionally about 2 to 14 inches, optionally about 5 to 12 inches, and optionally about 8 to 11 inches.

[0059] It should be understood that when a cylindrical component as described herein includes an elastic material, the diameter and outer perimeter of the component can change as the elastic material stretches. As used herein, the measurements provided with respect to the diameter and outer perimeter of the component can refer to the respective dimensions of the component when the component is in a non-stretched setting.

[0060] According to some embodiments, the cuff section can have a length relative to the length of the wearer's appendage that is about 1 to 20 inches, optionally about 1 to 15 inches, optionally about 1 to 10 inches, optionally about 2.5 to 7.5 inches, optionally about 5 inches, and optionally about 3 inches.

[0061] The barrier sleeve according to the present disclosure can further include a gasket section. The gasket section can be configured to be worn on the wearer's arm, particularly around the wearer's forearm. As used herein, the forearm extends from the wearer's wrist to just before the wearer's elbow.

[0062] In accordance with some embodiments, the gasket section can generally define a tubular shape sufficient to fit around the wearer's wrist, such as around the wearer's forearm, as described herein. The gasket section can have a length (e.g., the dimension in the direction of the wearer's arm length when worn) of about 1 to 20 inches, optionally about 1 to 15 inches, optionally about 1 to 10 inches, optionally about 2 to 7.5 inches, and optionally about 5 inches.

[0063] In accordance with some embodiments, the gasket section can have a diameter of about 1 to 10 inches, optionally about 1 to 6 inches, optionally about 1 to 5 inches, and optionally about 3.50 inches.

[0064] In accordance with some embodiments, the gasket section can have a gathered outer perimeter of about 3 to 25 inches, optionally about 5 to 20 inches, optionally about 7 to 18 inches, optionally about 8 to 15 inches, and optionally about 10 to 13 inches.

[0065] In accordance with some embodiments, the gasket section may have a first end and a second end, where the first end can be attachable to and / or attached to the second end of the cuff section, as described herein. In accordance with some embodiments, the "first end" as described herein can be the distal end, i.e., the end of the component that is furthest from the wearer's body when the component is worn. The "second end" can be the proximal end, as described herein, i.e., the end of the component that is closest to the wearer's body when the component is worn.

[0066] The term "attached," as used herein, must be understood to include both reversible attachment and permanent attachment. As used herein, the term "reversibly attached" refers to an attachment that can be easily separated, for example, an attachment through a fastener. Examples of fasteners include any fastener known in the art that is configured to reversibly connect two portions of clothing as described herein and is suitable for use in a medical setting. For example, the fastener can be selected from the group consisting of ties, snaps, buttons, fabric hook and loop fasteners, zippers, buckles, hooks, cords, toggles, brooches, eyelets, and / or combinations thereof. The term "permanently attached" has been described above.

[0067] In accordance with some aspects, the gasket section and the cuff section can include separate materials such that attachment is not necessarily required. For example, the gasket section and the cuff section may include one or more layers of material as described herein, where the one or more layers of material form at least a portion of the cuff section and at least a portion of the gasket section.

[0068] In accordance with some aspects, the gasket section can include a gasket material. In some non-limiting examples, the gasket material can include an extensible material such that the gasket section remains substantially in contact with the wearer's arm during use, and in particular, reduces or eliminates displacement of the gasket section relative to the wearer's arm during use.

[0069] Examples of gasket materials useful in accordance with the present disclosure include, but are not limited to, as described herein, one or more nonwoven materials, one or more woven materials, one or more knit fabrics, one or more stretchable materials, one or more foamed substances, or combinations thereof. In accordance with some aspects, the gasket material may include one or more nonwoven materials and / or one or more elastomeric films, as described herein. In accordance with some aspects, the gasket material may include one or more layers of a spunbond material, a meltblown material, and / or an SMS laminate material, as described herein.

[0070] In accordance with some aspects, the gasket material may include one, two, three, four or more layers of a stretchable material, as described herein, where each layer may include the same or different material than another layer. Each of the one, two, three, four or more layers of the stretchable material may be attached to at least one other layer by any attachment mechanism, as described herein.

[0071] In accordance with some aspects, the gasket material may include one, two, three, four or more layers of a spunbond material, a meltblown material, and / or an SMS laminate material, where each layer may be the same or different material than another layer. In accordance with some aspects, the gasket material may include one, two, three, four or more layers of an SMS laminate material, where each layer may independently have a weight of about 1 to 50 gsm, optionally about 1 to 40 gsm, optionally about 10 to 30 gsm, optionally about 20 gsm, and optionally about 25 gsm.

[0072] In accordance with some embodiments, the gasket material can include one or more stretchable strands as described herein. In accordance with some embodiments, the gasket material can include two or more layers as described herein with stretchable strands provided between two or more of the layers. In accordance with some embodiments, the stretchable strands can be attached to one or more of the layers by any suitable process in accordance with the present disclosure as described herein.

[0073] According to some aspects, the gasket material may include one or more stretchable strands having a linear weight and / or percent elongation such that, as described herein, during use, the wearer's forearm remains in substantial contact with the gasket section. In some non-limiting examples, the one or more stretchable strands may have a linear weight of at least about 400 dtex, optionally at least about 500 dtex, optionally at least about 600 dtex, optionally at least about 700 dtex, optionally at least about 800 dtex, optionally at least about 900 dtex, optionally at least about 1000 dtex, optionally at least about 1100 dtex, optionally at least about 1200 dtex, optionally at least about 1300 dtex, optionally at least about 1400 dtex, optionally at least about 1500 dtex, optionally at least about 1600 dtex, optionally at least about 1700 dtex, optionally at least about 1800 dtex, optionally at least about 1900 dtex, optionally at least about 2000 dtex. Additionally or alternatively, the one or more stretchable strands may have a linear weight of about 300 - 900 dtex, optionally about 400 - 800 dtex, optionally about 500 - 700 dtex, and optionally about 540 - 680 dtex. Additionally or alternatively, the one or more stretchable strands may have a linear weight of about 1100 dtex, or about 1520 dtex. In some non-limiting examples, the one or more stretchable strands may have a percent elongation of about 100% - 500%, optionally about 200% - 400%, optionally about 250% - 350%, optionally about 275% - 350%, and optionally about 275% - 325%.

[0074] In accordance with some embodiments, the gasket material may include one or more elastic strands spaced apart such that, as described herein, during use, the gasket section remains in substantial contact with the wearer's arm. For example, in accordance with some embodiments, the distance between at least a first elastic strand and a second elastic strand may be from about 0.1 to 5 inches, optionally from about 0.1 to 2 inches, and optionally about 1 inch. In accordance with some embodiments, the distance between at least a first elastic strand and a second elastic strand may be from about 3 to 100 mm, optionally from about 5 to 50 mm, and optionally about 25 mm.

[0075] In accordance with some embodiments, the gasket material may include one or more elastic strands, wherein when the gasket section is worn by the wearer, at least a portion of the elastic strands extends transversely with respect to the length of the appendage. In some non-limiting examples, the gasket material may include one or more elastic strands spaced substantially uniformly transversely with respect to the length of the appendage when the gasket section is worn by the wearer. In accordance with some embodiments, the gasket material may include from 1 to 10 elastic strands, optionally from about 4 to 7, and optionally 5 or 6. In accordance with some embodiments, the gasket material may include 1 strand, optionally 2 strands, optionally 3 strands, optionally 4 strands, optionally 5 strands, optionally 6 strands, optionally 7 strands, optionally 8 strands, optionally 9 strands, and optionally 10 strands.

[0076] In accordance with some embodiments, the gasket material may include a first portion of an elastic strand that extends transversely or substantially transversely with respect to the length of the appendage and a second portion of an elastic strand that extends longitudinally or substantially longitudinally with respect to the length of the appendage when the gasket section is worn by the wearer, thereby forming a web of elastic strands.

[0077] In accordance with some embodiments, the gasket material can have a second thickness that is greater than the thickness of the cuff material. For example, the gasket material can have a thickness of from about 1 to 20 mm, optionally from about 5 to 15 mm, and optionally from about 7.5 to 12 mm. In accordance with some embodiments, the gasket material can have a second thickness that is greater than the thickness of the cuff material. For example, the gasket material can have a thickness of from about 1 to 10 mm, and optionally from about 1 to 5 mm. In some instances, the gasket material can have a thickness of at least about 4 mm, optionally at least about 4.5 mm, optionally at least about 5 mm, optionally at least about 5.5 mm, optionally at least about 6 mm, optionally at least about 6.5 mm, optionally at least about 7 mm, optionally at least about 7.5 mm, optionally at least about 8 mm, optionally at least about 8.5 mm, optionally at least about 9 mm, optionally at least about 9.5 mm, optionally at least about 10 mm, optionally at least about 10.5 mm, optionally at least about 11 mm, and optionally at least about 11.5 mm. In accordance with some embodiments, the gasket material is configured to be wound within an elastic ring disposed on the forearm at a position distal to the edge of the glove and proximal to the wearer's wrist to create an additional thickness of up to 25 mm.

[0078] In accordance with some embodiments, the gasket material can include a gathered material as described herein.

[0079] In accordance with some embodiments, the gasket material can be easily compressible. As used herein, the term "easily compressible" refers to a material configured to have a first thickness and a second thickness upon compression, where the second thickness is different from the first thickness. In accordance with some embodiments, the compression can refer to the approximate compressive force provided by the edge of the glove when worn by the wearer.

[0080] According to some embodiments, a material that can be easily compressed can be a material that exhibits a specific change in thickness upon compression, i.e., a specific difference between a first thickness and a second thickness as described herein. In one non-limiting example, a device such as a caliper may be used to measure the change in thickness. Non-limiting examples of calipers useful for measurements according to the present disclosure include the Ames model AQD-2110N gauge that uses a 1-inch diameter foot. According to some embodiments, the first thickness of the material may be measured using a caliper with a first pressure applied thereto, and the second thickness thereof may be measured using a caliper having a second pressure applied thereto. According to some embodiments, the first pressure may correspond to the use of a caliper without an additional weight added thereto, and the second pressure may be provided by adding a weight to the caliper. In some non-limiting examples, the weight can be about 0.01 to 1 pound, optionally about 0.25 to 0.75 pound, and optionally about 0.5375 pound. For the purposes of this application, the conversion of 1 pound is 453.6 grams.

[0081] According to some embodiments, a material that can be easily compressed can be a material that exhibits a thickness change of at least about 30%, optionally at least about 40%, optionally at least about 50%, optionally at least about 55%, optionally at least about 60%, optionally at least about 65%, optionally at least about 70%, and optionally at least about 75% upon compression as described herein. According to some embodiments, a material that can be easily compressed can be a material that exhibits a thickness change of about 20% to 90%, optionally about 30% to 80%, and optionally about 40% to 70% upon compression.

[0082] In accordance with some embodiments, the gathered material may exhibit a change in thickness when compressed by the edge(s) of one or more gloves such that a channel is formed in the gathered material proximal to the edge(s) of the one or more gloves. For example, a barrier sleeve having a gasket section as described herein extends from a first end to a second end along the longitudinal direction of the length of the wearer's arm when worn, and when the wearer wears one or more gloves over the barrier sleeve, proximal to the edge(s) of the glove(s) (e.g., along the outer periphery of a cylindrical gasket section) that are substantially transverse (i.e., lateral) to the length dimension to form one or more channels, the gathered material may be configured to be compressed. In accordance with some embodiments, one or more channels may be sufficient to engage the edge(s) of the one or more gloves such that ingress of fluid towards the cuff section is precluded or reduced. Additionally or alternatively, one or more channels may be sufficient to engage the edge(s) of the one or more gloves such that curling of the edge(s) of the one or more gloves is precluded.

[0083] In accordance with some embodiments, the barrier sleeve may further include a bellows section. The bellows section may be configured to be worn over the wearer's arm, such as around the wearer's forearm. The bellows section may have a first end and a second end, and the first end may be attachable to and / or attached to the second end of the gasket section as described herein.

[0084] In accordance with some embodiments, the bellows section can have an outer perimeter and / or diameter that is greater than the outer perimeter and / or diameter of the gasket section. The bellows section can have a substantially constant outer perimeter and / or diameter. Alternatively, the bellows section can have an outer perimeter and / or diameter that varies along its length. For example, the bellows section can have an outer perimeter and / or diameter at a first end that is substantially equal to the outer perimeter and / or diameter at a second end of the gasket section. In this example, the outer perimeter and / or diameter of the bellows section can increase along the length of the bellows section towards the second end to form the shape of the bellows.

[0085] In accordance with some embodiments, the bellows section can include a bellows material. Examples of bellows materials useful in accordance with the present disclosure include, but are not limited to, nonwoven materials and stretchable materials as described herein. For example, the bellows material can include one or more nonwoven materials as described herein, such as a nonwoven material including a polyolefin. In accordance with some embodiments, the bellows material can include one or more layers of a spunbond material, a meltblown material, and / or an SMS laminate material. In accordance with some embodiments, the bellows material can include one, two, three, four or more layers of a material as described herein, where each layer can include the same or a different material than another layer. Further or alternatively, the bellows material can include one or more stretchable strands as described herein.

[0086] According to some aspects, the bellows section is attachable to and / or attached to the gasket section by any mechanism as described herein. Alternatively, the bellows section and the gasket section may include separate materials such that an attachment mechanism is not necessarily required. For example, the bellows section and the gasket section may include one or more layers of materials as described herein, and the one or more layers form at least a portion of the bellows section and at least a portion of the gasket section. In one non-limiting example, the bellows section and the gasket section may include one or more layers of an SMS laminate material as described herein. In this example, the gasket section may include one or more stretchable strands as described herein to provide a gasket material with gathers. The bellows section may also include stretchable strands, or the bellows section may not include stretchable strands such that the bellows material does not have gathers.

[0087] In accordance with some aspects, a barrier sleeve as described herein can be used with a corresponding sleeve portion of a gown. In accordance with some aspects, the gown is a protective gown, also referred to as a medical gown. As used herein, the term "medical gown" refers to a gown that can be used in a medical environment. Examples of medical gowns in accordance with the present disclosure include, but are not limited to, surgical gowns, isolation gowns, and those used in a hospital's central sterilization department where used reusable surgical instruments are manually disinfected at a sink before being placed in an automated washer, and non-surgical gowns used in a hazardous chemical environment with a high fluid exposure risk. Examples of medical environments include, but are not limited to, hospitals, clinics, blood banks, hospices, imaging and radiation centers, nursing homes, rehabilitation centers, and emergency centers. In accordance with some aspects, the gown is an industrial gown. As used herein, the term "industrial gown" refers to a gown that is used in a potentially hazardous industrial environment, such as an industrial environment that can be exposed to hazardous chemicals.

[0088] In accordance with some aspects, a medical gown as described herein meets the required performance standards as outlined in ASTM F2407 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities, and for medical gowns, but not limited to, tensile strength (e.g., ASTM D5034, ASTM D1682), tear resistance (e.g., ASTM D5587 (woven fabric), ASTM D5733 (non-woven fabric), ASTM D1424), seam strength (e.g., ASTM D751 (stretch woven or knit)), and for woven and non-woven materials ASTM D1683 / D1683M, lint generation (e.g., ISO 9073 part 10), abrasion resistance ASTM D4966, water vapor transmission (e.g., ASTM F1868 part B, ASTM D6701 (non-woven fabric), ASTM D737-75, ASTM E96 / E96M, ASTM F1249) performance standards or combinations thereof. Additionally or alternatively, it may meet the requirements of level 1, level 2, level 3, or level 4 of ANSI / AAMI PB 70. In one non-limiting example, the medical gown may meet the level 4 requirements of ANSI / AAMI PB 70 (i.e., ASTM F1670 and ASTM F1671). Additionally or alternatively, the medical gown may meet one or more requirements regarding virus penetration as specified by ASTM F1671. It should be understood that all performance requirements referred to herein are hereby incorporated by reference in their entirety.

[0089] According to some aspects, at least a portion of the protective gown may include a gown material having a low basis weight. For example, one or more of the sleeve portions may include a gown material having a basis weight low enough to provide acceptable drapability, i.e., the ability to conform to the surface shape. As used herein, "acceptable drapability" may refer to a drapability sufficient to provide one or more functions as described herein, such as providing one or more lateral channels at and around the glove / gown interface, as would be described in connection with a barrier sleeve. It should be understood that a gown material having a lower basis weight and / or higher drapability may be more easily formed into channels than, for example, a gown material that is stiffer and / or less drapable.

[0090] Non-limiting examples of gown materials useful in accordance with the present disclosure include laminates having a discontinuous bond. As used herein, a laminate having a "discontinuous bond" refers to a laminate in which less than 100% of the surface area of the laminated layers is bonded. For example, a laminate having a discontinuous bond may include two or more layers bonded through a thermally patterned calendar bond, a patterned hot melt spray, or a combination thereof. According to some aspects, the laminate may include one or more layers of a monolithic film, a nonwoven material, or a combination thereof.

[0091] In some non-limiting examples, the gown material may have a basis weight of from about 25 to 90 gsm, optionally from about 30 to 85 gsm, and optionally from about 34 to 75 gsm, including any value therebetween.

[0092] The medical gown according to the present disclosure may be a single-use gown or a multi-use gown. In some non-limiting examples, the multi-use gown may include a woven material sufficient to be laundered, as known in the art.

[0093] In some embodiments, the barrier sleeve can be used with a protective gown that can be used in any situation where the wearer of the gown should be protected from external environments or contaminants associated therewith and / or the external environment should be protected from contaminants that the wearer can introduce into the external environment.

[0094] In accordance with some embodiments, at least a portion of the barrier sleeve is configured to be worn by a user under the sleeve portion of a medical gown. As used herein, the term "under" refers to a position proximal to the wearer's arm. In one example of the aforementioned sealing interaction (also referred to as a sealing engagement), the edge of the stretch glove engages (e.g., can be maintained within or otherwise retained in a tethered manner in) a lateral channel formed in the gasket section through its compression, as described herein. The engagement interaction does not require the edge of the glove to directly contact the gasket section (e.g., the sleeve portion of the medical gown may be sandwiched therebetween). The engagement interaction can provide a sealing interaction with one or more additional layers between the channel of the gasket section and the edge of the glove such that the ingress of fluid towards the cuff section is precluded or reduced.

[0095] In one preferred example, the gasket section may be worn by a user under the gown sleeve, and the edge of the stretch glove may be maintainably retained within one or more channels formed in the gasket section as described herein, and a portion of the gown sleeve may also be maintainably retained between the edge of the glove and the gasket section. Thus, in the aforementioned example, the gasket section provides a seal or partial seal between the edge of the glove and the gown sleeve so as to reduce and / or preclude the ingress of fluid towards the cuff section. In some examples where fluid can ingress at the edge(s) of the glove, the gasket section can substantially or completely fill the space in the forearm region sufficient to reduce the flow of fluid between the glove and the gown down towards the wearer's hand.

[0096] Additionally or alternatively, the barrier sleeve can be configured such that if fluid breaches the gasket section as described herein, the cuff section can protect the hand from fluid exposure.

[0097] FIG. 1 shows an example 101 of a sleeve portion of a medical gown as described herein. The sleeve portion 101 can have a first outer perimeter 117, as is known in the art. For example, the sleeve portion 101 can have a relatively large first outer perimeter 117 such that the sleeve portion 101 is relatively oversized with respect to the wearer's arm (i.e., not sized to remain in contact with the wearer's arm during use). In some non-limiting examples, the sleeve portion of the medical gown can have a first outer perimeter that is about 10-20 inches, optionally about 15-21 inches, and optionally about 16-18 inches when measured 9 inches from the end of the gown sleeve.

[0098] As shown in FIG. 1, the sleeve portion 101 can have an outer perimeter that varies along its length. For example, the sleeve portion 101 can have a first outer perimeter 117 that is generally proximal to the bellows section 105 as described herein. It should be understood that the first outer perimeter 117 can be slightly smaller than the outer perimeter of the bellows section 105 at the second end 115 such that when the bellows section 105 and the sleeve portion 101 are attached to each other, the bellows section 105 does not pull so hard during donning that it cannot accommodate the sleeve portion 101.

[0099] Furthermore or alternatively, the sleeve portion may have a second outer perimeter 118 and / or a third outer perimeter 119 that are different from the first outer perimeter 117. In this example, the second outer perimeter 118 may be substantially proximal to the gasket section 104 as described herein, and the third outer perimeter 119 may be substantially proximal to the cuff section 103 as described herein. The second outer perimeter 118 may be about 10 to 20 inches, optionally about 10 to 15 inches, and optionally about 12 to 14 inches. The third outer perimeter 119 may be about 5 to 20 inches, optionally about 10 to 15 inches, and optionally about 11 inches.

[0100] FIG. 1 also shows an example of a barrier sleeve 102 having a cuff section 103, a gasket section 104, and a bellows section 105 as described herein. As shown in FIG. 1, the barrier sleeve 102 may be reversibly or permanently attached to the sleeve portion 101. For example, the bellows section 105 may have a second end 115 that can be attached directly or indirectly to the inner surface of the sleeve portion 101 and / or is attached as shown in FIG. 1. In accordance with some embodiments, the sleeve portion 101 may not include structural attachment components, i.e., components that are provided to facilitate attachment of the barrier sleeve 102 to the sleeve portion. Structural attachment may include, for example, flaps, tabs, and / or other appendages that would not be provided on a sleeve portion that does not include the barrier sleeve 102.

[0101] In accordance with some embodiments, the second end 115 of the nozzle section 105 may be attached to the inner surface of the sleeve portion 101 through permanent adhesion, as described herein. In some non-limiting examples, permanent adhesion may include hot melt. In this example, a portion 120 of the nozzle section 105 having a specific length in the longitudinal direction may be attached to the inner surface of the sleeve portion 101 by applying a hot melt spray onto the portion 120 of the nozzle section 105. In accordance with some embodiments, the length of the portion 120 may be about 0.1 - 1 inch, optionally about 0.25 - 0.75 inch, and optionally about 0.5 inch. Additionally or alternatively, the hot melt spray may be applied to the corresponding portion of the inner surface of the sleeve portion 101, and the two portions may be pressed together to form a permanent adhesion. However, it should be understood that the present disclosure is not necessarily limited to this method. For example, a portion 120 of the nozzle section 105 and the corresponding portion of the inner surface of the sleeve portion 101 may be attached through any permanent adhesion as described herein, including thermal bonding, ultrasonic bonding, or a combination thereof.

[0102] In one non-limiting example, first, a portion 120 of the nozzle section 105 may be attached to the inner surface of the sleeve portion 101 by providing the sleeve portion 101 on the back side on a support such that the inner surface of the sleeve portion 101 is exposed. Then, the nozzle section 105 may be provided on the sleeve portion 101, and at least a portion 120 of the nozzle section 105 may be folded and / or rolled up. Then, a hot melt spray may be applied, optionally with rotation of the support, to the inner surface of the sleeve portion 101 and / or the folded and / or rolled portion 120 of the nozzle section 105. Then, the folded and / or rolled portion 120 of the nozzle section 105 may be unfolded and / or unrolled to contact the inner surface of the sleeve portion 101, and then the portion 120 of the nozzle section 105 and the inner surface of the sleeve portion 101 may be pressed together to provide a permanent adhesion.

[0103] In another non-limiting example, to provide a permanent adhesion having the characteristics of a single nonwoven layer, a portion 120 of the bellows section 105 and the inner surface of the sleeve portion 101 may be adhered by ultrasonic bonding.

[0104] As shown in FIG. 1, at least a portion of the barrier sleeve 102 may not be attachable to and / or may not be attached to the sleeve portion 101. For example, the second end 106 of the gasket section 104 may be provided at the first end 116 of the bellows section 105, where the gasket section 104 is not otherwise connected to the sleeve portion 101. Further, as shown in FIG. 1, the gasket section 104 may have a second outer perimeter and / or a second diameter as described herein, where the second outer perimeter and / or the second diameter is shorter than the second outer perimeter 118 of the sleeve portion 101. In this way, the sleeve portion 101 is able to move freely with respect to the gasket section 104, and vice versa.

[0105] As shown in FIG. 1, the gasket section 104 may have a first end 107 at the second end of the cuff section 103 as described herein. In this example, the cuff section 103 may be attachable to and / or may be attached to the sleeve portion 101. For example, as shown in FIG. 1, the cuff section 103 may be attachable to and / or may be attached to the inner edge surface 108 of the sleeve portion 101 by any attachment mechanism as described herein. In accordance with some embodiments, the cuff section is attachable to and / or is attached to the inner edge surface of the sleeve portion sufficiently to avoid holes in the sleeve portion and / or the cuff portion and thus maintain the barrier properties of the medical gown.

[0106] It should be understood that the cuff section 103 may be attachable to and / or may be attached to the sleeve portion 101 at any position of the cuff section 103. For example, as shown in FIG. 1, the cuff section 103 may be attachable to and / or may be attached to the sleeve portion 101 at a first distance 110 from a first end 109 of the cuff section 103. It should be understood that the first distance 110 is not particularly limited. In some non-limiting examples, the first distance 110 may be about 1 to 10 inches, optionally about 1 to 5 inches, and optionally about 3 inches.

[0107] As shown in FIG. 1, when the cuff section 103 is attachable to and / or is attached to the inner edge surface 108 of the sleeve portion 101 at a first distance 110 from a first end 109 of the cuff section 103, the cuff section 103 will, as shown, include an exposed portion 111 and a non-exposed portion 112. In this example, the exposed portion 111 has a length equal to the first distance 110, while the non-exposed portion 112 will have a length equal to a second distance 113 corresponding to the distance between the second end 114 of the cuff section 103 and the attachment point of the cuff section 103 to the inner edge surface 108 of the sleeve portion 101. In some non-limiting examples, the second distance 113 may be about 1 to 10 inches, optionally about 1 to 5 inches, and optionally about 2 inches.

[0108] As shown in FIG. 1, barrier sleeve example 102, as described herein, includes a cuff section 103, a gasket section 104, and a handle section 105. However, it should be understood that the barrier sleeves of the present disclosure are not necessarily limited to this figure. For example, a barrier sleeve may include only one or two of the sections described herein, such as only the cuff section 103, only the exposed cuff section 111, only the gasket section 104, or only the handle section 105. In another example, a barrier sleeve may include only the handle section 105 and the cuff section 103, where the second end 114 of the cuff section is provided at the first end 116 of the handle section 105. In another example, a barrier sleeve may include only the gasket section 104, which may or may not be attachable to the sleeve portion 101 and / or may or may not be attached.

[0109] Furthermore or alternatively, barrier sleeve example 102 shown in FIG. 1 is attachable to and / or attached to the sleeve portion 101 at the second end 115 of the handle section 105 and at the cuff section 103. However, it should be understood that the present disclosure is not necessarily limited to this manner. For example, barrier sleeve 102 may be attachable to and / or attached to the sleeve portion 101 only at the second end 115 of the handle section 105 or only at the cuff section 103, as shown. Furthermore or alternatively, the sleeve portion 101 may be attachable to and / or attached to the handle section 105 at a specific distance from its second end 115. Alternatively, barrier sleeve 102 may not be attachable to and / or not attached to the sleeve portion 101 at all and may be presented as a "stand-alone" medical device. In this example, the handle section may be used by the wearer to aseptically don and doff the stand-alone device.

[0110] Furthermore or alternatively, the barrier sleeve example 102 shown in FIG. 1 can be attached to and / or is attached to the sleeve portion 101 over the entire outer periphery of both the barrier sleeve 102 and the sleeve portion 101. However, it should be understood that the present disclosure is not necessarily limited to this method. For example, only a part of the outer periphery of the second end 115 of the bellows section 105 can be attached to and / or may be attached to the inner surface of the sleeve portion 101. Furthermore or alternatively, only a part of the outer periphery of the cuff section 103 can be attached to and / or may be attached to the sleeve portion 101.

[0111] FIG. 4 shows a photograph of a barrier sleeve example 402 described in connection with FIG. 1 with similar features as shown in FIG. 1, including a cuff section 403 having a first end 409 and a second end 414, a gasket section 404 having a first end 407 and a second end 406, and a bellows section 405 having a first end 416 and a second end 415.

[0112] A barrier sleeve according to the present disclosure is configured to provide a reduction in fluid transfer between the wearer and the external environment. As used herein, "fluid" refers to any fluid that can be found in a medical setting, including but not limited to body fluids (e.g., blood, sweat, urine), medical fluids (e.g., sterile fluids, intravenous fluids), etc.

[0113] According to some embodiments, fluid transmission reduction can be at least partially achieved by reducing or eliminating the path of fluid drainage and / or entry when compared to a medical gown used without a barrier sleeve as disclosed herein. For example, a medical gown used without the barrier sleeve of the present disclosure, when used in combination with a medical glove as known in the art, can provide fluid drainage and / or entry at or near the glove / gown interface due to glove slippage, riding up, and / or folding during use. The barrier sleeve according to the present disclosure can also at least partially reduce or eliminate the presence of such slippage, riding up, and / or folding by means of a gasket material as described herein. Without wishing to be limited by theory, the gasket material according to the present disclosure can provide sufficient friction at and around the glove / gown interface to reduce or eliminate glove slippage, riding up, and / or folding. Additionally or alternatively, the gasket material described in the present disclosure can provide one or more lateral channels at and around the glove / gown interface as described herein that are sufficient to reduce or eliminate glove slippage, riding up, and / or folding. The present disclosure describes medical gloves, but it should be understood that other types of gloves, such as industrial gloves (i.e., gloves used in potentially hazardous industrial environments), may also be used.

[0114] In another example, a medical gown used without the barrier sleeve of the present disclosure, when used in combination with medical gloves as known in the art, can provide a vertical or substantially vertical fluid channel at the glove / gown interface by a gown material with loose gathers proximal to the edge of the glove. The barrier sleeve according to the present disclosure can at least partially reduce or eliminate the presence of such vertical fluid channels at the glove / gown interface by a gasket material as described herein. Without wishing to be limited by theory, the gasket material according to the present disclosure can provide sufficient volume and / or friction at the glove / gown interface to reduce or eliminate the presence of such vertical fluid channels as described herein. In an example where the gasket material is an easily compressible gathered gasket material as described herein, the gasket section can include at least one channel that is transverse or substantially transverse to the length or vertical direction of the gasket section (e.g., a channel extending along the outer periphery of a tubular gasket section). When used in combination with medical gloves as known in the art, the edge of the medical glove can create at least one channel in the gathered gasket material when the glove is pulled over the gathered gasket material as described herein. In this way, vertical or substantially vertical fluid channels that would otherwise be formed at the glove / gown interface can be reduced or eliminated.

[0115] In one example, a vertical or substantially vertical channel formed by an oversized gown sleeve that is cinched or otherwise tightened is interrupted or otherwise blocked by the edge of a stretchable glove that engages (e.g., is maintainably held therein) with a compressible gasket section that is also maintainably held between the edge of the glove and the gasket section.

[0116] In accordance with some embodiments, a barrier sleeve according to the present disclosure does not require any additional donning or doffing steps compared to steps known in the art for donning and doffing medical gowns and medical gloves, also referred to herein as conventional donning or doffing steps. That is, the barrier sleeve, medical gown, and / or system including them can be configured such that donning and / or doffing of the barrier sleeve, medical gown, and / or system is substantially the same as donning and / or doffing of a medical gown without a barrier sleeve. For example, donning a medical gown having a barrier sleeve according to the present disclosure may not require additional folding, lifting, and / or rolling-up steps that may be required for donning or doffing a similar medical gown that does not include a barrier sleeve as described herein. In accordance with some embodiments, non-conventional donning and / or doffing steps may include steps not described in AORN Guidelines for Perioperative Practice: Sterile Technique, published May 27, 2020, the entire contents of which are incorporated herein by reference, for example.

[0117] In accordance with some embodiments, all or a portion of a barrier sleeve, medical gown, and / or medical glove as described herein may be sterilized by a sterilization process known in the art. Examples of sterilization processes include, but are not limited to, ethylene oxide (EO) sterilization, gamma irradiation, e-beam irradiation, STERRAD® and dry or steam heat.

[0118] According to some aspects, all or part of the barrier sleeve and / or the interface between the barrier sleeve and the gown, and the gown having a barrier sleeve as described herein, can meet one or more performance standards including, but not limited to, tensile strength (e.g., ASTM D5034, ASTM D1682), tear resistance (e.g., ASTM D5587 (woven fabric), ASTM D5733 (non-woven fabric), ASTM D1424), seam strength (e.g., ASTM D751 (stretch woven fabric or knit)), lint generation (e.g., ISO 9073 part 10), abrasion resistance (e.g., ASTM D4966), water vapor transmission (e.g., ASTM F1868 part B, ASTM D6701, ASTM E96 / E96M, ASTM D737-75) or a combination thereof. Further or alternatively, all or part of the barrier sleeve and / or the interface between the barrier sleeve and the gown, and the gown having a barrier sleeve as described herein, can meet the requirements of level 1, level 2, level 3, or level 4 of ANSI / AAMI PB 70. Further or alternatively, all or part of the barrier sleeve and / or the interface between the barrier sleeve and the gown, and the gown having a barrier sleeve as described herein, can meet one or more requirements regarding virus penetration as specified by ASTM F1671.

[0119] The present disclosure also relates to a system including a barrier sleeve as described herein. According to some aspects, the system can include a medical gown and a barrier sleeve or a part thereof as described herein.

[0120] For example, FIG. 2 shows a medical gown 201 having a body portion 202, a first arm portion 203, and a second arm portion 204. At least one of the first arm portion 203 and the second arm portion 204 may include a barrier sleeve attached thereto, as described herein. Alternatively, the system may include a medical gown and a barrier sleeve attachable thereto, and the barrier sleeve may or may not be attached to the medical gown. According to some aspects, the system may include only a portion of the barrier sleeve as described herein. For example, the system may include only a cuff section as described herein, only a gasket section as described herein, and / or only a bellows section as described herein, of a medical gown as described herein. In another non-limiting example, the system may include only a portion of a medical gown, and a cuff section, a gasket section, and / or a bellows section, as described herein. For example, FIG. 5 shows a sleeve portion example 501 of a medical gown similar to the sleeve portion 101 shown in FIG. 1. In this example, the system may include only the exposed portion 511 of the cuff section as described in connection with FIG. 1, and the exposed portion 511 has a first end 5000 and a second end 5001 attached to the sleeve portion 501.

[0121] Systems in accordance with the present disclosure may further include medical gloves as described herein. As used herein, the term "medical glove" refers to a glove suitable for use in a medical setting as described herein. In accordance with some aspects, the medical glove may include any glove material useful in the art, including but not limited to natural rubber and / or synthetic elastomers. Non-limiting examples of natural rubber include para rubber (hevea) rubber latex and guayule rubber latex, and any other natural rubber known in the art. Non-limiting examples of synthetic rubber include polyisoprene, polychloroprene, polyurethane, polybutadiene, nitrile, styrene butadiene rubber, block copolymers of styrene and butadiene, block copolymers of styrene and isoprene, mixtures of these elastomers and vinyl, etc. Other synthetic rubbers that can be used include acrylic diene block copolymers, acrylic rubber, butyl rubber, EPDM rubber, chlorosulfonated polyethylene rubber, and fluororubber. Examples of glove materials useful in accordance with the present disclosure include those described in U.S. Patent No. 10,647,886, the entire contents of which are incorporated herein by reference.

[0122] Figure 3 shows an example of a medical glove useful in accordance with the present disclosure. As shown in Figure 3, glove 300 may include one or more finger portions 301, a palm portion 302, a cuff portion 303, and an edge 304. It should be understood that edge 304 may be a part of glove 300 proximal to the cuffed portion 303 that is rolled as known in the art. However, it should be understood that the medical glove is not particularly limited in this manner, and any means for forming an edge as known in the art may be provided.

[0123] In accordance with some aspects, the edge 304 can be configured to provide a reduction in fluid transfer between the wearer and the external environment when used with one or more other components of a system as described herein. For example, by providing an edge having a particular thickness 305 (e.g., the diameter of the rolled portion), it has been found that a reduction in fluid transfer can be achieved when used in combination with one or more other components of a system as described herein. In some non-limiting examples, the edge can have a thickness of at least about 2 mm, optionally at least about 2.5 mm, optionally at least about 3 mm, optionally at least about 3.5 mm, and optionally at least about 4 mm. In some non-limiting examples, the edge can have a thickness of about 2 mm, optionally about 2.5 mm, optionally about 3 mm, optionally about 3.5 mm, and optionally about 4 mm. It should be understood that a system as described herein can include a single pair of gloves or a double pair of gloves, where each glove can independently have the same edge thickness or a different edge thickness from another glove in the system. In the case of a double pair of gloves, it should be understood that two gloves can be worn on each hand. In this example, the edges of each glove can be substantially aligned with the edges of another glove on the same hand. Alternatively, as is known in the art, the edge of the outer glove can be provided proximal (i.e., closer to the body) to the edge of the inner glove on the wearer's forearm. Further, when two gloves can be worn on each hand, the edges of each glove can have substantially the same thickness as the edges of another glove on the same hand. Alternatively, the edge of the outer glove can be thicker than the edge of the inner glove, as is known in the art.

[0124] In accordance with some embodiments, the edge can be configured to engage and interact in a sealing relationship with one or more components of the system, such as a gasket section as described herein, such that the ingress of fluid towards the cuff section is reduced. For example, when provided with a gasket section having a gathered gasket material as described herein, the edge of the glove can be configured to be pushed down into the gathered gasket material to form one or more channels that are substantially transverse (e.g., along the outer periphery of a cylindrical gasket section) to the dimension of the length of the gasket section, such that when worn by a user, the edge of the glove will interact in a sealing relationship with the gasket section as described herein. In the case of a system that includes more than one pair of gloves, the gloves may be worn in a layered arrangement, where it should be understood that the edge of the outer glove of each pair of gloves is substantially proximal to the edge of another glove in the layered arrangement, as is known in the art. The edge of the glove may be arranged to roll outwardly or inwardly towards the skin when worn.

[0125] According to some aspects, the system can include all three of a barrier sleeve, a medical gown, and one or more medical gloves as described herein. In this example, the system can be configured for use in a medical setting as known in the art. For example, the system can be configured such that a wearer dons a medical gown having a barrier sleeve attached thereto, and subsequently dons one or more medical gloves (including a single glove on each hand and / or two gloves on each hand in a double - layer arrangement) on each hand such that the medical glove(s) overlap at least a portion of the sleeve portion of the medical gown and / or at least a portion of the barrier sleeve as described herein. The system can be configured such that no additional steps are required as compared to steps known in the art for donning a medical gown and medical gloves. For example, donning a medical gown having a barrier sleeve attached thereto and / or donning a medical glove as described herein may not require additional folding, lifting, and / or rolling - up steps that may be required for donning or removing a similar medical gown and / or medical glove not provided as part of the system as described herein.

[0126] According to some aspects, all or a portion of the system may be sterilized by a sterilization process as described herein. It should be understood that the components of the system may be sterilized together and / or one or more of the components of the system may be sterilized individually. In one non - limiting example, a medical gown provided with a gasket section as described herein may be sterilized within a transfer wrap inside a vented bag.

[0127] In accordance with some embodiments, all or a portion of the system may be single-use. Alternatively, one or more parts of the system may be individually reusable multiple times. In one non-limiting example, the system may include a reusable gown and one or more single-use gasket sections, as described herein.

[0128] Also included are methods of making and using the barrier sleeves, medical gowns, and / or systems described herein. In one non-limiting example, the method may include providing a barrier sleeve having a nozzle section, a gasket section, and a cuff section as described herein, and attaching at least one of the nozzle section and the cuff section to the inner surface of the sleeve portion of a medical gown as described herein.

[0129] Figures 6A - 6G show non-limiting embodiments of a method of making a medical gown sleeve having a barrier sleeve attached to a medical gown sleeve as described herein. In particular, Figure 6A shows a generally trapezoidal component 601 for forming an arm portion of a medical gown as described herein. As shown in Figure 6A, the method may include attaching a flap portion 602 to the component 601 at a first distance 605 from an end of the component 601. The first distance 605 may be, for example, about 5 - 12 inches, optionally about 6 - 12 inches, and optionally about 8 - 9 inches. In accordance with some embodiments, the flap portion 602 may be attached to the component 601, for example, through a seal 603 as described herein. Figure 6A shows that the flap portion 602 may have two unsealed portions 604a, 604b that are not attached to the component 601. The unsealed portions 604a, 604b may independently have a length of about 1 - 3 inches, optionally about 1.75 inches.

[0130] Figures 6B - 6D illustrate example steps for forming the arm portion of the medical gown from component 601 as shown in Figure 6A. For example, as shown in Figure 6B, the method may include folding component 601 in half along vertical axis 606. As shown in Figure 6C, the method may include folding one or both of unsealed portions 604a, 604b of flap portion 602. The method may then include connecting unjoined end 607 of component 601, for example, through seal 608. As shown in Figure 6C, seal 608 may optionally be provided at a specific distance 609 from proximal end 610 of component 601. Distance 609 may be about 0.01 - 2 inches, optionally about 1 inch. Additionally or alternatively, seal 608 may optionally be provided at a specific distance 611 from unjoined end 607. Distance 611 may be about 0.01 - 1 inch, optionally about 0.5 inch.

[0131] As shown in Figure 6D, the method may include connecting end 612 of flap portion 602 by any of the connecting mechanisms described herein, for example, by sewing through a seal and / or a surger. The portion of end 612 may then optionally be trimmed.

[0132] As shown in FIG. 6E, the method may include providing a barrier sleeve or a portion thereof 613, such as a bellows section 614 and a gasket section 615 as described herein. The method may include aligning the barrier sleeve or a portion thereof 613 with the flap portion 602, such as shown in FIG. 6F. It should be understood that if a portion 613 of the barrier sleeve does not include a cuff section 616, such as described herein, the method may include providing a cuff section 616 and aligning this portion with the gasket section 615 as shown in FIG. 6F. The method may further include connecting the bellows section 614 and the flap portion 602 and / or connecting the cuff section 616 and the gasket 615 by any connecting mechanism as described herein, such as by sewing through a seal and / or a surge, as shown in FIG. 6G. As shown in FIG. 6G, prior to attachment, a portion of the cuff section 616 may be folded to provide a double thickness section. The double thickness section may have a length of approximately 2 inches. In this manner, the end portion of the cuff section 616 may be reinforced as described herein. FIG. 6G also shows that any excess material may be removed. Although not shown, the arm portion 600 may then be inverted to provide an arm portion of a medical gown having a barrier sleeve attached to its inner surface as described herein.

[0133] The aspects described herein have been described in combination with the example aspects outlined above, but various alternatives, modifications, variations, improvements, and / or substantial equivalents may become apparent to at least the ordinary skilled person, whether known or currently not anticipated or not anticipatable. Accordingly, the example aspects shown above are intended to be illustrative and not limiting. Various changes may be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to include all known or later developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0134] Accordingly, the claims are not intended to be limited to the aspects shown herein, but rather are to be construed to cover the full scope consistent with the claim language, where references to singular elements are not intended to mean "one and only one" unless specifically so stated, but rather are intended to mean "one or more." All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be included within the claims. Further, nothing disclosed herein is intended to be dedicated to the public whether or not the disclosure is expressly recited in the claims. No claim element is to be construed as a means-plus-function element unless the element is expressly recited using the phrase "means for."

[0135] Furthermore, the word "example" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as an "example" is not necessarily considered to be preferred or favorable over other aspects. Unless expressly stated otherwise, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" include any combination of A, B, and / or C, and may include pluralities of A, pluralities of B, or pluralities of C. In particular, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any such combination may contain one or more members of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public whether or not the disclosure is expressly recited in the claims.

[0136] The following non-limiting examples illustrate specific embodiments of articles and processes as described herein. The examples are not intended to be an exhaustive coverage of the full scope of the articles and processes.

[0137] [Examples]

[0138] Example I: Preparation of the glove / gown interface

[0139] First, three medical gowns of the present invention having barrier sleeves as described herein were manufactured. Each barrier sleeve was formed of a cuff section, a gasket section, and a bellows section. The gasket section of each barrier sleeve was formed of two layers of non-woven material and an 1100 dtex stretch band between the layers of non-woven material. Each stretch band had an elongation percentage of 325%. Further characteristics of the gasket section were as shown in Table 1. [Table 1]

[0140] Using a 1-inch diameter measuring foot and a B.C. Ames model AQD-2110N caliper gauge, the compressibility of each gasket section was measured. Thickness measurements were taken with and without the addition of a 0.5375 lb weight. The measurement results are shown in Table 2. These measurements were made on the flattened cuff with respect to the two layers of gasket material. When making the measurements, the measuring foot was slowly lowered onto the flattened cuff to prevent compaction due to the foot rapidly dropping onto the surface. [Table 2]

[0141] Example II: Spray test at the glove / gown interface

[0142] First, four glove / gown interfaces were formed. As described in Test I, each interface included one of a comparison gown, Gown Example 1 of the present invention, Gown Example 2 of the present invention, and Gown Example 3 of the present invention. The comparison gown was identical to the gowns of the present invention except that it did not include a barrier sleeve as disclosed herein.

[0143] To form the glove / gown interfaces, the user first donned each gown and then, using traditional donning techniques, donned either a single medical glove or two medical gloves (double gloves) per hand, creating a glove / gown interface where the glove overlapped the sleeve portion of the gown. Each glove had a rim that was 2 mm, 3 mm, or 4 mm thick, as shown in Table 3 below. In the case of double gloves, the rim of the outer glove was proximal to the rim of the inner glove, as recommended for double gloves.

[0144] Next, each glove / gown interface was subjected to a 50 - second spray test. Specifically, after the user donned the gown and gloves (if any) as described above, the user then, through the opening, held the arm vertically, twisted the arm, moved the hand, and reached the gloved arm with respect to the simulated surgical movements. Here, a water / synthetic blood mixture was sprayed onto the gloved arm from above (i.e., proximal to the glove / gown interface) for 50 seconds. After spraying, if the user's hand and / or arm remained dry, the interface was considered to have passed the spray test. If it failed, the fluid breached the glove / gown interface, and as a result, reached the user's hand and / or arm. The test results are shown in Table 3 below.

Table 3

[0145] Example III: Immersion of the glove / gown interface

[0146] First, as described in Test II, four glove / gown interfaces were formed using a comparison gown, Gown Example 1 of the present invention, Gown Example 2 of the present invention, and Gown Example 3 of the present invention. Specifically, the user wore each gown and then, using traditional donning techniques, wore either a single medical glove or two medical gloves (double gloving) per hand, creating a glove / gown interface where the glove overlapped the sleeve portion of the gown. Each glove had a rim thickness of 2 mm, 3 mm, or 4 mm, as shown in Tables 4A and 4B below.

[0147] Next, a soak test was conducted by immersing the gloved hand and forearm into a 5-gallon bucket of water until water reached 3 inches above the glove / gown interface. The time it took for the water to reach the user's hand was then measured. The hand was not moved and the arm was not twisted during the soak. The results are shown in Tables 4A and 4B below.

Table 4A

Table 4B

[0148] Example IV: Wear Study

[0149] Sixteen participants wore a medical gown with a barrier sleeve as described herein (i.e., the sleeve of the present invention) and / or a medical gown without a barrier sleeve (i.e., a control sleeve). The sleeves were worn sequentially (i.e., first a medical gown with the sleeve of the present invention and then a medical gown with a control sleeve) or simultaneously (i.e., a medical gown with one sleeve of the present invention and one control sleeve). Each participant then placed a glove over the sleeve and performed normal laboratory and / or clinical activities for a period of 2 hours using each sleeve. After 2 hours, the distance 700 from the edge of the glove to the first end of the cuff section of the sleeve was measured as shown in FIG. 7.

[0150] Figures 8A and 8B show the results of the wear study. In particular, Figure 8A shows photographs of two control sleeves after 2 hours of wear. Figure 8B shows photographs of two sleeves of the present invention after 2 hours of wear. The sleeves of the present invention were determined to have an average distance 40% greater and show a statistically significant average difference. Further, the sleeves of the present invention show a standard deviation 26% lower compared to the control sleeves, indicating that among the participants, the sleeves of the present invention provide less variation in distance after wear.

Claims

Claim 1 A barrier sleeve that can be used with a protective gown, the barrier sleeve comprising: A tubular cuff section, including a cuff material, having a first end of the cuff section and a second end of the cuff section, said tubular cuff section; A tubular gasket section including a gasket material Including, The gasket section includes a first end of the gasket section at the second end of the cuff section and a second end of the gasket section; The gasket material includes a gathered material and / or an extensible material; The gasket material has a first thickness and is set to exhibit a thickness change of at least about 40% upon compression Said barrier sleeve. Claim 2 The barrier sleeve of claim 1, further comprising a bellows section having a first end of the bellows section at the second end of the gasket section and a second end of the bellows section. Claim 3 The barrier sleeve of claim 2, wherein the second end of the bellows section is connected to the inner surface of the sleeve portion of the protective gown. Claim 4 The barrier sleeve of claim 3, wherein the second end of the bellows section is thermally bonded to the inner surface. Claim 5 The barrier sleeve of claim 1, wherein the cuff material has a second thickness that is less than the first thickness. Claim 6 The gasket material of claim 1 is set to extend along the outer circumference of the gasket section upon a compressive force from the edge of a glove that is pulled over the gasket material of the protective gown and the sleeve portion, and to form at least one channel sufficient to provide a sealing engagement with the edge of the glove. Claim 7 The barrier sleeve of claim 6, wherein the sealing engagement is sufficient to pass a 50-second spray test. Claim 8 The barrier sleeve of claim 1, wherein the gasket material includes at least two layers of non-woven material having one or more elastic strands between the layers. Claim 9 The barrier sleeve of claim 8, wherein the non-woven material includes an SMS laminate material and / or a spunbond material. Claim 10 The barrier sleeve of claim 8, wherein the one or more elastic strands have a linear weight of at least 600 dtex. Claim 11 The barrier sleeve of claim 1, wherein a first end of the gasket section is attached to a second end of the cuff section through an adhesive, stitches, ultrasonic bonding, tape, sealing, or a combination thereof.

12. The barrier sleeve of claim 1, wherein the first thickness is at least about 7 mm.

13. A protective gown having a body portion, a first sleeve portion, and a second sleeve portion, A barrier sleeve attached to an inner surface of the first sleeve portion or the second sleeve portion, the barrier sleeve comprising: A tubular cuff section including a cuff material, having a first end of the cuff section attached to an inner surface of the first sleeve portion or the second sleeve portion, and a second end of the cuff section; the tubular cuff section A tubular gasket section including a gasket material, the gasket section including a first end of the gasket section at a second end of the cuff section and a second end of the gasket section, the gasket material including a gathered material and / or an extensible material, and the gasket material having a first thickness and being configured to exhibit a thickness change of at least about 40% upon compression; the tubular gasket section comprising the barrier sleeve and comprising a system.

14. The system of claim 13, further comprising a ladle section having a first end of the ladle section at a second end of the gasket section and a second end of the ladle section attached to the inner surface of the first sleeve portion or the second sleeve portion.

15. The system of claim 14, wherein the gasket section is not attached to the inner surface of the first sleeve portion or the second sleeve portion.

16. The system of claim 13, wherein the first thickness is at least about 4.5 mm.

17. The system according to claim 13, further comprising a glove having a rim of the glove, wherein when the rim of the glove is pulled over the gasket material and the first sleeve portion or the second sleeve portion, the gasket material is configured to form at least one channel sufficient to extend along the outer periphery of the gasket section against the compressive force from the rim of the glove and provide a sealing engagement with the rim of the glove.

18. The system according to claim 17, wherein the rim of the glove has a thickness of at least about 3 mm.

19. The system according to claim 13, wherein the gasket material comprises at least two layers of a non-woven material having one or more stretchable strands between the layers.

20. The system according to claim 13, wherein the first sleeve portion and the second sleeve portion do not include structural attachment components.

21. The system according to claim 13, wherein the system is configured such that donning and / or removing the system is substantially the same as donning and / or removing a protective gown without the barrier sleeve.

22. A protective gown having a body portion, a first sleeve portion, and a second sleeve portion, and a barrier sleeve attached to an inner surface of the first sleeve portion and / or the second sleeve portion comprising a system, wherein the barrier sleeve includes a tubular cuff section having a first end of a cuff section attached to the inner surface of the first sleeve portion and / or the second sleeve portion, and the cuff section comprises a cuff material comprising at least two layers of a non-woven material having one or more stretchable strands between the layers. said system.

23. A method of making a barrier sleeve having a gasket section, comprising: providing a gasket section having a gasket material with gathers, wherein the gasket material with gathers is capable of providing one or more stretchable strands in an extended position, attaching one or more stretchable strands in the extended position to one or more layers of a non-woven material, and shrinking one or more stretchable strands so that the one or more layers of non-woven material attached thereto have gathers. said method including said step.

24. A method of donning a system; Wearing a protective gown having a body portion, a first sleeve portion, a second sleeve portion, and a barrier sleeve attached to an inner surface of the first sleeve portion or the second sleeve portion, wherein the barrier sleeve is: A tubular cuff section, including a cuff material, having a first end of the cuff section attached to the inner surface of the first sleeve portion or the second sleeve portion and a second end of the cuff section, said tubular cuff section; A tubular gasket section including a gasket material, said gasket section including a first end of the gasket section at the second end of the cuff section and a second end of the gasket section, said gasket material including a gathered material and / or an extensible material, and said gasket material having a first thickness and being set to exhibit a thickness change of at least about 40% upon compression, said tubular gasket section Including; Said step; Wearing a glove having a glove edge such that the glove edge overlaps the first sleeve portion or the second sleeve portion having the barrier sleeve, wherein, upon a compressive force from the glove edge, the gasket material is configured to extend along the outer circumference of the gasket section and form at least one channel sufficient to provide a sealing engagement with the glove edge Said step; Including, said method.

Images